chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date in 2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection, 0.65 ml, administered subcutaneusly, reported as "the normal way" (lot# L031272, expiration date: 19-NOV-2016). No adverse effects were reported. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified patient of unknown age gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient may have been administered an improperly stored dose of either ROTATEQ (lot # M019691, expiration date 02-NOV-2017, oral; dose was unknown) or GARDASIL 9 (lot # L040054, expiration date 26-DEC-2017; dose and route were unknown) for prophylaxis. The temperature excursion was 35.8 Fahrenheit degree for 16 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved.  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 licensed practical nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in approximately 2016, the patients were vaccinated with improperly stored doses of ROTATEQ, administered orally, lot # K023535 with expiration date 22-MAY-2016 (doses of this vaccine were not administered after the expiry date) or lot # L013193 with expiration date 20-JAN-2017 (exact dose was not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 14.2 degrees Celsius for 1 hour 40 minutes on 03-FEB-2016, 9.4 degrees Celsius for 40 minutes on 23-FEB-2016, 8.5 degrees Celsius for 1 hour on 11-MAR-2016, 8.5 degrees Celsius for 30 minutes on 16-MAR-2016, 10.6 degrees Celsius for 1 hour 50 minutes on 23-MAR-2016, 17.2 degrees Celsius for 5 hours 40 minutes on 05-APR-2016 and 9 degrees Celsius for 4 hours 50 minutes on 19-APR-2016. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009027: US-009507513-1612USA004686.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in approximately 2016, the patients were vaccinated with improperly stored doses of VAQTA lot # L023232 with expiration date 25-FEB-2017 or lot # K005323 with expiration date 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of VAQTA lot # L023232 experienced a temperature excursion of 14.2 degrees Celsius for 1 hour 40 minutes on 03-FEB-2016, 9.4 degrees Celsius for 40 minutes on 23-FEB-2016, 8.5 degrees Celsius for 1 hour on 11-MAR-2016, 8.5 degrees Celsius for 30 minutes on 16-MAR-2016, 10.6 degrees Celsius for 1 hour 50 minutes on 23-MAR-2016, 17.2 degrees Celsius for 5 hours 40 minutes on 05-APR-2016 and 9 degrees Celsius for 4 hours 50 minutes on 19-APR-2016. Administered doses of VAQTA lot # K005323 experienced a temperature excursion of 14.2 degrees Celsius for 1 hour 40 minutes on 03-FEB-2016 and 9.4 degrees Celsius for 40 minutes on 23-FEB-2016. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009026: US-009507513-1612USA004686.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, concomitant therapies, drug reactions or allergies was provided. On unknown dates in 2016, between 11-NOV-2016 and 01-DEC-2016, the patients may had been vaccinated with improperly stored VAQTA lot# reported as M026309 (verified to be invalid for VAQTA), expiration date: 24-JAN-2018 (dose, route of administration were not reported). The administered doses of vaccine were stored in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Previously the vaccine was improperly stored in the temperature of 1.3 degrees Celsius for 11 hours 18 minutes, in the temperature of 1.4 degrees Celsius for 5 hours 32 minutes, in the temperature of 1.5 degrees Celsius for 9 hours and 42 minutes and in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Cumulatively the vaccine was stored in the temperature of 1.1 degrees Celsius for 43 hours and 18 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Lot number M026309 is an invalid lot number for VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1612USA009210: US-009507513-1612USA001131.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, concomitant therapies, drug reactions or allergies was provided.   On unknown dates in 2016, between 11-NOV-2016 and 01-DEC-2016, the patients might have been vaccinated with improperly stored ROTATEQ orally, lot# M016918, expiration date: 15-FEB-2018 (dose was not reported). The administered doses of vaccine were stored in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Previously the vaccine was improperly stored in the temperature of 1.3 degrees Celsius for 11 hours 18 minutes, in the temperature of 1.4 degrees Celsius for 5 hours 32 minutes, in the temperature of 1.5 degrees Celsius for 9 hours and 42 minutes and in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Cumulatively the vaccine was stored in the temperature of 1.1 degrees Celsius for 43 hours and 18 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter.         Additional information has been requested.; Sender's Comments:  US-009507513-1612USA001131: US-009507513-1612USA009209:
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Arthropathy, Computerised tomogram, Dizziness, Dysgeusia, Electrocardiogram
Clinical narrative: Suffered from joint and muscle weakness and extreme pain, dizziness, fainting, blurred vision, inability to walk without falling, numbness and tingling in feet and hands, metal taste in mouth, irritability, inability to sleep. Was given Flu shot while at work, on or about November 2, 2016.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Gait disturbance, Hypoaesthesia, Insomnia, Irritability
Clinical narrative: Suffered from joint and muscle weakness and extreme pain, dizziness, fainting, blurred vision, inability to walk without falling, numbness and tingling in feet and hands, metal taste in mouth, irritability, inability to sleep. Was given Flu shot while at work, on or about November 2, 2016.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Suffered from joint and muscle weakness and extreme pain, dizziness, fainting, blurred vision, inability to walk without falling, numbness and tingling in feet and hands, metal taste in mouth, irritability, inability to sleep. Was given Flu shot while at work, on or about November 2, 2016.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Vision blurred
Clinical narrative: Suffered from joint and muscle weakness and extreme pain, dizziness, fainting, blurred vision, inability to walk without falling, numbness and tingling in feet and hands, metal taste in mouth, irritability, inability to sleep. Was given Flu shot while at work, on or about November 2, 2016.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Diplopia, Drooling, Dysphagia, Dysphonia, Paraesthesia
Clinical narrative: Few days after injection, noticed tingling sensation both sides of lower face, drooling when chewing. Recurrence diplopia, dysphagia, altered phonation.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Hypoaesthesia, Lumbar puncture normal, Paraesthesia
Clinical narrative: Developed numbness and tingling and loss of sensation in soles of feet and progressed up bilateral legs to hips.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Sensory loss, Spinal X-ray normal
Clinical narrative: Developed numbness and tingling and loss of sensation in soles of feet and progressed up bilateral legs to hips.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Joint range of motion decreased, Mobility decreased, Pain, X-ray limb abnormal
Clinical narrative: Left shoulder intense pain on moving arm in any direction. Limited range of motion. Unable to sleep through night. Unable to use arm full range.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 11-week-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 07-DEC-2016, the patient was vaccinated with an expired dose of ROTATEQ, orally (lot# L008054, expiration date: 30-NOV-2016; dose was not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in 2011 (reported as five years ago), the patient first dose in the three dose series of GARDASIL (dosing details, lot# and expiry date were not reported) for prophylaxis. On 09-DEC-2016, the patient came to receive GARDASIL 9 (dosing details, lot# and expiry date were not reported) for prophylaxis. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M020103 with expiration date 15-FEB-2018 or lot # M024261 with expiration date 30-JUL-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 34 Fahrenheit degrees for 1 hour. There were no previous temperature excursions. Data logger was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013789.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown gender, approximately 23 year old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-DEC-2015, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot # and expiration date were not reported). The patient received second and third dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot # and expiration date were not reported) on 06-SEP-2016 and 20-NOV-2016, respectively. The doses were administered in altered schedule. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient received an improperly stored dose GARDASIL 9 injection (lot # L040054 with expiration date at 26-DEC-2017; dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 Fahrenheit (F) degrees for 20 hours. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013776: US-009507513-1612USA013777.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 22-DEC-2016 the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration and indication were not reported), which expired on 16-DEC-2016. No side effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with the second dose of  GARDASIL 9 (lot# L037554, expiry: 25-DEC-2017) four days after the administration of the first dose of GARDASIL 9 (dosing details, lot# and expiry date were not reported) for prophylaxis. No adverse effects were reported. There were no product quality complaints (PQC) 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 physician refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (17 doses) (lot # M004894, expiry date 26-JUL-20187) (dose and route were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA013772.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of  patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses VARIVAX (5 doses) (dose, route, lot# and expiry date were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA013766:
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 patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient received an improperly stored dose of ROTATEQ orally (lot # M025568 with expiration date at 07-NOV-2017; dose was not reported) for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 Fahrenheit (F) degrees for 20 hours. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013777: US-009507513-1612USA010622.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient received an improperly stored dose of PEDVAXHIB injection (involved lot numbers: L051124 with expiration date at 14-OCT-2018 and L014426 with expiration date at 08-MAR-2018; dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 Fahrenheit (F) degrees for 20 hours. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010622: US-009507513-1612USA013776.
Age: 27.0
Sex: U
Vaccine: TYP
Symptoms: Lymphadenopathy
Clinical narrative: Typhoid Vi administered on (L) deltoid on 12/13/16. Patient developed (L) axillary lymphadenopathy on 12/19/16. No fever. No (L) deltoid erythema.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dysgeusia, Paraesthesia
Clinical narrative: Metallic taste in mouth. Tingling in fingers/toes. Feeling faint.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia
Clinical narrative: Complaint of bilateral hip and knee pain that lasted from 10/11/16 - 12/13/16.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site mass
Clinical narrative: Injection site with reddened form mass 2 weeks after injection-supportive only. c/w-sterile abscess.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased eye contact, Irritability, Strabismus
Clinical narrative: Approximately 24 hours after vaccination, mother reports infant's eye's started "turning in" for 3-4 days. Also noted he would not make eye contact like he did pre vaccination. Times 7-8 days irritable and clingy during the period of time as well.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nodule, Peripheral swelling, Tenderness
Clinical narrative: Patient reports that day after receiving vaccine her arm was swollen, tender, and had a noticeable knot. Mother called to reported to Health Dept on 12/13/16. Instructed mom to take to doctor.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Patient presented with swelling of left arm (full arm just not injection site). Patient went to Urgent Care and received prednisone 20mg and Clindamycin 300mg.
Age: 11.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Dry skin, Erythema, Pallor, Pruritus, Rash erythematous
Clinical narrative: Clinic reports awoke 12-17-16 in am, brother noticed pale, pink rash to Rt. deltoid area. Client reports itchy feeling. Denies fever, HA, SOB, swelling to face or throat. 12-19-16 to clinic, mild erythema, skin dry, itchy, scaly, no drainage, (color unchanged), temp 97.9 oral.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Cellulitis, Injection site erythema, Local reaction
Clinical narrative: Developed redness around vaccine site 1 day after immunization. Local reaction versus ltd reaction versus cellulitis. Clinds given x 7 days.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Injection site erythema, Irritability, Pyrexia
Clinical narrative: Fever 103.9, irritable, redness at site left.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain and unable to lift arm.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site bruising, Peripheral swelling
Clinical narrative: Pt presented w/swelling of left arm (she stated it looked like bubbling of the skin w/fluid) over entire area of injection. She received Prednisone 20 mg and ATARAX 50 mg.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient and MOP agreed to MENVEO, MenB wasn't offered at first. MenB given. Advised MOP and Patient that MenB was given instead of MENVEO. MOP and patient verbalized understanding and 2nd MENVEO shot was then given.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Limb mass, Pyrexia
Clinical narrative: Pt called pharmacy to report a baseball sized lump on left arm, fever of 101 degrees on 12/23, 103 degrees on 12/25, redness to left elbow. Pt had to go to ER visit on 12/27/16 very early in morning. Diagnosed with cellulitis, goes from left side of arm to right 1 inch radius of injection site extends vertical to about 5 inches vertical of injection site.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness and swelling, heat about three days. Contacted MD awaiting response.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt has soreness at site and rash w/some swelling.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Calcinosis, Haematoma
Clinical narrative: Received PREVNAR 13 on 11/28/16 and hematoma formed shortly after and has not gone away. She was treated by her HC provider on 12/23/16 - warm compress to area - nodular calcification noted.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Dry skin, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, tenderness, warmth at and around injection site. Worst for 1 wk following injection. Got better but still dryness of peeling of skin noticed.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Skin exfoliation
Clinical narrative: Swelling, redness, tenderness, warmth at and around injection site. Worst for 1 wk following injection. Got better but still dryness of peeling of skin noticed.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Pain, Sinusitis, Walking aid user
Clinical narrative: Case number PHEH2016US032874, is an initial spontaneous report received from a consumer on 15 Dec 2016. This report refers to an adult male patient. Historical condition included stroke. Vaccination history included administration of seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) which caused dizziness and muscle aches (see case: PHEH2016US033492). Current conditions included cancer. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date in Oct 2016. On an unknown date after vaccination, the patient experienced dizziness, was using cane to walk, aches and pains. The patient went to emergency room and was told had sinus infection. The patient received hydration in emergency room. It was reported that the dizziness started after receiving flu vaccine last season and became worse after receiving again in Oct 2016 (date unspecified). The outcome of the events dizziness, aches and pains was reported as condition unchanged and for other events it was not reported. The seriousness of the event sinus infection was not reported and for other events it was reported as serious (disability). The causality of the events was not reported.
Age: 79.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Pt received vaccine 12-11-16. 12-19-16 - red, swollen, no pain.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Arthralgia, Back pain, Musculoskeletal pain
Clinical narrative: From the time, and day this vaccine was administered to me I have been in pain shoulder and back/hip.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: LEFT DELTOID AREA HOT TO TOUCH, REDNESS AND INDURATION( LARGE AREA).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Got the ZOSTAVAX vaccine yesterday and woke up to a rash on the sides of my neck, sides of my forehead as well as the front of my neck have taken BENADRYL throughout the day.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Pyrexia, Tremor
Clinical narrative: Reaction to Flu vaccine. Fever, chills, loss of appetite. Office visit w/Dr. 2 Visits to E.R. Tremors (arms and hands).
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Arm swelling- upper-around injection site-bilateral arm sore-bilateral 24 hours.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site inflammation, Injection site pain
Clinical narrative: Shoulder/arm inflammation and pain, can't lift arm. Patient says injected too high on arm.
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. On an unknown date, the patients were vaccinated with a dose of improperly stored PROQUAD, (which had a lot # of M033210 and an expiration date of 09-JAN-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. It was unknown the temperature excursions for vaccines, however it was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA013794.
Sex: F
Vaccine: HPVX
Symptoms: Cluster headache, Musculoskeletal disorder
Clinical narrative: This spontaneous report was received from a consumer regarding her daughter of unknown age. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (Unspecified HPV Vaccine) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (Unspecified HPV Vaccine) for prophylaxis. The patient had problems with her legs since the shot she gets cluster headaches and may be infertile.  Outcome and causality of the events were not reported. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
Sex: F
Vaccine: HPV4
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The medical history, current conditions and concomitant medication were not reported. On an unknown date the patient was vaccinated with first dose of GARDASIL (strength, dose, frequency, batch/lot number and expiry date not reported) intramuscularly for prevention of  HPV. On an unknown date (reported as next day), after the first dose of GARDASIL, the patient had a stroke. On an unknown date, the patient received the second dose of GARDASIL and had another stroke. On an unknown date, the patient was hospitalized. It was reported that the patient would not be receiving the third dose of GARDASIL. Therapy with GARDASIL was discontinued. The outcome of the events were reported as recovered. The patient had received the vaccines from her pediatrician. The causality assessment was not provided. 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 practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M018957, expiration date 22-NOV-2017 (exact dose was not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 34 Fahrenheit degrees for 1 hour. There were no previous temperature excursions. Data logger was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007729.
Sex: U
Vaccine: RV5
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. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, (which had a lot # of M019691 and an expiration date of 02-NOV-2017; however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. It was unknown the temperature excursions for vaccines, however it was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports recevied from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA002672.
Age: 30.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: She had a hard and painful lump at injection site. Skin became bright red to the back of the arm, about the length of a dollar bill. Denied any other symptoms. She applied heat packs to the back of the arm. The symptoms started resolving on 12/26/16. She still has some itching to site but redness is resolving. She did not take any medications OTC to help with pain or redness.
Age: 51.0
Sex: F
Vaccine: FLUC4, PNC, TDAP
Symptoms: Fatigue, Feeling abnormal, Joint range of motion decreased, Mobility decreased, Musculoskeletal disorder
Clinical narrative: I felt like my arm was going to "fall off" and could not use it at all. However, it had been a long time since I had the TDAP and figured that it would work its way out. For several days, I felt like I had just been hit by a truck. Literally, I just laud in the bed. No fever or any of those symptoms. The main problem was that I could not move my arm without pain. Ithe has gotten a little better and I have tried to exercise it out to no avail. My range of motion is limited now and I have painted with certain movements and a lot of soreness. I've never had this happen with a vaccine before.
Age: 51.0
Sex: F
Vaccine: FLUC4, PNC, TDAP
Symptoms: Pain
Clinical narrative: I felt like my arm was going to "fall off" and could not use it at all. However, it had been a long time since I had the TDAP and figured that it would work its way out. For several days, I felt like I had just been hit by a truck. Literally, I just laud in the bed. No fever or any of those symptoms. The main problem was that I could not move my arm without pain. Ithe has gotten a little better and I have tried to exercise it out to no avail. My range of motion is limited now and I have painted with certain movements and a lot of soreness. I've never had this happen with a vaccine before.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Blindness, Feeling of body temperature change, Loss of consciousness, Nausea
Clinical narrative: Pt c/o feeling hot, then cold. Then said she couldn't see. Passed out for a short time. c/o nausea.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody increased, Arthralgia, Borrelia test negative, Full blood count normal, Laboratory test normal
Clinical narrative: Bilateral joint Pain in hands, then 3 days later on 11/03/16 developed rash bilateral feet medial aspect that is when she reported symptoms to clinic. By that time the painful joints were resolving without treatment.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: Bilateral joint Pain in hands, then 3 days later on 11/03/16 developed rash bilateral feet medial aspect that is when she reported symptoms to clinic. By that time the painful joints were resolving without treatment.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Myoclonus, Provisional tic disorder
Clinical narrative: They never noticed before. He took an antibiotic recently and this happened afterward. (Had flu shot too.) Patient says this has been happening before his parents ever noticed. He says it happens when he is bored and dad agrees. Dad says church, watching a movie he has seen before. Says some jerking as he fell asleep (myoclonic).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Patient is unsure of the exact day that the rash started but that it was some time in the past week.  She presented 8 days after she received Prevnar 13 with a rash (about 3inx6in) at the site of injection.  She reports that it is warm to touch.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Flatulence
Clinical narrative: Hot red swollen area the size of the palm of his hand, covering the entire right deltoid. He had no other symptoms. No treatment was taken.  The symptoms completely resolved.  However 2 weeks later he developed RUQ fullness which was relieved with flatulence.  He did not seek medical attention at this time.  He had routine labwork on 12-13-16 as part of his routine checkup.  He saw the medical provider on 12-19-16 and discovered that he had elevated liver enzymes: ALK Phos 642 ALT 454 AST 385. He was taking Lipitor, Prilosec, Valsartan, Acyclovir and ASA at the time.  He discontinued these meds on 12-19-16, had a normal liver ultrasound. Plans to repeat the bloodwork in a few weeks.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Ultrasound liver normal
Clinical narrative: Hot red swollen area the size of the palm of his hand, covering the entire right deltoid. He had no other symptoms. No treatment was taken.  The symptoms completely resolved.  However 2 weeks later he developed RUQ fullness which was relieved with flatulence.  He did not seek medical attention at this time.  He had routine labwork on 12-13-16 as part of his routine checkup.  He saw the medical provider on 12-19-16 and discovered that he had elevated liver enzymes: ALK Phos 642 ALT 454 AST 385. He was taking Lipitor, Prilosec, Valsartan, Acyclovir and ASA at the time.  He discontinued these meds on 12-19-16, had a normal liver ultrasound. Plans to repeat the bloodwork in a few weeks.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Dizziness, Full blood count, Hot flush, Laboratory test, Malaise
Clinical narrative: Hot flashes, shaking, dizziness, malaise.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Metabolic function test, Tremor
Clinical narrative: Hot flashes, shaking, dizziness, malaise.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site rash
Clinical narrative: Patient had the Zostavax vaccination and woke up the following morning with a little rash at the administration site. We called her today 12/27/16 and it has disappeared.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Mouth ulceration, Oral discomfort, Pain, Pyrexia
Clinical narrative: BURNING SENSATION OF THE MOUTH, ULCERS IN MOUTH, FEVER, CHILLS, BODY ACHES.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Cyanosis, Erythema, Lethargy
Clinical narrative: Patient had turned red on his face and arms and hands 5 minutes after receiving vaccine, (1045am) holding his chest, lips were blue. Looked lethargic, Benadryl 27.875 mg given of a 12.5mg per 5 mls at 1102am.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Diarrhoea, Myalgia, Vaccination site swelling
Clinical narrative: SHE REPORTED DIARRHEA THAT LASTED 2 DAYS, BONES ACHED, MUSCLES ACHED AND ARM SWOLLEN WHERE VACCINE ADMINISTERED.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Feeling abnormal, Hypoaesthesia oral, Jaw disorder, Malaise
Clinical narrative: Tingling in tip of tongue.  Patient then informed us that she has burning tongue syndrome.  Then several mins. later gums in front teeth going numb tingling.  We gave her 50 mg liquid Benadryl.  Pt. then stated traversing jaw bone.  Not feeling well. I had patient stay longer then in a few mins. patient requested us to call 911. Tingling in arms and not good in chest area. Feeling some thing in back of throat. This weirdness traversing from one side of arm across the body to other arm.  Patient requested us to call 911.  Paramedics came out took it after this.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia, Paraesthesia oral, Throat irritation, Tongue discomfort
Clinical narrative: Tingling in tip of tongue.  Patient then informed us that she has burning tongue syndrome.  Then several mins. later gums in front teeth going numb tingling.  We gave her 50 mg liquid Benadryl.  Pt. then stated traversing jaw bone.  Not feeling well. I had patient stay longer then in a few mins. patient requested us to call 911. Tingling in arms and not good in chest area. Feeling some thing in back of throat. This weirdness traversing from one side of arm across the body to other arm.  Patient requested us to call 911.  Paramedics came out took it after this.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site warmth, Myositis
Clinical narrative: Upper arm was very sore from the day of vaccine.  On Dec 14, 2016, I noticed a circle the size of a half dollar at the injection site that was completely red.  Dr. saw me immediately and said it appeared to be warm and infected.  She put me on Bactrim for five days.  Two days after going off the antibiotic, my muscle in the same arm became very painful.  I again went to see Dr.  She thought the muscle was inflamed and suggested an ibuprofen med to take away the inflammation.  As long as I take Advil gel at night, I can sleep.  The pain and soreness in the muscle comes and goes, but most noticeable at night.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: Upper arm was very sore from the day of vaccine.  On Dec 14, 2016, I noticed a circle the size of a half dollar at the injection site that was completely red.  Dr. saw me immediately and said it appeared to be warm and infected.  She put me on Bactrim for five days.  Two days after going off the antibiotic, my muscle in the same arm became very painful.  I again went to see Dr.  She thought the muscle was inflamed and suggested an ibuprofen med to take away the inflammation.  As long as I take Advil gel at night, I can sleep.  The pain and soreness in the muscle comes and goes, but most noticeable at night.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Face injury, Fall, Fatigue, Musculoskeletal stiffness, Pallor
Clinical narrative: Pt in today with siblings for flu vaccine, due for HPV as well. She was given her vaccine in the seated position, and within about a minute, became very stiff, with arms shaking and moving, head leaning back and to the right. She then fell forward and hit her chin/face on the floor, chipping both of her front teeth.  Both mom and RN were unable to grab her in time before she fell as it happened quite quickly.  She was not responsive briefly afterwards- the whole episode was about 1 minute in duration. Afterwards she was tired but responsive and appropriate. VSS, BP and O2 sat WNL,  Heart and lung exam also WNL, good pulses. pale in color after the event.  911 called and ambulance came to transfer her to hospital; for further evaluation.  Report also called to receiving MD in the ER. ED REPORT: dx tooth #8, #9 fracture: tooth #8 - diagonal Ellis Class 2 fracture; tooth #9 - Ellis Class 3 fracture at gum line with exposed pulp. Treatment: applied calcium hydroxide cement paste to exposed root/pulp of tooth #9. Recommendation: needs further repair/reconstruction and possibility implants. Needs to see Trauma dentist.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Posture abnormal, Tooth fracture, Tremor, Unresponsive to stimuli
Clinical narrative: Pt in today with siblings for flu vaccine, due for HPV as well. She was given her vaccine in the seated position, and within about a minute, became very stiff, with arms shaking and moving, head leaning back and to the right. She then fell forward and hit her chin/face on the floor, chipping both of her front teeth.  Both mom and RN were unable to grab her in time before she fell as it happened quite quickly.  She was not responsive briefly afterwards- the whole episode was about 1 minute in duration. Afterwards she was tired but responsive and appropriate. VSS, BP and O2 sat WNL,  Heart and lung exam also WNL, good pulses. pale in color after the event.  911 called and ambulance came to transfer her to hospital; for further evaluation.  Report also called to receiving MD in the ER. ED REPORT: dx tooth #8, #9 fracture: tooth #8 - diagonal Ellis Class 2 fracture; tooth #9 - Ellis Class 3 fracture at gum line with exposed pulp. Treatment: applied calcium hydroxide cement paste to exposed root/pulp of tooth #9. Recommendation: needs further repair/reconstruction and possibility implants. Needs to see Trauma dentist.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Oedema, Swelling
Clinical narrative: Swelling to right upper arm x 4 days at time of visit (12/26/16), improving with use of BENADRYL. Given watch and wait doxycycline for possible cellulitis, continued improvement (12/27/16).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling to right upper arm x 4 days at time of visit (12/26/16), improving with use of BENADRYL. Given watch and wait doxycycline for possible cellulitis, continued improvement (12/27/16).
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling abnormal, Headache, Injection site pain, Injection site reaction
Clinical narrative: Significant injection site soreness, felt bad, aching all over, low grade fever, facial swelling, red splotches around injection site and axilla, headache, dizziness-onset evening of injection.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Rash macular, Swelling face
Clinical narrative: Significant injection site soreness, felt bad, aching all over, low grade fever, facial swelling, red splotches around injection site and axilla, headache, dizziness-onset evening of injection.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: Clinic nurse prepared flu vaccine syringe for administration to patient, assembled syringe/needle and injected needle in patient muscle. When she pushed on plunger to administer vaccine, the fluid came out around the syringe/needle juncture instead of being administered to patient. Upon inspection, she noticed a crack in the syringe on the connector section that connects with the needle. Nurse reports that needle was tight and appropriately placed on connector area of syringe.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Contusion, Fall, Feeling abnormal, Head injury
Clinical narrative: Approximately 10 minutes after vaccination, child C/O feeling "not right". While attempting to assist him from standing to sitting, he became limp, slumping to the floor, seated, then fell back hitting his head (back of the head) on the floor; was unaware of surroundings for 15 seconds or less; sits up on his own despite efforts to keep him lying down. Mom and nurse at his sides; C/O pain to occipital area at site of impact. No swelling noted, BP 80/60, P 120; mild twitching and muscle rigidity in arms while unaware of his surroundings. 10:45 - BP 80/60 P 100 R even unlabored; 911 call; mom states she believes his had seizure activity at least twice in his lifetime, unrelated to vaccination and undiagnosed. Ice pack to contusion; no meals eaten today, only a popsicle. 10:48 - EMS crew here; no other C/O of pain other than back of head; states he feels "normal". 11:05 - child walks himself to gurney; episode appears to be syncopal due to vasovagal response to injection. Transported for evaluation of head injury and reported history of seizure activity in the past. 11:30 - Reported incident to doctor. 12:45 - Spoke to mom; child released home with ice pack to head post fainting spell.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Hypotonia, Muscle rigidity, Muscle twitching, Presyncope
Clinical narrative: Approximately 10 minutes after vaccination, child C/O feeling "not right". While attempting to assist him from standing to sitting, he became limp, slumping to the floor, seated, then fell back hitting his head (back of the head) on the floor; was unaware of surroundings for 15 seconds or less; sits up on his own despite efforts to keep him lying down. Mom and nurse at his sides; C/O pain to occipital area at site of impact. No swelling noted, BP 80/60, P 120; mild twitching and muscle rigidity in arms while unaware of his surroundings. 10:45 - BP 80/60 P 100 R even unlabored; 911 call; mom states she believes his had seizure activity at least twice in his lifetime, unrelated to vaccination and undiagnosed. Ice pack to contusion; no meals eaten today, only a popsicle. 10:48 - EMS crew here; no other C/O of pain other than back of head; states he feels "normal". 11:05 - child walks himself to gurney; episode appears to be syncopal due to vasovagal response to injection. Transported for evaluation of head injury and reported history of seizure activity in the past. 11:30 - Reported incident to doctor. 12:45 - Spoke to mom; child released home with ice pack to head post fainting spell.