chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in hips; flare up on prednisone taper; numbness in hands; pain in legs; difficulty grasping things; chest tightness like an elephant sitting on her chest; headache; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (flare up on prednisone taper) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis.    Concomitant products included NAPROXEN SODIUM (ALEVE) for Cephalgia, PARACETAMOL and SUMATRIPTAN for Migraine, PREDNISONE, ACETYLSALICYLIC ACID, CAFFEINE, MECLOZINE, HYDROXYZINE and COLECALCIFEROL for an unknown indication.   In 2020, the patient started TERIFLUNOMIDE (AUBAGIO) (Oral) 14 mg. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (flare up on prednisone taper) (seriousness criterion medically significant), HYPOAESTHESIA (numbness in hands), PAIN IN EXTREMITY (pain in legs), GRIP STRENGTH DECREASED (difficulty grasping things), CHEST DISCOMFORT (chest tightness like an elephant sitting on her chest), HEADACHE (headache) and ARTHRALGIA (pain in hips). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (flare up on prednisone taper), HYPOAESTHESIA (numbness in hands), PAIN IN EXTREMITY (pain in legs), GRIP STRENGTH DECREASED (difficulty grasping things), CHEST DISCOMFORT (chest tightness like an elephant sitting on her chest), HEADACHE (headache) and ARTHRALGIA (pain in hips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Very limited information regarding this event has been provided at this time. Dates of administration for vaccine and onset date for the events are required for further assessment.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Dates of administration for vaccine and onset date for the events are required for further assessment.
pt recv vax 7JUL98 & seen by MD for T101 24hr post vax;crying for hr 2 noc MD said probably rxn to vax;
He had due to chemo hospital stay had 9 months of extremely low white blood cell count that didn't move at all. 1/07/21 on a Thursday he had his first COVID vaccine, his has labs drawn done every Friday and when he went to the Doc. On 1/8 the white blood cell count had moved up just a little. And it was still moving up just a little and had his 2nd dose on Friday 2/4/21. And from then on every week when he went in for bloodwork it would go up just a little more. It continued to go up slowly and when he had his 3rd vaccine Aug 7th after the shot while in the hospital his white blood cell count went up 40k (he hit 340K) in a 12 hour period. We got to the emergency room they took lab work and by 8pm the next day it went up by 40K. They were pulling white blood cells out and he was making more that they could pull out. On 9/10 we lost him, the white blood cells attached his organs and made them all start shutting down. On Aug 12th before his vaccine his white blood cell count was 104K. By 9/6 he was over 300K.  So his wbc tripled from his 2nd shot to his 3rd shot.
Immediately after each dose: Severe Uncontrolled Asthma  About two or three weeks after the second vaccine  Hyperimmune reaction - Exacerbation of Myasthenia Gravis  - Developed Stiff Person Syndrome
PT has hand pain after COVID vaccine/Both thumbs hurting; So this joint; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "PT has hand pain after COVID vaccine/Both thumbs hurting"; ARTHRALGIA (non-serious), outcome "unknown", described as "So this joint".  Additional Information: It was reported that the patient had the age range of 65-69-years. It was reported that the patient had hand pain after COVID vaccine. Both thumbs hurting and the joint or.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fatigue; fever; headache; pain; dizzy; hair loss; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 12Mar2021 at 13:30 at 58-years-old (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunization, at a workplace clinic; apixaban (ELIQUIS), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; levothyroxine sodium (TIROSINT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; liothyronine (MANUFACTURER UNKNOWN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; zinc (MANUFACTURER UNKNOWN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; also reported "other medications in two weeks: D, B, C, A", with no other details provided. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient's medical history included gluten sensitivity from an unknown date and unknown if ongoing, contrast media allergy (CAT dye) from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing (prior to vaccination). Concomitant medications were not reported.  The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy; start and stop dates were not reported. On 12Mar2021 at 18:00, the patient experienced: fatigue (non-serious), fever (non-serious), headache (non-serious), pain (non-serious), dizzy (non-serious), hair loss (non-serious). There was no treatment received in regard to the events. The action taken in response to the events for apixaban, levothyroxine sodium, liothyronine, and zinc was unknown. The clinical outcome of the events was recovering. The patient was not tested for COVID post vaccination.
Red  rash on back  and chest, Still there.. Cromolyn Sodium .Does not seam to do anything.
Gave pt flu vaccine, after a few mins pt states having heart fluttering and chest burning and constriction. Observed pt. Pt was able to continue to take deep breaths and was alert and responsive the entire time.  Continued to have heart flutting and due to pregnancy and heart symptoms, contacted 911. Pt was taken by ems to hospital for observation.
Muscle ache, headache, slight fever, chills, fatigue for about 12 hours.  Fatigue continued for an additional 24 hours.
Lethargic, chills. Injection site had a knot for three days as if the serum was not absorbed
Swollen hands and feet, high blood pressure, jitters, insomnia for 7 days.
Daughter took covid test today and tested positive with no symptoms/may have been exposed; This is a spontaneous report received from a contactable consumer (Patient). This female consumer reported for her husband (Patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The husband and her got 1st Pfizer dose on Monday. Daughter took covid test today and tested positive with no symptoms. Was with them outdoors on Friday, may have been exposed. Daughters schedule this afternoon to get the vaccine. Will the COVID test come up positive because we took the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Covid 19 On August 15, 2022 I experienced sore throat, headache and muscle aches, fatigue. I was taking Tylenol for my symptoms.
Swollen lymphnode... under left arm & left side of neck for 10 days.  Racing heart & skipping beats ..  2 days
Intense headache, neck ache, body aches (myofascial) and nausea for ~Spiked a fever twice. Chills. The most intense headache I've ever had, about 7/10
Xaiah had a slight fever of about 100 or 101 degrees since the time the shots were given. On february fourth the fever went up to 103 degrees.  She became completely lifeless; still with hollow eyes. She had been fussy the whole week but suddenly she wasn't even fussy any more.  For one week her fever was between 103 and 105 degrees.  Cold baths were administered frequently and she constantly had cold rags on her head. Tylenol and Motriin were rotated. the fever would only drop to 102 for thirty minutes before jumping up again.  She began screaming for long random periods of time. She would just start screaming uncontrollobly, nothing could soothe her.  The screaming bouts would  last about thirty minutes. The screaming fits lasted for a couple months and slowly began to slow down.  For the time being she has recovered but not sure of any possible future outcomes.
On March 13th developed itchy, red  rash on left side of chest, neck, arm,  elbow and wrist.    Self-treating  with hydrocortisone cream. Chest and neck has subsided as of 3/18/2021.   Wrist and elbow still itchy and inflamed.
Pt recv vax on 3/24/97; on 2/7/99 pt exp abdominal pain; on 2/8/99 pt exp lesions w/ fever; dx=chicken pox
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA322952 (same reporter). This case involves a 3 years old female patient who was vaccinated with 0.5 ml dose of IPOL (batch number: N1K921M, expiry date: 14 Nov 2019) via intramuscular route on 20 Nov 2018. The patients past medical history included tongue geographic and underweight. It was also reported that, the patient had no known drug allergy. The patients past medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that the patient received the vaccine which was out of the acceptable temperature range (might not be effective). It was reported that the patient did not experience any adverse event. It was also reported that, the patient did not need to be revaccinated. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Breast Cancer Right Breast.  Received lumpectomy on January 26, 2022 3 weeks of radiation ending on April 13, 2022
Sore vaccine site first 2 days, had sore joints next day, woke up the third morning and vomited every 20-30mins.  Was too dizzy to walk or move , lost sense of taste and smell, headache, cough, tiredness, high fever of 104, and chills. Had redness and pain at injection site the whole time and other symptoms lasted 3 days.
I received the 2nd vaccine at 1:30pm, by 8:30pm I was extremely fatigued and went to bed early. I woke up in the middle of the night (around 12:00AM) with terrible night sweats, chills, a fever of 101, a terrible headache (completely different from my migraines) and my arm was extremely sore and painful. I tried to avoid taking any medication as I heard that it could decrease the efficacy of the vaccine, but it became unbearable so I took ibuprofen around 3:00am. My symptoms lasted throughout the next day, the fever subsided after the first dose of ibuprofen however I still had chills and the headache. The chills finally subsided around 3:00pm and the headache did not subside until I woke up Friday (2/5/21) morning around 6:00am which was roughly 42 hours after my second dose was administered.
patient is approximately 34 weeks gestation; she inadvertently administered a dose of Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 40-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number FK54C, expiry date 13-MAR-2025) and (batch number 3C7P4, expiry date 05-MAY-2026) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy. On 01-NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: she inadvertently administered a dose of Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: patient is approximately 34 weeks gestation). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 01-NOV-2023 The pharmacist reported she inadvertently administered a dose of Arexvy instead of Abrysvo to a pregnant patient, which led to vaccine exposure during pregnancy and wrong vaccine administered. The pharmacist provided lot numbers FK54C and 3C7P4, though she was unsure which was the adjuvant and which was the antigen. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Same day of vaccination later on that night I noticed my arm on the vaccination site that it was a pinkish look & a little swollen as the days went by it kept getting more swollen & red. By 12/31/2021 It was very swollen, red, it was hot, hard, itchy & it was very sore. It measured 8cm by 12cm on 12/31/2020 I went to the doctors office & that's when she measured it. I had to see the doctor 6 times. I was prescribed medication  zyrtec & prednisone. It took about 3 weeks to go away.
Day after  Administered vaccines got the standard high fever and chills/sweats for 2 days time. After that, my asthma which is usually under control, severely flamed up. As of December 18th I started with severe itchy hives all over my body causing major swelling in affected areas/nerves.
vomited once 530PM t105 the evening of 27FEB96, cough, vax given 2Pm 27FEB96;
pt recv vax;pale & unresponsive for about 2 hr;this occurred about 3 hr p/ vax;in er;still pale but neurologically nl;
No adverse event; Expired dose of M-M-R II was administered to the patient; Information has been received from registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On 29-NOV-2021 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S037500, expiration date: 20-NOV-2021, 0.5 milliliter (route of administration and anatomical location were not reported) (expired product administered) for prophylaxis. The dose did not experience any known temperature excursions. No additional adverse event was reported (no adverse event).
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Nov2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: FENOFIBRATE; TRIAMTERENE; LOSARTAN. The following information was reported: COVID-19 (medically significant) with onset 01Mar2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 01Mar2023, outcome "not recovered". The events "drug ineffective" and "covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300097422 same patient, different drug/event;
Developed severe constant ringing in right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02May2021 11:00 (Lot number: EW0176) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8731, Location of injection: Arm Right, Vaccine Administration Time: 14:30), administration date: 11Apr2021, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 19May2021, outcome "not recovered", described as "Developed severe constant ringing in right ear". The event "developed severe constant ringing in right ear" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. Clinical Course: Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: SARS-Cov-2 RNA RT-PCR, Covid test date: 09Jul2021, Covid test result: Negative, covid test type post vaccination: Nasal Swab, covid test name post vaccination: Randox COVID-19 qPCR, covid test date: 05Aug2021, covid test result: Negative, covid test type post vaccination: Nasal Swab, covid test name post vaccination: COVID-19 Molecular Lab Test PCR/NAAT, covid test date: 23Nov2021, covid test result: Negative, covid test type post vaccination: Nasal Swab, covid test name post vaccination=SARS-Cov-2 RT-PCR, covid test date=19Dec2021, covid test result; Negative, covid test type post vaccination=Nasal Swab, Covid test name post vaccination=2019-nCOV qPCR Assay, Covid test date: 07Feb2022, Covid test result: Negative  No other vaccine in four weeks and no medications in two weeks. No COVID confirmed prior vaccination. No Known allergies No follow-up attempts are possible. No further information is expected.
vaccine 1- got COVID; eyes are extremely dry; crackling noise in the ears; extreme brain fog; sleeping 12 hours+ per day; eye sight is blurry; There are days that I cannot drive; mucus or something in them every day; I cannot see well; can barely wake up; This is a spontaneous report from a contactable Other HCP (patient).  A 48-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EJ1686, age at the time of vaccination: 47-year-old), via an unspecified route of administration, in arm right on 05Jan2021 as dose 1, single for covid-19 immunisation. Medical history celiac, migraines, GERD, mixed connective tissue disease. Concomitant medications included omeprazole (PRILOSEC); fluticasone propionate (FLONASE); norgestimate; ethinyl estradiol all for unknown indication since an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 at 20:00 the patient got COVID after the first vaccine, nothing ever went back to normal but had body aches, headaches, fever, fatigue, joint pain, no smell or taste, shortness of breath, extreme fatigue, sleeping 12 hours+ per day, eye sight was blurry, eyes were extremely dry, with mucus or something in them every day. Also have crackling noise in the ears all the time super annoying. There were days that she cannot drive because she cannot see well. She can sleep and do sleep during all hours when she was not at work, can barely wake up for work in the morning with extreme brain fog all day. Therapeutic measures were taken as a result the events with Tylenol, ointment for rash, xiidra and steroid eye. No Hospitalization Prolongation was present. The adverse event resulted doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included Covid test as positive on an unknown date in 2021. The outcome of the events was not recovered.
Patient reports filling numbess in left arm immediately after vaccination. Progressed to having severe pain in arm, and inability to move arm later that night. The following morning, patient stated she couldn't move arm and was experiencing severe pain despite taking ibuprofen.
Exhaustion, hot and cold sweats - both started roughly 2 hours after injection, lasted approx. 8-10 hours.  Arm soreness - lasted for about 1 week
This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 7th September 2018 10:30, the patient received the 1st dose of SHIGNRIX (intermuscular). On 9th September 2018, 2 days after receiving SHINGRIX, the patient experienced tiredness and upset stomach. In September 2018, the patient experienced fever, chills and tremor. The patient was treated with TYLENOL. On 12th September 2018, the outcome of the tiredness and upset stomach were recovered/resolved. In September 2018, the outcome of the fever, chills and tremor were recovered/resolved. It was unknown if the reporter considered the fever, tiredness, upset stomach, chills and tremor to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. Same day of vaccination, later on around midnight the patient experienced chills, tremors and fever. He waited till 2 am and took a TYLENOL. One hour after taking the TYLENOL the tremors and chills were gone. On 8th September 2018, the patient took the body temperature around 6 am and it was at 101.5 degrees F. The patient called pharmacy, and the pharmacist told him to take another Tylenol at 6 am. Around 7 am he took his body temperature at it was finally under 100 degrees F. He finally got some sleep, and he wake up around 9 am and his temperature was 98.8 degrees F. On the following day, he experienced upset stomach on and off, and felt tired. On 12th September 2018, the patient completely recovered. The patient has denied permission to contact their physician. No further details were provided.
Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild