chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Injection site induration, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: This is the second of the three reports. This is an initial spontaneous report by a contactable Medical Assistant. This Medical Assistant reported that a currently 4-year-old female patient received PREVNAR 13 0.5 ml intramuscular injection on 06April2011. Relevant medical history was none. Relevant concomitant medications included measles, mumps, rubella and chickenpox vaccine from an unknown date. Other vaccines given to her included PREVNAR which was given when the baby was 2 months old. Vaccine given on the same day included measles, mumps, rubella and chicken pox vaccine on 06Apr2011. Vaccines taken within the last four weeks were none. On 07Apr2011, she experienced hardening of skin, hives and little bumps and warmth at the site of injection. Relevant lab data was unknown. At the time of the report the clinical outcome of the above events was unknown. Follow-up (27May2011): Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Discomfort, Incorrect route of drug administration, Injection site vesicles
Clinical narrative: This is a spontaneous report from a contactable nurse. The nurse reported on a 3-year-old male patient received PREVNAR13 at 0.5 ml single on 21APR2011. Relevant medical history and concomitant medications were unknown. On 21APR2011 the patient was administered PREVNARA13 in the right thigh subcutaneously instead of intramuscularly and the patient experienced unknown discomfort. In addition the patient developed a small bubble on the skin at the spot where he was administered the PREVNAR13. The  relevant laboratory data was unknown. Therapeutic measures in response to discomfort and vaccination site bubble included application of pressure and use of ice pack. The patient was also prescribed ibuprofen at 8.9 ml every 6 hours as needed and TYLENOL at 8.3 ml up to four times a day as needed. The patient recovered from vaccination site bubble on 21APR2011. The clinical outcome of discomfort was unknown at the time of this report. Follow-up (03JUN2011): Follow-up attempts completed. No further information expected. Follow-up status: Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Crying, Erythema, Pain
Clinical narrative: This is a spontaneous report from a contactable Healthcare Professional (other) communicated to a Pfizer sales representative. An infant (age and gender unknown) 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 PREVNAR13 it was reported that the infant turned red from crying as it was painful. At the time of this report, the patient  outcome was unknown. The office does not wish to be contacted for further follow-up information. Follow-up (24MAY2011): New information reported from a contactable office staff member includes statement from staff member. Follow-up attempts completed. No further information expected. Follow-up (03JUN2011): Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This is first of three reports from the same reporter. This is a spontaneous report from a contactable Physician, reported through a Pfizer sales representative. A 3-year-old male patient was administered a dose of PREVNAR13 on the thigh on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the dame day were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date, after administration of PREVNAR13 the patient experienced redness, erythema, pain and itchiness on the thigh. Relevant lab data was unknown. At the time of report the patient was recovering from the above mentioned events.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. This physician reported for the same patient for three different events. This is the third of three reports. A 4-year-old male patient receive PREVNAR13 on an unknown dose at an unknown time in the thigh on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were reported. Vaccines given on the same day were unknown. On an unknown date the patient experienced redness on the thigh. At the time of report clinical outcome of the event was not reported.
Age: 0.19
Sex: M
Vaccine: PNC13, RV5
Symptoms: Frequent bowel movements, Gastric disorder
Clinical narrative: This spontaneous report from a contactable medical assistant. This medical assistant reported similar events for two patients. This is the second of two reports. The case is non-serious. The first case is serious. A 2-month old male patient received a first dose of PREVNAR13, intramuscular, on 25APR2011 along with a first dose of ROTATE$Q, oral, on 25APR2011. Relevant medical history, concomitant medications and past product history were unknown. On an unspecified date, the patient developed a gastric problem. On 03MAY2011, ,the patient experienced 6 bowel movements in 24 hours. The event of 6 bowel movements in 24 hours recovered on an unspecified date with no treatment provided. The outcome of the event of gastric problem was unknown. Follow-up (23MAy2011): New information reported from a contactable medical assistant includes: Birthday with updated age. Product details including dose number, additional suspect vaccine, additional event details leading to a change in the event from bowel problem to 6 bowel movements in 24 hours, onset date of the event,  updated recovery status and information noting that no treatment was given for the 6 bowel movements in 24 hours. Follow-up attempts completed. No further information expected.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This is second of three reports from the same reporter. This is a spontaneous report from a contactable physician through  a Pfizer sales representative. A four-year-old male patient was administered a dose of PREVNAR13 by injection on the thigh on an unknown date. Five unspecified vaccines were administered on the same date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date, after administration of PREVNAR13 on the thigh, the patient experienced swelling, pain and itchiness on the thigh. Relevant lab data was unknown. At the time of report the clinical outcome of the events was unknown.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 3-year-old male patient received a dose of PREVNAR13, lot number #80083 in the left thigh on 10MAY2011. Past vaccine history included four doses of PREVNAR13. Relevant medical history included allergy to grass pollens, week pollens, tree pollens, egg white, corn, maize, peanut, sesame seed, wheat, walnut, milk and soy bean. There is no drug allergies or any other relevant drug history. The child vaccines were not up-to-date. The patient's parents also have unspecified allergies. Concomitant medications were not provided. On 10MAY2011, the patient experienced redness and swelling around the injection site. ON 11MAYh2011, the day after administration of the vaccination, the patient developed swelling on the left thigh and had difficulty walking. The patient recovered from the vaccination site swelling and erythema (11MAY2011). On 12MAY2011, the following day, the patient was evaluated by the reporting physician. Following the evaluation, the physician stated the patient was much improved. The outcome of the events of swelling on the left thigh and difficulty walking were reported as recovering. Follow-up (08JUN2011): New information reported from a contactable physician includes: patient demographics, relevant medical history, dose, details, clinical course and outcome.
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse. A female patient (age unknown) received a dose of PREVNAR13 on an unspecified date. Relevant medical history, concomitant medications and past product history were not reported. Following administration of the vaccine, the patient experienced urticarial rash. The patient's vital statistics at the time of the event were weight 31 lbs, head circumference: 48cm and height 36.5 in. The patient's physical growth was normal and developmental milestones (language/speech; emotional/social; fine/gross motor skills; and cognitive thinking) were all within normal range. Subsequently, on an unspecified date, the patient recovered from the event. Follow-up (23MAR2011): Follow-up attempts completed. No further information expected. Follow-up (18APR2011): New information reported from a contactable nurse includes: clarification that the event was urticarial rash. Follow-up attempts completed. No further information expected.
Age: 0.64
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This  nurse reported similar events for five patients. This is the first of five reports. A 7-month-old female patient received a third dose of PREVNAR13, via intramuscular route of administration, in the left thigh, on 11FEB2011. There was no relevant medical history. Concomitant medications and past product history were not reported. On 12FEB2011, the day after administration of the vaccination, the patient developed a reaction at the injection site consisting of site redness and swelling. It was reported that no treatment was required. Subsequently, on an unspecified date, the patient recovered from the events. According to the reporting nurse, PREVNAR13 was permanently withdrawn. The reporting nurse started that there was a reasonable possibility that the events were related to PREVNAR13. Follow-up (28APR2011): New information reported from the same contactable nurse included patient demographics, dosing information, reaction details, treatment information, updated event outcome, action taken with drug and reporter causality assessment. Also, additional adverse events of site redness and swelling were reported. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is second of five reports. A 3-year-old patient (gender unknown) received the fifth dose of PREVNAR13 (the patient had previously received four doses on unknown dates). The patient received a dose of PREVNAR13, via intramuscular route of administration, in the left arm, on 21MAR2011. Relevant medical history and concomitant medications were unknown. On an unknown date, following administration of the vaccination, the patient developed a reaction at the injection site4 consisting of redness and swelling at the injection site. At the time of this report, the patient outcome was unknown. Follow-up (28APR2011): New information reprot4ee from the same contactable nurse included patient age, dosing information and reaction information. Also additional adverse events of redness at injection site and swelling at injection site were reported. Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A nurse reported similar events for five patients. This is the third of five reports. A nurse reported that a 3-year-old female patient received a fifth dose of pneumococcal conjugate vaccine (the patient had previously received 4 doses on unknown dates). The patient received a dose of PREVNAR13 (lot number 915704) on 09MAR2011 via an intramuscular route of administration in the right arm. The patient had no relevant medical history or relevant concomitant medications and it was reported that the patient is up-to-date on vaccinations. Drug allergies or relevant history was denied. On an unspecified date, the patient developed a reaction at the injection  site characterized by  pain and redness at the injection site. The nurse feels there is a reasonable possibility that the events are elated to PREVNAR13 since the events resulted in a doctor's visit. Relevant laboratory data was unknown. The patient recovered from the events. The nurse did not wish to be contacted for additional information. Follow-up attempts completed. No further information provided. Follow-up (28APR2011): New information re4ported from a contactable nurse includes patient's date of birth and gender, lot number, medical history, product details, and event details leading to the additional codes of vaccination site pain and redness, and outcome.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse. This is fourth of the five reports by the same reporter. A nurse reported on behalf of a 4-year-old male patient who received a 5th dose of pneumococcal conjugate vaccine (previously received 4 doses of pneumococcal conjugate vaccine (dates unknown). The patient received a dose of PREVNAR13 (lot number915065) on 01MAR2011 via an intramuscular route of administration in the right arm. The patient had no relevant medical history or relevant concomitant medications. Drug allergies or re4levant family history was  denied. ON an unspecified date, the patient had a reaction at the injection site characterized by pain and red ness at the site. Relevant laboratory dates was unknown. The patient recovered from the events. The nurse does not wish to be contacted for additional information. Follow-up attempts completed. No further information expected. Follow-up (28APR2011): New information reported from a  contactable nurse includes: patient's date of birth and gender, lot number, medical history, product details, and event details leading to the additional codes of vaccination site pain and redness, and outcome.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This is fifth of five reports by the same reporter. This nurse reported on behalf of a 3-year-old female patient who received a 5th dose of PREVNAR13 (lot number915373), intramuscularly administered into the right arm on 13APR2011. The patient had no relevant medical/drug history. Drug allergies or relevant family history was denied. Concomitant medications were not reported. On 14APR2011, the patient experienced a reaction at injection site characterized by vaccination site redness and swelling. On an unspecified date, the patient also experienced vaccination site pain. The events did not result in a doctor visit. Relevant laboratory data was not provided. The status of therapy was unknown at the time of the report. Therapeutic measures taken in response to event were unknown. The patient recovered from the events. The nurse did not wish to be contacted for additional information. Follow-up attempts completed. No further information expected. Follow-up  (28APR2011): New information reported from a contactable nurse includes: patient's date of birth and gender, lot number, medical history, product details and event details leading to the additional codes of vaccination site pain, swelling and redness, event onset dates, and outcome.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician. A patient (age and gender unknown) received a "supplemental" dose of PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were not reported. Past product history included primary immunization series (not further specified). On an unknown date,, following administration of PREVNAR13, the patient developed an injection site reaction and their entire arm broke out in hives. At the time of this report, the outcome of the events was unknown. Follow-up (20MAY2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer company representative. This physician reported similar events for three patients. This is the first of three reports. Three children, all being administered routine kindergarten immunizations, 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 PREVNAR13. It was reported that "the site was swollen the size of a softball, hard, and warm to the touch". Two of the children also had hives at the site At the time of this report, the outcome of the events was unknown. Follow-up (27MAY2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. The physician reported similar events for three patients all getting kindergarten routine immunizations. This is the second of three reports. The patient (sex and origin unknown) received a dose of PREVAR (injection) on an unknown date. Past relevant medical history and concomitant medication were not reported. On an unspecified date, the patient experienced vaccination site swollen to the size of a softball, hard, and warm to the touch. Two of the children also had hives at the site Treatment was not reported. The outcome of the events was unknown. Follow-up (27MAY2011): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: HEP, PNC13
Symptoms: Crying, Irritability
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for six patients. This is the second of six reports. A male patient (age unknown) received a dose of PREVNAR13 on an unknown date. Relevant medical history was unknown. Relevant concomitant medications included hepatitis B on an unknown date. On an unknown date, the patient experienced irritability and inconsolable crying. Relevant laboratory data were unknown. Therapeutic measures taken in response to event were unknown. The patient recovered from the events on an unknown date after three to four days. Follow-up (06JUN2011): This is a follow-up spontaneous report from the same contactable nurse. The nurse reported that she had only reported on one patient, but had receive five letters, for the same patient, in error. As a result, five cases were erroneously created regarding the same patient. There is actually only one patient and one valid case (201111773).
Sex: M
Vaccine: PNC13
Symptoms: Crying, Irritability
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for six patients. This is the fourth of six reports. A patient (gender, age and race unknown) received a dose of PREVNAR13 on an unknown date. Relevant medical history was unknown. Relevant medical history and concomitant medications were unknown.  On an unknown date, the patient experienced irritability and inconsolable crying. Relevant laboratory data were unknown. Therapeutic measures taken in response to event were unknown. The patient recovered after a couple of weeks on an unknown date. Follow-up (06JUN2011): This is a follow-up spontaneous report from the same contactable nurse. The nurse reported that she had only reported on one patient, but had receive five letters, for the same patient, in error. As a result, five cases were erroneously created regarding the same patient. There is actually only one patient and one valid case (201111773).
Sex: M
Vaccine: PNC13
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. This is fifth of the six cross linked reports from the same reporter. This reporter called for a male patient (rage and age unknown) who received  PREVNAR13 on an unknown date at an unknown dose. The relevant medical history  and concomitant medications were unknown. On an unknown date, the patient experienced irritability fever and inconsolable crying. Relevant laboratory data were unknown. Last action taken with vaccination in response to events were not applicable. Therapeutic measures taken in response to event were unknown. At time of reporting clinical outcome of the event was unknown. Follow-up (06JUN2011) This is a follow-up spontaneous report from the same contactable nurse. The nurse reported that she had only reported on one patient, but had receive five letters, for the same patient, in error. As a result, five cases were erroneously created regarding the same patient. There is actually only one patient and one valid case (201111773).
Sex: M
Vaccine: PNC13
Symptoms: Crying, Irritability
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for six patients. This is the third of six reports. A male patient (age and race unknown) received a dose of PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were unknown. On an unknown date, the patient experienced irritability and inconsolable crying. Relevant laboratory data were unknown. Therapeutic measures taken in response to event were unknown. At time of reporting,  the patient had recovered on an unknown date after experiencing the events for couple of weeks. Follow-up (06JUN2011): This is a follow-up spontaneous report from the same contactable nurse. The nurse reported that she had only reported on one patient, but had receive five letters, for the same patient, in error. As a result, five cases were erroneously created regarding the same patient. There is actually only one patient and one valid case (201111773).
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report by a contactable nurse. This is second of the three reports. This nurse reported that a patient (age and gender unknown) received PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were unknown. Other vaccines given to the patient were not reported. Vaccines taken within the last four weeks were unknown. On an unknown date after vaccination, the patient experienced swelling and redness at the site of injection. Relevant lab data was unknown. Treatment regimen was not reported. At the time of the report the clinical outcome of the above event was unknown. Follow-up (14JUL2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report by a contactable nurse. This is first of the three reports. This nurse reported that a patient received PREVNAR 13 on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date after vaccine administration, the patient experienced swelling and redness at the site of injection. Relevant lab data was unknown. Treatment regimen was not reported. At the time of the report the clinical outcome of the above event was unknown. Follow-up (14JUL2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable nurse. A patient (age and gender unspecified) received a dose of PREVNAR 13 on an unspecified date. On an unspecified date, the patient developed a rash. The outcome was unknown. Follow-up (04AUG2011): Follow-up attempts completed. No further information 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 Pfizer sales representative. This nurse reported similar events for six patients. This is the second of six reports. A patient received PREVNAR 13, on an unspecified date, for vaccination. Relevant medical history, concomitant medication 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 the injection. It was reported that no emergency room or physician visit was required. At the time of this report, the outcome of the event was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report by a contactable nurse via a Pfizer Sales Representative. This nurse reported similar events for six patients. This is the fourth of six reports. A patient (age, sex and race unknown) received a dose of PREVNAR 13 as a schedule vaccination on an unknown date. Relevant medical history and concomitant medications were unknown. On an unknown date after being administered the PREVNAR 13, the patient experienced dark red, hard, and raising swelling at the site of injection. Relevant lab data was unknown. At the time of the report, the clinical outcome was unknown. Follow-Up (04Aug2011) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Skin reaction, Skin swelling
Clinical narrative: This is a spontaneous report from a contactable infectious disease pediatrician. This pediatrician reported similar events for five patients. This is the third of five reports. A patient (of 2, 3 or 4 years of age and gender unknown) received a dose of PREVNAR 13 on an unspecified date. Relevant medical history and concomitant medications were not provided. On an unspecified date, the patient developed a skin reaction and skin swelling. The pediatrician reported that one of their practices was seeing an increase in the amount of skin reactions to PREVNAR 13 in 2, 3, and 4-year-olds with the vaccine. The skin reactions were greater than 2.5 inches in diameter and they were seeing approximately five children a week with this type of swelling. The outcomes for the events were unknown.
Sex: U
Vaccine: PNC13
Symptoms: Skin reaction, Skin swelling
Clinical narrative: This is a spontaneous report from a contactable infectious disease pediatrician. This pediatrician reported similar event for five patients. This is the truth of five reports. A patient (of 2, 3 or 4 years of age and gender unknown) received a dose of PREVNAR 13 on an unspecified date. Relevant medical history and concomitant medications were not provided. On an unspecified date, the patient developed a skin reaction and skin swelling. The pediatrician reported that one of their practices was seeing an increase in the amount of skin reactions to PREVNAR 13 in 2, 3, and 4-year-olds with the vaccine. The skin reactions were greater than 25 inches in diameter and they were seeing approximately 5 children a week with this type of swelling. The outcome of the events were unknown.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported to a Pfizer Sales Representative on behalf of a patient who began on PREVNAR 13 unknown dose for an unknown indication on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. On an unknown date after vaccination, the patient had a fever. Relevant lab data was unknown. At the time of the report the clinical outcome of the event was unknown. Follow-up (08JUL2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report by a contactable nurse. This is third of the three reports. This nurse reported that a patient received PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were unknown. Vaccines taken within the last four weeks were not provided. On an unknown date after vaccination, the patient experienced swelling and redness at the site of injection. Relevant lab data was unknown. Treatment given was not provided. At the time of the report the clinical outcome of the above event was unknown. Follow-up (14JUL2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Skin reaction, Skin swelling
Clinical narrative: This is a spontaneous report from a contactable infectious disease pediatrician. This pediatrician reported similar events for five patients. This is the fifth of five reports. A patient (2, 3, or 4 years of age) (gender unknown) received a dose of PREVNAR 13 on an unspecified date. Relevant medical history, concomitant medications, and past drug events were not provided. On an unspecified date, the patient developed skin reaction and skin swelling. The pediatrician reported that one of their practices is seeing an increase in the amount of skin reactions to PREVNAR 13 in 2, 3, and 4-year-olds with the vaccine. The skin reactions are greater than 2.5 inches in diameter and they are seeing approximately five children a week with this type of swelling. The outcomes for the events were unknown.
Sex: U
Vaccine: PNC13
Symptoms: Skin reaction, Skin swelling
Clinical narrative: This is a spontaneous report from a contactable infectious disease pediatrician. This pediatrician reported similar events for five patients. This is the second of five reports. A patient (of 2, 3 or 4 years of age and gender unknown) received a dose of PREVNAR 13, on an unspecified date. Relevant medical history, concomitant medications and past product history were not provided. On an unknown date, following administration of the vaccination, the patient developed a skin reaction and skin swelling. The pediatrician further commented that one of their practices was seeing an increase in the amount of skin reactions to PREVNAR 13 in 2, 3, and 4-year-olds. The skin reactions were described as being greater than 2.5 inches in diameter and they were seeing approximately five children a week with this type of swelling. At the time of this report, the outcome of the events was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Colitis
Clinical narrative: This is a spontaneous report from a contactable mother reporting on behalf of her son. A male patient (age unknown) received a dose of PREVNAR 13 on an unknown date. Relevant medical history includes an allergy to any derivatives of soy. Concomitant medications were not provided. On an unspecified date, the patient experienced colitis. On an unknown date the patient had a reaction to the PREVNAR 13 (reaction not further specified). The patient's mother further inquired about PREVNAR 13 containing soy proteins, coconut oil, or any coconut derivative. The mother noted that she confirmed with medical facility that PREVNAR 13 has derivatives of soy and that it should be labeled properly. The outcome of the event was unknown. Follow-up (12Aug2011): Follow-up attempts completed. No further information expected. Follow-up (30Aug2011): New information reported from the contactable consumer includes: medical history.
Sex: M
Vaccine: PNC13
Symptoms: Crying, Injection site erythema, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A male infant (age unknown) received a dose of PREVNAR 13, Lot number 916598) on an unspecified date. Relevant medical history and concomitant medications were not provided. The patient experienced a lot of redness at the injection site and crying for several hours after being administered the vaccine. Therapeutic measures taken as a result of the events included treatment with TYLENOL. About 30 to 40 minutes after treatment to mitigate any pain, the patient had settled down. Outcome was unknown. Follow-up (30Aug2011): New information reported from this contactable consumer includes: patient and physician informed and lot number.
Sex: U
Vaccine: PNC13
Symptoms: Skin reaction, Swelling
Clinical narrative: This physician reported similar events for five patients. Thi sis the first of five reports. This case is non-serious. A child of unknown age and ex was administered a dose of PREVNAR 13, by unknown route of administration on an unknown date. Relevant medical history and concomitant medications were not reported. The physician was an infectious disease pediatrician. He reported that the patient had an unspecified skin reaction and swelling. He stated that a one of their practices, he was seeing an increase in the amount of skin reactions to PREVNAR13 in the 2.4 and 4-year old children receiving this vaccine. The skin reactions were greater than 2 & 1/2 inches in diameter, and they were seeing 5 kids a week at that practice with his swelling. The outcome was unknown.
Age: 7.0
Sex: M
Vaccine: PNC13
Symptoms: Respiratory disorder
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient (the grandson of the consumer) received a dose of PREVENAR 13, which was reported as pneumococcal C, on an unspecified date. The number of previous doses was unspecified. The patient, currently aged 7 years, developed respiratory issues on an unspecified date. The patient's physician reported that he might have missed a dose of pneumococcal C in the past and was considering a supplemental dose. The reporter was not sure of which vaccines were missed. Therapeutic measures taken as a result of the event included treatment with steroids, SINGULAIR and ADVAIR inhaler, for six months. The outcome was unknown. Follow-up (05Aug2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer representative. The physician informed that another physician's patient (age, gender unknown) received PREVNAR 13 on an unknown date. On an unknown date, the patient required hospitalization due to high fever after immunization. Outcome of the event is unknown.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative with follow-up from the contactable physician. A four-year-old female patient was administered a dose of PREVNAR intramuscularly in the right leg on 19Apr2011. A dose of DTAP was also administered intramuscularly in the same right leg on 19Apr2011. Relevant medical history was not reported. Concomitant medications were not used. Other illnesses were not reported. On 20Apr2011, the patient experienced local swelling on the vaccinated leg of 13 to 14 cm area, described as local reaction to vaccines. The patient returned to the doctor's office on 21Apr2011, and a physical examination confirmed the swelling. The outcome was unknown. The physician reported that she had noticed an increase in the number of large local reactions with PREVNAR 13 in children greater than 3.5 years-old, and questioned what would be the reason for a more elevated local reaction. Follow-up (14Jun2011): This spontaneous follow-up report from a contactable physician included: patient demographics, suspect product and administration date, description of event, event onset date, resolution unknown, concomitant medications not used, no medical history, physician comments.
Sex: U
Vaccine: PNC13
Symptoms: Insomnia
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A patient (age and gender unknown), on an unspecified date. Relevant medical history, concomitant medications and past product history were unknown. On an unknown date following administration of the vaccination, the patient developed difficulty in sleeping. At the time of this report, the outcome of the event was unknown. Follow-up (05AUG2011): Follow-up attempts completed. No further information expected.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, Therapy change
Clinical narrative: This is a spontaneous report by a contactable nurse. A 4-year-old male patient received a dose of PREVNAR 13 0.5 ml intramuscular injection at 11 AM on right deltoid of the arm as a recommended vaccination on 21Jun2011. Relevant medical history and concomitant medication was none. Relevant vaccine history included the first three doses of PREVNAR. This constituted a therapy regimen change. On 22Jun2011 the patient experienced an extremely swollen right arm. Outcome was unknown at time of report. Follow up (30Jun2011): New information reported from the contactable nurse includes: outcome changed to unknown and clinical details.
Sex: M
Vaccine: PNC13
Symptoms: Circumstance or information capable of leading to medication error, Scratch
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A male patient (age unknown) received a dose of PREVNAR 13 on 29Oct2011. Relevant medical history and concomitant medications were unknown. On 29Oct2011, during vaccination, the patient moved and the needle of the vaccine scratched his finger. Relevant laboratory data were unknown. Therapeutic measures taken as a result of the event were unknown. The clinical outcome of the event was unknown at the time of report.
Sex: U
Vaccine: PNC13
Symptoms: No therapeutic response
Clinical narrative: This is a spontaneous report from a contactable physician. A child (age and gender unknown) received the 4 dose series of PREVNAR 13, at 1 DF. Relevant medical history and concomitant medications were not provided. The patient received the previous 3 doses of PREVNAR 13 on unspecified dates. The physician reported that the serotype analysis shows an incomplete response. Therapeutic measures taken for the event were unknown. The outcome of the event is unknown. Follow-up (13Jan2012): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: No therapeutic response
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck from a nurse. A 27-month-old male patient received the first dose of PREVENAR 13 in Sep-2011. Relevant medical history includes therapy regimen changed from PREVNAR to PREVNAR 13, genetic anomaly, defective immune system, and immunoglobulin A deficiency. Concomitant medications were not reported. Past vaccine history included 4 doses of PREVNAR administered on unknown dates. On an unknown date the patient was reported to have a low immune response to PREVNAR 7. No pneumococcal event was reported and no additional information was reported. The outcome was unknown. The reporter mentioned that the patient had genetic anomaly, defective immune system, immunoglobulin A deficiency and this probably would be the reason that the patient did not respond to the PREVNAR 13. FOLLOW UP # 01 (17JAN2012): New information from a contactable reporter who was calling from a physicians office provided patient information, additional medical history and other cause of event.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a sales representative. A patient (age and gender unknown) received a dose of PREVNAR 13 and on unspecified date. Relevant medical history and concomitant medications were unknown. The nurse wanted to know "why does PREVNAR 13 hurt more than the rest?" Outcome was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Eye disorder
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a sales representative. A male patient (age unknown) received a dose of PREVNAR13 intramuscularly in DEC2011. Relevant medical history, concomitant medications and past product history were not provided. On an unknown date following administration of PREVNAR13, the patient developed an unspecified reaction in the eye. Subsequently, the patient was taken to the emergency room for evaluation (not further specified). The outcome of the event at the time of the report was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is an initial spontaneous report from a non contactable physician. This physician reported for a patient. This 4 year old, patient (gender, race unknown) received PREVNAR 13 intramuscularly on an unknown date. Relevant medical history and concomitant medication of the patient were unknown. It was reported that on an unknown date in Jan2012 the patient experienced large red area with puffiness and tenderness at the site of injection in arm being administered with PREVNAR 13. Relevant laboratory tests were unknown. Therapeutic measures taken in response to the event reported were unknown. The patient had recovered from the event tenderness after 10 days of experiencing it and had not recovered from the event large red area with puffiness.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Crying
Clinical narrative: This is a spontaneous report from a contactable nurse. A 3-month-old male patient received a dose of PREVNAR 13 at 1013 hrs in the left thigh, a dose of Rotavirus vaccine, and a dose of PENTACEL all on an unknown date. Relevant medical history and concomitant medications were not reported. On an unknown date, the patient experienced crying. The patient recovered on an unknown date.
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable medical assistant. A female child received a dose of PREVNAR13 on an unspecified date. Relevant medical history, concomitant medications and past product history were not provided. On an unknown date, following administration of the vaccination, the child developed a large welt on her leg. An emergency room or doctor visit was not required. The outcome of the event at the time of the report was unknown. Follow-up (29FEB2012). Follow-up attempts completed. No further information expected.
Age: 0.24
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient's mother. A 3-month-old male patient received a dose of PREVNAR13 intramuscularly in the thigh and the first dose of ACT-HIB intramuscularly at 14:00 on 09JAN2012. The patient had no relevant medical history or relevant concomitant medications. Vaccines taken within the last four weeks were none. On 09JAN2012, the patient had decreased sleep. Relevant lab data was none. The event did not require an emergency room or doctor visit, At the time of the report, the patient had not recovered from the event.
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Crying, Dysphonia, Haemorrhage, Hypersomnia
Clinical narrative: This is a spontaneous report from a contactable father. A female patient (age unknown) received a dose of PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient experienced bruising, bleeding, fever, slept more, high pitched crying and voice changes (hoarse). The father noted that they were trying to find a cause for the bleeding and bruising because they were being accused of causing th events. The outcome of the events were unknown.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable father. A female patient (age unknown) received a dose of PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient experienced bruising, bleeding, fever, slept more, high pitched crying and voice changes (hoarse). The father noted that they were trying to find a cause for the bleeding and bruising because they were being accused of causing th events. The outcome of the events were unknown.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Crying
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a sales representative. A 3-year-old female patient received "a supplemental dose" of PREVNAR13, intramuscular, on 18NOV2010. Relevant medical history, concomitant and past product history were not reported. On 18NOV2010, following administration of the vaccination, the patient developed high-pitched, prolonged crying. At the time of this report, the outcome of the event was unknown. Follow-up (29AUG2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a sales representative. A patient (age and gender unknown) received a dose of PREVNAR13 and a dose of FLUVIRIN, both on an unspecified date. Relevant medical history, concomitant medications and past product history were not reported. On an unknown date, following administration of the vaccinations, the patient developed a fever. Subsequently, on an unknown date, the  fever resolved.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician. A patient (sex and age unknown0 was administered a dose on PREVNAR13 by an unknown route of administration on an unknown date. Medical history was not reported. Concomitant medications were not reported. After vaccination , on an unknown date, the patient developed a rash on the thigh . The outcome was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is an initial spontaneous report by a contactable nurse via a sales representative. This is first of the six reports.  A patient (race/gender unknown) received a dose of PREVNAR13, administered on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Past product or vaccines given on the same day were unknown. On an unknown date, the patient experienced dark red, hard and raised swelling at the site of injection that did not require an emergency room or doctor visit. Relevant laboratory data was unknown. At the time of the report the clinical outcome of the events was unknown. Follow-up (05AUG2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report by a contactable nurse via a sales representative. This nurse reported similar events for six patients. Thi sis the sixth of six reports. A patient (age, sex and race unknown) received a dose of PREVNAR13 as a scheduled vaccination on an unknown date. Relevant medical history and  concomitant medications were unknown. ON an unknown date after being administered the PREVNAR13, the patient experienced dark red, hard and raised swelling at the site of injection. Relevant lab data was unknown. At the time of the report, the clinical outcome was unknown. Follow-up (05AUG2011): Follow-up attempts completed. No further information expected.