chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus generalised, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 673799) under the Freedom of Information Act referring to a 14 year old female patient. The patient's concurrent conditions included an allergic reaction to "carme" (not specified). Pertinent medical history and concomitant medications were not mentioned. On 16-DEC-2016, the patient was vaccinated with a dose of GARDASIL 9) in the left arm, intramuscularly (lot # L040054, expiration date was not provided), for prophylaxis. On 17-DEC-2016, the patient experienced generalized hives (pruritus generalized) and 5 x 5 cm redness (injection site erythema), hot indurated circular area around the injection site (injection site warmth). Additionally, the patient complained of generalized itching (pruritus generalized). At the reporting time, the patient had recovered from the events. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal X-ray, Abdominal pain upper, C-reactive protein, Chills, Diarrhoea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 677883) concerning a 15 year old female patient with no concurrent conditions or medical history. On 27-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M028323) intramuscularly in the right arm. There were no concomitant medications. On 28-DEC-2016, the patient experienced vomiting and diarrhea once. On the same date at 14:00, the patient experienced a general ill feeling all day with nausea and stomach pain. The patient had an emergency visit and underwent the following laboratory tests: abdominal X-ray, C-reactive protein, influenza virus test, mononucleosis heterophile test, ultrasound of abdomen, ultrasound of pelvis, urine analysis and viral test (results not provided). On 29-DEC-2016, the patient experienced vomiting again for 2 hours. She also experienced chills and then a feeling of hot during most of the day. On 31-DEC-2016, the patient experienced tingling in hands and feet (off and on for about 10 days). She also experienced eye hurting and blurry vision (off and on that was still occurring). At the time of the report, the patient had not recovered from the events. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Eye pain, Feeling hot, Influenza virus test, Malaise, Mononucleosis heterophile test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 677883) concerning a 15 year old female patient with no concurrent conditions or medical history. On 27-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M028323) intramuscularly in the right arm. There were no concomitant medications. On 28-DEC-2016, the patient experienced vomiting and diarrhea once. On the same date at 14:00, the patient experienced a general ill feeling all day with nausea and stomach pain. The patient had an emergency visit and underwent the following laboratory tests: abdominal X-ray, C-reactive protein, influenza virus test, mononucleosis heterophile test, ultrasound of abdomen, ultrasound of pelvis, urine analysis and viral test (results not provided). On 29-DEC-2016, the patient experienced vomiting again for 2 hours. She also experienced chills and then a feeling of hot during most of the day. On 31-DEC-2016, the patient experienced tingling in hands and feet (off and on for about 10 days). She also experienced eye hurting and blurry vision (off and on that was still occurring). At the time of the report, the patient had not recovered from the events. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Paraesthesia, Ultrasound abdomen, Ultrasound pelvis, Urine analysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 677883) concerning a 15 year old female patient with no concurrent conditions or medical history. On 27-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M028323) intramuscularly in the right arm. There were no concomitant medications. On 28-DEC-2016, the patient experienced vomiting and diarrhea once. On the same date at 14:00, the patient experienced a general ill feeling all day with nausea and stomach pain. The patient had an emergency visit and underwent the following laboratory tests: abdominal X-ray, C-reactive protein, influenza virus test, mononucleosis heterophile test, ultrasound of abdomen, ultrasound of pelvis, urine analysis and viral test (results not provided). On 29-DEC-2016, the patient experienced vomiting again for 2 hours. She also experienced chills and then a feeling of hot during most of the day. On 31-DEC-2016, the patient experienced tingling in hands and feet (off and on for about 10 days). She also experienced eye hurting and blurry vision (off and on that was still occurring). At the time of the report, the patient had not recovered from the events. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Viral test, Vision blurred, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 677883) concerning a 15 year old female patient with no concurrent conditions or medical history. On 27-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M028323) intramuscularly in the right arm. There were no concomitant medications. On 28-DEC-2016, the patient experienced vomiting and diarrhea once. On the same date at 14:00, the patient experienced a general ill feeling all day with nausea and stomach pain. The patient had an emergency visit and underwent the following laboratory tests: abdominal X-ray, C-reactive protein, influenza virus test, mononucleosis heterophile test, ultrasound of abdomen, ultrasound of pelvis, urine analysis and viral test (results not provided). On 29-DEC-2016, the patient experienced vomiting again for 2 hours. She also experienced chills and then a feeling of hot during most of the day. On 31-DEC-2016, the patient experienced tingling in hands and feet (off and on for about 10 days). She also experienced eye hurting and blurry vision (off and on that was still occurring). At the time of the report, the patient had not recovered from the events. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Feeling hot, Influenza virus test, Malaise, Mononucleosis heterophile test, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 677883) concerning a 15 year old female patient with no concurrent conditions or medical history. On 27-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M028323) intramuscularly in the right arm. There were no concomitant medications. On 28-DEC-2016, the patient experienced vomiting and diarrhea once. On the same date at 14:00, the patient experienced a general ill feeling all day with nausea and stomach pain. The patient had an emergency visit and underwent the following laboratory tests: abdominal X-ray, C-reactive protein, influenza virus test, mononucleosis heterophile test, ultrasound of abdomen, ultrasound of pelvis, urine analysis and viral test (results not provided). On 29-DEC-2016, the patient experienced vomiting again for 2 hours. She also experienced chills and then a feeling of hot during most of the day. On 31-DEC-2016, the patient experienced tingling in hands and feet (off and on for about 10 days). She also experienced eye hurting and blurry vision (off and on that was still occurring). At the time of the report, the patient had not recovered from the events. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Paraesthesia, Ultrasound abdomen, Ultrasound pelvis, Urine analysis, Viral test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 677883) concerning a 15 year old female patient with no concurrent conditions or medical history. On 27-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M028323) intramuscularly in the right arm. There were no concomitant medications. On 28-DEC-2016, the patient experienced vomiting and diarrhea once. On the same date at 14:00, the patient experienced a general ill feeling all day with nausea and stomach pain. The patient had an emergency visit and underwent the following laboratory tests: abdominal X-ray, C-reactive protein, influenza virus test, mononucleosis heterophile test, ultrasound of abdomen, ultrasound of pelvis, urine analysis and viral test (results not provided). On 29-DEC-2016, the patient experienced vomiting again for 2 hours. She also experienced chills and then a feeling of hot during most of the day. On 31-DEC-2016, the patient experienced tingling in hands and feet (off and on for about 10 days). She also experienced eye hurting and blurry vision (off and on that was still occurring). At the time of the report, the patient had not recovered from the events. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 677883) concerning a 15 year old female patient with no concurrent conditions or medical history. On 27-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M028323) intramuscularly in the right arm. There were no concomitant medications. On 28-DEC-2016, the patient experienced vomiting and diarrhea once. On the same date at 14:00, the patient experienced a general ill feeling all day with nausea and stomach pain. The patient had an emergency visit and underwent the following laboratory tests: abdominal X-ray, C-reactive protein, influenza virus test, mononucleosis heterophile test, ultrasound of abdomen, ultrasound of pelvis, urine analysis and viral test (results not provided). On 29-DEC-2016, the patient experienced vomiting again for 2 hours. She also experienced chills and then a feeling of hot during most of the day. On 31-DEC-2016, the patient experienced tingling in hands and feet (off and on for about 10 days). She also experienced eye hurting and blurry vision (off and on that was still occurring). At the time of the report, the patient had not recovered from the events. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 680951) on 10-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient's drug allergies included penicillin allergy. The patient's medical history included eczema and Henoch-Schonlein purpura. The patient's prior vaccinations included influenza (seasonal) vaccine (manufacturer unknown) (Henoch-Schonlein purpura) at 12 years of age, flu vaccine (manufacturer unknown) and measles+mumps+rubella vaccine (manufacturer unknown) (patient's sibling at 5 years of age) (anaphylaxis). There were no concurrent illnesses. On 13-JAN-2017, the patient was vaccinated with GARDASIL 9 (lot#, expiry date and dosing details were not reported) (unknown route) and MENACTRA (lot#, expiry date and dosing details were not reported) (unknown route) for prophylaxis. On the same day, the patient had arm swelling, double in size from shoulder/injection site to fingers. Red, warm, hives in palm, occurred a few hours after vaccine administered, lasted for seven days. The patient had an emergency visit. Later, erythema, peripheral swelling, injection site swelling, urticaria and skin warm resolved. The causality of erythema, peripheral swelling, injection site swelling, urticaria and skin warm with respect to GARDASIL 9 and MENACTRA was not reported. Additional information is not expected as follow up information cannot be obtained from the Agency.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Headache, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported via a Medical Liaison. The age at vaccination was not reported. The patient experienced persistent headache and fever after taking a dose of BEXSERO. Medical liaison did not have lot number information for the BEXSERO and the patient's initials. The date that the medical liaison was notified of the adverse event was not obtained. An attempt was made to call back the medical liaison and obtain that information, but it was unsuccessful. Follow up information was received on 11th May 2017 from a physician via call center representative. The patient was 16 years old at the time of vaccination. The patient details were updated. On 17th January 2017, the patient received BEXSERO vaccine (batch number 165401A, expiry date 31st March 2018) intramuscularly. On 21st January 2017, 4 days after vaccination, the patient experienced headache. On 27th January 2017, 10 days after vaccination, the patient experienced fever and aseptic meningitis (serious criteria GSK medically significant). The outcome of the event aseptic meningitis was reported as unknown. The VAERS details were updated.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Headache, Meningitis aseptic, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported via a Medical Liaison. The age at vaccination was not reported. The patient experienced persistent headache and fever after taking a dose of BEXSERO. Medical liaison did not have lot number information for the BEXSERO and the patient's initials. The date that the medical liaison was notified of the adverse event was not obtained. An attempt was made to call back the medical liaison and obtain that information, but it was unsuccessful. Follow up information was received on 11th May 2017 from a physician via call center representative. The patient was 16 years old at the time of vaccination. The patient details were updated. On 17th January 2017, the patient received BEXSERO vaccine (batch number 165401A, expiry date 31st March 2018) intramuscularly. On 21st January 2017, 4 days after vaccination, the patient experienced headache. On 27th January 2017, 10 days after vaccination, the patient experienced fever and aseptic meningitis (serious criteria GSK medically significant). The outcome of the event aseptic meningitis was reported as unknown. The VAERS details were updated.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Headache, Influenza, Lumbar puncture abnormal, Meningitis aseptic, Mononucleosis heterophile test positive
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported via a Medical Liaison. The age at vaccination was not reported. The patient experienced persistent headache and fever after taking a dose of BEXSERO. Medical liaison did not have lot number information for the BEXSERO and the patient's initials. The date that the medical liaison was notified of the adverse event was not obtained. An attempt was made to call back the medical liaison and obtain that information, but it was unsuccessful. Follow up information was received on 11th May 2017 from a physician via call center representative. The patient was 16 years old at the time of vaccination. The patient details were updated. On 17th January 2017, the patient received BEXSERO vaccine (batch number 165401A, expiry date 31st March 2018) intramuscularly. On 21st January 2017, 4 days after vaccination, the patient experienced headache. On 27th January 2017, 10 days after vaccination, the patient experienced fever and aseptic meningitis (serious criteria GSK medically significant). The outcome of the event aseptic meningitis was reported as unknown. The VAERS details were updated.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported via a Medical Liaison. The age at vaccination was not reported. The patient experienced persistent headache and fever after taking a dose of BEXSERO. Medical liaison did not have lot number information for the BEXSERO and the patient's initials. The date that the medical liaison was notified of the adverse event was not obtained. An attempt was made to call back the medical liaison and obtain that information, but it was unsuccessful. Follow up information was received on 11th May 2017 from a physician via call center representative. The patient was 16 years old at the time of vaccination. The patient details were updated. On 17th January 2017, the patient received BEXSERO vaccine (batch number 165401A, expiry date 31st March 2018) intramuscularly. On 21st January 2017, 4 days after vaccination, the patient experienced headache. On 27th January 2017, 10 days after vaccination, the patient experienced fever and aseptic meningitis (serious criteria GSK medically significant). The outcome of the event aseptic meningitis was reported as unknown. The VAERS details were updated.
Sex: M
Vaccine: HPV9, MENB, MNQ, VARCEL, HPV9, MENB, MNQ, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This initlial spontaneous report was received from a healthcare professional via the Agency in a Freedom of Information line listing referring to a 17 year old male patient.  Medical history was not provided.  On 23-FEB-2017, the patient received a third dose of VARIVAX subcutaneously in the right arm (lot # M033214).  He was administered a varicella vaccine that he did not need (extra dose administered) as he had already been fully vaccinated against this vaccine preventable disease.  That same day, he also received his first dose of GARDASIL 9 intramuscularly in the left arm (lot # M017983), his first dose of MENVEO intramuscularly in the right arm (lot # M16005), and his first dose of BEXSERO intramusculalry in the left arm (lot # 156701).  The outcome was unknown. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Syncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of syncope in a 18 years old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, immediately after receiving BEXSERO, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. It was reported that the sales representative would not provide any more detail of the adverse event. Follow up information was received from nurse via sales representative on 11th May 2017: The patients and reporters details were updated. On 29th March 2017, the patient received the 0.5 ml of 1st dose of BEXSERO (batch number: 166701, expiry date: 31st May 2018) intramuscularly on left arm. The patient briefly passed out while sitting on exam table. The patient's eyes were open, but unresponsive for up to 15 seconds. No twitching of limbs occurred. The patient was fully aware when he became alert after the brief spell without sequelae. He remained in exam room approximately for 20 minutes. Thereafter the patient tolerated 2 popsicles and felt well. There was no medication error reported. The VAERS details were updated.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of syncope in a 18 years old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, immediately after receiving BEXSERO, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. It was reported that the sales representative would not provide any more detail of the adverse event. Follow up information was received from nurse via sales representative on 11th May 2017: The patients and reporters details were updated. On 29th March 2017, the patient received the 0.5 ml of 1st dose of BEXSERO (batch number: 166701, expiry date: 31st May 2018) intramuscularly on left arm. The patient briefly passed out while sitting on exam table. The patient's eyes were open, but unresponsive for up to 15 seconds. No twitching of limbs occurred. The patient was fully aware when he became alert after the brief spell without sequelae. He remained in exam room approximately for 20 minutes. Thereafter the patient tolerated 2 popsicles and felt well. There was no medication error reported. The VAERS details were updated.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Heart rate increased, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 53 year old female patient. The patient's concurrent conditions included environmental unspecified allergies. The patient's medical history was not provided. The patient's concomitant therapies included unspecified allergy injections. The patient had no drug allergies. On 03-MAY-2017, the patient received a single dose of injectable PNEUMOVAX 23, intramuscularly in her left upper arm for vaccination (lot # M036728 with expiration date on 20-MAY-2018) (strength was not reported). On the same date (reported as "a few hours after administration"), the patient developed generalized muscle aching. On 04-MAY-2017, the patient developed a rash involving her left upper arm, and a painful and hard lump at the injection site. The reporter stated that, on an unspecified date, the patient called the pharmacy and she was recommended to apply ice compresses to the affected area, and to take TYLENOL and unspecified antihistamines. At the time of reporting, the patient was recovering from the events. It was reported that there were not diagnostic laboratories or studies performed. The relationship between the therapy with PNEUMOVAX 23 and the events of generalized muscle aching, rash involving her left upper arm and Injection site mass was not provided. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pruritus, Injection site warmth, Myalgia, Pain, Raynaud's phenomenon
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 53 year old female patient. The patient's concurrent conditions included environmental unspecified allergies. The patient's medical history was not provided. The patient's concomitant therapies included unspecified allergy injections. The patient had no drug allergies. On 03-MAY-2017, the patient received a single dose of injectable PNEUMOVAX 23, intramuscularly in her left upper arm for vaccination (lot # M036728 with expiration date on 20-MAY-2018) (strength was not reported). On the same date (reported as "a few hours after administration"), the patient developed generalized muscle aching. On 04-MAY-2017, the patient developed a rash involving her left upper arm, and a painful and hard lump at the injection site. The reporter stated that, on an unspecified date, the patient called the pharmacy and she was recommended to apply ice compresses to the affected area, and to take TYLENOL and unspecified antihistamines. At the time of reporting, the patient was recovering from the events. It was reported that there were not diagnostic laboratories or studies performed. The relationship between the therapy with PNEUMOVAX 23 and the events of generalized muscle aching, rash involving her left upper arm and Injection site mass was not provided. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Restlessness
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 53 year old female patient. The patient's concurrent conditions included environmental unspecified allergies. The patient's medical history was not provided. The patient's concomitant therapies included unspecified allergy injections. The patient had no drug allergies. On 03-MAY-2017, the patient received a single dose of injectable PNEUMOVAX 23, intramuscularly in her left upper arm for vaccination (lot # M036728 with expiration date on 20-MAY-2018) (strength was not reported). On the same date (reported as "a few hours after administration"), the patient developed generalized muscle aching. On 04-MAY-2017, the patient developed a rash involving her left upper arm, and a painful and hard lump at the injection site. The reporter stated that, on an unspecified date, the patient called the pharmacy and she was recommended to apply ice compresses to the affected area, and to take TYLENOL and unspecified antihistamines. At the time of reporting, the patient was recovering from the events. It was reported that there were not diagnostic laboratories or studies performed. The relationship between the therapy with PNEUMOVAX 23 and the events of generalized muscle aching, rash involving her left upper arm and Injection site mass was not provided. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site rash, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 53 year old female patient. The patient's concurrent conditions included environmental unspecified allergies. The patient's medical history was not provided. The patient's concomitant therapies included unspecified allergy injections. The patient had no drug allergies. On 03-MAY-2017, the patient received a single dose of injectable PNEUMOVAX 23, intramuscularly in her left upper arm for vaccination (lot # M036728 with expiration date on 20-MAY-2018) (strength was not reported). On the same date (reported as "a few hours after administration"), the patient developed generalized muscle aching. On 04-MAY-2017, the patient developed a rash involving her left upper arm, and a painful and hard lump at the injection site. The reporter stated that, on an unspecified date, the patient called the pharmacy and she was recommended to apply ice compresses to the affected area, and to take TYLENOL and unspecified antihistamines. At the time of reporting, the patient was recovering from the events. It was reported that there were not diagnostic laboratories or studies performed. The relationship between the therapy with PNEUMOVAX 23 and the events of generalized muscle aching, rash involving her left upper arm and Injection site mass was not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site phlebitis, Injection site reaction, Skin tightness
Clinical narrative: Edema, erythema, pain to inoculation arm and area LUE, IM injection.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Ultrasound scan
Clinical narrative: Edema, erythema, pain to inoculation arm and area LUE, IM injection.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Edema, erythema, pain to inoculation arm and area LUE, IM injection.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Abasia, Decreased appetite, Dyspnoea, Pyrexia
Clinical narrative: Mom called on call provider after hours with concerns about fever, decreased appetite, refusal of pt to walk, and drowsiness. Parent was advised to take pt to ER for evaluation.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Abasia, Decreased appetite, Pyrexia, Somnolence
Clinical narrative: Mom called on call provider after hours with concerns about fever, decreased appetite, refusal of pt to walk, and drowsiness. Parent was advised to take pt to ER for evaluation.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: PT REPORTS TO PHARMACY 8 DAYS AFTER INJECTION STATING THAT HER ARM IS STILL SORE AND HAS LIMITED ROM IN THE INJECTION ARM (LEFT). SHE SHOWS THAT SHE CAN ONLY LIFT HER ARM ~45 DEGREES AWAY FROM HER BODY. REPORTS THAT IN THE DAYS FOLLOWING THE INJECTION, THE INJECTION SITE WAS ERYTHEMATOUS AND SWOLLEN. THE PAIN HAS NOW RADIATED DOWN HER ARM TO HER FOREARM. SHE HAS USED IBUPROFEN 400MG BID UP TO THIS POINT TO CONTROL THE PAIN. I INFORMED HER SHE COULD DOSE THIS AT 600 MG BID OR 400 MG TID IF NEEDED, BUT THAT SHE NEEDS TO HAVE THE ARM INSPECTED BUT HER PCP OR URGENT CARE DUE TO THE LIMITED ROM.
Age: 0.58
Sex: F
Vaccine: 6VAX-F, HIBV
Symptoms: Crying, Diarrhoea, Electroencephalogram, Emotional distress, Head banging
Clinical narrative: On 01/05/2017 (Hib #3, PEDIARIX #3, PREVNAR 13 (3) (1), ROTARIX 1) she got fever that weekend and diarrhea, she seemed so fussy and unhappy. She would just cry. Then about 2 weeks later, she had a runny nose for like 2 weeks, but no cold. I mentioned it to her doctor, but he said it could be allergies, and into the weekend of the 2 weeks she became ill again with fever of 103, I gave her medicine to reduce her fever and by the following day, she had no more fever, but she continued to have a slight rash in her lower back on her hip of and on. She also got rashes off and on in her bottom after that, but what was weird is that the rash would come and go, and it didn't seem like a diaper rash. I thought she might be having an allergic reaction to her diaper, but usually it was gone by the next day. I gave her infant cold medicine zarbbies and a pediatric nasal spray to clear her nose because she got a slight stuffy nose, then she had a cough for a few days. Her cold symptoms finally cleared up but she started to have some repetitive and stereotypical behaviors such as hand flapping at her ear, shaking, repetitive open and close movement of her hands, rocking back and forth while sitting, starring at the wall in silence, holding her head in agony, banging her head on the floor and lots of fussiness and crying where I could not console her through-out the entire day. She had problems sleeping though-out the night and would constantly wake up like every 3 hours as if she were in pain and rubs her little feet and hands.
Age: 0.58
Sex: F
Vaccine: 6VAX-F, HIBV
Symptoms: Irritability, Middle insomnia, Nasal congestion, Pain, Pyrexia
Clinical narrative: On 01/05/2017 (Hib #3, PEDIARIX #3, PREVNAR 13 (3) (1), ROTARIX 1) she got fever that weekend and diarrhea, she seemed so fussy and unhappy. She would just cry. Then about 2 weeks later, she had a runny nose for like 2 weeks, but no cold. I mentioned it to her doctor, but he said it could be allergies, and into the weekend of the 2 weeks she became ill again with fever of 103, I gave her medicine to reduce her fever and by the following day, she had no more fever, but she continued to have a slight rash in her lower back on her hip of and on. She also got rashes off and on in her bottom after that, but what was weird is that the rash would come and go, and it didn't seem like a diaper rash. I thought she might be having an allergic reaction to her diaper, but usually it was gone by the next day. I gave her infant cold medicine zarbbies and a pediatric nasal spray to clear her nose because she got a slight stuffy nose, then she had a cough for a few days. Her cold symptoms finally cleared up but she started to have some repetitive and stereotypical behaviors such as hand flapping at her ear, shaking, repetitive open and close movement of her hands, rocking back and forth while sitting, starring at the wall in silence, holding her head in agony, banging her head on the floor and lots of fussiness and crying where I could not console her through-out the entire day. She had problems sleeping though-out the night and would constantly wake up like every 3 hours as if she were in pain and rubs her little feet and hands.
Age: 0.58
Sex: F
Vaccine: 6VAX-F, HIBV
Symptoms: Rash, Rhinorrhoea, Staring, Stereotypy, Tremor
Clinical narrative: On 01/05/2017 (Hib #3, PEDIARIX #3, PREVNAR 13 (3) (1), ROTARIX 1) she got fever that weekend and diarrhea, she seemed so fussy and unhappy. She would just cry. Then about 2 weeks later, she had a runny nose for like 2 weeks, but no cold. I mentioned it to her doctor, but he said it could be allergies, and into the weekend of the 2 weeks she became ill again with fever of 103, I gave her medicine to reduce her fever and by the following day, she had no more fever, but she continued to have a slight rash in her lower back on her hip of and on. She also got rashes off and on in her bottom after that, but what was weird is that the rash would come and go, and it didn't seem like a diaper rash. I thought she might be having an allergic reaction to her diaper, but usually it was gone by the next day. I gave her infant cold medicine zarbbies and a pediatric nasal spray to clear her nose because she got a slight stuffy nose, then she had a cough for a few days. Her cold symptoms finally cleared up but she started to have some repetitive and stereotypical behaviors such as hand flapping at her ear, shaking, repetitive open and close movement of her hands, rocking back and forth while sitting, starring at the wall in silence, holding her head in agony, banging her head on the floor and lots of fussiness and crying where I could not console her through-out the entire day. She had problems sleeping though-out the night and would constantly wake up like every 3 hours as if she were in pain and rubs her little feet and hands.
Age: 0.58
Sex: F
Vaccine: 6VAX-F, HIBV
Symptoms: Viral upper respiratory tract infection
Clinical narrative: On 01/05/2017 (Hib #3, PEDIARIX #3, PREVNAR 13 (3) (1), ROTARIX 1) she got fever that weekend and diarrhea, she seemed so fussy and unhappy. She would just cry. Then about 2 weeks later, she had a runny nose for like 2 weeks, but no cold. I mentioned it to her doctor, but he said it could be allergies, and into the weekend of the 2 weeks she became ill again with fever of 103, I gave her medicine to reduce her fever and by the following day, she had no more fever, but she continued to have a slight rash in her lower back on her hip of and on. She also got rashes off and on in her bottom after that, but what was weird is that the rash would come and go, and it didn't seem like a diaper rash. I thought she might be having an allergic reaction to her diaper, but usually it was gone by the next day. I gave her infant cold medicine zarbbies and a pediatric nasal spray to clear her nose because she got a slight stuffy nose, then she had a cough for a few days. Her cold symptoms finally cleared up but she started to have some repetitive and stereotypical behaviors such as hand flapping at her ear, shaking, repetitive open and close movement of her hands, rocking back and forth while sitting, starring at the wall in silence, holding her head in agony, banging her head on the floor and lots of fussiness and crying where I could not console her through-out the entire day. She had problems sleeping though-out the night and would constantly wake up like every 3 hours as if she were in pain and rubs her little feet and hands.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large area of redness and swelling at injection site, warm and painful to touch.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, RVX
Symptoms: Blood test, Febrile convulsion, Urine analysis
Clinical narrative: Febrile Seizure. Was given fluids and TYLENOL.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm to touch on right arm from injection side down to elbow. Painful to touch. Started on Benadryl until swelling gone and Cephalexin 2x daily for 7 days.
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Lesion excision, Respiratory papilloma
Clinical narrative: This literature report as received from the authors of a published literature article, refers to a 44 year old male patient with a recurring nasopharyngeal papilloma that was excised transorally at an outside hospital 4 months earlier presented to the authors' office with throat irritation. Endoscopic exam showed a papilloma on the left posterior nasopharyngeal wall, and surgical excision was performed with CO2 laser under transnasal endoscopic visualization. A 10 x 9 x 5 mm lesion on the nasopharyngeal surface of the soft palate was removed en bloc, and a second lesion on the posterior nasopharynx was also visualized and resected. Histopathologic analysis confirmed the lesion to be squamous papilloma, which was positive for HPV 11 on sequencing analysis. On an unknown date, on the follow-up 2 weeks after surgery, the patient was vaccinated with the three doses of GARDASIL administered at 0, 2 and 6 months, for recurring nasopharyngeal papilloma. Two months after surgery, the patient noted mild throat irritation, and endoscopic exam showed a 5 x 6 mm recurrent nasopharyngeal papilloma. It was recommended that the patient finish the vaccination with GARDASIL before further intervention. In the interim, the papilloma on the dorsal aspect of the soft palate shrank to approximately 3 x 4 mm in size. After the patient completed the course of GARDASIL, the lesion was excised with CO2 laser under a solely endoscopic approach. Final pathology of the 8 x 5 x 3 mm lesion confirmed the diagnosis of squamous papilloma. In the 33 months' follow-up since the last operation, fiberoptic exams showed no evidence of recurrence. This is one of the two cases from the same article (linked with MARRS # 1705USA009624). Additional information has been requested. Sender's Comments: US-009507513-1705USA009624.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, 2 weeks after the first dose, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Road traffic accident
Clinical narrative: This spontaneous report as received from an Immunization Specialist referring to a 23 year old male patient. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported.  On 08-MAY-2017, the patient was vaccinated with GARDASIL 9 (dose, route of of administration, and anatomical location of administration was not reported) lot # M036059, expiration date: 03-JUN-2019 for prophylaxis. After the GARDASIL 9 vaccination, the patient laid down for 15 minutes and then was released to go from the office. It was reported that the patient left in his car, felt lightheaded and had a motor vehicle accident. The patient was taken by ambulance to to a hospital emergency room for evaluation and then was released. Unspecified treatment was given for the patient's lightheadedness. Laboratory diagnostic studies were not performed. The outcome of lightheaded was not provided. Causality assessment was not provided.  The Immunization Specialist has requested a lot check on the vaccine. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HEP, PNC13, RV5
Symptoms: Choking, Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified 6-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patient received the first and the second dose of ROTATEQ orally (strength, dose, lot # and expiration date were not reported), for prevention of rotavirus. On 10-MAY-2017, the patient choked and then vomited twice, while the administration of third dose of ROTATEQ via oral route (strength, dose, lot # and expiration date were not reported), for prevention of rotavirus. There was no treatment given for the adverse events. The patient did not seek medical attention. The outcome of aforementioned events was unknown at the time of the report. Upon internal review, the event of choking was determined to be medically significant. The causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Pregnancy test, Psychotic disorder
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age. The last menstrual period (LMP) and estimate date of delivery (EDD) were not known. The patient's pertinent medical history included psychosis. The patient did not have drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (route, dosage information and lot number were not informed) for Prevention of HPV. Concomitant medication included "mood stabilizers". The physician reported that the patient "may be pregnant". The patient who was presently in the hospital for "psychosis", was "being tested to determine if she was pregnant". However, it was also reported that no adverse effect were reported. Treatment was not given for the adverse event. Laboratory diagnostics studies were not performed. There was no product quality complaint involved. At the time of reporting, the pregnancy outcome was pending as well as the outcome of psychosis. The causality assessment between psychosis and therapy with GARDASIL 9 was not provided. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning a 16 year-old male patient. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 09-MAY-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 injection (dose, frequency and route were not reported) lot # reported as K010215 with expiration date of 05-MAY-2017, for prophylaxis. No adverse effects were reported. Additional information is not expected, as no consent to contact the reporter was granted.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse in her 50's via a company representative referring to herself. Information about concurrent condition, concomitant medication and medical history of the patient was not provided. On an unknown date in April 2017, the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot # were not reported) for prevention of shingles. On an unknown date of 2017, shortly after receiving ZOSTAVAX, the patient's arm got red from the shoulder down to her elbow, and began to whelp up. The nurse stated that about a week later (unspecified date) her arm became very itchy. The nurse thought she was developing shingles. The nurse did not specify seeing a physician, or give any physician information or any confirmed diagnosis of shingles. The nurse stated that the symptoms eventually went away (unspecified date), and no other incidents happened. The causality was not provided. Additional information has been requested.