chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a sales representative. This nurse reported similar events for six patients. This is the fifth of six reports. A patient received PREVNAR13, on an unspecified date. Relevant medical history, concomitant medications and past product history were not reported. On an unknown date, following administration of the vaccination, the patient developed dark red, hard and raised swelling at the site of injection. IT was reported that no emergency room or physical visit was required. At the time of this report, the outcome of the event was unknown. Follow-up (05AUG2011): Follow-up attempts completed. No further informtion expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a sales representative. This nurse reported similar events for six patients. This is the third of six reports. A patient received PREVNAR13, on an unknown date. Relevant medical history, concomitant medications and past product history were not reported. On an unknown date, following administration of the vaccination, the patient developed dark red, hard and raised swelling at the site of injection. It was reported that no emergency room or physical visit was required. At the time of this report, the outcome of the event was unknown. Follow-up (05AUG2011): Follow-up attempts completed. No further informtion expected.
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A male patient (age unknown) received a dose of PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date, the patient experienced a fever. Outcome was unknown at the time of report. No follow-up attempts possible. No further information expected.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Antinuclear antibody increased, Arthralgia, Blood test normal, Eye pain, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer and from a contactable health care professional (HCP). A 51-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR13, via an unspecified route of administration, on 04NOV2014. The patient's medical history included ulcerative colitis and ongoing chronic bronchitis since an unknown date. Concomitant medications were none. On 05NOV2014, the patient experienced red circular spots on arm, also described as red circles the size of a quarter around the injection spot. The patient mentioned that she had called her pharmacist and they said that there was not need to worry and that the spots would have gone away. On 05NOV2014 she experienced stiffness in her body/stiffness in both her arms, all the joints in her body were severely in pain all of the joints in her body were brutally painful, all the muscles specially the arm muscles were aching/muscle pain. ON an unknown date in NOV2014, a week after vaccination, she had bad headache/non-stop headaches, head to toe tingly feeling/weird sensations, eye pain, heavy  feeling in lifting of limbs. Within two weeks, on 20NOV2014, she was in her doctor's office. The doctor did blood work which sowed the ANA was a little bit up, all other numbers ere fine. The patient did not receive treatment for the rash macular. She received anti-inflammatory treatment for the stiffness, joint pain, muscle pain, headache, paraesthesia, eye pain, heaviness in limbs and she was sent to a Rheumatologist for all adverse events. The patient reported that all of the symptoms were starting to dissipate, however, the clinical outcome for the events of stiffness in body/stiffness in both her arms, all the joints in her body were severely in pain/all of the joints in her body were brutally painful, all of the muscles specially the arm muscles were aching/muscle pain, a head to toe tingly feeling/weird sensations, heavy feeling in lifting her limbs was not recovered. The clinical outcome for the event Eye pain, had bad headache/non-stop headaches, of red circular spots on arm/red circles the size of a quarter around the injection spot was recovered on an unknown date in NOV2014. The patient did not provide any information to the reporting HCP regarding the previously reported adverse events with the use of the product. Follow-up (12DEC2014): New information reported from a contactable consumer includes: added relevant medical history, added relevant lab data, and added events of a head to toe tingly feeling/weird sensations, eye pain, heavy feeling in lifting her limbs. Follow-up (05JAN2014): Additional information reported from the same contactable consumer includes date of birth provided, outcome and treatment received fro the events. Follow-up (09FEB2015): New information from a contactable health care professional incldues: was not aware of the reported adverse events.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site rash, Limb discomfort, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer and from a contactable health care professional (HCP). A 51-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR13, via an unspecified route of administration, on 04NOV2014. The patient's medical history included ulcerative colitis and ongoing chronic bronchitis since an unknown date. Concomitant medications were none. On 05NOV2014, the patient experienced red circular spots on arm, also described as red circles the size of a quarter around the injection spot. The patient mentioned that she had called her pharmacist and they said that there was not need to worry and that the spots would have gone away. On 05NOV2014 she experienced stiffness in her body/stiffness in both her arms, all the joints in her body were severely in pain all of the joints in her body were brutally painful, all the muscles specially the arm muscles were aching/muscle pain. ON an unknown date in NOV2014, a week after vaccination, she had bad headache/non-stop headaches, head to toe tingly feeling/weird sensations, eye pain, heavy  feeling in lifting of limbs. Within two weeks, on 20NOV2014, she was in her doctor's office. The doctor did blood work which sowed the ANA was a little bit up, all other numbers ere fine. The patient did not receive treatment for the rash macular. She received anti-inflammatory treatment for the stiffness, joint pain, muscle pain, headache, paraesthesia, eye pain, heaviness in limbs and she was sent to a Rheumatologist for all adverse events. The patient reported that all of the symptoms were starting to dissipate, however, the clinical outcome for the events of stiffness in body/stiffness in both her arms, all the joints in her body were severely in pain/all of the joints in her body were brutally painful, all of the muscles specially the arm muscles were aching/muscle pain, a head to toe tingly feeling/weird sensations, heavy feeling in lifting her limbs was not recovered. The clinical outcome for the event Eye pain, had bad headache/non-stop headaches, of red circular spots on arm/red circles the size of a quarter around the injection spot was recovered on an unknown date in NOV2014. The patient did not provide any information to the reporting HCP regarding the previously reported adverse events with the use of the product. Follow-up (12DEC2014): New information reported from a contactable consumer includes: added relevant medical history, added relevant lab data, and added events of a head to toe tingly feeling/weird sensations, eye pain, heavy feeling in lifting her limbs. Follow-up (05JAN2014): Additional information reported from the same contactable consumer includes date of birth provided, outcome and treatment received fro the events. Follow-up (09FEB2015): New information from a contactable health care professional incldues: was not aware of the reported adverse events.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Paraesthesia, Rash macular
Clinical narrative: This is a spontaneous report from a contactable consumer and from a contactable health care professional (HCP). A 51-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR13, via an unspecified route of administration, on 04NOV2014. The patient's medical history included ulcerative colitis and ongoing chronic bronchitis since an unknown date. Concomitant medications were none. On 05NOV2014, the patient experienced red circular spots on arm, also described as red circles the size of a quarter around the injection spot. The patient mentioned that she had called her pharmacist and they said that there was not need to worry and that the spots would have gone away. On 05NOV2014 she experienced stiffness in her body/stiffness in both her arms, all the joints in her body were severely in pain all of the joints in her body were brutally painful, all the muscles specially the arm muscles were aching/muscle pain. ON an unknown date in NOV2014, a week after vaccination, she had bad headache/non-stop headaches, head to toe tingly feeling/weird sensations, eye pain, heavy  feeling in lifting of limbs. Within two weeks, on 20NOV2014, she was in her doctor's office. The doctor did blood work which sowed the ANA was a little bit up, all other numbers ere fine. The patient did not receive treatment for the rash macular. She received anti-inflammatory treatment for the stiffness, joint pain, muscle pain, headache, paraesthesia, eye pain, heaviness in limbs and she was sent to a Rheumatologist for all adverse events. The patient reported that all of the symptoms were starting to dissipate, however, the clinical outcome for the events of stiffness in body/stiffness in both her arms, all the joints in her body were severely in pain/all of the joints in her body were brutally painful, all of the muscles specially the arm muscles were aching/muscle pain, a head to toe tingly feeling/weird sensations, heavy feeling in lifting her limbs was not recovered. The clinical outcome for the event Eye pain, had bad headache/non-stop headaches, of red circular spots on arm/red circles the size of a quarter around the injection spot was recovered on an unknown date in NOV2014. The patient did not provide any information to the reporting HCP regarding the previously reported adverse events with the use of the product. Follow-up (12DEC2014): New information reported from a contactable consumer includes: added relevant medical history, added relevant lab data, and added events of a head to toe tingly feeling/weird sensations, eye pain, heavy feeling in lifting her limbs. Follow-up (05JAN2014): Additional information reported from the same contactable consumer includes date of birth provided, outcome and treatment received fro the events. Follow-up (09FEB2015): New information from a contactable health care professional incldues: was not aware of the reported adverse events.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pain in extremity, Pruritus, Swelling
Clinical narrative: This is a spontaneous report from a non-contactable nurse who reported for herself. A female patient of an unspecified age and ethnicity received PREVNAR13, via an unspecified route of administration in DEC2014 at single dose. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced redness, swelling itchiness, pain and her arm hurt. The events were non-serious with outcome of unknown. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia oral
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR13, via an unspecified route of administration, on an unspecified date, as a single dose. Medical history and concomitant medications were not reported. On an unknown date, the patient stated that, after she ate sugar free candy, her lips went numb. The clinical outcome of the event, after she ate sugar free candy her lips went numb, was unknown. She wondered if this was a side effect of the vaccine. Follow-up (26JAN2015): New information reported from the same contactable consumer includes: patient information (patient date of birth). Follow up (12MAR2015): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Pain, Productive cough, Pyrexia, Secretion discharge
Clinical narrative: A 76-year-old male patient received, on 02DEC2014, intramuscular PREVNAR13, lot J49845, expiration date: 01MAR2015 0.5 ml single dose. Relevant medical history included diabetes, hypertension, and tobacco user. No allergies were reported. Concomitant medication included oral AMLODIPINE (tablet)  5 mg daily, oral CIALIS (table) 20 mg, as needed, oral LIPITOR (tablet) 20 mg, once daily, oral ASPIRIN (tablet) 81 mg, daily and oral METFORMIN (tablet) 500 mg once daily (2 pills by mouth for 3 months (90 day). The patient previously received a flu shot two months ago. On 02DEC2014, 4 hours after the vaccination, the patient experienced a temperature of 103 F degrees. Patient remained febrile for 3 days and he was treated with ibuprofen. Fever went high up to 103.4F. On 04DEC2014 temperature went to 101F and he went to play tennis that day. The patient recovered from fever on an unspecified date. Nurse mentioned that in addition to fever he experienced severe cough, mucous and aches and pain. Clinical outcome of the events, productive cough and pain, was unknown. Causal relationship between the event, fever and PREVNAR13 was unknown. Follow-up (20JAN2015): New information reported from the contactable nurse includes: medical history, suspect drug and concomitant medications details, patient's clinical course and reporter's assessment. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Feeding disorder, Mastication disorder, Pain, Pain in extremity, Pain in jaw
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 70 years old female consumer received PREVNAR13 on unknown date in DEC2014, at single dose, in left arm. Medical history was not provided, however, the consumer stated she was in very good health. Concomitant medications were none. The first two days, since 09DEC2014 the arm was very sore. The consumer stated it felt like somebody had punched it and it hurt to lift the arm. The next day it was improved an don day of reporting it was fine. She also stated that on the second day (the day before the report) her left jaw was very sore. She could not eat and chew on it. The patient recovered from arm pain. Event outcome of jaw pain was reported as resolving.
Age: 50.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50-year-old male patient received PREVNAR13, via an unspecified route of administration on 22MAR2012 at 0.5 ml , once. The patient medical history was not reported. The patient's concomitant medications were not reported. On 22MAR2012 or 23MAR2012, after receiving the dose of PREVNAR13, the patient experienced pain at injection site, tenderness at injection site and muscle and joint pain, was not applicable. Therapeutic measures taken for the events, pain at injection site, tenderness at injection site and muscle and joint pain, were unknown. The clinical outcome of the events, pain at injection site, tenderness at injection site and muscle and joint pain, was unknown. Follow-up (24MAY2012): Follow-up attempts completed. No further information expected.
Age: 1.37
Sex: F
Vaccine: DTAP, MMR, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. This physician reported similar events for three patients. This is the second of three reports. A 15-month-old male child received a dose of PREVNAR 13 on 20Mar2012, Lot#/ expiration date: F24141/31Mar2012, Administered site: Left thigh, route of administration: intramuscular, number of previous doses: 3. No relevant drug history, nor drug allergies. The patient also received DTaP, Lot# ACC14B140BA administered site: Left thigh, route of administration: intramuscular, number of previous doses: 3, and MMR II Lot# 1001AA, number of previous doses: 0. On 20Mar2012 the child experienced a reaction to the vaccination, which included Left thigh swelled, red, hot, painful, became feverish and developed swelling across the entire upper thigh radiating up into the upper back. All other vaccines administered on the date of the Adverse Event: HIB, Lot# UH345AA, Administered site: Left thigh, route of administration: intramuscular, Number of previous doses: 3, Varicella Virus Vaccine, Lot# 1247AA, Administered site: Right thigh, route of administration: intramuscular, Number of previous doses: 0. The following treatment was administered BENADRYL, Ice, MOTRIN. The outcome of event was recovered. Follow-up (24Apr2012): New information from a contactable nurse includes: vaccines details, event outcome and treatment, patient's age at vaccination, and vaccination history. Follow-up (30MAY2012) Follow-up attempts completed. No further information expected.
Age: 1.37
Sex: F
Vaccine: DTAP, MMR, PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. This physician reported similar events for three patients. This is the second of three reports. A 15-month-old male child received a dose of PREVNAR 13 on 20Mar2012, Lot#/ expiration date: F24141/31Mar2012, Administered site: Left thigh, route of administration: intramuscular, number of previous doses: 3. No relevant drug history, nor drug allergies. The patient also received DTaP, Lot# ACC14B140BA administered site: Left thigh, route of administration: intramuscular, number of previous doses: 3, and MMR II Lot# 1001AA, number of previous doses: 0. On 20Mar2012 the child experienced a reaction to the vaccination, which included Left thigh swelled, red, hot, painful, became feverish and developed swelling across the entire upper thigh radiating up into the upper back. All other vaccines administered on the date of the Adverse Event: HIB, Lot# UH345AA, Administered site: Left thigh, route of administration: intramuscular, Number of previous doses: 3, Varicella Virus Vaccine, Lot# 1247AA, Administered site: Right thigh, route of administration: intramuscular, Number of previous doses: 0. The following treatment was administered BENADRYL, Ice, MOTRIN. The outcome of event was recovered. Follow-up (24Apr2012): New information from a contactable nurse includes: vaccines details, event outcome and treatment, patient's age at vaccination, and vaccination history. Follow-up (30MAY2012) Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Sales Representative. This physician reported similar events for three patients. This is second of three reports. A 3-year-old male patient received the second dose of PREVNAR-13, lot number F24141, on 19Mar2012, at left thigh, intramuscular, Number of Previous Doses: 1. The following vaccinations were administered to the patient: DTAP, administered on 19Mar2012, Lot # PENTACEL (C4059AA), at left thigh, intramuscular, Number of Previous Doses: 1, 11Jan2012, IPV, administered on 19Mar2012, Lot #/ Expiration date: PENTACEL (C4059AA), at left thigh, subcutaneous, Number of Previous Doses: 1, on 11Jan2012. MMR II, administered on 19Mar2012, Lot # 1001AA, at right thigh, subcutaneous, Number of Previous Doses: None. Varicella virus vaccine, administered on 19Mar2012, Lot # 1247AA, at right thigh, subcutaneous, Number of previous doses: None. Hepatitis B vaccine, administered on 19Mar2012, at left thigh. No relevant medical history was provided. On 20Mar2012, the patient experienced redness, pain, and feverish swelling across the entire upper thigh radiating up into the upper back, rash all over, left thigh swollen and hot, and fever. The patient was referred to the treating physician on 20Mar2012 and was prescribed BENADRYL for swelling and rash. The patient recovered from all the events on 24Mar2012. The physician considered PREVNAR 13 as the only suspect product. Follow-up (24Apr2012): New information from a contactable nurse reported on behalf of physician includes: Vaccinations details, event outcome.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Sales Representative. This physician reported similar events for three patients. This is second of three reports. A 3-year-old male patient received the second dose of PREVNAR-13, lot number F24141, on 19Mar2012, at left thigh, intramuscular, Number of Previous Doses: 1. The following vaccinations were administered to the patient: DTAP, administered on 19Mar2012, Lot # PENTACEL (C4059AA), at left thigh, intramuscular, Number of Previous Doses: 1, 11Jan2012, IPV, administered on 19Mar2012, Lot #/ Expiration date: PENTACEL (C4059AA), at left thigh, subcutaneous, Number of Previous Doses: 1, on 11Jan2012. MMR II, administered on 19Mar2012, Lot # 1001AA, at right thigh, subcutaneous, Number of Previous Doses: None. Varicella virus vaccine, administered on 19Mar2012, Lot # 1247AA, at right thigh, subcutaneous, Number of previous doses: None. Hepatitis B vaccine, administered on 19Mar2012, at left thigh. No relevant medical history was provided. On 20Mar2012, the patient experienced redness, pain, and feverish swelling across the entire upper thigh radiating up into the upper back, rash all over, left thigh swollen and hot, and fever. The patient was referred to the treating physician on 20Mar2012 and was prescribed BENADRYL for swelling and rash. The patient recovered from all the events on 24Mar2012. The physician considered PREVNAR 13 as the only suspect product. Follow-up (24Apr2012): New information from a contactable nurse reported on behalf of physician includes: Vaccinations details, event outcome.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Irritability, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This is first of the four reports from the same reporter. This nurse reported for a 2-month-old female patient who received the first dose of PREVNAR 13 via the intramuscular route, ROTATEQ orally, DTaP, PENTACEL via the intramuscular route on 26Mar2012 at 9:55 am. The relevant medical history and relevant concomitant medications were unknown. The nurse mentioned that the patient experienced extra puffiness, crying excessively, fever, and fussiness since 26Mar2012. The relevant laboratory data was unknown. The patient did not receive treatment for the events. The outcomes of the events extra puffiness and crying excessively were reported as recovering. The outcomes of the events fever and fussiness were reported as recovered on 26Mar2012. Follow-up (17Apr2012): New information received from a contactable physician included confirmation of events, route of administration of vaccine products, treatment details, outcome information, and additional adverse event of fever and fussiness with onset and resolution dates. Follow-up (23MAY2012) Follow-up attempts completed. No further information expected.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia, Swelling, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for four patients. This is the fourth of four reports. A 4-month-old male patient received the second dose of PREVNAR13 via the intramuscular route on 28MAR2012 at 10:03, the second dose of rotavirus vaccine orally on 28MAR2012 at 10:30, and the second dose of PENTACEL (ACELLULAR)) via the intramuscular route on 28MAR2012. The patient medical history was not reported. The patient's concomitant medications were not reported. On 28MAR2012, the patient experienced low grade fever, fussiness, vomiting, and extra puffiness. Therapeutic measures taken as a result of the events were not specified. The outcome of the events low grade fever, fussiness, and vomiting were recovered on 29MAR2012. The outcome of the event extra puffiness was recovering at the t ime of the report. Follow-up (17APR2012): New information reported by a contactable physician included product lot numbers and expiration dates, route of administration, additional adverse event of fussiness, onset and resolution dates, and outcome information. Follow-up (30APR2012): Follow-up attempts completed. No further information expected. Follow-up (24MAY2012) 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 (age and gender unknown) received the first dose of PREVNAR13, USA, Lot Number: F75398, Expiration Date: October 2013). Suspension 0.5 MLX10 on an unknown date. Relevant medical history includes therapy regimen changed. The patient previously received four doses of PREVNAR on unknown dates. The physician noticed that the patient was only fully immune to one of the 13 PREVAR serotypes. The physician inquired whether he should administered another dose of PREVNAR13 to ensure immunization for the thirteen strains contained in PREVNAR13. The outcome of the event was unknown.  Information was subsequently reported from Product Quality Complaint Group (UPC/NDC#: 00005-1971-02). Description of Complaint: MD has a patient that was administered 3 doses of PREVNAR7 and a 4th dose of PREVNAR13. After conducting an assay MD noticed that patient was only fully immune to 1 of the 13 PREVNAR Serotypes. MD asked if he should administer another dose of PREVNAR13. Please send any and all pertinent information on whether MD should administer a 5th dose to ensure immunization for the 13 strains contained in PREVNAR13. Conclusion/Summary: The plant has reviewed all investigations associated with this batch from a manufacturing and technical perspective and all investigations were appropriately closed and addressed. No quality issues were identified in this review of batch related documents, review of release testing or inspection of retained samples. Retained samples meet the product description and the product is in date. No product was returned for examination and the product is not on stability. Follow-up (16MAY2012): Follow-up attempts completed. No further information expected. Follow-up (31MAY2011): New information reported from Product Quality Complaint Group includes: PREVNAR  product description: UPC/NCD#; lot number; expiration date; description of complaint.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspepsia
Clinical narrative: This is a spontaneous report from a contactable nurse . A 53-year-old female patient received a dose of PREVNAR13, 0.5 ml single dose intramuscularly  in left deltoid on 09MAR2012. Medical history and concomitant medications were unknown. On 09MAR2012 she experienced stomach burning. Relevant lab data was unknown. No treatment was required for the stomach burning. At the time of the report she had not recovered from the stomach burning. Follow-up (06APR2012): New information received from a contactable nurse includes: suspect product data and treatment received. Follow-up (23APR2012) Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Nausea, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer via a internal colleague. A 61-year-old male patient received a dose of PREVNAR13, intramuscularly on 13MAR2012 at 06:15 in the left arm. Relevant medical history included high blood pressure, high cholesterol and chronic back pain; all from unknown dates and ongoing. Concomitant medications included BENICAR HCT, lisinopril, verapamil, PROTONIX, ULORIC and ENBREL; all from unknown dates and ongoing. On 15MAR2012 at 23:00, the patient experienced nausea, diarrhea, vomiting, body ache and fatigue. The outcome of the events, nausea, diarrhea, vomiting, body ache and fatigue was recovering.  Follow-up (03APR2012): New information reported from a contactable physician via internal colleague includes: the case is not medically confirmed and no further information is available. Follow-up attempts completed. No further information expected. Follow-up (26APR2012): Follow-up attempts completed. No further information expected.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (mother) via the DTC First Connect Line. A 4-year-old male patient received a dose of PREVNAR13 on 19MAR2012. Relevant medical history was none, but the patient recently was on continuous positive airway pressure (CPAP) machine (date not specified). Concomitant medication included IBUPROFEN at one and a half teaspoons thee times a day orally from an unknown date and discontinued on 21MAR2012. The patient previously received polio-vaccine and MMR on an unknown dates. On 19MAR2012, the patient experienced an "irritable" leg (leg discomfort). On 22MAY2012, the patient developed leg swelling. No therapeutic measures were taken in response to the events. The patient had not yet recovered from leg swelling. The outcome for leg discomfort was unknown. Follow-up (17MAY2012) Follow-up attempts completed. No further information expected.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer. A 4-year-old male patient received the second catch-up dose of PREVNAR13 on 28DEC2011. Past vaccine history included 4 doses of PREVNAR7 as an infant and a dose of PREVNAR13 in 2010 (therapy regimen changed). Relevant medical history and concomitant medications were not provided. The patient was administered a second catch-up dose of PREVNAR13 on 28DEC2011. The patient appears to be tired which was reported to be normal for him after being administered vaccines. The outcome was unknown. Follow-up (02MAR2012): Follow-up attempts completed. No further information expected.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: This is an initial spontaneous report from a contactable reporter who was calling from a physicians office. A 1-year-old, female patient (race unknown) received a dose of PREVNAR13 on 29DEC2011. Relevant medical history included cold, coughing and allergy to soy, all since an unknown date. There were no relevant concomitant medications. It was reported that the patient threw-up within 15 minutes of receiving PREVNAR12 on 29DEC2011. The patient had no relevant laboratory data. Therapeutic measures taken in response to the event were none. The consumer had recovered from reported event on 29DEC2011. Follow-up (06FEB2012): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Gastrooesophageal reflux disease, Irritability
Clinical narrative: This is a spontaneous report from a contactable nurse. A male child patient (age unknown) received a dose of PREVNAR13 on 29FEB2012. Relevant medical history and concomitant medications were unknown. Since 29FEB2012 the patient experienced reflux which has worsened over time, had poor appetite and was irritable. Relevant laboratory tests of the patient were unknown. The therapeutic measures taken at the time of report were unknown. The clinical outcome of the event was unknown at the time of report. Follow-up (29APR2012) Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Mass
Clinical narrative: This is a spontaneous report from a contactable physician assistant communicated to a sales representative. A female patient (age unknown) received a dose of PREVNAR13 in the quadriceps, along with a dose of VARIVAX, both on 25FEB2012. Relevant medical history, concomitant medications and past product history were not provided. On 25FEB2012, following administration of the vaccinations, the patient developed a lump on the quadriceps. The outcome of the event was unknown. Follow-up (03MAY2012) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a non-contactable nurse. A patient (age and gender not provided) received a dose of PREVNAR13 on an unspecified date. Relevant medical history and concomitant medications were not provided. The nurse had a general question regarding the reporting of soreness after PREVNAR13 vaccination. The outcome was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PPV
Symptoms: Antibody test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. This physician reported that a 4-year-old child (unknown gender) received full 4 dose series of PREVNAR13. Medical history and concomitant medications were unknown. On an unknown date, titers are checked and they were found low or inadequate.
Sex: U
Vaccine: PNC13
Symptoms: Drug interaction
Clinical narrative: This is an initial spontaneous report from a contactable reporter (Non Health Care). A child (age, gender and race unknown) started to receive PREVNAR 13 and an unspecified liquid multivitamin (for pediatric), both since an unknown date, at an unknown dose and frequency, for an unknown indication. The relevant medical history and relevant concomitant medications were unknown. It was reported that the consumer might had experienced drug interaction between PREVNAR 13 and unspecified liquid multivitamin on an unknown date. She further mentioned she came to know about the interaction when she observed a pop up in the electronic medical records suggesting it. The relevant laboratory test was unknown. The last actions taken with both the therapies were unknown, at the time of report. Therapeutic measures taken in response to the event, if any, were unknown. Clinical outcome of the event was unknown, at the time of the report.
Sex: U
Vaccine: PNC13
Symptoms: Burning sensation
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A patient (age and gender unknown) received PREVENAR-13 on an unknown date. On an unknown date, the patient developed burning sensation after vaccination.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable colleague who reported on himself. A 55-year old male received a dose of PREVNAR13, injection on 12MAR2012. Relevant medical history included sleep apnea for 12  years and nasal polyps since an unknown date. Concomitant medications included NASONEX starting in MAR2012 for nasal polyps. The patient reported that  he received the vaccine at work. The patient experienced swelling at injection site on 12MAR2012. The patient reported he had a sore site of inoculation. Therapeutic measures takes as a result of the event were reported as none. The patient had not recovered from the swelling at the injection site as of 13MAR2012. The clinical outcome of the event sore site of inoculation was unknown. Follow-up (21MAR2012): Follow-up attempts completed. No further information expected. Follow-up (13APRIL2012): New information received from a contactable consumer includes: reaction data (added: sore site of inoculation). Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: IPV, PNC13
Symptoms: Arthralgia, Arthritis, Erythema, Joint swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 24 month old male child (Birth weight: 08 Lbs. and 10 ounces) started taking PREVNAR 13, 0.5 ml, single, intramuscular injection on his right thigh on an unknown date. Relevant medical history includes sinus infection from which he had recovered on an unknown date. Number of brothers and sisters/siblings was 2. Relevant concomitant medications included AUGMENTIN and NASONEX. Vaccines given on the same day included polio vaccine (Sanofi Pasteur, Bath/Lot H1330), dose2, intramuscularly in the right thigh. Vaccines taken within the last four weeks were none. In Apr2012 while on PREVNAR 13 unknown dose unknown frequency he had arthritis associated symptoms which was explained as knee pain, swelling of joint, knee swelling and redness. Relevant lab data was none. At the time of the report it was unknown if he was taking PREVNAR 13. At the time of the report he had not recovered from the above mentioned events.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Back pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable via a Pfizer sales representative and then from a contactable Pharmacist reporting on behalf of physician. This is the third of three reports. A 3-year-old child female patient of an unspecified ethnicity received PREVNAR 13 intramuscular on right thigh on 19Mar2012, Lot # F24141 and expiration date 31Mar2013. The patient received also second dose of HEPATITIS A VACCINE, intramuscular on left thigh, lot # AHAVB462BA and expiration date 17Mar2013. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced reaction to PREVNAR vaccinations including the following symptoms: unusual redness, pain, fever, and swelling across the entire upper thigh radiating up into the upper back within 24 hours post vaccination. The pharmacist describes the events as right thigh very swollen, red, hot, swelling up and around back. The pharmacist provided onset date of the events as 19Mar2012 and recovery date as 24Mar2012. Treatment was provided: BENADRYL, Ice and MOTRIN. Follow-up (24Apr2012): New information received from the contactable Pharmacist reporting on behalf of physician included: updated suspect drug info, cosuspect Hepatitis A vaccine, onset date and recovery date, outcome, treatment and demography. Follow-up attempts completed. No further information expected. Follow-up (10MAY2012) Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site warmth, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable via a Pfizer sales representative and then from a contactable Pharmacist reporting on behalf of physician. This is the third of three reports. A 3-year-old child female patient of an unspecified ethnicity received PREVNAR 13 intramuscular on right thigh on 19Mar2012, Lot # F24141 and expiration date 31Mar2013. The patient received also second dose of HEPATITIS A VACCINE, intramuscular on left thigh, lot # AHAVB462BA and expiration date 17Mar2013. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced reaction to PREVNAR vaccinations including the following symptoms: unusual redness, pain, fever, and swelling across the entire upper thigh radiating up into the upper back within 24 hours post vaccination. The pharmacist describes the events as right thigh very swollen, red, hot, swelling up and around back. The pharmacist provided onset date of the events as 19Mar2012 and recovery date as 24Mar2012. Treatment was provided: BENADRYL, Ice and MOTRIN. Follow-up (24Apr2012): New information received from the contactable Pharmacist reporting on behalf of physician included: updated suspect drug info, cosuspect Hepatitis A vaccine, onset date and recovery date, outcome, treatment and demography. Follow-up attempts completed. No further information expected. Follow-up (10MAY2012) Follow-up attempts completed. No further information expected.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: This is a spontaneous report from a contactable physician. This is a report received via a Pfizer sales representative. A 2-year-old male patient of an unspecified ethnicity received four doses of PREVNAR 13, intramuscular, all on unknown dates at 1 single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the physician reported that the patient's titers were undetectable. The physician was inquiring if the patient could receive a fifth dose of PREVNAR 13 in order to check his IGG responses. The clinical outcome of the event, the patient's titers were undetectable, was unknown.
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Nodule, Secretion discharge, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. The nurse reported for a 2 months old female patient who received PREVNAR 13 on 16Jan2012 at 0.5 ml single as immunization for the prevention of invasive disease. The patient had no relevant medical history and relevant concomitant medications. It was reported that the patient had a large red bump since 16Jan2012 after she was administered PREVNAR 13 as it was further elaborated that the bump was big and round which grew bigger, was hard and was like a red purplish knot after couple of months. It was further elaborated that when the patient came for her fourth month immunization the bump was very red and was hard like a keloid so she was administered with her second dose of PREVNAR 13 on an unknown date in 2012 on the other leg, after which the patient had similar large red bump on her leg and there was yellow greenish drainage from the previous bump. No relevant laboratory data was reported. The status of PREVNAR 13 therapy was unknown at the time of report. Therapeutic measures taken included unspecified antibiotic ointment. The clinical outcome of the reported events was unknown at the time of report.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for three patients. This is the third of three reports. A 60-year-old male patient received the first dose of PREVNAR 13 (Lot Number F8804) intramuscularly, in the left deltoid on 09Mar2012. Relevant medical history, concomitant medications, and past product history were unknown. On 16Mar2012, following administration of the vaccination, the patient developed a red raised rash at the site of the injection. Treatment was not required for the event. The outcome of the event was unknown. Follow-up (06Apr2012): New information reported from a contactable nurse includes: Lot Number, patient information, and treatment details. Follow-up (26APR2012) Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse, a Pfizer internal colleague, reported events on three patients. This is the second of three reports. A 52-year-old female patient received a dose of PREVNAR 13 intramuscularly in the left deltoid of pneumococcal infection on 09Mar2012. No other vaccines administered on same day. Relevant medical history and concomitant medications were unknown. On 10Mar2012, the patient experienced red raised rash a six inch in diameter at the site of injection. Relevant lab data was unknown. No treatment required. The outcome of the event is ongoing as on 06Apr2012. Follow-up (06Apr2012): New information received from the same contactable nurse includes: reaction data. Follow-up (27APR2012) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician. A patient (age and gender unknown) received the first dose of PREVNAR 13 (Lot #916973) on an unknown date. Relevant medical history and concomitant medications were not reported. On an unknown date following vaccination the patient developed hives. The reporting physician, an allergist (not vaccinating physician), has requested QA follow-up. The outcome of the event was unknown at the time of this report. Follow-up (05APR2012): Follow-up attempts completed. No further information expected. Follow-up (06Apr2012): This is a follow-up report from Product Quality Complaint Group. This reporter reported that "Product Description: PREVNAR 13 PFS SUSPENSION 0.5MLX10-USA, UPC/NDC#: 00005-1971-02, Lot Number: 916973, Expiration Date: 1/2013." Follow-up (30May2012): This is a follow-up report from Product complaint group. This contactable physician reported that AE/PC: Physician stated that a patient experienced hives after receiving PREVNAR 13. He wonders if it could have been a batch specific reaction to lot 916973 Exp. Jan2013. The physician specifically requests that Pfizer QA follow-up to let him known whether there have been any issues reported for this specific lot number. He declined transfer to Pfizer Safety and declined to provide additional information at this time due to having patients waiting to be seen. However, he did state that he will be glad to provide additional information if Pfizer Safety and QA will follow-up by mail, phone, or email. He mentioned that he was not the physician who administered the vaccine as he is an allergist.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a nurse. A 59 (units not provided) female consumer received a single dose (0.5 ml) of PREVNAR 13, intramuscularly for immunization. Relevant medical history and concomitant medications were not provided. On an unspecified date post-vaccination, the patient experienced a swollen and painful injection site. Treatment was not provided. The patient recovered from the events on an unspecified date. The reporter noted a probable relationship between the event and PREVNAR 13. Follow-up (10MAY2012) 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 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.