chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, TDAP
Symptoms: Nausea, Pallor, Retching, Syncope, Vomiting
Clinical narrative: Fainting, quaking, extreme nausea and weakness for more than 6 hours.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a male patient who received BEXSERO. In July 2017, the patient received BEXSERO. In July 2017, less than a week after receiving BEXSERO, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to BEXSERO. Additional details were reported as follows: This case was reported by a Licensed Nurse Practitioner (LPN). The age at vaccination was not reported. About 2 hours before at the time of reporting, the nurse reported that within the past 2 weeks the patient received a dose of BEXSERO. The next day of vaccination, the patient returned to the office for redness, heat, and pain at the injection site. No further related details were provided by the reporter. The reporter gave permission for Agency to contact her at the clinic, if necessary.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Eye swelling, Eyelid oedema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of periocular swelling in a 18-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a day after receiving BEXSERO, the patient experienced periocular swelling. The patient was treated with BENADRYL. On an unknown date, the outcome of the periocular swelling was recovered/resolved. It was unknown if the reporter considered the periocular swelling to be related to BEXSERO. Additional details were reported as follows: The patient received vaccine in the morning then later in the day developed isolated swelling around the eyes. After administered of BENADRYL the swelling was resolved with no further issues. No further information was available regarding the report. Field Representative, reported the initial report received from the health care professional was via email with limited information and that she would follow-up with the health care professional for more details regarding health care professional contact information, product information and patient details and she would call back to Medical Information with further details of the event.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No adverse event, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The patient was 19 year old at the time of reporting. The age at vaccination was not reported. The healthcare professional reported that patient had received complete Hepatitis B series and tested negative for hepatitis B antibody titer. Thus, leading the patient to be a therapy non-responder. The healthcare professional was not sure which Hepatitis B brand was used. No side effects were reported.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased
Clinical narrative: Pt. states her arm was hard to move for 3 days after vaccine. It is still hard to raise her arm over her head. She is unable to join her hands behind her back. She spoke with her MD here and elsewhere. She went for acupuncture in March. That helped some and the acupuncturist recommended she report her issues. We notified pt's primary MD.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Within in a couple of hours of dose, there was an itchy red area around the injection site. It took a couple weeks to go down. Still barely noticeable, but not itchy, at time of report on 7/20. No Tx sought after.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Chills, Headache, Myalgia
Clinical narrative: Chills, body aches, headache, temp 99.7.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: She has had swelling in the lateral Rt upper arm since at least 18 hrs from the injection. 7-18-17 - mother reported the arm was improving.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult female patient who received dTpa vaccine. On 16th July 2017, the patient received dTpa vaccine. On 17th July 2017, 1 days after receiving dTpa vaccine, the patient experienced injection site itching, injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site itching and injection site swelling were unknown and the outcome of the injection site erythema and injection site pain were unchanged. It was unknown if the reporter considered the injection site itching, injection site erythema, injection site pain and injection site swelling to be related to dTpa vaccine. Additional details were provided as follows: The patient came in on the pregnancy registry line, but she was not pregnant. The patient was nearly 70 at the time of reporting. The age at vaccination was not provided. The patient was vaccinated with an unknown Tdap vaccine. The patient began to experience injection site reactions consisting of itching, pain, redness, and swelling. When the patient went to the pharmacy to inform them, they referred her to GlaxoSmithKline. No idea what the brand was. The patient had denied permission to contact their physician.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAPHEPBIP, HIBV
Symptoms: Injection site discolouration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 2-month-old male patient who received HIBERIX (batch number 5FC3Z, expiry date 20th January 2018). Co-suspect products included HIBERIX (batch number 2S27K, expiry date 17th September 2017) and HIBERIX (batch number 4294M, expiry date 20th January 2018). On 9th December 2016, the patient received the 1st dose of HIBERIX. On 15th February 2017, the patient received the 2nd dose of HIBERIX. On an unknown date, the patient received the 3rd dose of HIBERIX. On an unknown date, less than a year after receiving HIBERIX and not applicable after receiving HIBERIX and HIBERIX, the patient experienced injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. On an unknown date, the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation was not recovered/not resolved. It was unknown if the reporter considered the injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation to be related to HIBERIX, HIBERIX and HIBERIX. Additional details were reported as follows: Health care provider was called back with additional patient details regarding an adverse event he reported on 13th June 2017. He stated that the patients developed a hyperpigmented dark spot at the site of the injection of HIBERIX that was not resolved. It occurred with all three doses of HIBERIX which the patient received. The batch number reported for HIBERIX (25K27K) did not exist and was updated to 2S27K, as per sales database. This case was 1 of 3 cases, reported by same reporter.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Nausea, Pyrexia
Clinical narrative: Pt stopped by the office today to report redness at the injection site from her immunization yesterday. She also noted she had a fever last night and c/o nausea last night.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Haemorrhage, Paraesthesia, Pruritus
Clinical narrative: Intense itching sensation and pins/needles sensation throughout body, sensation will be in one spot (ie. lower calf for several minutes then stop and an hour later on head). Pt also experienced blisters on inner elbows. Pt stating itches so intensely, she will bleed from itching.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Erythema, Pain in extremity, Peripheral swelling, Skin induration
Clinical narrative: Chill, left arm swollen/red-size approximately 10" x 4" patch skin gets hardened. Pain in left arm. Treatment BACTRIM DS #14 one BID. ZYRTEC 10 mg #30 one QD.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site mass
Clinical narrative: Lump on (L) leg to shot reaction.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Fever for 3 days and rash at Inj site.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Pallor
Clinical narrative: After the injection, she turned pale and passed out for a short period time (less than 30 seconds).
Age: 51.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Lymph node pain, Pruritus, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Is here for evaluation of rash on his face and neck x 1 day Post vaccination On 7/3/17 with MMR, varicella and meningococcal vaccine, TDAP, Has developed a rash week later, yesterday, esp on face and neck spreading to chest wall, feels feverish also says he felt like he had painful nodes on his neck but went away. Only has mild itching and has not taken any pills. Denies sore throat, joint pain or neck pain. Erythematous maculopapular rash over face and neck spreading to upper chest wall. Has mild itching, some confluent, no vesicles or pustules and not weeping. Nursing note and vitals reviewed. No joint tenderness or swelling.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal pain, Pyrexia
Clinical narrative: Fever 101.9. Shoulder blade pain on vaccine arm.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Pt. was given vaccines and a few minutes later the pt. complained of not feeling well. The pt. was laying down and I gave the pt. a lollipop and water and the pt was feeling better. The doctor was notified and was with the pt. and her mother in his office and 10-15 mins later the pt lost consciousness.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Gravitational oedema, Pain, Swelling
Clinical narrative: Per patient. Patient felt painful, erythema, swelling w/dependent edema. She stated 6 hr. from vaccine. She did warm shower compression to reduce the dependent edema.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram, Dyskinesia, Electrocardiogram, Loss of consciousness, Pallor
Clinical narrative: Information has been received from a nurse via a company representative referring to a 18 year old male patient. The patient's drug reactions/allergies was unknown. Pertinent medical history was reported as none. On 05-JUN-2017, the patient was vaccinated with GARDASIL 9 (lot # M042853, expiration date 17-JUL-2019, 0.5 ml; route was unknown) to prevent HumanPapillomavirus (HPV) (drug administered to patient of inappropriate age). Tuberculosis (TB) Skin Test was done during the same visit. After being given GARDASIL 9, the patient passed out and stopped breathing, and he had bradycardia and no pulse was considered life threatening. The patient was given chest compressions as an intervention to prevent serious criteria and he responded but was lethargic and had low blood pressure. The patient was transported to the emergency room (ER) of an unspecified hospital but was released that day and not admitted to the hospital. Even though the patient had stopped breathing and had no pulse, there was no indication that the patient was considered dead. The patient had recovered from the events he experienced at the nurse practitioner's office, but the patient was also sent for a neurology consult because of possible seizure activity that took place when the he passed out. Until the results came back from that consult, the patient's present status was unspecified. The patient did not actively seek any of the medication that he was given at the time of the events and it was unspecified if the patient had yet gone for the neurology consult. It was unknown if lab diagnostics/studies was performed. This was the first dose of GARDASIL 9 the patient was given and the patient would not be getting any additional doses of GARDASIL 9. Upon internal review, seizure was considered to be medically significant.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Peripheral coldness, Pulse absent, Respiratory arrest, Resuscitation, Tremor
Clinical narrative: Information has been received from a nurse via a company representative referring to a 18 year old male patient. The patient's drug reactions/allergies was unknown. Pertinent medical history was reported as none. On 05-JUN-2017, the patient was vaccinated with GARDASIL 9 (lot # M042853, expiration date 17-JUL-2019, 0.5 ml; route was unknown) to prevent HumanPapillomavirus (HPV) (drug administered to patient of inappropriate age). Tuberculosis (TB) Skin Test was done during the same visit. After being given GARDASIL 9, the patient passed out and stopped breathing, and he had bradycardia and no pulse was considered life threatening. The patient was given chest compressions as an intervention to prevent serious criteria and he responded but was lethargic and had low blood pressure. The patient was transported to the emergency room (ER) of an unspecified hospital but was released that day and not admitted to the hospital. Even though the patient had stopped breathing and had no pulse, there was no indication that the patient was considered dead. The patient had recovered from the events he experienced at the nurse practitioner's office, but the patient was also sent for a neurology consult because of possible seizure activity that took place when the he passed out. Until the results came back from that consult, the patient's present status was unspecified. The patient did not actively seek any of the medication that he was given at the time of the events and it was unspecified if the patient had yet gone for the neurology consult. It was unknown if lab diagnostics/studies was performed. This was the first dose of GARDASIL 9 the patient was given and the patient would not be getting any additional doses of GARDASIL 9. Upon internal review, seizure was considered to be medically significant.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Trismus, Urinary incontinence
Clinical narrative: Information has been received from a nurse via a company representative referring to a 18 year old male patient. The patient's drug reactions/allergies was unknown. Pertinent medical history was reported as none. On 05-JUN-2017, the patient was vaccinated with GARDASIL 9 (lot # M042853, expiration date 17-JUL-2019, 0.5 ml; route was unknown) to prevent HumanPapillomavirus (HPV) (drug administered to patient of inappropriate age). Tuberculosis (TB) Skin Test was done during the same visit. After being given GARDASIL 9, the patient passed out and stopped breathing, and he had bradycardia and no pulse was considered life threatening. The patient was given chest compressions as an intervention to prevent serious criteria and he responded but was lethargic and had low blood pressure. The patient was transported to the emergency room (ER) of an unspecified hospital but was released that day and not admitted to the hospital. Even though the patient had stopped breathing and had no pulse, there was no indication that the patient was considered dead. The patient had recovered from the events he experienced at the nurse practitioner's office, but the patient was also sent for a neurology consult because of possible seizure activity that took place when the he passed out. Until the results came back from that consult, the patient's present status was unspecified. The patient did not actively seek any of the medication that he was given at the time of the events and it was unspecified if the patient had yet gone for the neurology consult. It was unknown if lab diagnostics/studies was performed. This was the first dose of GARDASIL 9 the patient was given and the patient would not be getting any additional doses of GARDASIL 9. Upon internal review, seizure was considered to be medically significant.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Bradycardia, Hypotension, Lethargy, Loss of consciousness, Pulse absent
Clinical narrative: Information has been received from a nurse via a company representative referring to a 18 year old male patient. The patient's drug reactions/allergies was unknown. Pertinent medical history was reported as none. On 05-JUN-2017, the patient was vaccinated with GARDASIL 9 (lot # M042853, expiration date 17-JUL-2019, 0.5 ml; route was unknown) to prevent HumanPapillomavirus (HPV) (drug administered to patient of inappropriate age). Tuberculosis (TB) Skin Test was done during the same visit. After being given GARDASIL 9, the patient passed out and stopped breathing, and he had bradycardia and no pulse was considered life threatening. The patient was given chest compressions as an intervention to prevent serious criteria and he responded but was lethargic and had low blood pressure. The patient was transported to the emergency room (ER) of an unspecified hospital but was released that day and not admitted to the hospital. Even though the patient had stopped breathing and had no pulse, there was no indication that the patient was considered dead. The patient had recovered from the events he experienced at the nurse practitioner's office, but the patient was also sent for a neurology consult because of possible seizure activity that took place when the he passed out. Until the results came back from that consult, the patient's present status was unspecified. The patient did not actively seek any of the medication that he was given at the time of the events and it was unspecified if the patient had yet gone for the neurology consult. It was unknown if lab diagnostics/studies was performed. This was the first dose of GARDASIL 9 the patient was given and the patient would not be getting any additional doses of GARDASIL 9. Upon internal review, seizure was considered to be medically significant.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Respiratory arrest
Clinical narrative: Information has been received from a nurse via a company representative referring to a 18 year old male patient. The patient's drug reactions/allergies was unknown. Pertinent medical history was reported as none. On 05-JUN-2017, the patient was vaccinated with GARDASIL 9 (lot # M042853, expiration date 17-JUL-2019, 0.5 ml; route was unknown) to prevent HumanPapillomavirus (HPV) (drug administered to patient of inappropriate age). Tuberculosis (TB) Skin Test was done during the same visit. After being given GARDASIL 9, the patient passed out and stopped breathing, and he had bradycardia and no pulse was considered life threatening. The patient was given chest compressions as an intervention to prevent serious criteria and he responded but was lethargic and had low blood pressure. The patient was transported to the emergency room (ER) of an unspecified hospital but was released that day and not admitted to the hospital. Even though the patient had stopped breathing and had no pulse, there was no indication that the patient was considered dead. The patient had recovered from the events he experienced at the nurse practitioner's office, but the patient was also sent for a neurology consult because of possible seizure activity that took place when the he passed out. Until the results came back from that consult, the patient's present status was unspecified. The patient did not actively seek any of the medication that he was given at the time of the events and it was unspecified if the patient had yet gone for the neurology consult. It was unknown if lab diagnostics/studies was performed. This was the first dose of GARDASIL 9 the patient was given and the patient would not be getting any additional doses of GARDASIL 9. Upon internal review, seizure was considered to be medically significant.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 78-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot # R28322, Expiry Date Mar2018, NDC # 0005197102, UPC # 30005197102) via an unspecified route of administration at single dose on 10Jul2017 for immunization, since over 65. The patient medical history was not reported. Concomitant medication included one single dose of ZOSTAVAX on an unknown date for immunization and just a regular schedule medication, nothing special. The patient experienced site was red and she felt warm to the touch, it was red and it was warm and itchy on 16Jul2017. Course of events: On 16Jul2017 the patient noticed the site was red and she felt warm to the touch and further right, a week after, it was over a week after the vaccination it was red and it was warm and itchy. The itching stopped but the patient said it's still red.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 78-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot # R28322, Expiry Date Mar2018, NDC # 0005197102, UPC # 30005197102) via an unspecified route of administration at single dose on 10Jul2017 for immunization, since over 65. The patient medical history was not reported. Concomitant medication included one single dose of ZOSTAVAX on an unknown date for immunization and just a regular schedule medication, nothing special. The patient experienced site was red and she felt warm to the touch, it was red and it was warm and itchy on 16Jul2017. Course of events: On 16Jul2017 the patient noticed the site was red and she felt warm to the touch and further right, a week after, it was over a week after the vaccination it was red and it was warm and itchy. The itching stopped but the patient said it's still red.
Age: 0.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 17-year-old female patient of unspecified ethnicity received the second dose of TRUMENBA (lot# R47584, exp date Jul2018), via an unspecified route, on 18Jul2017 2:09pm, at single, for immunization. Relevant medical history and concomitant medications were not reported. The patient previously received first dose of MENACTRA (Lot# M15066, Exp date 30Sep2016), for immunisation, with no adverse effect and the second dose of MENACTRA from lot# A15066 and the first dose of TRUMENBA from lot # M37314, exp date Apr2016, intramuscular in the left arm, both on 25Mar2016 and she had experienced syndrome of meningeal irritation. On an unknown date the patient experienced severe headache, nausea, vomiting, body aches, meningitis type neck stiffness, and swelling in mouth. The outcome of the events was unknown. The patient's parents took her to ER where she was treated with IV fluids, Morphine, and an anti-nausea drug. Patient was later sent home on anti-nausea drug and was not admitted to hospital. Follow-up attempts completed. No further information expected.
Age: 0.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Mouth swelling, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 17-year-old female patient of unspecified ethnicity received the second dose of TRUMENBA (lot# R47584, exp date Jul2018), via an unspecified route, on 18Jul2017 2:09pm, at single, for immunization. Relevant medical history and concomitant medications were not reported. The patient previously received first dose of MENACTRA (Lot# M15066, Exp date 30Sep2016), for immunisation, with no adverse effect and the second dose of MENACTRA from lot# A15066 and the first dose of TRUMENBA from lot # M37314, exp date Apr2016, intramuscular in the left arm, both on 25Mar2016 and she had experienced syndrome of meningeal irritation. On an unknown date the patient experienced severe headache, nausea, vomiting, body aches, meningitis type neck stiffness, and swelling in mouth. The outcome of the events was unknown. The patient's parents took her to ER where she was treated with IV fluids, Morphine, and an anti-nausea drug. Patient was later sent home on anti-nausea drug and was not admitted to hospital. Follow-up attempts completed. No further information expected.
Age: 0.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 17-year-old female patient of unspecified ethnicity received the second dose of TRUMENBA (lot# R47584, exp date Jul2018), via an unspecified route, on 18Jul2017 2:09pm, at single, for immunization. Relevant medical history and concomitant medications were not reported. The patient previously received first dose of MENACTRA (Lot# M15066, Exp date 30Sep2016), for immunisation, with no adverse effect and the second dose of MENACTRA from lot# A15066 and the first dose of TRUMENBA from lot # M37314, exp date Apr2016, intramuscular in the left arm, both on 25Mar2016 and she had experienced syndrome of meningeal irritation. On an unknown date the patient experienced severe headache, nausea, vomiting, body aches, meningitis type neck stiffness, and swelling in mouth. The outcome of the events was unknown. The patient's parents took her to ER where she was treated with IV fluids, Morphine, and an anti-nausea drug. Patient was later sent home on anti-nausea drug and was not admitted to hospital. Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: HPV9, HEPA, HPV9
Symptoms: Dizziness, Injection site pain, Mydriasis, Pupil fixed, Seizure like phenomena
Clinical narrative: Syncope and vomiting. (Mom has had same reaction to immunization).
Age: 17.0
Sex: F
Vaccine: HPV9, HEPA, HPV9
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Syncope and vomiting. (Mom has had same reaction to immunization).
Age: 17.0
Sex: F
Vaccine: HPV9, HEPA, HPV9
Symptoms: Syncope, Vomiting
Clinical narrative: Syncope and vomiting. (Mom has had same reaction to immunization).
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, TDAP
Symptoms: Asthenia, Nausea, Syncope, Tremor
Clinical narrative: Approximately 10 minutes after the administration of the vaccines, the patient had a syncope episode (witnessed by the physicians in the office). She regained consciousness after approximately 20-30 seconds but continued to be quite diaphoretic, pale, and dizzy for the subsequent 2 hours. She had abdominal pain and nausea and was retching in the office but did not vomit. She continued to be very dizzy and pale, even while laying down in the exam room, for at least 2 hours after the syncopal episode. Her blood pressure remained stable. About 1 hour after the syncopal event, glucose level was checked and was 97. She very gradually recovered and was able to leave clinic 2 hours after the syncopal episode but continued to feel very light headed. Her mother called clinic the following morning and informed us that she had proceeded to vomit every 45 minutes overnight. The next day, she gradually improved and has been tolerating clear liquids. We called again that afternoon to check on her and she was feeling much better.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, TDAP
Symptoms: Abdominal pain, Blood glucose normal, Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Approximately 10 minutes after the administration of the vaccines, the patient had a syncope episode (witnessed by the physicians in the office). She regained consciousness after approximately 20-30 seconds but continued to be quite diaphoretic, pale, and dizzy for the subsequent 2 hours. She had abdominal pain and nausea and was retching in the office but did not vomit. She continued to be very dizzy and pale, even while laying down in the exam room, for at least 2 hours after the syncopal episode. Her blood pressure remained stable. About 1 hour after the syncopal event, glucose level was checked and was 97. She very gradually recovered and was able to leave clinic 2 hours after the syncopal episode but continued to feel very light headed. Her mother called clinic the following morning and informed us that she had proceeded to vomit every 45 minutes overnight. The next day, she gradually improved and has been tolerating clear liquids. We called again that afternoon to check on her and she was feeling much better.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, TDAP
Symptoms: Nausea, Pallor, Retching, Syncope, Vomiting
Clinical narrative: Approximately 10 minutes after the administration of the vaccines, the patient had a syncope episode (witnessed by the physicians in the office). She regained consciousness after approximately 20-30 seconds but continued to be quite diaphoretic, pale, and dizzy for the subsequent 2 hours. She had abdominal pain and nausea and was retching in the office but did not vomit. She continued to be very dizzy and pale, even while laying down in the exam room, for at least 2 hours after the syncopal episode. Her blood pressure remained stable. About 1 hour after the syncopal event, glucose level was checked and was 97. She very gradually recovered and was able to leave clinic 2 hours after the syncopal episode but continued to feel very light headed. Her mother called clinic the following morning and informed us that she had proceeded to vomit every 45 minutes overnight. The next day, she gradually improved and has been tolerating clear liquids. We called again that afternoon to check on her and she was feeling much better.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Chills, Headache, Hyperhidrosis
Clinical narrative: Sever headaches, joint pain, muscle cramps, sweating and chills.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Sever headaches, joint pain, muscle cramps, sweating and chills.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Mobility decreased, Monoplegia
Clinical narrative: Temporary paralysis in left arm for 3 weeks. Arm was completely immobile and was dominant hand. I could write because I could bend my wrist some, but it was very difficult. I had to physically lift my arm with my right arm. My skin had sensation but my arm would not move. I still have phamtom pains to this day at the injection site and sometimes my arm randomly goves out on occassion no matter if I am using it or not. No treatment was given after symptoms were explained, we were told to just wait it out.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Headache, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Mother called to state that 1 day after receiving vaccines, patient complained of severe left arm pain, fever, nausea, and headache. Fever lasted about 24 hours, resolved with MOTRIN. Mom stated patient was unable to get out of bed due to the amount of pain she was in. She was not having any pain in her right arm at all. Mom had not given patient anything except 1 dose of MOTRIN. Mom was advised to alternate MOTRIN/TYLENOL, and to use a heating pad or to apply ice to the injection sites. Mom was contacted the following day for follow up, she stated all of patients symptoms had resolved.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Night sweats, Pain, Pyrexia, Skin infection
Clinical narrative: Skin infection, rash, and swelling at site of vaccine and putting off heat. Fever, night sweats, body aches/joint pain.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Skin infection, rash, and swelling at site of vaccine and putting off heat. Fever, night sweats, body aches/joint pain.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: Projectile vomiting, fever.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose normal, Dizziness, Flushing
Clinical narrative: The patient was asked before vaccine administration if any reaction had occurred in the past and patient replied no "I just don't like getting shots." Patient was administered vaccine 2:58 pm and at 3:00 pm patient reported feeling faint, looked flushed and was laid down onto the bed with head of bed at 45 degree angle. No syncope. Vital signs checked at 3:00 PM: BP 88/50, pulse 71, 02 98% and respirations 20. Given cold cloth to forehead. Blood sugar checked at 3:02 pm 81. Patient given water and apple juice. Patient was alert and oriented x3. Vital signs taken at 3:05 pm: BP 90/58 02 98%, pulse 73, resps 16. Patient verbalized she felt better after drinking apple juice. Patient vital signs at 3:19 pm: BP 104/64, pulse 74, temp 98.0 and resp 18. Patient was able to walk out to waiting area with her mother and was advised to call the office if she experienced any further symptoms.
Sex: U
Vaccine: HPV9, MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 11-JUL-2017 from a medical assistant regarding an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The medical assistant reported that on unspecified dates an unspecified number of patients were administered improperly stored doses of GARDASIL 9 (lot # M042853 expiration 17-JUL-2019) unknown route for prophylaxis and ROTATEQ (lot # N045546 expiration 12-JUN-2018) oral for prophylaxis. The medical assistant reported that on unspecified dates an unspecified number of patients were administered improperly stored doses of M-M-R II (lot # M042846 expiration 21-OCT-2018) subcutaneous for prophylaxis which was reconstituted with properly stored sterile diluent (lot # and expiration unknown). No adverse effects were reported. The vaccines were stored at the temperature range of 47 degrees Fahrenheit and 77 degrees Fahrenheit for the time frame of 15 minutes. There were no previous temperature excursions. The call was made due to a data logger. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received 11-JUL-2017 via a phone call from a healthcare worker who reported that a 60 year old patient (gender not provided, only patient initials and age) was vaccinated on 11-JUL-2017 with improperly stored ZOSTAVAX (Lot number N010494, expiration 16-MAR-2018) that was reconstituted with properly stored Merck Diluent (Lot number and expiration date were unknown).  The ZOSTAVAX had been stored at 7 degrees Fahrenheit for 5 hours and 10 minutes. There had not been a previous temperature excursion. The report had been called in due to a data logger. No adverse effects were reported. No further information was provided.  Additional information was requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 17-JUL-2017 from a registered nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with PROQUAD lot # M033216, expiration 09-JAN-2018 subcutaneous for prophylaxis which was improperly stored and reconstituted with properly stored sterile diluent (lot # and expiration unknown.)  No adverse effects reported. The vaccine was stored at the temperature range of 15 degrees Fahrenheit to 46 degrees Fahrenheit for the time frame of 1 hour and 10 minutes. There were no previous temperature excursions. The call was made due to a data logger. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. In September 2016, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis. The patient inadvertently received the second dose of ZOSTAVAX in September 2016. The doses of the vaccine were reconstituted with sterile diluent (MERCK STERILE DILUENT). The patient experienced no adverse event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date, the patient experienced incorrect dose administered, product leakage and no adverse event. The outcome of incorrect dose administered, no adverse event and product leakage is unknown. The reporter considered incorrect dose administered and product leakage to be not related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Varicella
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On 18-MAY-2017, the patient experienced varicella. On an unknown date, the patient experienced hypersensitivity. The outcome of hypersensitivity and varicella was reported as not recovered/not resolved.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 71 year old male patient. The medical history, concurrent conditions and concomitant medications were not reported. On 23-MAY-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N001007 19-SEP-2018, N011491 04-NOV-2018, M047519, 08-APR-2018  for prophylaxis. On 23-MAY-2017(reported as within 24 hours), the patient experienced redness, pain and swelling in the entire arm. The nurse reported that the pain radiated to the patient's shoulder. The patient was instructed to take an unspecified over the counter pain reliever and to apply warm compresses to the arm. The nurse reported that the symptoms lasted at least 3days and it resolved. The nurse was unsure which patient received which vaccine. Lab tests was not performed. The outcome of the events were reported as recovered/resolved. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided. On unknown date in 2017, reported as since March 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot M036059 with an expiration date on 03-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There were no previous temperature excursions. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 (lot # M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008831: US-009507513-1707USA008799: US-009507513-1707USA008817: US-009507513-1707USA008818: US-009507513-1707USA008819: US-009507513-1707USA008862: US-009507513-1707USA008863: US-009507513-1707USA008793: US-009507513-1707USA008820: US-009507513-1707USA008821: US-009507513-1707USA008839: US-009507513-1707USA008864: US-009507513-1707USA008865: US-009507513-1707USA008794: US-009507513-1707USA008822: US-009507513-1707USA008823: US-009507513-1707USA008840: US-009507513-1707USA008866: US-009507513-1707USA008867: US-009507513-1707USA008795: US-009507513-1707USA008824: US-009507513-1707USA008825: US-009507513-1707USA008841: US-009507513-1707USA008868: US-009507513-1707USA008869: US-009507513-1707USA008796: US-009507513-1707USA008826: US-009507513-1707USA008827: US-009507513-1707USA008828: US-009507513-1707USA008842: US-009507513-1707USA008870: US-009507513-1707USA008797: US-009507513-1707USA008829: US-009507513-1707USA008830: US-009507513-1707USA008843: US-009507513-1707USA008798: US-009507513-1707USA006643: US-009507513-1707USA008832: US-009507513-1707USA008844: US-009507513-1707USA008845: US-009507513-1707USA008800: US-009507513-1707USA008833: US-009507513-1707USA008801: US-009507513-1707USA008802: US-009507513-1707USA008834: US-009507513-1707USA008846: US-009507513-1707USA008803: US-009507513-1707USA008804: US-009507513-1707USA008835: US-009507513-1707USA008847: US-009507513-1707USA008848: US-009507513-1707USA008805: US-009507513-1707USA008806: US-009507513-1707USA008849: US-009507513-1707USA008850: US-009507513-1707USA008807: US-009507513-1707USA008808: US-009507513-1707USA008851: US-009507513-1707USA008852: US-009507513-1707USA008853: US-009507513-1707USA008789: US-009507513-1707USA008809: US-009507513-1707USA008810: US-009507513-1707USA008854: US-009507513-1707USA008855: US-009507513-1707USA008790: US-009507513-1707USA008811: US-009507513-1707USA008812: US-009507513-1707USA008836.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided. On unknown date in 2017(reported as since March 2017), the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot M036059 with an expiration date on 03-JUN-2019 (strength, dose and route of administration were not reported) as prophylaxis, which was exposed to a temperature from 47 to 77 Fahrenheit degrees for 12 hours. There were no previous temperature excursions. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter.. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. The vaccine was exposed from 32°F to 35°F for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643: Original Case: 1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643: Original Case: 1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 (lot # M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.