chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day following vaccination, soreness and swelling started to worsen. Arm visibly red and hot to the touch. This area has increased the following 2 days after vaccination. There is now a hard area under the vaccination site. Arm hurts to the touch and is itchy.
Sensory disturbances began approximately 7 days after receiving vaccine, numbness and tingling in hands and feet, weakness, and gait imbalance.
Low levels of TSH; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD THYROID STIMULATING HORMONE DECREASED (Low levels of TSH) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM tablet for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and LEVOTHYROXINE SODIUM (unknown route) 100 microgram. On an unknown date, the patient experienced BLOOD THYROID STIMULATING HORMONE DECREASED (Low levels of TSH). At the time of the report, BLOOD THYROID STIMULATING HORMONE DECREASED (Low levels of TSH) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Female patient of 72 years of age who suffers from COPD and cardiac prolapse, allergic to glycerin according to what she refers in an interview, 5-7 days after receiving her dose of the Janssen vaccine, she presents inflammation, redness in the chest area, including the breast area with palpable breast swelling. According to the report's interview, the woman reports that 42 days after being vaccinated, she has a headache, chest pain, high glucose, for which she has had labs, chest X-rays, and has visited a pulmonologist, who guides and refers to report the case to the vaccine provider. At the time of visiting the specialist, the patient reports having presented a skin rash manifested in the axillary area and chest area, in addition to presenting a skin rash similar to blood spots on her thighs mostly manifested on her left leg. The patient reports that on  December 10, she visited the Hospital due to respiratory distress, palpitations, chest pain, hair loss, bruises under the armpit and chest, as well as the nail of the first toe on both feet, which were purple. To date, the patient has a burning sensation and tenderness in the chest and poor coordination.
This spontaneous report was received from a medical assistant refers to an unknown number patient of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (strength, dose/frequency, lot # unspecified) (incorrect product storage). Concomitant medication was not reported. No adverse effects were reported. This is one of the five reports received from the same reporter. Additional information is not expected, no contact details were provided.
45 year old Asian woman with history of Rheumatoid Arthritis and Anxiety developed right arm numbness and pain approximately 10 minutes after receiving her first  Pfizer Covid vaccine. She also complained of nausea and vomited up a small amount of stomach contents. No rash, no neurologic changes, no shortness of breath.  After she took her own Zofran 4 mg po, her nausea cleared. She was observed for 45 minutes and the pain and numbness in her right arm resolved.
Generally not feeling well after first shot. Shortness of breath the day after getting the second shot. The patient died the day after getting the second shot.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date in 2009 the patient was vaccinated with the first dose of GARDASIL. The patient received the second dose of GARDASIL in February 2013. No adverse effects had been reported. Additional information has been requested.
Pt daughter called 20 days later saying that the pain from the flu shot never go away but got worse. Pt not able to lift arm due to the pain. Pharmacist recommeded pt to go to emergency if pain is severe enough. If not, need to make apt with MD PCP to find out and help with pain.
At time of injection, sharp pain, tingling, different than any other vaccination I have ever recieved. Got worse every day. Today it hurts to raise my arm even slightly, sharp pain from shoulder to fingers, severe pain in elbow. Hand is tingling as if it fell asleep. Could hardly dress myself this morning, favoring right hand (injection in left).
Child developed seizure 2 hours after receiving vaccine high fever. Seen at local ER. Child should have no long term sequelae.
Patient had several ED visits: 5/6/2021, 5/10/2021, 5/12/2021 for infectious mononucleosis. On 5/15/2021 patient was hospitalized for pharyngitis due to infectious mononucleosis. These visits are within 6 weeks of first covid vaccination. Patient did get second vaccination on 5/22/2021.
Moderna COVID?19 Vaccine EUA--extreme body aches, all joints hurt, extreme tiredness, nausea, headache, loss of appetite.  Aches were so severe that any pressure hurt, including lying down with blankets on.  No fever was presented.  Symptoms lasted about 24 hours.  Migraine headache remained an additional 12 hours
Narrative: Patient received two doses of Pfizer COVID 19 vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 27 August 2021 and was admitted to the hospital with COVID Pneumonia. The patient was treated with remdesivir and dexamethasone and was discharged on 23 September 2021 in stable condition.
6 x 6 cm lesion, slightly raised, dull erythema, nontender anterior thigh.
LARGE AREA TO DELTOID AREA OF ARM WITH REDNESS, ITCHING, AND SWELLING.  FIRM NODULE-LIKE AREA UNDER SKIN AT INJECTION SITE.  SX PRESENTED 03/18/2010.  REDNESS AND FIRM NODULES STILL NOTED TO ARM ON 03/22/2010.  PT INSTRUCTED TO APPLY ICE TO SITE AND TAKE BENADRYL ORALLY IF PT EXPERIENCES SX OF TOTAL BODY ITCHING OR SOB.
feels ache when she movies her arm up down and in any way; started feeling pain while being injected with shot and progressively gotten worse; feels like pain in muscle area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feels ache when she movies her arm up down and in any way), MYALGIA (feels like pain in muscle area) and VACCINATION SITE PAIN (started feeling pain while being injected with shot and progressively gotten worse) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B201A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy (Patient has allergic to an ingredient of Aleve.). Concomitant products included AMLODIPINE, METOPROLOL SUCCINATE (METOPROLOL SUCC CT), COLECALCIFEROL (VIT D3), VITAMIN D2, FENOFIBRATE, MAGNESIUM OXIDE (MAG OXIDE), ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) and FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MYALGIA (feels like pain in muscle area). On an unknown date, the patient experienced PAIN IN EXTREMITY (feels ache when she movies her arm up down and in any way) and VACCINATION SITE PAIN (started feeling pain while being injected with shot and progressively gotten worse). At the time of the report, PAIN IN EXTREMITY (feels ache when she movies her arm up down and in any way), MYALGIA (feels like pain in muscle area) and VACCINATION SITE PAIN (started feeling pain while being injected with shot and progressively gotten worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has not taken anything yet. Patient had not issues after first dose.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3249), on 01Feb2021 as dose 2, single (Lot number: EL9265) and on 29Sep2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "NAFLD" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: camphor, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: If vaccine received: Yes. Other medication in 2weeks: Unknown. patient took COVID 19 Treatment as Paxlovid, Treatment start date: 06Aug2022, Lot number: GF4424. Persistent strange/bad taste in mouth and back of throat that quickly returns after eating or drinking (does not disappear with other methods). Began 3 hours after first dose of Paxlovid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the reported events VACCINATION FAILURE, COVID-19  are assessed as related to suspect drug .
Patient was scheduled to have craniotomy on 11/1/2021 due to brain metastasis, but was found to be COVID-19 positive and subsequently developed a pulmonary embolism. He received monoclonal antibodies and symptoms remained mild requiring not other treatment. He was discharged with 14 days of anticoagulation and procedure was postponed until until 11/23/2021. Procedure was uneventful and he was discharged to inpatient rehab on 11/30/2021. Patient expired on 12/4/2021.
New muscular pain in her calves and thighs; Immobile; Pain worsened; A spontaneous report was received from a 60-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed worsened pain, immobility and muscular pain in her calves and thighs.    The patient's medical history included sciatica, pain, arthritis and high blood pressure. The concomitant medication was unknown.   On 30 Dec 2020 approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 with unknown batch number intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient's pain worsened which led to immobile on 02 Jan 2021. Her physician had increased her prednisone and now she could function. The event immobile was considered to be medically significant.  On an unknown date she had developed new muscular pain in her calves and thighs.    Treatment included prednisone, Celebrex and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of developed worsened pain and muscular pain were considered unknown and for immobility had been recovered.; Reporter'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. Further information has been requested.
Developed rash all over legs day after vaccine. Rash was small flesh colored bumps. Worsened two days after vaccine.
This spontaneous case reported by a consumer, describes the occurrence of dizziness, vomiting projectile (projectile vomiting), vertigo (vertigo-like feeling) and duodenogastric reflux (bile released) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 029L20A) for COVID-19 immunization. No medical history reported. On Jan 23, 2021, at 9:00 am, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 24, 2021, patient experienced dizziness, vomiting projectile (projectile vomiting), vertigo (vertigo-like feeling) and duodenogastric reflux (bile released). On 24-Jan-2021, dizziness, vomiting projectile (projectile vomiting), vertigo (vertigo-like feeling) and duodenogastric reflux (bile released): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment information not provided.
light headed, dizzy; Pain underneath the arm pits, I guess in the lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 (Lot number: EL9262) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sulfar allergy" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; TYLENOL; SIMVASTATIN; VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "light headed, dizzy"; LYMPH NODE PAIN (non-serious), outcome "not recovered", described as "Pain underneath the arm pits, I guess in the lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, lymph node pain. Additional information: 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 and since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Patients calls the day after immunization was given c/o fever low back and B/L hip pain.  States "difficult to walk" due to pain.  Symptoms occurred (onset) at about 3 hours post immunization.  Also notes 2 blisters on labia-never had before.
Physician reported she has a patient who received the first dose of ROTATEQ after 15 weeks of age; No additional AE reported; This spontaneous report was received from a physician referring to a 15-week-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1, oral (lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Severe vomiting, diarrhea, severe chills.  This lasted for a few hours in the early morning.  After I slept several more hours, I was O.K. When I got up, just very exhausted and weak, but improved throughout the day.  I contacted my GP, but she encouraged me to take the second shot anyway, as did my heart doctor.  Second shot will be April 1.
really bad headache; some sinus congestion; sneezing; Tested positive for COVID 19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HEADACHE (really bad headache) and COVID-19 (Tested positive for COVID 19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included RA. Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID 19). On an unknown date, the patient experienced HEADACHE (really bad headache). At the time of the report, HEADACHE (really bad headache) and COVID-19 (Tested positive for COVID 19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
At about 9:30 pm I started getting chills.  I went to bed and had a terrible night of severe chills, thirst and I think that I had a very high fever along with severe muscle aches.  I was up and down the entire night feeling terrible with the severe chills. The next morning I felt better but I still had bad muscle aches.  At about 2pm I took my temperature and it was 101.Bt 8Pm I was feeling much better and the aches were gone I did nit take any Advil or Tylenol because the nurse told me to fight it out if I could.  If I couldn?t she said to take it &call my dr. I believe my fever during that first night was probably very high
1 week after vaccine, woke up and area around vaccination was itchy. It was then red, swollen, tender, and hot - 10 degrees hotter than my other arm.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with a bowel obstruction and cholecystectomy. Vaccination took place on 06/13/2007. According to physician, the relationship is none. We would be happy to fax you the study's SAE report. Fax requests to Jen at 612.625.0080. ID G105056.
This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of GARDASIL (dose, route and lot numbers were not reported). This is one of several reports received from the same source. Additional information has been requested.
Issues with some PNEUMOVAX23 having a broken flange; no adverse event; This spontaneous report was received from an office manager. The reporter stated there were issues with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (lot number U026796, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 28-JAN-2023). The flange was broken (syringe issue). No adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2111USA008646: US-009507513-2111USA009249: US-009507513-2204USA007667: US-009507513-2204USA007829:
I felt weak,  my heart rate went up to 120's, my SBP went up to 150's, I had SOB and felt I was thirsty and I need air and I had severe headache few minutes  about 5 -20 minutes after I had shots.   I took Ibuprofen for severe headache and sore on my Left upper arm at the injection site. Yesterday 1/2/21 I observed at  the injection site has some redness in circular area, warmth to the touch and slightly sore. I met my PCP last 1/28/20 and had my physical exam.
Information has been received from a physician concerning a 22 month old caucasian female with no past medical history and no known drug allergies who on 17 JUL 2001 was vaccinated with the third dose of hepatitis b vaccine recombinant (yeast) in the deltoid. There was no concomitant medication or illness at the time of vaccination. The physician reported that the patient was vaccinated by another physician from the same office and returned two days later, on 19 JUL 2001, with an injection site reaction. The site was hot, tender, red and about 2" x 3" in size. The patient had painful swelling of the deltoid muscle, about 5 cm across, with erythema and warmth. The patient sought unspecified medical attention. It was reported that the patient recovered on 21 JUL 2001. No further information is expected.
threw up a few times; I actually past out that morning; I woke up 5 AM and I was bleeding very heavy; My right side (side I fell on) of the head still hurts; severe headache/ My right side (side I fell on) of the head still hurts; feel nauseous; I got my period days early from my usual; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (I actually past out that morning) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nausea and Pain. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, NAPROXEN SODIUM (ALEVE) for Pain.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced MENSTRUAL DISORDER (I got my period days early from my usual). On 29-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (I actually past out that morning) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (I woke up 5 AM and I was bleeding very heavy), FALL (My right side (side I fell on) of the head still hurts), HEADACHE (severe headache/ My right side (side I fell on) of the head still hurts) and NAUSEA (feel nauseous). On an unknown date, the patient experienced VOMITING (threw up a few times). At the time of the report, LOSS OF CONSCIOUSNESS (I actually past out that morning) was resolving, HEAVY MENSTRUAL BLEEDING (I woke up 5 AM and I was bleeding very heavy), MENSTRUAL DISORDER (I got my period days early from my usual), FALL (My right side (side I fell on) of the head still hurts) and VOMITING (threw up a few times) outcome was unknown and HEADACHE (severe headache/ My right side (side I fell on) of the head still hurts) and NAUSEA (feel nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient never had any issues with the menstrual cycle and never had this much blood. Patient went to emergency department and ran a few imaging tests like CT scans and others which were turned out as normal. Treatment medication were not reported.  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.Very limited information regarding this event has been provided at this time.; 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.Very limited information regarding this event has been provided at this time
Started have pain on right torso front and back about 4 days ago. Went in today for the second dose of the vaccine and about 5 hours later started to develop a rash on right side front and back. Went to the doctor who said it was shingles
MODERNA COVID #3 VACCINE GIVEN 11/28/21, LOT #018F21A; 4/1/22 pt had a positive COVID test at Medical Center; was admitted to hospital with confusion, enterococcal bactremia; persistent encephalopathy; was dc'd to Hospice with uncontrolled pain and agitation, not alert enough to swallow; pt passed away in the hospice facility