chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a vaccination of fluzone high-dose quadrivalent after the physician was informed that it was no longer suitable for use/ no AE; Initial information was received on 01-OCT-2021 regarding an unsolicited valid non-serious case received from a Physician (Reference number- 00794512) and transmitted to Sanofi on 01-OCT-2021.  This case involves a 69-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after the physician was informed that it was no longer suitable for use with no adverse event (Product administration error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 27-Sep-2021, the patient received a 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ748AA and expiry date 30-Jun-2022] via unknown route in unknown administration site for prophylactic vaccination.  It was reported "Caller states that a patient received a vaccination of FLUZONE HIGH-DOSE QUADRIVALENT on 27SEP2021 after the physician was informed that it was no longer suitable for use."  It was a case of actual medication error due to Drug administration error (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Anaphylaxis, lightheadedness  33F with hx epilepsy, asthma, and multiple food and drug allergies who reported that she was experiencing chest pain/heaviness as well as feeling warm and throat tightness shortly after receiving her first COVID vaccine.
On Oct 26,2021, I got my second Pfizer Covid vaccine around 3 pm. Later in the evening my fever went up to 102 F. and lasted for a full 24 hours around 101 degrees Fahrenheit. The evening after vaccine I was feeling freezing cold, shaking with chills and later sweating on/off, tension headache, and vertigo. My right foot kept tightening and was unable to put any weight on it from pain and my hands tightening up, it was difficult to open them. Around 5am my heart rate was beating very fast, and fit bit said it was at 122 bpm. The next day after vaccine I had vertigo, tension headache, chills, fever but my limbs tightening got better. Body felt overly bruised. Oct 30th- Severe upper abdominal pain around 11am, then around 2 pm watery diarrhea 10x and one more the next day. Afterwards stool is normal consistency since with 1-2 bowel movements day. Pain has made it difficult to walk and do daily activities. Feeling full, bloated, stomach really loud, carbonated, feels like volcano is erupting inside. Burning pain that feels like being punched really hard between middle rib, right in the center area where adrenals are located, adrenal pain constant for almost 2 weeks and gradually went away. Prescription Tincture 2 oz. 2 ounce(s) liquid2 dropper(s), 3 times a day. Ashwagandha, Prescribed By Dr., Prescribed On Nov 18, 2021. Prescription Tincture 4 oz. 4 ounce(s) liquid2 dropper(s), 3 times a day. Adrenal support. Prescribed By Dr., Prescribed On Nov 18, 2021. RelaxMax Unflavored 180 gram(s) powder1.0 scoop(s), Once a day, At Bedtime Mixed in liquid. Myo-inositol for thyroid antibodies. Manufacturer. Prescribed By Dr. Prescribed On Nov 18, 2021 Ther-biotic Complete Powder 2 ounce(s) powder 0.25 teaspoon, Twice a day, With Meals. Manufacturer: Prescribed By Dr. Prescribed On Nov 18, 2021   Saccharomyces Boulardii 60 cap(s) capsule1 capsule(s), Twice a day. CortiVive 120 cap(s) capsule2.0 capsule(s), Twice a day NEW: Capsule adrenal support. Do not take past 2pm.
First shot January 20, 2021. Soon after pain in right shoulder and hop and then right shoulder hand and  wrist. Second Shot February 15, 2021. Soon after pain increased now also to neck buttocks thights.  Excrutialing pain in all joint. Went on Predsisone. Up to 30 mg and Tramadal for pain no help as of  March 25, 2021 March 28 - Woke up stiffer today (PL  7-8). Very rainy day. 20mg. pred 50 mg tram.  Glucose 106. 5mg pred 6PM. Pain lessened as day progressed PL  3-4.  March 29  Still stiff. PL 3-4 easier movement.20 mg pred 50 mg tram Glucose 95.  ADDITIONAL PAIN INFORMATION:  To help relieve pain, I walk inside my home several times a day. The pain reduces  temporarily. Use moist heat on affected areas, which also results in temporary relief.  Woke every morning extremely stiff, in severe pain and unable to accomplish simple  tasks like removing the blanket from my body in order to get out of my bed. It was  several hours before the stiffness lessened.  Sometimes, I feel slight pain in my elbows and knees. Not as extreme as in the other  parts of my body.
Narrative: Patient received two doses of covid vaccine. Patient with PMH of pulmonary fibrosis 2/2 organizing pneumonia on chronic immunosuppression. Patient was admitted for worsening breathing and after family meeting decidedly to change patient to DNR/DNI. Patient passed with no other documentation of death relating to other causes. Reporting per facility instructions.
Symptoms of nasal congestion, dry cough, headache, COVID-19; Symptoms of nasal congestion, dry cough, headache, COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Fish allergy" (unspecified if ongoing), notes: Known allergies: Fish, but not shell fish. Concomitant medication(s) included: OMEPRAZOLE, start date: Jan2018; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "recovering" and all described as "Symptoms of nasal congestion, dry cough, headache, COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Negative, notes: I had tested negative on 17Jul2022; (27Jul2022) Positive, notes: Tested positive for COVID on 27Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details Product=COVID 19 Treatment, Brand Paxlovid, Treatment start date was 11Jul2022, Treatment stop date was 16Jul2022, Indication for Treatment of COVID-19. Symptoms of nasal congestion, dry cough, headache started again about 25Jul2022. Tested positive for COVID on 27Jul2022, 11 days after completing Paxlovid.Other medication in 2 weeks product was Multivitamin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Erythematous, swollen, large local reaction greater then 30cm 1 week after vaccine for DTAP.
pt states on 9/23 had flu-like symptoms and noticed redness at injection site-redness spread-seeked medical help and md diagnosed as allergic reaction-rph 98% sure pt recevied pneumovax 23 in left arm where allergic reaction site is
Slight blockage in heart; Shortness of breath; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4338136-00.  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single, intramuscular, administration date 02Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. Relevant medical history included: "Ankylosing Spondylitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CORONARY ARTERY OCCLUSION (medically significant), outcome "unknown", described as "Slight blockage in heart"; DYSPNOEA (non-serious) with onset Aug2021, outcome "unknown", described as "Shortness of breath". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira: The reporter's causality for the event(s) of SLIGHT BLOCKAGE IN HEART with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of SHORTNESS OF BREATH was not provided.  The reporter considered "slight blockage in heart" and "shortness of breath" 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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.  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.
This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in an child male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown deltoid). The lot number was reported as PY3D2 from the reporter; however, based on a safety lot number review, the lot number was updated to PY3DZ. Less than one week after vaccination with KINRIX, the subject experienced injection site cellulitis, injection site tenderness, injection site warmth, injection site redness, extensive swelling of vaccinated limb and was unable to move arm. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case was associated to a product complaint. This case was one of 8 cases of injection site reaction reported by the same reporter regarding the same lot of vaccine.
Breakthrough case admission after 4 vaccines  Moderna 4/6/21 Lot# 040B21A;  Moderna 5/5/21 Lot# 005C21A;  Moderna 12/2821 Lot3 034F21A;  Moderna 7/1/22 Lot# 060A22A
Swollen Lymph nodes under left Armpit ongoing Extreme Fatigue ongoing Low grade fever for 1 day Body aches and chills for 1 day
Developed Itching and feeling of tightness in back of nose/throat. Advised employee to go to ED. Was given 1L fluid, Solu-Medrol and Benadryl. No swelling of airways was observed and no respiratory distress noted. ED discharged patient to home.
One day after vaccine adm. Mother noted swelling redness to Left arm. She applied cold pack and swelling as well  as redness had diminished considerably per mother child has not c/o pain is able to move/use arm without any problem.
I noticed the arm soreness about 2 hours after the vaccine was given.  I woke up the next morning at about 0500 with a fever highest at 99.8 and it stayed all day long along with extreme fatigueness. I awoke on 02/05/2021 at 0500 with no fever and fatigue gone!!
After 2 weeks later she diagnosed with heart arrhythmia; Patient heart rate was 205 and doctor does not want it go over 100; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (After 2 weeks later she diagnosed with heart arrhythmia) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (After 2 weeks later she diagnosed with heart arrhythmia) (seriousness criteria hospitalization and medically significant) and HEART RATE INCREASED (Patient heart rate was 205 and doctor does not want it go over 100). At the time of the report, ARRHYTHMIA (After 2 weeks later she diagnosed with heart arrhythmia) and HEART RATE INCREASED (Patient heart rate was 205 and doctor does not want it go over 100) outcome was unknown. Serious event as per Important medical event terms list (version 24.0)    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 205 (High) Patient heart rate was 205 and doctor does not want it go over 100..  Treatment for the heart arrhythmia included alprazolam. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
(R) thigh swelling & redness 9 x 7 cm (worsened by 2/10/11).
Within 6 hours, expected R arm pain and beginnings of a headache.  On 1/28/21, moderate headache continued but was fatigued/lethargic and had muscle pain and body aches.  On 1/29/21,  headache decreased and felt refreshed.  On 1/30/21, had moderate headache, slight body aches, and was sleepy.  1/31/21, slept most of the day, was irritable and some nasal congestion noted along with the headache.  2/1/21, sweated throughout the night, no fever but was either hot or cold. Irritable with brain fog as well. Facial flushing, neck pain, swollen lymph nodes in pelvic and bilateral submandibular areas.  Throat does not look red or patchy but some post nasal drip involved.  Tongue has geographical patches which started about 1 year ago and is random.  Had unilateral lymphedema and geo tongue both 1 year ago for reference.  CT results, reactive.
This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (Lot# and expiration date were unknown) for prophylaxis, which had a temperature excursion 27°F for 10 minutes and 28°F for 14 hours. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.  Sender's Comments: US-009507513-1702USA009058: US-009507513-1702USA009059: US-009507513-1702USA008645.
I received my 4th dose on 04/18/2022 and my adverse event started on 04/19/2022 Left leg side; tops of the toes burning; tingling; numbness; my whole body was numb; pain. On the left side on a scale 9 and half outside of leg; tops of the feet. For all of my symptoms. After 1 day my right side also had the same symptoms scale of 8. I went my doctor on 06/09/2022. 12 dose of pantoprazole; 100 milligram hydroquinone to help with the burning. As of now I am taking gabapentin (pain); FIORICET. I take medication on depending on my symptoms. I haven't fully recovered yet. My right foot top of ankle still painful. Left top of my feet and ankles painful.
mild tenderness at the injection site; nausea; tiredness; feeling under the weather like she was catching a cold or the beginning of a flu; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: Caller reports history of her and her husband being slightly immunocompromised. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "mild tenderness at the injection site"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feeling under the weather like she was catching a cold or the beginning of a flu". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Full body rash/hives on day after shot (04/30). Day after that (05/01) rash has faded a little bit feels like sunburn
This case was reported by a nurse via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. On 13th December 2018, the patient received the 1st dose of SHINGRIX and PNEUMOVAX 23. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, chills, fatigue, general body pain and activities of daily living impaired. On an unknown date, the outcome of the fever, chills, fatigue and general body pain were recovered/resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the fever, chills, fatigue, general body pain and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient had fever, chills, fatigue and body aches that lasted 4 days and the patient was unable to function. The patient also received PNEUMOVAX-23 on the same day. The reporter provided the consent to follow up. It was unknown if the reporter considered the fever, chills, fatigue, general body pain and activities of daily living impaired to be related to PNEUMOVAX-23 as well.
BLOOD CLOT IN LEG; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient was reported to be over 6 feet tall and not overweight. The patient's past medical history included cataract surgery (in his 60s); and concurrent conditions included former smoker (ex-smoker who quit 1 year ago). The patient had no chronic medical conditions and had no history of recent travel or trauma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The patient was not taking any concomitant medications. On 04-APR-2021, the patient's leg felt abnormal and on 05-APR-2021, the patient went to urgent care center, where an ultrasound found a blood clot. The patient was prescribed Eliquis (apixaban) and was since feeling better, however, still had leg discomfort.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in leg. This report was serious (Other Medically Important Condition).  Additional information was received from consumer (daughter of patient) via telephone follow up on 16-APR-2021. The following information was updated and incorporated into the case narrative: patient details, medical history, concurrent conditions, medical story including treatment, and event details.; Sender's Comments: V1: Follow up from the patient's daughter provided additional clinical details. This case concerns a 72 year-old male without significant medical history who was diagnosed with a blood clot in his leg 4 days after receiving the Janssen Covid-19 vaccine. He is not overweight, is not taking chronic medication, and had no recent trauma or travel. He quit smoking one year ago. Three days after vaccination, his leg felt abnormal. The following day, he went to an urgent care center where an ultrasound revealed a lower extremity blood clot. He was sent home with apixaban. No information regarding blood testing was provided. As of the time of the report (i.e. 11 days after his diagnosis), he is feeling better but still has leg discomfort. Based on the limited information, the relationship with Janssen Covid-19 vaccine is considered inconsistent. Additional information is being sought.
Rash and itchiness started at around 10 PM on 1/7/2021. Rash described as "traveling across chest" and similar to what happens when she takes prednisone. Stated she has not taken prednisone for over a year. Client stated that rash did not appear anywhere else on her body. Itchiness was experienced on chest and arms only.  Client also stated symptoms of fatigue, muscle weakness,  and "super sore arm" that lasted from day of vaccination until 1/10/2021. Client also reported a headache that lasted 2 day after vaccination. She contacted her provider on 1/7/2021 and, per provider's instruction, took 1 tablet of Benadryl. Client was unsure of dosage of Benadryl. On the morning of  1/8/2021 she took a second tablet of Benadryl and reported that her rash resolved after the second dose of Benadryl. Her itchiness resolved the morning of 1/9/2021. Stated that her Doctor did not specify a diagnosis but did state to hold off on the second dose of this vaccine.
Mom reported "jerking"movement of upper extremities and "staring" episodes - 2 episodes lasting 2-4 mins. approx 2 hrs after immunizations. Seen at ER for neuro admission. ACTH started; EEG sched for 9/9/14. Neurology appt. Infantile spasms.
Breakthrough Case of COVID Sx  started on 05/21/2022, with a scratchy throat and progressed to nasal and ear congestion, chills, body aches, fevers up and down between 100.2 and 100.4. I tested positive on a home test on 05/22/2022. I spoke to the doctor on 05/22/2022, she called in a RX for Paxlovid. I did not start taking the med until the evening of 05/23/2022. I am still taking the Paxlovid, sx have improved and I have no fever and body aches, but I still nasal congestion and fatigue as of 05/225/2022. Paxlovid has left a terrible metallic taste in  my mouth and I have had some diarrhea.
About 5 hours after receiving the second dose, the arm that had been injected started to feel very sore. I also began to feel a soreness in the back of my throat and my ears. Mild fatigue was also observed. Around 2am, 14 hours following the injection, I woke up with whole body muscle aches and a mild fever. Mild fatigue, muscle soreness and arm soreness continued into the next day.