chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass
Clinical narrative: Patient stated that she still has a "lump" where she got her flu shots. She stated she was unable to take tylenol or ibuprofen although patient is getting acetaminophen in the Norco that she takes.  Explained that heat or ice may help and if it was not getting better to follow up with her doctor.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Loss of consciousness, Pallor, Syncope, Vomiting
Clinical narrative: Patient began to faint almost immediately after receiving vaccine. She sat down on the bench near the pharmacy with her mother's assistance. Pt regained conciousness but still appeared pale, she began coughing and proceeded to vomit in the trash can near the pharmacy several times. She went into the restroom with her mother to wipe her face and said she felt fine when she came out. Mother stated she has fainted and had this reaction before when having blood drawn.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Erythema, Injection site swelling, Injection site warmth
Clinical narrative: BODYACHES, UNABLE TO MOVE, DISORIENTATED, CHILLS, REDNESS,  SWELLING AT THE SITE OF INJECTION AND HOT TO THE TOUCH.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Pain
Clinical narrative: BODYACHES, UNABLE TO MOVE, DISORIENTATED, CHILLS, REDNESS,  SWELLING AT THE SITE OF INJECTION AND HOT TO THE TOUCH.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Feeling cold, Feeling hot, Hypoaesthesia, Tremor
Clinical narrative: After vaccination came home couldn't feel hands or feet. They would feel hot and cold and had no feeling in them. Just felt out of it like I received a weird drug. Had the shakes.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Influenza like illness
Clinical narrative: PATIENT CALLED STATING SHE FELT VERY LIGHT HEADED AND ALMOST FAINT. SHE DESCRIBES HER SYMPTOMS LIKE FLU-LIKE , LOSS OF APPETITE
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site infection, Product administered at inappropriate site
Clinical narrative: patient received vaccine in shoulder instead of deltoid. It was given too far up according to patient. patient ended up having to go to the doctor to treat an infection that arose from the vaccine at the injection site.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Full body hives shortly after injection.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient tells pharmacy on 10/14/20 that she does not want the second dose in the series; says she is still having pain in her arm from the vaccine and "can't move it all the way."
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: In about 24 hours of taking the flu shot, my pinky finger on the right hand (opposite arm of flu shot) started to feel pain and became swollen along the right side of my hand.  I thought this was a temporary side effect but it reoccurs every couple of weeks.
Age: 65.0
Sex: F
Vaccine: PNC13, FLU4, PNC13
Symptoms: Injection site reaction, Local reaction
Clinical narrative: doctor called to inform us that patient had a local reaction at injection site
Age: 65.0
Sex: F
Vaccine: PNC13, FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: doctor called to inform us that patient had a local reaction at injection site
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Oedema peripheral, Pyrexia
Clinical narrative: Fever 101.2, chills, swelling near armpit
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Was notified two days after the vaccine was already given that It was the wrong dose. Patient received a hep A vaccine on 10-12-20 for her 12 month check up. She was suppose to receive. 5 ml but instead was given 1ml. I was called today at 10-14-20 around 5 pm to be notified that she was given the wrong dose.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Pain, Product administered at inappropriate site, Ultrasound scan abnormal
Clinical narrative: Patient called and stated pain in shoulder starting shortly after the vaccine was administered, once returned home on 09/26. Unable to significantly move arm without pain/discomfort. Pain not relieved by OTC pain mediation. Pain persisted into next day when following up via phone call at 3:30pm 09/27.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Discomfort, Lymphadenopathy, Pain in extremity
Clinical narrative: EXACTLY 24 HRS AFTER I RECEIVED THE FLUAD QUAD VACCINE, I DEVELOPED SWELLING OF A LYMPH NODE ABOVE MY LEFT CLAVICLE.  THE EXACT SAME THING HAPPENED LAST YEAR.   BECAUSE I WANTED TO BE SURE THAT INDEED THE VACCINE CAUSED THIS, I HAD CHECKED FOR SWELLING THIS MORNING AND THAT WAS NEGATIVE. THE LEFT ARM SORENESS HAS LESSENED SOMEWHAT, BUT I SPENT HALF THE DAY IN BED DUE TO GENERALIZED DISCOMFORT.  I DID NOT TAKE ANY OTC PRODUCTS FOR SYMPTOM RELIEF.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dyskinesia, Laboratory test normal, Nausea, Posture abnormal
Clinical narrative: Patient slumped to her right while sitting. She jerked twice while mother tried to sit her up.  She then was alert but skin was damp and clammy.  She also experienced nausea a few minutes later and tried to vomit but did not
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Retching, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Patient slumped to her right while sitting. She jerked twice while mother tried to sit her up.  She then was alert but skin was damp and clammy.  She also experienced nausea a few minutes later and tried to vomit but did not
Age: 86.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site rash, Myalgia, Rash, Rash pruritic, Urticaria
Clinical narrative: I got hives within a few hours.  Rash type right arm few inches below injection site  Also rash under both breasts, What looked like insect bites. larger than mosquito about 8 over body and upper legs and itchy. Also I have gotten muscle pain in right leg. and still do.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Blood test, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Patient had immediate in her right arm starting at the shoulder and radiates to the elbow and hand. She had a fever for a week. Her family doctor prescribed antibiotics due to the fever. She went to the ER on 10/13/20 due to the pain in her right arm. The ER did blood work and ruled out infection. They determined it's likely "nerve related pain".
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient had immediate in her right arm starting at the shoulder and radiates to the elbow and hand. She had a fever for a week. Her family doctor prescribed antibiotics due to the fever. She went to the ER on 10/13/20 due to the pain in her right arm. The ER did blood work and ruled out infection. They determined it's likely "nerve related pain".
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Hypoaesthesia, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Under arm  pit  and by breast burning itchy sensation. Numbness and tingling down the  arm into the left fingers. Area where shot was give  swollen, hot and painful to raise the arm. Using ice under the arm for pain and relief of itching.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: Under arm  pit  and by breast burning itchy sensation. Numbness and tingling down the  arm into the left fingers. Area where shot was give  swollen, hot and painful to raise the arm. Using ice under the arm for pain and relief of itching.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Hypertension, Myalgia, Syncope
Clinical narrative: Patient received vaccine at 11;04 and stated she felt good.  She left the immediate area and returned approximately at 11:15 am feeling dizzy, faint, muscle aching in arms and legs, High blood pressure of 146/104
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expiration Date 6/30/2020. Date given 10/09/2020. 13 weeks past expiration date. Vaccine for 2019 flu? HCP working in hospital in NICU.
Age: 84.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Muscular weakness
Clinical narrative: pt felt fine after both immunizations. she walked out the door and her legs were rubbery and she felt dizzy. next thing she knew she was laying down. She ended up passing out. Pt was taken to ER and had a bump on her head from her fall. she also broke a bone in her left wrist from her fall.
Age: 84.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Wrist fracture
Clinical narrative: pt felt fine after both immunizations. she walked out the door and her legs were rubbery and she felt dizzy. next thing she knew she was laying down. She ended up passing out. Pt was taken to ER and had a bump on her head from her fall. she also broke a bone in her left wrist from her fall.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Urticaria
Clinical narrative: Patient received Flucelvax Quad 2020-21 vaccine drawn up from multidose vial on 10/12/2020 by pharmacist around 4:20 pm. Patient had no immediate reaction to the flu vaccine while at the pharmacy. Patient was waiting for other friends to finish receiving vaccine for about 10 or 20 minutes with no reaction then either. Patient called pharmacy on 10/14/2020 at 11:20 AM to notify pharmacy of potential allergic reaction to flu vaccine. Patient states she woke up the morning of 10/14/2020 with hives all over her body, as well as swollen lips. Patient also states she did not receive any other vaccines since Monday 10/12/2020 and does not believe she had any exposure to any other allergen in that time. Patient did not have to use epinephrine, but she has been taking loratidine. In addition, MD prescribed a course of steroids to help with patient's symptoms.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Pain
Clinical narrative: Local soreness and mother noticed tiny bumps near the site of the injection that night (about 12 hours after injection)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Erythema, Headache, Pruritus
Clinical narrative: Itchy, Hot, Raised, Red patch, Headache, Cough, Fever, Chills
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Itchy, Hot, Raised, Red patch, Headache, Cough, Fever, Chills
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Injection site rash, Nausea
Clinical narrative: pt had 4 inch rash near injection site, nausea, and dizziness, she said she was not sick enough to seek medical care, she is to check in with me again if she does not get better or if anything gets worse, also told she can seek outside medical attention if needed
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Peripheral swelling, Skin warm
Clinical narrative: SWOLLEN, HOT, FELT LIKE WAS HIT IN THE ARM WITH A BASEBALL BAT, FEELS BRUISED
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Chills, Dizziness, Fatigue
Clinical narrative: Approximately 7-8 hours after receiving the vaccine I was awakened with uncontrolled shivering and feeling cold. After about 90 minutes the shaking subsided and I was able to continue sleeping for a short time.  When I got out of bed I had moderate lower back pain and some dizziness, neither of which is normal. I felt weak and tired for the next 24-30 hours and finally felt normal after 48 hours.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling cold, Sleep disorder
Clinical narrative: Approximately 7-8 hours after receiving the vaccine I was awakened with uncontrolled shivering and feeling cold. After about 90 minutes the shaking subsided and I was able to continue sleeping for a short time.  When I got out of bed I had moderate lower back pain and some dizziness, neither of which is normal. I felt weak and tired for the next 24-30 hours and finally felt normal after 48 hours.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Low grade fever. This is my first day of fever, so I don't know if this will continue.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Angiogram, Blood electrolytes normal, Blood glucose increased, Blood pressure increased, Dizziness
Clinical narrative: She was in her normal state of health and received high dose flu shot 10/12/20 around noon. At 5:30 AM 10/13/20, she woke up experiencing dizziness/vertigo, nausea, lightheadedness, and unsteady gait. She fell upon trying to get up. Her BP at this time was 149/60,  fasting blood glucose 163.  She called EMS and was brought to the ER as a stroke activation. Work as below.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Fall, Gait disturbance, Laboratory test normal, Magnetic resonance imaging normal, Nausea
Clinical narrative: She was in her normal state of health and received high dose flu shot 10/12/20 around noon. At 5:30 AM 10/13/20, she woke up experiencing dizziness/vertigo, nausea, lightheadedness, and unsteady gait. She fell upon trying to get up. Her BP at this time was 149/60,  fasting blood glucose 163.  She called EMS and was brought to the ER as a stroke activation. Work as below.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: SARS-CoV-2 test negative, Vertigo
Clinical narrative: She was in her normal state of health and received high dose flu shot 10/12/20 around noon. At 5:30 AM 10/13/20, she woke up experiencing dizziness/vertigo, nausea, lightheadedness, and unsteady gait. She fell upon trying to get up. Her BP at this time was 149/60,  fasting blood glucose 163.  She called EMS and was brought to the ER as a stroke activation. Work as below.
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Almost immediately she said she started having pain, then swelling and was unable to raise her arm very far.  After 5 days it is getting a little better, she's able to raise her arm 1/2 way without too  much pain, but it is still hurting.
Age: 37.0
Sex: M
Vaccine: FLUR4
Symptoms: Axillary pain, Injection site pain
Clinical narrative: PATIENT CALLED 10/13/2020 0815 (APPROX 72 HORS POST IMMUNIZATION) MAIN COMPLAINT PAIN AT INJECTION SITE AND ARMPIT. PAIN SCALE 5-6 OUT OF 10
Age: 58.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Nodule, Pain in extremity, Skin tightness
Clinical narrative: Patient states the morning after the vaccine her arm felt sore, tight and knotted, and feels about the same today, 5 days later. Patient took a muscle relaxer and Tylenol without relief of symptoms
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: hives on left shoulder extending from neck down my back a bit, happened 5 hours after, was itchy for hours leading up to it; took allergy medicine and it went down
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Patient experienced hand/arm numbness since the time of vaccine administration. Patient stated that her hand and arm below elbow are numb. Onset of symptom occurred a few days after the vaccine and lasted until now. She was advised to follow-up with PCP.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Malaise, Oral pruritus, Throat irritation, Vision blurred
Clinical narrative: APPROXIMATELY  10 MINUTES AFTER RECEIVING THE VACCINE, PATIENT BEGAN TO EXPERIENCE ITCHING ON THE ROOF OF HER MOUTH  AND BACK OF HER THROAT, GENERAL FEELING OF MALAISE, LIGHT HEADEDNESS AND SLIGHT BLURRED VISION.  PATIENT REFUSED EPI SHOT,  BUT WANTED TO  TAKE AN ORAL DOSE OF DIPHENHYDRAMINE.  PATIENT TOOK 25 MG DIPHENHYDRAMINE AT APPROX 8:20.  DOSE WAS REPEATED AT 9:00.  AT 9:20, PATIENT STATED SYMPTOMS WERE DISSIPATING.  11:50 am PATIENT WAS SLEEPING, BUT STATED SYMPTOMS WERE WERE VERY LIGHT, NO MORE BLURRED VISION.   6:20 pm PATIENT REPORTED NO SYMPTOMS AND NO MORE DIPHENHYDRAMINE  HAD BEEN TAKEN .
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Joint swelling, Peripheral swelling, Vaccination complication
Clinical narrative: Patient reported an allergic reaction to the vaccine with arm and elbow swelling as well as swelling at the injection site. Swelling has not resolved until now. She sought medical attention from PCP who advised that this was a vaccine related adverse event and instructed not to get the high-dose vaccine in the future.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Patient describes weakness in the arm that he received his flu vaccine. The weakness has been occurring since about a week after getting the vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Tinnitus, Vaccination complication, Vomiting
Clinical narrative: About 12 hours after receiving the vaccine, began shivering uncontrollably. Shivered for 5 hours. Then, vomited several times. After nausea, began feeling better. Then, a week later began noticing ringing in ears. Ringing has developed and progressively gotten worse. Had ears checked and suspect side effect of Shingrix.  Until this vaccine, have never had a side effect. Did fine with 1st shot and receive flu shot every year.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dysphonia, Impaired work ability, Oropharyngeal pain, Pain
Clinical narrative: The morning after my flu shot, I was very weak, body aches, fever, sore throat. No energy, loss of voice strength, general weakness. I?ve missed 2 days of work and my job made me get a Covid test which, came back negative.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: The morning after my flu shot, I was very weak, body aches, fever, sore throat. No energy, loss of voice strength, general weakness. I?ve missed 2 days of work and my job made me get a Covid test which, came back negative.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Irritability, Nausea
Clinical narrative: Headache above left eyebrow and irritated. Nausea, tired. Started the next day.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Hyperhidrosis, Impaired work ability
Clinical narrative: severe pain right arm, overall body pain, headache, shivering for 2-3 hours followed by sweating (fever?), nausea, stomach ache. headache and arm pain and general body pain decreased after 24-48 hours after injection.  side effects prevented me from working until 24hours passed after the injection.  Ibuprofen taken.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: severe pain right arm, overall body pain, headache, shivering for 2-3 hours followed by sweating (fever?), nausea, stomach ache. headache and arm pain and general body pain decreased after 24-48 hours after injection.  side effects prevented me from working until 24hours passed after the injection.  Ibuprofen taken.
Age: 83.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness speading outward from the injection site, warm to touch, pain. no fever,. No treatment at time of complain
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Mass, Rash
Clinical narrative: 2 days after receiving the vaccine patient started getting rashes behind neck which traveled up to the head, left side of the waist area.   2 weeks later patient started getting clear blisters and pumps on arms legs and stomach area,
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site discolouration, Injection site pruritus, Injection site rash, Injection site reaction, Livedo reticularis
Clinical narrative: Rash, mottled in appearance, appeared on R arm on mid-arm between elbow and shoulder about 3 inches below deltoid.  Flat, no pustules, dark pigmented, itchy.. Not accompanied by fever, chills or other rashes or symptoms.  Sore arm x 24 hrs.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Rash, mottled in appearance, appeared on R arm on mid-arm between elbow and shoulder about 3 inches below deltoid.  Flat, no pustules, dark pigmented, itchy.. Not accompanied by fever, chills or other rashes or symptoms.  Sore arm x 24 hrs.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site rash, Rash maculo-papular
Clinical narrative: Rash, mottled in appearance, appeared on R arm on mid-arm between elbow and shoulder about 3 inches below deltoid.  Flat, no pustules, dark pigmented, itchy.. Not accompanied by fever, chills or other rashes or symptoms.  Sore arm x 24 hrs.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: Red swollen site -lasted 3 days White spotted rash under skin on left arm only.  -lasted less than 24 hours Rash was itchy burning and painful- lasted less than 24 hours  Low grade fever
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Red swollen site -lasted 3 days White spotted rash under skin on left arm only.  -lasted less than 24 hours Rash was itchy burning and painful- lasted less than 24 hours  Low grade fever
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, aches, headache, extreme fatigue
Age: 62.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Burning sensation, Incorrect route of product administration, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Patient states had burning sensation during vaccination. Then about 2 hours later states her arm was swollen, painful, and red from her elbow up to her shoulder. By the third day states she could barely move her arm. At that point she went to her doctor who examined her left arm. In the doctor's opinion, the vaccine was administered subcutaneously rather than intramuscularly, which caused the adverse reaction. The patient was not prescribed any medication as a result and just took OTC Naproxen for the pain. Patient is doing much better now with no follow up needed.
Age: 62.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site swelling
Clinical narrative: Patient states had burning sensation during vaccination. Then about 2 hours later states her arm was swollen, painful, and red from her elbow up to her shoulder. By the third day states she could barely move her arm. At that point she went to her doctor who examined her left arm. In the doctor's opinion, the vaccine was administered subcutaneously rather than intramuscularly, which caused the adverse reaction. The patient was not prescribed any medication as a result and just took OTC Naproxen for the pain. Patient is doing much better now with no follow up needed.
Age: 98.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Frequent bowel movements, Nausea, Tremor, Vertigo
Clinical narrative: Vertigo lasting 8 hrs. Nausea Chills Shakes Multiple bowl movements (5)
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Infection
Clinical narrative: Patient claimed that she got in infection after getting a flu vaccine from pharmacy. She claimed that provider from Urgent Care confirmed that. Tried to get clarification from patient to no avail. She claimed that "Pharmacy screwed up" so she does not want to talk.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Patient called approx. 1 1/2 hours post - vaccine to report to RPh that he felt light - headed when leaving the building (after waiting for bus ride). He was still feeling this way somewhat at time of call (~11:05am). He said no other sx except feeling "weird". RPh advised to call if additional sx & referred to primary provider if continued.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time, Blood lactic acid, C-reactive protein, Computerised tomogram head, Dizziness
Clinical narrative: Dizziness, fever, malaise Took an ambulance to ER Followed up with PCP on 10/14/20
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Fibrin D dimer, Full blood count, Malaise, Prothrombin time, Pyrexia
Clinical narrative: Dizziness, fever, malaise Took an ambulance to ER Followed up with PCP on 10/14/20
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Dizziness, fever, malaise Took an ambulance to ER Followed up with PCP on 10/14/20
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling hot, Loss of consciousness, Syncope, Visual impairment
Clinical narrative: patient, mom + sister at pharmacy for flu shots. Pt did not appear anxious + got shot after mom + before sister. Family walked away together after a few minutes + pt fainted approx 20yards from pharmacy Mom caught patient so he did not fall to floor Family returned to pharmacy + pt was observed for 15 minutes, mom requested Gatorade for pt. Pt stated feeling better + family went to lunch after. Pt stated right before fainting felt hot + vision was black + white. Per mom pt not conscious for no more than 10 seconds. Follow up phone call to mom 10-14-2020: mom stated patient fine from after observation on and pt's dad has had history of fainting after an immunization.
Age: 82.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Patient complains of sore arm. DR tells her she now has bursitis
Age: 82.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Balance disorder, Diplopia, Dizziness, Pain, Pyrexia
Clinical narrative: Patient complains of sore arm. DR tells her she now has bursitis
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling
Clinical narrative: Upon checking with patient on 10/14/2020 still massaging, still swollen But did not seek MD care. Self treating. MD office contActed, pt did not contAct MD.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Syringe issue, Underdose
Clinical narrative: When flu shot was administered some of the vaccine came out from the sides. I am not sure how much of the vaccine she received.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received flu shot on 10/13/2020. When pt was walking to car she fainted, Pt woke up soon after. 911 was called. Patient called member information. Did not remember passing out. She was sent home and going to be monitored by parents
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema
Clinical narrative: 10/6 - vaccine given. 10/14 - mother notice "red spot" at injection site. Measure 30 mm x 12 mm.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 10/12/20 - initially swelling/warm to touch around injection site  10/14/20 - swelling expanded past injection site to elbow area
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Today during an encouter, patient mentioned she had muscle pain in arm ever since her shingles vaccine 1 year ago. I recommended she contact her PCP
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Swelling at site of injection lasting > 3 days & Mild Erythema. Local reaction, red cellulitis; no systemic reaction.
Age: 68.0
Sex: U
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Fluad vaccine was given to Patien on 8/21/2020. She is still complaining of pain in the arm. Hard time to move the arm. She is reporting it on 10/13/2020
Age: 20.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Arthralgia, Brain natriuretic peptide increased, C-reactive protein increased, Chest X-ray normal, Chest pain
Clinical narrative: He reported that on 29 Mar he had right sided chest pain with radiation to right shoulder. Pain described as steady and throbbing. Reported slight relief with ibuprofen, unknown if anything made it worse. He had a slight fever, nausea, SOB and dizziness. Was seen in f/u on 01 Apr no recall of chest pain and was told he had a cold. Returned to clinic on 02 Apr feeling better, fever gone and was released to go back to duty. He reported that while he was walking back to his unit the chest pain returned. He went back to clinic and was transferred to hospital where he was admitted with a diagnosis of myocarditis. He had ekg changes and positive Troponin I. He reported that his vaccination site was red and slightly swollen.   Symptoms: CHEST PAIN, UNSPECIFIED(R079), SHORTNESS OF BREATH(R0602), DIZZINESS AND GIDDINESS(R42), NAUSEA(R110), FEVER, UNSPECIFIED(R509).
Age: 20.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Dizziness, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment depression
Clinical narrative: He reported that on 29 Mar he had right sided chest pain with radiation to right shoulder. Pain described as steady and throbbing. Reported slight relief with ibuprofen, unknown if anything made it worse. He had a slight fever, nausea, SOB and dizziness. Was seen in f/u on 01 Apr no recall of chest pain and was told he had a cold. Returned to clinic on 02 Apr feeling better, fever gone and was released to go back to duty. He reported that while he was walking back to his unit the chest pain returned. He went back to clinic and was transferred to hospital where he was admitted with a diagnosis of myocarditis. He had ekg changes and positive Troponin I. He reported that his vaccination site was red and slightly swollen.   Symptoms: CHEST PAIN, UNSPECIFIED(R079), SHORTNESS OF BREATH(R0602), DIZZINESS AND GIDDINESS(R42), NAUSEA(R110), FEVER, UNSPECIFIED(R509).
Age: 20.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Injection site erythema, Mitral valve incompetence, Myocarditis, Nasopharyngitis, Nausea
Clinical narrative: He reported that on 29 Mar he had right sided chest pain with radiation to right shoulder. Pain described as steady and throbbing. Reported slight relief with ibuprofen, unknown if anything made it worse. He had a slight fever, nausea, SOB and dizziness. Was seen in f/u on 01 Apr no recall of chest pain and was told he had a cold. Returned to clinic on 02 Apr feeling better, fever gone and was released to go back to duty. He reported that while he was walking back to his unit the chest pain returned. He went back to clinic and was transferred to hospital where he was admitted with a diagnosis of myocarditis. He had ekg changes and positive Troponin I. He reported that his vaccination site was red and slightly swollen.   Symptoms: CHEST PAIN, UNSPECIFIED(R079), SHORTNESS OF BREATH(R0602), DIZZINESS AND GIDDINESS(R42), NAUSEA(R110), FEVER, UNSPECIFIED(R509).
Age: 20.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate increased, Troponin I increased, Vaccination site swelling
Clinical narrative: He reported that on 29 Mar he had right sided chest pain with radiation to right shoulder. Pain described as steady and throbbing. Reported slight relief with ibuprofen, unknown if anything made it worse. He had a slight fever, nausea, SOB and dizziness. Was seen in f/u on 01 Apr no recall of chest pain and was told he had a cold. Returned to clinic on 02 Apr feeling better, fever gone and was released to go back to duty. He reported that while he was walking back to his unit the chest pain returned. He went back to clinic and was transferred to hospital where he was admitted with a diagnosis of myocarditis. He had ekg changes and positive Troponin I. He reported that his vaccination site was red and slightly swollen.   Symptoms: CHEST PAIN, UNSPECIFIED(R079), SHORTNESS OF BREATH(R0602), DIZZINESS AND GIDDINESS(R42), NAUSEA(R110), FEVER, UNSPECIFIED(R509).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose, Syncope
Clinical narrative: FAINTED IN THE OFFICE; This report was identified from a line listing obtained on request by the Company from the FDA under the Act.   This spontaneous report was received from a other health professional referring to a 12-year-old female patient. The patient's pertinent concurrent conditions, medical history and concomitant medications were not reported, the patient had chills at the time of vaccination or one month earlier, also the patient had no known previous allergies to food or medications.  On 27-SEP-2019 at 10:00, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular in the left arm as prophylaxis (strength, vaccination scheme frequency, lot number and expiration date were not reporter).  On 27-SEP-2019 at 10:10, the patient fainted in the office (syncope). The patient was monitoring and fluids were administered to the patient, also a random glucose test was performed. The outcome of syncope was reported as recovered/resolved.        The agency assessed this event as non-serious.  The causality assessment between suspect vaccine and the aforementioned event was not reported.   As of 09-OCT-2020, the telephone attempt trying to obtain additional information has been unsuccessful.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: rotator cuff surgery; Puffiness / Swelling at the injection site; Hot to touch and swelling at the injection site; Bright redness, hot to touch and swelling at the injection site; Reaction at injection site as a large welp; Strong desire to eat dinner; Strong desire to eat dinner and sleep; Feeling achy, pain; Feeling achy, pain and over bad (malasie); She could remember her own name; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (as a child).   On 5th August 2020 17:00, the patient received the 1st dose of Shingrix (intramuscular). On 6th August 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, injection site erythema, injection site wheal, increased appetite, sleepiness, pain, malaise and memory loss. On an unknown date, the patient experienced rotator cuff repair. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema, injection site wheal, increased appetite, sleepiness, pain, malaise, memory loss and rotator cuff repair were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema, injection site wheal, increased appetite, sleepiness, pain, malaise, memory loss and rotator cuff repair to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix in left arm. The next day patient noticed puffiness, bright redness, hot to touch and swelling at the injection site.  The patient described reaction at injection site as a large welp. The patient reported that her husband touched the affected area for examination. While at work the next day, the patient reported leaving midway through shift with a strong desire to eat dinner and sleep due to feeling achy, pain and over bad malasie. On the same night, the patient's sister called her and she could remember her own name. The patient had a surgery (rotator cuff) and at the time of reporting was on a leave of absence. The did not believe that the surgery contributed to side effects or her husband contracting shingles. The patient complained and was persistent that her husband contracted shingles from her between 15th to 17th August 2020 after she received Shingrix vaccine. The patient stated her husband had chickenpox as a child too, and that he did touch the welp on her injection site; her husband did not receive Shingrix. Initially the patient's husband suspected he had contracted poison ivy due to working outside, but was later diagnosed as shingles and prescribed an unspecified antiviral. The reporter was persistent her husband contracted shingles due to her receiving Shingrix vaccine and was hesitant to receive second dose due to risk of her husband contracted shingles again and similar or worse side effects for her. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal pain upper, Injection site mass, Injection site pain, Injection site urticaria, Pain in extremity
Clinical narrative: Pain in her stomach; The consumer got a rash, hives, and then swelling at injection site; The consumer got a rash, hives, and then swelling at injection site; The consumer got a rash, hives, and then swelling at injection site; This spontaneous report as received from a health professional and refers to a 60-year-old female patient. The patient had asthma and diverticulitis. She did not have drug reactions/allergies neither concomitant therapies.   On 21-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)( PNEUMOVAX23) 0.5 milliliter, injection (route and anatomical site of vaccination was not reported; lot # T021485, has been verified to be a valid lot number, expiration date reported and validated as 31-JUL-2021), it was recommended as the patient had asthma.         On the same date, the patient experienced a rash, hives, and then swelling at the injection site (vaccination site rash, vaccination site urticaria and vaccination site swelling).    Then, on 22-SEP-2020 (reported as the night after the injection), the patient had pain in her stomach (abdominal pain).  She had sought medical attention and received treatment for the events (conflicting information also reported as no treatment provided).   On 27-SEP-2020, she recovered from the events.   The reporter assessed the pain in her stomach may be due to her diverticulitis. The reporter did not assess the causal assessment between vaccination site rash, vaccination site urticaria and vaccination site swelling and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal pain upper, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Pain in her stomach; The consumer got a rash, hives, and then swelling at injection site; The consumer got a rash, hives, and then swelling at injection site; The consumer got a rash, hives, and then swelling at injection site; This spontaneous report as received from a health professional and refers to a 60-year-old female patient. The patient had asthma and diverticulitis. She did not have drug reactions/allergies neither concomitant therapies.   On 21-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)( PNEUMOVAX23) 0.5 milliliter, injection (route and anatomical site of vaccination was not reported; lot # T021485, has been verified to be a valid lot number, expiration date reported and validated as 31-JUL-2021), it was recommended as the patient had asthma.         On the same date, the patient experienced a rash, hives, and then swelling at the injection site (vaccination site rash, vaccination site urticaria and vaccination site swelling).    Then, on 22-SEP-2020 (reported as the night after the injection), the patient had pain in her stomach (abdominal pain).  She had sought medical attention and received treatment for the events (conflicting information also reported as no treatment provided).   On 27-SEP-2020, she recovered from the events.   The reporter assessed the pain in her stomach may be due to her diverticulitis. The reporter did not assess the causal assessment between vaccination site rash, vaccination site urticaria and vaccination site swelling and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 23.0
Sex: F
Vaccine: UNK, FLUC4
Symptoms: Arthralgia, Joint range of motion decreased, Magnetic resonance imaging, Mobility decreased, Pain
Clinical narrative: Patient's human resource department contacted me about information to report the incident and I sent her the VAERS information.  She said her arm started hurting and she saw a doctor for it.
Age: 23.0
Sex: F
Vaccine: UNK, FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient's human resource department contacted me about information to report the incident and I sent her the VAERS information.  She said her arm started hurting and she saw a doctor for it.
Age: 65.0
Sex: F
Vaccine: PNC13, FLU4, PNC13
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Left arm swelled and became red at injection site, then redness spread below injection site approx 15 cm. Area is warm to the touch. Arm is improving with ice and elevation.
Age: 65.0
Sex: F
Vaccine: PNC13, FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swelled and became red at injection site, then redness spread below injection site approx 15 cm. Area is warm to the touch. Arm is improving with ice and elevation.
Age: 59.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Shivering, Low Grade Fever, Aches, Dizziness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Injection site was hot to touch and very sore. Ran low grade fever next day (100 degrees). Upset stomach,  explosive  diarrhea.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Swelling face
Clinical narrative: After took the vaccine on 10/12, my arm felt swelling and pain. On 10/14 when I woke up around 8am, I found my right face was swelling so big and my left face was swelling too at night around 10pm.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye pruritus, Pruritus, Swelling of eyelid
Clinical narrative: right lower eye lid slightly puffy, generalized skin itchy, eyes itchy
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administered; This spontaneous report was received from a physician concerning a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On an unknown date, the patient was administered with improperly stored vaccine of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S038702, expiration date: 01-DEC-2021; at the dose of 0.5 ml, frequency and route were not reported) as prophylaxis (product storage error). The temperature was -9.5 degrees Celsius for 8 hours and 53 minutes and -10.1 degrees Celsius for 6 hours and 40 minutes. There was no previous temperature excursion. The call was because of a data logger.   This is one of three reports from the same reporter.  ; Sender's Comments:  US-009507513-2009USA008520: US-009507513-2009USA008533:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored administered PROQUAD; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 17-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA (Lot # T013540 with expiration date on 17-OCT-2021; dosage regimen and route of administration not reported) for prophylaxis. The administered vaccine underwent a temperature excursion from 6 degree farenheit (F) to 14 F (average 11.7 F) during 25 minutes (no previous temperature excursions). The call was performed by data logger.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 5-year-old patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.     On 10-SEP-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S025608, expiration date 18-AUG-2021, for prophylaxis  (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported) that was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine was stored in a temperature of -14°C to-10°C (-12.50C) for 1 minute and -14°C to-10°C (-14C) for 1 minute (multiple excursions) as recorded by a data logger. There was no previous temperature excursion reported.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; incorrect product storage; This spontaneous report was received from an administrator, referring a female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.  On 05-OCT-2020, at the age of 4-year-old, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T003706, which has been verified to be valid, expiration date reported and validated as 30-JAN-2022), as prophylaxis (product storage error).  Also, a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR ll) was administered to the patient, lot number S029454, which has been verified to be valid, expiration date reported and validated as 19-SEP-2021.   The vaccines administered were stored at temperatures that went -14.27 degrees Celsius (C) to for a time frame of 20 minutes, as recorded by a data logger. There was no previous temperature excursion.  This is one of two reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The pharmacist stated that she administered one of the Varivax doses that underwent a temperature excursion; This spontaneous report has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 08-OCT-2020, the patient was vaccinated with one of the varicella virus vaccine live (oka/merck)(VARIVAX) doses that underwent a temperature excursion, 0.5 ml (strength, route of administration and anatomical site of vaccination were not reported; lot number S032351, expiration date 14-OCT-2021) given as prophylaxis.   The vaccine administered experienced a temperature excursion of 41 Fahrenheit (F), time frame 120 hours, as recorded by a data logger. There was no previous temperature excursion reported.