chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site warmth, Mobility decreased, Muscle spasms, Myalgia, Nausea
Clinical narrative: Shaking, muscle spasms, muscle pain. 7/9/2016- Injection side swelled to size of a nickel. 101 degree fever. Flu-like symptoms. Chills. Nausea. Injection site rash spreading, raise, hot, burning. Rash from shoulder to elbow. Extremely limited arm movement. 7/10/16- Injection sit rash spread further. Blotchy. Raised, hot. Fever continues 100 degrees. Extremely limited arm movement. 7/11/16- Injection site rash spread to bicep. Blotchy, raised, burning. No fever. Body aches.
Age: 25.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain, Pyrexia, Rash macular, Tremor
Clinical narrative: Shaking, muscle spasms, muscle pain. 7/9/2016- Injection side swelled to size of a nickel. 101 degree fever. Flu-like symptoms. Chills. Nausea. Injection site rash spreading, raise, hot, burning. Rash from shoulder to elbow. Extremely limited arm movement. 7/10/16- Injection sit rash spread further. Blotchy. Raised, hot. Fever continues 100 degrees. Extremely limited arm movement. 7/11/16- Injection site rash spread to bicep. Blotchy, raised, burning. No fever. Body aches.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 10 week old, female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 25-APR-2016 at 18:27, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K010215, expiration date 15-MAY-2017, exact doses and route of administration were not reported). It was reported that the vaccines were exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not clearly previously. No previous temperature excursion was noted. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: Information has been received from a company senior specialist referring to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route, lot # and expiration date were not reported). On an unknown date the patient experienced adverse event which was posted on Facebook. The outcome of adverse event was unknown. Reporter's causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 24-MAY-2016, the patient was vaccinated with improperly stored dose GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017 (strength, dosing details and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Muscle spasms
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date, the patient started having very heavy periods and very bad cramping. It was reported that the patient sought medical attention due to the events. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. 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 nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L045954 and expiration date 17-NOV-2017, lot # reported as M000997 and expiration date 07-JAN-2018, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 8.7 Fahrenheit degrees for 15 hours before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date "over a year ago", the patient was vaccinated with the first dose of GARDASIL (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). At the time of the report (reported as "now"), the patient would like to received a second dose of GARDASIL (inappropriate schedule of vaccine administration). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #L044058 and expiration date 02-MAY-2017, lot # M002058 and expiration date 11-JUL-2017, lot # reported as M007962 and expiration date 15-AUG-2017, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 8.7 Fahrenheit degrees for 15 hours before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. 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 healthcare worker refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L043213, expiry date: 28-AUG-2017 and lot # M005714, expiry date: 03-OCT-2017) via intramuscular route. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. It was stated that on  10-AUG-2015, the patient received the first dose of GARDASIL (does, route of administration, lot number and expiration date were not reported) and at the time of the report the patient would like to received a second dose of GARDASIL. No other suspect or concomitants therapies were reported. No adverse symptoms were reported. 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 multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified improperly stored ROTATEQ (valid lot number K016261, expiration date 23-JUN-2016, and non-valid lot number L013241 with expiration date 28-JAN-2017). The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no previous excursion. This report was for data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.28
Sex: F
Vaccine: HEPA, MMR
Symptoms: Blood culture negative, CSF culture negative, Chest X-ray, Computerised tomogram normal, Electroencephalogram
Clinical narrative: Acute onset of seizures on 6-30-16 while at park. Fever upon arrival to ER. Status epilepticus admitted to PICU. Fever lasted for 3 days. Developed rash on 7-02-16 that lasted for 48 hours. Had CT Scan, culture from all body fluids including CSF all WNL. She was discharge on 7-3-16 with only rash remaining.
Age: 1.28
Sex: F
Vaccine: HEPA, MMR
Symptoms: Intensive care, Nuclear magnetic resonance imaging, Pyrexia, Rash, Seizure
Clinical narrative: Acute onset of seizures on 6-30-16 while at park. Fever upon arrival to ER. Status epilepticus admitted to PICU. Fever lasted for 3 days. Developed rash on 7-02-16 that lasted for 48 hours. Had CT Scan, culture from all body fluids including CSF all WNL. She was discharge on 7-3-16 with only rash remaining.
Age: 1.28
Sex: F
Vaccine: HEPA, MMR
Symptoms: Status epilepticus
Clinical narrative: Acute onset of seizures on 6-30-16 while at park. Fever upon arrival to ER. Status epilepticus admitted to PICU. Fever lasted for 3 days. Developed rash on 7-02-16 that lasted for 48 hours. Had CT Scan, culture from all body fluids including CSF all WNL. She was discharge on 7-3-16 with only rash remaining.
Sex: U
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This solicited report has been received from a patient's mother, as part of a marketing research program, refers 2 patients (age and gender were not reported). The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose, route and anatomical location of administration were not reported). On an unknown date, the patients experienced adverse reaction. The reporter stated "I have known two people with adverse reactions. I did not trust GARDASIL vaccine (in response to the question "what specific aspects of the commercial (language, images, ideas etc.) make you feel..."). The reporter also stated "I thought it was a scare tactic. It annoyed me that they played that card-like parents were horrible if they choose not to do the vaccine. Cancer from HPV vaccine (manufacturer unknown) was very rare-meanwhile I knew two teens who had reactions from the vaccine, [gave my children all other vaccines-even flu. Not this one" (In response to the question "what about this commercial make you less likely to favor vaccination?"] Action taken was not reported. The outcome of the event was not reported. The causality between event and therapy with GARDASIL was not reported. Additional information is not expected as the reporter did not consent for further follow up.
Age: 0.21
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 10 week old, female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-APR-2016 at 18:16, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Age: 0.54
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 6 months old, female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-APR-2016 (also reported as 26-APR-2015) at 9:52, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None, no ill side effects.
Age: 63.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Hyperhidrosis, Malaise, Pallor, Posture abnormal
Clinical narrative: After receiving HepB & Typhoid inject client stated, "do not feel so well." Drank water & apple juice and stated felt better. Approx. 15 min. later became diaphoretic and pale. Slumped over in chair. Aroused with ammonia inhalant. HRRR, oriented X 3. Remained in clinic until skin, warm, dry & pink and able to stand & ambulate without symptoms.  Wife to drive home. Inst. to report any further symptoms to nurse or doctor. Instructed to report incident to physician.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anxiety, Dyspnoea, Hyperhidrosis, Tachycardia, Tachypnoea
Clinical narrative: Wheezing, dyspnea, tachycardia, tachypnea, diaphoresis, and anxiety. Taken to urgent care at clinic where oxygen and intramuscular diphenhydramine were given then transferred in stable condition to local hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Wheezing
Clinical narrative: Wheezing, dyspnea, tachycardia, tachypnea, diaphoresis, and anxiety. Taken to urgent care at clinic where oxygen and intramuscular diphenhydramine were given then transferred in stable condition to local hospital.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Loss of consciousness, Rash
Clinical narrative: This spontaneous report was received from an 87 year old female consumer referring to herself. The patient's medical history included hypertension and allergy to penicillin. On 19-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # and Expiry date not reported). Other co-suspect medications included unspecified thyroid medication and unspecified low dose blood pressure medication. On 14-AUG-2015, the patient discovered a rash under her right breast. Since then, the patient developed the worst case of shingles while on the vaccine, that hospital has seen (herpes zoster). The patient was admitted to hospital on an unspecified date after passing out (syncope). The patient stated that she still was suffering from the shingles that were on her right breast, her back and armpit. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of syncope was unknown. Additional information is not expected as no information for follow up was provided.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Blood culture, Culture urine, Cyanosis, Respiratory viral panel
Clinical narrative: Apnea and cyanosis on/off x 20 minutes. Called 911, suctioned nose, normal pulse ox. Saw PCP next day -> admit to hospital for apnea monitoring, blood/urine studies.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (route, dose#, site of administration and lot# not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. 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 healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates in June 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M005714, expiration date 03-OCT-2017, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 9 Fahrenheit degrees (3 cycles) for 72 hours before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (manufacturer report number 2015171240) on 29 June 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, route and site of administration was not reported) on an unspecified date. The patient's medical history was not reported. Concomitant medications included Cyclobenzaprine 10 mg, loatus, Levetiracetam 500 mg, Lorazepam 1 mg, LYRICA 200 mg 1 capsule by mouth three times a day-oral (expiration date 01 June 2017) from 01 June 2016 to 01 July 2016, metformin, morphine sulfate ER 30, oxycodone 5, vitamin 6, AMBIEN 10. On an unspecified date, following vaccination, patient experienced allergy to tetanus. Lab data and corrective treatment was not reported. Outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of unspecified patient's (information about the patients' gender and age was not reported). Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On unknown dates in 2016 (reported as starting in February 2016), the patients were vaccinated with improperly stored ROTATEQ (lot # L035510, expiration date: 14-MAY-2017; lot # L033694, expiration date: 16-JUN-2017; doses were not reported) orally. The vaccine was stored at 51 degrees Fahrenheit for a time frame of 126 hours and 34.3 degrees Fahrenheit for at time frame of 19.94 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint was not filed. 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 as received from a physician refers to an unknown number of unspecified patients (information about the patients' gender and age was not reported). Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unknown dates in 2016 (reported as started in February 2016), the patients were vaccinated with improperly stored VAQTA (lot # L015460, expiration date: 20-JUL-2017; lot # M011116, expiration date: 17-JUL-2017; doses and routes of administration were not reported). The vaccine was stored at 51 degrees Fahrenheit for a time frame of 126 hours and 34.3 degrees Fahrenheit for a time frame of 19.94 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint was not filed. 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 physician refers to an unknown number of unspecified patients (information about the patients' gender and age was not reported). Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unknown dates in 2016 (reported as starting in February 2016), the patients were vaccinated with improperly stored GARDASIL 9 (lot# reported as L037554, expiration date 25-DEC-2017; lot # L016429, expiration date 09-AUG-2017; doses and routes of administration were not reported). The vaccines were stored at 51 degrees Fahrenheit for a time frame of 126 hours and 34.4 degrees Fahrenheit for a time frame of 19.94 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed Practical Nurse refers to multiple patients of unknown age and gender. Concurrent conditions, medical history and concomitant therapies were not reported. Approximately in June 2016 (reported as "27-JUN-2016 or 28-JUN-2016"), the patients were vaccinated with improperly stored doses of (temperature: 28 F, time frame: 3 hours and 42 minutes) GARDASIL 9 (# lot M004116, expiry date 12-OCT-2017, dosing details not provided). No adverse effects were reported. Digital data logger was involved. There was no previous temperature excursion. No product quality issue was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Cough, Dizziness, Gastrooesophageal reflux disease
Clinical narrative: LARGE RED SWELLING, ITCHING AND DISCOMFORT AT SITE LOTS OF COUGHING AND ASTHMA ALL NIGHT THROAT BASE PAIN ACID REFLUX LASTING THROUGH MONDAY.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Oropharyngeal pain
Clinical narrative: LARGE RED SWELLING, ITCHING AND DISCOMFORT AT SITE LOTS OF COUGHING AND ASTHMA ALL NIGHT THROAT BASE PAIN ACID REFLUX LASTING THROUGH MONDAY.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hot to touch, tenderness at injection site.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Bronchiolitis, Ear infection, Influenza virus test negative, Pallor, Productive cough
Clinical narrative: Started within 24 hours with upper airway congestion, very wet rumbly cough developed over the following week, MD not concerned till it lasted for a couple weeks at which point they started albuterol nebulizers, and then antibiotics for an ear infection with the diagnosis of bronchiolitis. ER visit related to pale and mottled color with low 90's spO2 at home and tachypnea.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Respiratory syncytial virus test negative, Skin discolouration, Tachypnoea, Upper respiratory tract congestion
Clinical narrative: Started within 24 hours with upper airway congestion, very wet rumbly cough developed over the following week, MD not concerned till it lasted for a couple weeks at which point they started albuterol nebulizers, and then antibiotics for an ear infection with the diagnosis of bronchiolitis. ER visit related to pale and mottled color with low 90's spO2 at home and tachypnea.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of unspecified patients (information about the patients' gender and age was not reported). Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unknown dates in 2016 (reported as starting in February 2016), the patient were vaccinated with improperly stored RECOMBIVAX HB (lot # L048849, expiration date: 04-FEB-2018; lot # L048236, expiration date: 31-MAR-2018; doses and routes of administration were not reported). The vaccine was stored at 51 degrees Fahrenheit for a time frame of 126 hours and 34.3 degrees Fahrenheit for a time frame of 19.94 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Pyrexia
Clinical narrative: Low grade fever, one day after vaccination.
Age: 0.5
Sex: M
Vaccine: DTAP, FLUX, HIBV, PNC13, RV5
Symptoms: Bronchiolitis, Fatigue, Productive cough, Respiratory rate increased, Respiratory tract congestion
Clinical narrative: Within 24 hours became very congested, wet cough, rapid breathing at times, easy to tire for weeks again with repeated prescription of albuterol 3-4 times a day and diagnosed bronchiolitis.  Same exact thing happened after 4 month shots but this time occurred faster and more aggressively rather then slower worsening symptoms with 4 month shots.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient noted circumferential erythema to injection site with pain and warmth locally within first 12 hours. Symptoms worsened despite conservative therapy into cellulitic reaction without abscess formation, fever, chills, or streaking.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR
Symptoms: Clumsiness, Decreased appetite, Diet refusal, Fall, Flatulence
Clinical narrative: Fever of 101 for three days, high pitched scream (one that I have never heard from her before) for hours at a time for the majority of the day and night started on 7/7/16 and lasted for three days, less screaming and fussiness on 7/8/16, but still present, naps and nighttime sleep greatly disturbed, wakes screaming instead of happy as usual, refused bottles for three days starting 7/7/16 and wouldn't breastfeed either on  7/10/16, ate almost nothing that day, lack of appetite for solid food as well, as of today, she has only had one bowel movement since immunization (regularly goes every day), clumsy on 7/9/16 and fell much more than usual, rash appeared on trunk 7/10/16 and is still there, gassy and seems to have digestive pain starting on 7/10/16 which is still ongoing.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR
Symptoms: Gastrointestinal pain, Infrequent bowel movements, Irritability, Pyrexia, Rash
Clinical narrative: Fever of 101 for three days, high pitched scream (one that I have never heard from her before) for hours at a time for the majority of the day and night started on 7/7/16 and lasted for three days, less screaming and fussiness on 7/8/16, but still present, naps and nighttime sleep greatly disturbed, wakes screaming instead of happy as usual, refused bottles for three days starting 7/7/16 and wouldn't breastfeed either on  7/10/16, ate almost nothing that day, lack of appetite for solid food as well, as of today, she has only had one bowel movement since immunization (regularly goes every day), clumsy on 7/9/16 and fell much more than usual, rash appeared on trunk 7/10/16 and is still there, gassy and seems to have digestive pain starting on 7/10/16 which is still ongoing.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR
Symptoms: Screaming, Sleep disorder
Clinical narrative: Fever of 101 for three days, high pitched scream (one that I have never heard from her before) for hours at a time for the majority of the day and night started on 7/7/16 and lasted for three days, less screaming and fussiness on 7/8/16, but still present, naps and nighttime sleep greatly disturbed, wakes screaming instead of happy as usual, refused bottles for three days starting 7/7/16 and wouldn't breastfeed either on  7/10/16, ate almost nothing that day, lack of appetite for solid food as well, as of today, she has only had one bowel movement since immunization (regularly goes every day), clumsy on 7/9/16 and fell much more than usual, rash appeared on trunk 7/10/16 and is still there, gassy and seems to have digestive pain starting on 7/10/16 which is still ongoing.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Two days after receiving Tdap patient developed 1.5 inch swelling of the left arm, mildly tender, redness. Denies fever, chills or sweats. Advised to apply warm compress & ADVIL. 7/11 patient reported size of swelling decrease to about size of a marble, redness resolved.
Age: 0.55
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives. Unknown if r/t vaccine as several hours later. Benadryl PRN and sent to allergist for further evaluation before next set of vaccines. No other intervention required.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased
Clinical narrative: States she was unable to lift arm the vaccine was given in for 1 week after the vaccine. Was not able to lift higher that shoulder.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L027591, expiration date 23-JUL-2017, exact doses and route of administration were not reported). It was reported that the vaccines were exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. No adverse effects were reported. This is one of the several reports received from the same source. 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 licensed Practical Nurse refers to multiple patients of unknown age and gender. Concurrent conditions, medical history and concomitant therapies were not reported. Approximately in June 2016 (reported as "27-JUN-2016 or 28-JUN-2016"), the patients were vaccinated with improperly stored doses of (temperature: 28 F, time frame: 3 hours and 42 minutes) ROTATEQ (# lot L044476, expiry date 07-SEP-2017, dosing details not provided). No adverse effects were reported. Digital data logger was involved. There was no previous temperature excursion. No product quality issue was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Information on the concurrent conditions, pertinent medical history and drug allergies were not reported. On 25-JUN-2016, the patient was vaccinated with a properly stored, expired dose of GARDASIL lot #J015378, expiry date 09-APR-2016 (dose number, dose units, route and anatomical location were not reported) (expired product administered). Concomitant mediation were not reported. No adverse reactions were reported. There were no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified improperly stored VAQTA (lot # L004742, expiration date 18-AUG-2016). The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no previous excursion. This report was for data logger. No adverse effects reported. 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: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' current condition, concomitant therapies or medical history provided. On unknown dates, patients were administered an unspecified number of improperly stored dose of ROTATEQ orally, lot number L037921, expiration date: 31-MAY-2017, (dose was not reported0. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 29 degree Fahrenheit for 1 hour on unknown date. Data logger was involved. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.
Age: 74.0
Sex: M
Vaccine: RAB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Patient stated arm of injection site was itchy later that day and late that evening/early the next morning her arm became swollen radiating from injection site.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out in the waiting room after vaccine administration.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: The patient received the vaccine 7-10-16. The patient had no reaction on that day. She woke up the next morning with pain at the injection site. She had a large swollen, reddish rash at the site, about golf ball size and said it hurt.
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 48 hours after vaccine administered pt developed swelling, redness, pain a site of injection (L) arm, difficulty lifting arm and feeling very sleepy and tired.
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Somnolence
Clinical narrative: 48 hours after vaccine administered pt developed swelling, redness, pain a site of injection (L) arm, difficulty lifting arm and feeling very sleepy and tired.
Age: 17.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness, Dyspnoea, Incoherent, Malaise
Clinical narrative: 8:30A patient stated she didn't feel well after receiving hep B and tetanus vaccines and PPD. She immediately closed her eyes and slumped forward in her chair. She was incoherent for approximately 10-15 seconds. States she felt light headed. EMT activated. Vitals at 8:30A B/P 112/68, Pulse 50, Resp 16. Skin warm and dry. 8:35P Pulse 48, heart rate, 52, pulse oximeter 98%. C/O SOB, no wheezing or difficulty breathing observed. Requested trash can, no vomiting. 8:38A said on exam table with feel elevated pulse oximeter 98%, heart between 39-53. C/O "can't breath", Ambo bag applied. Said she felt better after few minutes of Ambo bag being utilized, EMT called again. 8:44A Resp. 14, pulse 46, pulse oximeter 99%. Patient reports feels better. Reported H/O Chron's disease, said she was on no medication. Patient stated this type of reaction has never happened before but her husband said it has, back in Feb/2016 after getting a tooth pulled. 8:45A EMT arrived, report of events given and patient taken to hospital. 12N Husband reports patient still in ER, but no further symptoms.
Age: 1.46
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR
Symptoms: Urticaria
Clinical narrative: Diffuse hives within 24 hours of vaccinations.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Influenza virus test negative, Metabolic function test normal, Vomiting
Clinical narrative: Vomiting and diarrhea after 6 month vaccines. Diarrhea x 5 days. Onset 30 hours after vaccines administered. 12-14 stools/day.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Left arm rash and swollen shoulder to elbow. Sent to doctor.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Eczema, Headache, Productive cough
Clinical narrative: Patient states phlegmy cough and headaches began within a few hours and continue through today, eczema reaction on hands appeared about 1 week later and is ongoing.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Chills, Erythema, Musculoskeletal stiffness
Clinical narrative: Redness, stiffness, chills.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test abnormal, Body temperature increased, Chills, Erythema, Fatigue
Clinical narrative: May 3, 2016 - administered pneumococcal pneumonia shot. May 4, 2016 - woke up feeling sick, large square red, chills, tired, arm swollen, went to work and had to go nurse, temp 105. Called doctor, brought TYLENOL, still sick next day, went to ER, took blood test.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Malaise, Peripheral swelling
Clinical narrative: May 3, 2016 - administered pneumococcal pneumonia shot. May 4, 2016 - woke up feeling sick, large square red, chills, tired, arm swollen, went to work and had to go nurse, temp 105. Called doctor, brought TYLENOL, still sick next day, went to ER, took blood test.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 30-JUL-2014 and on  02-FEB-2015 the patient was vaccinated with GARDASIL injection (lot number, expiration date, route and anatomical location of administration were reported). On 11-SEP-2015, the patient was vaccinated with the partial dose of GARDASIL 9 injection, (lot number, expiration date, route and anatomical location of administration were not reported). No adverse symptoms were reported and no product quality complaint was involved. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain, Skin tightness
Clinical narrative: Swelling, redness, tightness at the site of injection within few hours of the shot. Pt was seen in ER and received prednisone taper, clindamycin and NORCO for pain. Pt was seen today, improving swelling and redness.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient had redness and swelling at injection site. Reported fever and chills and aches overnite. Referred pt to see primary care physician.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Irritability
Clinical narrative: Patient inadvertently given a hepatitis A at 4 months of age and developed fussiness.
Age: 90.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site bruising
Clinical narrative: Patient experienced a bruising on the site of injection a few days after receiving the injection. Bruising became larger and darker and is still apparent 7 days after getting the vaccination.  There is no bleeding, no fever, and no pain. But the bruising have not subsided.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Abdominal pain upper, Feeding disorder, Injection site erythema, Injection site pain
Clinical narrative: Patient complained of erythema, pain at injection site and was having difficulty eating and drinking due to stomach pain.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Soreness in arm which radiated to shoulder and neck area. Sought treatment after 2 weeks and was given a muscle relaxer.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dizziness, Electrocardiogram normal, Tremor, Vision blurred
Clinical narrative: Intermittent blurry vision, dizziness, shakiness, chest tightness (mild); no shortness of breath, no rash, no edema, no nausea/vomiting, no palpitations.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling around injection site to the size of an apple, itching, pain, hot to the touch.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Body temperature increased, Chills, Dizziness, Fatigue, Headache
Clinical narrative: She complained of not being able to move her left arm and her fingers tingling after having the Trumenba injection in that arm. She felt achy, tired, light-headed. Had the chills and a slight elevated temperature, a headache, and was nauseaus. Saw the MD today, came home went to bed and had to call off work and cannot get out of bed as of yet. C/o being extremely tired.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Impaired work ability, Injected limb mobility decreased, Nausea, Pain, Paraesthesia
Clinical narrative: She complained of not being able to move her left arm and her fingers tingling after having the Trumenba injection in that arm. She felt achy, tired, light-headed. Had the chills and a slight elevated temperature, a headache, and was nauseaus. Saw the MD today, came home went to bed and had to call off work and cannot get out of bed as of yet. C/o being extremely tired.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, red reaction at injection site. Did not occur until 6 days following injection.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives all over body and face.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram, Dysarthria, Electroencephalogram, Injected limb mobility decreased, Swollen tongue
Clinical narrative: This is from the patient, "sensation of momentarily not being able to control my left arm as I could only raise it a few inches. I thought my speech was slurred and sounded funny for about 3-5 seconds. My tongue on the left side felt enlarged. My husband who was in the car next to me did not notice anything."
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: AFTER ADMINISTRATION OF VACCINES PATIENT PASSED OUT. PATIENT WAS SUPPORTED BY NURSE WHEN SHE CAME TO SHE VOMITED x1. SHE WAS HELPED TO A COT AND COOL PACKS APPLIED TO BACK OF NECK. PATIENT WAS GIVEN JUICE AND MONITORED FOR 15 MINS. PATIENT LEFT WITH FAMILY.
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Body temperature increased, Chills, Full blood count normal, Haematuria, Musculoskeletal stiffness
Clinical narrative: Bilateral neck stiffness, Rigors, Low grade temp (99.5).
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Myoglobin urine absent, Urine analysis abnormal
Clinical narrative: Bilateral neck stiffness, Rigors, Low grade temp (99.5).
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Fall, Loss of consciousness, Moaning
Clinical narrative: After placing a bandaid over injection site on patients left arm she proceeded to fall forward and lose consciousness, then I stopped her from falling forward out of her seat, she was moaning for 5 seconds during which time I called over her parents and she came to. I requested the patient to stay in the area and stay seated for at least 20 minutes, (the patient stated that she normally faints when getting vaccines that is why she usually gets them in Doctors office) during wich time I gave her father a vaccine, after her father got the vaccine they walk out of the store.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Asterixis, Seizure
Clinical narrative: Held her hands out to her side and flapped them. We were told not to worry about it. Later told it was likely seizures. Flapping got worse over the next week and began to become less frequent until disappearing at two weeks past the vaccination date.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Hypopnoea, Hypotonia, Sleep apnoea syndrome
Clinical narrative: Quit breathing during sleep. Would gasp when picked up. Laid back down and breathing became shallow again until she stopped. Gasped upon being picked up. Did not wake up with all the up and down. Was completely limp. Slept holding her upright and jolting her when her breathing would become too shallow.
Age: 26.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Blood test, Eye irritation, Measles post vaccine, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient received an MMR vaccine on 6/27/16. On 7/7/16 patient started to develop a fever, and the next day a rash. Patient also develop sore throat, rash and eye irritation. Physician diagnosed as Measles. Product was MMR vaccine from Merck Lot # L041457.