chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Rash, Sinusitis
Clinical narrative: This spontaneous report was received from a 52 year old female patient, reporting on herself. The patient's medical history or concurrent conditions were not reported. On 11-NOV-2014, the patient was vaccinated with ZOSTAVAX subcutaneous (strength, dose, lot number and expiration date were not provided). Other suspect therapy included prednisone (manufacture unknown) tablet, orally (strength, dose, route, indication, lot number and expiration date were not provided) started on 04-MAY-2016. Concomitant medication included FLONASE, CLARITIN and unspecified hormone therapy. On 30-APR-2016, the patient developed a painful rash, which progressively got worse. On 03-MAY-2016, the patient went to her provider and was diagnosed with shingles. Therefore, the patient was given an unspecified antiviral for 7 days, the patient did not state how her treatment was working as she just started it. At the time of reporting, the outcome of shingles was reported as recovering. The action taken with prednisone (manufacture unknown) was unknown. Additionally, the patient stated that she did not know if prednisone (manufacture unknown) contributed to her symptoms. Follow up information has been received from a physician on 20-JUN-2016 referring to the patient. There was no pre-existing allergies, birth defects, medical conditions and no illness at the time of vaccination. On 11-NOV-2014 (at 10:20 am), the patient was vaccinated with the first dose of ZOSTAVAX (lot#K009770, in left deltoid/arm). On 01-MAY-2016, the patient was given prednisone (manufacturer unknown) (previously reported as suspect therapy) by ear, nose and throat(ENT) specialist for sinus infection (onset date unknown). On 03-MAY-2016 (at 3:15 pm) (previously reported as 30-APR-2016) the patient experienced probable shingles on the left upper eyelid (previously location was unspecified) and was treated with VALTREX. No relevant diagnostic tests and laboratory data was reported. The outcome of sinus infection was unknown. The physician considered the herpes zoster outbreak was not temporally associated with ZOSTAVAX. Upon internal review, shingles on the left upper eyelid was considered to be medically significant. Additional information is not expected as all attempts to obtain follow-up information had been received. Reporter information, patient information, product, event, serious criteria and narrative were updated.
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a Licensed Vocational Nurse via a field representative referring to a 4 years female patient. The patient had no concurrent condition, drug allergies or medical history. Concomitant medication included unspecified DTaP. On 27-JUL-2016, the patient was vaccinated with VARIVAX (dose number, dose, unit, frequency and route unknown, lot # M002062, expiration date 12-JAN-2018), M-M-R II (dose, frequency, route unknown, lot # M002418, expiration date 12-JAN-2018) and hepatitis A Vaccine, Inactivated (manufacturer unknown) (dose, frequency, route unknown). On 28-JUL-2016, the patient's mother called the medical office report the patient had a fever of 104.7 (unit unknown). No other lab test was performed. The patient received unspecified treatment. The outcome of fever was unknown. No product quality issue involved. The causal relationship between fever and VARIVAX, M-M-R II and hepatitis A Vaccine, Inactivated (manufacturer unknown) was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator referring to unspecified patients. The patients' concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with two improperly stored doses of M-M-R II (dose, unit, route unknown, lot # L023386, expiration date 25-JUN-2017, another lot # K014832, expiration date 14-SEP-2016) once. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Initial solicited report received on 05 October 2015 from a consumer in the below mentioned study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject reported that on an unspecified date the side effects were very mild compared to other medicines. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Initial unsolicited report received from a nurse on 12 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, one week following the vaccination, the patient had developed circular, red, warm area, the area was tender. It was reported that the redness, warmth and tenderness were progressively worsening. Laboratory data and corrective treatment were not reported. The patient was not recovered from the event. Follow up information received from nurse on 30 November 2015. The patient was vaccinated with a dose of FLUZONE HIGH DOSE (batch number: UI442AA, expiry date: 06 April 2016) in left deltoid on 21 September 2015. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Initial solicited report received from a consumer in study on 05 October 2015. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject was well after taking a dose of vaccination and did not get sick. However the subject had mild side effects on an unspecified date. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Pain, Swelling
Clinical narrative: Initial solicited report received from a consumer in study on 05 October 2015. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject reported that the vaccination was less painful and the swelling was expected by the subject and it was not very bothersome. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial solicited report received on 05 October 2015 from a consumer in the study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject was sick on an unspecified date post vaccination. It was reported that the subject was not sick anymore because of the vaccine. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Aggression
Clinical narrative: Initial solicited report received from partner on 05 October 2015 from a consumer in the study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject had received a dose of vaccination two years ago and got a violent reaction on an unspecified date. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a healthcare professional  on 14 October 2015. This case involves a patient (age: unknown, gender: not provided) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series route and site of administration were not reported) on an unknown date. The patient's illness at time of vaccination; pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient went to emergency department with an adverse reaction (not severe). Laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a healthcare professional on 14 December 2015. No new information reported.
Sex: U
Vaccine: FLU3
Symptoms: Malaise, Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse via company representative on 14 October 2015. This case involves three patients (age and gender not reported) who were vaccinated with a dose [route and dose series not reported] of FLUZONE HD (batch number, expiry date and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date following the vaccination, patients experienced severe reactions, felt sick for several days and had extensive arm pain in the arm of the injection. Laboratory investigation and corrective treatments were not reported. Patient had recovered from the event felt sick and the outcome of other events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Initial unsolicited report received from a healthcare professional on 16 October 2015. This case involves patients (no of patients: 15, age and gender not reported) who were vaccinated with a dose of FLUZONE HD (Batch number: UI455AC, expiry date: 30 June 2016, dose, dose in series were not reported) via subcutaneous route in the back of upper arm on 13 October 2015. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions reported as unknown. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 13 October 2015, same day following the vaccination, the patient had developed redness mid to lower back of arms, itching and golf ball size swelling. The patient required ER/doctor visit. Relevant diagnostic tests/laboratory data and corrective treatment was not reported. The outcome of the events were unknown. List of documents held by sender: none.
Age: 0.8
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Papule, Rash
Clinical narrative: Based on additional information received on 30 November 2015, this case becomes medically confirmed. Initial unsolicited report received from a consumer (patient's mother) on 16 October 2015. This case involves a 09-months-old male patient who was vaccinated with first dose of FLUZONE (batch number was unknown, expiry date, dose were not reported) intramuscularly in thigh on 12 October 2015. The patient's illness at time of vaccination reported as unknown, pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as no known allergy (NKA). Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 13 October 2015, one day following the vaccination, the patient had developed a rash on leg around injection site which then spread to back, shoulder, neck and arms. It was reported that the doctor saw it on 14 and 15 October 2015. The patient required ER/doctor visit. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none. Follow-up information was received from a physician on 30 November 2015. The patient was vaccinated with a first dose of 0.25 ml FLUZONE QIV (batch number: 45304FA, expiration date, route of administration were not reported) In the left thigh on 12 October 2015. Illness at time of vaccination was none and the patient had no Pre-existing physician diagnosed allergies, birth defects, medical conditions and no known drug allergies. It was reported that patient visited office for rash on 14 October and 15 October, non-allergic rash. Patient developed flesh colored papules on the right arm, shoulder, back and left leg. There are no records of an ER visit. On an unspecified date patient was recovered.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Local swelling, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse on 16 October 2015. This case involves a 14-years-old male patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI462AB, expiry date: 30 June 2016, dose, dose in series were not reported) via intramuscular route in left deltoid on 14 October 2015. The patient's illness at time of vaccination reported was not reported, pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as none known. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 15 October 2015, one day following the vaccination, the patient woke up with swelling at left axilla area and severe pain of left arm and it hurts to move arm up and down. The patient had received vaccine several times previously. Laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injury, Laceration, Syringe issue
Clinical narrative: Initial unsolicited misuse report received from a nurse on 04-Nov-2015. This case involves a female patient and reported that a box of 10 prefilled syringes of FLUZONE (Batch number: UI498AA expiry date: 30-Jun-2016) stepped on and crunched. Most of the syringes were broken and there was a couple of shard of glass. It was reported that the nurse cut herself when opened the box. It was an accidental injury and syringe broken. Documents held by Sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) on 09 November 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (dose, dose in series, route and site of administration were not reported) on 07 November 2015. Medical history and concomitant medications were not reported. On an unknown date, around four hours following the vaccination, the patient had developed a bit of tenderness and a lump about the size of half a baseball at the injection site. The outcomes of events were not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Muscle contractions involuntary, Paraesthesia
Clinical narrative: Initial unsolicited report received from a consumer on 06 November 2015. This case involves a [age and gender unknown] patient who was vaccinated with a [dose in series were not reported] intramuscular first dose of INFLUENZA VACCINE (INTRAMUSCULAR FLU SHOT) ([batch number, expiry date and site of administration were not reported) on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, few years following the vaccination, patient developed six months of fasciculation and tingling. Lab data and corrective treatment were not reported. The outcome of event was recovered. List of documents held by sender: none.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Blood test normal, Electrocardiogram normal, Endotracheal intubation, Febrile convulsion, Intensive care
Clinical narrative: Febrile Seizures started at 11:00 am one big one followed 20 minutes later by an ongoing seizure that wouldn't stop. ATIVAN was administered in the ER and then a sedative and a breathing tube. We were sent to the PICU for 2 days of video EKG, spinal tap and blood work. Everything came back negative and it was ruled FEBRILE SEIZURE brought on by vaccination.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Lumbar puncture normal, Seizure, Vaccination complication
Clinical narrative: Febrile Seizures started at 11:00 am one big one followed 20 minutes later by an ongoing seizure that wouldn't stop. ATIVAN was administered in the ER and then a sedative and a breathing tube. We were sent to the PICU for 2 days of video EKG, spinal tap and blood work. Everything came back negative and it was ruled FEBRILE SEIZURE brought on by vaccination.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Received Meningococcal vaccine on 8/02/16 and the injection site is larger than a saucer, smaller than a dinner plate. Red, Swollen, Warm to the touch and painful, worse on 8/4/16. Advised of evaluation.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator referring to unspecified patients. The patients' concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with two improperly stored doses of PEDVAXHIB (dose, unit, route unknown, lot # M006710, expiration date 12-JUN-2018, another lot # M001813, expiration date 14-OCT-2018) once. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator referring to unspecified patients. The patients' concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose, unit, route unknown, lot # L045956, expiration date 17-NOV-2017) once. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot#, dose#, dose and route unspecified). No adverse symptoms reported. No product quality complaint was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On unknown dates in 2016 (reported as starting on or after 06-JUL-2016), patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M010440 and expiration date 09-DEC-2018, lot # M006710 and expiration date 06-DEC-2018, lot # L0151123 and expiration date 13-OCT-2018, dose and route of administration were not reported). The temperature of excursion was 31F and the time frame was 2 hours. There was no previous temperature excursion and the call was not due to a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unknown dates in 2016 (reported as started on or after 06-JUL-2016), patients were vaccinated with improperly stored doses of VAQTA (lot # L015460 and expiration date 20-JUL-20107, lot # M017982 and expiration date 13-SEP-2017, dose and route of administration were not reported). The temperature of excursion was 31F and the time frame was 2 hours. There was no previous temperature excursion and the call was not due to a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of 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: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses in GARDASIL 9, lot number M005714, expiration date: 03-OCT-2017 and lot number M004116, expiration date: 22-OCT-2017, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. 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: Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On 01-AUG-2016 the patients was vaccinated with improperly stored (at 10.4 degree centigrade for 6 hours and 17 minutes) GARDASIL (lot # K010215 with expiration date of 05-MAY-2017, lot # K014191 with expiration date of 10-MAY-2017, lot # K008931 with expiration date 04-MAR-2017, dose and route unknown). There was no temperature excursion previously. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Condition aggravated, Syncope
Clinical narrative: I gave the patient the vaccine, and told her to wait and be seated so that we can monitor her for a possible allergic reaction. She sat down but then fainted 5 minutes later. She woke up after 30 to 40 seconds. I assessed to see if there was an allergic reaction but there was not. She said she had a prior history of fainting after recieving a shot. She refused any medical care. She sat down for 15 more minutes and left the pharmacy.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Pain of skin, Skin burning sensation
Clinical narrative: Pt. called and reported that the skin on his back and shoulders were burning and it was very painful. No fever/chills. No rash. No difficulty breathing. Pt. was advised to see his medical provider for further evaluation. During follow up call, pt. indicated he visited the ER and received an anti inflammatory medication.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On 01-AUG-2016 the patients were vaccinated with improperly stored (at 10.4 degree centigrade for 6 hours and 17 minutes) GARDASIL 9 (lot # L026602, expiration date 19-OCT-2017, dose and route unknown). There was no temperature excursion previously. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unknown dates in 2016 (reported as starting on or after 06-JUL-2016), patients were vaccinated with improperly stored doses of GARDASIL 9  (lot # L024993 and expiration date 17-OCT-2017, lot # L038503 and expiration date 18-DEC-2017, dose and route of administration were not reported). The temperature of excursion was 31F and the time frame was 2 hours. There was no previous temperature excursion and the call was not due to a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. 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: Information has been received from a vaccine coordinator referring to unspecified patients. The patient's concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, unit, route unknown, lot # L031459, expiration date 30-APR-2017) once. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, dose#, dose and route unspecified). No adverse symptoms reported. No product quality complaint was involved. No further information provided. This is one of 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: This spontaneous report as received from a nurse refers to an unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (confirmed not GARDASIL quadrivalent) (lot#, dose#, dose and route unspecified). No adverse symptoms reported. No product quality complaint was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator referring to unspecified patients. The patients' concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with ROTATEQ (dose, unit, route unknown, lot # L033694, expiration date 16-JUN-2017). No adverse event was reported. No product quality issue involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown). The pharmacist stated there was no record of the patient receiving ZOSTAVAX in his pharmacy. On an unknown date, one year later the vaccination, the patient developed shingles. The outcome and causality of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of unknown age. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. In June 2015, the patient was vaccinated with a dose of GARDASIL (lot#, expiry date, dose and route unknown). In June 2016, the patient received a dose of GARDASIL 9 (lot#, expiry date, dose number, dose and route unknown) (interchange of vaccine products). No adverse effect was reported. Additional information is not expected because there is no consent for follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses in VAQTA immunization series, lot number L022259, expiration date: 06-APR-2017, lot number M003011, expiration date: 15-NOV-2017 and lot number M021124, expiration date: 02-FEB-2018, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant, who reported that on unspecified dates, an unspecified number of patients (demographics unknown), received improperly stored dosages of VARIVAX (lot # M002064, expiration date 12-JAN-2018 or lot # M005973, expiration date 02-FEB-2018) (dosages and route of administration not provided). No adverse effect reported. No further details provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator referring to unspecified patients. The patients' concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, unit, route unknown, lot # L044475, expiration date 12-MAY-2017) once. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unknown dates in 2016 (reported as starting on or after 06-JUL-2016), patients were vaccinated with improperly stored doses of GARDASIL (lot# L040460 and expiration date 27-MAY-2017, dose and route of administration were not reported). The temperature of excursion was 31F and the time frame was 2 hours. There was no previous temperature excursion and the call was not due to a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via field employee refers to a 2 year old patient of unknown gender. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 03-AUG-2016, the patient was inadvertently vaccinated with dose 3 of oral ROTATEQ (dosing details not provided) via oral route. Physician reported that the patient had previously received two doses of oral ROTATEQ on unknown dates at the age of 2 months and 4 months, respectively. 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 licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses of MMR II immunization series, lot number L024265, expiration date: 01-JUL-2017 and lot number L036853, expiration date: 24-SEP-2017, (dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of 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: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L048237, expiration date 18-MAY-2017 or lot #M003659, expiration date 08-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine with lot # L048237 experienced a temperature excursion of maximum 53 degrees Fahrenheit for 8 hours. Doses of vaccine with lot # M003659 experienced a temperature excursion of maximum 53 degrees Fahrenheit for 100 hours. Data logger was involved. 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 practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses of RECOMBIVAX HB immunization series, lot number L009155, expiration date: 29-OCT-2016, lot number L045117, expiration date: 16-OCT-2018, lot number M001578, expiration date: 20-NOV-2018, lot number reported as M001579, expiration date: 05-OCT-2018 and lot number L019299, expiration date: 15-APR-2017, (dose, route of administration and injection site were not provided. There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses in PNEUMOVAX 23 immunization series, lot number L014876, expiration date: 13-JAN-2017 and lot number M005287, expiration date: 08-OCT-2017, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. 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 registered nurse refers to unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On 06-JUL-2016, the patients were inadvertently vaccinated with improperly stored MMR II injection (lot # L028273 with expiry date 28-JUL-2016, dose and route were not reported). No adverse effects reported. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter denied consent to be contacted for further information.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses GARDASIL, lot number reported as L048459, expiration date: 22-FEB-2018 and lot number reported as M007728, expiration date: 21-MAR-2018, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 20 year old male patient. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 02-JUN-2016, the patient was vaccinated with a pediatric dose of VAQTA (dose: 0.5 ml, lot # L023232, expiry date: 25-FEB-2017). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Anaphylactoid reaction, Swelling, Vaccination complication
Clinical narrative: Initial unsolicited report received from a pharmacist on 2 November 2015. This case involves a (age unknown) female patient who was vaccinated with a [route and dose series not reported] dose of FLUZONE H1N1 (batch number, expiry date and site of administration were not reported) on an unspecified date of 2009. Illness at time of vaccination was reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions was not applicable. Other medical history and concomitant medications were not reported. On an unspecified date of 2009, following the vaccination patient had severe reactions to H1N1 fluzone, 'severe swelling, like anaphylactic. Patient laboratory investigation and corrective treatment were not reported. The outcome of event was recovered. Upon internal review, company decided to consider the event serious because of important medical event severe reactions to H1N1 fluzone, 'severe swelling, like anaphylactic". List of documents held by sender: none. Sender's Comments: Anaphylactic reaction is listed following INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. Time to onset is not reported. Information such as patient medical history, concomitant medication, and adverse reactions to previous vaccinations, is needed to further assess this case.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The patient woke up the morning after receiving her vaccine and complained of severe pain throughout her arm. Unable to lift her arm or extend her arm.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site pain
Clinical narrative: Mother explains that her daughter had muscle soreness at the injection sites, but no other symptoms.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Ear pain, Neck pain, Otitis media
Clinical narrative: R ear pain with radicular symptoms into R side of neck.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Injection site, red, swollen, itching over past 6 days. Swelling has improved but pain and sensitivity and rash remain at injection site.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Injection site, red, swollen, itching over past 6 days. Swelling has improved but pain and sensitivity and rash remain at injection site.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old male patient. The patient did not have any medical history, drug reactions or allergies. On 16-JUL-2015, the patient was vaccinated with first dose of GARDASIL 9 at a dose of 0.5 ml (route of administration: subcutaneous). The patient did not take any concomitant medications. On an unknown date, after receiving first dose, the patient experienced annular, well demarcated systemic rash on legs, arms, hands and wrist. On 21-JUL-2016, the patient was vaccinated with second dose of GARASIL 9 (lot # reported as M014929, expiry date: 27-MAY-2017) at a dose of 0.5 ml (route of administration: subcutaneous). On 30-JUL-2016, the patient experienced annular, well demarcated systemic rash on legs, arms, hands and wrist. No complaints of pain or itching were reported. No lab diagnostic tests were performed. Patient received treatment for the events and patient condition was stable at the time of the report. The outcome of the events was unknown. The causality of the events was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist regarding to a 17 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 09-JUL-2016, patient was inadvertently administered with a 1 mL (adult dose) as the first dose of VAQTA (lot# M013653, expiry date: 26-MAY-2017) (route of administration: intramuscular). No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored oral ROTATEQ (lot#, dose# and dose unspecified) via oral route. No adverse symptoms reported. No product quality complaint was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 02-AUG-2016 (reported as 'yesterday') the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # reported as M005972, expiry date 02-FEB-2018 (dose, route of administration and anatomical location were not specified). The administered dose of VARIVAX underwent temperature excursion at 26 Fahrenheit degrees for 6 hours. No previous temperature excursion was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unspecified age and gender. On 05-JUL-2016, the patient was vaccinated with MMR II, (lot# unspecified) dose 0.5 ml (one time vaccination), via subcutaneous route for prophylaxis that had an expiration date of 26-JUN-2016 (also reported as 27-JUN-2016). The nurse reported no untoward effects observed in this patient. No product quality complaint was involved. No further information provided. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chills, Deafness unilateral, Dizziness, Headache, Lethargy
Clinical narrative: The following day of vaccination, patient felt lethargic. Two days after vaccination patient had headache, body aches, and chills. Three days after vaccination the patient complained of loss of hearing in the left ear and dizziness.
Age: 44.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pain
Clinical narrative: The following day of vaccination, patient felt lethargic. Two days after vaccination patient had headache, body aches, and chills. Three days after vaccination the patient complained of loss of hearing in the left ear and dizziness.
Age: 0.54
Sex: M
Vaccine: DTP, RVX
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomiting.
Age: 21.0
Sex: F
Vaccine: MEN
Symptoms: Anxiety, Arthralgia, Arthritis, Decreased appetite, Dizziness
Clinical narrative: Severe pain, swelling, lump, redness at the injection site, weakness in left arm. joint pain, arthritis, muscle spasms, headaches, fatigue, nausea, vomiting, loss of appetite, dizziness, difficulty breathing, wheezing, anxiety.
Age: 21.0
Sex: F
Vaccine: MEN
Symptoms: Dyspnoea, Fatigue, Headache, Injection site erythema, Injection site mass
Clinical narrative: Severe pain, swelling, lump, redness at the injection site, weakness in left arm. joint pain, arthritis, muscle spasms, headaches, fatigue, nausea, vomiting, loss of appetite, dizziness, difficulty breathing, wheezing, anxiety.