chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Vaccine; Nine days after receiving the vaccine, I noticed slight soreness in the injection site muscle. When I got out of the shower the next morning, my arm had a red circle at the injection site.   I had no other symptoms.  The redness faded during the day.  A  friend of mine is a nurse who said I should report this, even though the symptoms were very mild.  Later, I remembered scratching my arm before the redness occurred.  My skin is dry during winter, so I hadn't made any connection to the vaccine site.
sugar level increased; This is a spontaneous report from a Pfizer sponsored program Support from a contactable female consumer (patient). A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that her sugar level increased on 24Feb2021 after the vaccine. Patient was inquiring if it is normal to have that side effect and how long it will last. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
I have fibromyalgia and this pain I have had ever since I woke up this morning is far worse than any fibro pain I have ever experienced. It is in my neck all the way to my lower back, down my legs and the bottoms of my feet. I have taken hydrocodone 10/325mg, morphine 15mg IR and nothing is touching this pain. I am also having extreme thirst (over and above what my medications would have happen).
POST VACCINATION DURING 15 OBSERVATION PERIOD, PATIENT BECAME DROWSY AND APPEARED TO POSSIBLY PASSOUT BRIEFLY.  LAYED PATINET DONE, CALLED 911, PATIENT WAS AWAKE, ALERT AND DRINKING WATER, BUT DROWSY, MEDICS EXAMED AND PATIENT REFUSED TRANSPORT TO HOSPITAL.  PATIENT LEFT WITH HER MOM
I noticed around 01:00 pm or so, I told my daughter at three that I couldn't go to lunch with her. I was sure I had a fever. That continued until early evening yesterday.   I couldn't walk upstairs. Both of my feet hurt me so bad. This time, the insteps on both of my feet were hurting It was just killing me. The toe - the right big toe was swollen. Very swollen. The left foot and toe - pain only; no swelling on it. I can't even touch it (right big toe) without pain. I can't get up or eaten anything except go to bathroom. But I do feel a little better today.  I am still having swollenness on the right big toe. I have an appt at Urgent Care today.
PATIENT CAREGIVER(MOTHER) REPORTED 104 DEGREE FEVER, VOMITING, NAUSEA, FATIGUE, AND SHAKINESS
This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3294 and Expiration Date unknown) via an unspecified route of administration on 11Jan2021 07:15 AM (Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 03:45 PM (Left arm) at single dose for COVID-19 immunisation.No covid prior vaccination, no covid tested post vaccination and no known allergies.Other medical history included thyroiditis and scleritis The concomitant medications included Levothyroxine, Vitamins, paracetamol (TYLENOL), Pepsid, Melatonin. No other vaccine in four weeks. Patient experienced, fatigue, left under eye bruise, right eye injection, joint swelling, gum bleeding with brushing on 13Jan2021 08:00 AM, resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with unknown treatment.
VARIVAX to R thigh received 6/11/08, pt developed indurated red area 3cm diameter on R thigh at injection site, seen by me 6/20/08, then 6/22/08 developed a spotty red rash on legs/trunk reported by mother.  No fever.  No vesicles.  No treatment given.
It was reported that a 35 year old female patient received a Fluzone SV vaccination on 11/30/2000 at 10:15 am in the left forearm. Reportedly one hour later the patient complained of itching all over her body. Medication was given approximately one hour later. The patient also complained of dizziness and throat closing and still itching. From additional correspondence received 02/21/2001, it was reported, "reviewed, no additional information at this time" - CD 02/14/2001. This case is closed.
Not an adverse medical event.  Pt had Moderna for first dose and was given Pfizer for second dose.  No reaction to vaccination, injection tolerated well.
Severe and constant pain to upper rt shoulder, arm radiating to back of neck. Distal arm and hand feels slightly weak. Not a headache but a heaviness.. Unable to sleep on rt side, excruciating pain when turning. Unable to raise or abduct arm. Generalized body aches. Used hot packs and Motrin with little effect. Pain continues.
Increasing tinnitus beginning roughly 3 weeks after 1st shot. Last gotten much worse following 2nd shot. Constant ringing 24/7 in both ears. Difficult to concentrate and fall asleep due to noise.  Currently taking 20mg prednisone.  Have upcoming appointment with an ENT.
chills; fever; nausea; vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomiting) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomiting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced chills, fever, nausea and vomiting now. Concomitant medication use was not provided Treatment information was not provided   Reporter did not allow further contact
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in 2016, reported as since 16-FEB-2016, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) injection (lot# L023112, expiry date 24-DEC-2016; lot# L005292, expiry date 17-AUG-2016; lot# reported as L046506, expiry date 17-MAY_2017; lot# reported as L041629, expiry date 22-APR-2017; lot # L032761, expiry date 24-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The reporting nurse stated that the vaccines were exposed to a temperature excursion of 31.1 degrees Fahrenheit, for a cumulative time of 105 hours since 16-FEB-2016. No adverse effects were reported. There was no product quality complaint involved. This is on of several reports received from the same reporter. Additional information has been requested.
Bruising; Sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 12:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included syncope vasovagal, anxiety, depression and fruit allergy (Strawberries). Concomitant medications included fludrocortisone acetate (FLORINEF), and duloxetine hydrochloride (CYMBALTA) from an unknown date for an unspecified indication. The patient previously took cabergoline (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication, and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 21:00, the patient experienced sore at injection site, bruising. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore at injection site, bruising was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
17 X 13 patch of erythema right upper thigh developed 1/23/2002 Treated with Zithomax. Hx of similar reaction in past w/ DTaP
Currently admitted at health Care. Likely adverse event is viral myocarditis (chest pain, elevated troponin, changes in ekg) possibly due to booster covid vaccination.
Immunizations given in AM 8/28/07; around 9PM patient had temp of 103F and 5 minute generalized tonic-clonic seizure; patient brought to ER, seizure stopped before patient arrived in ER.  Septic work-up including spinal tap was done - initial results are all negative.  9/7/07 Reviewed hospital medical records which reveal patient experienced limpness, eyes rolled back in head, vomiting, fever & tonic clonic seizure activity.  Admitted 8/28-8/30/2007.  Afebrile & no further seizure activity in hospital.  D/C to home w/pcp f/u. FINAL DX: Febrile seizure.
Resident received vaccination at 9:12 am, she was monitored and checked at the 15 minute interval 9:27 am, reassessed, vitals were fine.    Within 20 (9:32 am) minutes of receiving the vaccine she was unresponsive, pupils were fixed at 9:45 am, no vital signs noted; hospice came out and reported her time of death 10:21 am.  This person was on hospice.
rash on upper back and lower leg; A spontaneous report was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on upper back and lower leg/rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) rash on upper back and lower leg.  Treatment details included Patient received high doses of antihistamines .  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash on upper back and lower leg was unknown.
Vision - brightly colored light flashes at edge of vision, left eye at 11:20 am,  10 minutes later also added blurred vision left eye. Both symptoms gone by 1:40 pm with no residual effects from the side effect afterwards. Fatigue for remainder of the day. No treatment other than rest in a chair until vision returned to normal.
The patient had COVID19 infection diagnosed 12/14/2020, and he stated 5 to 10 days after this, he developed shortness of breath.  Had vaccine on 12/24/2020.  Hypoxic and short of breath with COVID19 pneumonia on 12/29/2020.  I do not know if this is an adverse effect or temporally related or if the vaccine activated prior infection.
stroke; always tired; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and FATIGUE (always tired). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) and FATIGUE (always tired) outcome was unknown.            Concomitant product use was not provided by the reporter.   The patient had stroke 3 months after taking the 2nd shot.  Treatment information was not provided.  Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.
On 10/25 patient recieved covid moderna booster and flu shot. Patient called pharmacy on 10/26 to report that shortly (about 30 minutes) after the vaccines, she could began to experience an unbearable pain in her left arm and could hardly move her fingers. Patient reported no problems in her right arm.
pt states 20min p/vax pt started w/chills, feeling hot & cold, skin was clammy;pt became nauseated & dizzy;then devel abd pains;states went home & to be & sx persisted for 48hr;pt concerned about getting next vax;
sore arm; body ache; fever; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, body ache/myalgia, fever/pyrexia.  The patient's medical history was not provided. Concomitant medications reported were Tylenol for drug use for unknown indication.  On 7 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 7 Mar 2021, the patient experienced sore arm/pain in extremity, body ache/myalgia, fever/pyrexia.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  on an unknown date the outcome of sore arm/pain in extremity, body ache/myalgia, fever/pyrexia was not reported.
This spontaneous report was received from a back office lead and refers to a 49 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Woke up the day after getting the vaccine with soreness and aches all over my body. Was very fatigued throughout the day. However, I took 800 mg of Advil and felt much better.
body aches, headache, temp of 102.5 , chills, sweats, extreme joint pain dizziness. bed for two days slowly subsided during the third day.  Did not know if this is common with first shot.
The weeks following vaccination, the patient felt lethargic, dizzy, unstable on his feet. Mental cognitive ability was unchanged, and he seemed to still be sharp. Up until the day of death, the patient was still active, able to drive, speak, make jokes, eat, and do everything normally. The morning of death, he had a bad fall, but couldn't recall what happened. It's assumed that a low blood pressure event, syncope, partial aneurysm, something of that nature causing temporary loss of consciousness occurred. We attended a funeral that afternoon, ate lunch, and dropped him off at his home. Sometime during that evening, he fell and died. The cause is unknown and still "undetermined" on the death certificate. (Heart attack or brain aneurysm is what I'm guessing)
racing heart, pain/discomfort in chest, felt like heart attack. Heart rate would not go below 100 bpm for better part of day.  eventually went to ER at  Medical Center.  aspirin, chest xray, cardiac CT, nitro, and monitoring.
Pt recv vax on 2/11/99; 1 1/2 hr post vax pt exp swollen lips, eyes, hands, rapid heart rate x 30 min; tx=Epinephrine SC, Dexamethasone, Benadryl
Later that night, injection area became swollen the size of a fist and very tender to the touch. No redness noted.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age. On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX dose 1, subcutaneously in the back, or triceps region, of the arm. No adverse effect was reported. Additional information has been requested.
Was just brought to our attention (4/24/23) that this child was given an adult dose of Pfizer Covid vaccine back on 09/11/2021. There was no report from parent at that time of any adverse s/s of the dose. Parent was notified of the error today (4/24/23). Dr was also notified of the error today (4/24/23).
1. Immediately post injection for a period of 3 days: nausea, headache, chills, fever, joint pain, loss of appetite 2. Longer term and still persists: mental fog, thought focus challenges, lethargy, headaches
Patient received dose two of the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose of Shingrix in 2019.).   On 25-APR-2023, the patient received the 2nd dose of Shingrix. On 25-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received dose two of the series). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The pharmacist reported that patient forgot to return for the second dose within the approved timeframe. The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to drug dose administration too long. Pharmacist declined to provide further details on call. The reporter consented to follow up.
The evening after vaccination she developed hoarseness and a sore throat.  A few days later she developed a cough with a right sided temporal and facial pain with 1 small red area on left arm.  Headache has interfered with her ability to sleep and attend classes.  Afebrile but reports hot flashes.  No loss of facial sensation.  No papilledema.  No facial asymmetry.  She has been prescribed Percocet for pain and placed on Augmentin for treatment of possible sinus infection.
This spontaneous report was received from a registered nurse refers to a 23 year old female patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II, (lot number, expiry date and route was not reported). On an unknown date, the patient was rubeola IGG negative. The nurse stated that the first antibody titer showed equivocal results but the second antibody titer showed rubeola IGG negative. The outcome of second antibody titer showed rubeola IGG negative is unknown. Additional information is not expected.
Small red lump at injection site a week after injection. Lump spread and became hot and sensitive  to the touch. Followed by fever and vomiting the next day.
Chills, Headache, Fever, muscle pain, fatigue, joint pain, chest pain, right had numbness
knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version".  Clinical course: The reporter stated that she knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version.  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-202201300085 similar report from same reporter;US-PFIZER INC-202201300196 similar report from same reporter;US-PFIZER INC-202201300195 similar report from same reporter;US-PFIZER INC-202201300197 similar report from same reporter;
One week after receiving the vaccine the injection site became swollen and hot with a red area and tender to the touch it lasted 48 hours  and then just went away. Treated with Ibuprofen and ice.
Clot in Right Eye suspected possible stroke. Also Tinnitus. Evaluated by retina specialist, Discovered clot and advised to admit to emergency for possible stroke.
Information was received from a pharmacist who reported that multiple unspecified patients were vaccinated with improperly stored ZOSTAVAX 19400 PFU (dosages and routes of administration not provided), (lot #M040145, expiration date 26-DEC-2017), reconstituted with properly stored sterile diluent (lot #M044952, expiration date 01-JUL-2019) on multiple unspecified dates. No adverse effects reported. Excursion information: Temperature: 24.8F Time frame: 1 hour 30 minutes Previous temperature excursion: Yes, 6F to 14F (8.6F) for 45 minutes. Call was because of a data logger. No further information provided. 20-APR-2017: Lot number M040145 has been verified to be a valid lot number for ZOSTAVAX. 20-APR-2017: Lot number M044952 has been verified to be a valid lot number for the sterile diluent. Additional information has been requested.
DAY AFTER I HAD ALL THE SYMPTOMS. BODY ACHES, FEVER SORE ARM, KNOT IN ARM, NAUSEA, HEADACHE, AND FATIGUE. AFTER ABOUT 48 HOURS ALL YMSYMPTOMS WENT AWAY AND I WAS FINE, STILL HAD A SMALL KNOT IN MY ARM BUT THE REDNESS AND MOST OF THE PAIN HAD WENT AWAY BY THE 9TH.  ON 1/18/21 I NOTCIED RADIATING PAIN IN MY RIGHT ARM WHERE I WAS VACCINATED. I LOOKED AND I HAD A HUGE RED CIRCLE WITH EXTREME FEVER AND SWELLING AEOUND THE VACCINE SITE. PAIN STILL RADIATING IN ARM REDNESS AND SWELLING HAS NOT WENT DOWN. ALSO IT HAS STARTED TO ITCH.   ALSO, IM NOT SURE IF ITS RELATED, BUT I HAD A COUPLE OF DIZZY SPELLS 1/14-1/17 THAT CONSISTED OF TINGLING LIPS AND RIGHT SIDE OF YMFACE FELT FUZZY. IT HAS WENT AWAY. CURRENTLY JUST DEALING WITH PAIN AND SWELLING AT THE INJECTION SITE.
I felt woozy all day after the flu shot but at night I became extremely dizzy. I felt like I had just gotten off a roller coaster. I felt very nauseous. This lasted hours and I finally went to bed.