chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates,  the patients were vaccinated with an improperly stored dose of VARIVAX with lot number M005973 and expiration date of 02-FEB-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at more than -15 Celsius degrees (°C) but less than -10 °C (more than 5 Fahrenheit degrees (°F) but less than 14°F) for 69 minutes. There was a previous temperature excursion of more than -10°C but less than 8°C (more than 14°F but less than 46°F) for 185 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012187:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an immunization coordinator refers to an unknown number of patients of unknown age and gender. No information regarding their pertinent medical history, concomitant medications, drug reactions, or allergies was provided. Since an unknown date in January 2017, the patient was receiving incorrectly stored doses of VARIVAX (lot # M030138, expiration date: 15-JUN-2018; lot# M033214, expiration date: 13-JUL-2017; lot# M04584, expiration date: 27-JUL-2018; lot# reported as M038557, expiration date: 14-SEP-2018; dose and route of administration were not provided). No adverse effects were reported. Administered doses of vaccine experienced the temperature excursion of above 46 degrees Fahrenheit (F) but below 77 F for an unspecified time. There was the following previous temperature excursions: above 14 F but below 46 F (above 10 degrees Celsius but below 8 degrees Celsius) for 23 hours, and above 46 F but below 77 F (above 8 degrees Celsius but below 25 degrees Celsius) for 12 hours. Digital Data Logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1702USA010130:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthma, Chest discomfort, Chest pain, Condition aggravated, Fatigue
Clinical narrative: Initial unsolicited report received from a consumer on 06-Feb-2017. This case involves female patient (age reported as now 66 years old) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiry date, dose, dose in series, site and route of administration were not reported) on 2009. (Date and month not reported). Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) included numerous allergies: many antibiotics, seasonal allergies, cats, dogs, birds, shellfish, pollen, trees allergies and bronchial asthma. Illness at the time of vaccination were none. Any other vaccinations within four weeks of vaccinations was not reported. On 2009 (date and month not reported), following vaccination patient experienced symptoms of the flu, worsening of bronchial asthma, chest pressure and pain. Patient felt tired for 2 years following vaccination. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. On an unknown date patient got recovered from all the events. It was also reported that after two years symptoms gradually improved and for last couple years patient had no symptoms. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer on 06-Feb-2017. This case involves female patient (age reported as now 66 years old) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiry date, dose, dose in series, site and route of administration were not reported) on 2009. (Date and month not reported). Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) included numerous allergies: many antibiotics, seasonal allergies, cats, dogs, birds, shellfish, pollen, trees allergies and bronchial asthma. Illness at the time of vaccination were none. Any other vaccinations within four weeks of vaccinations was not reported. On 2009 (date and month not reported), following vaccination patient experienced symptoms of the flu, worsening of bronchial asthma, chest pressure and pain. Patient felt tired for 2 years following vaccination. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. On an unknown date patient got recovered from all the events. It was also reported that after two years symptoms gradually improved and for last couple years patient had no symptoms. List of documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Arthritis, Fibromyalgia, Headache, Major depression
Clinical narrative: Sleep apnea, arthritis. Headache. Major depression, anxiety, fibromyalgia.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep apnoea syndrome
Clinical narrative: Sleep apnea, arthritis. Headache. Major depression, anxiety, fibromyalgia.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Decreased appetite, Dizziness, Nausea
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 12 year old female patient. The patient did not have pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies. On 17-JAN-2017, the patient was vaccinated with GARDASIL 9, (strength, dose, frequency and route of administration were not provided) lot # L026602 and expiration date 19-OCT-2017 for routine vaccination. On 18-JAN-2017, the patient experienced nausea (without vomiting), lack of appetite, abdominal cramps and dizziness after receiving a vaccine. It was stated by the reporter that the patient took an unspecified dose of acetaminophen (TYLENOL) for the abdominal pain. On 02-FEB-2017, the patient sought medical attention and her physician assistant ordered a diet of clear fluids for 24 hours followed by a diet of bananas, rice, applesauce, toast and also use warm compresses to aid the abdominal cramps. At the time of reporting the outcome of nausea (without vomiting), lack of appetite, abdominal cramps and dizziness was not recovered. Product quality complaint was not involved. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a 66 year old female patient, reporting on herself. The patient's concurrent conditions included high blood pressure, unspecified neuropathy and allergy "to cholesterol medicine". Concomitant therapies included acyclovir and other unspecified medications. In September 2016, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot number and expiration date were not reported) for prevention of shingles.      Approximately in January 2017 (reported as "about two weeks ago"), the patient experienced singles. On an unknown date, she visited an unspecified emergency room for a different unspecified reason and was diagnosed with shingles. The patient reported that she received no treatment for the shingles, because she was on acyclovir therapy on a regular basis and was also "beyond the scab stage" when she was seen in the emergency room. Therefore, she "hung out at home and beared it". Additionally, the patient explained "it still burns and stings like it want to break out". No labs diagnostics were performed. No product quality complain was reported. The causal relationship between the event and the suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance, concerning a patient of an unknown gender and age. There were no concurrent conditions, medical history and concomitant medications reported. On 06-FEB-2017, the patient was vaccinated with an expired MMRII (dose, frequency and route not reported) lot # L003856 with expiration date of 05-FEB-2017. The vaccine did not have any previous temperature excursions. No adverse symptoms were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a practice manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-FEB-2017, the patient was vaccinated with an expired dose of VAQTA (formulation, dose, frequency, route of administration and anatomical location of administration were not reported) lot # L031196, expiration date 05-FEB-2017, for prophylaxis. No adverse effects were reported. Product quality complain was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Blood thyroid stimulating hormone normal, Depression, Eating disorder, Fatigue
Clinical narrative: This spontaneous report as received from a physician refers to a 13-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 09-JAN-2017, the patient was vaccinated with properly-stored GARDASIL 9 injection (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date in 2017 (reported as "shortly after receiving the GARDASIL 9 injection"), the patient began experiencing symptoms of depression, further described as feeling tired, not feeling well, not eating well and feeling depressed. The physician reported also that the patient used to be outgoing and on an unknown date in 2017 (reported as "now"), she was not going out, was sleeping all the time, felt depressed and was missing days at school. The physician reported that due to missing days at school, the patient "got a D in math at school for the first time in her life". On an unknown date in approximately 2017, the physician did the Columbia Depression Scale with the patient and she scored a 9. On an unknown date, the patient had a thyroid-stimulating hormone laboratory test performed, which result was normal. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected because there was no consent to contact the physician.
Sex: F
Vaccine: HPV9
Symptoms: Hypersomnia, Malaise
Clinical narrative: This spontaneous report as received from a physician refers to a 13-year-old female patient. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 09-JAN-2017, the patient was vaccinated with properly-stored GARDASIL 9 injection (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date in 2017 (reported as "shortly after receiving the GARDASIL 9 injection"), the patient began experiencing symptoms of depression, further described as feeling tired, not feeling well, not eating well and feeling depressed. The physician reported also that the patient used to be outgoing and on an unknown date in 2017 (reported as "now"), she was not going out, was sleeping all the time, felt depressed and was missing days at school. The physician reported that due to missing days at school, the patient "got a D in math at school for the first time in her life". On an unknown date in approximately 2017, the physician did the Columbia Depression Scale with the patient and she scored a 9. On an unknown date, the patient had a thyroid-stimulating hormone laboratory test performed, which result was normal. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected because there was no consent to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was administered a dose of VARIVAX (lot # L048467, date of expiration: 02-DEC-2017)(dosage and route of administration were not reported), instead of receiving ZOSTAVAX (lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 20-FEB-2017 from a pharmacist who reported that a patient of unknown age and gender received a dose of VARIVAX (lot M039317, expires 20-SEP-2018) subcutaneously, on an unknown date after a temperature excursion of 14-46 degrees F for 48 hours (noted on a data logger).  No medical history or concomitant medications were reported for the patient. No adverse effect reported in the patient. No other information is available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX subcutaneous injection (strength and dose were not reported) (lot # M035141, expiration date 03-AUG-2018; lot # M000996, expiration date: 07-JAN-2017; lot # M039316, expiration date: 20-SEP-2018) for prophylaxis. According to the reporter, VARIVAX doses were exposed to the following temperature excursions: between > -9  degrees Celsius (C) and < 8C, and between > -15C and < -10C for an unknown time frame. No adverse effects were reported. A digital data logger was involved.  Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Conjunctivitis, Fine motor skill dysfunction, Measles, Memory impairment, Nervous system disorder
Clinical narrative: This spontaneous report as received from a registered nurse refers to her son, a currently 18 year old male patient with no drug reactions or allergies. The patient's concurrent conditions included Langerhans cell histiocytosis with a low absolute neutrophil count and a low overall white blood cell count. Information regarding concomitant medications was not reported. In approximately September 1999 (reported as "at 15 months of age"), the patient was vaccinated with M-M-R II (therapy type, dose, route of administration, lot # and expiration date were not reported) as routine vaccination. On an unknown date, the patient developed a measles rash, conjunctivitis, pneumonia and a fever of 104 Fahrenheit degrees "for over a week". The reporter stated that her son had multiple visits with the pediatrician following development of these symptoms, and he received acetaminophen (manufacturer unknown) and ibuprofen "altering every 2 hours around the clock". He was also prescribed unspecified antibiotics during this period of time. She stated that the pediatrician said this was the second time they had seen this in 25 years of practice. On unknown dates, the patient also suffered long-term neurological damage from the events described above, and he had sensory-processing issues, difficulty with memorization and fine-motor control issues. The outcome of the events was unknown. The relatedness between the events and M-M-R II was not reported. Upon internal review, the events of measles and pneumonia were considered to be medically significant. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pneumonia, Pyrexia, Rash, Sensory processing disorder
Clinical narrative: This spontaneous report as received from a registered nurse refers to her son, a currently 18 year old male patient with no drug reactions or allergies. The patient's concurrent conditions included Langerhans cell histiocytosis with a low absolute neutrophil count and a low overall white blood cell count. Information regarding concomitant medications was not reported. In approximately September 1999 (reported as "at 15 months of age"), the patient was vaccinated with M-M-R II (therapy type, dose, route of administration, lot # and expiration date were not reported) as routine vaccination. On an unknown date, the patient developed a measles rash, conjunctivitis, pneumonia and a fever of 104 Fahrenheit degrees "for over a week". The reporter stated that her son had multiple visits with the pediatrician following development of these symptoms, and he received acetaminophen (manufacturer unknown) and ibuprofen "altering every 2 hours around the clock". He was also prescribed unspecified antibiotics during this period of time. She stated that the pediatrician said this was the second time they had seen this in 25 years of practice. On unknown dates, the patient also suffered long-term neurological damage from the events described above, and he had sensory-processing issues, difficulty with memorization and fine-motor control issues. The outcome of the events was unknown. The relatedness between the events and M-M-R II was not reported. Upon internal review, the events of measles and pneumonia were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not reported. On an unknown date, approximately in  2015 "reported as about a year or two ago", the patient's spouse was vaccinated with ZOSTAVAX. This patient was not vaccinated but developed a bad case of shingles (secondary transmission). A the time of reporting, the outcome of shingles and secondary transmission was unknown. It was unknown by the reporter if the patient sought medical attention. The relatedness between the events and ZOSTAVAX was not provided. MARRS: 1702USA009259. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009259:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M032636 with expiry date 06-APR-2018, orally (exact dose was not reported). The doses were exposed to the temperature higher than 8 degrees Celsius but lower than 25 degrees Celsius for a time frame of 1 hour 7 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Patient began experiencing heat and redness when he woke up in the morning with some slight pain. Patient made PCP aware but they did not have the "time to see him" so he followed up with urgent care. They advised him to take ibuprofen and benadryl until his symptoms were resolved.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, Seizure, Streptococcus test negative
Clinical narrative: Fever at bedtime of 102.4 axillary. Administration of melt-away TYLENOL. Seizures at 12:45 am. Ambulance arrived, temp at 101.3 otic. Taken to hospital. IV antibiotic, oral TYLENOL. Transfer to another hospital.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: X-ray normal
Clinical narrative: Fever at bedtime of 102.4 axillary. Administration of melt-away TYLENOL. Seizures at 12:45 am. Ambulance arrived, temp at 101.3 otic. Taken to hospital. IV antibiotic, oral TYLENOL. Transfer to another hospital.
Age: 26.0
Sex: M
Vaccine: TYP, YF
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Echocardiogram, Hyperhidrosis
Clinical narrative: Post administration of vaccine patient became pale, diaphoretic and began twitching and slumped in chair with loss of consciousness for approximately 45 seconds. Responded to stimuli 911 called. BP 80/40 70/40. Transported by EMS to ER. Spoke with patient at 11:35 AM, stated he is having diagnostic testing done at this time and feeling much better.
Age: 26.0
Sex: M
Vaccine: TYP, YF
Symptoms: Loss of consciousness, Muscle twitching, Pallor
Clinical narrative: Post administration of vaccine patient became pale, diaphoretic and began twitching and slumped in chair with loss of consciousness for approximately 45 seconds. Responded to stimuli 911 called. BP 80/40 70/40. Transported by EMS to ER. Spoke with patient at 11:35 AM, stated he is having diagnostic testing done at this time and feeling much better.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported). On an unknown date the patient developed redness with "tiny blisters", inflammation, tenderness to touch and pain at the injection site. The outcome of the events was unknown at the time of the report The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The patient received M-M-R II (strength, lot # and expiration date were not reported) the first dose on 27-MAY-2008, the second dose on 18-MAR-2013, and the third dose on 27-JAN-2017. On 01-FEB-2017, the patient was inadvertently administered  subcutaneously with a fourth dose of  M-M-R II (therapy type: rHA, lot# L005291 and expiration date: 17-FEB-2017). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported. On an unknown date, the patient might have received one improperly stored dose of VAQTA (lot number reported as M033334, expiration date 11-AUG-2018, dose and route were not reported), RECOMBIVAX HB (lot number reported as M033611 and M036459, expiration dates 30-MAR-2018 and 18-JAN-2018, dose and route were not reported), ROTATEQ orally (lot numbers reported as M007307, M031651 and M016918, expiration dates 30-NOV-2017, 30-MAR-2018 and 15-FEB-2018, dose was not reported) or GARDASIL 9 (lot numbers L037554 and M020103, expiration dates 25-DEC-2017 and 15-FEB-2018, dose and route were not reported). The medical assistant reported that she was not sure which of the vaccines received the patient. The temperature exposure was between 32°F and 36°F and the time frame was 14 days. There was not previous temperature excursion, and a data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Lot numbers M036459 and M033611 are invalid lot numbers for RECOMBIVAX HB, and lot number M033334 is an invalid lot number for VAQTA. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Erythema, Joint swelling, Muscular weakness, Myalgia, Pruritus
Clinical narrative: This spontaneous report was received from a currently 76 year old male patient, reporting on himself. The patient's pertinent medical history and drug reactions/allergies were reported as none. Concurrent conditions and concomitant medications were not reported. On 11-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous for prophylaxis (dose, lot # and expiration date were not reported). Other suspect therapies included PNEUMOVAX23 and an unspecified "flu shot" for prophylaxis (dose, route, lot, expiration date an indication were not reported for both therapies). On an unknown date, the patient experienced a "swollen elbow on the right arm, that was also itchy, red and had muscle aches." It was stated that the patient was experiencing muscle pain "from (his) elbow to (his) shoulder and around (his) neck" and that he had weakness in his legs. No treatment was given for the adverse events. It was reported that the patient had monthly follow up appointments with his physician so his arm could constantly be looked at. At the time of reporting the outcome of the events was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX, PNEUMOVAX23 and the unspecified influenza vaccine was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Nephropathy
Clinical narrative: Information was received from a physician who reported that an unspecified patient received a three dose series of an unknown Hepatitis B vaccine (manufacturer unknown) that was completed at age 4 (dates of vaccination, dosage and route of administration unknown). While a Merck vaccine could not be identified, a Merck vaccine could also not be ruled out. The patient, now age 13, has an anti-HB titer of 9 mIU/mL (test was performed on an unspecified date). The physician stated that the patient was diagnosed with renal disease, on an unspecified date after the initial vaccination series was completed.  The outcome of the anti-HB titer of 9 mIU/mL and the renal disease was not reported. No additional information is available. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received an improperly stored doses of RECOMBIVAX HB injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature between 32 degrees Fahrenheit (F) and 36 degrees Fahrenheit (F), with the lowest temperature of 33 degrees Fahrenheit (F), for unknown period of time. No previous temperature excursion was reported. Data logger was used to track the temperature. 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.; Sender's Comments: US-009507513-1703USA000338: US-009507513-1703USA000337: US-009507513-1703USA000335: US-009507513-1703USA000336:
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician concerning a 14 year old patient of unknown gender. In 2003, the patient was vaccinated with M-M-R II and VARIVAX via an unknown route (no adverse events reported). The patient's concurrent conditions and concomitant medications were not provided. On 17-JAN-2017, at age of 14, the patient was vaccinated with PROQUAD, lot # M014302 with expiration date 22-SEP-2017 (dose, strength and anatomical location were not provided), subcutaneously, for prophylaxis. 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 registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received an improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature between 32 degrees Fahrenheit (F) and 36 degrees Fahrenheit (F), with the lowest temperature of 33 degrees Fahrenheit (F), for unknown period of time. No previous temperature excursion was reported. Data logger was used to track the temperature. 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.; Sender's Comments: US-009507513-1703USA000338: US-009507513-1703USA000337: US-009507513-1703USA000336: US-009507513-1702USA009503:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received an improperly stored doses of GARDASIL 9 injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature between 32 degrees Fahrenheit (F) and 36 degrees Fahrenheit (F), with the lowest temperature of 33 degrees Fahrenheit (F), for unknown period of time. No previous temperature excursion was reported. Data logger was used to track the temperature. 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.; Sender's Comments: US-009507513-1703USA000338: US-009507513-1703USA000337: US-009507513-1703USA000335: US-009507513-1702USA009503:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received an improperly stored doses of VAQTA injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature between 32 degrees Fahrenheit (F) and 36 degrees Fahrenheit (F), with the lowest temperature of 33 degrees Fahrenheit (F), for unknown period of time. No previous temperature excursion was reported. Data logger was used to track the temperature. 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.; Sender's Comments: US-009507513-1703USA000338: US-009507513-1702USA009503: US-009507513-1703USA000335: US-009507513-1703USA000336:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received an improperly stored doses of LIQUID PEDVAXHIB injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature between 32 degrees Fahrenheit (F) and 36 degrees Fahrenheit (F), with the lowest temperature of 33 degrees Fahrenheit (F), for unknown period of time. No previous temperature excursion was reported. Data logger was used to track the temperature. 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.; Sender's Comments: US-009507513-1702USA009503: US-009507513-1703USA000337: US-009507513-1703USA000335: US-009507513-1703USA000336:
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 2 patients. This is 2nd of 2 reports. A female patient of unknown age and race received TRUMENBA at single dose via unknown route of administration on an unspecified date for immunization. Relevant medical history and concomitant medication were unknown. The patient fainted after being vaccinated with TRUMENBA and other unknown vaccines. The patient recovered quickly with no further complications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017081609 same reporter/drug/AE, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 1st of 10 cases. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a lot of pain at the injection site. Clinical outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083819 same porter/drug/event, different patient.; US-PFIZER INC-2017083816 same reporter/drug/event, different patient.; US-PFIZER INC-2017083815 same reporter/drug/event, different patient.;US-PFIZER INC-2017083818 same reporter/drug/event, different patient.; US-PFIZER INC-2017083817 same reporter/drug/event, different patient.; US-PFIZER INC-2017083820 same reporter/drug/event, different patient.; US-PFIZER INC-2017083821 same reporter/drug/event, different patient.; US-PFIZER INC-2017083639 same reporter/drug/event, different patient.; US-PFIZER INC-2017083698 same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 4th of 10 cases. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a lot of pain at the injection site. Clinical outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/drug/event, different patient.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Nuclear magnetic resonance imaging, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable consumer (Consumer's wife). A contactable 74-year-old male patient received PREVNAR 13 on 13Feb2017 at single dose for immunization via an unspecified route. Medical history included gout, ongoing and thyroid. Concomitant medication included allopurinol 300 mg, 1x/day, orally and aspirin 325 mg, 1x/day both were taking over 10 years and ongoing and levothyroxine 25 mg, 1x/day and ongoing. On the same date the patient experienced stroke like symptoms. The patient referred to the hospital and he was tested and it wasn't stroke, the vaccine caused those symptoms. A MRI was done at hospital and the patient had a blood work done on 17Feb2017 both with unknown results. The outcome of the event was unknown.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: 10/12/2015 - Symptoms - currently in treatment severe head pain in the back of my head and neck, fatigue, body ache, joint pain and nauseous, diarrhea, neck stiffness, muscle spasms both legs, cold chills, dizziness.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Muscle spasms, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: 10/12/2015 - Symptoms - currently in treatment severe head pain in the back of my head and neck, fatigue, body ache, joint pain and nauseous, diarrhea, neck stiffness, muscle spasms both legs, cold chills, dizziness.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Occipital neuralgia, Pain
Clinical narrative: 10/12/2015 - Symptoms - currently in treatment severe head pain in the back of my head and neck, fatigue, body ache, joint pain and nauseous, diarrhea, neck stiffness, muscle spasms both legs, cold chills, dizziness.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Syncope-fainting.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Employee states left deltoid started to swell with redness noted, c/o slight headache persisting for 12 hours. Donor denies any pain at injection site donors temperature at time of notification 98.3.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Pt's arm was red, swollen, and tender to touch after receiving the PNEUMOVAX 23 vaccine.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Severe localized reaction with swelling, redness and warmth to injection site.
Age: 28.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Pt reports at 0800 on 24 Feb 17 she noticed tingling and slight burning sensation in her Left hand from wrist moving distally. She denies any loss of function or feeling or numbness. TX: given motrin 600mg TID for 5 days; ICE to affected area and watchful waiting. ER precautions given to include loss of function, ability, and complete numbness. Pt instructed to walk into PCM during regular hours if needed.
Age: 23.0
Sex: M
Vaccine: JEVX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: NAUSEA/VOMITING/DIARRHEA.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain, Biopsy bone marrow abnormal, Chronic myeloid leukaemia, Full blood count abnormal, Haemoglobin decreased
Clinical narrative: My daughter complained of severe pain in her right arm.  She continued to complain of intermittent pain in her extremities and abdomen.  On 10/7/2016 she was diagnosed with chronic myelogenous leukemia (CML)based on CBC.  This diagnosis was confirmed by bone marrow biopsy on 10/10/2016.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pain in extremity, Platelet count increased, White blood cell count increased
Clinical narrative: My daughter complained of severe pain in her right arm.  She continued to complain of intermittent pain in her extremities and abdomen.  On 10/7/2016 she was diagnosed with chronic myelogenous leukemia (CML)based on CBC.  This diagnosis was confirmed by bone marrow biopsy on 10/10/2016.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RED RAISED AREA ABOUT THE SIZE OF A QUARTER ON RIGHT UPPER THIGH.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-FEB-2017, the patient was vaccinated with expired doses of VARIVAX lot # L002871 and expiration date: 27-JAN-2017 (strength, dose, frequency, route and site of administration were not reported) and M-M-R II, lot# L003855 and expiration date: 05-FEB-2017 (therapy type, strength, dose, frequency, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Soreness in shoulder and soreness in lower back lower back pin radiated to right buttock and to shin of right leg and has remained and gotten worse.
Age: 18.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, redness and swelling at site of injection. Swelling measures 55mm in width and 65mm in height. Redness is larger in diameter than the swelling.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Chills, fever...aches...arm swollen three times its size with extreme pain and redness.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Chills, fever...aches...arm swollen three times its size with extreme pain and redness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Blister, Erythema, Incisional drainage, Induration, Injection site erythema
Clinical narrative: Developed redness on left thigh the morning after the injection which gradually became more painful and red. Went to outside network ED and received no antibiotics or imaging and was sent home. Presented to Hospital the early morning of 3/1/2017 with progression of erythema with induration and blistering.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Surgery, X-ray limb abnormal
Clinical narrative: Developed redness on left thigh the morning after the injection which gradually became more painful and red. Went to outside network ED and received no antibiotics or imaging and was sent home. Presented to Hospital the early morning of 3/1/2017 with progression of erythema with induration and blistering.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abscess drainage, Abscess limb, Injection site erythema, Injection site swelling, Laboratory test
Clinical narrative: Developed redness on left thigh the morning after the injection which gradually became more painful and red. Went to outside network ED and received no antibiotics or imaging and was sent home. Presented to Hospital the early morning of 3/1/2017 with progression of erythema with induration and blistering.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Muscle abscess, Wound, X-ray
Clinical narrative: Developed redness on left thigh the morning after the injection which gradually became more painful and red. Went to outside network ED and received no antibiotics or imaging and was sent home. Presented to Hospital the early morning of 3/1/2017 with progression of erythema with induration and blistering.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M037652 with expiration date 28-FEB-2018, for prophylaxis (route was not reported). The vaccine was exposed to a temperature between > -15 but < -10 Celsius degrees with a highest temperature of -12.97 Celsius degrees. The time frame was 4.5 hours. No previous temperature excursions were reported. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 26-JAN-2017, the patients were vaccinated with a dose of improperly stored PROQUAD which had a lot # of M022403 with expiration date of 01-NOV-2017 and  M007964 with expiration date: 15-AUG-2017, however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions: on 26-JAN-2017 more than -15 degree centigrades (C), but less than 10 degree C (-12.7 degree C) during 1 hour and 4 minutes of; on 14-FEB-2017, more than -15 degree centigrades (C), but less than 10 degree C  (-11.1 degree C) for 6 hours and 4 minutes, and on 15-FEB-2017, more than -15 degree centigrades (C), but less than 8 degree C (-6.2 degree C) for 10 hours and 24 minutes. There had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000468:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported.     On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (route, dosage schedule, lot # and expiration date were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 25 minutes: more than 46 grades Fahrenheit but less than 77 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000488: US-009507513-1703USA000486: US-009507513-1703USA000487: