chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Fatigue, Injection site bruising, Nausea
Clinical narrative: Reaction to flu shot, bruise at site, weakness, dizziness, nausea, fatigue, Left. MEDROL Dose Pak started AM 9/30/16.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 17-DEC-2015, the patient was vaccinated with improperly stored dose of M-M-R II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. No adverse events were reported. The administered dose was stored in 47F for 8 hours. There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Severe headache, fatigue, nausea. Administered 9/21/16. Reported by patient 10/4/16.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 02-DEC-2015, the patient was vaccinated with improperly stored dose of M-M-R II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. The administered dose was stored in 47 F for 8 hours. There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient exhibited redness and swelling on the left arm from the deltoid muscle and down 120mm. Area was warm to touch and slightly hard and raised. The affected area measured approximately 120 x 85 mm. Mother did not give TYLENOL or apply ice to area. Mother stated patient scratched area.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Left arm redness and swelling 50mm x 30mm 2 days following vaccines. Painful. Cold compresses, HYTONE and MOTRIN. F/u 2 days.
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Pt has a reddened circle area surrounding injection site that started within 24 hours of immunization.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 50-year-old female patient who received HAVRIX adult (batch number MB3Y2, expiry date 10th June 2018). On 3rd August 2016, the patient received the 1st dose of HAVRIX adult (intramuscular) 1 ml. In August 2016, 14 days after receiving HAVRIX adult, the patient experienced injection site lump. On an unknown date, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site lump was recovered/resolved and the outcome of the injection site pain and injected limb mobility decreased were recovering/resolving. The reporter considered the injection site lump, injection site pain and injected limb mobility decreased to be possibly related to HAVRIX adult. Additional details were provided as follows: The patient received numerous vaccines in the past without issues. The patient received HAVRIX adult on left arm, which was her non-dominant side. On 15th August 2016, the patient received a flu vaccine in her right arm without incidence. It was reported that the patient was concerned about receiving the 2nd dose, as she was unsure if that was specific to the vaccine, the person's technique or what can she do to prevent the issues from occurring with the next vaccination. The patient had spoken with her physician, who referred her back to the facility where she received the vaccination from. It was reported that serious criteria questions not addressed. Caller became upset when GlaxoSmithKline was not able to answer her specific questions.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient passed out in clinic hallway hitting head on wall after GARDASIL was given. LOC < 1 min. Cool wash cloth applied to neck. Pt assisted to exam room and monitored x 30min. Alert and orient.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 23-DEC-2015, the patient was vaccinated with improperly stored dose of M-M-R II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. The administered dose was stored in 47 F for 8 hours. There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and drainage of right upper arm noted on 10/6/16 in afternoon. He was seen at ED and told to provide supportive care. Still getting worse on 10/7 so seen in clinic by Dr and found to have swelling of right upper arm with erythema and warmth and wound in center. Diagnosed with cellulitis and started treatment with clindamycin.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 13-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot # L024993 with expiration date: 17-OCT-2017). Concomitant medications were not reported. No adverse effects were reported. The administered dose was stored in 25.7 Celsius degrees for 57 hours. There was no previous temperature excursion. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Dyskinesia, Musculoskeletal stiffness, Nausea, Pallor
Clinical narrative: At 9:20am patient fainted after administration of vaccine. Jerking and stiffness of the body noted. Lasting approximately 1 min. Complain of feeling nauseated, blurred vision and dizzy. Skin pale in color. Cool compress applied to head and neck blood pressure monitored. Remained in center until.
Age: 12.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Syncope, Vision blurred
Clinical narrative: At 9:20am patient fainted after administration of vaccine. Jerking and stiffness of the body noted. Lasting approximately 1 min. Complain of feeling nauseated, blurred vision and dizzy. Skin pale in color. Cool compress applied to head and neck blood pressure monitored. Remained in center until.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Erythema, Flushing
Clinical narrative: Dizziness and face/neck became flushed/red
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warmth started morning of 10/2/16 7cm by 7cm measuring. Pt started on Cephalexin 500mg qid x 7 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Localized reaction on left upper arm (redness, warmth and tenderness).
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Headache, Mobility decreased, Pain, Pyrexia
Clinical narrative: Tdap vaccine given 8:20 am and at 11:00 pm that same day, developed chills, fever 102.5, all over body aches, difficulty raising arm that vaccine administered in (left) she is right handed. Massive headache. Took TYLENOL resolved 9/13 630AM.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Myalgia
Clinical narrative: Severe pain left hip all the way past knee from hip bone thru knee area. A little better now (9-29-16) but still pretty severe pain - 2 1/2 months and still hurts bad effecting joints and muscles.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Arthropathy, Gait disturbance, Impaired driving ability, Mobility decreased
Clinical narrative: Severe pain in right hip down thru leg. Hip is still (2 1/2 months) hurting but not as bad-effects my driving a car-hard to walk and get out of car-joints and muscles.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Muscle disorder, Pain in extremity
Clinical narrative: Severe pain in right hip down thru leg. Hip is still (2 1/2 months) hurting but not as bad-effects my driving a car-hard to walk and get out of car-joints and muscles.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Neck pain, Pain in jaw
Clinical narrative: Left sided neck pain that radiates to jaw with associated HA.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Low grade fever. Vomiting (more than once). Lethargy.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: Arm where vaccine shot was given turned bright red the size of a half dollar. Still have red spot by is now getting lighter (this is now 6 days later).
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Severe body wide joint and muscle pain.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Irritability, Malaise, Pain, Pyrexia
Clinical narrative: Running 100.9 fever. Fever continued throughout the day. Very achy and fussy and malaise.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Injection site pruritus, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Swollen arm, warm to touch, fever, itching at injection site, loss of appetite.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site of administration.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: RED, ITCHY, WARM TO TOUCH ON RIGHT ARM. ALSO TENDER. SPREAD TO INSIDE OF ARM AND DOWN ARM. ON THURSDAY STILL RED.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Injection site reaction, Pyrexia
Clinical narrative: Fever site muscles chills, fatigue.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache, Palpitations
Clinical narrative: Dizziness, severe headache, heart palpitations /racing heart, lightheaded, feeling faint.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Peripheral sensory neuropathy
Clinical narrative: Seosory peripheral neuropathy in feet up to mid-calf extended to over knees after vaccination.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Peripheral sensory neuropathy
Clinical narrative: Seosory peripheral neuropathy in feet up to mid-calf extended to over knees after vaccination.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain and loss of range of motion starting right after vaccine administration and still present after 1 month.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen to the left of the injection site. Gave Advil and Benadryl at 9:30 PM. On 10/08/2016 she woke and the swelling had gotten worse and the swelling area was bigger. I have photographs to document if needed. Gave more Advil and cold compress. Temp is 99.4.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site cellulitis, Vaccination site inflammation
Clinical narrative: Pt came from a doctor office with a prescription for cephalexine 500mg. She experienced cellulitis and inflamation at the site of vaccine injection given to her 10/4/16.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Immediate pain during vaccination, young man said he had hit the bone.  Arm is sore and aches, especially on waking.  Soreness extends to neck and down arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Neck pain
Clinical narrative: Patient reported sore neck after administration of FLUZONE HD, ZOSTAVAX and PREVENAR 13.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Axillary pain, Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: Malaise and legs aching, weakness. Later before bed swelling of lymph glands under armpits, very painful on left side, not so pronounced on right side.  Vaccine was given on left arm.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Conversion disorder, Depression, Feeling abnormal, Inappropriate affect, Mood altered
Clinical narrative: STARTED WITH FEVER/BODY ACHES. LED INTO MOODINESS, DEPRESION, HISTERICAL IN A GOOD WAY IE: LAUGHING, FOGGINESS, MIND WANDERING, SNEEZING.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Sneezing, Thinking abnormal
Clinical narrative: STARTED WITH FEVER/BODY ACHES. LED INTO MOODINESS, DEPRESION, HISTERICAL IN A GOOD WAY IE: LAUGHING, FOGGINESS, MIND WANDERING, SNEEZING.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness at injection site and radiating about 3 inches below site.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Oropharyngeal pain, Rash
Clinical narrative: Cough, fatigue, sore throat and rash on trunk.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Influenza, Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling and redness which included inside of the upper arm. Mild flu symptoms. Per Pharmacist recommendation the patient took Benadryl and Tylenol. At 11:10AM on 10/8/16 the patient reported resolution of swelling and absence of flu symptoms. She stated she did not need further medical treatment.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient has redness, swelling and warmness at injection site. Patient also feeling tired and achy.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Choking sensation, Swollen tongue
Clinical narrative: Pt called the pharmacy informing that his tongue was swollen and felt like he was choking. Pt went to the ER and was prescribed a rescue inhaler, Corticosteroid tabs, antihistamine and H2 Antagonist.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Fatigue, Feeling cold, Renal pain
Clinical narrative: Severe lowerback and kidney pain. Felt like I was freezing cold. Very Tired. Ibuprofen, Aleve, Tylenol.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash generalised
Clinical narrative: Rash on entire body.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUC4, PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Per patient, rt shoulder became painful approximately 2 hours after vaccination at 1:15 pm. Patient stated holding newborn around lunchtime at noon. At time of observation by pharmacist at 2:00 pm, patient could not lift rt arm upward or laterally, but could make fist and had range of motion in rt forearm. Arm appeared slightly swollen and warm to touch. Under protocol, I offered 30 minutes of observation to ensure no anaphylactic reaction. Patient refused. I also offered to call 911, which was refused and urged an ER visit, which was refused. Patient agreed to urgent care visit.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUC4, PPV, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Ultrasound scan normal
Clinical narrative: Per patient, rt shoulder became painful approximately 2 hours after vaccination at 1:15 pm. Patient stated holding newborn around lunchtime at noon. At time of observation by pharmacist at 2:00 pm, patient could not lift rt arm upward or laterally, but could make fist and had range of motion in rt forearm. Arm appeared slightly swollen and warm to touch. Under protocol, I offered 30 minutes of observation to ensure no anaphylactic reaction. Patient refused. I also offered to call 911, which was refused and urged an ER visit, which was refused. Patient agreed to urgent care visit.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUC4, PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Per patient, rt shoulder became painful approximately 2 hours after vaccination at 1:15 pm. Patient stated holding newborn around lunchtime at noon. At time of observation by pharmacist at 2:00 pm, patient could not lift rt arm upward or laterally, but could make fist and had range of motion in rt forearm. Arm appeared slightly swollen and warm to touch. Under protocol, I offered 30 minutes of observation to ensure no anaphylactic reaction. Patient refused. I also offered to call 911, which was refused and urged an ER visit, which was refused. Patient agreed to urgent care visit.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot, Hypotension, Syncope
Clinical narrative: A minute or 2 after receiving immunization, patient experienced dizziness/lightheadedness, warm feeling, fainting for a few seconds (less than 10 seconds, and no fall), hypotension (77/48). Donor was instructed to lie down with legs elevated, and given water and crackers. Donor's dizziness subsided shortly after fainting episode and all symptoms had resolved within 17 minutes. BP was 104/71 at that time. Donor left center with no further complaints.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: RIGHT THIGH: pain, redness, swelling. FEVER: 101.3.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT HAD REDNESS, PUFFINESS, AND WAS ITCHING NEAR THE INJECTION SITE.  SHE WAS COUNSELED TO TAKE BENADRYL AND THE AREA LOOKED BETTER THE NEXT DAY.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted about 1 minute after receiving the vaccine. She has a history of fainting when having blood drawn but never from receiving a vaccine. Patient woke up on her own before the smell salt was opened.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Erythema, Injection site pain, Mobility decreased, Nausea
Clinical narrative: It first Bbgan with soreness at injection sight. The next day, I experienced nausea, shooting pains I various parts of my body, and chills. Then there was a lot of redness and swelling for several days, and I was unable to lift my arm above shoulder height or carry anything or even touch the arm without a significant amount of pain. A week in a half later, I still have some mild swelling and redness.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Swelling
Clinical narrative: It first Bbgan with soreness at injection sight. The next day, I experienced nausea, shooting pains I various parts of my body, and chills. Then there was a lot of redness and swelling for several days, and I was unable to lift my arm above shoulder height or carry anything or even touch the arm without a significant amount of pain. A week in a half later, I still have some mild swelling and redness.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: Paleness, Sweating, Nausea, Dizziness, Weakness Immediately following injection.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor
Clinical narrative: Paleness, Sweating, Nausea, Dizziness, Weakness Immediately following injection.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came into pharmacy Saturday morning of 10/08/16. She had received FLUZONE HD on 10/02/16 in the upper right deltoid area as per VAR. Patient stated her arm was swollen, red and painful after getting vaccination. Patient called pharmacy during weekday with concern that her arm was still hurting. Patient was advised to take ADVIL to help relieve the pain and contact her doctor. Patient did NOT take ADVIL or call her doctor. On 10/08/16 patient came into pharmacy complaining of pain in her right upper arm.
Age: 69.0
Sex: F
Vaccine: FLU3, TD, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: REDNESS AND SWELLING ON RIGHT ARM.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt received Pneumovax 23 and Afluria PF syringe on same arm and experienced mild swelling and redness of entire arm-- advised pt to contact her physician if symptoms got worse.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drug administered at inappropriate site, Peripheral swelling
Clinical narrative: Patient came in 10/05/2016 to walmart pharmacy saying that she was given the injection too high on her arm. She had a lot of pain and her arm swollen up and that she has been off of work for the whole week. She went to the doctor the following day. Md said there was no tendon rupture. However, Md assumed it could be because she got the injection too high on her arm. The pharmacist who gave the injection said it was given on the deltoid muscle and that it wasnt too high.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Meningism, Muscle rigidity, Myositis
Clinical narrative: Patient was admitted to hospital with "meningitis-like" symptoms.  MD later confirmed diagnosis of Cellulitis, Myolitis and Muscle Rigidity resulting from vaccinations.
Age: 26.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Local swelling, Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen red knot on arm that vaccine was administered in. Hot to the touch. Intense pain in arm vaccine was administered in. Swollen lymph nodes on the same side of the body that the vaccine was given in.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Oropharyngeal pain, Pruritus
Clinical narrative: I experienced a severe headache that day following the immunization and the skin on my stomach started itching intensely that night for about fifteen minutes then I developed a sore throat on the right side the same night. It felt like strep and the pain started easing up Saturday morning. It's still sore but at least I can swallow today. I had no fever through this. I also did not see a doctor.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: PT STATES THAT THEY ARE NOW 3 WEEKS OUT FROM VACCINE ADMINISTRATION AND STILL EXPERIENCING INJECTION SITE PAIN (LEFT ARM). PT REPORTS PAIN IS EVIDENT AT REST THROUGHOUT THE DAY BUT DOES NOT CHANGE WHEN THEY ROTATE ARM. PT DENIES ANY BRUSING. PT HAS TRIED ORAL NSAIDS WITH MODERATE RELIEF. RECOMMENEDED PT TO SEE PCP FOR EXAMINATION. STATES THEY WILL SEEK MEDICAL ATTENTION IF PAIN CONTINUES TO PERSIST AN ADDITIONAL WEEK.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Dysstasia, Hyperhidrosis, Presyncope
Clinical narrative: Patient reported dizziness, inability to stand due to disorientation, sweating, sensation near syncope, & shakiness lasting about 25 minutes.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient reported dizziness, inability to stand due to disorientation, sweating, sensation near syncope, & shakiness lasting about 25 minutes.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Burning sensation, Delivery, Exposure during pregnancy, Guillain-Barre syndrome
Clinical narrative: Tingling and burning in feet, loss of balance. Sharp pains up legs. Delivered twins in June 28, 2012 and then loss of use of left hand and no balance until given IVIG. Then had little more use of left hand but still have neuropathy in both legs and feet.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Immunoglobulin therapy, Mobility decreased, Musculoskeletal disorder, Neuropathy peripheral, Pain
Clinical narrative: Tingling and burning in feet, loss of balance. Sharp pains up legs. Delivered twins in June 28, 2012 and then loss of use of left hand and no balance until given IVIG. Then had little more use of left hand but still have neuropathy in both legs and feet.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Tingling and burning in feet, loss of balance. Sharp pains up legs. Delivered twins in June 28, 2012 and then loss of use of left hand and no balance until given IVIG. Then had little more use of left hand but still have neuropathy in both legs and feet.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Vomiting
Clinical narrative: On day of vaccination, he developed redness and swelling in the left deltoid (site of injection).  The following day his left arm was markedly swollen (6cm larger circumference than other side) and the redness/swelling had spread to include circumferential arm from upper shoulder to elbow.  Also had 2 episodes of vomiting on day after vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception 5 weeks after rotavirus vaccination.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain
Clinical narrative: 9 x 13 cm redness and induration on (L) arm moving arm well but pain when he elevates arm.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild swelling of upper left arm, mild erythema approx. 5x5 cm from.
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site bruising, Injection site discolouration
Clinical narrative: Pt has severe bruising from right shoulder to half of his arm 10 days later. It has a yellow ring around it. It is not swollen or hurt. Pt. complain of headache ever since. Pt did not seek any medical for further evaluation. Call pt on 9/30/16 pt say he is fine just his head hurts.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Soft tissue swelling at site of injection, no induration or itching so that upper arm was 1/2 inch bigger (R arm 7.75 inches around; L arm 8.25 inches around)
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Patient returned to pharmacy 10/6/16 to report continued pain at the site of injection. She reported a burning sensation as vaccine was administered and she is going to see doctor for continued arm/shoulder pain. Reports no other problems with previous flu vaccines.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Really painful at injection time, progressively worse, by third day she couldn't lift her arm. As of 10/7/16, had seen a chiropractor and was using ALEVE and a sling. Advised to see MD 10/7. Saw MD 10/8. Flexeril 5mg TID prn and Prednisone 10 taper. See ortho if not improved.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt came to Pharmacy for flu shot. Stated he got hives several days after last Flu shot and needed hospitalization. Wanted to try again this year at advice of his doctor and daughter. Today reported hives again.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Deafness, Fatigue, Neck pain, Pain
Clinical narrative: Pt said after few days of pneumonia shot her whole body ache, back ache, tired, hearing loss, little rash on arm, neck pain.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Pt said after few days of pneumonia shot her whole body ache, back ache, tired, hearing loss, little rash on arm, neck pain.
Sex: U
Vaccine: HPVX
Symptoms: Incomplete course of vaccination, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with first dose of with unidentified Merck HPV vaccine. The physician stated the consumer fainted shortly after receiving the injection. It is unclear as to whether the consumer was still in the physician's office at the time of fainting. No hospitalization or treatment information was reported. The physician stated that due to the incident with the first injection that the consumer has refused to complete the series. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with unidentified Merck HPV vaccine. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The pertinent medical history and concomitant therapy of the patient were not reported. On an unspecified date in October 2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot#, expiration date, dose and route were unspecified). On an unspecified date in July 2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot#, expiration date, dose and route were unspecified). At the time of this report, the patient had not yet received the third dose. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 03-MAR-2016, the patient was vaccinated with GARDASIL dose 1. On 29-JUL-2016, the patient was vaccinated with GARDASIL dose 2 later than the recommended schedule. On 28-SEP-2016, the patient was in the office to receive GARDASIL dose 3 earlier than the recommended schedule. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. On an unknown date from 28-JUL-2016 to 03-OCT-2016, the patients were vaccinated with improperly stored ROTATEQ lot # L013204, expiry date 28-JAN-2017, # L020861, expiry date 25-JAN-2017, # M014318, expiry date 30-SEP-2017 for 66 hours, previous excursion 10 centigrade for 10 hours, Time 0.89 centigrade. No adverse effects were reported. This is one of the several cases reported from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. On an unknown date from 28-JUL-2016 to 03-OCT-2016, the patients were vaccinated with improperly stored GARDASIL 9 M003659, 20-SEP-2017 for 66 hours, previous excursion 10 Centigrade for 10 hours, Time 0.89 Centigrade. No adverse effects were reported. This is one of the several cases reported from the same reporter. 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 licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX with either lot number M010671 with expiration date of 20-JUN-2018 or L048209 with expiration date 03-MAY-2018(strength, dose and route of administration were not reported, which was stored at 1.1 celsius degrees for 24 hours. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. On an unknown date from 28-JUL-2016 to 03-OCT-2016, the patients were vaccinated with improperly stored RECOMBIVAX for 66 hours, previous excursion 10 Centigrade for 10 hours, Time 0.89 Centigrade. No adverse effects were reported. This is one of the several cases reported from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. On an unknown date from 28-JUL-2016 to 03-OCT-2016, the patients were vaccinated with improperly stored VAQTA for 66 hours, previous excursion 10 centigrade for 10 hours, Time 0.89 centigrade. No adverse effects were reported. This is one of the several cases reported from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a medical student, concerning a 62 years old male patient. The patient's concurrent conditions included hyperlipidaemia. There were no drug reactions or allergies. No pertinent medical history was reported. On May 2014, the patient was vaccinated with an unspecified dose of ZOSTAVAX (lot number J013449 with an expiration date of 24-JAN-2015) (strength, dose, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. On AUG-2016, the patient developed a widespread, erythematous, pruritic rash. It was reported that the patient sought medical attention by visiting the physician on an unknown date, a skin biopsies were performed (result no provided), the patient also had been prescribed with unspecified corticosteroid and antihistamine medications. The reporter stated that the only therapy that had controlled the rash was an unspecified cyclosporine concomitantly with CELLCEPT, which the patient was currently taking. At the time of reporting, the outcome of rash erythematous, rash pruritic and rash generalised was reported as not recovered. The relatedness between the events and therapy with ZOSTAVAX was not reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. A couple years ago, on an unknown date the patient was vaccinated with VAQTA dose 1. It was reported that the patient was unclear if the second dose in VAQTA immunization series was administered in 6 calendar months and may have been administered earlier than 6 months. No adverse event was reported. No concomitant medication was involved. The outcome of the event was unknown. No PQC (product quality complaint) was involved. 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 regarding an unspecified number of unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown dates between 26-SEP-2016 through 29-SEP-2016, the patient were vaccinated with improperly stored PEDVAXHIB lot # M010440/expiration date-09-DEC-2018 and lot no. M020101/expiration date- 07-MAR-2019, intramuscular. No adverse events was reported. No concomitant medication was reported. Temperature of excursion was 35F for 38 hours 50 minutes and call was because of data logger. There was no previous temperature excursion. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a pharmacist referring to an unspecified adult patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies and concomitant medication were not provided. On 22-SEP-2016, the adult patient was vaccinated with a pediatric dose of VAQTA (0.5 ml, once; route, lot # and expiration date were unknown). No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Blister, Burning sensation, Rash
Clinical narrative: Information has been received from a physician concerning a 61 year old female patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 19-SEP-2016 (reporter as "ten days ago"), the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, via subcutaneous route (dosage schedule, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On 24-SEP-2016, the patient experienced rash on her chest and arms that was painful and burning (rash and thermal burn), and also had "some blistering" but no fever. The reporter stated that her primary doctor prescribed VALTREX and she took 3 doses, one daily by mouth. On an unknown date in September 2016, the patient also had an unspecified type of biopsy, but the results were not provided. At the time of reporting, the outcome of thermal burn, rash and blister was reported as recovering. The relatedness between the events and therapy with ZOSTAVAX was not reported. No product quality complaint was involved. 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 Certified Medical Assistant referring to an unknown number of patients of unknown ages and genders. Pertinent medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with incorrectly stored doses of GARDASIL lot # K007828 and expiration date 02-MAR-2017. Dose, route and anatomical location were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ, orally, with either lot number L048854 with expiration date of 31-AUG-2017 or M002254 with expiration date of 15-NOV-2017 or L033693 with expiration date of 31-MAY-2017 (strength and dose were not reported), which was stored at 1.1 celsius degrees for 24 hours. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of 0.5ml of improperly stored GARDASIL 9 either with lot number L040054 with expiration date of 26-DEC-2017 or L037554 with expiration date of 25-DEC-2017 (strength and route of administration were not reported), which was stored at 1.1 Celsius degrees for 24 hours. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: FLUX, HEPA, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown demographics. There was no information about concurrent conditions and historical medication. On 24-SEP-2010, the patient was vaccinated with VARIVAX dose 1, on 01-SEP-2015, dose 2 and 19-SEP-2016, dose 3. No adverse event was reported. No concomitant medication was involved. The outcome of the event was unknown. No PQC(product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. On an unknown date from 28-JUL-2016 to 03-OCT-2016, the patients were vaccinated with improperly stored PNEUMOVAX 23 M005286, 08-OCT-2017 for 66 hours, previous excursion 10 centigrade for 10 hours, Time 0.89 centigrade. No adverse effects were reported. This is one of the several cases reported from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received via a company representative from a female patient under fifty year old, who is also a Certified Nursing Assistant concerning herself. Information regarding the patient's concurrent conditions and medical history was not provided. On an unknown date, when the patient was "under fifty", she was possible vaccinated with ZOSTAVAX (dose, route of administration, anatomical location and expiration date were not provided). There were no concomitant medications provided. On an unknown dates, on three separate occasions, the patient developed shingles. The outcome of shingles and the casual relationship were not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received via a company representative from a female patient under fifty year old, who is also a Certified Nursing Assistant concerning herself. Information regarding the patient's concurrent conditions and medical history was not provided. On an unknown date, when the patient was "under fifty", she was possible vaccinated with ZOSTAVAX (dose, route of administration, anatomical location and expiration date were not provided). There were no concomitant medications provided. On an unknown dates, on three separate occasions, the patient developed shingles. The outcome of shingles and the casual relationship were not provided. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old patient of unknown gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date in April 2016 the reporter stated that the patient who was indicated for ZOSTAVAX accidentally received a dose of VARIVAX (dosing details were not reported). No adverse effects were reported. There was no product quality complaint involved. 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 refers to an unspecified patients of unknown age. On an unknown date from 28-JUL-2016 to 03-OCT-2016, the patients were vaccinated with improperly stored GARDASIL, K009482, 06-MAR-2017 for 66 hours, previous excursion 10 Centigrade for 10 hours, Time 0.89 Centigrade. No adverse effects were reported. This is one of the several cases reported from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Skin irritation
Clinical narrative: FLUARIX - Left arm site red, rash, hot, swollen.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: FLUARIX - Left arm site red, rash, hot, swollen.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUC4, PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: EXTREME pain in upper arm and unable to move arm from shoulder. Unable to move or use arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUC4, PPV, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Ultrasound scan normal
Clinical narrative: EXTREME pain in upper arm and unable to move arm from shoulder. Unable to move or use arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUC4, PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: EXTREME pain in upper arm and unable to move arm from shoulder. Unable to move or use arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Felt fine this am but 3 hrs after awakening I had a severe lower back pain. It is almost impossible to get up or sit down, bend over, etc. I have not experienced back pain this severe before.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations
Clinical narrative: Heart racing, most of the day shortly after the flu shot was received. Resulting in feeling like I had been running a race all day. Heart beating hard and fast. Even laid down for a few hours in the early evening thinking it would help. Symptoms seemed to clear upon waking next morning.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING, PAIN AT INJECTION SITE. 10/09/2016 - PAIN, ITCHING, SWELLING, REDNESS; APPLIED ANTI-ITCH CREAM AND TOOK BENADRYL CAPSULES.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Lump and swelling at injection site.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Chills, Cold sweat, Dizziness
Clinical narrative: EMPLOYEE REPORTS HE AWAKENED ON 10.04.2016 WITH JOINT PAIN, BY EVENING HE HAD WEAKNESS, DIZZINESS, CHILLS/CLAMMY, PALPATATIONS, NIGHT SWEATS.  10.05.2016 CALLED OFF FROM WORK DUE TO SYMPTOMS.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Impaired work ability, Night sweats, Palpitations
Clinical narrative: EMPLOYEE REPORTS HE AWAKENED ON 10.04.2016 WITH JOINT PAIN, BY EVENING HE HAD WEAKNESS, DIZZINESS, CHILLS/CLAMMY, PALPATATIONS, NIGHT SWEATS.  10.05.2016 CALLED OFF FROM WORK DUE TO SYMPTOMS.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mass, Pain
Clinical narrative: Patient reported redness, raised bump, and extreme soreness for several days after immunization that only started to subside on 10/08/2016.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Skin warm, Swelling
Clinical narrative: Leg inflamed, warm, red, very swollen.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Epistaxis, Headache
Clinical narrative: Headache lasting 24 hours; Nose bleed at 8:00pm lasting 10 minutes; Back pain lasting 24 hours.