chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Incomplete course of vaccination, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient's medical history included allergic rhinitis. The patient's other medications included cetirizine and Multivitamin. The patient had no current illnesses and patient's prior vaccinations was reported. On 26-JAN-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L018351, intramuscularly in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number 1; vaccinated date: 26-JAN-2016, intramuscularly in the left arm, lot # 9NA32, (dose, frequency and lot expiration date unknown) and MENVEO dose number 1; vaccinated date: 26-JAN-2016, intramuscularly in the right arm, lot # M15066, (dose, frequency and lot expiration date unknown). The patient's mother stated that the patient became weak in legs and dizzy after leaving clinic on 26-JAN-2016 and the patient had activities of daily living impaired. The patient's mother related incident after first dose of of GARDASIL 9 so GARDASIL 9 dose 2 was declined at that time. Symptoms (Sx) remained until 28-JAN-2016 when she was allowed to return to school. The patient was in clinic on 04-OCT-2016 for flu. The patient's mother did not reported symptoms (sx) until that visit. The outcome of muscular weakness, dizziness, incomplete course of vaccination and activities of daily living impaired was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling, Muscle mass, Pain
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient had no other medications, current illnesses and medical history. The patient's prior vaccinations was not reported. On 28-SEP-2016, the patient was vaccinated with of GARDASIL 9, lot # M016193 and expiration date: 24-APR-2018, in the right arm (route of administration, dose number, dose and frequency unknown) for prophylaxis. And the same day, after injection the patient had right upper arm pain, swelling at injection site and lump in a muscle. Swelling has decreased, but patient felt pain when moving arm. The outcome of muscle mass, injection site swelling and injection site pain was reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Musculoskeletal pain, Neck pain, Palpitations
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 # 660176) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient had no concurrent illnesses, lab data and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 11-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L036301 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 12-OCT-2016, the patient experienced difficulty breathing, palpitations, neck pain and musculoskeletal pain (shoulder pain). On 13-OCT-2016, the patient's father called and stated that the patient had complaints of neck and shoulder pain. On 18-OCT-2016, the patient stated that she also had palpitations and difficulty breathing which had resolved. The outcome of musculoskeletal pain and neck pain was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site discharge, Injection site pain, Injection site reaction, Injection site swelling, Wound
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 # 660478) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old male patient. The patient's medical history included swells with bee and ants stings. The patient had no concurrent illnesses, lab data and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 03-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm (reported as left deltoid) without any discomfort/compliant, lot # M020103 with expiration date: 15-FEB-2018 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 29-SEP-2016, the patient returned for 2nd dose of HPV9, however reported swelling at the site of first dose. Staff and doctor examined the area and discussed with mother and patient and decided to hold 2nd dose of HPV9 and observe area for improvement before going ahead with 2nd dose. On 11-OCT-2016, the patient had swollen area with serosanguinous drainage, pain got worsen (reported as 10-AUG-2016) with approximately dime sized open wound. On 13-OCT-2016, the patient returned and reported that the above changes happened. The patient was prescribed with the clindamycin 300mg three times in a day (TID). The patient required an emergency room (ER) visit. The outcome of injection site discharge, injection site pain, injection site reaction, injection site swelling and wound was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV9, MNQ, TDAP
Symptoms: Facial asymmetry
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 # 660530) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. Information on the patient's medical history, concurrent illnesses, other medications, lab data and prior vaccinations were not reported. On 04-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L043214 (lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA (dose number 1, intramuscularly in the left arm, lot # U5390AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported), ADACEL (dose number 1, intramuscularly in the left arm, lot # U1543AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) and influenza virus vaccine (unspecified) (dose number 4, intramuscularly in the right arm, manufacturer: Unknown; lot and expiration date were not reported) for prophylaxis. On 17-OCT-2016, the patient developed right sided facial asymmetry. The patient required emergency room (ER) visit. The outcome of facial asymmetry was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain, 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 # 661093) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's concurrent illness was reported as L83, R21 and N 94.6. The patient's concomitant therapies, prior vaccinations, medical history and other medications were not reported. On 21-SEP-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # M004116, lot expiration date 12-OCT-2017 (dose: not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapy which was given on the same day included FLUARIX QUADRIVALENT (intramuscularly in the right arm, lot# 5077A; dose, dose number and expiration date were not reported) for prophylaxis. The patient's mother reported that her child had abdominal pain and vomiting issues on 23-SEP-2016. The mother suspected that these events were due to HPV vaccine. The last dose was given on 21-SEP-2016. The patient was sent for gastrointestinal evaluation. The patient had visited the emergency room. The outcome of abdominal pain and vomiting was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 23.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Chills, Headache, Mononucleosis heterophile test, Pain, Pyrexia
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 # 662303) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 23 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 lot # L040054, via unknown route in the right arm for prophylaxis. Other suspect therapies included M-M-R II  (dose number: 1, via unknown route in the right arm, lot# M015931; dose and expiration date unknown) and VARIVAX (dose number: 1, via unknown route in the right arm, lot# M027885; dose and expiration date unknown). On unknown dates, the patient underwent mononucleosis heterophile test and also experienced experienced chills, rash generalised, pyrexia, pain, and headache. The outcome of chills, rash generalised, pyrexia, pain, mononucleosis heterophile test and headache were unknown. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 23.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Rash generalised
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 # 662303) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 23 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 lot # L040054, via unknown route in the right arm for prophylaxis. Other suspect therapies included M-M-R II  (dose number: 1, via unknown route in the right arm, lot# M015931; dose and expiration date unknown) and VARIVAX (dose number: 1, via unknown route in the right arm, lot# M027885; dose and expiration date unknown). On unknown dates, the patient underwent mononucleosis heterophile test and also experienced experienced chills, rash generalised, pyrexia, pain, and headache. The outcome of chills, rash generalised, pyrexia, pain, mononucleosis heterophile test and headache were unknown. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Back pain, Fall, Headache, Injection site pain, Loss of personal independence in daily activities
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 # 662863) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history and other medications were reported as none. The patient mentioned runny nose at the time of visit. Information on the patient's lab data and prior vaccinations were not reported. On 24-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm for prophylaxis (lot # M018810 and expiration date: 28-MAY-2018). On the same day, the patient was also vaccinated with ADACEL (dose number 1, intramuscularly in the left arm, lot # C4990AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) and MENACTRA (dose number 1, intramuscularly in the left arm, lot # U5392AB, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On 24-OCT-2016, the patient complained of left upper back/top of shoulder pain radiating between shoulder blades and back pain. The patient developed cramp like pain on both thighs then suddenly dropped to the ground like paralyzed. Around 15 minutes later, the patient's mother assisted the patient up, after sitting, the patient said that it was painful and didn't want touch or movement and was hunched over. The patient also complained of nausea and had low grade fever in the evening. The patient had no headache that night but did have headache in the morning. On 25-OCT-2016 (also reported as 25-OCT-2015), the patient's father went to the office to notify that the patient had reactions which was not on the VIS (Vaccine Information Statement) and she was given Tylenol and Ibuprofen. The patient's mother was contacted who stated that the patient had done gymnastics in the past and flips around at home and when she left for work at 15:00 on 25-OCT-2016 the patient seemed fine. The patient was kept at home from school that day. On 31-OCT-2016, the patient's mother was contacted (follow-up) who stated that she feels things were back to normal. The patient was not taken for evaluation but did have side and back pain for a couple of days. The outcome of the events was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Muscle spasms, Musculoskeletal pain, Nausea, Pain, Paralysis
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 # 662863) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history and other medications were reported as none. The patient mentioned runny nose at the time of visit. Information on the patient's lab data and prior vaccinations were not reported. On 24-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm for prophylaxis (lot # M018810 and expiration date: 28-MAY-2018). On the same day, the patient was also vaccinated with ADACEL (dose number 1, intramuscularly in the left arm, lot # C4990AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) and MENACTRA (dose number 1, intramuscularly in the left arm, lot # U5392AB, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On 24-OCT-2016, the patient complained of left upper back/top of shoulder pain radiating between shoulder blades and back pain. The patient developed cramp like pain on both thighs then suddenly dropped to the ground like paralyzed. Around 15 minutes later, the patient's mother assisted the patient up, after sitting, the patient said that it was painful and didn't want touch or movement and was hunched over. The patient also complained of nausea and had low grade fever in the evening. The patient had no headache that night but did have headache in the morning. On 25-OCT-2016 (also reported as 25-OCT-2015), the patient's father went to the office to notify that the patient had reactions which was not on the VIS (Vaccine Information Statement) and she was given Tylenol and Ibuprofen. The patient's mother was contacted who stated that the patient had done gymnastics in the past and flips around at home and when she left for work at 15:00 on 25-OCT-2016 the patient seemed fine. The patient was kept at home from school that day. On 31-OCT-2016, the patient's mother was contacted (follow-up) who stated that she feels things were back to normal. The patient was not taken for evaluation but did have side and back pain for a couple of days. The outcome of the events was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pyrexia, Tenderness
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 # 662863) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history and other medications were reported as none. The patient mentioned runny nose at the time of visit. Information on the patient's lab data and prior vaccinations were not reported. On 24-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm for prophylaxis (lot # M018810 and expiration date: 28-MAY-2018). On the same day, the patient was also vaccinated with ADACEL (dose number 1, intramuscularly in the left arm, lot # C4990AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) and MENACTRA (dose number 1, intramuscularly in the left arm, lot # U5392AB, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On 24-OCT-2016, the patient complained of left upper back/top of shoulder pain radiating between shoulder blades and back pain. The patient developed cramp like pain on both thighs then suddenly dropped to the ground like paralyzed. Around 15 minutes later, the patient's mother assisted the patient up, after sitting, the patient said that it was painful and didn't want touch or movement and was hunched over. The patient also complained of nausea and had low grade fever in the evening. The patient had no headache that night but did have headache in the morning. On 25-OCT-2016 (also reported as 25-OCT-2015), the patient's father went to the office to notify that the patient had reactions which was not on the VIS (Vaccine Information Statement) and she was given Tylenol and Ibuprofen. The patient's mother was contacted who stated that the patient had done gymnastics in the past and flips around at home and when she left for work at 15:00 on 25-OCT-2016 the patient seemed fine. The patient was kept at home from school that day. On 31-OCT-2016, the patient's mother was contacted (follow-up) who stated that she feels things were back to normal. The patient was not taken for evaluation but did have side and back pain for a couple of days. The outcome of the events was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Face injury, Fall
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 # 663078) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient had no concurrent illnesses, lab data and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 28-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # M023169 (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day, patient had became lightheaded and fell out of chair face first. The outcome of dizziness and fall was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Computerised tomogram head normal, Concussion, Face injury, Facial bones fracture, Fall
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 # 663283) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no concurrent illnesses and medical history. Information on patient's other medications and prior vaccinations were not reported. On 01-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M030380 (Expiration date: 01-FEB-2019) dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENACTRA (Manufacturer: Sanofi Pasteur, vaccinated date: 01-NOV-2016, lot # U54564AA, dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, 5 minutes after vaccination, the patient fainted, hit the head on the door (head injury) and then fell on his face. The patient sustained a concussion and a broken nose. The patient also experienced retrograde amnesia, which improved over an hour, but was still not back at the baseline. He was then sent to the emergency room for imaging. The patient underwent a computerised tomogram head (CT), which was found to be normal. The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Head injury, Retrograde amnesia, Syncope
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 # 663283) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no concurrent illnesses and medical history. Information on patient's other medications and prior vaccinations were not reported. On 01-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M030380 (Expiration date: 01-FEB-2019) dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENACTRA (Manufacturer: Sanofi Pasteur, vaccinated date: 01-NOV-2016, lot # U54564AA, dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, 5 minutes after vaccination, the patient fainted, hit the head on the door (head injury) and then fell on his face. The patient sustained a concussion and a broken nose. The patient also experienced retrograde amnesia, which improved over an hour, but was still not back at the baseline. He was then sent to the emergency room for imaging. The patient underwent a computerised tomogram head (CT), which was found to be normal. The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Paraesthesia
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 # 663479) on 02-MAY-2017. This spontaneous report refers to a 14 year old female patient. The patient's medical history included scoliosis. The patient's concurrent illnesses and other medications were reported as none. Information on the patient's lab data and prior vaccinations were not reported. On 12-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm for prophylaxis (lot # L023230 and expiration date: 28-JUL-2017). On the same day post vaccination (also reported as 15-OCT-2015), the patient developed pain in the right leg. She described the pain as "shooting". The patient also complained of tingling of her right leg. The pain lasted for several days. The outcome of the events was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on the patients' pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On an unknown dates in 2016, the patients received improperly stored doses of PROQUAD injection lot # M004891 with expiry date: 25-JUL-2017, M022399 with expiry date: 01-NOV-2017. The administered doses of PROQUAD underwent a temperature excursion on 21-SEP-2016 at 16.3 Fahrenheit degrees for 2 hours and on 23-SEP-2016 at 6.1 Fahrenheit degrees for 2 hours and 15 minutes. The call was due to the data logger. Prior temperature excursions were noted on 15-SEP-2016 with temperature of 13.5 Fahrenheit degrees for 4 hours and on 16-SEP-2016 with temperature of 63.1 Fahrenheit degrees for 4 hours. No adverse effect were reported. No product quality complaint (PQC) was involved. Follow up information has been received on 08-MAY-2017. The medical assistant reported that she did not keep a log of the patients who received the vaccines. She was not able to provide any patient identifiers. There were no adverse events reported. This is one of the three reports received from the same reporter. Additional information is not expected as no further information is available. Sender's Comments: US-009507513-1610USA012429: US-009507513-1610USA013496: MERCK 1610USA013495: Mfr number.
Age: 11.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Asthenia
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 # 665450) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 13-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M013636, Expiry date: 15-FEB-2018, dose number 1 (dose and frequency unknown) via intramuscular route in the left arm and VAQTA lot # M015290, Expiry date: 20-SEP-2017, dose number 1 (dose and frequency unknown) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included FLUZONE Quadrivalent (Manufacturer: Sanofi Pasteur, Vaccinated date: 13-SEP-2016, lot # 4Z27T, dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm and MENACTRA (Manufacturer: Sanofi Pasteur, Vaccinated date: 13-SEP-2016, lot # U5410AA, dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On the same day, the patient began to feel weak after she received vaccines. There was no symptoms of syncope. Patient lied down and recovered well. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Rash papular, Rash pruritic
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 # 667188) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history, concurrent illnesses and lab data were reported as none. The patient's other medication included Albuterol sulfate and cetirizine HCL (1 mg/ml, syrup, oral, 5ml daily). Information on the patient's prior vaccinations was not reported. On 21-OCT-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # M009378 (dose number 3; lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX QUADRIVALENT (dose number 2, intramuscularly in the right arm, lot # CS979, manufacturer: GlaxoSmithKline; lot expiration date was not reported) and MENVEO (dose number 2, intramuscularly in the right arm, lot # A15078, manufacturer: Novartis; lot expiration date was not reported) for prophylaxis. On the same day 6 hours post vaccination, the patient was reported to emergency department (ED) with mildly pruritic but diffusely popular rash. The patient's vital signs were within normal limits: respiratory rate 14, pulse 78, temperature 97.7 (orally) and SPO2 (peripheral capillary oxygen saturation) 99%. The patient was treated with Benadryl 12.5 mg. The patient was sent home with his mother and asked to continue with Benadryl. The patient was seen in ED two other time for continued rash. Follow up was provided after three days with no improvement of rash. On 09-NOV-2016 the patient was seen finally by a doctor and was referred to a dermatologist. The outcome of the event was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 21.0
Sex: M
Vaccine: FLU3, HEP, HPV9, VARCEL
Symptoms: Asthenia, Fatigue, Injection site pain
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 # 667823) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 21 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 18-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # M017983, intramuscularly in the right arm for prophylaxis. Other suspect therapies included VARIVAX (dose, frequency and lot expiration date were not reported) lot # M028552, dose number: 1, subcutaneously in the right arm, ENGERIX-B (dose number: 3, vaccinated date: 18-NOV-2016, intramuscularly in the left arm, lot# XR9GF; dose and expiration date unknown) and FLUVIRIN (vaccinated date: 18-NOV-2016, intramuscularly in the left arm, lot# 1618501; dose and expiration date unknown). On 18-NOV-2016, the patient experienced asthenia, injection site pain and fatigue. Patient had pain in entire upper right arm and body weakness. The outcome of asthenia, injection site pain and fatigue was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: U
Vaccine: PPV, FLU4, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot# N003993 with expiration date on 20-OCT-2018) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, FLU4, HPV9
Symptoms: Crying, Dizziness, Presyncope, Syncope, Visual impairment
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot# N003993 with expiration date on 20-OCT-2018) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: PPV, FLU4, HPV9
Symptoms: Incorrect product storage, No adverse event
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 # 667885) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 16 year old male patient. The patient had no significant medical history, patient was being treated for simple viral warts on distal extremities and had no known food/drug allergies. Information on current illnesses, concomitant medications and prior vaccinations were not reported. On 22-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # L036301 dose number 2 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. Other suspect therapies included FLUARIX QUADRIVALENT (Manufacturer: GlaxosmithKline, Vaccinated date: 22-NOV-2016, lot # 23L7C (dose, dose number, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On the same day, the patient experienced pre-syncopal symptoms of dizziness, vision changes and weakness with assisted collapse to floor after walking approximately 30 feet from clinic room to waiting room. Patient was transferred to wheel chair then Gurney with assistance where he rested and was monitored for approximately 30 minutes. Symptoms subsided and patient was ambulatory to leave clinic with his family friend who was driving. The outcome of all the events were reported as recovered/resolved. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: PPV, FLU4, HPV9
Symptoms: Crying, Dizziness, Presyncope, Syncope, Visual impairment
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 # 667885) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 16 year old male patient. The patient had no significant medical history, patient was being treated for simple viral warts on distal extremities and had no known food/drug allergies. Information on current illnesses, concomitant medications and prior vaccinations were not reported. On 22-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # L036301 dose number 2 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. Other suspect therapies included FLUARIX QUADRIVALENT (Manufacturer: GlaxosmithKline, Vaccinated date: 22-NOV-2016, lot # 23L7C (dose, dose number, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On the same day, the patient experienced pre-syncopal symptoms of dizziness, vision changes and weakness with assisted collapse to floor after walking approximately 30 feet from clinic room to waiting room. Patient was transferred to wheel chair then Gurney with assistance where he rested and was monitored for approximately 30 minutes. Symptoms subsided and patient was ambulatory to leave clinic with his family friend who was driving. The outcome of all the events were reported as recovered/resolved. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Nausea, Pallor
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 # 668027) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's concurrent illnesses and other medications were reported as none. The patient's concomitant therapies, prior vaccinations and medical history were not reported. On 23-NOV-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L036301 (dose and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapy which were given on the same day included first dose of FLULAVAL QUADRIVALENT (intramuscularly in the left arm, lot# 7NT2G; dose and expiration date were not reported) for prophylaxis. On the same day, the patient experienced dizziness, pale and diaphoretic with nausea in the waiting area. The patient's mother picked the child up and immunization staff pulled a wheel chair over and placed her in the wheel chair and brought to the treatment room. There was no loss of consciousness. Cool compresses was applied to neck and head. The patient had an emesis of about 50 ml green fluid and afterwards, she said her stomach felt better but still felt funny. The patient was then assisted to treatment bed with head elevated at 30 degrees. The patient had not eaten anything that day. She took few sips of water without difficulty and ate a lollipop. Blood pressure of the patient was 92/58 (units not provided). According to the patient's mother, her blood pressure was normally low. The patient remained lying down for 10 minutes, then slowly sitting up and sitting for 3 minutes. The patient had no dizziness or nausea then. Skin was warm, dry and pink in color. The patient was accompanied to waiting area and allowed to go home after sitting for another 15 minutes. The patient was instructed to remind about the incident when she comes for the next dose and would administer her in the lying down position. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: FLU4, 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 # 668027) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's concurrent illnesses and other medications were reported as none. The patient's concomitant therapies, prior vaccinations and medical history were not reported. On 23-NOV-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L036301 (dose and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapy which were given on the same day included first dose of FLULAVAL QUADRIVALENT (intramuscularly in the left arm, lot# 7NT2G; dose and expiration date were not reported) for prophylaxis. On the same day, the patient experienced dizziness, pale and diaphoretic with nausea in the waiting area. The patient's mother picked the child up and immunization staff pulled a wheel chair over and placed her in the wheel chair and brought to the treatment room. There was no loss of consciousness. Cool compresses was applied to neck and head. The patient had an emesis of about 50 ml green fluid and afterwards, she said her stomach felt better but still felt funny. The patient was then assisted to treatment bed with head elevated at 30 degrees. The patient had not eaten anything that day. She took few sips of water without difficulty and ate a lollipop. Blood pressure of the patient was 92/58 (units not provided). According to the patient's mother, her blood pressure was normally low. The patient remained lying down for 10 minutes, then slowly sitting up and sitting for 3 minutes. The patient had no dizziness or nausea then. Skin was warm, dry and pink in color. The patient was accompanied to waiting area and allowed to go home after sitting for another 15 minutes. The patient was instructed to remind about the incident when she comes for the next dose and would administer her in the lying down position. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: DTAP, HEPA, HPVX, MEN, HEPA, HPV9, MNQ
Symptoms: Bone marrow oedema, Injection site oedema, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pain and swelling at the site of injection - left deltoid. Took NSAIDS. Symptoms worsened. She continued with NSAIDS, ice and heat. Symptoms continued. Worked with trainer at school and did therapy, ice, heat and NSAIDS over the next several weeks without notifying us. Presented for routine sports physical at school that I happened to be providing for free- and she brought it to my attention at that time. I palpated heat and definite soft tissue enlargement/edema when compared to the right deltoid. I advised follow up and she was seen in our office for this for the first time on 04/28/2017. It was exquisitely tender and she had limited ROM of the left upper extremity. I referred for MRI. Results: "MRI joint upper extremity wo/C 1. Moderate teres minor peritendinous and myotendinous edema near its insertion, with reactive bone marrow edema of the greater tuberosity inferior facet, site of teres minor tendon insertion. No evidence of muscle or tendon tear. While findings are nonspecific, given location and provided history of pain after immunization booster injection, this is most suggestive of shoulder injury related to vaccine administration (SIRVA)." I referred to orthopedics. "Left Subacromial Bursitis and Cuff Tendonitis due to vaccination injury" was diagnosis and it was treated with steroid injection on 05/26/2017.
Age: 17.0
Sex: M
Vaccine: DTAP, HEPA, HPVX, MEN, HEPA, HPV9, MNQ
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Nuclear magnetic resonance imaging, Oedema
Clinical narrative: Pain and swelling at the site of injection - left deltoid. Took NSAIDS. Symptoms worsened. She continued with NSAIDS, ice and heat. Symptoms continued. Worked with trainer at school and did therapy, ice, heat and NSAIDS over the next several weeks without notifying us. Presented for routine sports physical at school that I happened to be providing for free- and she brought it to my attention at that time. I palpated heat and definite soft tissue enlargement/edema when compared to the right deltoid. I advised follow up and she was seen in our office for this for the first time on 04/28/2017. It was exquisitely tender and she had limited ROM of the left upper extremity. I referred for MRI. Results: "MRI joint upper extremity wo/C 1. Moderate teres minor peritendinous and myotendinous edema near its insertion, with reactive bone marrow edema of the greater tuberosity inferior facet, site of teres minor tendon insertion. No evidence of muscle or tendon tear. While findings are nonspecific, given location and provided history of pain after immunization booster injection, this is most suggestive of shoulder injury related to vaccine administration (SIRVA)." I referred to orthopedics. "Left Subacromial Bursitis and Cuff Tendonitis due to vaccination injury" was diagnosis and it was treated with steroid injection on 05/26/2017.
Age: 17.0
Sex: M
Vaccine: DTAP, HEPA, HPVX, MEN, HEPA, HPV9, MNQ
Symptoms: X-ray
Clinical narrative: Pain and swelling at the site of injection - left deltoid. Took NSAIDS. Symptoms worsened. She continued with NSAIDS, ice and heat. Symptoms continued. Worked with trainer at school and did therapy, ice, heat and NSAIDS over the next several weeks without notifying us. Presented for routine sports physical at school that I happened to be providing for free- and she brought it to my attention at that time. I palpated heat and definite soft tissue enlargement/edema when compared to the right deltoid. I advised follow up and she was seen in our office for this for the first time on 04/28/2017. It was exquisitely tender and she had limited ROM of the left upper extremity. I referred for MRI. Results: "MRI joint upper extremity wo/C 1. Moderate teres minor peritendinous and myotendinous edema near its insertion, with reactive bone marrow edema of the greater tuberosity inferior facet, site of teres minor tendon insertion. No evidence of muscle or tendon tear. While findings are nonspecific, given location and provided history of pain after immunization booster injection, this is most suggestive of shoulder injury related to vaccine administration (SIRVA)." I referred to orthopedics. "Left Subacromial Bursitis and Cuff Tendonitis due to vaccination injury" was diagnosis and it was treated with steroid injection on 05/26/2017.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RVX
Symptoms: Acoustic stimulation tests, Developmental delay, Imaging procedure, Nuclear magnetic resonance imaging
Clinical narrative: Development delay.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Fever 103.2; erythematous macular rash to torso and extremities.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and the patient's mother and referred to a male patient of an unknown age. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with the first, second, and third doses of GARDASIL (dose, frequency, route of administration, lot numbers and expiration dates were not reported) for prophylaxis and completed the series. Then, on 08-MAY-2017, the patient was vaccinated inadvertently with a fourth dose of GARDASIL (dose and route of administration were not reported; lot number L036301 and expiration date 20-DEC-2017). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse prescriber referring to an unknown number of patients. Information regarding the patients' current conditions, medical history, concomitant therapies and drug reactions or allergies was not provided. It was reported that on 15-MAY-2017, an unknown number of patients were vaccinated with improperly stored doses of GARDASIL 9, lot number: M042853 and an expiration date: 17-JUL-2019 (dose number, route and anatomical location were not provided). The GARDASIL 9 doses, were exposed to a temperature ranges between 32° (F) Fahrenheit and 35 °F, during a time frame of 2 hours, which were called by a data logger, then returned back in range. There were not previous temperature excursions. No adverse events were reported. This is one of several cases from  the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA009812: US-009507513-1705USA009810: US-009507513-1705USA009811.