chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain, Activities of daily living impaired, Appendicitis, Burning sensation, Fatigue
Clinical narrative: This spontaneous report was received from a patient's mother and refers to her 14-year-old son. The patient had no known drug reactions or allergies and there was no information about his concurrent conditions, concomitant therapies or medical history provided. On unknown date in April 2015, the patient was vaccinated intramuscularly with a dose of GARDASIL lot # K008213 with an expiration date 17-DEC-2016, (dose and anatomical location were not reported). On the same day, reported as 3 hours after receiving GARDASIL, the patient experienced burning sensations in legs, severe headaches and severe abdominal pains. The symptoms lasted a few hours and then subsided. On an unknown date in 2015, reported as a few days later, the symptoms returned and the patient was examined by his pediatrician. The physician stated that the patient's appendix was "inflamed". The patient continued to have the symptoms on an off (dates not provided). On unknown date in September 2015, after waking up, the patient was not able to feel his legs. He visited an emergency room and was diagnosed with Lyme disease. The patient received doxycycline for 28 days and another unspecified medicine (time not reported) as a treatment. According to the patient's mother "the doxycycline seemed to make her son's symptoms worse". She requested performing some sort of "metal" tests to rule out the relatedness between GARDASIL and his son symptoms but the pediatrician refused the testing. On an unknown date, the patient was consulted with an orthopedic and neurologist with a results described as "nothing was wrong".  At the day of this report, the patient was still experiencing the same symptoms along with fatigue and more unspecified soreness (start date not provided). He had also a hard time playing sports or doing any other physical activities. The patient's mother refused to vaccinate her son with another dose GARDASIL and she believed that all her son's symptoms were a result of GARDASIL vaccination. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Incomplete course of vaccination, Lyme disease, Pain
Clinical narrative: This spontaneous report was received from a patient's mother and refers to her 14-year-old son. The patient had no known drug reactions or allergies and there was no information about his concurrent conditions, concomitant therapies or medical history provided. On unknown date in April 2015, the patient was vaccinated intramuscularly with a dose of GARDASIL lot # K008213 with an expiration date 17-DEC-2016, (dose and anatomical location were not reported). On the same day, reported as 3 hours after receiving GARDASIL, the patient experienced burning sensations in legs, severe headaches and severe abdominal pains. The symptoms lasted a few hours and then subsided. On an unknown date in 2015, reported as a few days later, the symptoms returned and the patient was examined by his pediatrician. The physician stated that the patient's appendix was "inflamed". The patient continued to have the symptoms on an off (dates not provided). On unknown date in September 2015, after waking up, the patient was not able to feel his legs. He visited an emergency room and was diagnosed with Lyme disease. The patient received doxycycline for 28 days and another unspecified medicine (time not reported) as a treatment. According to the patient's mother "the doxycycline seemed to make her son's symptoms worse". She requested performing some sort of "metal" tests to rule out the relatedness between GARDASIL and his son symptoms but the pediatrician refused the testing. On an unknown date, the patient was consulted with an orthopedic and neurologist with a results described as "nothing was wrong".  At the day of this report, the patient was still experiencing the same symptoms along with fatigue and more unspecified soreness (start date not provided). He had also a hard time playing sports or doing any other physical activities. The patient's mother refused to vaccinate her son with another dose GARDASIL and she believed that all her son's symptoms were a result of GARDASIL vaccination. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Specialist consultation
Clinical narrative: This spontaneous report was received from a patient's mother and refers to her 14-year-old son. The patient had no known drug reactions or allergies and there was no information about his concurrent conditions, concomitant therapies or medical history provided. On unknown date in April 2015, the patient was vaccinated intramuscularly with a dose of GARDASIL lot # K008213 with an expiration date 17-DEC-2016, (dose and anatomical location were not reported). On the same day, reported as 3 hours after receiving GARDASIL, the patient experienced burning sensations in legs, severe headaches and severe abdominal pains. The symptoms lasted a few hours and then subsided. On an unknown date in 2015, reported as a few days later, the symptoms returned and the patient was examined by his pediatrician. The physician stated that the patient's appendix was "inflamed". The patient continued to have the symptoms on an off (dates not provided). On unknown date in September 2015, after waking up, the patient was not able to feel his legs. He visited an emergency room and was diagnosed with Lyme disease. The patient received doxycycline for 28 days and another unspecified medicine (time not reported) as a treatment. According to the patient's mother "the doxycycline seemed to make her son's symptoms worse". She requested performing some sort of "metal" tests to rule out the relatedness between GARDASIL and his son symptoms but the pediatrician refused the testing. On an unknown date, the patient was consulted with an orthopedic and neurologist with a results described as "nothing was wrong".  At the day of this report, the patient was still experiencing the same symptoms along with fatigue and more unspecified soreness (start date not provided). He had also a hard time playing sports or doing any other physical activities. The patient's mother refused to vaccinate her son with another dose GARDASIL and she believed that all her son's symptoms were a result of GARDASIL vaccination. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 13 Jan 2017 to transfer all the information from case 2016SA229834 into case 2016SA226875. Initial unsolicited case received from a nurse on 08 Dec 2016. This case involves a 66 year old female patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route, dose and site of administration was not reported) on 08 Nov 2016. On 11 Nov2016, the patient commenced treatment with alirocumab injection at a dose of 75 mg every other week (route, lot/batch number and expiry date: unknown) delivered via alirocumab prefilled pen for hyperlipidemia. The patient received his second dose of PRALUENT (Batch number: unknown, expiry date and route was not reported) on 25 Nov 2016 again. The patient relevant medical history and concomitant medications were not reported. On an unknown date in Nov 2016, few days after the vaccination, the patient experienced dizziness. The nurse said the patient couldn't explain the dizziness and all he said was that he just didn't feel like himself (onset: Nov-2016 and latency: few days). The patient again experienced the same dizziness about 2-3 days after the second dose of PRALUENT. The dizziness was not as severe as the last time. Patient said the dizziness only lasted 1-2 hours and resolved. The patient did not go to urgent care for this recurrence of dizziness. It was reported that the patient went to urgent care at the time of first onset of dizziness. The patients lab tests and corrective treatment was not reported. The outcome of the event dizziness was recovered on an unknown date (reported as dizziness lasted a day or so and couldn't find anything wrong and that the dizziness just went away) and the outcome of event didn't feel like himself was reported as not recovered. List of documents held by sender: none. Addendum on 13 Jan 2017: Upon second medical examination of case at time of internal review the following has been modified in this case: All the information from case 2016SA229834 was transferred into case 2016SA226875.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Decreased appetite, Pain in extremity, Rash, Weight decreased
Clinical narrative: She states she has been having side effects from PREVNAR 13. Was  given on 12/02/2016 and started having a rash, decreased appetite. Joint pain, fatigue, dizziness, and weakness she still has a rash, fatigue, joint and muscle aches, and swelling in her right knee.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Fatigue
Clinical narrative: She states she has been having side effects from PREVNAR 13. Was  given on 12/02/2016 and started having a rash, decreased appetite. Joint pain, fatigue, dizziness, and weakness she still has a rash, fatigue, joint and muscle aches, and swelling in her right knee.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Joint swelling, Myalgia, Rash
Clinical narrative: She states she has been having side effects from PREVNAR 13. Was  given on 12/02/2016 and started having a rash, decreased appetite. Joint pain, fatigue, dizziness, and weakness she still has a rash, fatigue, joint and muscle aches, and swelling in her right knee.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Pain in extremity
Clinical narrative: She states she has been having side effects from PREVNAR 13. Was  given on 12/02/2016 and started having a rash, decreased appetite. Joint pain, fatigue, dizziness, and weakness she still has a rash, fatigue, joint and muscle aches, and swelling in her right knee.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Rash, Vomiting, Weight decreased
Clinical narrative: She states she has been having side effects from PREVNAR 13. Was  given on 12/02/2016 and started having a rash, decreased appetite. Joint pain, fatigue, dizziness, and weakness she still has a rash, fatigue, joint and muscle aches, and swelling in her right knee.
Age: 60.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Mobility decreased
Clinical narrative: Today's date January 18th 2017 limited use of left arm pain at injection site cannot lift arm more than a few inches throbbing pain when sleeping cannot sleep on arm.
Age: 60.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder
Clinical narrative: Today's date January 18th 2017 limited use of left arm pain at injection site cannot lift arm more than a few inches throbbing pain when sleeping cannot sleep on arm.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On an unknown date, the patient was vaccinated with ROTATEQ, orally (dosage schedule, lot # and expiration date were not reported) for prophylaxis. Then, the patient vomited (vomiting) immediately after administration of  ROTATEQ. It was reported that the patient sought medical attention (office visit). At the reporting time, the outcome of the patient's vomiting was unknown. The reporter did not assess the causality between the patient's vomiting and the use of ROTATEQ. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dose, lot number, expiration date, anatomical location and route were not reported) for prophylaxis. Later, on 15-DEC-2016, the patient was vaccinated with a second dose of PNEUMOVAX23 (strength, dose, lot number, expiration date, anatomical location and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.       Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLUX, TTOX, VARZOS, FLUX, TTOX, VARZOS
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 62 year old male patient; with no known drug reactions/allergies and with no relevant medical history or concomitant therapies. On 13-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (route of administration, frequency, lot# and expiration date were not provided) for prophylaxis. Then on 24-DEC-2016, the patient was vaccinated with another dose of ZOSTAVAX (route of administration, frequency, lot# and expiration date were not provided) for prophylaxis; the same date the patient also was vaccinated with influenza virus vaccine (unspecified) and tetanus toxoid (unspecified) (route of administration, frequency, lot# and expiration date were not provided) for prophylaxis. On 25-DEC-2016, the patient experienced rash and a high fever; and from an unspecified date in December 2016, the patient has been sick in bed (malaise). It was reported that the patient sought medical attention, he contacted the pharmacist but no treatment was given nor lab diagnostic studies were performed. At the time of reporting the outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX, influenza virus vaccine (unspecified) and tetanus toxoid was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product packaging confusion, Product preparation error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. The healthcare worker reported that three vials of sterile diluent (manufacturer Sanofi) for haemophilus influenza B vaccine (HIB) was missing from the stock and was not shipped that way, so it could have potentially been used to reconstitute M-M-R II. Product (packaging) confusion was involved.. It could not be ruled out if M-M-R II was or was not reconstituted with the sterile diluent and administered to the patient. No adverse effects was reported. No product quality complaint was involved. Additional information had been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: his spontaneous report was received from a registered nurse and refers to four patients ages 18-22 years old of an unknown gender. The patients' pertinent medical histories, drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of hepatitis b vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). On unspecified dates, lab diagnostic studies were performed and all of the patients had negative titers after the vaccination. Product quality complaint (PQC) was not involved. The outcome of the event of negative titers was not reported. The relatedness between the event and hepatitis b vaccine (manufacturer unknown) was not provided. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 16 year old patient of unknown gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 25-JUN-2015, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, anatomical location of administration, lot# and expiry date were not reported). On 03-JAN-2017, the patient received the second dose in series with GARDASIL 9 (dose, route of administration, anatomical location of administration, lot# and expiry date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M031805, expiration date 07-MAR-2018 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit for 8 hours. Data logger was involved. There were no previous temperature excursions reported. Product quality complaint (PQC) was not involved. 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 medical assistant (who was also the administrator) refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M015931, expiration date 30-MAR-2018 (therapy type, dose and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccines experienced the temperature excursion of more than 8 but less than 25 degrees Celsius for 1 hour and 18 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007587:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 05-JAN-2017, the patient received improperly stored doses of M-M-R II injection, subcutaneously lot # reported as M029919, expiration date 13-JUN-2018 (also reported as 23-JUN-2018) (dose was not provided) and STERILE DILUENT (strength, dose, frequency, route of administration and indication were not reported), lot# reported as M024781, expiration date 21-FEB-2019. There was no adverse effects reported. Administered doses of vaccines and the diluent experienced the temperature excursion of -3 degrees Celsius for 6 hours. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007831.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unspecified dates, multiple number of patients were vaccinated with doses of improperly stored ZOSTAVAX 19400 PFU, for prophylaxis, dose, route, anatomical location were not reported (with Lot # reported as M011665, expiration date 17-MAY-2017). No adverse effects reported. The temperature registered was of more than 5° Fahrenheit (F) but less than 14°F with a time frame of 337 hours. No previous temperature excursion was reported. No digital data logger, nor Product Quality Complaint (PQC) were involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005962:
Sex: U
Vaccine: UNK
Symptoms: Mumps, Pain in jaw, Pyrexia, Swelling face, Vaccination failure
Clinical narrative: This spontaneous report was received from an unspecified reporter via a news concerning to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) or Mumps Virus Vaccine Live (manufacturer unknown) (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date over Thanksgiving break, the patient got a fever, painful to bite down and swell at the cheek. The physician diagnosed to the patient with mumps. The patient state "they got vaccinated for it; it was just sounded like something that nobody got. So the patient just did not think that it was possible that they would get it". At the time of the report, the outcome of mumps and vaccination failure was not reported. The causal relationship between the events and M-M-R II or MUMPSVAX was not reported. This is one of several reports from the same source. Additional information is not expected as there is not contact details of the reporter. Sender's Comments: US-009507513-1701USA006589: Original Case: 1701USA005463.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a "over 65" year old female patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX, intramuscular route for prophylaxis (dosage schedule,  anatomical location, lot number and expiration date were not reported). In approximately 2014 (reported as "approximately 3 years ago"), the patient had a rash outside of the upper arm at the site of the ZOSTAVAX shot and it looked like a shingle rash, blistering and red (herpes zoster) and it reportedly lasted 4 weeks. No treatment was given for the adverse events. The outcome of herpes zoster was reported as recovered at the time of reporting. The relatedness between the herpes zoster and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a physician via Pfizer (MFR# 2016569308) on 03-JAN-2017 referring to a currently 75 year old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route unknown) for prophylaxis. On an unknown date, the patient experienced allergy to PNEUMOVAX 23. The outcome of the event was unknown. All available medical records will be provided upon request. This is one of the two reports that received from the same reporter and concerned the same patient. Additional information has been requested. Sender's Comments: US-009507513-1701USA001371.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (who was also the administrator) refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M034799, expiration date 01-FEB-2018, oral (dose was not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccines experienced the temperature excursion of more than 8 but less than 25 degrees Celsius for 1 hour and 18 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA002338:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral (lot #, expiration date and dose were not reported). There was no adverse effect reported. Administered doses of vaccines experienced excursion of temperature range between 32 and 36 degrees Fahrenheit for 80 hours. Data logger was not involved. There were no previous excursions reported. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 05-JAN-2017, the patient received improperly stored doses of M-M-R II injection, subcutaneously lot # reported as M029919, expiration date 13-JUN-2018 (also reported as 23-JUN-2018) (dose was not provided) and sterile diluent (STERILE DILUENT) (strength, dose, frequency, route of administration and indication were not reported), lot# reported as M024781, expiration date 21-FEB-2019. There was no adverse effects reported. Administered doses of vaccines and the diluent experienced the temperature excursion of -3 degrees Celsius for 6 hours. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1701USA003660.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Dizziness, Syncope
Clinical narrative: This spontaneous case, initially received on 09-Jan-2017, was reported by a health professional and concerns patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date about 2 years ago, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced chills (hospitalized, outcome: not reported), dizziness (hospitalized, outcome: not reported), fainting spells (hospitalized, outcome: not reported). Sender's Comments: Listedness: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, syncope and dizziness are unlisted. Chills is listed. Causality: Unassessable. Time to onset following vaccination not specified. Temporal relationship cannot be established; causality is unassessable.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Bursitis-type pain in arm.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Induration
Clinical narrative: Induration improving 2 weeks after vaccine but still present.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever started 1/12/17 (TYLENOL/ibuprofen for Tx). Rash started 1/15/17. Less active.
Sex: U
Vaccine: RV5
Symptoms: Liquid product physical issue, Product quality issue, Vomiting projectile
Clinical narrative: This spontaneous report was received from a nurse referring to a 4 month old patient of unknown gender. It was reported that the baby was healthy and had no prior reflux or vomiting issues. Patient's concomitant medications were not reported. The baby received a prior dose of ROTATEQ at age 2 months in approximately October 2016. In 2016, on an unspecified date, the patient was vaccinated with the second dose of ROTATEQ (orally, Lot # M022373, expiration date: 20-FEB-2018; dose not reported) for prophylaxis. In December 2016, reported as within the last week, the patient experienced projectile vomiting after took the complete dose of ROTATEQ. The baby did not receive another dose of ROTATEQ. There was no treatment given for this adverse event. A product quality complaint was filed because the ROTATEQ seemed more viscous. To be sure that the ROTATEQ was not a bad batch, the physician put a few drops of the ROTATEQ on his fingers and then tasted the vaccine. He reported that this vaccine was fine and he did not experience an adverse effect. The outcome of vomiting projectile was reported as recovered/resolved. The causality between this event and the therapy with ROTATEQ was unknown. This is one of the several reports received by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010099: US-009507513-1612USA010136: US-009507513-1701USA004136.
Sex: U
Vaccine: RV5
Symptoms: Liquid product physical issue, Product quality issue, Vomiting projectile
Clinical narrative: This spontaneous report was received from a nurse referring to a 2 month old patient of unknown gender. It was reported that the baby was healthy and had no prior re-flux or vomiting issues. The patient did not have any pertinent medical history or drug reactions or allergies. In 2016, on an unspecified date, the patient was vaccinated with the first dose of ROTATEQ (orally, Lot # M022373, expiration date: 20-FEB-2018; dose not reported) for prophylaxis. The patient did not have concomitant medications. On 12-DEC-2016, reported as within the last week, the patient experienced projectile vomiting after took the complete dose of ROTATEQ. The baby did not receive another dose of ROTATEQ. There was no any treatment given for this adverse event. No laboratory test were performed. A product quality complaint was filed. At the time of the reporting, the outcome of vomiting projectile was reported as recovered/resolved in December 2016. The causality between this event and the therapy with ROTATEQ was unknown. This is one of the 4 cases reported by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010135: US-009507513-1612USA010099: US-009507513-1701USA004119:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX, lot # M035142, expiry date 13-AUG-2018, lot # M025867, expiry date 24-MAY-2018, lot # M033904, expiry date 20-JUL-2018, lot # L010148, expiry date 24-MAR-2017, lot # M017292, expiry date 07-APR-2018, lot # M023382, expiry date 11-MAY-2018, lot # L046887, expiry date 23-NOV-2017 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. Administered vaccines underwent a temperature excursion of 5 to 14 degrees Fahrenheit for 2 hours and 5 to 14 degrees Fahrenheit for 5 hours 10 minutes. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007865: US-009507513-1701USA007866.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 04-JAN-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # K008873, expiry dose 06-FEB-2017 (dose, anatomical location and route of administration were not reported). No adverse effect reported. Reported temperature was higher than 46 Fahrenheit degrees but less than 77 Fahrenheit degrees for 36 hours. Previous temperature excursion revealed the temperature higher than 46 Fahrenheit degrees but less than 77 Fahrenheit degrees for 16 hours. Data logger was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-AUG-2016 and then on 26-OCT-2016, the patient was vaccinated with the first and second doses of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The third dose of GARDASIL 9 was administered early, on 28-DEC-2016  (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Anticoagulant therapy, Arthralgia, Deep vein thrombosis, Erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a physician referring to a 15 year old female patient. The patient's medical history or concurrent conditions were not reported. On 20-DEC-2016, the patient was vaccinated with GARDASIL 9 (which had the lot # M036059, expiration date unknown) in the left deltoid, (dose and route were not informed). Information regarding concomitant medication was not provided. The physician reported that on 30-DEC-2016, the patient returned and was admitted to hospital because of symptoms, (swelling, fever, redness, and pain in left shoulder and swelling, redness, and pain in right hand, wrist, and elbow). It was also confirmed that the patient presented with pain at both injection site and in the opposite upper extremity. In the hospital, deep vein thrombosis (DVT) was diagnosed. Therefore, anticoagulation therapy with LOVENOX 60mg twice daily for 3 months was initiated. Finally the patient was discharged on 31-DEC-2016. At the time of reporting, the outcome of deep vein thrombosis was reported as recovering. The causality assessment between the event and therapy with GARDASIL 9 was not provided. Upon internal review the event  deep vein thrombosis was determined to be medically significant. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Joint swelling, Pain in extremity, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician referring to a 15 year old female patient. The patient's medical history or concurrent conditions were not reported. On 20-DEC-2016, the patient was vaccinated with GARDASIL 9 (which had the lot # M036059, expiration date unknown) in the left deltoid, (dose and route were not informed). Information regarding concomitant medication was not provided. The physician reported that on 30-DEC-2016, the patient returned and was admitted to hospital because of symptoms, (swelling, fever, redness, and pain in left shoulder and swelling, redness, and pain in right hand, wrist, and elbow). It was also confirmed that the patient presented with pain at both injection site and in the opposite upper extremity. In the hospital, deep vein thrombosis (DVT) was diagnosed. Therefore, anticoagulation therapy with LOVENOX 60mg twice daily for 3 months was initiated. Finally the patient was discharged on 31-DEC-2016. At the time of reporting, the outcome of deep vein thrombosis was reported as recovering. The causality assessment between the event and therapy with GARDASIL 9 was not provided. Upon internal review the event  deep vein thrombosis was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX, lot # M032638, expiry date 04-OCT-2017 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. Administered vaccines underwent a temperature excursion of 5 to 14 degrees Fahrenheit for 2 hours and 5 to 14 degrees Fahrenheit for 5 hours 10 minutes. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007866: US-009507513-1701USA002418.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot # L046508, expiry date 17-MAY-2017, lot # M007964, expiry date 15-AUG-2017 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. Administered vaccines underwent a temperature excursion of 5 to 14 degrees Fahrenheit for 2 hours and 5 to 14 degrees Fahrenheit for 5 hours 10 minutes. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA002418: US-009507513-1701USA007865.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Pain
Clinical narrative: Patient stated he started to feel weak that night. Over the past couple days has felt a headache, weakness and body aches. No reaction at injection site.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PAIN, REDNESS, AND SWELLING OF LEFT ARM THAT DEVELOPED INTO CELLULITIS.
Age: 55.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Computerised tomogram head, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Spinal myelogram abnormal
Clinical narrative: He woke up to have a bowel movement in the morning and noticed his left gluteal region/perianal area felt numb like he could hardly feel it when he touched it.  As the day progressed, he had a similar feeling on the left chest, particularly related to heat and cold, and then he said the process ultimately involved his left upper and lower extremity.  In his chest, things went to the midline.  He said even his kind of left hemiscrotum seemed to feel numb compared to the right side.  This was not a sudden onset.  He did not have any trouble with vision.  He denied any weakness.  There was no true imbalance.  He thought maybe if he ran, it was not quite as balanced like sometimes his left knee wanted to give way but he thought it was more of a sensory rather than a motor issue.  He did not have any trouble with speech or hearing, no facial numbness/weakness.  He denied any other complaints on review of systems.  No rashes, no fevers, no myalgias.
Age: 55.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anal hypoaesthesia, Arthropathy, Computerised tomogram abnormal, Demyelination, Genital hypoaesthesia
Clinical narrative: He woke up to have a bowel movement in the morning and noticed his left gluteal region/perianal area felt numb like he could hardly feel it when he touched it.  As the day progressed, he had a similar feeling on the left chest, particularly related to heat and cold, and then he said the process ultimately involved his left upper and lower extremity.  In his chest, things went to the midline.  He said even his kind of left hemiscrotum seemed to feel numb compared to the right side.  This was not a sudden onset.  He did not have any trouble with vision.  He denied any weakness.  There was no true imbalance.  He thought maybe if he ran, it was not quite as balanced like sometimes his left knee wanted to give way but he thought it was more of a sensory rather than a motor issue.  He did not have any trouble with speech or hearing, no facial numbness/weakness.  He denied any other complaints on review of systems.  No rashes, no fevers, no myalgias.
Age: 55.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging abnormal, Spinal myelogram abnormal
Clinical narrative: He woke up to have a bowel movement in the morning and noticed his left gluteal region/perianal area felt numb like he could hardly feel it when he touched it.  As the day progressed, he had a similar feeling on the left chest, particularly related to heat and cold, and then he said the process ultimately involved his left upper and lower extremity.  In his chest, things went to the midline.  He said even his kind of left hemiscrotum seemed to feel numb compared to the right side.  This was not a sudden onset.  He did not have any trouble with vision.  He denied any weakness.  There was no true imbalance.  He thought maybe if he ran, it was not quite as balanced like sometimes his left knee wanted to give way but he thought it was more of a sensory rather than a motor issue.  He did not have any trouble with speech or hearing, no facial numbness/weakness.  He denied any other complaints on review of systems.  No rashes, no fevers, no myalgias.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, pain and swelling at the injection site.  She went to the urgent care and they said it was infected and prescribed her Bactrim DS.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistance and refers to a 24 year old patient of unknown gender. On 19-DEC-2016, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 0.5mcg/0.5 ml intramuscular injection (lot # M026309, expiration date 11-NOV-2016, indication and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to a currently 26 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with two doses of GARDASIL 9 (strength, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis, before he turned 26 years of age. And the patient will not receive the third dose of GARDASIL 9 because "he was over the indicated age". No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information is not expected because there was no consent to contact for follow-up.
Age: 0.33
Sex: F
Vaccine: HPV4, DTAPHEPBIP, HPV9, PNC13, RV5
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: This spontaneous report was received from a physician via other company and refers to a 4-month-old female patient. The patient was normal and she was a vaginally delivered term baby with no problems. The patient had no relevant concomitant medications or past drug history. On 29-DEC-2016 at 16:30, the patient was accidentally vaccinated with a 0.5 ml dose of GARDASIL, lot # M028323 with expiry date on 26-SEP-2018 (indication was reported as accidental administration and route of administration was reported as injection), which was intended for another, 13-year-old patient. The physician did not observe any adverse reactions after the vaccination. At the time of this report the patient was breast feeded calmly. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: HPV4, DTAPHEPBIP, HPV9, PNC13, RV5
Symptoms: Blood sodium increased, Decreased appetite, Developmental delay, Drug administered to patient of inappropriate age, Failure to thrive
Clinical narrative: This spontaneous report was received from a physician via other company and refers to a 4-month-old female patient. The patient was normal and she was a vaginally delivered term baby with no problems. The patient had no relevant concomitant medications or past drug history. On 29-DEC-2016 at 16:30, the patient was accidentally vaccinated with a 0.5 ml dose of GARDASIL, lot # M028323 with expiry date on 26-SEP-2018 (indication was reported as accidental administration and route of administration was reported as injection), which was intended for another, 13-year-old patient. The physician did not observe any adverse reactions after the vaccination. At the time of this report the patient was breast feeded calmly. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: HPV4, DTAPHEPBIP, HPV9, PNC13, RV5
Symptoms: Gastrointestinal tube insertion, Hyponatraemia, Muscular weakness, Pyrexia, Selective eating disorder
Clinical narrative: This spontaneous report was received from a physician via other company and refers to a 4-month-old female patient. The patient was normal and she was a vaginally delivered term baby with no problems. The patient had no relevant concomitant medications or past drug history. On 29-DEC-2016 at 16:30, the patient was accidentally vaccinated with a 0.5 ml dose of GARDASIL, lot # M028323 with expiry date on 26-SEP-2018 (indication was reported as accidental administration and route of administration was reported as injection), which was intended for another, 13-year-old patient. The physician did not observe any adverse reactions after the vaccination. At the time of this report the patient was breast feeded calmly. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: HPV4, DTAPHEPBIP, HPV9, PNC13, RV5
Symptoms: Wrong patient received medication
Clinical narrative: This spontaneous report was received from a physician via other company and refers to a 4-month-old female patient. The patient was normal and she was a vaginally delivered term baby with no problems. The patient had no relevant concomitant medications or past drug history. On 29-DEC-2016 at 16:30, the patient was accidentally vaccinated with a 0.5 ml dose of GARDASIL, lot # M028323 with expiry date on 26-SEP-2018 (indication was reported as accidental administration and route of administration was reported as injection), which was intended for another, 13-year-old patient. The physician did not observe any adverse reactions after the vaccination. At the time of this report the patient was breast feeded calmly. Additional information has been requested.