chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received HAV (Havrix) (batch number T57F3, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-FEB-2023 Reporter's comment:  The reporter reported that an expired dose of Havrix was administered to a patient.  The reporter consented to follow up via email. Additional supportive information. The patient received expired dose of Havrix, which led to expired vaccine used.
Pt recvd series of 3 hep B vax from spring 1990 thru AUG90.Titer revealed pt was non-responder.
The vaccine was not administered intramuscularly. I did not realize this until I was sitting in the post vaccine waiting area.   I contacted the health department and left a message about my experience.  I requested a call back but still have yet to hear from the health department.  I am concerned about vaccine efficacy. How will this affect immunity of my vaccine and should I receive a third dose?
compromised immune system/immune system was down; covid vaccination and humira were fighting each other with humira; flare ups seemed to have occurred between humira injection; Wearing off effect; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4392189-00 (Agency).  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159929) at unk (citrate free), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "recovering", described as "compromised immune system/immune system was down"; DRUG INTERACTION (non-serious), outcome "unknown", described as "covid vaccination and humira were fighting each other with humira"; CONDITION AGGRAVATED (non-serious), outcome "recovering", described as "flare ups seemed to have occurred between humira injection"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "unknown", described as "Wearing off effect". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial  The reporter's assessment of the causal relationship of "compromised immune system/immune system was down", "covid vaccination and humira were fighting each other with humira" and "wearing off effect" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "flare ups seemed to have occurred between humira injection" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of immunodeficiency, drug interaction,condition aggravated,therapeutic response shortened. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
7 days after injection, I experienced swelling in my upper left arm.  The area was red and hot to the touch. After about 2 days, the area became itchy.
Pt recv vax on 10/23/98; on 10/27/98 pt exp weakness, lightheaded & chills
The patient was accidently given flu shot when they only needed covid vaccine. The patient had received a flu shot month and a half ago already. So, patient was double vaccinated for Flu shot.
pt recv vax & arm hurt so bad came home from school;tired-unable to sleep d/t pain;c/o feeling warm;sore throat last noc;also TD rt arm sore;30SEP96 swelling gone, redness dec;feels ok but exhausted;
Seven hours after getting FLUZONE High-Dose flu vaccine I got ill - terrible chills and disoriented. Had muscle aches throughout evening. Went to bed and woke up at 5:00 am with terrible chills again and feeling nauseous.
Shot given 06/14/2021, pt Fainted 6/16/21 Mom reported on 7/5/21. Unsure op correllation. So filed vaers in case. pt was fine after episode
63 year old patient presented to the clinic 3 days after PCV13 vaccine given today for acute sudden left shoulder pain. Patient was recently at the clinic OCT 31 2018 and he received PREVNAR vaccine on his left arm. That night he started feeling the injection area stiff and sore but then he developed a sharp 10/10 left shoulder pain with radiation to the left arm, no weakness of numbness, he is not able to lift his left arm about the head, limited to about less than 15 degree in abduction, he uses his right arm hand to help lift the left one. He denies lifting any heavy objects, denies trauma, denies any further injuries. He had pneumonia vaccine before and never had reaction to it. Denies swelling of the shoulder, redness, no other issues. Patient then presented a day later to the ER c/o itching, redness to face and neck, tongue swelling and wheezing. Pt stated s/sx began after he took his second dose of naproxen. Pt was prescribed naproxen for the pain and hydrocodone. Pt stated he took both medications last night, today only the naproxen, then the other s/sx began. Symptoms: Muscle pain; Treatment Drugs Used: Naproxen Dose: 500 Units: MG Freq: BID Route: PO
Vaccine given 1-12-09.  Pt complained of severe pain at injection site on 01-16-09.  It was not relieved by ice or EXCEDRIN.  ADVIL provided minimal relief.  No redness swelling or drainage or numbness at site.
Pt complained pain in his injection arm. I looked at his arm and there was no redness or irritation.  He said there wasn't a nodule or hard spot, and I also felt for one and couldn't find any.  He said it is painful and isn't improving.  I advised him that the injection could have nicked a blood vessel and caused some bruising or possible even a nerve and causing pain.  I told him to check with his doctor if it was really bothering him.  He also said that he had been taking some pain meds and muscle relaxers to try and alleviate the pain.
Tiredness; Dizziness; Nausea; body aches; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced tiredness on Jan2021 with outcome of recovered, dizziness on Jan2021 with outcome of recovered, nausea on Jan2021 with outcome of recovered and body aches on Jan2021 with outcome of unknown. The action taken was not applicable. the reporter stated "she got her first dose on 12Jan and a few days later she had tiredness that went away. She had some issues the past couple of days and wanted to see if it was related. She had dizziness and nausea that went away, she had body aches for a couple of days. Stated that she is getting her second dose on Friday." Information on the lot/batch number has been requested.
I95.9 HYPOTENSION 8/27/2022 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 8/27/2022 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 8/27/2022 ATRIAL FIBRILLATION, UNSPECIFIED R09.02 HYPOXIA 8/27/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Immediately after getting the flu shot, felt pain down the L arm and numbness/tingling to fingers; numbness and tingling continues but moving from index/thumb to pinky overnight; soreness persists; afebrile, no swelling, no redness; applied ice pack and took ibuprofen orally.
Breakthrough case admission after 3 vaccines Pfizer 3/16/21 Lot# EN6207;  Pfizer 4/6/21 Lot# Ew0150;  Pfizer 2/1/22 Lot# FJ6369
Intense pain to bilateral legs, hips, feet w/burning, unsteady gait, weakness,shortness of breath. Worsening pain when sitting/lying down. Unable to do household chores, pain 10/10, pain medication taken w/o complete relief. Unable to sleep more than 2 hrs waking up w/pain. Still having intense pain. Saw ARNP at pain clinic for scheduled appt, set up epidural appt.
It started as redness and itching at the injection sight.  It just kept swelling all the way to my elbow.  It became tight and still itchy.  After it began to go past my elbow I contact my doctor and they prescribed a steroid.  After 3 days they swelling went down and the itching went away.
Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in March 2013, the patient was vaccinated with the first dose of ZOSTAVAX (strength, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. On 19-SEP-2017, the patient received a second dose of ZOSTAVAX (strength, anatomical location, administration route, lot number and expiration date were not reported) also for prophylaxis. No adverse symptoms were reported.
Patient states it started 11/5/2018 she had arm pain and her arm is swollen and has trouble lifting her arm. She states she doesn't understand why because the shot was pain free and was given in the middle of the deltoid muscle where it is supposed to be. She was curious to know if it was a side effect of allergic reaction and was going to her MD 11/6/2018 and would check back in with me.
pt recv vax 16OCT96 & rash on stomach, back, face & lower legs devel 8NOV96;rash persisted through 22NOV96;no other problems noted;to see family MD 22NOV96;
i woke up around 5:30 a.m. on january 8th, and besides my left arm hurting when i tried to raise it,  i noticed that i had ear  aches and a headache.   In addition,  I also noticed that i was very lethargic and it lasted all the day into sunday january 9th..    I just wanted to sleep and had no energy all day and all night..   Previous to my booster shot, i only had general arm soreness but no fatigue.. with my first 2 shots.
Spontaneous coronary artery dissection.  heart attack symptoms (chest pain), pain lasted over an hour
Given PPSV23 vaccine and presented the following day with no systemic symptoms but local area described as: Significant area of erythema and warmth to the entire medial deltoid area on the left side. She has edema but no fluctuance. No indication that this required I and D. Arms NV intact. Pt was treated for cellulitis. Cellulitis: erythema, warmth, edema, local pain, decreased ROM. Cephalexin 500 mg QID, Ibuprofen 600 mg tid.
Patient had been in his usual health when he received his primary anthrax vaccination on 03 September 1998. After that time, he started having vague symptoms of weight loss, heartburn, fatigue, joint pain (mainly in his knees), muscle twitches and generally did not feel well following each anthrax vaccination. He states that his symptoms would come and go, however he feels that his overall physical condition has declined over the period time of time that he received the vaccinations and has continued to decline to this date. He did not seek medical attention until March 2004. He states that he pushed on, but he noticed that he was getting progressively worse physical injuries due to his physical weakness. He deployed in March 2004. He states that while deployed, he became "clumsy". He states that he had, and still has, problems with feeling imbalanced. He has suffered ankle injuries secondary to his imbalance problem. He was fired from his job because he was unable to make his meetings in the morning (his symptoms are worse at that time of day). During his deployment he states that he would experience "pins and needles" sensation in his arms and legs and his arms would fall asleep easily from his elbow down to his hand including only the 3-5 digits. He continues to have some of these same symptoms but states that they are milder in intensity. Currently he complains of morning stiffness, nausea, fatigue and does not feel rested upon waking. It takes him 1-2 hours to get going in the morning. On weekends he sleeps late and takes naps, as well as retiring early. He has "twitching' in his muscles worse in his lower extremities. He also complains of sporadic muscle fasciculations in his muscles, but is almost constant in his lower extremities. He also had pain intermittently in his bilateral arm pits. He has tinnitus that sometimes "drowns out" what he is listening to. He is also experiencing headaches that have had associated symptoms of cloudy vision in his left eye and light shards in the right eye. He often gets the headaches when his tinnitus is at its loudest. Occasionally he experiences numbness in his arms and legs in association with headaches. The headaches resolve on their own. He complains of cognitive problems, including short term memory loss. He feels that this was one the earliest symptoms he exhibited. He states that he thought he was developing a learning disorder. He also states that he had slurred speech. He states that he feels like he has a "disconnect" between what he wants to say and what comes out. He gets disoriented easily, for example gets lost in buildings and even parking lots. Addendum 1 Mar 2005: This service member is being evaluated for atypical chest wall pain with reflux disease and other gastrointestinal complaints Jan-Feb 2005. He is pending rheumatology and dermatology evaluations.
Sore arm, low-grade fever, sore throat, muscle & joint aches, headache and fatigue
Patient had swelling 2inches above the elbow on the inside in the left arm. It was warm to the touch and red. The doctor put her on doxycyline and it went away. When the patient lays on her side she gets a shooting pain. She said that the pain is relieved by Ibuprofen.  She still has the pain and it is at least once a day when she has problems.
Weakness, labored breathing, and heaviness in body  Leading to vagal response within 3-5 minutes of receiving the vaccine. Same symptoms occurred with first dose, which did not lead to vagal response but I was assured it was ?fine and it happens all the time.? They should have had me lay down at the very least for the second shot but instead I passed out and fell out of the waiting room chair, hitting my forehead with all of my body weight  onto the linoleum covered concrete floor.  I ended up getting an MRI a few days later due to blood pooling around my eyes(through Immediate Care) this bruising/blood pooling dissipated after about 3 weeks
Got the new H1N1 vaccine and Started with weird cool sensations in head neck back arms and legs. Has since then turned into burning contant pain in head neck back arms and legs. Started so bad that I couldn't hold head up was in bed for the first 2 months. Was weak, had rapid heart beat chest pain. Started having zapping burning pains in head that is constant and never goes away. Has been constant for the past 4 months, getting worse not getting better. Even started with burning gums and tongue. Feeling of cool air going through left eye. Have had chronic nausea but the worst is the burning pain in my head. Left toes started mildy tingling on occasion. So far have been in and out of emergency room since shot, have had to be admitted to hospital for testing and evaluation. Have seen neurologist, rheumatologist, infectious disease doctor, primary physician, and the list goes on and on. All say since all testing is showing negative it points to vaccine.
Sore throat; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the left arm on 25Feb2021 at 14:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 03:00, the patient experienced sore throat, fever, chills and body aches. Therapeutic measures were taken as a result of events and included treatment with Advil. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore throat, fever, chills and body aches was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vertigo, sensation of floating and imbalance. Began the day after getting the vaccine, accompanied by severe aches, headache, chills, fatigue, and fever. Other symptoms went away, vertigo worsened on the second day after getting the vaccine and continues to impact daily function.
VACCINE GIVEN IN LEFT DELTOID.  ARM SWELLED, PAINFUL, WARM TO TOUCH.  PAIN RADIATING UP NECK. FEVER 99.7.
Client here from 06/27/2005 left arm upper swollen at site of injection with inflammed area, measures 2 1/2 across and 2 3/4 down hot to touch.
not feeling well; felt dizzy; Fatigue/quite tired; she was upset that she doe not have energy and is quite tired; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/other non-professional.  This case involves a 66-year-old female patient who was not feeling well (malaise), felt dizzy (dizziness), fatigue/quite tired (fatigue) and was upset that she did not have energy (asthenia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, concomitant medications, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Oct-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date were not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 02-Oct-2020, the patient was not feeling well (malaise), felt dizzy (dizziness), fatigue/quite tired (fatigue) and was upset that she did not have energy (asthenia) 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that the patient did not believe in flu vaccines, but she was advised this year to get it due to Coronavirus Disease [COVID]. She did not want the high dose vaccine, due to due to the mercury, formaldehyde and the quadruple whammy of the vaccine. She wanted the regular one only. The dizziness was more when she was lying down and while getting up. When she was moving around she was okay, but she did feel a little spacey. She mentioned the dizziness was more on her right side; the side she got her Fluzone vaccine.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for all the events at the time of report.
None - A/E. Pt given vaccine for children 4+ yrs old at 2 mos.
Constant pain that feels like a toothache that started on the day the vaccine was given, weakness, limited mobility, difficulty with certain activities due to sharp pain - pouring coffee, carrying a bucket of water, for example. Pain is 8/10.
Prolonged soreness at injection site Flu-like body pain Headache No fever, no cough, no sneezing, no congestion
Adverse event information provided in this submission, is per a report received by Public Health Department from a submitting facility. Covid-19 vaccination information is from Immunization Registry. Pfizer; Date: 3/16/2021 Lot # ER2613 Pfizer; Date: 4/6/2021 Lot # EW0151  Pfizer; Date: 8/16/21 Lot # FA7485  Pfizer COVID-19 tris 12+ Date: 4/15/22 Lot # FP4554  Pfizer BvlntBstr 12+ Date: 9/26/2022 Lot # GJ5342   Per Web report submitted: ?The patient presented to Hospital ED with a cough, runny nose, malaise, body aches and generalized weakness. He had a positive home COVID test today. He has been around his wife who also tested positive for COVID. He has a history of multiple sclerosis and states his illness has progressively worsened. He is generally weak to the point that he is unable to ambulate. He has noted chills and body aches. He denied chest pain. He is not short of breath. He has no abdominal pain. No nausea, vomiting or diarrhea. He has no focal or localizing neurologic deficits. However in the Neuro exam in the ER showed dysarthria, right hemiparesis, power 0/5 right upper and lower extremities. He also states that she feels much more tired and occasionally short of breath. The infection has exacerbated his multiple sclerosis. CBC revealed anemia with hemoglobin of 7.3. A stool guaiac is currently pending. He received Protonix. He was typed and screened. CMP reveals elevated glucose of 119 but is otherwise unremarkable. Troponin is normal. Chest x-ray reveals no acute findings. COVID testing confirms positivity. He is not hypoxic and therefore does not require Decadron. Patient was admitted to hospital on 11/14/2022 for further evaluation and treatment." Public Health Department has no further information on the outcome of this patient. If you?re in need of additional information, please contact the provider.
Patient received 2nd dose of Moderna COVID-19 Vaccine on Friday (8/6/21). Saturday (8/7/21) night patient reported fever chills requiring the patient to take 3-4 tablets of acetaminophen 325mg around the clock until Sunday (8/8/21) morning when symptoms subsided. Patient reports symptoms of fatigue aggressive enough to not report into work on Monday (8/9/21). At the time of this report, Monday afternoon, then patient states that they are not fully recovered from symptoms but are feeling better than past weekend.