chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right and then left hand stiffness and muscle cramping with tightness felt. Pain in finger joints of right then left hand. Joint and muscle stiffness of upper extremities then both feet.
Recepient experienced immediate burning where innoculated. Was aching, tired, and nauseous within 1/2 hour of shot. Neck became sore and stiff. Symptoms lasted for about ten(10) days
Pulmonary embolism; tested positive for covid; A spontaneous report was received from a consumer concerning an 84-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary embolism, and tested for positive for Covid-19/COVID-19.  The patient's medical history included arthritis, and high blood pressure.  Concomitant medication history was not provided.  On 26-Jan-2021,  the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 12-Feb-21, she started experiencing shortness of breath and went to her local urgent care. They sent her to the emergency room where she was admitted and diagnosed with a Pulmonary Embolism. The patient was prescribed a blood thinner.   While in the hospital, she tested positive for Covid-19 on 14-Feb-21. She was in the hospital from 12-Feb-21 to 22-Feb-21.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, pulmonary embolism were recovered.  The outcome of the event, COVID-19 was recovering.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Covid-19 is assessed to be unlikely related.
Received vaccination on Saturday night, 3/13/2021.  On Tuesday developed headache, fever( highest recorded was 101.2), chills and body aches, with most sever pain left side mid-back.  Treated with Tylenol and it lasted about two days.  On Friday developed a rash on my right foot, that by Sunday had spread to the other foot, both hands and arms, and around my waist and partially down my legs. Bright red and itchy.  Still have splotchy rash two weeks later.   Due to get my second shot tomorrow, Saturday, April 3rd.
MOM SAID THAT THE DAY OF SHOTS (4/22/19) AND THE NEXT DAY (4/23/19) WERE ROUGH FOR PATIENT. PATIENT HAD A TEMP OF 99.6, HIS LEGS WERE IN PAIN, AND HE WAS VERY IRRITABLE. PT WOKE UP ON 4/24/19 SCREAMING. AT TIME OF THE CALL (AROUND 11 AM ON 4/24/19) PT WAS CONTENT. MOM HAD BEEN GIVING TYLENOL. THIS OFFICE FOLLOWED UP WITH MOM THE NEXT DAY (4/25/19). PER MOM, ALL ADVERSE SYMPTOMS HAD RESOLVED
Information has been received from a licensed practical nurse concerning a 63 year old white male laborer with coronary artery disease, hyperlipidemia, and no known allergies who on the afternoon of Oct 04 2004 was vaccinated intramuscularly into the left deltoid muscle with a second dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M). That same day, the patient developed pain in his shoulder near the injection site with swelling. The arm was very swollen, red sore and it hurt to raise it. It was reported that the patient was unable to sleep on his left side for three days. The patient sought medical attention and was treated with ice, acetaminophen (Tylenol) and ibuprofen. Subsequently, the patient recovered. The nurse also reported 2 other patients who has similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 645255/1212M) (WAES0410USA00811, WAES0411USA01577). Additional information has been requested.
Within 1 minute of receiving the vaccine, patient was walking down an aisle in the store and lost consciousness.  He bumped the back of his head on a shelf and fell to the floor.  He quickly regained consciousness and remained still.  His blood pressure was taken and was within normal range.  EMS was called and arrived 10 minutes later and patient was taken under their care.
Information has been received from a nurse practitioner concerning a 22 year old female with no pertinent medical history and a drug hypersensitivity to clindamycin who on 01-NOV-2007 was vaccinated with a first dose of Gardasil (lot #659435/1265U).  There was no concomitant therapy.  On 01-NOV-2007 while the patient was checking out of the office she became dizzy and light headed.  Medical attention was sought.  The patient rested in the office for 30 minutes and then left.  The patient called the office 02-NOV-2007 and reported that she felt queasy and light headed.  The patient was told to drink fluids and rest.  At the time of the report the patient had not recovered.  Additional information has been requested.
ED 11/15/2021 - transferred to Hospital -admitted Hospitalized (11.16.21 - 11/22/21; COVID-19 positive (11.15.21); Fully vaccinated  Details of Hospital Stay PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE: This is a 69-year-old female with past medical history significant for asthma, OSA, morbid obesity, borderline personality disorder and GERD who presented to emergency department with weakness and cough.  For in the emergency department, the patient was found to be hypoxic requiring 2 L nasal cannula.  COVID-19 PCR was positive.  Chest x-ray showed nonspecific left lower perihilar opacity.  The patient received Decadron in the emergency department and was transferred to Hospital for further evaluation.   The patient was treated with Decadron and remdesivir for COVID-19 pneumonia.  Procalcitonin was noted to be normal with low suspicion for bacterial infection.  The patient's prescribed Lasix was continued.  Oxygen saturation remained stable on 3-4 L nasal cannula. She was seen by Rehab who recommended 4L NC with rest and 8L with oximizer with activity. PT recommended home with assist. She was discharged on decadron to complete course at home as well as given scripts for tessalon and guaifenesin. The patient was hemodynamically stable and all questions were answered at discharge.    Consults None   Procedures None
Pediatric dose of pfizer was given instead of adult/12-18 year old dose.
fetal demise; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Prev dose product is COVID 19, brand unknown is True, brand name unknown is COVID19 Vaccine, Is bivalent was False, lot unknown was True, lot unknown reason was Not available/provided to reporter at the time of report completion, dose number was 2.), for Covid-19 Immunization; Covid-19 vaccine (Prev dose product was COVID 19, brand unknown was True, brand name unknown was COVID19 Vaccine, bivalent is False, lot unknown was True, lot unknown reason was Unable to locate or read the details, dose number is 1.), for Covid-19 Immunization. The following information was reported: FOETAL DEATH (death, medically significant), outcome "fatal", described as "fetal demise". The event "fetal demise" required physician office visit and emergency room visit. The patient date of death was unknown. Reported cause of death: "fetal demise". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Given the limited information in narrative, and for the purpose of submission the company considerers, casual association between the event fetal demise and suspected vaccine cannot be excluded. 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. Linked Report(s) : PFIZER INC-202201198744 EDP Case-Same vaccine, different patient/event; Reported Cause(s) of Death: fetal demise.
I have a burn on my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin burning sensation in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced skin burning sensation (Verbatim: I have a burn on my arm). The outcome of the skin burning sensation was not reported.   It was unknown if the reporter considered the skin burning sensation to be related to Arexvy.     It was unknown if the company considered the skin burning sensation to be related to Arexvy.  Additional Information: GSK Receipt Date: 28-OCT-2023 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had burn on his/her arm after RSV vaccine. The follow-up could not be possible as no contact details were available. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR151221:Same reporter US-GSK-US2023AMR151214:Same reporter
Patient reported before vaccine administration that he was bothered by his high blood pressure-LPN checked-150/100-then used automatic BP cuff-was 128/88- within 15 minutes patient complained of chest pain which worsened when laid down. BP-138/88.  Requested EMS-was transported to Hospital.
Child fell from his chair about 1 minute after, receiving his immunization he appeared to be going into convulsion. Bach arched, arm raised and eyes not focused. Slightly pale. Resp, ok, pulse strong and reg. BP 100/50. Body stayed rigid for about 10-15 sec. Then came out of it crying for mother. 911 called he checked out ok. Small knot on back of head. Parents will take to their physician. Mother called back after doctor visit, not a real convulsion, called it a shock reaction no RX or treatment needed.
Pt recvd 3 doses of Engerix-B 5NOV90, 4DEC90, & 30APR91 & 7SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-MAR-2021. This report was non-serious.
I have a rash on my legs and around my elbows and on my back and two dermatologists have said they do not know what it is but it looks like some kind of allergy. They scraped the rash and it is not fungal. It is itchy and it fades until I am hot or in the sun.  It is in the shape of rings. Ringworm was ruled out. I have  fatigue. Also, 12 hours after I received my second shot, I ran fever of 103 degrees for approximately 15 hours.
Brachial Neuritis  I had Severe pain in my left shoulder.  Tingling and numbness from my shoulder to fingertips.  The severe pain lasted 2 weeks. The tingling and numbness and moderate pain lasted a month.... There is still tingling from time to time. my tricep, bicep and chest muscles began to atrophy within a week and are still atrophied. I have began to build back my strength gradually. I never visited my primary physician because I thought I had slept on it wrong. Started using a chiropractor but it did not relieve the symptoms.
flu; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, formulation, expiry date was unknown)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
poor appetite, rapid water weight gain (one pound per day), trouble with balance, shallow breathing, fatigue, fever, headache, severe urinary tract infection, itching skin, severe pain in joints, muscle soreness, vertigo.  Lasted several days.  UTI resolved with medication.
Development of cluster of small whiteheads and redness on both cheeks.  Doesn't itch or hurt, isn't warm to the touch.  Started evening  of 5/22/21, by 5/23/21 in the evening they covered most of the cheeks.  I put coconut oil on and took 1 Benadryl in in the evening and morning of 5/24/21 there is a reduction of the amount but redness is prevalent.
Woke up from a deep sleep at 11:30 pm with my heart racing and irregular heart beat.  Called 911  and they took me to the Hospital  I was having an Atrial Fibrillation episode that took about 4 hours to subside.  I was given Cardizem IV drip for 3 doses before it resolved.  Was admitted to the hospital for approximately 36 hours.
9/12/12 - Immunization given in afternoon. 9/13/12 - Sore arm, feeling "tired". 9/14/12 Feeling tired, achy, headache, fever to 101 degrees. 9/15/12 - Feeling tired, achy, headache, fever to 101 degrees. 9/16/12 - Fever down to 99-100 degrees.
Information has been received from a 66 year old male pharmacist with no allergies and no pertinent medical history, who in February 2000, was vaccinated with a first dose of PNEUMOVAX 23 ( Lot# not reported), in approximately February 2005 was vaccinated with a second dose of PNEUMOVAX 23 (Lot# not reported), and in approximately 2010 "Over one year ago" was vaccinated with a third dose of PNEUMOVAX 23 (Lot# not reported), IM.  Concomitant therapy included aspirin.  It was reported that the patient had received three doses of PNEUMOVAX 23 in the past "spaced about 5 years apart".  Pharmacist stated that "About 4-5 weeks ago" on approximately 14-FEB-2011 had developed pneumonia in the right lung; some cough and fever of 101 F for 4-5 days.  Pharmacist also stated that missed work about 4-5 days of work".  X-rays were performed (No results reported).  It was reported the patient received the following treatment for the adverse events: montelukast sodium (MSD), LEVAQUIN, TUSSIONEX, DELSYM, VENTOLIN HFA and FLUNASE.  The patient sought unspecified medical attention.  At the time of the report the patient was recovering and had some cough.  Pneumonia in the right lung, fever 101F and cough, were considered to be disabling by the reporter.  Additional information has been requested.
This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 18-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # 029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
pt recvd vax & was hospitalized 11JAN93 because of a joint infect of the rt elbow; blood culture pos for H. Influenzae (type unk); treated w/IV Rocephin;
Case number PHEH2014US025093, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 52-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 24 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Approximately 2 days after Anthrax vaccination, began to have redness and swelling of ipsilateral arm extending quickly to his wrist from the vaccination site. By 3rd day, there was circumferential swelling and patient was admitted for IV antibiotics. Gradually improved and was discharged after 36 hours. To finish course of antibiotics.
I was okay after waiting the 15-20 minutes. I woke up in the middle of the night with my chest hurting and pain all over. My arm was weak and I felt like I couldn't firmly hold something. I don't trust myself doing anything with this left arm. When I got up to go to the bathroom, only a few steps away, I felt soreness in my thighs and lower leg area like I just got done running.
Right sided neck pain/stiffness radiating up upward to right side of head. Started day after injection given in right arm. Continues to date. Referred to neurologist 1/28/09 as NSAID heat- no improvement.
Elevated temperature, muscle aches. 26 hours later still 100 degree temp, muscle aches, feels like fuel symptoms. This is my second vaccination. My first was in August 2018 and this same reaction of being in bed for two days. I recovered before after 2 days and assume I will be improved tomorrow.
Information has been received from a medical assistant in a physician's office concerning a patient who on approximately 17-OCT-2009 was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). On approximately 20-OCT-2009 ("6 weeks ago") the patient developed a mild case of chickenpox within 3 days of vaccination. Unspecified medical attention was sought via office visit. On an unspecified date, the patient recovered. Additional information has been requested.
CYST LIKE OVAL LUMP AT THE INJECTON SITE ON LEFT ARM; INJECTION SITE PAIN; FATIGUE; This spontaneous report received from a patient concerned a 63-year-old White female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported,1 total, administered in left deltoid on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced injection site pain, fatigue. On 11-APR-2021, the patient experienced cyst like oval lump at the injection site on left arm that was painful to touch. It continued to be there two weeks later. The patient had an appointment with healthcare professional today (as reported,28-APR-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fatigue on 11-APR-2021, had not recovered from cyst like oval lump at the injection site on left arm, and the outcome of drug allergy was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
after 3 days of the shot she had huge spot red, major area with redness and hives.; broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives) and ERYTHEMA (after 3 days of the shot she had huge spot red, major area with redness and hives.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced URTICARIA (broke out in hives). On 07-Feb-2021, the patient experienced ERYTHEMA (after 3 days of the shot she had huge spot red, major area with redness and hives.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Feb-2021 at a dose of 1 dosage form; PREDNISONE on 07-Feb-2021 at a dose of 1 dosage form and PEPTIDES NOS on 07-Feb-2021 at a dose of 1 dosage form. At the time of the report, URTICARIA (broke out in hives) and ERYTHEMA (after 3 days of the shot she had huge spot red, major area with redness and hives.) had resolved.        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.
Chills, joint pain at first - then (L) knee increased pain with swelling - 2nd knee same a few hrs. later then that evening pain went (L) wrist - unable to walk stand or bear any wt w/in 28 hrs. getting shot. To ER - admitted w/sepsis dx.
4/14/21 c/o migraine, leg spasms, abdominal cramps, fatigue 4/16-Recommend caller contact PCP; caller states she does not have health insurance and does not feel "bad enough" to go to hospital or urgent care. She states if symptoms worsen, she will be evaluated at a HCF. She also asked for f/u call to be scheduled for Sunday 4/18 as she will be working all day 4/17 and won't be able to take call. 4/17-called the patient , no new issues , no migraine , nothing new to report
Narrative: Patient received Moderna covid vaccine #1 on 4/12/21. She is noted to have PMH of premenopausal breast cancer stage IIa and was admitted to a facility on 4/27/21 for removal of an IJ port a cath due to stenosis and thrombus. A few weeks later, on 5/13/21, she had a tunneled infusion catheter removed and on her way home had four syncopal episodes; therefore she returned to the facility and upon return was noted to tachycardic, shaking, short of breath and had chest pain. She was admitted and a CT of the chest was negative for PE but did now a thrombus in her superior vena cava. A head CT was negative for hemorrhagic bleed or emboli. She was also noted to have a pericardial effusion. On 5/17/21 around 0500, she had a code blue with PEA and was intubated, shocked and had CPR. ROSC was obtained and she underwent an emergent pericardial window and pericardiocentesis as well as an emergent sternotomy. Per notes, there was a laceration in her aorta and due to massive blood loss, they were unable to maintain a cardiac rhythm and she passed away. No autopsy results available. Time for covid vaccine to date of death was 32 days.
Initially noted a 1 cm x 1cm red mark, raised evening of vaccination.  Then when woke the next day 11/2, it was 3.5 inches by 1.5 inches, it was hot, angry red and muscle was painful.  Then went to my doctor, and he started me on Clarithromycin.  Then I when woke on 11/3 the entire deltoid and tricep area was involved, and felt into my neck and jawline, I was feverish, hot and sweaty and exhausted.  I went back to my physician and I was started on Bactrim and steroids to help with the swelling.  It continued to progress on 11/4,  but I started to feel a little better, but the muscle is still painful.