chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dysuria, Ear tube insertion, Epstein-Barr virus test positive, Fatigue
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL (lot, dosage regimen unknown) by "injection" route. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post-mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not sought medical attention and no treatment was given for the adverse events. The outcome of the events was unknown. Product quality complaint (PQC) was not filed. Causality assessment for the event of mononucleosis was not provided. Follow up information has been received from the nurse practitioner on 06-JUN-2016. The patient was a non-smoker with no known allergy. The patient was vaccinated with three doses of GARDASIL on 29-OCT-2014 09:18 (lot# K006124, in left deltoid), 08-JAN-2015 09:01 (lot# K009482, in right deltoid) and 15-JUN-2015 15:21 (lot# K014191, in right deltoid) via intramuscular respectively. On an unknown date the patient experienced Attention-Deficit Hyperactivity Disorder (ADHD), dysuria (recovered on 15-JUN-2015), left breast mass (recovered on 15-JUN-2015) and underwent ear tube insertion. The patient also complained of vertigo intermittently, always being tired, headache, wired rashes on different spots (2-3 months) lasting only a couple hours and episodes of facial twitching to her right cheek by her nose lasted for 4 days (only felt it, not visible). The patient had episodes of abdominal pain and constipation and diarrhea and celiac disease. On 30-NOV-2015, the patient tested positive for Epstein-Barr virus (EBV) and the white blood cell (WBC) was decreased at that time. Blood in toilet was noticed 2-3 weeks ago (February 2016), initially after stool. The patient had episode of blood in toilet and on paper without bowel movement in the night on 06-MAR-2016. The patient was on period but did not feel it is related to that. The patient's mother was concerned that it was related to the 3rd dose of vaccine along with multiple other health related concerns. On 07-MAR-2016, physical examination of the patient was normal. Complete blood count (CBC) and urinalysis were normal. WBC was 5.7, red blood cell count was 4.91 and hemoglobin was 13.8. The rectal bleeding was suspected to be related with constipation by the reporter. The causality between the events except rash and fatigue was not provided. The outcome of the other events that was not mentioned above was unknown. Upon internal review, rectal bleeding was determined to be medically significant. Additional information is not expected as all correspondence was received. Patient information, product, event, narrative and serious criteria were all updated.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine analysis normal, Vertigo, White blood cell count decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL (lot, dosage regimen unknown) by "injection" route. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post-mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not sought medical attention and no treatment was given for the adverse events. The outcome of the events was unknown. Product quality complaint (PQC) was not filed. Causality assessment for the event of mononucleosis was not provided. Follow up information has been received from the nurse practitioner on 06-JUN-2016. The patient was a non-smoker with no known allergy. The patient was vaccinated with three doses of GARDASIL on 29-OCT-2014 09:18 (lot# K006124, in left deltoid), 08-JAN-2015 09:01 (lot# K009482, in right deltoid) and 15-JUN-2015 15:21 (lot# K014191, in right deltoid) via intramuscular respectively. On an unknown date the patient experienced Attention-Deficit Hyperactivity Disorder (ADHD), dysuria (recovered on 15-JUN-2015), left breast mass (recovered on 15-JUN-2015) and underwent ear tube insertion. The patient also complained of vertigo intermittently, always being tired, headache, wired rashes on different spots (2-3 months) lasting only a couple hours and episodes of facial twitching to her right cheek by her nose lasted for 4 days (only felt it, not visible). The patient had episodes of abdominal pain and constipation and diarrhea and celiac disease. On 30-NOV-2015, the patient tested positive for Epstein-Barr virus (EBV) and the white blood cell (WBC) was decreased at that time. Blood in toilet was noticed 2-3 weeks ago (February 2016), initially after stool. The patient had episode of blood in toilet and on paper without bowel movement in the night on 06-MAR-2016. The patient was on period but did not feel it is related to that. The patient's mother was concerned that it was related to the 3rd dose of vaccine along with multiple other health related concerns. On 07-MAR-2016, physical examination of the patient was normal. Complete blood count (CBC) and urinalysis were normal. WBC was 5.7, red blood cell count was 4.91 and hemoglobin was 13.8. The rectal bleeding was suspected to be related with constipation by the reporter. The causality between the events except rash and fatigue was not provided. The outcome of the other events that was not mentioned above was unknown. Upon internal review, rectal bleeding was determined to be medically significant. Additional information is not expected as all correspondence was received. Patient information, product, event, narrative and serious criteria were all updated.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deafness unilateral
Clinical narrative: Initial unsolicited report received from a non-health professional on 27 June 2016. This case involves a male patient (age no reported) who was vaccinated with a dose of FLUZONE QIV (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had left ear hearing loss. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. Upon medical review, the case was considered as serious due to important medical event: left ear hearing loss. List of documents held by sender: none. Sender's Comments: This is a poorly documented case. The patient developed left ear hearing loss on an unspecified date following FLUZONE QIV vaccine. Further information on patient's past medical history, recent ear infection, any history of trauma to ear, recent neurological infection like meningitis and encephalitis, any concomitant medications, etc. are needed to further assess the case. Based on the available information, a role of vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a 66 year old female patient regarding herself. Patient suffers from a concurrent condition of seasonal allergy. On 27-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 (dose information, lot number and expiry date not reported), intramuscularly in the left arm. Concomitant medication included steroid 80 mg of "DEPO MUDERIL". On 27-JUN-2016, within 3 hours of administration of the vaccine, the patient experienced debilitating pain in the left shoulder, all the way down to "risk" and could not use her left arm. The pain continued "to crescendo". The patient also experienced severe muscle pain in the left arm (site of vaccine administration) and was not able to use left arm. She also reported diminished range of motion. The patient sought medical attention-she went to the physician for treatment of the events. No laboratory tests were done. The outcome of the events was reported as recovering. Causality assessment was not provided. Upon internal review, the event "diminished range of motion, could not use left arm" was considered to have caused disability. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a 66 year old female patient regarding herself. Patient suffers from a concurrent condition of seasonal allergy. On 27-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 (dose information, lot number and expiry date not reported), intramuscularly in the left arm. Concomitant medication included steroid 80 mg of "DEPO MUDERIL". On 27-JUN-2016, within 3 hours of administration of the vaccine, the patient experienced debilitating pain in the left shoulder, all the way down to "risk" and could not use her left arm. The pain continued "to crescendo". The patient also experienced severe muscle pain in the left arm (site of vaccine administration) and was not able to use left arm. She also reported diminished range of motion. The patient sought medical attention-she went to the physician for treatment of the events. No laboratory tests were done. The outcome of the events was reported as recovering. Causality assessment was not provided. Upon internal review, the event "diminished range of motion, could not use left arm" was considered to have caused disability. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood test, Computerised tomogram, Crying, Headache, Hypoaesthesia
Clinical narrative: Flu symptoms the next day- 6/22/16. About 5 weeks later three toes went numb and had pain off and on. Revisited doctor on 6/22/2016 and told them I suspected a adverse reaction to vaccine.  I was told the numb/pain in toes was not related. Patient was given her 2nd dose. About 12 hours later she experienced pain in her left side (arm, leg) head hurt on left side, jaw. I brought her to the doctor and was told to bring her to the ER. She received a CT scan and was released. On 6/27/16 returned to ER because she was not able to move her left side at all and was experiencing severe shooting pain in arm and leg. Head on left side severe hurt. This lasted for 10 hours. 6/29/16 terrible headache and neck and spine. Patient was screaming and crying for 4 hours. We were almost to ER again when she felt a bit better so we went home. (we live 90 minutes from the hospital). Patient has had headaches on and off but no more ER visits so far. I hope and pray she continues to improve. We were referred to a Neurologist and have an EEG apt scheduled.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Influenza, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: Flu symptoms the next day- 6/22/16. About 5 weeks later three toes went numb and had pain off and on. Revisited doctor on 6/22/2016 and told them I suspected a adverse reaction to vaccine.  I was told the numb/pain in toes was not related. Patient was given her 2nd dose. About 12 hours later she experienced pain in her left side (arm, leg) head hurt on left side, jaw. I brought her to the doctor and was told to bring her to the ER. She received a CT scan and was released. On 6/27/16 returned to ER because she was not able to move her left side at all and was experiencing severe shooting pain in arm and leg. Head on left side severe hurt. This lasted for 10 hours. 6/29/16 terrible headache and neck and spine. Patient was screaming and crying for 4 hours. We were almost to ER again when she felt a bit better so we went home. (we live 90 minutes from the hospital). Patient has had headaches on and off but no more ER visits so far. I hope and pray she continues to improve. We were referred to a Neurologist and have an EEG apt scheduled.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain in jaw, Screaming, Spinal pain
Clinical narrative: Flu symptoms the next day- 6/22/16. About 5 weeks later three toes went numb and had pain off and on. Revisited doctor on 6/22/2016 and told them I suspected a adverse reaction to vaccine.  I was told the numb/pain in toes was not related. Patient was given her 2nd dose. About 12 hours later she experienced pain in her left side (arm, leg) head hurt on left side, jaw. I brought her to the doctor and was told to bring her to the ER. She received a CT scan and was released. On 6/27/16 returned to ER because she was not able to move her left side at all and was experiencing severe shooting pain in arm and leg. Head on left side severe hurt. This lasted for 10 hours. 6/29/16 terrible headache and neck and spine. Patient was screaming and crying for 4 hours. We were almost to ER again when she felt a bit better so we went home. (we live 90 minutes from the hospital). Patient has had headaches on and off but no more ER visits so far. I hope and pray she continues to improve. We were referred to a Neurologist and have an EEG apt scheduled.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood magnesium decreased, Blood test, Computerised tomogram head normal, Condition aggravated, Headache
Clinical narrative: Flu symptoms the next day- 6/22/16. About 5 weeks later three toes went numb and had pain off and on. Revisited doctor on 6/22/2016 and told them I suspected a adverse reaction to vaccine.  I was told the numb/pain in toes was not related. Patient was given her 2nd dose. About 12 hours later she experienced pain in her left side (arm, leg) head hurt on left side, jaw. I brought her to the doctor and was told to bring her to the ER. She received a CT scan and was released. On 6/27/16 returned to ER because she was not able to move her left side at all and was experiencing severe shooting pain in arm and leg. Head on left side severe hurt. This lasted for 10 hours. 6/29/16 terrible headache and neck and spine. Patient was screaming and crying for 4 hours. We were almost to ER again when she felt a bit better so we went home. (we live 90 minutes from the hospital). Patient has had headaches on and off but no more ER visits so far. I hope and pray she continues to improve. We were referred to a Neurologist and have an EEG apt scheduled.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Hemiparesis, Hypoaesthesia, Migraine, Muscular weakness, Pain
Clinical narrative: Flu symptoms the next day- 6/22/16. About 5 weeks later three toes went numb and had pain off and on. Revisited doctor on 6/22/2016 and told them I suspected a adverse reaction to vaccine.  I was told the numb/pain in toes was not related. Patient was given her 2nd dose. About 12 hours later she experienced pain in her left side (arm, leg) head hurt on left side, jaw. I brought her to the doctor and was told to bring her to the ER. She received a CT scan and was released. On 6/27/16 returned to ER because she was not able to move her left side at all and was experiencing severe shooting pain in arm and leg. Head on left side severe hurt. This lasted for 10 hours. 6/29/16 terrible headache and neck and spine. Patient was screaming and crying for 4 hours. We were almost to ER again when she felt a bit better so we went home. (we live 90 minutes from the hospital). Patient has had headaches on and off but no more ER visits so far. I hope and pray she continues to improve. We were referred to a Neurologist and have an EEG apt scheduled.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Paraesthesia, Scan
Clinical narrative: Flu symptoms the next day- 6/22/16. About 5 weeks later three toes went numb and had pain off and on. Revisited doctor on 6/22/2016 and told them I suspected a adverse reaction to vaccine.  I was told the numb/pain in toes was not related. Patient was given her 2nd dose. About 12 hours later she experienced pain in her left side (arm, leg) head hurt on left side, jaw. I brought her to the doctor and was told to bring her to the ER. She received a CT scan and was released. On 6/27/16 returned to ER because she was not able to move her left side at all and was experiencing severe shooting pain in arm and leg. Head on left side severe hurt. This lasted for 10 hours. 6/29/16 terrible headache and neck and spine. Patient was screaming and crying for 4 hours. We were almost to ER again when she felt a bit better so we went home. (we live 90 minutes from the hospital). Patient has had headaches on and off but no more ER visits so far. I hope and pray she continues to improve. We were referred to a Neurologist and have an EEG apt scheduled.
Age: 55.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Extra dose administered, Inappropriate schedule of drug administration, Nasal congestion
Clinical narrative: Initial unsolicited misuse report received from a physician on 15 Jun 2016. This case involves a 55-year-old female patient who was vaccinated with second dose of MENACTRA (batch number, expiry date, dose, route and site of administration were not reported) on 15 Jun 2016. The reporter stated that her medical assistant gave the patient MENACTRA for a second time in 2 weeks. Patient's medical history and concomitant medications were not reported. Illness at the time of vaccination was reported as none. On 15 Jun 2016, unspecified time since the first dose and same day after receiving the second dose, the patient experienced diarrhea and a stuffy nose. The reporter was planning to see the patient some time later in the day to evaluate. It was also a case of extra dose administered. Lab data and corrective treatment were not reported. The patient required ER/ Doctor visit. The outcome of the events diarrhea and stuffy nose was unknown. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 21 June 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 15 June 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unknown date, following the vaccination the patient's left arm was swollen for 5 days and can't lift the arm as usual. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood test, Bradycardia, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: Dizzy, pain, tachacardia, bradycardia, exhaustion, headaches.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Headache, Pain, Tachycardia, Tilt table test
Clinical narrative: Dizzy, pain, tachacardia, bradycardia, exhaustion, headaches.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea, diarrhea.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Vertigo
Clinical narrative: This solicited report has been received f rom a 62 year old female patient enrolled in a study conducted by MSW Research. The patient's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with dose of PNEUMOVAX23 (dose, route and anatomical location were not reported).  On an unknown date, patient reported that she suffered from vertigo after receiving the last vaccine. The outcome of vertigo was unknown. Action taken with the therapy was unknown (not applicable). The causality between the event and PNEUMOVAX23 was anot reported. Additional information is not expected as the reporter did not consent for further follow-up.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This solicited report has been received from a 76 year old male patient enrolled in a study conducted by MSW Research. The patient's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX23. On an unknown date the patient reported that he had a reaction to pneumonia vaccine many years ago and do not know whether he should get another one. So he wanted to ask doctor. The outcome of the event was unknown. Action taken with the study therapy was unknown. The causality between the event and PNEUMOVAX23 was not reported. Additional information is not expected as the reporter did not consent for further follow up.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous repor0t as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-JUN-2016, the patient was inadvertently vaccinated intramuscularly in the left arm with an unknown dose of PNEUMOVAX23, which was expired (lot # K010465, expiry date 23-MAR-2016). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L044475, expiration date 12-MAY-2017). The excursion temperature was 33.8 degree Fahrenheit. The excursion time frames were 1 hour 59 minutes and 1 hour and 43 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # J013394, expiration date 25-AUG-2016). The excursion temperature was 22.8 degree Fahrenheit. The excursion time frames were 1 hour 59 minutes and 1 hour and 43 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Mild localized erythema with calor. No lost work or limited duty.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Headache, Pyrexia, Vomiting
Clinical narrative: Vomiting, Headache, Stomach Cramps and Low Grade Fever all lasting three days.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Extreme aching of right shoulder, site of the injection.  Unable to move right arm without significant pain.  Iced throughout night and took aspirin (325 mg, 2 tablets).
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Asthenia, Headache, Vomiting
Clinical narrative: Vomiting, Headache, Stomach Cramps and Weakness all lasting three days.
Sex: U
Vaccine: MENB
Symptoms: Dyspnoea, Vision blurred
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of difficulty breathing in a patient who received BEXSERO. On 29th June 2016, the patient received BEXSERO. On 29th June 2016, 10 min after receiving BEXSERO, the patient experienced difficulty breathing (serious criteria other: as per reporter) and blurred vision. The patient was treated with BENADRYL. In June 2016, the outcome of the difficulty breathing and blurred vision were recovered/resolved. The reporter considered the difficulty breathing and blurred vision to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by an office manager. The age at vaccination was not reported. The patient visited the emergency room. The sales representative was unable to provide full street address.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-JUN-2016, the patient inadvertently received an expired dose of ROTATEQ oral liquid, orally lot # K023537, expiration date: 22-JUN-2016 (exact dose and dose number were not provided). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # K005958, expiration date 09-FEB-2017). The excursion temperature was 33.8 degree Fahrenheit. The excursion time frames were 1 hour 69 minutes and 1 hour and 43 minutes. The temperature was back in range. There were no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter of unknown age. Over a year ago, the patient was vaccinated with the first dose of GARDASIL 9 (lot number not provided) by intramuscular. On 22-JUN-2016, the patient received the second dose of aforementioned vaccine (inappropriate schedule of drug administration). The reporter reported that the patient "missed doses" of GARDASIL 9. No adverse effect reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of unspecified patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unknown dates in 2016 (reported as "unknown dates starting on or after 15-JAN-2016") the patients were administered with improperly stored doses of GARDISAL (dose, route, lot# and expiration date not reported). The vaccine was improperly stored at 0 degrees for 90 hours. Data logger was involved. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. There was no information on the patients' concurrent conditions, medical history and concomitant medications. On unspecified dates, the patients were administered doses of improperly stored PNEUMOVAX23 (lot # L029306, with expiry date 26-MAR-2017). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. There was no information on the patients' concurrent conditions, medical history and concomitant medications. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB (lot # M001578, with expiry date 21-NOV-2018 and lot # L045117, with expiry date 06-OCT-2018). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of unspecified patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unknown dates in 2016 (reported as "unknown dates starting on or after 15-JAN-2016") the patients were administered with improperly stored doses of GARDASIL 9 (dose, route, lot# and expiration date not reported). The vaccine was improperly stored at 0 degrees for 90 hours. Data logger was not involved. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 81 years old female consumer referring to herself. The patient had no pertinent medical history. In 2006 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date not reported). Concomitant therapy was not reported. On approximately 24-JUN-2016 (reported as "3 days ago") the patient developed shingles. The patient spoke to the physician. Unspecified medicine was given for the event. No laboratory test was performed. The outcome of the event was reported as recovering/resolving. Reporter's causality was not provided. Additional information is not expected as there is no contact information for the reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of unspecified patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unknown dates in 2016 (reported as "unknown dates starting on or after 15-JAN-2016") the patients were administered with improperly stored doses of PNEUMOVAX23 (dose, route, lot # and expiration date not reported). The vaccine was improperly stored at 0 degrees for 90 hours. Data logger was involved. There was no previous excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician (patient's parent) via a company representative refers to a male patient of unknown age (also reported as middle school aged at the time of the report). It was reported that on an unknown date, as young child the patient had received the requisite two VARIVAX injections (subcutaneously, dose and lot # not reported) and then on an unknown date (also reported as very recently), contracted chickenpox. The patient did not seek medical attention. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Herpes zoster, Hot flush, Insomnia
Clinical narrative: This spontaneous report as received from a consumer refers to a 69 year old male patient. The patient's drug reactions or allergies were reported as none. In May 2012, the patient was vaccinated with one dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included losartan potassium (manufacturer unknown), levothyroxine sodium (manufacturer unknown), omeprazole (manufacturer unknown), furosemide (manufacturer unknown), simvastatin (manufacturer unknown), sertraline hydrochloride, tolterodine, amlodipine besylate, clopidogrel, metoprolol succinate, doxazosin and clonazepam. In August 2015, the patient had an unspecified herniatic stomach surgery (also reported as the patient's medical history). IOn 08-MAY-2016, the patient developed shingles. He experienced hot flashes, pain in his eyes and head, and had difficulty sleeping. The patient went to a walk-in clinic and was directed to go to the emergency room (ER), where he received fluids and unspecified pain killers. He was prescribed unspecified pain killers and an unspecified antibiotic. The patient said that the antibiotic he was given "knocked (the shingles) down some" but he continued to have symptoms of the shingles, especially the pain in his eyes. Laboratory diagnostic studies were not performed. The patient did not received another dose of ZOSTAVAX (also reported as "no reintroduction - one vaccine"). The outcome of the unspecified herniatic stomach surgery was not reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 12-APR-2016 the patient inadvertently received a dose of PROQUAD (dose, route, lot# and expiration date not reported) (Unapproved dose administered). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # L028273, expiration date 28-JUL-2017). The excursion temperature was 33.8 degree Fahrenheit. The excursion time frames were 1hour 59 minutes and 1 hour and 43 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot # and expiration date unknown). The excursion temperature was 33.8 degree Fahrenheit. The excursion time frames were 1 hour 59 minutes and 1 hour and 43 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.67
Sex: M
Vaccine: RV5
Symptoms: Cough, Rhinorrhoea, Secretion discharge
Clinical narrative: Information has been received from a consumer referring to her 8 months old son. The patient had no pertinent medical history or drug allergies. ON 27-JUN-2016 the patient was vaccinated with ROTATEQ (strength, dose, frequency, lot # and expiration were not reported) orally. The reporter did not remember the dosage the patient received but she felt that the amount received was too much and constituted an overdose. There was no concomitant therapy. On 28-JUN-2016 the patient experienced runny nose, cough and producing excess mucous. The patient did not seek medical attention. No treatment was given to the patient. No lab test was done. Vaccination with ROTATEQ was discontinued. The outcome of the adverse events was reported as not recovered. Reporter's causality was not reported. Additional information is not expected as the physician does not want to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 74-year-old male patient. The patient's concurrent conditions included chronic obstructive pulmonary disease and osteoporosis. The patient's medical history and concomitant therapies were not reported. On an unknown date in 2013 (reported as about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, strength, dose and frequency were not reported) subcutaneously. On an unknown date, the patient experienced a nodule at the injection site that appeared almost right away and had never gone away which was found by the pharmacist on 30-JUN-2016 during the patient's visit. There was not treatment given for the adverse event and no diagnostic were performed. The outcome of the event was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In approximately 2015 (reported as "about a year ago"), the patient received an improperly stored and expired dose of ZOSTAVAX (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). There were no adverse effects reported. The temperature excursion details were not provided. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist who was also the pharmacy manager referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 27-JUN-2016 the patient inadvertently received expired dose of PNEUMOVAX23 (lot # K019933 with expiration date 20-APR-2016, dose and route unknown). Concomitant therapy was not provided. NO adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On 28-JUN-2016 the patient was vaccinated with ZOSTAVAX (lot #, dose and frequency were not reported), intramuscularly (product use issue). No adverse symptoms were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, MEN, TDAP
Symptoms: Fall
Clinical narrative: CHILD FELL DOWN WHILE STANDING ABOUT 10 MINUTES AFTER THE VACCINATION WITH Tdap, Menactra and Hep A. Outside the Exam room. Did not pass out, No seizures, No cyanosis, No Injury, stood up at her own. Responding well on floor as well as on standing, PE completely Normal after that. No injury. I called G. ma three hours after at home, child playing and well. No problems.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Redness, Swelling, fever, body aches, burning/itching sensation.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Redness, Swelling, fever, body aches, burning/itching sensation.
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fainting in a adolescent male 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 fainting. On an unknown date, the outcome of the fainting was unknown. It was unknown if the reporter considered the fainting to be related to BEXSERO. Additional details were provided as follows: The patient's age at vaccination was not reported. The nurse reported to the sales representative that, the patient after receiving BEXSERO experienced fainting. The reporter did not have any other information to report.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Patient returned to department with complaints of fever of 101 degrees, dizziness, severe occipital headache, nausea, and she was cold and clammy. Our OcMD notified and was instructed to send patient to ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eye swelling, Rash, Urticaria
Clinical narrative: Rash, hives, swelling of eyes (mild) within 30 minutes of receiving vaccine listed below. No problem breathing. Benadryl orally given once, followed by DEPO-MEDROL 40 mg X 1 IM. Hives started to fade. Patient left in stable condition.
Age: 22.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Abdominal pain, Erythema, Oedema peripheral, Tenderness
Clinical narrative: Localized erythema and edema to right arm. Tenderness to touch. Abdominal pain.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Unevaluable event
Clinical narrative: Please see attached summary.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Vomiting
Clinical narrative: Child vomited twice at approximately 6:30 pm.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Per pt's mother pt began to show rash on arms the day after vaccines were given to pt. Rash looks bumpy with red spots from wrist up to past the elbow, doesn't seem to be bothering him and is not warm to the touch.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Computerised tomogram head normal, Seizure
Clinical narrative: This is a spontaneous report from a contactable pediatrician. A 20 year-old female patient received the first dose of TRUMENBA intramuscular on 27Jun2016 at 0.5 ml single. No relevant medical history was reported, there were not concomitant medications. On 27Jun2016, 30 seconds after having received the vaccine, the patient experienced generalised seizure. She underwent laboratory tests and procedures which included computerised tomogram of the brain with normal result on 27Jun2016. The patient completely recovered on an unspecified date in Jun2016 without any treatment. The reporter believed that generalized seizure was related to TRUMENBA, he added there were no other vaccines given at the time and the patient was otherwise a healthy patient.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Body temperature increased, Influenza like illness, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Stiffness and pain in my shoulder, slight temperature increase, feeling like I was coming down with the flu.
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Influenza like illness, Musculoskeletal pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiffness and pain in my shoulder, slight temperature increase, feeling like I was coming down with the flu.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Induration, Lip swelling, Paraesthesia oral, Pruritus
Clinical narrative: 12 hours after vaccines developed symptom of lip swelling and tingling and a slightly itchy, the left side swelled more than right, felt hard.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: Itchy rash.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Accidentally gave client 2 Yellow Fever vaccines.  Had client wait 20 minutes after vaccine and no adverse side effects noted.  Called CDC and Sanofi Pastuer Medical Information nurse and called client's father with information.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dyskinesia, Muscle twitching, Pyrexia, Speech disorder
Clinical narrative: Mild Fever for one day, the remaining symptoms developed on day 2. Lips pursed, unable to open mouth or vocalize, a strained humming through nose. Tongue twitch with tongue extremely extended, appears not controllable in 15 min intervals. No vocal chatter (stopped normal chatter that existed before event), no crying day or night. Appears to struggle to use mouth but can't start on her own. Symptoms lasted 6 days before improving, resolving over additional 2 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Injection site erythema, Injection site pain, Rash
Clinical narrative: Patient experianced red and soreness at site of injection and realized big red mark on her back and it was hurting. On 06/29/2016 she had rash on her back, around her stomach, on her arms and shoulders. Patient was seen by her dermatologist 07/08/2016 and they had prescribed her triamcinolone cream, Dove soap/lotion and Benadryl.
Age: 36.0
Sex: M
Vaccine: MMR
Symptoms: Immune thrombocytopenic purpura, Petechiae, Platelet count decreased, Rash
Clinical narrative: Patient received MMR vaccine on 06/10/16. 2 1/2 weeks later developed petechial rash on extremities. Platelet count of 29,000, was hospitalized for ITP.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reaction/allergies were reported. On an unknown date, starting on or after 13-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L050560, expiry date: 14-DEC-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 10.67F for 12 hours. There was no previous temperature excursion. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date, starting on or after 13-MAY-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050907, expiry date: 14-JUN-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 10.67F for 12 hours. There was no previous temperature excursion. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: CSF test normal, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Lower extremity weakness. Presumptive Guillain-Barre syndrome.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Nuclear magnetic resonance imaging spinal normal, Scan with contrast normal
Clinical narrative: Lower extremity weakness. Presumptive Guillain-Barre syndrome.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Urticaria, Vaccination site swelling
Clinical narrative: Hives on entire length of both arms and face.  Vaccine site swollen.  (Upper arm). Treatment:  Benadryl every 4 hours continuindv
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Hypoaesthesia, Lymph node pain, Paraesthesia
Clinical narrative: Arm that received injection numb/tingly.  Following morning sore at armpit.  Seems tender at lymph node.