chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Four days after the vaccine I started to get muscle cramps and joint pain. They were mainly in my knee hips and shoulders. It seemed to be worse on the right side than the left. The pain got much worse and I was given some Prednisone. The first course cleared up the problems with the joints in my legs. Three weeks after the shot, the  pain in my shoulders persisted. I could not sleep at night and the joint pain which seemed to improve toward the evening kept me up all night. My shoulder joints were locked up. in pain even twelve weeks after the shot. That lasted for three weeks. The Bursae in both my shoulders were highly inflamed and I got Cortisone shots in my shoulders. I was prescribed Lyrica by a Neurologist. My arm muscles were also hurting and my Thumb joints were painful. I tried every kind of painkiller and I was taking as much as possible but the pain was still there. I have also experienced Brain fog during this whole experience. Tylenol, Ibuprofen and Naproxen at the same time. After Steroid Injections, High Dose Famotidine and Lyrica treatment I started to recover twelve weeks after the shot and I was able to sleep and not deal with pain. I have felt better for the last three weeks and my Prednisone is being reduced as well as the amount of Lyrica. Ruled out Lupus, and RA. I did not get the second dose of the vaccine.
Moderna COVID-19 Vaccine EUA Rash to arm, legs, dorsal hands and feet, and ears
This spontaneous report was received from an 80 year old male patient referring to himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 1994 or 1995, the patient received a placebo dose of zoster vaccine live (reported as Shingles vaccine) as part of company clinical trial. In approximately 1996 (reported as "two years later"), the patient received a dose of ZOSTAVAX for prevention of Shingles during follow-up visit (dose, route, lot # and expiration date not reported). Concomitant therapies included clopidogrel bisulfate(PLAVIX), rosuvastatin calcium(CRESTOR), tadalafil(CIALIS) and metoprolol succinate(TOPROL). On an unknown date, the patient experienced high blood pressure, heart attacks (myocardial infarction), underwent two stent placement (further not specified), and developed kidney cancer with metastasis to the ribs (renal cancer metastatic, metastases to bone). He received an unspecified chemotherapy for kidney cancer with metastasis to the ribs. Then, on an unknown date he developed transitional cell carcinoma in the bladder (bladder transitional cell carcinoma) for which the patient underwent bladder reconstruction and received more chemotherapy. On approximately 21-DEC-2017 (reported as "about 2 weeks ago") the patient developed shingles (Herpes zoster), began getting pain in his "sides and breast area, nipple pain as well as spots on his back". The patient's physician prescribed valacyclovir hydrochloride(VALTREX) on an unknown date and he began taking it on 04-JAN-2018. The outcome of all the events was unknown. Causality assessment was not provided by the reporter. Upon internal review, bladder transitional cell carcinoma, renal cancer metastatic, metastases to bone, stent placement and myocardial infarction were determined to be medically significant.
I got pregnant but was told due to PCOS I was infertile. I was advised that the pregnancy could have been triggered by the Yaz birth control. I thought I loss the pregnancy due to bleeding but did not go to the doctor. A few weeks later my PCP had me go in and do an ultrasound. Pregnancy was still viable, but the bleeding was caused by SCH. They told me to get established with an OBGYN who deals with high-risk pregnancy. They also gave me progesterone suppositories to help my uterus. At 24 weeks, I developed preeclampsia and planned to induce at 37 weeks. At 36 weeks, during my ultrasound, they found a mass that was 12.6 centimeters on my ovaries. They decided to deliver by C-section and removed the cyst. They were unable to surgically stage my cancer.  A few weeks later I got the pathology results back that I have a undifferentiated/ DE differential juvenile granulosa cell ovarian cancer.  I start chemo on Thursday. After chemo, I will go through a procedure to surgically stage me.
There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose on 1/9/21: Approximately 53 hours after Dose #1: Redness on hands and wrist, rash-like small dot appearance on hands and wrists, skin dryness and tightness  of hands. I experienced no itching of hands or wrists. Approximately 53 hours after Dose #2: Small, painful red pustule-like occurrence on base of right thumb, with the appearance of a few small dots in it. I experienced no itching of  thumb or hand. These events both occurred within the same timeframe following the vaccine doses. Following the first event I was seen in the ER. I checked out fine and they could not say exactly what this was. They said it did not appear to be an allergic reaction to the vaccine because it was not systemic and I had no other symptoms such as trouble breathing. They thought perhaps it was coincidental...I work in the hospital as a radiologic technologist where I hand-wash and hand-sanitize all day. Perhaps I just over-washed that day? However I've worked there for 17 years and never had this happen. The redness and rash dissipated by end of day. Following the second  event I did not follow up with any medical provider. This pustule I got happened while I was at home, and otherwise I felt fine so I left it at that. It took several days for the pustule to  go away. I hope you don't mind but I am writing to report this information in the event it may be helpful to you and I am also reporting it because I want to know if what I experienced could be considered an immune response to the vaccine? Another words, not an allergic response but an immune response ? I can find absolutely nothing about this on-line and no one knows what to make of it. Thank you.
administration of FLUZONE HD QIV to a 19-year-old patient, with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 19-years-old female patient who was administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant: No Other Vaccines.  On 24-Oct-2023, the 19-years-old patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (Frequency: Once; batch number: UT8137DA; expiry date: 30-Jun-2024) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency). Treatment: None  No additional information at the time of the report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
First noticeable event at dinner Nov 18, 2021. Tuna dish w/seaweed salad, which seemed high in sodium. Experienced 5-10 min of dizziness, some ringing in ears. Tinnitus continued thru night and calmed down over coming days but ear felt ?full? or blocked partially with wax Dec 1, appt w/Dr. to clear wax --not as much as is often the case Dec 13, appt w/audiologist bc ear still felt ?full?. Results show loss of high frequency in left ear vs results from 3-4 years previously Dec 16, hearing loss episode in left, about half gone. Called next morning to have nurse relay msg to Dr. Hearing seemed back to ?normal? morning of 17th. Advised to call back if it happens again, or go to ER Dec 30, Moderna booster shot received  Jan 4, hearing loss episode again, about same feeling w/all low frequencies half gone Jan 5, audiologist test, big drop in low frequency end Jan 7, Rx finally filled by Pharmacy, oral Prednisone for 12 days and water pills Jan 19, recheck hearing, further low freq loss. Prednisone direct injection into inner ear, #1, no relief Jan 24, Prednisone injection #2 Jan 27, Prednisone #3 scheduled Feb 3, MRI scheduled to consider next steps
Body aches for two full days; Can't get comfortable because I'm hot then I'm cold.; Can't get comfortable because I'm hot then I'm cold.; Can't sleep well; Feeling better on 3rd day but still very tired.; Soreness in my chest from movement not from breathing; Soreness in my left arm of course.; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 13:30 (Lot number: 330308D) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, very minor symptoms that lasted about a half a day from dose2), administration date: 31Mar2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "very minor symptoms"; Bnt162b2 (Dose Number: 1, Batch/Lot No: FN6207, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM,  I had no symptoms from dose1), administration date: 10Mar2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Body aches for two full days"; DISCOMFORT (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset 30Nov2021 22:00, outcome "not recovered" and all described as "Can't get comfortable because I'm hot then I'm cold."; INSOMNIA (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Can't sleep well"; FATIGUE (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Feeling better on 3rd day but still very tired."; CHEST PAIN (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Soreness in my chest from movement not from breathing"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021 22:00, outcome "not recovered", described as "Soreness in my left arm of course.". Therapeutic measures were not taken as a result of pain, discomfort, feeling of body temperature change, insomnia, fatigue, chest pain, vaccination site pain.  Additional information: It was reported that, no other vaccine in four weeks and no other medications in two weeks prior to dose 3 Bnt162b2. The patient not had covid prior to vaccination and no covid test post vaccination. No Known allergies were reported. Reported as very healthy. Clinical course: The patient had no symptoms from dose1, very minor symptoms that lasted about a half a day from dose2, and dose3 has really kicked my butt. I haven't been that sick in years.  No follow-up attempts are possible. No further information is expected.
Soreness in (L) arm 1 hour after vaccination. By end of evening - had severe pain and weakness in (L) arm - "felt like someone was hitting arm with a  hammer" patchy red rash from (L) shoulder to (L) elbow developed at same time and became progressively worse for 2 days. Arm was also swollen from (L) shoulder to (L) elbow during this time - "looked like fluid under the skin". Symptoms began improving after 2 days pain-free 10/27/12 pm. Rash, redness, and swelling were all gone 10/28/12 morning.
Pfizer 3/16/21, 5/3/21. Positive on 7/28/22
Pain down arm, pain in elbow, deep purple bruise (lasted for 9 days) large lump at injection site, neck pain on side of injection, spasms in deltoid muscle down arm radiating to the hand, pain during night-causing me to wake, easily bruised, deep purple bruises-causes unknown.
ENGERIX B given IM at approx 14:00 pm on 3/19/12. Reports swelling in Rt arm, hand & face started approx. 1030 pm.
Left knee inner aspect, hard warm area (3 cm) less than 50  lesions scattered over right side of trunk and right deltoid.  Vesicular & macular lesions.  Right deltoid warm hard area 3 cm round.  KEFLEX and BENADRYL prescribed.  Dx - VARICELLA breakthrough.
Receive influenza vaccine 10-22-07. Urticarial rash on both legs.
Agitation, Confusion, Dizziness, trembles/shakes for Narrative: Day 2 woke up with trembles/shakes and felt confused all day. Resolved by next morning.
Vaccine administered had beyond use date of 2/11/23 but administered on 2/17/23. No adverse event reported
pain in left arm; pain in left shoulder; pain in thigh muscle; pain in left hip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (pain in left shoulder), PAIN IN EXTREMITY (pain in thigh muscle) and ARTHRALGIA (pain in left hip) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 011A21A;) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL, GABAPENTIN, ALPRAZOLAM, ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D 3), glucosamine chondroitin + vitD and DICLOFENAC for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (pain in left shoulder), PAIN IN EXTREMITY (pain in thigh muscle) and ARTHRALGIA (pain in left hip). The patient was treated with IBUPROFEN on 14-Apr-2021 for Pain, at a dose of 200 milligram twice a day. At the time of the report, PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (pain in left shoulder), PAIN IN EXTREMITY (pain in thigh muscle) and ARTHRALGIA (pain in left hip) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment to the events given as Ice pack on back and leg is making it go away.   This case was linked to US-MODERNATX, INC.-MOD-2021-077967 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077967:1 st dose
Patient reported arm was "very, very sore", red rash across entire width of arm from injection site to elbow, swollen, greatly improving as of today 9/30 Monday (3 days post-injection)
Fever, headache, body aches for 3 to 4 days and resolved without any medications.  Bilateral ankle swelling started 5 days after vaccine (started on 3/16/22).  Patient is out of town and provided a phone number that is invalid.
8 weeks after receiving the second dose, Child woke with neck pain and unable to move her head due to limited ROM. Upon MRI inflammation was discovered causing subluxation and cervical instability in C1-C2.  Also being treated for suspected bone infection as symptoms do not align with actute onset of JIA, due to single joint affected.  Child now also being treated for cdifficile.  Cervial Fusion surgery is currently under consideration to maintain stability in cervical spine; pending re-imagining.
I got the second shot for Pfizer-BioNTech COVID-19 Vaccine EUA on Monday and immediately started to react on the arm it was injected into. I had redness and some bruising that last almost three weeks after the first one. I got the second one in the same arm and this time I had the same redness at the injection site that immediately started bruising. I also saw a red bump develop 24 hours later just below the injection site and after 48 hours it was a round red bump the size of a tangerine. It?s hard to the touch as if some callus formed under the skin. It?s still there three days later
This spontaneous report as received from a medical assistant refers to a 4 year old female patient. On 11-APR-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot#N031929, expiry date 12-MAY-2019) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot# N021030, expiry date 19-NOV-2019). No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 41 hours and 17 minutes. No previous temperature excursion was involved. A data logger was present. No product quality complaint was present. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010458:
Status epilepticus, ear infect seen by MD taken to hosp pt is apparently retarded; prolonged sz & encephalitis;
PT RECEIVED DOSE TWO ON DAY 15 INSTEAD OF RECOMMENDED DAY OF 21.  NO SYMPTOMS REPORTED.
Patient received Pfizer booster vaccine 6 weeks before the recommended interval of 5 months.
Fever to 101.1 (temporal artery) chills, diffuse myalgias, nausea, headache lasting 24 hours. Local pain and tenderness at vaccination site lasting 48 hours.
Information has been received from a physician concerning an 18 year old female patient who on 05-SEP-2010, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported), however no adverse effect was present. On approximately 06-MAR-2011, the patient was vaccinated with the second dose of GARDASIL (dose and route not provided) (Lot number "14372" is an invalid lot number for GARDASIL). The physician reported that on 08-MAR-2011, 24-36 hours after receiving her second dose of GARDASIL, the patient experienced nausea, vomiting, vertigo, near syncope, ataxia, and difficulty walking. The patient did not seek medical attention. No treatment for the adverse events was given. It was reported that the series may be discontinued and the adverse event improved on therapy. The patient recovered on 11-MAR-2011. Follow up information has been received from the Medical assistant (previously reported as physician) who reported that the 18 year old female student patient with no known drug allergies and no known food allergies and no illness at the time of vaccination who on 03-SEP-2010 (previously reported as 05-SEP-2010), was vaccinated with the first dose of GARDASIL intramuscularly on the left deltoid (lot number 666163/0664Z). On 08-MAR-2011, the patient was vaccinated with the second dose of GARDASIL intramuscularly on the left deltoid (Lot number 667866/1437Z). On 09-MAR-2011, the patient experienced nausea, emesis, vertigo, ataxia and near syncope. On 17-MAR-2011, the physician reported that the patient called the office and referred adversities 24-36 hours after inoculation. The physician advised the patient against the third dose of the vaccine. Patient's nausea, emesis, vertigo, ataxia and near syncope were considered to be disabling by the Medical assistant. Additional information has been requested.
one died of stroke; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: CEREBROVASCULAR ACCIDENT (death, medically significant), outcome "fatal", described as "one died of stroke". The patient date of death was unknown. Reported cause of death: "one died of stroke". It was not reported if an autopsy was performed. Additional information: The reporter has lost family members from it they have died. They have tried, they reported to VAERS, already reported the deaths. They were on there and then they were scrubbed or taken off because they didn't find it was an actual Pfizer or vaccine death. One died of a heart attack, one died of stroke, and they said, no they died of a heart attack and a stroke not a Pfizer shot even though it was just 3 weeks after.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: one died of stroke
Patient answered "no" to receiving any other COVID vaccine and denied verbally. When processing vaccine, there was a history of patient receiving Janssen vaccine on 4/12/21. Called patient to verify and patient never answered. Received a copy of the consent form she filled out on 4/12/21 and it is the same patient.
14-year-old patient brought in by Ambulance to our ED last Sunday complaining of numbness and vomiting 3 hours after he received a Pfizer Vaccine .  In ED pt given 1L NS, Zofran 4mg IVP,   Pt given discharge script for Zofran ODT
Information has been received from a consumer referring to her 69 year old husband with arthritis, diabetes mellitus, hypertension and retinal vein occlusion. The patient was a pacemaker user and allergic to amiodarone and azithromycin. The patient's medical history included triple bypass and back surgery. In approximately October 2015 (reported as "4 or 5 months ago"), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date unknown, 1 shot, subcutaneous). Concomitant therapies included PRAVACHOL, LASIX, hydralazine (reported as "hydrolazine"), potassium (unspecified), NORVASC, ZESTRIL, TORPOL XL tablets, allopurinol, fenofibrate and warfarin. In approximately October 2015, within a week after the vaccination of PNEUMOVAX 23, the patient developed a cold-like infection and has raspiness in his throat. The raspiness had been gradual but had continued to become worse. The patient sought medical attention and the doctor recommended anti-allergy medications such as ZYRTEC (reported as "ZYRTEK") and using a humidifier but without improvement. Then the patient consulted a specialist who performed an endoscopy and stated that there appeared to be some paralysis in the vocal cords. The outcome of the events was reported as not recovered/not resolved. The causality between the events and PNEUMOVAX 23 was unspecified. Upon internal review, the event vocal cord paralysis was considered to be medically significant. Additional information has been requested.
vaccine was administered outside of storage recommendations. patient returned on 6/4/21 to re-vaccinate
Patient date of birth was incorrect on vaccination card. Year of birth was listed as 2008 instead of 2009. Card was corrected. Patient was 11 years old at time of first vaccination.
Very painful group of 4 blisters suddenly developed on my right upper lip. It is a herpes simplex cold sore. I have never had a cold sore in my life.
paresthesia in all extremities, a little bit bothersome but doesn?t interfere with functioning. tingling accompanied by intermittent muscle ache similar to when a limb ?falls asleep,? present from hand to elbow bilaterally, from left foot to knee, and in right foot. worsened immediately by pressures that might otherwise make a limb fall asleep in a few hours, immediate recovery upon removal of pressure. motion of the limbs did not affect the paresthesia. no medications taken, but it may be starting to get a little better now, about 1.5 hours after onset.
Patient was given both a MMRV and a VAR. Patients mother was informed by PCP to give the patient tylenol.