chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Urinary incontinence
Clinical narrative: Acute onset transverse myelitis with lower extremity paralysis and loss of bowel/bladder control 4 days after high dose flu vaccine FLUZONE High Dose.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: (L) arm cellulitis. Clindamycin 11/05/15 x 1 day changed to cephalexin 11/06/15.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date in November 2014 (one year ago), the patient was vaccinated with the first dose of ZOSTAVAX (lot number, expiration date, strength, dose and route were unknown). On 27-OCT-2015 the patient was vaccinated with the second dose of ZOSTAVAX (lot # L000450, expiration date 09-MAR-2016, strength, dose and route were unknown). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored M-M-R II (lot # K026366, expiration date 15-DEC-2016; lot # K007982, expiration date 03-JUN-2016; lot # K008198, expiration date K008198; lot # K007106, expiration date 16-MAY-2016, route not provided). No adverse events were reported. Product quality complaint was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unspecified amount of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # K016263, expiry date: 26-JUN-2016, orally, dose unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional (also reported as a medical assistant) refer to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 21-AUG-2015, the patients had been vaccinated with VARIVAX (Merck) (lot # L004654, expiration date 11-FEB-2017, dose and route not reported), which were improperly stored. Information regarding concomitant medications was not reported. No adverse effects reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Feeling abnormal, Nausea, Pain
Clinical narrative: Patient received FLUVIRIN, PNEUMOVAX, and BOOSTRIX all on 11/4. She had never received a flu shot prior to this and was diagnosed with pertussis 18 months ago. Hours after the vaccination administration, she began to have chills, body aches, nausea, and overall poor feeling. She took Ibu and APAP q6h to help with symptoms and diphenhydramine at night. By 11/7 she was feeling better but was still feeling mild symptoms.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified amount of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered improperly stored doses of PROQUAD (Merck) injection (lot# L024124 with expiration date 30-DEC-2016; dose, frequency and route were not provided); that was stored at 39F for an unspecified amount of time. No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. In January 2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided). Subsequently, on 05-NOV-2015 the patient was vaccinated again with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided) leading to an inappropriate schedule of drug administration. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 5 year old female patient. Information about concurrent conditions, medical history and concomitant medication was not provided. On 19-OCT-2015 the patient was vaccinated with M-M-R II (lot # J013315, expiration date 18-OCT-2015, albumin status rHA, 0.5 ml, subcutaneous in the left arm) (expired product administered). No adverse effects were reported. Additional information is not expected since there was no consent to contact physician.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain
Clinical narrative: Arm pain up to at least 4 weeks sometimes radiated down to forearm.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Pain in extremity, Ultrasound Doppler normal
Clinical narrative: Arm pain up to at least 4 weeks sometimes radiated down to forearm.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Exposure during pregnancy, Injection site pain, Injection site pruritus, Mobility decreased
Clinical narrative: Hives beginning on buttocks and spreading to elbows during 11/07/2015.  Intense burning and itching at site.  Hives spread to forearms backs of thighs, knees, and calves on 11/08/2015.  On 11/09/2015 hives spread to wrists, neck, below left eye, behind ears, ankles, top of right foot, knuckles of both hands causing redness, swelling, and difficulty bending digits.  On 11/09/2015 saw my OB who recommended 50 mg of Benadryl at bedtime.  Benadryl has lessened the burning/itching sensation for several yore after being taken, but the swollen welts remain, and itching is never completely relieved and returns at full force a few hours after Benadryl is administered.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Hives beginning on buttocks and spreading to elbows during 11/07/2015.  Intense burning and itching at site.  Hives spread to forearms backs of thighs, knees, and calves on 11/08/2015.  On 11/09/2015 hives spread to wrists, neck, below left eye, behind ears, ankles, top of right foot, knuckles of both hands causing redness, swelling, and difficulty bending digits.  On 11/09/2015 saw my OB who recommended 50 mg of Benadryl at bedtime.  Benadryl has lessened the burning/itching sensation for several yore after being taken, but the swollen welts remain, and itching is never completely relieved and returns at full force a few hours after Benadryl is administered.
Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Headache, Induration, Peripheral swelling, Rash, Skin warm
Clinical narrative: 10/06/15 2:00 AM Arm is swollen, hard and hot. 10/06/15 11:00 PM severe headache. 10/07/15 6:00 AM Rash on face. Headache pain is less and rash is starting to subside 11/05/15.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood thyroid stimulating hormone normal, Borrelia test negative, Burning sensation, C-reactive protein normal, Epstein-Barr virus test negative
Clinical narrative: Redness, pain, $ burning on bilateral palms of hands and soles of feet, fingers and toes; 10/25/15 @ 06:00 AM - palms hands and fingers skin started peeling; 11/1/2015 @ 06:00 AM - soles of feet and toes skin started peeling.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Full blood count normal, Liver function test normal, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: Redness, pain, $ burning on bilateral palms of hands and soles of feet, fingers and toes; 10/25/15 @ 06:00 AM - palms hands and fingers skin started peeling; 11/1/2015 @ 06:00 AM - soles of feet and toes skin started peeling.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oestradiol normal, Pain in extremity, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Skin exfoliation
Clinical narrative: Redness, pain, $ burning on bilateral palms of hands and soles of feet, fingers and toes; 10/25/15 @ 06:00 AM - palms hands and fingers skin started peeling; 11/1/2015 @ 06:00 AM - soles of feet and toes skin started peeling.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vitamin B12 normal, Vitamin D
Clinical narrative: Redness, pain, $ burning on bilateral palms of hands and soles of feet, fingers and toes; 10/25/15 @ 06:00 AM - palms hands and fingers skin started peeling; 11/1/2015 @ 06:00 AM - soles of feet and toes skin started peeling.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Borrelia test negative, Burning sensation, Erythema, Full blood count normal, Impaired work ability
Clinical narrative: Redness, pain, $ burning on bilateral palms of hands and soles of feet, fingers and toes; 10/25/15 @ 06:00 AM - palms hands and fingers skin started peeling; 11/1/2015 @ 06:00 AM - soles of feet and toes skin started peeling.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mononucleosis heterophile test negative, Pain in extremity, Reaction to preservatives, Red blood cell sedimentation rate normal, Skin exfoliation
Clinical narrative: Redness, pain, $ burning on bilateral palms of hands and soles of feet, fingers and toes; 10/25/15 @ 06:00 AM - palms hands and fingers skin started peeling; 11/1/2015 @ 06:00 AM - soles of feet and toes skin started peeling.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Hyporesponsive to stimuli, Loss of consciousness, Syncope
Clinical narrative: Patient fainted couple of minutes after giving the flu shot. Pharmacist assessed breathing and called 911. Patient was unconscious for couple of seconds then responded but not fully. Pharmacist gave him liquid glucose to raise his sugar level b/c of history of diabetes.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Fine motor skill dysfunction, Hypoaesthesia
Clinical narrative: Pt got flu vaccine Rt deltoid 10/19 numbness developed in rt arm x 9 days, got better but returned on 11/5. Forearm to fingers feels asleep. Fine motor control of thumb, index and middle fingers seems decreased. No pain at time of injection. No pain in arm.hand. Problems with counting holding utensils; No weakness.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Had injection sight reaction with erythema mild increased warmth and tenderness.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm, Vaccination complication
Clinical narrative: Had injection sight reaction with erythema mild increased warmth and tenderness.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: (+) flu vac reaction to right arm area red, raised, warm to touch. 11/4/15 1330 pm.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm, Vaccination complication
Clinical narrative: (+) flu vac reaction to right arm area red, raised, warm to touch. 11/4/15 1330 pm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Muscle soreness at injection site. Patient is going for physical therapy treatment and still complain of muscle pain.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Tendonitis
Clinical narrative: Patient felt sharp pain upon administration of shot, then had excessive soreness and bruising. Since pain wasn't improving she made appt. with MD who said shot must've been given in her tendon and now has tendonitis. He predicted she'd feel better in approximately seven days.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Vaccine adminsitered on 10/13/15. (Flu shot). Complained that arm hurt where received vaccination. Arm got worse over time. Got to a point where couldn't move arm. Went to Dr. on 11/2/15. Dr. says needs physical therapy three times a week.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Disorientation, Dizziness
Clinical narrative: 3 hours after patient was given vaccine (after which she engaged in strenuous exercise via a dance class), she began to feel disoriented and faint. Her friends brought her to the ER where her temp was measured at 103 degrees F and her HR at 120 bpm.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. No information on patient's concurrent conditions, medical history or concomitant medications was provided. On 29-OCT-2015, the patient was vaccinated with the dose of ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported). On 30-OCT-2015, the patient experienced severe swelling at the injection site after ZOSTAVAX therapy. No lab diagnostic studies were performed. The patient sought unspecified medical attention. The outcome of severe swelling at the injection site and the causality between the adverse event and ZOSTAVAX were not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L020000 with expiration date 02-JUN-2017, 0.5 ml, frequency was not reported) subcutaneously. On an unknown date the patient missed a dose of VARIVAX (Merck). No adverse effect was reported. Product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Pharyngeal oedema
Clinical narrative: This medically confirmed spontaneous report (initial receipt 26-Oct-2015) concerns an unknown demographics patient. On an unspecified date, the patient received an unspecified flu vaccine (influenza vaccine, manufacturer and batch number not provided) for an unknown indication. On an unspecified date, the patient experienced throat swelling. No additional information provided. The outcome was not provided. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Brand of vaccine not provided. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, throat swelling is unlisted. Causality: Unassessable. Time to onset not provided. Anaphylactic reaction is a possibility, however insufficient information regarding other associated event, investigation and or treatment, hence causality is unassessable.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 14-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L011084, expiration date 01-APR-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.
Age: 1.56
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015, a call was received from the certified medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 18-month-old patient of unknown gender. On 07-AUG-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot number was confirmed as L001325 with an expiry date of 04-FEB-2017. This is one of several reports received from the same source. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
Age: 16.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Induration, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Right arm from elbow to shoulder became extremely swollen, hard, red, and tender to touch.  Patient was uable to move the arm without pain. As of 11/10/15, the arm is still swollen and painful but decreasing.
Age: 16.0
Sex: M
Vaccine: FLUX
Symptoms: Tenderness, X-ray limb
Clinical narrative: Right arm from elbow to shoulder became extremely swollen, hard, red, and tender to touch.  Patient was uable to move the arm without pain. As of 11/10/15, the arm is still swollen and painful but decreasing.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Back pain, Confusional state, Disturbance in attention
Clinical narrative: Chronic Fatigue/Narcolepsy 6+ Years. Muscle weakness 6+ years. Memory loss/confusion 6+ years. Chronic joint and back pain 6+ years. Vision problems 5+ years. Trouble concentrating 6+ years.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Fatigue, Muscular weakness, Narcolepsy, Sleep study, Visual impairment
Clinical narrative: Chronic Fatigue/Narcolepsy 6+ Years. Muscle weakness 6+ years. Memory loss/confusion 6+ years. Chronic joint and back pain 6+ years. Vision problems 5+ years. Trouble concentrating 6+ years.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Burning sensation, Injection site pain, Injection site vesicles, Neuralgia
Clinical narrative: Pain and blisters all up and down my left arm, the arm that received the vaccine. Painful nerve burning feeling all up and down my left arm. Surges of pain all up and down my left arm.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain and blisters all up and down my left arm, the arm that received the vaccine. Painful nerve burning feeling all up and down my left arm. Surges of pain all up and down my left arm.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diet refusal, Dyspnoea, Feeling cold, Heart rate increased
Clinical narrative: Patient came home and slept for 3 hours at 1pm after receiving the vaccion. Around 11:30PM that night he spiked a 104.7 fever, difficulty Breathing, elevated heartbeat and shaking from being so cold. Refused to eat. Took him to the hospital and they checked his ears and said he may have the start of an ear infection so gave him antibiotics. Fever has not dropped since 11/07/2015. If symptoms do not go away today, he will be going to a hospital. He won't eat, just drinking plenty of fluids. Hes throwing up from the meds and is complaining that his hair, arms, legs and belly hurts.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Patient came home and slept for 3 hours at 1pm after receiving the vaccion. Around 11:30PM that night he spiked a 104.7 fever, difficulty Breathing, elevated heartbeat and shaking from being so cold. Refused to eat. Took him to the hospital and they checked his ears and said he may have the start of an ear infection so gave him antibiotics. Fever has not dropped since 11/07/2015. If symptoms do not go away today, he will be going to a hospital. He won't eat, just drinking plenty of fluids. Hes throwing up from the meds and is complaining that his hair, arms, legs and belly hurts.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test positive, Alopecia, Amenorrhoea, Autoimmune disorder, Ear pain
Clinical narrative: Development of autoimmune effects including permanent scalp hair loss, thyroid irregularities, loss of menstrual period/development of menstruation irregularities, food allergies (none previously existing), ear pain, chronic fatigue.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Food allergy, Hormone level abnormal, Menstruation irregular, Thyroid disorder
Clinical narrative: Development of autoimmune effects including permanent scalp hair loss, thyroid irregularities, loss of menstrual period/development of menstruation irregularities, food allergies (none previously existing), ear pain, chronic fatigue.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test abnormal
Clinical narrative: Development of autoimmune effects including permanent scalp hair loss, thyroid irregularities, loss of menstrual period/development of menstruation irregularities, food allergies (none previously existing), ear pain, chronic fatigue.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: Rash appeared 1 day post administration along with patient reported total body joint soreness and fever. Patient reports self treatment with oral diphenhydramine, oral ibuprofen and APAP, topical cortisone and topical diphenhydramine.
Age: 19.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Back pain, Blood creatine phosphokinase increased, CSF protein increased, Full blood count normal, Guillain-Barre syndrome
Clinical narrative: Patient received FLUARIX (Lot # 25N22) on 4 Nov 2015. Began to experience lower extremity weakness/tingling and low back pain on 07 Nov 2015. Reported to ED and admitted to hospital for treatment of Guillain-Barre Syndrome. Pt. is still under treatment.
Age: 19.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Metabolic function test normal, Muscular weakness, Paraesthesia
Clinical narrative: Patient received FLUARIX (Lot # 25N22) on 4 Nov 2015. Began to experience lower extremity weakness/tingling and low back pain on 07 Nov 2015. Reported to ED and admitted to hospital for treatment of Guillain-Barre Syndrome. Pt. is still under treatment.
Age: 19.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Back pain, Computerised tomogram, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Patient received FLUARIX (Lot # 25N22) on 4 Nov 2015. Began to experience lower extremity weakness/tingling and low back pain on 07 Nov 2015. Reported to ED and admitted to hospital for treatment of Guillain-Barre Syndrome. Pt. is still under treatment.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left upper arm. Patient prescribed KEFLEX 750 mg cap for 10 days. Return to clinic if symptoms worsen.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Onset of fever (to 102 degrees), headache, sore throat, nausea, diarrhea < 12 hr after receiving TIV/Flu vaccine - EHOL?; Coincidental.
Sex: F
Vaccine: PPV
Symptoms: Immunodeficiency
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency were unknown). On an unknown date in 2011, the patient experienced a horrible reaction. The nurse stated that the patient had a condition that causes her to be immunocompromised. The outcome of the adverse events was unknown. The relatedness of the events with PNEMOVAX 23 was not provided. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Local swelling, Pain in extremity, Ultrasound scan
Clinical narrative: Vaccine - Influenza, received on 11/05/15; pt developed pain in RUE. The next day she developed swelling in the underarm area of the RUE, associated with soreness.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L008057, expiration date: 01-DEC-2016, oral, dose was unknown). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a patient's aunt and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patient pregnant at 34 weeks of gestation was inadvertently administered with a dose of unidentified Merck HPV vaccine (name, lot #, expiration date, exact dose and route of administration were not provided). It was unknown if the patient received GARDASIL or GARDASIL 9. No adverse events were reported. No PQC (product quality complaint) was involved. Based on the number of weeks of pregnancy at the time of report, the patient became pregnant with last menstrual period (LMP) date of 10-MAR-2015 and estimated delivery date (EDD) of 15-DEC-2015. It was unknown at which week the initial exposure to unidentified Merck HPV vaccine was. The pregnancy outcome was pending. Fetal outcome was unknown. The outcome of vaccine exposure during pregnancy was unknown. Additional information is not expected because of lack of the reporter's contact details.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. On an unknown date, the patient was vaccinated with 2 doses of PNEUMOVAX 23 (dose, frequency and route were not reported) within a year. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2015 (also reported as unspecified dates ranging from 01-SEP-2015 through 29-OCT-2015), the patients were vaccinated with improperly stored VARIVAX (Merck) injection, lot # K005428, expiry date 15-APR-2016, (dose and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Palpitations
Clinical narrative: Buring of eyes. Heart palpitations.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Thigh pain bilaterally for several days.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Muscular weakness, Musculoskeletal pain, Pain, Periarthritis
Clinical narrative: A few hours after receiving the shot my arm and shoulder started to freeze up. I was unable to more any part of my arm without excruciating pain. as time went on the pain go back to where without help I could not move my arm and hand. The next day I called Dr. and was advised to take different medications I already had. I had already tried the medication so I was referred to go to the ER. At the ER they only prescribed pain medication and let me know nothing was found on the X Ray. I was sent home even though the pain still was there. It took several days for the pain to subside a little so that I could move it some. Three weeks latter I still have weakness in the arm and pain in my shoulder.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: X-ray normal
Clinical narrative: A few hours after receiving the shot my arm and shoulder started to freeze up. I was unable to more any part of my arm without excruciating pain. as time went on the pain go back to where without help I could not move my arm and hand. The next day I called Dr. and was advised to take different medications I already had. I had already tried the medication so I was referred to go to the ER. At the ER they only prescribed pain medication and let me know nothing was found on the X Ray. I was sent home even though the pain still was there. It took several days for the pain to subside a little so that I could move it some. Three weeks latter I still have weakness in the arm and pain in my shoulder.
Age: 84.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Ecchymosis, Induration, Peripheral swelling, Tenderness
Clinical narrative: Patient given Flu IZ preservative free and Zoster IZ, both in left upper arm. Arm became very swollen with ecchymosis extending to upper part of forearm. Not hot to touch, but firm and tender. Pt taking NSAIDs and NORCO.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, swelling and pain at injection site occurring at approximately third day after administration. Patient was advised to use Benadryl and cold compresses.
Age: 20.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: Redness and swelling 6cm X 8 cm at injection site, erythema, warm to touch, low grade fever, itchy. Pt provided Tylenol, loratadine.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Conjunctival hyperaemia, Conjunctivitis, Eye irritation, Eye pruritus, Headache
Clinical narrative: Patient reports that she started having watery, itchy and burning eyes about 5 hours after the administration of the flu vaccine. She also reports experiencing pain with swallowing, headache and some nasal congestion. Her eyes were also pink. She says that the pain with swallowing and nasal congestion subsided about 20 hours after getting the vaccine and the pink eye is also clearing up. She reports to clinic about 24 hours after injury. Now, conjunctiva is still erythematous. No other positive finding on physical examination. Treatment: Supportive.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Lacrimation increased, Nasal congestion, Odynophagia
Clinical narrative: Patient reports that she started having watery, itchy and burning eyes about 5 hours after the administration of the flu vaccine. She also reports experiencing pain with swallowing, headache and some nasal congestion. Her eyes were also pink. She says that the pain with swallowing and nasal congestion subsided about 20 hours after getting the vaccine and the pink eye is also clearing up. She reports to clinic about 24 hours after injury. Now, conjunctiva is still erythematous. No other positive finding on physical examination. Treatment: Supportive.
Age: 35.0
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site swelling, Mobility decreased
Clinical narrative: Night of vaccine: nausea, silver dollar size welt on arm, swollen/painful/itchy site of injection, trouble raising arm, red dot in middle of welt.
Age: 35.0
Sex: F
Vaccine: FLUR3
Symptoms: Nausea, Urticaria
Clinical narrative: Night of vaccine: nausea, silver dollar size welt on arm, swollen/painful/itchy site of injection, trouble raising arm, red dot in middle of welt.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Urticaria
Clinical narrative: Hives, numbness & pain from toes to hips.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Erythema, Vaccination complication
Clinical narrative: Patient presented to clinic on 10/26/15 for an appointment with pcp complaining of redness on right upper extremity. Patient had an adverse reaction to pneumococcal immunization PCV13 administered on 10/19/15. Patient was evaluated by pcp on 10/26/15 and treated for cellulitis with Zpack, recommended cold pack on area, area of redness  marked; patient verbalized understanding of warning sxs.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Injection site erythema, Injection site reaction, Pruritus
Clinical narrative: Pruritis, severe red "blotchy" raised spots (hives?) covering right arm from injection site down to elbow, rhinitis, followed by COPD exacerbation on 10/9/15.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular, Rhinitis
Clinical narrative: Pruritis, severe red "blotchy" raised spots (hives?) covering right arm from injection site down to elbow, rhinitis, followed by COPD exacerbation on 10/9/15.
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from a healthcare professional on 28 October 2015. This case involves a female (age not reported) patient who was vaccinated with a dose of FLUZONE (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced unspecified two adverse events. One required minimal intervention and the other required hospitalization. Laboratory test and corrective treatments were not reported. The outcome of event was not reported. Upon internal review, company assessed the event of had 2 adverse events as serious and medically significant. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Tendon disorder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tendon disorder ni a 23-year-old female patient who received FLUARIX quadrivalent (batch number DX4SN, expiry date 30th May 2016). Concomitant products included birth control. On 7th October 2015, the patient received the 1st dose of FLUARIX quadrivalent (intramuscular) .5 ml. On 7th October 2015, several hours after receiving FLUARIX quadrivalent, the patient experienced tendon disorder, injection site pain and injected limb mobility decreased. The patient was treated with ibuprofen, ice pack (NOS) and NAPROSYN. On an unknown date, the outcome of the tendon disorder, injection site pain and injected limb mobility decreased were recovering/resolving. The reporter considered the tendon disorder, injection site pain and injected limb mobility decreased to be related to FLUARIX quadrivalent. Additional details were as follows: On 7th October 2015, at 16:01 pm, the patient received the 1st dose of FLUARIX quadrivalent in her left deltoid. On 7th October 2015, same evening, several hours after vaccination, the patient began experiencing severe pain at the injection site with limited range of motion. The healthcare professional reported that there was no redness or warmth at the injection site. On 19th October 2015, the patient came to the office to visit the doctor and she had continued to have limited movement to her left arm so was treated with the ibuprofen and an ice pack. On 2nd November 2015, the patient again returned to the office and the doctor felt that the issues were due to a reaction from the flu vaccine. She was diagnosed as having an irritated tendon in her left deltoid (injection site) and was prescribed NAPROSYN 500 mg one tab twice daily with food for 5 days. The patient did not receive any vaccines within 4 weeks after receiving the FLUARIX quadrivalent vaccine. An outbound call was made to verify the information. The reporter did not wish to provide the name of the administrator or the physician responsible.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Nausea, Vaccination site induration
Clinical narrative: DEVELOPMENT AND WORSENING OF RED RASH AND A HARD LUMP AT VACCINATION SITE. PAINFUL AND RASH SPREAD. FOLLOWING DAY FELT NAUSEOUS. BEGAN TREATMENT WITH CEPHALEXIN 500MG TID. RASH STILL SPREAD, REPEAT TRIP TO WALK IN CLINIC, RECEIVED CEFTRIAXONE INJECTION AND INCREASED CEPHALEXIN TO 500MG QID. RASH IMPROVED, PAIN IMPROVED.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: DEVELOPMENT AND WORSENING OF RED RASH AND A HARD LUMP AT VACCINATION SITE. PAINFUL AND RASH SPREAD. FOLLOWING DAY FELT NAUSEOUS. BEGAN TREATMENT WITH CEPHALEXIN 500MG TID. RASH STILL SPREAD, REPEAT TRIP TO WALK IN CLINIC, RECEIVED CEFTRIAXONE INJECTION AND INCREASED CEPHALEXIN TO 500MG QID. RASH IMPROVED, PAIN IMPROVED.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV4, VARCEL
Symptoms: Asthenia, Blood glucose decreased, Unresponsive to stimuli, Weight bearing difficulty
Clinical narrative: Patient became unresponsive for prolonged time over 3 plus minutes. Patient came back around but she was unable to feel strong enough to stand.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Culture, Herpes zoster, Rash, Rash pruritic, Sleep disorder
Clinical narrative: Rash in circular type pattern on torso, front left below breast and a few other spots going to left of front torso. Rash was itchy and woke me up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Smear test
Clinical narrative: Rash in circular type pattern on torso, front left below breast and a few other spots going to left of front torso. Rash was itchy and woke me up.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Arm around injection site became red and itchy.
Age: 16.0
Sex: M
Vaccine: FLUX
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncopal episode with brief loss of consciousness. No treatment. Self Resolved.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Dysphemia
Clinical narrative: Developed sudden and progressive stutter.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness/swelling. Warm to touch.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Scab, Scratch
Clinical narrative: Itching all over causing to have scabs because of it. Scratched head so much that I took most skin off.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Headache, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: 11/1/15 One hour after vaccination, pt. complained of a severe headache. 11/2/15 pt complained of having a fever 100.7 F; pt took TYLENOL after speaking with the pharmacist, 11/3/15 pt felt a little better. No headache or fever. 11/4/15 pt noticed that the injection site on the left arm was swollen and warm. Red area was 2 1/2 inch in diameter when she showed it the pharmacist. Pharmacist told her to see the doctor. She went to urgent care-which referred pt to hospital emergency room. Er said that pt has cellulitis and gave the patient cephalexin 500 TID x 7 days. 11/9/15 pharmacist called pt to check up w/pt. Pt is feeling better and arm is darker at the site of injection not red. Pt has an appt w/MD on Thurs. 11/1/15 per pt.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: 11/1/15 One hour after vaccination, pt. complained of a severe headache. 11/2/15 pt complained of having a fever 100.7 F; pt took TYLENOL after speaking with the pharmacist, 11/3/15 pt felt a little better. No headache or fever. 11/4/15 pt noticed that the injection site on the left arm was swollen and warm. Red area was 2 1/2 inch in diameter when she showed it the pharmacist. Pharmacist told her to see the doctor. She went to urgent care-which referred pt to hospital emergency room. Er said that pt has cellulitis and gave the patient cephalexin 500 TID x 7 days. 11/9/15 pharmacist called pt to check up w/pt. Pt is feeling better and arm is darker at the site of injection not red. Pt has an appt w/MD on Thurs. 11/1/15 per pt.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 11/19/15 Rash on entire arm, sprad to chest area, 11/10/15 prednisone prescribed by MD.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: See enclosed note.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Full blood count normal, Metabolic function test normal, Muscle tightness, Palpitations
Clinical narrative: Pt developed anxiety and panic attacks 30 minutes after receiving the flu shot. No previous flu shot, no previous panic attacks. Symptoms include muscle tightness, palpitations and anxiety. Resolve spontaneously in 1-2 hrs.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Panic attack, Thyroid function test normal
Clinical narrative: Pt developed anxiety and panic attacks 30 minutes after receiving the flu shot. No previous flu shot, no previous panic attacks. Symptoms include muscle tightness, palpitations and anxiety. Resolve spontaneously in 1-2 hrs.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Musculoskeletal pain, Neck pain, Neuralgic amyotrophy, Pain
Clinical narrative: Debilitating pain left shoulder and neck, radiating to arm and hand, palsy of left hand saw several neurologists and eventually was diagnosed with Parsonage Turner Syndrome prescribed PT and OT. Left hand palsy and chronic pain remain.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paralysis
Clinical narrative: Debilitating pain left shoulder and neck, radiating to arm and hand, palsy of left hand saw several neurologists and eventually was diagnosed with Parsonage Turner Syndrome prescribed PT and OT. Left hand palsy and chronic pain remain.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Large area of redness and irritation; Right arm upper and lower.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever, sore arm, headache, nausea, vomiting.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Impaired work ability, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Flu vaccine administered 11/2/15 at 1600 by 1800 right arm and nad hand swelling, pain, decrease movement. On 11/09/15 patient was seen in Occupational Health. Patient received flu vaccine on 11/02/15 in Occupational Health at approximately 1600. She reports that about 1.5 hours after the vaccination (approximately 1800) she experienced pain, swelling, and decreased mobility due to swelling in right arm and hand requiring her to leave work. She took ibuprofen 800 mg and an undisclosed antihistamine when she arrived home. After 4 hours there was no relief and she took and additional ibuprofen 600 mg. She was unable to report to work on 11/03/15 and called in for absence. She repeated the ibuprofen 800 mg with undisclosed antihistamine in the A.M., then later repeated the ibuprofen 600 mg without relief of symptoms. On 11/04/15 she had decrease pain and swelling and was able to return to work but by afternoon was having return of symptoms. On 11/05/15 she was seen in ER. She was given IV Clindamycin after culture of hand done. Previous lab work was consulted and found she was positive for RA. MD in ER told her that the Flu vaccine caused an exacerbation of her RA condition causing the swelling and pain She was started on Prednisone 60 mg daily for 5 days and then 50 mg daily for 5 days. Also she was prescribed Meloxicam 7.5 mg daily. She states by 11/7/15 she was better with less swelling, pain, and able to close hand. Note from MD for Return to Work on 11/16/15.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Flu vaccine administered 11/2/15 at 1600 by 1800 right arm and nad hand swelling, pain, decrease movement. On 11/09/15 patient was seen in Occupational Health. Patient received flu vaccine on 11/02/15 in Occupational Health at approximately 1600. She reports that about 1.5 hours after the vaccination (approximately 1800) she experienced pain, swelling, and decreased mobility due to swelling in right arm and hand requiring her to leave work. She took ibuprofen 800 mg and an undisclosed antihistamine when she arrived home. After 4 hours there was no relief and she took and additional ibuprofen 600 mg. She was unable to report to work on 11/03/15 and called in for absence. She repeated the ibuprofen 800 mg with undisclosed antihistamine in the A.M., then later repeated the ibuprofen 600 mg without relief of symptoms. On 11/04/15 she had decrease pain and swelling and was able to return to work but by afternoon was having return of symptoms. On 11/05/15 she was seen in ER. She was given IV Clindamycin after culture of hand done. Previous lab work was consulted and found she was positive for RA. MD in ER told her that the Flu vaccine caused an exacerbation of her RA condition causing the swelling and pain She was started on Prednisone 60 mg daily for 5 days and then 50 mg daily for 5 days. Also she was prescribed Meloxicam 7.5 mg daily. She states by 11/7/15 she was better with less swelling, pain, and able to close hand. Note from MD for Return to Work on 11/16/15.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored VAQTA lot # K018531, expiration date: 28-APR-2017 (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning multiple patients of unknown age. On unspecified dates multiple patients were vaccinated either with VARIVAX (Merck) (lot # K002048, expiration date 10FEB2016) or ZOSTAVAX (lot# L011533, expiration date 03JUL2016) that was improperly stored. No adverse event was reported. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 12 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On 02-NOV-2015, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K005428, expiration date 15-APR-2016, 0.5 ml, intramuscular. Concomitant therapy information was not provided. On 02-NOV-2015, there was incorrect product storage and incorrect route of drug administration as the patient received improperly stored VARIVAX (Merck) via intramuscular. Also on the same date, the patient had a PPD tuberculin test placed and the results were not provided (medication error). No adverse events were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.