chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored either ROTATEQ orally, lot # L008057, expiration date: 01-DEC-2016 (dose was not reported) or RECOMBIVAX HB lot # J014855, expiration date: 16-APR-2016 (dose, dose number, route of administration and anatomical location were not reported). There were no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified patient of unknown age and gender. On 24-NOV-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # L021609, expiration date: 10-SEP-2016, (dose, dose #, route and application site were not reported). No adverse effect reported. Additional information has been requested.;
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a two different patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. The reporter stated, that on unknown dates, 2 doses of improperly stored GARDASIL lot # K023432, expiration date: 18-JUN-2016 (dose, dose number, route of administration and anatomical location were not reported) were administered to two unspecified patients. There was no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.66
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Consistently running fever over 101 for 7 days (and still going) following vaccine. No known source.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red rash developed around injection site.  Itchy, hot to touch.  Pt was advised to take Benadryl and ibuprofen.  Pt was advised to contact PCP if rash did not go away or if rash got any worse.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Hives, rash left side of trunk.  Vaccine given in left arm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthropathy, Rash, Urticaria
Clinical narrative: Rash and hives on body trunk, joints began on Wednesday, continue through Thursday, visited doctor on Friday.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Dry mouth, Hyperhidrosis, Hypersensitivity
Clinical narrative: Patient received the high dose flu vaccine. Patient had received the regular flu vaccine in the past, but this was his first time receiving the high dose version. There were no known allergies and no other contraindications. Within 10 minutes of vaccine administration, patient began sweating profusely and experienced a dry mouth. Patient was given oral diphenhydramine 50mg and also had two small glasses of water. Within 5-10 minutes of taking the diphenhydramine dose, all symptoms of an allergic reaction had subsided, and BP & pulse were both normal. Patient left the pharmacy (feeling better) about half an hour after receiving vaccine. This vaccine was added as an allergy to the patient's profile at our pharmacy. Patient said he would inform his primary care doctor about the allergic reaction to Fluzone High-Dose.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Pain, swelling and redness starting at injection site, then spreading over entire forearm.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Pain, swelling and redness starting at injection site, then spreading over entire forearm.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pustular
Clinical narrative: SEVERE RASH THAT IS STILL GROWING AND FORMING WHITE PUSTULES.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Chickenpox like rash. Non injection site.
Age: 38.0
Sex: F
Vaccine: DTP
Symptoms: Asthenia, Contusion, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: After DPT INJECTION upper arm was very sore... two weeks after severe bruise and still very sore... for three months knot could be felt under skin and still sore but since first month I have weakness in shoulder and still have very strong weakness cannot lift things high my shoulder will give out even if its just my handbag. The shoulder also feels achy and tender to pressure often for no reason. Also I cannot raise my arm from my side past about 8 inches without pain as it goes higher the pain is much more significant.
Age: 38.0
Sex: F
Vaccine: DTP
Symptoms: Skin mass, Tenderness
Clinical narrative: After DPT INJECTION upper arm was very sore... two weeks after severe bruise and still very sore... for three months knot could be felt under skin and still sore but since first month I have weakness in shoulder and still have very strong weakness cannot lift things high my shoulder will give out even if its just my handbag. The shoulder also feels achy and tender to pressure often for no reason. Also I cannot raise my arm from my side past about 8 inches without pain as it goes higher the pain is much more significant.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: 5 hours after receiving Pneumovax vaccine Patient complained of Deltoid pain and severe pain in the elbow of the right arm that was her vaccinated arm. Patient went to the ER for treatment. She was treated with Dilaudid.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Chest pain, Dizziness
Clinical narrative: Patient complained of dizziness, lightheadedness, substernal chest pain that was transient in nature.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: L upper anterior arm (injection site) rash, was a little itchy and burning.  Pt reports no reaction immediately after the vaccines.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Feeling hot, Irritability, Mood altered, Pyrexia, Rash
Clinical narrative: Began with a fever, 101. Treated with Motrin, was very fussy and hot all night. Woke up on Thursday with a slight rash on her face, just small red dots. I figured it was a heat rash from the fever she'd had. The rash progressed through Thursday, into Friday where it worsened. Took her into our local hospitals pediatric unit, they said that it was a viral infection possibly from the vaccinations, possibly not. Its Saturday now and the symptoms seem to be getting worse, she is still very moody and has a bad facial rash, with small dots all over her body.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Rash erythematous, Rash generalised, Viral infection
Clinical narrative: Began with a fever, 101. Treated with Motrin, was very fussy and hot all night. Woke up on Thursday with a slight rash on her face, just small red dots. I figured it was a heat rash from the fever she'd had. The rash progressed through Thursday, into Friday where it worsened. Took her into our local hospitals pediatric unit, they said that it was a viral infection possibly from the vaccinations, possibly not. Its Saturday now and the symptoms seem to be getting worse, she is still very moody and has a bad facial rash, with small dots all over her body.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Fatigue, Gait disturbance, Impaired work ability, Motor dysfunction
Clinical narrative: ABOUT 1.5 HOURS AFTER THE SHOT PT STARTED TO EXPERIENCE IMPAIRED MOTOR SKILLS- SPECIFICALLY TROUBLE WALKING- " FELT LIKE FEET WERE DISCONNECTED FROM LEGS" AROUND 11PM PT HAD FEVER/ CHILLS AND EXTREME BODY ACHES " FELT LIKE RUN OVER BY A TRUCK", HAD TO CALL IN SICK TO WORK. RECOVERED IN ABOUT 24 HOURS.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain
Clinical narrative: ABOUT 1.5 HOURS AFTER THE SHOT PT STARTED TO EXPERIENCE IMPAIRED MOTOR SKILLS- SPECIFICALLY TROUBLE WALKING- " FELT LIKE FEET WERE DISCONNECTED FROM LEGS" AROUND 11PM PT HAD FEVER/ CHILLS AND EXTREME BODY ACHES " FELT LIKE RUN OVER BY A TRUCK", HAD TO CALL IN SICK TO WORK. RECOVERED IN ABOUT 24 HOURS.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Continued pain in my left upper arm/ shoulder - especially when lifting my arm higher then parallel to the floor. This pain only occurred after my shot; I've not previously had pain in my left shoulder. I had the Quadrivalent Flulaval Q2036 Lot#93T79 VIS Issued 08/07/2015.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has not reported any adverse events. (Duplicate flu shot and FLUZONE HD given within last 4 weeks of each other -> 1 shot at Dr. office and 1 shot at pharmacy).
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has not reported any adverse events. (Duplicate flu shot - FLUZONE HD - given within last 4 weeks of each other). One also given at Dr. office and one at pharmacy.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Nuclear magnetic resonance imaging, Periarthritis, Rotator cuff syndrome
Clinical narrative: *Injection very high on shoulder, into rotator cuff and bursa. *Rotator cuff tendonitis, capsulitis, fluid surrounding biceps tendon. *Corticosteroid injections by orthopedic. *Continued physical therapy.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 21 anonymous patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug allergies were noticed. On an unknown date in 2015 (also reported between 01-SEP-2015 and 30-OCT-2015) the patients were vaccinated with improperly stored GARDASIL 9 (strength, dose, frequency and route were not reported) lot # L014415 with an expiry date of 25-JUL-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 22-OCT-2015 the patient was vaccinated with ZOSTAVAX, (strength, dose, frequency were not reported) subcutaneously for prevention of herpes zoster. No concomitant medications were reported. On 21-NOV-2015 (about 30 days later), after vaccination the patient developed a red rash on her neck with a small blister inside the rash. The patient sought medical attention via visiting the physician. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. 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 nurse refers to 8 anonymous patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug allergies were reported. On an unknown date in 2015 (also reported between 01-SEP-2015 and 30-OCT-2015) the patients were vaccinated with improperly stored ROTATEQ (strength, dose, frequency and route were not reported) lot # L013202 with an expiry date of 27-JAN-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient, over the age of 65 years. The patient's concurrent conditions, medical history and concomitant medications were not reported. The pharmacist reported that on an unspecified date the patient (over the age of 65 years old), received a first dose of an PNEUMOVAX 23 (reported as unspecified PNEUMOVAX 23 could not be ruled out) (strength, lot#, dose and route not reported). The pharmacist reported that on an unspecified subsequent date, the patient was given a possible 2nd dose of PNEUMOVAX 23 (strength, lot#, dose and route not reported). No adverse effects reported. Product quality complaint (PQC) was not involved. No additional information available. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 24-NOV-2015, the patient was accidentally vaccinated with RECOMBIVAX HB (dose and route of administration not reported) and PEDIARIX. No concomitant therapy was reported. No adverse effects was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner via healthcare worker refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patients received improperly stored RECOMBIVAX HB injection 10 Y, lot # K026666 with expiration date: 22-OCT-2016; (strength, dose number, dose and route was not reported). Concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner via healthcare worker refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patient received improperly stored PNEUMOVAX 23 lot # L014458 with expiration date 11-FEB-2017; (strength, dose number, dose and route was not reported). Concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner via healthcare worker refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patients received improperly stored, oral, ROTATEQ suspension 2, lot # K020181 with expiration date: 24-JUN-2016; (strength, dose number, dose and route was not reported). Concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner via healthcare worker refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patients received improperly stored VARIVAX (Merck) lot # L019126 with expiration date: 27-MAY-2016; (strength, dose number, dose and route was not reported). Concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified doses of improperly stored MMR II (lot # K024825, expiry date 02-DEC-2016; lot # L012479, expiry date 10-APR-2017) (strength, dose and route were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified dose of improperly stored VAQTA (lot # was reported as L031196, expiry date 05-FEB-2017) (strength, dose and route were unspecified). No adverse effects had been reported. This is one of several 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 registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number-L011846, expiry date-16-JUN-2017, dosing regimen unknown) following multiple excursions, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during a Vaccines for Children audit and that no specified dates of administration was currently available. No doses were administered after their expiration dates. PNEUMOVAX 23 and MMR II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. On adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot number-K021487, expiry date-03-NOV-2016, dosing regimen unknown) following multiple excursions, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during a Vaccine for Children audit and that no specified dates of administration was currently available. No doses were administered after their expiration dates. PNEUMOVAX 23 and M-M-R II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medication were reported. On an unknown date the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot number-H022058, expiry date-10-Oct-2015, dosing regimen unknown) following multiple excursions, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during a Vaccines for Children audit and that no specified dates of administration was currently available. No doses were administered after their expiration date. PNEUMOVAX 23 and M-M-R II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medication were reported. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II (lot number-J002504, expiry date-25-FEB-2015, dosing regimen unknown) following multiple excursions, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during a Vaccines for Children audit and that no specified dates of administration was currently available. No doses were administered after their expiration dates. PNEUMOVAX 23 and M-M-R II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved.  The outcome of the events was unknown. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot number-K010215, expiry date-05-MAY-2017 and lot number-H020002, expiry date-08-AUG-2015, dosing regimen unknown) following multiple excursion, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during a Vaccines for Children audit and that no specified dates of administration was currently available. No doses were administered after their expiration dates. PNEUMOVAX23 and M-M-R II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. 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 registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (Batch number-K004431, expiry date-26-JAN-2016, dosing regimen unknown) following multiple excursions, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during an audit and that no specified dates of administration was currently available. No doses were administered after their expiration dates. PNEUMOVAX 23 and MMR II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Exercise tolerance decreased, Impaired work ability, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain after influenza vaccination provided at my employer. Initially very painful and limited ROM. This lasted at least a couple impacting my ability to work and exercise. Pain and limited ROM lasted for about 9 months.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness on site and itching.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Rash, Skin warm, Viral test
Clinical narrative: Fever to 101 and myalgias starting evening of vaccination (11/24) resolved after 2 days; 11/27 with hotness to upper arm, rash developed 11/28 below area of injection, ?cellulitis vs allergic reaction vs possible shingles.
Age: 1.17
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Patient started with low grade fever that culminated with pt having fever of 105.6 degrees on 11/16/15.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient has been diagnosed with Shingles per his physician.
Age: 59.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Burning sensation, Erythema, Inflammation
Clinical narrative: Burning senstation, redness, inflammation.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Left arm sore at injection site. 2 weeks later, any quick movement or stretching of my biceps results in acute pain that immobilizes me temporarily.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Nausea, Pain
Clinical narrative: Ongoing symptoms: severe nausea, dizziness, body aches, chills. Have tried Tylenol and Advil but symptoms are persisting.
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: Severe headache, moderate vertigo and dizziness; continued for 3 days, through 11/27/2015, as a result of receiving Shingles vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient reported large (2-3inch) red, raised, hardened spot at injection site.  Patient did not report until 11/24/15, at which time spot was <1 inch, red but not raised or hard.  Note:  patient takes Fexofenadine 180mg qd for allergy symptoms which could account for improved site appearance.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Original red, hard, warm 3" diameter around injection site spread to half of upper arm with high pain levels into elbow, armpit, and nerve pain into back; fever reached 100.5 first night, then Tylenol was taken twice during the night; fever (after Tylenol) climbed again following afternoon to 99.5; significant pain & "flu feeling" continues, as arm pain is increasing; five small, welt-like spots appeared within 3" diameter circle near injection site; went to walk-in clinic, nurse practioner mentioned one of three causes:  allergic reaction, cellulitis, or chicken pox reaction.  Antibiotic was given with instructions to take if temperature rises again tonight.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Neuralgia, Pain in extremity, Pyrexia
Clinical narrative: Original red, hard, warm 3" diameter around injection site spread to half of upper arm with high pain levels into elbow, armpit, and nerve pain into back; fever reached 100.5 first night, then Tylenol was taken twice during the night; fever (after Tylenol) climbed again following afternoon to 99.5; significant pain & "flu feeling" continues, as arm pain is increasing; five small, welt-like spots appeared within 3" diameter circle near injection site; went to walk-in clinic, nurse practioner mentioned one of three causes:  allergic reaction, cellulitis, or chicken pox reaction.  Antibiotic was given with instructions to take if temperature rises again tonight.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Original red, hard, warm 3" diameter around injection site spread to half of upper arm with high pain levels into elbow, armpit, and nerve pain into back; fever reached 100.5 first night, then Tylenol was taken twice during the night; fever (after Tylenol) climbed again following afternoon to 99.5; significant pain & "flu feeling" continues, as arm pain is increasing; five small, welt-like spots appeared within 3" diameter circle near injection site; went to walk-in clinic, nurse practioner mentioned one of three causes:  allergic reaction, cellulitis, or chicken pox reaction.  Antibiotic was given with instructions to take if temperature rises again tonight.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Head injury, Loss of consciousness, Pain
Clinical narrative: Pateint recieved the Flu vaccine and was able to leave the administration area under his own power.  He was walking back to the pharmacy bench when he lost consciousness and passed out resulting in him striking the floor with the back of his head.  When we came to he was in pain and disoriented.
Age: 15.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Hyperhidrosis, Nausea, Pallor, Syncope
Clinical narrative: Patient developed signs of syncope after Afluria and Adacel administered. Paleness, sweating, nausea, weakness and visual disturbances.
Age: 15.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Visual impairment
Clinical narrative: Patient developed signs of syncope after Afluria and Adacel administered. Paleness, sweating, nausea, weakness and visual disturbances.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reports pain in the injection site arm when arm is moved in forward and across movement at injection site.
Age: 64.0
Sex: F
Vaccine: DTP, FLUX
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Within an hour a bruise appeared at injection site and grew to 1 1/2" circle. Over the weeks pain grew at the site and swelling appeared beneath the site. Still have pain in upper arm.
Age: 1.0
Sex: F
Vaccine: FLUX, HEPATYP, MMR
Symptoms: Discomfort, Pruritus, Pyrexia, Rash morbilliform
Clinical narrative: Fever severe rash that appeared like the measles and caused severe itching and discomfort. Doctor did not give any treatment.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: C-reactive protein increased, Gait disturbance, Musculoskeletal stiffness, Myalgia, Red blood cell sedimentation rate increased
Clinical narrative: Severe Muscular pain/stiffness. Difficulty walking. Severe pain Cortisone Treatment. Lab/Physician involvement ongoing. ESR 92 C-Reactive protein 60.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMR
Symptoms: Asthenia, Diarrhoea, Pyrexia, Vomiting, Weight decreased
Clinical narrative: Vomiting, diarrhea, weakness, low fever. Lasted 4 days resulting in weight loss.
Age: 83.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Both arms got very sore when the pt went home and continued on up to this date; Pt's arm hurt when lifting any object. His right arms hurts the most.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Fatigue, Joint swelling, Musculoskeletal pain, Myalgia
Clinical narrative: Some hand, wrist swelling on opposing arm from vaccine, muscle aches, joint pain, excessive fatigue, shoulder pain.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling
Clinical narrative: Some hand, wrist swelling on opposing arm from vaccine, muscle aches, joint pain, excessive fatigue, shoulder pain.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt stated he has an itchy shoulder a couple times a week since his flu shot.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Within 24 hours upon receiving AFLURIA 2015-2016 seasonal flu vaccine, patient's left arm developed erythema at injection site and patient self-treated w/ BENADRYL tablets. Erythema of arm resolved on its own by 11-25-15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker (also reported as medical assistant) refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 12-OCT-2015, the patients were vaccinated with improperly stored ROTATEQ (lot # L004466, expiration date 02-AUG-2016, oral, dose not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple, unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot# K004863 with expiration date of 04-OCT-2016, lot# L007228 with expiration date of 03-SEP-2016, dose, strength and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple, unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot# L001325 with expiration date of 13-JAN-2017, lot# K011797 with expiration date of 21-AUG-2016, dose, strength and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report has been received from a pharmacist via company representative referring to a female patient of unknown age. On approximately 24-Oct-2015 (reported as about a month ago) the patient was vaccinated with ZOSTAVAX (route and lot# not reported), 1 vial at unspecified time. The pharmacist learned in an unspecified way (either phone call or a visit back to the pharmacy by the patient,) that the patient started experiencing pain at an unspecified time, on the day the ZOSTAVAX was administered. The patient reported that she was having pain in the unspecified arm that she received the vaccine. The patient was still in pain at the time of reporting (24-NOV-2015). The causality was not reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain
Clinical narrative: Information has been received from an 83 year old female patient with chronic obstructive pulmonary disease (COPD) and asthma referring to herself. On 20-AUG-2015, the patient was vaccinated with PNEUMOVAX23, (lot number and dose not provided) intramuscularly. In 2015, the patient experienced muscle ache and pain after receiving PNEUMOVAX23. She visited office and performed unspecified labs (result unknown). The patient was treated with unspecified steroid. The outcome of myalgia was reported as not recovered. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site pain
Clinical narrative: Information has been received from a nurse (also a husband) referring to a 74 year old female patient. The patient did not have pertinent medical history or drug reactions. On an unspecified date ("more than 10 years ago" at age younger than 65 years), the patient was vaccinated with the initial dose of PNEUMOVAX 23 (strength, lot#, expiration date, dose and route were unknown). On 05-NOV-2015 the patient was vaccinated with the second dose of PNEUMOVAX 23 (strength, lot#, expiration date, dose and route were unknown, in upper left arm) (following ACIP recommendations for patients who receive an initial dose of PNEUMOVAX 23 younger than age 65 years to receive a second dose of PNEUMOVAX 23 once they are 65 years of age or older). On 06-NOV-2015, the patient awoke with pain her left upper left arm in a "5-inch diameter" around the injection site. The patient reported to employee that the area felt "inflamed and very sensitive to touch." The patient sought medical attention by consulting the nurse. No treatment was given for the adverse events. None lab diagnostics studies were performed. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L014429, expiration date 15-MAR-2018 and/or lot# K019700, expiration date 16-JUL-2017, dose and route not provided). No adverse effects were reported. 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: Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L023936, expiration date 15-MAR-2017, dose and route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker (also reported as medical assistant) refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 12-OCT-2015, the patients were vaccinated with improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. Since 15-MAR-2015 doses of (Oka/Merck) VARIVAX (lot # K015971 with expiration date 23-SEP-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range, had been administered to the patients. The reporter was not aware of any adverse experiences. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. Since 15-MAR-2015 doses of M-M-R II (lot #, strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range, had been administered to the patients (incorrect product storage). The reporter was not aware of any adverse experiences. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. Since 15-MAR-2015 doses of PROQUAD (Merck)(lot # K022447 with expiration date of 13-MAY-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range, had been administered to the patients. The reporter was not aware of any adverse experiences. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Angina pectoris, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: Myalgia, nausea vomiting, angina and injection site pain and swelling.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Myalgia, nausea vomiting, angina and injection site pain and swelling.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Dizziness, Dyspnoea
Clinical narrative: Developed Guillain-Barre syndrome 2 days after administration.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity, Hypoaesthesia, Muscular weakness, Oropharyngeal pain, Paraesthesia
Clinical narrative: Developed Guillain-Barre syndrome 2 days after administration.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paralysis, Respiratory tract congestion, Throat irritation, Wheezing
Clinical narrative: Developed Guillain-Barre syndrome 2 days after administration.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Developed Guillain-Barre syndrome 2 days after administration.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Headache, Injection site erythema, Injection site pain, Mobility decreased
Clinical narrative: Continuous aching pain in posterior neck and down back, affecting gait, sleep and normal activities and exercise and necessitating 2 trips to the ER.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Musculoskeletal pain, Neck pain, Peripheral swelling
Clinical narrative: Continuous aching pain in posterior neck and down back, affecting gait, sleep and normal activities and exercise and necessitating 2 trips to the ER.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Activities of daily living impaired, Back pain, Full blood count normal, Gait disturbance, Neck pain
Clinical narrative: Continuous aching pain in posterior neck and down back, affecting gait, sleep and normal activities and exercise and necessitating 2 trips to the ER.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Red blood cell sedimentation rate normal, Sleep disorder
Clinical narrative: Continuous aching pain in posterior neck and down back, affecting gait, sleep and normal activities and exercise and necessitating 2 trips to the ER.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 68 year old female patient. The patient's concurrent conditions included heart disease, Type II diabetes and high cholesterol. The patient had no known drug reactions/allergies. On 20-NOV-2015, the patient was vaccinated with PNEUMOVAX 23, intramuscular in the right deltoid area of the upper arm, lot # K007824 with expiration date 05-NOV-2015, (dose was not provided), for prevention of pneumonia. Concomitant medication was not reported. The reporter stated that she used a 22 gauge needle to administer the PNEUMOVAX 23, the patient experienced some bleeding and swelling at the site immediately after injection. The patient did not seek medical attention. No treatment was given. At the time of reporting, the outcome of the injection site haemorrhage and injection site swelling was unknown. The reporter did not assess the relatedness from injection site haemorrhage and injection site swelling to PNEUMOVAX 23. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 68 year old female patient. The patient's concurrent conditions included heart disease, Type II diabetes and high cholesterol. The patient had no known drug reactions/allergies. On 20-NOV-2015, the patient was vaccinated with PNEUMOVAX 23, intramuscular in the right deltoid area of the upper arm, lot # K007824 with expiration date 05-NOV-2015, (dose was not provided), for prevention of pneumonia. Concomitant medication was not reported. The reporter stated that she used a 22 gauge needle to administer the PNEUMOVAX 23, the patient experienced some bleeding and swelling at the site immediately after injection. The patient did not seek medical attention. No treatment was given. At the time of reporting, the outcome of the injection site haemorrhage and injection site swelling was unknown. The reporter did not assess the relatedness from injection site haemorrhage and injection site swelling to PNEUMOVAX 23. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC, FLU3
Symptoms: Cough
Clinical narrative: Bronchial type cough began about 9:45 PM and lasted approximately 5 days. Began to improve after 2nd day. Treated with Mucinex 400mg and phenylephrine 10mg per 4 hours.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP, PNC13, TDAP
Symptoms: Body temperature increased, Chills, Pain, Vaccination site pain
Clinical narrative: Per Pt's Email message "spiked a fever of 101 in the evening by around 7pm, accompanied by severe chills and joint/body aches. By the time I went to bed at 10pm, after taking Tylenol, my temperature had dropped to 99, and was 98.8 when I woke up this morning. I went back to work today but had to leave a little early as I started feeling a little chills and body aches starting up again. I checked my temperature when I got home and it was 99.8"
Age: 41.0
Sex: M
Vaccine: PPV, TDAP, PNC13, TDAP
Symptoms: Arthralgia, Chills, Impaired work ability, Pain, Pyrexia
Clinical narrative: Per Pt's Email message "spiked a fever of 101 in the evening by around 7pm, accompanied by severe chills and joint/body aches. By the time I went to bed at 10pm, after taking Tylenol, my temperature had dropped to 99, and was 98.8 when I woke up this morning. I went back to work today but had to leave a little early as I started feeling a little chills and body aches starting up again. I checked my temperature when I got home and it was 99.8"