chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Erythema, Hypersensitivity, Impetigo, Injection site induration
Clinical narrative: FOLLOW UP INFORMATION CONTAINED additional safety information from the physician regarding PREVNAR 13 was received from a healthcare professional regarding a 3 year old female patient who experienced vaccination site swelling, rash in buttocks, approximately 20 red papules all small, acting a little less energetic than usual, right thigh with 2 small area that were warm to touch and firm, local allergic reaction to vaccine, impetigo, right thigh with 2 small area that were warm to touch and firm, right thigh with 2 small area that were warm to touch and firm, listlessness and fever. The patient received a dose on 14 Jun 2010. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on 14 Jun 2010. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced vaccination site swelling on 14 Jun 2010, rash in buttocks, approximately 20 red papules all small, acting a little less energetic than usual, right thigh with 2 small area that were warm to touch and firm, local allergic reaction to vaccine, impetigo, right thigh with 2 small area that were warm to touch and firm and right thigh with 2 small area that were warm to touch and firm on 15 Jun 2010 and listlessness and fever on 16 Jun 2010. Patient was treated with BENADRYL and TYLENOL for the hypersensitivity and KEFLEX oral suspension for the impetigo. The outcomes of the events were not reported. TEST RESULTS: Body temperature (results: 99.1 deg. F.) was done on 15 Jun 2010. Additionally, physical examination (results: normal) was done on an unspecified date. No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Listless, Papule, Pyrexia, Rash
Clinical narrative: FOLLOW UP INFORMATION CONTAINED additional safety information from the physician regarding PREVNAR 13 was received from a healthcare professional regarding a 3 year old female patient who experienced vaccination site swelling, rash in buttocks, approximately 20 red papules all small, acting a little less energetic than usual, right thigh with 2 small area that were warm to touch and firm, local allergic reaction to vaccine, impetigo, right thigh with 2 small area that were warm to touch and firm, right thigh with 2 small area that were warm to touch and firm, listlessness and fever. The patient received a dose on 14 Jun 2010. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on 14 Jun 2010. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced vaccination site swelling on 14 Jun 2010, rash in buttocks, approximately 20 red papules all small, acting a little less energetic than usual, right thigh with 2 small area that were warm to touch and firm, local allergic reaction to vaccine, impetigo, right thigh with 2 small area that were warm to touch and firm and right thigh with 2 small area that were warm to touch and firm on 15 Jun 2010 and listlessness and fever on 16 Jun 2010. Patient was treated with BENADRYL and TYLENOL for the hypersensitivity and KEFLEX oral suspension for the impetigo. The outcomes of the events were not reported. TEST RESULTS: Body temperature (results: 99.1 deg. F.) was done on 15 Jun 2010. Additionally, physical examination (results: normal) was done on an unspecified date. No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site swelling
Clinical narrative: FOLLOW UP INFORMATION CONTAINED additional safety information from the physician regarding PREVNAR 13 was received from a healthcare professional regarding a 3 year old female patient who experienced vaccination site swelling, rash in buttocks, approximately 20 red papules all small, acting a little less energetic than usual, right thigh with 2 small area that were warm to touch and firm, local allergic reaction to vaccine, impetigo, right thigh with 2 small area that were warm to touch and firm, right thigh with 2 small area that were warm to touch and firm, listlessness and fever. The patient received a dose on 14 Jun 2010. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on 14 Jun 2010. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced vaccination site swelling on 14 Jun 2010, rash in buttocks, approximately 20 red papules all small, acting a little less energetic than usual, right thigh with 2 small area that were warm to touch and firm, local allergic reaction to vaccine, impetigo, right thigh with 2 small area that were warm to touch and firm and right thigh with 2 small area that were warm to touch and firm on 15 Jun 2010 and listlessness and fever on 16 Jun 2010. Patient was treated with BENADRYL and TYLENOL for the hypersensitivity and KEFLEX oral suspension for the impetigo. The outcomes of the events were not reported. TEST RESULTS: Body temperature (results: 99.1 deg. F.) was done on 15 Jun 2010. Additionally, physical examination (results: normal) was done on an unspecified date. No additional information was available at the time of this report.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Abnormal behaviour, Aggression, Anger, Emotional distress, Mental status changes
Clinical narrative: This is an spontaneous report from a contactable nurse. This nurse reported to Pfizer sales representative that a 30-month-old female patient received her first dose of PREVNAR 13 on 15OCT2010 at about 0815, in her left thigh, used as a one time booster dose for vaccination. The patient had the following relevant medical history: this child has a history of constipation, which was treated with MIRALAX; patient had a very calm and pleasant temperament during past visits at the pediatricians office. She had always been very cooperative; She had never had a major meltdown or any mental status changes prior to using PREVNAR 13. MIRALAX was a concomitant medication. The patient's drug history is relevant for having previously received 4 doses of PREVNAR 7 on separate occasions with on adverse events. On 15OCT2010, about 10 hours after the patient received the booster injection of PREVNAR 13, at 1815, the infant suddenly had a major meltdown at dance class. The major meltdown consisted of mental status changes. She had an uncontrollable fit, she showed a lot of anger toward her normal daily activities such as when she attempted to get dressed, when she had to use the potty, when she had to go to daycare. Her general demeanor was angry. As an example, she kicked the side of the bathtub and pulled her mothers hair prior to receiving a bath. Then, she snapped out of the mental status changes abruptly, and her behavior returned to normal so suddenly that it was a shock to her mother. Although she quickly snapped out of the mental status changes, she continued to have them on a regular basis. They were episodic, beginning suddenly and ending suddenly. In OCT2010, she also had begun experiencing the following events without improvement: nightmares, 3 to 4 nights a week, phobias of strings or anything hanging on her shirt or clothing, and she had panic attacks. There was no relevant laboratory data, relevant diagnosis, or treatment received. The events continue as described. Follow-up 10NOV2010 included product information, event details, medical history, patient demographics, and outcome.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Nightmare, Panic attack, Phobia
Clinical narrative: This is an spontaneous report from a contactable nurse. This nurse reported to Pfizer sales representative that a 30-month-old female patient received her first dose of PREVNAR 13 on 15OCT2010 at about 0815, in her left thigh, used as a one time booster dose for vaccination. The patient had the following relevant medical history: this child has a history of constipation, which was treated with MIRALAX; patient had a very calm and pleasant temperament during past visits at the pediatricians office. She had always been very cooperative; She had never had a major meltdown or any mental status changes prior to using PREVNAR 13. MIRALAX was a concomitant medication. The patient's drug history is relevant for having previously received 4 doses of PREVNAR 7 on separate occasions with on adverse events. On 15OCT2010, about 10 hours after the patient received the booster injection of PREVNAR 13, at 1815, the infant suddenly had a major meltdown at dance class. The major meltdown consisted of mental status changes. She had an uncontrollable fit, she showed a lot of anger toward her normal daily activities such as when she attempted to get dressed, when she had to use the potty, when she had to go to daycare. Her general demeanor was angry. As an example, she kicked the side of the bathtub and pulled her mothers hair prior to receiving a bath. Then, she snapped out of the mental status changes abruptly, and her behavior returned to normal so suddenly that it was a shock to her mother. Although she quickly snapped out of the mental status changes, she continued to have them on a regular basis. They were episodic, beginning suddenly and ending suddenly. In OCT2010, she also had begun experiencing the following events without improvement: nightmares, 3 to 4 nights a week, phobias of strings or anything hanging on her shirt or clothing, and she had panic attacks. There was no relevant laboratory data, relevant diagnosis, or treatment received. The events continue as described. Follow-up 10NOV2010 included product information, event details, medical history, patient demographics, and outcome.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reports similar events of 2 different children. This is the second of 2 reports. This physician reports about a 3-year-old girl received PREVNAR 13, dose and indication unknown, on 05Nov2010; the dose at the onset of events was unknown. Relevant medical history, concomitant medications, and medication history are unknown. It is unknown if the patient had received any other vaccines at the same time or within the previous 4 weeks. After receiving PREVNAR 13, the patient experienced pain and a rash above the injection site. There is no relevant laboratory data, diagnosis, or action taken. As of 10Nov2010, it is unknown if the patient continued on PREVNAR 13. The outcome of the events was unknown.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 34 month old female patient who experienced swelling of leg, from the knee to the thigh, which was warm to the touch. At 34 months of age, the patient received a dose on 17 Sep 2010. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on 17 Sep 2010. Dose regimen 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced swelling of leg, from the knee to the thigh, which was warm to the touch on 17 Sep 2010. Diphenhydramine was administered as treatment, which helped a little. The outcome is unknown. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to receive PREVNAR, via an unspecified route of administration, on 05JAN2015. The patient's medical history and concomitant medications were not reported. The patient experienced injectable site is red and hot to the touch on 10JAN2015. The outcome of experienced injectable site is red and hot to the touch was unknown. Follow-up (19FEB2015): Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Irritability, Malaise, Pain in extremity
Clinical narrative: Information regarding PREVNAR 13 vaccine was received from a healthcare professional regarding a 3 year old male patient who experienced fussy, acting like he didn't feel well and soreness of legs. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced fussy, acting like he didn't feel well and soreness of legs. The outcome of the events is unknown. No additional information was available at the time of this report.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Abnormal behaviour, Constipation
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 16-month-old female patient who was reported to be not acting like herself, straining to have a bowel movement because she was severely constipated and stool came out as half the size of M & M and hard like rock. At 16 months of age, the patient received the first dose on 19-Aug-2010. MEDICAL HISTORY: The patient previously experienced no adverse event while PREVNAR. The patient had previously received 4 doses of PREVNAR prior to 18 months. PRODUCT DETAILS: Indication for PREVNAR 13 was immunization. Product was administered on 19-Aug-2010. Dose regimen was 1 dose 1 time per day (intramuscular). CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: In Aug-2010, a few days after receiving PREVNAR 13, The patient was not acting like herself, and was straining to have a bowel movement because she was severely constipated. The mother noted that "nothing had changed in the patient's diet". The mother gave the patient more water, apple and prune juice and fiber but the patient remained constipated. The mother reported she now has to give the patient enema, but the patient's stool still came out as half sized of an M & M and was hard like a rock. The events persisted. No additional information was available at the time of this report. Follow-up (10Nov2010): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. This is a spontaneous follow-up report from a contactable nurse. The patient's surname, the name of the nurse who administered the vaccine, the Country where the vaccine was administered and the vaccine Lot # (913955) were additionally provided. The patient was born at full term. The patient's mom called for phone advice for her baby's constipation on 07Oct2010 and stated her child had had problem with constipation since 19Aug2010. The patient's birth weight was 6.7 oz, head circumference was 33 cm and she was 19 inches high. she had no siblings. The patient's mom was given advice for constipation on 07Oct2010, she was advised to start the child on MIRALAY, to stop potty training for 3 months, which was considered as a risk factor that may have contributed to the patient's adverse event and to continue high fibers diet and increase fluid intake. No further concerns about constipation have been received in the nurse's office after that time.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced injection site pain, swelling and excessive redness. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced injection site pain, swelling and excessive redness. Outcome was unknown. No additional information was available at the time of this report. MANUFACTURER'S COMMENT: The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced injection site pain, excessive redness and excessive swelling. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced injection site pain, excessive redness and excessive swelling. Outcome was unknown. No additional information was available at the time of this report. MANUFACTURER'S COMMENT: The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced injection site pain, excessive redness and excessive swelling. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The patient experienced injection site pain and excessive swelling. Outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a physician regarding a patient who experienced "large swelling areas in the limbs which was more than expected". The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication of PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced "large swelling areas in the limbs which was more than expected". Outcome was unknown. No additional information was available at the time of this report. RELATED CASE (S): See related case (s): US WYE H18212110 (adverse event, expedited).
Sex: U
Vaccine: PNC13, RV5
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a physician regarding a "population of patients" 5 years old and under who experienced pain and swelling at injection site when PREVNAR 13 and ROTATEQ were given together. The patients received a dose on unspecified dates. The patients experienced pain and swelling at injection site when PREVNAR 13 and ROTATEQ were given together. Outcome for event was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: New information in product details and event details regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced PREVNAR 13 hurts worse for everybody then other vaccines. The patients received a dose in 2009. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered in 2009. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patients experienced PREVNAR 13 hurts worse for everybody than other vaccines in 2009. Outcome was unknown. No additional information was available at the time of this report. It has been determined that US WYE H16088719 is a duplicate report of US WYE H17546510. Therefore, the reports are being consolidated into US WYE H17546510, which will remain the official case of record.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 1-year-old patient who experienced swelling at injection site and redness at injection site. The patient received a dose sometime in 2010. Relevant medical history was not provided. The patient received other unknown immunizations (manufacturer unknown) at the same time as PREVNAR 13. The patient experienced swelling at injection site and redness at injection site in 2010. The patient's mom was told to apply ice to the site. The outcome for swelling and redness at injection site were unknown. No additional information was available at the time of this report. Follow-up Report (17Nov2010): This is a spontaneous report from a contactable physician. The physician reports that this female infant recovered from the events on an unknown date. Patient's current weight is 20 lbs 11 oz, with head circumference of 18 cm and a height of 28 and 1/4 inches. Child's physical growth has been normal and she has not failed to meet any developmental milestones since starting the medication. Developmental milestones history for Language/Speech, Emotional/Social, Fine/Gross Motor Skills, and Cognitive thinking prior to starting the medication were also reported as normal.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Bronchiolitis, Cough, Wheezing
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 4 month old female patient who experienced bronchiolitis described as coughing and wheezing. The patient received the second dose in Aug 2010 and the first dose in Apr 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. The dose regimen was 1 dose 1 time per day in Apr 2010 and then was 1 dose 1 time per day in Aug 2010. Additional suspect medication included ROTARIX. Concomitant medications were not reported. About two weeks after the patient received her initial dose of PREVNAR 13, in Apr 2010 or May 2010, she began to experience having bronchiolitis described as wheezing and coughing. She was treated with inhalation of unspecified nebulized medications. The reporter states she brought her daughter to a physician, then to an emergency room due to bronchiolitis, however her daughter was not admitted to the hospital and there were no laboratory tests performed due to the event. In 2010, bronchiolitis resolved. On 31 Aug 2010, she received her next dose of PREVNAR 13 and she was not given any other vaccinations at this time. On 01 Sep 2010, the coughing and wheezing returned due to which the patient again saw a physician on 03 Sep 2010 and due to which the patient was restarted on inhalation of nebulized medications once more. In 2010 after her recurrence of symptoms the reporter states her daughter's physician said she had never heard of the patient's event being associated with PREVNAR 13, however the reporter states she has done research and found information that reads similar events have been associated with PREVNAR 13. On an unspecified date, in 2010 the event resolved for the second time. No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 3-year-old female patient who experienced area was swollen and puffy and area or redness at the injection site- involved 4.5 to 5 inches. At 3 years of age, the patient received the first dose in 2010. The patient's concurrent illness includes therapy regimen changed (patient received 4 doses of PREVNAR 7 vaccine in the past). Healthy child. Indication for PREVNAR 13 was immunisation. Product was administered in 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced area was swollen and puffy at the injection site-involved 4.5 to 55 inches and area of redness at the injection site on an unknown date in 2010. Unknown immunizations had been administered to the child at the same time (vaccines and administrations sites were not reported). The physician had the child come in to the office daily and ice was applied to the site. The redness and swelling resolved on an unknown date in 2010. No additional information was available at the time of this report. Follow-up (17Nov2010): This is a follow-up report from a contactable health care professional. Vaccination Lot #: E47475. The vital statistics at time of adverse event included a weight of 33 lbs and a height of 3ft 3/4 inches. The health care professional administered the vaccine to the patient. The vaccine was not altered in any way to accommodate administration. The medicine was stored as per manufacturer's instructions. Developmental milestones including language/speech, emotional/social, fine/gross motor skills, and cognitive thinking were all with normal range. The child has not failed to meet any developmental milestones since receiving the vaccine. The child's physical growth has been normal. The outcome of the event is recovered.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced swelling and redness at the injection site. The patients received a dose in 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered in 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patients experienced swelling and redness at the injection site on unknown dates in 2010. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a one of six patients who experienced excessive redness the size of a softball or larger. The patient received a dose in 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered in 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced excessive redness the size of a softball or larger in 2010. The injection site was treated with application of heat and MOTRIN with subsequent resolution the next day in 2010. As of 31 Aug 2010, it is unknown if the excessive redness at the resolution site in these children have resolved. No additional information was available at the time of this report.
Age: 1.53
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding an 18 month old male patient who experienced diarrhea. At 18 months of age, the patient received a dose on 19 Aug 2010. Negative for reactions to vaccines or any illness at the time. Indication for PREVNAR 13 was immunisation. Product was administered on 19 Aug 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced diarrhea on 21 Aug 2010. The patient was recovering. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced injection hurting more, swelling at injection site and redness at the injection site. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced injection hurting more, swelling at injection site and redness at the injection site. The outcome for the events was not reported. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced vaccination site pain. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced vaccination site pain. The outcome for this event was not reported. No additional information was available at the time of this report.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Injection site erythema, Injection site warmth
Clinical narrative: This is an initial spontaneous report from a contactable registered medical assistant via a Pfizer sales representative. A 4.5-year-female patient received a dose of PREVNAR 13 in her left thigh on 22Oct2010 as a catch up supplemental vaccine. No other vaccines were given. The patient's relevant medical history, past drug history, and concomitant medications are unknown. Within a day or two after the vaccine was given, the injection site was red and it was warm to touch. On 24Oct2010 the patient was taken to the emergency room and was diagnosed as having allergies to vaccine. There was no relevant lab test done or treatment given. The patient had recovered from the events within 24 hours.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: This is a spontaneous report from a contractible registered medical assistant (RMA) via a sales representative. A 3-year-old male patient received a dose of PREVNAR13 on 06AUG2010 as a catch up suppl3ekental vaccine. The patient's relevant medical history, past drug history, and concomitant medications were unknown. No other vaccines were given. Within a day or two after the vaccine was given, there was a red "knot" on the injection site and it was warm to touch. There was no relevant lab test done, diagnosis or treatment given. In AUG2010, within 24 hours, the adverse events were gone and patient had recovered from the events.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reports similar events on 2 different children. This is the first of 2 reports. This physician reports as 29-month-old male received a dose of PREVNAR 13, solution for injection in pre-filled syringe, indication unknown, on 08Sep2010. Relevant medical history, concomitant vaccines and medications, and medication history are unknown. On an unspecified date in 2010, the patient experienced pain and a rash above the injection site. There is no relevant laboratory data. Treatment of the events was unknown. As of 10Nov2010, the injection site rash had resolved after a few days. The outcome of the injection site pain was unknown.
Age: 0.3
Sex: M
Vaccine: PNC13
Symptoms: Injection site induration
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4month old male patient who experienced hard knot appeared (size of a nickel). At 4 months of age, the patient received the second in Oct 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered in Oct 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced hard knot which was the (size of a nickel) in Oct 2010. Outcome was not provided. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Abnormal behaviour, Crying, Lethargy, Pain in extremity
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 3-year-old male patient who experienced leg hurt badly, crying, lethargic and acting very strange. At 3 years of age, the patient received a dose on 25-Oct-2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on 25-Oct-2010. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Haemophilus Influenzae. Concomitant medications were not reported. The patient experienced leg hurt badly and crying in Oct-2010 and lethargic and acting very strange on 26-Oct-2010. Outcome for all events was unknown. No additional information at the time of this report. See related case (s): US-WYE-H18418010 (adverse event, non-expedited). Follow-up (17Nov2010): This nurse reports additional information. The patient had no relevant medical history. The patient was 38 weeks gestation and 8 lbs at birth. The medication was stored as per manufacturers instructions, was not altered in any way and was administered by a health care professional. The patients developmental milestones were within normal range. The patients physical growth has been normal and the patient has recovered from the events.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding an 86 year old patient who received PREVNAR 13 instead of PNEUMOVAX. The patient received a dose of an unspecified date. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced received PREVNAR 13 instead of PNEUMOVAX. No adverse event was reported. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a physician regarding a child who experienced "large swelling areas in the limbs". The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced "large swelling areas in the limbs". Outcome was unknown. No additional information was available at the time of this report. See related case (s): US WYE H18212010 (adverse event, non expedited).
Sex: F
Vaccine: PNC13
Symptoms: Arthritis, Erythema, Insomnia, Joint swelling, Mobility decreased
Clinical narrative: This is a spontaneous report from a non contactable consumer (Pfizer colleague) reporting for his/her mother. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on 08Dec2014, at single dose and PNEUMOVAX, via an unspecified route of administration, on 09Feb2015, at unspecified dose and frequency. Relevant medical history and concomitant medications were not reported. On 09Feb2015 her arm from shoulder to elbow was so swollen/inflamed; her skin was bright red from shoulder to elbow, after 4 day her arm went from red to yellow; her skin itched and was painful to the touch; she had difficulty sleeping due to pain; the patient had limited mobility in that arm- her muscles were tight/contracted. All of these events lasted 4 days from 09Feb2015. Although patient's reaction was to the PNEUMOVAX vaccine, the reporter this in case there was an adverse event related to the combination of PREVNAR 13 and Pneumovax being given 2 months apart.
Sex: F
Vaccine: PNC13
Symptoms: Muscle contracture, Muscle tightness, Pain of skin, Pruritus, Skin discolouration
Clinical narrative: This is a spontaneous report from a non contactable consumer (Pfizer colleague) reporting for his/her mother. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on 08Dec2014, at single dose and PNEUMOVAX, via an unspecified route of administration, on 09Feb2015, at unspecified dose and frequency. Relevant medical history and concomitant medications were not reported. On 09Feb2015 her arm from shoulder to elbow was so swollen/inflamed; her skin was bright red from shoulder to elbow, after 4 day her arm went from red to yellow; her skin itched and was painful to the touch; she had difficulty sleeping due to pain; the patient had limited mobility in that arm- her muscles were tight/contracted. All of these events lasted 4 days from 09Feb2015. Although patient's reaction was to the PNEUMOVAX vaccine, the reporter this in case there was an adverse event related to the combination of PREVNAR 13 and Pneumovax being given 2 months apart.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for himself. A 65-year-old male patient received PREVNAR 13, intramuscular in the left upper arm, on unspecified date in Sep2014 (reported as about 4 months before the report), at 0.5 ml single, for pneumonia prevention. Relevant medical history included ongoing enlarged prostate and ongoing idiopathic peripheral neuropathy. Concomitant medications included ongoing LYRICA capsule oral at 3 dosage forms daily for idiopathic peripheral neuropathy and ongoing tamsulosin capsule oral at 0.14 mg once a day for prostate enlargement. No other medications, medical conditions or vaccines were given on the same day as the PREVNAR 13 vaccination. On an unknown date in Sep2014, the patient experienced muscle pain in the bicep area/upper arm near the injection. The patient stated that it was pretty bad for a couple of weeks then got better, but it never went away. He added that he had not had any injury to the area and he had tried to stop using the arm. Additionally in Oct2014, the patient experienced left upper arm pain, from his left elbow up to his left shoulder. The pain persisted, but seemed to get a little better within a few weeks. The patient did not receive any treatment or require hospitalization due to the events. The clinical outcome of the events was not recovered. The patient stated that the muscle pain had not gone away and seemed to be permanent damage. Follow-up (02Feb2015): New information received from a contactable consumer reporting for himself included: patient's details, event "Left upper arm pain" added, vaccination date, site of administration updated, indication updated, medical history, concomitant medications. Follow up (24Feb2015): New information received from the same contactable consumer includes: concomitant medications (ongoing), reaction data, treatment (NO), and outcome (not recovered).
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Bone pain, Dizziness, Hypotension, Influenza like illness, Mobility decreased
Clinical narrative: This is a spontaneous report from a non clinical study program (Pfizer) from a contactable consumer, reporting to herself. This 73 year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration in her left arm on 23Dec2014. Medical history included ongoing chronic obstructive pulmonary disease since about 20 years. Concomitant medication included EFFEXOR 150 mg once a day, PROTONIX 40 mg once a day. In the minutes after having received the vaccine her arm got sore. She could not sleep on the arm. It was so painful that she could not lift the arm. She went to see her doctor and he said her that it would go away. On an unspecified date in Dec2014 her whole body began to ache, every bone, every muscle and she had flu like symptoms: she thought she had the flu so she went to the emergency doctor, but he said that it was not flu. On an unspecified date her oxygen was very low, she had to get back on oxygen and her blood pressure went lower than usual. She was dizzy. She inquired if these events were caused by the vaccine and how long they would last. The patient still had pain, outcome of the other reported events was unknown.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Oxygen saturation decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: This is a spontaneous report from a non clinical study program (Pfizer) from a contactable consumer, reporting to herself. This 73 year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration in her left arm on 23Dec2014. Medical history included ongoing chronic obstructive pulmonary disease since about 20 years. Concomitant medication included EFFEXOR 150 mg once a day, PROTONIX 40 mg once a day. In the minutes after having received the vaccine her arm got sore. She could not sleep on the arm. It was so painful that she could not lift the arm. She went to see her doctor and he said her that it would go away. On an unspecified date in Dec2014 her whole body began to ache, every bone, every muscle and she had flu like symptoms: she thought she had the flu so she went to the emergency doctor, but he said that it was not flu. On an unspecified date her oxygen was very low, she had to get back on oxygen and her blood pressure went lower than usual. She was dizzy. She inquired if these events were caused by the vaccine and how long they would last. The patient still had pain, outcome of the other reported events was unknown.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Insomnia
Clinical narrative: This is a spontaneous report obtained from a contactable nurse who is calling on behalf of her mother (nurse's mother). A 87-year-old female patient received intramuscular PREVNAR 13; Lot J80525; Expiration Date Apr2016) in the left arm at 0.5 ml single dose on 13Feb2015 around 11:00 or 12:00, for immunization. Previously in 2013 she received pneumonia vaccine as immunization. Patient took hydrocortisone cream in Jan 2010. Medical history included ongoing arthritis, high blood pressure for twenty five years and ongoing, acid Reflux for 10 years and ongoing. She had allergy to DEMEROL and allergy tot adhesive tape. Concomitant medication included atenolol for blood pressure, NEXIUM for acid reflux, hydrochlorothiazide at 25mg 1x/day since more than 20 years for high blood pressure, pindolol orally at 5 mg 1x/day since more than 20 years for high blood pressure, KLOR-CON orally at 10mg 1x/day since more than 20 years, omeprazole 20mg 1x/day for reflux, diazepam orally at 5 mg as needed, Multivitamin orally 1x/day and Ibuprofen 200 mg as needed. On 13Feb2015 the patient experienced ached all over, joint pain, she had fever and chills during the night, she received the injection in the left arm and it was sore as the devil, her arm hurt red about the size of baseball with heat in it and she was unable to sleep; she was not exactly well, not feeling her best, she had extreme fatigue, muscle pain and appetite decreased. Patient did not received any treatment for the event unable to sleep, which recovered on an unknown date. She took ibuprofen for pain in arm and aches all over (with frequency of 2x/day) and also for fever chills and joint pain and these events recovered. Due to the event fatigue, patient followed a naps healthy diet; event arm with redness was treated with hydrocortisone cream. It was reported that 9 days post injection, the patient did not fully recover from fatigue, red/hot arm; she felt badly, she had still redness but fading. Patient had to continuously take Ibuprofen. The clinical outcome of the other events was unknown. Follow-up (17Feb2015): New information obtained from a contactable nurse includes: medical history updated (high blood pressure), additional concomitant drug, events updated (not feeling her best, Fatigue, Muscle pain, Joint pain, Appetite decreased, Arm hurts red about the size of base ball with heat in it, unable to sleep, ached all over, Fever chills). Follow-up (09Mar2015): New information received from the same contactable nurse includes: lot and expiration date, event details (outcome, treatment), concomitants, vaccination and medical history.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable nurse who is calling on behalf of her mother (nurse's mother). A 87-year-old female patient received intramuscular PREVNAR 13; Lot J80525; Expiration Date Apr2016) in the left arm at 0.5 ml single dose on 13Feb2015 around 11:00 or 12:00, for immunization. Previously in 2013 she received pneumonia vaccine as immunization. Patient took hydrocortisone cream in Jan 2010. Medical history included ongoing arthritis, high blood pressure for twenty five years and ongoing, acid Reflux for 10 years and ongoing. She had allergy to DEMEROL and allergy tot adhesive tape. Concomitant medication included atenolol for blood pressure, NEXIUM for acid reflux, hydrochlorothiazide at 25mg 1x/day since more than 20 years for high blood pressure, pindolol orally at 5 mg 1x/day since more than 20 years for high blood pressure, KLOR-CON orally at 10mg 1x/day since more than 20 years, omeprazole 20mg 1x/day for reflux, diazepam orally at 5 mg as needed, Multivitamin orally 1x/day and Ibuprofen 200 mg as needed. On 13Feb2015 the patient experienced ached all over, joint pain, she had fever and chills during the night, she received the injection in the left arm and it was sore as the devil, her arm hurt red about the size of baseball with heat in it and she was unable to sleep; she was not exactly well, not feeling her best, she had extreme fatigue, muscle pain and appetite decreased. Patient did not received any treatment for the event unable to sleep, which recovered on an unknown date. She took ibuprofen for pain in arm and aches all over (with frequency of 2x/day) and also for fever chills and joint pain and these events recovered. Due to the event fatigue, patient followed a naps healthy diet; event arm with redness was treated with hydrocortisone cream. It was reported that 9 days post injection, the patient did not fully recover from fatigue, red/hot arm; she felt badly, she had still redness but fading. Patient had to continuously take Ibuprofen. The clinical outcome of the other events was unknown. Follow-up (17Feb2015): New information obtained from a contactable nurse includes: medical history updated (high blood pressure), additional concomitant drug, events updated (not feeling her best, Fatigue, Muscle pain, Joint pain, Appetite decreased, Arm hurts red about the size of base ball with heat in it, unable to sleep, ached all over, Fever chills). Follow-up (09Mar2015): New information received from the same contactable nurse includes: lot and expiration date, event details (outcome, treatment), concomitants, vaccination and medical history.