chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified patient of an unknown age and gender. The patient's medical history or concurrent conditions were not provided. In October 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). On 21-SEP-2015, the patient inadvertently received another dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were administered with an unspecified number of improperly stored doses of GARDASIL 9 injection (lot #L006547 with expiration date 04-MAR-2017, Lot# L014415 with expiration date 25-JUL-2017 and Lot# K026246 with expiration date 28-JAN-2017; strength, dose and route were not provided). There was no concomitant medication. It was unknown if the patients sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports received from the same reporter. Lot number L014415 has been verified to be valid lot number for GARDASIL 9. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site discolouration, Injection site mass
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old male patient without pertinent medical history, drug reactions or allergies. On 19-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9, 0.5 ml, (lot # and expiration date were not provided) which was administered intradermally instead of intramuscularly (incorrect route of drug administration). There was no concomitant medication. On 26-AUG-2015, the patient experienced injection site discoloration referred as skin discoloration and injection site mass referred as a lump at the injection site. The patient sought medical attention and WESTCORT cream 0.2% for 10 days was given as a treatment. No labs were performed. The outcome of injection site discoloration and injection site mass was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that since 08JUN2015, the patients were administered with an unspecified number of improperly stored doses of ROTATEQ oral liquid (lot # K015816 with expiration date 29MAY2016, lot # K013868 with expiration date 27MAY2016 and lot # K020182 with expiration date 25JUN2016; dose was not provided. There was no concomitant medication. It was unknown if the patients sought medical. Product quality complaint was not involved. No adverse experiences were reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report received from a healthcare worker refers to a patient of unknown demographics. No medical history was reported. On an unknown date the patient was vaccinated with an improperly stored  GARDASIL 9 (lot # L011846, expiry date: 16-JUN-2017, dose and route: unknown). No other concomitant therapy was reported. The outcome was unknown. This case is linked to cases: # 1509USA011272 and # 1509USA007856. (Same reporter link). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed mild case of shingles, which is being treated with VALTREX.
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report received from a health care worker refers to a patient of unknown demographics. No medical history was reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9 (lot # L011846, expiry date: 16-JUN-2017, dose and route: unknown) and (Merck) VARIVAX (lot # L007224, expiry date: 03-MAR-2017, dose and route: unknown). No other concomitant therapy was reported. The outcome of the event was unknown. This case is linked to cases: # 1509USA011273 and # 1509USA011272. (same reporter link). Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Crying, Decreased appetite, Pallor, Pyrexia, Rash erythematous
Clinical narrative: Pt had a low grade fever at exam on 9/21/15. She held her breath during vaccines, but was crying and alert when she left the office. Mom states sleepy and decreased appetite last night. This morning developed a flat, red, blanchable rash on face and torso and extremities.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Somnolence
Clinical narrative: Pt had a low grade fever at exam on 9/21/15. She held her breath during vaccines, but was crying and alert when she left the office. Mom states sleepy and decreased appetite last night. This morning developed a flat, red, blanchable rash on face and torso and extremities.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction, classic type started before 24 hours after shot and by 48 hrs was above shoulder joint and to elbow on shoulder (L). No fever, mildly tender, very hard, indurated, red.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. Since 07-JUL-2015, the patients were vaccinated with RECOMBIVAX HB lot # J009051, expiration date 26-MAR-2016 (route was not provided). Concomitant therapy information was not provided. Since 07-JUL-2015, there had been incorrect product storage as the multiple unspecified patients were given doses of improperly stored RECOMBIVAX HB. On 07-JUL-2015, the temperature excursion started. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Malaise, Myalgia
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself via Pfizer (MFR # 2015293612) on 10-SEP-2015. The patient's concurrent conditions included a bladder infection and sore throat. On 27-AUG-2015, also reported as several days ago, on this past Thursday, the patient was vaccinated with a PNEUMOVAX 23 (manufacturer unknown) (dose, route, lot No. and expiration date were unknown). Other suspect therapies included fluticasone for sore throat and macrobid for bladder infection (dose and frequency were not informed). On 29-AUG-2015, the patient experienced fatigue, loss of appetite, muscle aches, a little breathless, felt feverish and felt quite sick. The patient had not been noticed her physician about these adverse events still. At the time of this report, the outcome of fatigue, loss of appetite, muscle aches, a little breathless, felt feverish and felt quite sick was recovering. The reporter considered as related the relationship between the events and PNEUMOVAX 23 (manufacturer unknown). No product quality issue was involved. Additional information is not expected because the reporter declined to provide additional information for this report.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself via Pfizer (MFR # 2015293612) on 10-SEP-2015. The patient's concurrent conditions included a bladder infection and sore throat. On 27-AUG-2015, also reported as several days ago, on this past Thursday, the patient was vaccinated with a PNEUMOVAX 23 (manufacturer unknown) (dose, route, lot No. and expiration date were unknown). Other suspect therapies included fluticasone for sore throat and macrobid for bladder infection (dose and frequency were not informed). On 29-AUG-2015, the patient experienced fatigue, loss of appetite, muscle aches, a little breathless, felt feverish and felt quite sick. The patient had not been noticed her physician about these adverse events still. At the time of this report, the outcome of fatigue, loss of appetite, muscle aches, a little breathless, felt feverish and felt quite sick was recovering. The reporter considered as related the relationship between the events and PNEUMOVAX 23 (manufacturer unknown). No product quality issue was involved. Additional information is not expected because the reporter declined to provide additional information for this report.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Increase redness and pain on the injection site 5 days after administration.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a pharmacist referring to a 92 year old female patient with diabetes, only one kidney, and was allergic to unspecified SULFA products, iodine and penicillin. The patient had previous history of shingles. On 03-SEP-2015 the patient was vaccinated with ZOSTAVAX, lot # K026365, expiry date 15-MAR-2016, 0.65 ml, subcutaneous. Concomitant therapies included insulin, unspecified gout medication, and "other" unspecified medications. The pharmacist reported that the patient developed an "itchy" unspecified rash on her "waist area" after receiving ZOSTAVAX on 14-SEP-2015. No treatment was given for the event. None lab diagnostics studies were performed. The outcome of the event was reported as not recovered. The patient had called the pharmacist on the reporting day to report the event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-FEB-2015, 23-MAY-2015 and 09-JUL-2015, the patient was vaccinated with the first, second and third dose of GARDASIL (dose, lot# and route were unknown for all the three doses) respectively. On 12-SEP-2015 the patient was inadvertently vaccinated with the 4th dose of GARDASIL (lot 2, dose and route were unknown). No adverse effects reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Per patient: injection site was turning red and sore to the touch. Guest proceeded to the hospital 9/18/15 where she was prescribed KEFLEX.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a female patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On 18-SEP-2015, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23, which had expired on 16-AUG-2015 (administration route, dose and anatomical location and lot number were not provided). No concomitant therapies were reported. No adverse effects were noted and no product quality complaint was reported. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Activities of daily living impaired, Asthenia, Cold sweat, Dyspnoea, Feeling hot
Clinical narrative: At 2:00 approx while in school he reported nausea and feeling hot and weak; at 5:30 I observed patient to go white, diaphoretic, clammy, c/o of trouble breathing (though visibly breathing), headache, nausea, low grade fever 99.4 lasted all weekend. Cold sx next day. Missed school on Monday.
Age: 9.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Headache, Hyperhidrosis, Nasopharyngitis, Nausea, Pallor
Clinical narrative: At 2:00 approx while in school he reported nausea and feeling hot and weak; at 5:30 I observed patient to go white, diaphoretic, clammy, c/o of trouble breathing (though visibly breathing), headache, nausea, low grade fever 99.4 lasted all weekend. Cold sx next day. Missed school on Monday.
Age: 9.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: At 2:00 approx while in school he reported nausea and feeling hot and weak; at 5:30 I observed patient to go white, diaphoretic, clammy, c/o of trouble breathing (though visibly breathing), headache, nausea, low grade fever 99.4 lasted all weekend. Cold sx next day. Missed school on Monday.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Pain
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, referring to a currently 76 year old non pregnant female patient. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot# L011529, expiration date unknown) 0.65 ml, subcutaneous (route of administration were not reported). Concomitant medication was not reported. Within 24 to 48 hours after receiving ZOSTAVAX the patient experienced severe pain in her ears, which radiated up to her head. The patient was treated at an unspecified Emergency Room with unspecified medications. Ten days later, the patient was treated with unspecified medications for additional pain. The outcome and causality of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the pharmacy has been administering ZOSTAVAX (dose, route, lot number and expiry date) into the outer tricep area of the arm rather than the indicated deltoid (drug administered at inappropriate site) to an unspecified number of patients. No adverse effects reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Catarrh, Measles antibody positive, Mumps antibody test positive, Rash, Rubella antibody positive
Clinical narrative: C/o development of non pruritic rash 10 days following MMR vaccine - preceded by one day of catarrhal sxs. (no fever). Rash duration: 5 days; all symptoms resolved without treatment by 5-7 days.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot, Syncope
Clinical narrative: After Tdap administration few mins patient became dizzy and immediately fainted. I assisted her to the floor. She became verbally responsive after about 1 min. She was following commands. Elevated legs and placed cold compress to head. Rested on floor about 10 mins. then placed on exam table with fan and ice pack drinking water. For about 20 mins room was very hot.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: One raised lesion on left abdomen. Two raised lesions on right side of abdomen.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Eye movement disorder, Fall, Pallor, Syncope
Clinical narrative: Explain immunizations ordered by physician. Administer vaccine to (L) leg and then (R) leg. Next retrieve immunization record from printer return to room where mom reports patient fainted "fell back" in my arms. RN observes patient pallor with eye rolling assist to exam table give water and monitor. Patient resume behavior same as at the start of the visit.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site warmth, Pain
Clinical narrative: Was fine at first, within 24 hrs headachy, soreness. Within 48 hrs - soreness increased. Looked under left arm at injection site - red as apple, hot to touch, headache like none other and lump fist sized.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Folliculitis, Pruritus, Rash, Rash morbilliform, Rash papular
Clinical narrative: 9-10-15 presented with small bumps on legs with itching. Dx with folliculitis and tx with hydroxyzine, betamethasone valerate 0.1% cream and clindamycin phosphate 1% cream from Dr. 9-14-15 presents with worsening rash now small erythematous papules on trunk and extremities morbilliform on upper legs/hips. Tx with ZYRTEC 10mg, ZANTAC 150mg, prednisone 20mg.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Irritability, Pyrexia
Clinical narrative: Within 3 or 4 hours after injections pt. began to be irritable and soon began a fever as high as 102 degrees F and had several episodes of diarrhea.
Age: 16.0
Sex: F
Vaccine: DT
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Gave pt DT booster when she should have had Td booster. No adverse reaction. Patients mother notified.
Age: 1.01
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased
Clinical narrative: Temp 105.6 3 hrs. after PENTACEL; symptomatic treatment; resolved 24 hrs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain in extremity, Rash
Clinical narrative: Red and swollen at injection site. Rash on lower arm- headache 1 week.Pain in arm for 2 weeks.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Wrong drug administered
Clinical narrative: Nurse administered the wrong vaccine. I was to get annual TB test and the nurse injected T-dap in error. Red, not, sore, swollen spot on forearm - increasing in size and hurts.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Pain started around 9/7/15. Rash was visible around 9/10/15.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching pain at injection site that spread to entire forearm, still present.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, slight puffiness at inj site.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Patient states that his big toenails on both fee had bruising after getting ZOSTAVAX vaccine.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Mom presented to office stating 9/16/15 child developed a rash right leg lateral thigh, approximately 2 wks after Varicella injection 8/28/15.
Sex: M
Vaccine: PNC
Symptoms: Condition aggravated, Decreased appetite, Gastrooesophageal reflux disease, Irritability
Clinical narrative: This is an initial spontaneous report from a contactable nurse. The nurse was reporting for a child. A male child patient (age and race unknown) received PREVNAR on 29FEB2012 at an unknown dose and frequency for unknown indication. Relevant medical history of the patient included acid reflux since an unknown duration. Relevant concomitant medications of the patient were unknown. It was reported that the patient was irritated, his acid reflux was getting worse and had poor appetite. Relevant laboratory tests were unknown. Therapeutic measures taken for the reported events were unknown. Clinical outcome of the reported events was unknown at the time of report. Follow-up (29APR2012) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration from an unspecified date to an unspecified date for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a local site reaction with redness, swelling and warmth on an unspecified date with outcome of not recovered. Therapeutic measures were taken as a result of the event: the patient received BENADRYL, hydrocortisone cream on the local site of reaction, but still getting worse. Follow-up (13Mar2015): Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, a Pfizer sales representative, who reported himself. A 51-year-old male patient received a single dose of PREVNAR 13 for prevention of pneumococcal on 13Feb2015. Concomitant medications and medical history were not reported. On 19Feb2015, the patient experienced a baseball size red rash, a raised area that spread at the site of injection that's about the size of a baseball. The event was never reported to the physician. The clinical outcome of the event was resolved without treatment. Follow-up (10Mar2015): New information received from the same contactable consumer includes: treatment (NOS) and outcome (recovered). Follow-up attempts completed. No further information expected.
Age: 0.6
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 7-month-old female patient of unspecified ethnicity received the first dose of PREVNAR, via an unspecified route of administration on 07Aug2012 at a single dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On 07Aug2012, after the first dose of PREVNAR, the patient broke out in hives. Relevant laboratory data was unknown. Therapeutic measures taken in response to the event, broke out in hives, were unknown. The clinical outcome of the event, broke out in hives, was unknown at the time of report. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: PNC
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: This is spontaneous report from a contactable nurse practitioner. A male patient of unknown age or ethnicity received PREVNAR 7 on an unknown date. The patient's medical history and concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date after the patient received the PREVNAR 7 the patient experienced a hypersensitivity which was described as a local reaction. Relevant lab data was unknown. As of 19Apr2012, the clinical outcomes of the events hypersensitivity and local reaction were unknown. Follow-up (25MAY2012) 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 non-contactable physician. A patient of an unspecified age, gender and ethnicity was administered 3 doses of PREVNAR and a fourth dose of PREVNAR 13 on unspecified dates. The patient's medical history and concomitant medications were not provided. After conducting an assay on an unspecified date, the physician noticed that the patient was only fully immune to 1 of the 13 serotypes. Clinical outcome is unknown. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC
Symptoms: Antibody test abnormal, Condition aggravated, Sinusitis
Clinical narrative: This is a spontaneous report from a contactable health care professional reporting on her daughter. A female patient of an unspecified age and ethnicity received fourth dose of PREVENAR (Lot number D81705) on 12Feb2010. The patient received the first dose (Lot number D21053) on 16Feb2009, the second dose (Lot number D21053) on 27Apr2009 and the third dose (Lot number D33245) on 29Jun2009. The patient has a history of sinus infections. The patient's concomitant medications were not reported. On unspecified dates, the patient continued to get sinus infections after receiving the fours doses of PREVNAR 7. On an unspecified date, the patient had titers done and was found to be deficient in protection against serotypes 1,3,8 and 9N. The clinical outcome of the sinus infections was unknown. The physician reported that the patient did not provide information regarding the reported adverse event with the use of the product. The physician cannot confirm the occurrence of the events reported by the patient. Follow up (14Nov2012): New information received from a contactable physician includes: medical confirmation (not medically confirmed). Follow-up attempts completed. No further information expected. Follow-up (21NOV2012): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC
Symptoms: Accidental exposure to product, Burning sensation
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An adult female patient of an unspecified ethnicity accidentally received PREVNAR 7 via an unspecified route of administration on an unspecified date in 2000. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2000, when the patient (nurse) was administering PREVENAR to a child, she accidentally immunized herself and experiencing burning. The patient was not the intended recipient of PREVENAR. The clinical outcomes of the events were unknown. Follow-up (26JUN2012) Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer reported that a male patient of an unspecified age and ethnicity received PREVNAR, intramuscularly on 10Dec2012. The patient's medical history and concomitant medications were not reported. The patient's left arm hurt for approximately 1 week after receiving the PREVNAR 7 immunization in his left shoulder. Therapeutic measures, if any, taken in response to the vaccination site pain were unknown. The clinical outcome of the event, vaccination site pain was unknown. No follow up attempts possible. No further information expected.
Age: 24.0
Sex: M
Vaccine: PNC
Symptoms: Asthma, Drug administered to patient of inappropriate age
Clinical narrative: This is a spontaneous report from a contactable nurse received via the non-clinical study program. A 24-year-old male patient of unspecified ethnicity received PREVNAR single dose via an unspecified route of administration on an unspecified date in 2008 at 24 (units not provided). Relevant medical history included germ cell cancer from an unknown date to 1996 (patient has been cancer free since 1996). Relevant concomitant medications were not reported. The patient experienced off-label use when he received PREVNAR at the age of 24 (units not provided) and asthma on an unspecified date. The outcome of the events was unknown. Patient was now 31 years of age and the oncologist recommended a booster of PREVNAR 13 which the patient received on an unspecified date and experienced no adverse events.  Follow-up (08Oct2014): New information reported from the same contactable nurse includes: Patient information (age) and subsequent information regarding booster dose of PREVNAR 13. Follow-up (09NOV2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC
Symptoms: Decreased appetite, Fatigue, Malaise
Clinical narrative: This is a spontaneous report reported by Pfizer sales representative on behalf of a non-contactable Physician. A patient of unspecified age ethnicity and gender received PREVNAR via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fatigue, loss of appetite, and body malaise on an unspecified date. The outcomes of the events, fatigue, loss of appetite, and body malaise, were unknown.
Sex: U
Vaccine: PNC
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer (Pfizer employee). A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR, via an unspecified route of administration, on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient's arm was swollen significantly on an unspecified date. The clinical outcome of arm was swollen significantly was not reported. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PNC
Symptoms: Rash generalised, Rash pruritic, Respiratory tract infection viral, Wrong drug administered
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This patient of unspecified age, ethnicity, and gender received PREVNAR single dose on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced came down with bad viral infection in chest and bad rash all over upper body that itches like crazy on an unspecified date with outcome of unknown. The patient "was due for pneumococcal booster, but got PREVNAR instead". No additional information was reported. Follow-up (30Jan2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-clinical study program. A contactable male consumer of an unspecified age and ethnicity received PREVNAR. via an unspecified route of administration, on an unspecified date. The consumer's medical history and concomitant medication were not reported. The consumer reported that he had shoulder pain and soreness in his arm; it was confirmed that the events started after receiving the PREVNAR. The consumer's clinical outcome was not specified. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer, a Pfizer employee/clinician who reported for her nephew. A 6-month-old male patient received a single dose of PREVNAR; rotavirus vaccine; DTaP; IPV; Hib vaccine; and hepatitis B vaccine, all were given via an unspecified route of administration on 24Oct2014 between 10:00 AM and 2:00 PM, and administered in a doctor's office. It was unknown if the vaccines were purchased from public fund, private fund or military fund. The dose and lot numbers of the vaccines were unknown. The reporter stated that the vaccines were probably administered on the leg, but did not know for sure. No information was available about other vaccines given four weeks prior to the event. Medical history included ongoing acid reflux disease since birth taking baby ZANTAC, and was started with a cold before he got the vaccines from an unknown date. Concomitant medications included ZANTAC. It was reported that the patient was being weaned from ranitidine hydrochloride; however the patient did receive ranitidine hydrochloride on the night of 24Oct2014. The patient previously received the rotavirus vaccine on an unknown date and experienced a fever. The reporter was not sure if the patient was given PREVNAR last time (when he had shots) or not. The patient experienced throwing up on 24Oct2014 at night at an unknown time. The patient was not hospitalized and the reporter did not think the patient visited the doctor due to the event. It was unknown if the patient went for any blood work due to the event. The clinical outcome for the event of throwing up was recovered on an unknown date in Oct2014. It was reported that it was unknown if the patient received PREVNAR 7 or PREVNAR 13. It was reported that the mother of the patient thought that it was the rotavirus vaccine that caused the vomiting. Also, the mother of the patient thought that the patient was coming down with a cold before the patient got the vaccines, which might have contributed to the event. The reporter was not sure about the causality of the event, if the event happened due to these vaccines. Follow-up (29Nov2014): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Injection site induration, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via the non-clinical study program for healthcare providers. A 65-year-old female patient of unspecified ethnicity started to receive PREVNAR, single dose via an unspecified route of administration on 04FEB2015. Relevant medical history and concomitant medications were not reported. The patient experienced little soreness, felt little hard in the injection site area and tenderness in the area where it was administered on an unspecified date with outcome of unknown. The pharmacist was not sure if the events were due to PREVNAR or not.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist based on information received. A patient of unspecified age, ethnicity, and gender received a single dose of PREVNAR, via an unspecified route of administration on 16OCT2014. The patient's medical history and concomitant medications were not reported. On an unspecified date in OCT2014,, the patient experienced injection site reaction of redness, swelling, hardness and itching. The clinical outcome for the events of injection site reaction of redness, swelling, hardness and itching in was unknown. Follow-up attempts completed. No further information expected.
Age: 0.33
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer via a pharmacist. An infant male patient of an unspecified age and ethnicity received a single dose PREVNAR, via an unspecified route of administration on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced a high fever. The patient was brought to the hospital by the patient's father and "tried everything to control the patient's temperature". The patient's temperature decreased to normal. The clinical outcome for the event of a high fever was unknown. Follow-up (23JAN2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Information regarding PREVNAR 13 vaccine was received from a nurse regarding several patients who experienced redness and swelling subsequent to receiving PREVNAR 13. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced redness and swelling subsequent to receiving PREVNAR 13 (swelling) (erythema). Outcome was unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: New information in product details regarding PREVNAR 13 was received from a nurse regarding a 3 year old male patient who experienced redness, swelling and had a ring around the injection site. The patient received a dose on 20 Sep 2010. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisatiton. Product was administered on 20 Sep 2010. Dose regimen was 0.5 mL 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced redness, swelling and had a ring around the injection site in Sep 2010 "within 24 hours of injecting the vaccine". Outcome for all events was not recovered. No additional information was available at the time of this report.
Age: 1.53
Sex: M
Vaccine: PNC13
Symptoms: Crying, Gait disturbance, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding an 18 month old male patient who experienced warm with a fever to the touch, a little swelling at the injection site, did not want to walk, crying, second dose of PREVNAR 13 given 4 weeks too early and pain/tenderness/soreness at the injection site. At 18 months of age, the patient received the second dose on 21 Sep 2010. On 21 Sep 2010 the patient experienced warm with a fever to the touch, a little swelling at the injection site, second dose of PREVNAR 13 given 4 weeks too early, crying and pain/tenderness/soreness at the injection site. The patient did not want to walk and laid on a pillow on the floor for a couple of hours and later he was walking some. Although the patient's temperature was not taken, the fever was treated with TYLENOL. On 22 Sep 2010 the outcome of the events was unknown since the child had not yet awoken at the time the reporter called. See related case(s): US WYE H17733710 (adverse event, non expedited). No additional information was available at the time of this report.
Age: 1.53
Sex: M
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding an 18 month old male patient who experienced warm with a fever to the touch, a little swelling at the injection site, did not want to walk, crying, second dose of PREVNAR 13 given 4 weeks too early and pain/tenderness/soreness at the injection site. At 18 months of age, the patient received the second dose on 21 Sep 2010. On 21 Sep 2010 the patient experienced warm with a fever to the touch, a little swelling at the injection site, second dose of PREVNAR 13 given 4 weeks too early, crying and pain/tenderness/soreness at the injection site. The patient did not want to walk and laid on a pillow on the floor for a couple of hours and later he was walking some. Although the patient's temperature was not taken, the fever was treated with TYLENOL. On 22 Sep 2010 the outcome of the events was unknown since the child had not yet awoken at the time the reporter called. See related case(s): US WYE H17733710 (adverse event, non expedited). No additional information was available at the time of this report.
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer received via the non-clinical study program Pfizer. This reporter reported similar events for 2 patients. This is the second of 2 reports. A male patient of unspecified age and ethnicity received PREVNAR single dose via an unspecified route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced pinkish rash all the way down inside of his arm on an unspecified date with outcome of unknown. Unspecified therapeutic measures were taken as a result of pinkish rash all way down inside of his arm. Follow-up (05FEB2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding an unknown number of patients who may have received PREVNAR 13 that was stored improperly on 2 occasions. The patients may have received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product may have been administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patients may have received PREVNAR 13 vaccine that was stored improperly on 2 occasions. No adverse events were reported. No additional information was available at the time of this report.
Age: 1.44
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site movement impairment, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 17 month old male patient who experienced fever, pain/tenderness/soreness at the injection site, a little swelling at the injection site and not able to walk due to pain at vaccination site. At 17 months of age, the patient received the first dose on 18 Aug 2010. The patient also received the third dose of DTAP (manufacturer unknown) on 18 Aug 2010. On 18 Aug 2010 the patient experienced pain/tenderness/soreness at the injections site and a little swelling at the injection site which continued to worsen. Later that same day the patient experienced fever that resolved the next day. On 19 Aug 2010 the patient was not able to walk due to pain at vaccination site. The events of pain/tenderness/soreness at the injection site, a little swelling at the injection site and not able to walk due to pain at vaccination site resolved 3 days later.  See related case(s): US WYE H17904010. No additional information was available at the time of this report.
Age: 2.3
Sex: F
Vaccine: PNC13
Symptoms: Injection site nodule
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 30 month old female patient who experienced softball sized nodule on the upper thigh. At 30 months of age, the patient received a dose on 17 Sep 2010. Patient received PREVNAR therapy on 17 Sep 2010. On 19 Sep 2010, the patient experienced softball sized nodule on the upper thigh and was taken to emergency room. Patient was discharged on the same day. As of 20 Sep 2010, the outcome was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Discomfort, Laboratory test, Pain
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced pain and discomfort. The patient received a dose on an unspecified date. The patient experienced pain and discomfort. The outcome of the events were not reported. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Pain in extremity, Weight bearing difficulty
Clinical narrative: New information was received in patient details, medical history, and event outcomes. Information regarding PREVNAR 13 was received from a physician regarding a male patient who experienced soreness in the leg, didn't want to walk or put weight on it. The patient received a dose in 2010. The patient experienced soreness in the leg, didn't want to walk or put weight on it on an unknown date in 2010, after administration of PREVNAR 13. The patient returned to the doctor's office on 16 Sep 2010. Diagnostic tests and treatments were not reported. The outcome of all events is recovered. No additional information was available at the time of this report. See Related Case: US WYE H1764310, same source (non expedited event).
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Pain in extremity, Weight bearing difficulty
Clinical narrative: New information was received in patient details, medical history and outcome of events. Information regarding PREVNAR 13 was received from a physician regarding a female patient who experienced soreness in the leg, didn't want to walk or put weight on it. The patient received a dose on an unknown date in 2010. The patient experienced soreness in the leg, didn't want to walk or put weight on it in 2010, after administration of PREVNAR 13. The patient returned to the doctor's office on 16 Sep 2010 due to soreness of leg. Tests, diagnosis and treatments were not reported. The outcome of all events is recovered. No additional information was available at the time of this report. See Related Case: US WYE H17604310, same source (non expedited event).
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Irritability
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 2 year old male patient who experienced wanted to be held and pain in leg that was injected. At 2 years of age, the patient received the first dose on 10 Aug 2010. MEDICAL HISTORY: The patient's concurrent illness includes therapy regimen changed. Past therapies included 4 injections of PREVNAR. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on 10 Aug 2010. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced wanted to be held (irritability) and pain in leg that was injected (pain in extremity) in Aug 2010. Outcome was resolved in August 2010. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Information regarding PREVNAR 13 was receive from a healthcare professional regarding a 4-year-old male patient who experienced difficulty walking due to leg pain and leg pain. The patient received a dose on an unspecified date. MEDICAL HISTORY: Therapy regimen changed. Past therapies included 4 doses of PREVNAR, given on unspecified dates. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: On an unspecified date in either Mar or Apr-2010, the patient received a dose of PREVNAR 13 and subsequently experienced difficulty walking due to leg pain. On an unspecified date, the patient recovered. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Adverse event, Pyrexia, Vomiting
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-year-old male patient who experienced high fever, vomiting, and "he was a different kid". The patient received the first dose on an unspecified date. MEDICAL HISTORY: The patient's concurrent illness includes cochlea implant. PRODUCT DETAILS: Indication of PREVNAR 13 was immunisation (supplemental dose). Product was administered on an unspecified date. Dose regimen was 1 dose. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced high fever and vomiting. The child was sent for a neurological consult because "he was a different kid" (unevaluable event). Outcome was unknown. No additional information was available at the time of this report. Follow-up (16Nov2010): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of the migration, the follow-up CIOMS I, Medwatch or VAERS may indicate in the appropriate field that it is an initial report. Follow-up attempts completed. No further information expected.