chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Fatigue, Head discomfort, Hypersomnia
Clinical narrative: 10/29/19: Severe dizziness prevented from getting out of bed at 5:30 am. Could not stand for more than one minute. After drinking some water and about 30-45 minutes rest, I was able to perform some routine activities but head was still very heavy and felt dizzy. I could not work for more than two hours. Came back home and was very tired and slept from 9am to 7pm with getting up in between for lunch and water. I have never slept so much in my life for any reason during the day. 10/30/19: Seen by PCP team member in the am and by then the symptoms were resolved without any medication. That evening, I started having pain in the right knee and right elbow as well as widespread muscle pain in the right side. The pain increased and was severe during the night and could not sleep. I could not move or turn my right knee and right elbow was hurting. Touching certain places was hurting at these sites. 10/31/19: Right knee and right elbow was visibly swollen. Seen by PCP team member around 12.30pm. Advised to take 3 X 200mg Ibuprofen in the morning and night and 1000 mg Tylenol during lunch time and asked to report in 24 hours. The pain continued and no improvement. 11/01/19 ? 11/04/19: Continued medication as advised. No improvement in the swelling. Right arm and elbow symptoms have resolved. Right knee swelling persists with pain. Have been able to bend the leg slightly but cannot apply pressure and climbing stairs is one step at a time.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Joint swelling, Myalgia, Sleep disorder
Clinical narrative: 10/29/19: Severe dizziness prevented from getting out of bed at 5:30 am. Could not stand for more than one minute. After drinking some water and about 30-45 minutes rest, I was able to perform some routine activities but head was still very heavy and felt dizzy. I could not work for more than two hours. Came back home and was very tired and slept from 9am to 7pm with getting up in between for lunch and water. I have never slept so much in my life for any reason during the day. 10/30/19: Seen by PCP team member in the am and by then the symptoms were resolved without any medication. That evening, I started having pain in the right knee and right elbow as well as widespread muscle pain in the right side. The pain increased and was severe during the night and could not sleep. I could not move or turn my right knee and right elbow was hurting. Touching certain places was hurting at these sites. 10/31/19: Right knee and right elbow was visibly swollen. Seen by PCP team member around 12.30pm. Advised to take 3 X 200mg Ibuprofen in the morning and night and 1000 mg Tylenol during lunch time and asked to report in 24 hours. The pain continued and no improvement. 11/01/19 ? 11/04/19: Continued medication as advised. No improvement in the swelling. Right arm and elbow symptoms have resolved. Right knee swelling persists with pain. Have been able to bend the leg slightly but cannot apply pressure and climbing stairs is one step at a time.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On 01-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S006022, expiration date 27-FEB-2021 (exact dose, route and site of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # S026376, expiration date 24-MAR-2022). The vaccine experienced a temperature excursion between 6 to 14 degrees Fahrenheit (F) (7.2 F) for 2 hours. There was no previous temperature excursion reported. Digital data logger was involved to capture the temperature excursion. No adverse effect was reported.
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: arm pain especially when lifting his arm; malaise; This spontaneous report was received from a pharmacist via a company representative and refers to a male patient of unknown age. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. In approximately 2017 (reported as 2 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for unspecified chronic condition. On unknown date in 2017, the patient experienced arm pain, especially when he was lifting his arm and malaise. The outcome of events was reported as recovered within one week of the administration. There was no causality assessment provided by the reporter.  This is one of several reports received from the same reporter.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Mobility decreased, Pain in extremity
Clinical narrative: severe pain in arm; Couldn't move arm and couldn't walk properly; Couldn't move arm and couldn't walk properly; This spontaneous report was received from a 60-year-old female patient who was reporting on herself. The patient did not have any pertinent medical history or concomitant therapies. Drug reactions or allergies included amoxicillin (+) clavulanate potassium (AUGMENTINE).  On 05-AUG-2019 at 15:00, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular in the left arm (exact doses, lot number and expiration date were not reported) for prevention from pneumonia.  On 05-AUG-2019 at 21:00, the patient experienced severe pain in her arm. She said that she could not move her arm and that she could not walk properly. The patient tried using acetaminophen (TYLENOL) and ibuprofen (ADVIL) but they did not stop the pain. She went to the emergency room on 10-AUG-2019 and was prescribed medication that she had to take for five days. No laboratory diagnostics or studies were performed. The patient was no longer feeling pain after taking the medications. She recovered from the events on 15-AUG-2019.  The causal relationship between the events and the suspect drug was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle Pain; Headache; Severe chills; In bed for three days; This case was reported by a nurse and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, bedridden, muscle pain, headache and chills. On an unknown date, the outcome of the fever, muscle pain, headache and chills were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the fever, bedridden, muscle pain, headache and chills to be related to Shingrix.  Additional case details were reported as follows: The patient was a runner and very healthy. The age at vaccination was not reported. This vaccine has had patient in bed for three days with fever, muscle pain, headache, and severe chills.  It was reported that something was wrong with this vaccine. It scares patient to think of what she put in her body. The warnings on the side effects should be much stronger. The patient would never recommend this vaccine to anyone professionally or personally. The reporter consent to follow up. This is 1 of the 2 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Light headedness; Nauseous; This case was reported by a consumer and described the occurrence of light headedness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced light headedness and nausea. On an unknown date, the outcome of the light headedness and nausea were unknown.   It was unknown if the reporter considered the light headedness and nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter asked can you have side effects 2 weeks after getting your first Shot. The patient said experiencing light headedness and nauseous.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Fatigue; Flu like symptoms; Feel terrible; This case was reported by a nurse via call center representative and described the occurrence of fever in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain, fatigue, influenza-like symptoms and feeling bad. On an unknown date, the outcome of the fever, general body pain, fatigue, influenza-like symptoms and feeling bad were unknown.   It was unknown if the reporter considered the fever, general body pain, fatigue, influenza-like symptoms and feeling bad to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The reporter stated all the patients she had been involved with feel terrible after getting their first Shingrix shot. Every other provider she worked with, said the same thing about their patients getting the first Shingrix. The reporter even heard people discuss it at a conference she went to.  The patients told me that they had flu like symptoms, after their first Shingrix vaccination. The reporter did not have specific patient or product information to provide at time of initial report. The reporter consent to follow up.
Age: 74.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: By the night of the shot, my arm was swollen, bright red from shot site and wrapped around inside my left arm. The nerve endings were alive and well near injection site. That was the worst.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Nasopharyngitis, Swelling
Clinical narrative: Woke with Fatigue, cold, swelling under Left axillae, wEakNEss, swElling in dEltoid area
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Immediate post-injection reaction, Influenza like illness, Injected limb mobility decreased
Clinical narrative: strong burn on administration; extreme muscle pain  and immobility of left arm; flu like aches that proceeded to takeover body  for 48 hours, included neck pain and headache for same 48 hours
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain
Clinical narrative: strong burn on administration; extreme muscle pain  and immobility of left arm; flu like aches that proceeded to takeover body  for 48 hours, included neck pain and headache for same 48 hours
Age: 33.0
Sex: F
Vaccine: FLUR4
Symptoms: Chest pain, Dizziness, Dyspnoea, Throat tightness, Urticaria
Clinical narrative: PATIENT PRESENTED IN IMMEDIATE CARE A COUPLE HOURS AFTER VACCINE ADMINISTERED COMPLAINING OF CHEST PAIN, SHORTNESS OF BREATH, THROAT FELT TIGHT, HIVES AND DIZZINESS. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO EMERGENCY ROOM.  PATIENT RECEIVED IV FLUIDS AND PRESCRIBED STEROIDS.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient reported on 11/3/19 that after the shot he developed a rash on both of his arms and his sternal area.  He did not specify date of onset. He also reported that after his shot he had worn multiple layers of clothing to work and did not know if the rash was related to the vaccine or the clothing.  The patient had applied Aveeno one day and then on 11/3/19 applied Noxzema to the rash.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Body temperature decreased, Chills, Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: The night of the vaccine, patient started feeling very fatigued. Sleep 20 hours each day from Monday night through Friday. Saturday had chills, nausea, and temperature of 95. Also experienced "brain fog" the whole time. By Sunday she was fine.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Nausea
Clinical narrative: The night of the vaccine, patient started feeling very fatigued. Sleep 20 hours each day from Monday night through Friday. Saturday had chills, nausea, and temperature of 95. Also experienced "brain fog" the whole time. By Sunday she was fine.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives within 24 hours after receiving immunization. Patient took Benadryl and is consulting her physician.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling cold, Headache, Hyperhidrosis, Influenza, Pyrexia
Clinical narrative: patient reports severe flu symptoms (fever, sweating, chills, and headache) that developed Friday night after the vaccine (11/1/2019), lasted throughout Saturday (11/2/19) and subsided Sunday (11/3/19)
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Clonic convulsion, Condition aggravated
Clinical narrative: Client has had an active seizure disorder since the age of 18 (per client report); however, client told clinician, "this flu shot won't cause a seizure".   Flu Vaccine was administered and as the safety needle was retracting, client experienced a clonic seizure.  Client remained in chair through seizure which lasted about two minutes.  After seizure stopped, client laid on floor for a few minutes and then sat in chair for a few minutes.  Office lights were turned off and client was given a cold pack.  Client walked to his car with supervision from clinician and client's wife drove him home.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising
Clinical narrative: Pt came to the pharmacy on 11/2/19 with a dark bruise about 1.5 inches around the injection site.  The bruise was really dark (blackish/red) in color.  Pt will follow up wth her Dr.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Malaise, Pain, Pain in extremity
Clinical narrative: malaise, body aches and arm pain beyond expected and rash at site of injection
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Gastroenteritis, Vomiting
Clinical narrative: Agency nursing staff called to report client had uncontrollable vomiting about 2 hours after the injection was given. Another individual had the same reaction, so probably gastroenteritis, but reporting it just in case.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Agency Nursing staff called to report uncontrollable vomiting started about 2 hours after the injection
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Muscular weakness, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Weakness and pain starting in legs and traveling up body to neck. All my joints are painful - feet, knees, hips, shoulders, neck, and even jaw, but especially swollen hands/ fingers. Only short relief from hot showers or heat.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Coating in mouth, Dry mouth, Lip dry
Clinical narrative: Later in the day of the vaccine, I noticed dry mouth, tongue and lips.  When I eat or drink, it gets worse and feels like something coats my tongue and mouth.  When it persisted, I searched the internet for dry mouth as a flu shot reaction, but it was not listed on web sites that came up.  This has gone on  continually for almost two weeks now and I have had no other symptoms.  I have nothing else to  relate it to except starting from the flu shot.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: That evening, patient experienced itching, warmth and rash at the injection site.  A large red welt developed over the injection site that evening and she came to show me the following Monday that the welt remained, but the itching had subsided some.  She had been taking diphenydramine after speaking with her daughter who is in pharmacy school over the weekend. No other generalized reaction was noted.  The welt subsided over one week.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Injection caused pain and limited ROM.  Unable to lift arm past 90 degrees without significant pain.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Left shoulder pain persistent consistent with tendonitis secondary to influenza vaccine
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient was vaccinated Wednesday and states she experienced no adverse events until Thursday.  Thursday she reported sore arm.  Thursday through Friday she experienced a headache, which patient states is very rare for her (resolved by Friday evening).  Saturday she noticed large area of redness/swelling/warmth around injection site.  All are documented ADRs, but pt requested it be reported.  This was patient's 2nd vaccination (with first vaccine 8/16/2019 and reported no adverse reactions)
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain in right upper arm increasing in the late afternoon on 11/03. Pain was most noticeable on inside of right upper arm where pneumonia vaccine was given. Naproxen taken and pain mostly relieved. On the morning of 11/04, mild pain still experienced. Site examination showed redness on right arm from below injection site to the inner side of the arm where there is a hard red site.  I went to care center and was diagnosed as having a reaction to the pneumonia vaccine and prescribed prednisone and Benadryl.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site rash, Pyrexia, Rash erythematous
Clinical narrative: fever and red patches over body and at site of injection
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Arm still has a little itching; This case was reported by a consumer and described the occurrence of itchy upper limbs in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced itchy upper limbs. On an unknown date, the outcome of the itchy upper limbs was unknown.   It was unknown if the reporter considered the itchy upper limbs to be related to Shingrix.  Additional case details were reported as follows: At the time of this report, the patient continued to have a little itching after shingles shot. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Induration, Skin reaction
Clinical narrative: Cutaneous reaction 15x17 cm area with mild induration and increased warmth in the right deltoid; Increased warmth in the right deltoid; cutaneous reaction; This case was reported by a physician via call center representative and described the occurrence of induration in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2019, the patient received Shingrix. On 25th October 2019, 1 days after receiving Shingrix, the patient experienced induration, localized feeling of warmth and skin reaction. On an unknown date, the outcome of the induration was not recovered/not resolved and the outcome of the localized feeling of warmth and skin reaction were unknown.   It was unknown if the reporter considered the induration, localized feeling of warmth and skin reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The next day  of vaccination the patient developed a cutaneous reaction 15 by 17 cm area with mild induration and increased warmth in the right deltoid.   This event was ongoing at the time of this report. The HCP did not have the lot number or expiration date as the vaccine was not given at his office.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Erythema, Swelling
Clinical narrative: Bedridden; Redness; Swelling; This case was reported by a nurse via call center representative and described the occurrence of bedridden in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced bedridden, erythema and swelling. On an unknown date, the outcome of the bedridden, erythema and swelling were unknown.   It was unknown if the reporter considered the bedridden, erythema and swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. A nurse reports that approximately 15 to 20 percent of patients who were injected with Shingrix ended up bedridden with unspecified side effects.  The reporter did mention redness and swelling but was not specific if there were injection site reactions.  The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Right arm swelled.  Was red from elbow up to shoulder and hot to the touch.  Body aches and slight fever.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension, Presyncope, Visual field defect
Clinical narrative: Hypotension to the point where my BP would not register on my home BP monitor.  I near  passed out twice & would have fallen had I not clued in to the warning signs, i.e. loss of peripheral vision, dizziness.  I took it easy the rest of the day & by late afternoon, I was fine.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Child received a flu shot and 2-3 hours later developed significant swelling of left arm from above elbow to shoulder- Arm very red, hard,  tender & warm  to touch. Mother of child spoke with nurse practitioner @ pediatrician's office. Also, texted photos of child's arm. Benadrl and  Ibuprofen prescribed. Symptoms gradually resolved over the next 2 1/2 days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Dysphagia, Headache, Immune thrombocytopenic purpura, Influenza like illness
Clinical narrative: SEVERE SORE THROAT, TROUBLE SWALLOWING 3 HOURS AFTER VACCINE, WENT TO URGENT CARE AND WAS GIVEIN BENADRYL AND RANITIDINE. THROAT ISSUES RESOLVED QUICKLY BUT HAD  FLU-LIKE SYMPTOMS IN EVENING AND HEADACHE NEXT MORNING. TOOK IBUPROPHEN AND ALL RESOLVED. ON OCTOBER 16, ABOUT 2AM, WHILE PREPARING FOR COLONOSCOPY, NOTICED BRUISES AND PETECHIAE ON LEGS. WENT TO GI CLINIC NEXT MORNING WHERE THEY DID BLOOD WORK AND FOUND THAT I HAD NO PLATELETS. I WAS HOSPITALIZED FOR AND DIAGNOSED WITH IMMUNE THROMBOCYTOPENIC PURPURA (ITP). TREATED WITH PLATELET TRANSFUSION AND HIGH DOSE STERIODS.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Petechiae, Platelet count decreased, Platelet transfusion
Clinical narrative: SEVERE SORE THROAT, TROUBLE SWALLOWING 3 HOURS AFTER VACCINE, WENT TO URGENT CARE AND WAS GIVEIN BENADRYL AND RANITIDINE. THROAT ISSUES RESOLVED QUICKLY BUT HAD  FLU-LIKE SYMPTOMS IN EVENING AND HEADACHE NEXT MORNING. TOOK IBUPROPHEN AND ALL RESOLVED. ON OCTOBER 16, ABOUT 2AM, WHILE PREPARING FOR COLONOSCOPY, NOTICED BRUISES AND PETECHIAE ON LEGS. WENT TO GI CLINIC NEXT MORNING WHERE THEY DID BLOOD WORK AND FOUND THAT I HAD NO PLATELETS. I WAS HOSPITALIZED FOR AND DIAGNOSED WITH IMMUNE THROMBOCYTOPENIC PURPURA (ITP). TREATED WITH PLATELET TRANSFUSION AND HIGH DOSE STERIODS.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Malaise, Oral herpes, Pain
Clinical narrative: PATIENT RECEIVED SHOT WITHOUT INCIDENCE . THREE HOURS LATER DEVELOPED 103 FEVER , ACHES, CHILLS, MALAISE. TWO DAYS LATER BETTER BUT STILL WEAK
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Patient reports immediate onset of pain with injection. She then continued to have right shoulder pain since then. She reports pain with use of the arm and difficulty sleeping due to moving the arm. She is doing all usual activities. Physical examination today 11/4/19 indicates no erythema, no warmth, no lesions, no edema. Mild diffusely tender. Full range of motion but with pain at the end of movements in abduction and forward flexion.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injury associated with device, Peripheral swelling, Product use complaint
Clinical narrative: Patient's mother called and stated that her daughter's arm had swollen to the size of a baseball around 3pm the day after the vaccinations (11/3/19).  She stated that the pharmacist was having trouble giving the vaccine.  The pharmacist who gave the vaccine states that the patient moved right as she was giving the vaccine so the needle grazed the arm, but did not go in so she proceeded to switch the needle with a new clean needle, then gave the vaccine as she normally would.  The patient's mother said she does not have a fever or any other side effects.  The mother was instructed to call the pediatrician's office and the pediatrician told her she could ice the vaccine site.  They told her if the swelling got worse or did not improve to bring her into the office.  The patient's mother is going to call us after the patient gets home from school to let us know how her daughter is doing.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient reports continuing pain at the injection site 16 days after vaccination. Denies redness, itching or lump.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Paraesthesia, Tremor
Clinical narrative: Patient had initial vaccination and experienced bilateral joint pain within a few hours that persisted for around 1 month. Patient did not consider this an issue as it is a common side effect with her vaccination site soreness. Patient received second dose on 01NOV2019 and on 02NOV2019 experienced paresthesia and tremors in all extremities. This was ongoing for around 1-3 hours consistently. Patient is currently asymptomatic.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Arm stiffness and pain at and around injection site, pain level "20/10." Pain persisted throughout the night and into the next morning, when patient went to PCP. Could not lift arm beyond 90 degrees. Patient used NSAIDs, antihistamines, cold compress (heating pad later) with minimum relief. PCP prescribed Prednisone tablets and patient received Prednisone shot, pain has lessened but still present.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site paraesthesia, Injection site warmth, Neck pain
Clinical narrative: Patient described an almost immediate feeling of warmth and tingling in shoulder and up into the left side of her neck following administration.  This feeling increased over a few days and became painful in shoulder and neck.  She has difficulty lifting her arm above her head.
Age: 6.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Redness around injection site, 1 hive just above injection site. Patient was treated with Benadryl 12.5mg liquid orally and had an ice pack over reaction.   Patient was monitored in office for 15 minutes  at which point the redness had decreased significantly. The hive was still present. He did not have signs/symptoms of anaphylaxis at any point.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site urticaria, Joint swelling
Clinical narrative: Patient called at 9:10 AM on 11/4/19 to report she had an adverse reaction to pneumovax-23 she received on 11/2/19.  She stated within 1 hour she had a raised red area with hives at injection site which has now gone down.  She had swelling under her arm and currently reports swelling and soreness at elbow area.  She did not seek medical treatment.  She has no fever.  She did report over the phone that she received Fluzone HD at pharmacy on 9/27/19 and experienced a similar reaction.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Patient called at 9:10 AM on 11/4/19 to report she had an adverse reaction to pneumovax-23 she received on 11/2/19.  She stated within 1 hour she had a raised red area with hives at injection site which has now gone down.  She had swelling under her arm and currently reports swelling and soreness at elbow area.  She did not seek medical treatment.  She has no fever.  She did report over the phone that she received Fluzone HD at pharmacy on 9/27/19 and experienced a similar reaction.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dizziness, Eye discharge, Eye irritation, Headache
Clinical narrative: Swollen throat, burning eyes, cough, headache, muscle aches, mucous in eyes, dizziness, vomiting.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pharyngeal swelling, Vomiting
Clinical narrative: Swollen throat, burning eyes, cough, headache, muscle aches, mucous in eyes, dizziness, vomiting.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Eye discharge, Feeling cold, Ocular hyperaemia, Pyrexia, Throat tightness
Clinical narrative: About 5pm in evening, started getting cold, shaking, white of eyes turned pink, there was matter in eyes, temperature was 100.2 ; laid down and it lasted 45 minutes.  Took a couple of Tylenol for the fever which reduced it. Eyes were still pink, throat was not sore but felt like if it was closing up. Sat down and drank some Gatorade/fluids. Next morning felt fine, eyes were just a little pink--they took one more day to clear up.   Called doctor the next day, and thought it was probably a virus not a vaccine reaction.   This is the first time the patient received the High Dose vaccine
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Viral infection
Clinical narrative: About 5pm in evening, started getting cold, shaking, white of eyes turned pink, there was matter in eyes, temperature was 100.2 ; laid down and it lasted 45 minutes.  Took a couple of Tylenol for the fever which reduced it. Eyes were still pink, throat was not sore but felt like if it was closing up. Sat down and drank some Gatorade/fluids. Next morning felt fine, eyes were just a little pink--they took one more day to clear up.   Called doctor the next day, and thought it was probably a virus not a vaccine reaction.   This is the first time the patient received the High Dose vaccine
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Upper respiratory tract infection
Clinical narrative: both my wife and i got vaccinations at the same time a both came down with severe upper respiratory infections at the same time .We do not normally have  "colds '' much any more and were both bed ridden for several days . We read of the concern that measles can weaken immune response  and wanted to report this as it might indicate a relationship.   We are both on the mend now but wanted to give a heads up about it .
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; patient received one dose of PNEUMOVAX 23 approximately 4-5 months too early; This spontaneous report was received from a pharmacist and refers to a 79-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-OCT-2019, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S021740, expiry date 25-MAR-2021) (exact dose and route of administration were not reported) for prophylaxis, approximately 4-5 months too early. No adverse effects were reported. The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Mouth ulceration, Tongue ulceration
Clinical narrative: Open ulcers in her mouth, primarily under her tongue; Open ulcers in her mouth, primarily under her tongue; This case was reported by a physician via sales rep and described the occurrence of mouth ulcer in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. In September 2019, couple of days after receiving Shingrix, the patient experienced mouth ulcer and tongue ulceration. On an unknown date, the outcome of the mouth ulcer and tongue ulceration were resolved with sequelae.   It was unknown if the reporter considered the mouth ulcer and tongue ulceration to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was over 65 years old.  The physician reported to a field representative that a patient developed open ulcers in her mouth, primarily under her tongue, a couple days after receiving Shingrix.  This occurred within the last month.  The physician did not want any follow up. The reporter did not consent to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chronic obstructive pulmonary disease, Diabetes mellitus, Dyspnoea, Flank pain
Clinical narrative: don't spit up sputum maybe once in a while; pneumococcal pneumonia; pneumococcal pneumonia; COPD; shortness of breath; had a pain in my side; sweat a lot; no energy; diabetes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that the female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient had got pneumococcal pneumonia twice in a row within two months. Her last doctor in the hospital, the second hospital, put her into a breathing unit. And the doctor thought she had got chronic obstructive pulmonary disease (COPD). The patient had diabetes too and it came on suddenly. The patient didn't cough at all. The patient had a pain in her side and she sweated a lot. And shortness of breath and no energy. For the first time she was in the hospital for two weeks. Two months later she had the same thing happen to her all at once. And again she was sweating. She had pain in her side once in a while. Shortness of breath. No energy. And she was in the hospital for four days. That doctor sent her out oxygen unit home with her that she could not get rid of because the doctor thought she had COPD. The patient was at the moment undergoing lung tests to verify what she had because she didn't want it to happen again. As she said it was very sudden, she had no colds, she didn't wheeze. She didn't spit up sputum maybe once in a while. And she did spit up some for the hospital, the last hospital, but they never got it in the lab. The patient believed this was bacterial and not viral. The outcome of events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis, Pneumonia pneumococcal, Productive cough, Pulmonary function test
Clinical narrative: don't spit up sputum maybe once in a while; pneumococcal pneumonia; pneumococcal pneumonia; COPD; shortness of breath; had a pain in my side; sweat a lot; no energy; diabetes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that the female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient had got pneumococcal pneumonia twice in a row within two months. Her last doctor in the hospital, the second hospital, put her into a breathing unit. And the doctor thought she had got chronic obstructive pulmonary disease (COPD). The patient had diabetes too and it came on suddenly. The patient didn't cough at all. The patient had a pain in her side and she sweated a lot. And shortness of breath and no energy. For the first time she was in the hospital for two weeks. Two months later she had the same thing happen to her all at once. And again she was sweating. She had pain in her side once in a while. Shortness of breath. No energy. And she was in the hospital for four days. That doctor sent her out oxygen unit home with her that she could not get rid of because the doctor thought she had COPD. The patient was at the moment undergoing lung tests to verify what she had because she didn't want it to happen again. As she said it was very sudden, she had no colds, she didn't wheeze. She didn't spit up sputum maybe once in a while. And she did spit up some for the hospital, the last hospital, but they never got it in the lab. The patient believed this was bacterial and not viral. The outcome of events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Injection site pain
Clinical narrative: Experienced pain at this injection site; This is a spontaneous report from a contactable pharmacist via a sales representative.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), at single dose and influenza vaccine (unknown manufacturer), both via an unspecified route of administration in the arm on the same unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at this injection site on an unspecified date with outcome of unknown.   Information on the batch number has been requested.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Erythema, Tenderness
Clinical narrative: Redness and tender below the area of administration for 3 days.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Abscess drainage, Blood test, Headache, Imaging procedure, Musculoskeletal stiffness
Clinical narrative: The evening of the day the child received the vaccines, they started running a fever. The next day the child complained of their head and neck hurting. After two days of fever and complaints of a stiff neck and sore head, the child was taken to the local ER. Many tests were done and it was discovered that there was something in the neck. The child was transported to a hospital where they were admitted for 5 days. The diagnosis was a retropharyngeal abscess. The child received IV antibiotics and had interventional radiology done to drain the abscess. The child had no previous illness before receiving the vaccine. The child was also diagnosed with the RHino virus and Strep throat at the ER.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pharyngeal abscess, Pharyngitis streptococcal, Pyrexia, Rhinovirus infection
Clinical narrative: The evening of the day the child received the vaccines, they started running a fever. The next day the child complained of their head and neck hurting. After two days of fever and complaints of a stiff neck and sore head, the child was taken to the local ER. Many tests were done and it was discovered that there was something in the neck. The child was transported to a hospital where they were admitted for 5 days. The diagnosis was a retropharyngeal abscess. The child received IV antibiotics and had interventional radiology done to drain the abscess. The child had no previous illness before receiving the vaccine. The child was also diagnosed with the RHino virus and Strep throat at the ER.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Patient's arm began to swell around the injection site and there was some bruising
Age: 15.0
Sex: F
Vaccine: HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Client had a 52mm X 42 mm circular red swollen area on left upper arm. client applies warm compresses and uses Motrin.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Immediate post-injection reaction, Malaise, Unresponsive to stimuli
Clinical narrative: The patient received his shingrix injection first, followed by fluarix. Immediately after receiving his fluarix the patient stated that he did not feel well. After saying that, he became immediately unresponsive.  The patient was unable to respond to verbal commands or questions. He was injected with an Epipen 2 minutes after receiving the last vaccine at 12:23pm. At 12:25 Epinephrine was given and patient became responsive again at 12:27.  EMS arrived on the scene, patients heartrate was in the 40s still and patient was taken to emergency room
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Influenza vaccine was given to client approx at 1:30pm on 10/26/2019.  Parent stated that client started with hives on 10/26/19 approx. 8:30 pm. Hives started on her back, sides, stomach and chest and gradually over the next couple of days more hives appeared on hips and legs. Parent stated that she had given client Benadryl at home and applied hydro-cortisone cream to affected areas. Denied any breathing issues, fever and any other symptoms. Parent called client's PCP and an appointment was made on 10/31/2019 to be seen by PCP.
Age: 86.0
Sex: M
Vaccine: FLUA3
Symptoms: Back pain, Dizziness, Fall
Clinical narrative: I happened to walk by towards the customer service desk when the patient had already fallen on the ground, a couple of minutes after receiving her flu shot. When we were able tog et her to respond she stated she felt a little dizzy at the moment and fell. She also stated her back was hurting at the time.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: PNEUMOVAX VACCINE 11/1/2019 CAUSED SWELLING IN SHOULDER THAT MOVED DOWN THE ARM AND APPROXIMATELY 1/2 OF THE ARM WAS NOTICEABLY SWOLLEN BY 11/02/2019. SHE VISITED THE ER AND THE MD ADVISED ICE AND DIPHENHYDRAMINE. SWELLING STARTED RESOLVING 11/3/2019 AND BY 11/4/2019 HAS MOSTLY RESOLVED BUT LOCALIZED INCREASED DENSITY OF DELTOID AT LOCATION OF THE SHOT IS NOTED. PAIN WAS ELEVATED LATER 11/1/2019 AND PEAKED 11/2/2019 AND HAS NOT FULLY RESOLVED BUT IS MUCH LOWER 11/4/2019 PER PATIENT.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Registered Nurse Registered Nurse Progress Notes Signed Encounter Date:  10/31/2019     Signed        Patient comes to the department with pain in her arm post influenza vaccine.  Patient state the pains runs from her left deltoid muscle down to her wrist.  She state it is a 5/10 all the time.  With certain movements it will increase to a 8 or 9/10 with certain movements.  Patient was encourage to take ibuprofen and to apply heat as needed.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, HIV antibody negative, Streptococcus test, Vomiting
Clinical narrative: Vomiting and diarrhea same day as vaccine.  Hives day after vaccine lasting for three days to date.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Injection site erythema, Injection site streaking, Injection site warmth
Clinical narrative: Arm was sore the day of the vaccine. Next day felt tired, sore--but did not think it was out of norm.  On Friday started feeling bad, around 8am, patient noticed the redness on site; there was a red streak 3 inches long coming down from site, bicep completely red and had elevated temperature.  It was red enough that patient thought it looked like inflammation.    Patient called vaccine administrator and took Tylenol 650; patient felt better somewhat.   Patient went to doctor and specified it was not coming from vaccination site.  Doctor asked whether patient had low immune system and specified it was strep under the skin.  Doctor specified that it was not contagious and prescribed generic Augmentin. Patient felt better after taking antibiotic; it lasted for 5 days.   The redness slowly went away,   went to doctor on 10/30, because redness was still there and told that did not need more antibiotics. By yesterday patient felt better.   Today, only a little bit of redness remains.    Today patient not feeling great and not sure whether related vaccine or not.   Reaction to Flu vaccine in 2009 was similar but much worse; redness and warmth were similar but did not take any antibiotics.   Patient did not have carcinoma at the time but lung infection micro bacteria avian complex. Patient has received Flu vaccines after that year with no problems
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Streptococcal infection
Clinical narrative: Arm was sore the day of the vaccine. Next day felt tired, sore--but did not think it was out of norm.  On Friday started feeling bad, around 8am, patient noticed the redness on site; there was a red streak 3 inches long coming down from site, bicep completely red and had elevated temperature.  It was red enough that patient thought it looked like inflammation.    Patient called vaccine administrator and took Tylenol 650; patient felt better somewhat.   Patient went to doctor and specified it was not coming from vaccination site.  Doctor asked whether patient had low immune system and specified it was strep under the skin.  Doctor specified that it was not contagious and prescribed generic Augmentin. Patient felt better after taking antibiotic; it lasted for 5 days.   The redness slowly went away,   went to doctor on 10/30, because redness was still there and told that did not need more antibiotics. By yesterday patient felt better.   Today, only a little bit of redness remains.    Today patient not feeling great and not sure whether related vaccine or not.   Reaction to Flu vaccine in 2009 was similar but much worse; redness and warmth were similar but did not take any antibiotics.   Patient did not have carcinoma at the time but lung infection micro bacteria avian complex. Patient has received Flu vaccines after that year with no problems
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Head injury, Headache, Vertigo
Clinical narrative: Patient describes a severe headache and severe dizziness/vertigo. She fell twice on 11/3/2019 and hit her head and back on the first fall and fell forward landing on her hands and knees down 3 stairs the second time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Palpitations, Pyrexia
Clinical narrative: The patient called the pharmacy to report that the evening after her first shingrix shot she started to feel her heart racing a lot more than normal, and then she was feverish throughout the night. In the morning she still didn't feel good and ended up blacking out and falling over. She notified the pharmacy on the Monday after and said she is feeling fine now.  She has called her primary physician and on of her specialist MDs in order to determine if she should be seen as well as to find out if she should get the second dose.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Streptococcus test, Vomiting
Clinical narrative: Vomiting the same day as the vaccine.  Diarrhea the morning after the vaccine.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reports arm was sore and could not lift arm--patient feels that she got an infection from vaccination--patient planned on going to After Hours Clinic
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Fatigue, Pain, Pyrexia
Clinical narrative: Extreme pain throughout entire body.  Fever of 101. A little bit of confusion at times. Chills. Extremely tired.