chrisvoncsefalvay/vaers-outcomes huggingface dataset:
~6days after receiving MMR vaccine Pt had onset of bilateral knee and hip aches/pain. Lightheadedness and fever by her report. Also reports ~3" rash at the site of the injection. Advised ER eval ( ER report attached) Pt reports Hx. of Arthritis. Final diagnosis in ER was allergic reaction. -IV fluid, Toradol, Zofran, Solumedrol. "I'm finally feeling normal" on 06/22/04.
I was having a sore throat which lasted for a few days. By Monday it was worse and I took a home COVID-19 test and that was negative. I ended up going to the Doctor and they tested me and it was positive. The next day I was violently ill and was trying to throw up but I was so weak I was just on the floor and could not even  lift my head to throw up in the toilet. I could not move or get up. My husband who was also positive called EMS who was able to get me up but I was able to sit and talk with them and we did not end up taking me to the ER. I was having a horrible cough and headache at this point and was so tired. I had no appetite and ended up calling my doctor back because I was still so sick. As of now I do not have the cough but my voice is gruff and I am still fatigued all the time. I have brain fog and it is hard to hold a conversation. I know that most things I do will make me exhausted so I have to pick and choose what I do because I still have this lingering fatigue. While I have tested negative I am still impacted with lingering issues and would say I have not recovered.
This spontaneous report as received from a physician refers to an unspecified patient of unknown age and gender. On 09-JUL-2014 the patient was vaccinated with the third dose of GARDASIL (route not reported). The patient had received the first two doses of GARDASIL 6 years earlier, in approximately 2008. No adverse events were reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 27-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
site of injection-red, hot,  raised area, temp 101.4 x 1 day headache, nausea x3 days
Shivering, feeling cold despite layers of clothing and 70F room temperature.  temperature measured at 100.7F, pulse rate of 120 (normal rate is 65-70).  Tylenol taken.
Information has been received from a physician concerning a 5 year old male, with no medical history and no allergies, who in January 2003, was vaccinated with a first 0.5 ml SQ dose of Varivax vaccine (lot#654128/1147F). There was no concomitant medication. It was reported that the patient received a first dose of Havrix vaccine in January 2007. On 27-JAN-2007 the patient developed facial swelling and difficulty breathing. The physician administered epinephrine, Benadryl, and two breathing treatments in the office. The patient was prescribed a course of steroids and fully recovered after two days of treatment, on 29-JAN-2007. No product quality complain was involved. No other information was provided. The reporter considered the patient's experiences to be immediately life-threatening, disabling and an other important medical event. Additional information has been requested.
vaccine given at age 17 years.  This person had sore arm and slight fever per mom.
Right sided neck pain with rotation and radiating into the right upper thorax anterior and posteriorly also Affects her shoulder. In addition she relates pain with inhalation that increases the thoracic pain.  At the same time,she is complaining of left sided leg pain along the posterior thigh and lateral calf into her foot.
feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood sugar (not diabetic); Dizziness; Clammy feet; Very scary; Thyroid was in rage during this event; This is a spontaneous report from a contactable health professional (patient).   A 41-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 41-years-old), administered in Arm Left on 08Mar2021 10:00 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included Hashimoto's. The patient had no known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced Face numbness, Dizziness, Events of low blood sugar (not diabetic), SOB, Clammy feet. Most importantly, feeling of blood moving in arms/legs with cold sensation. The patient was hospitalized for the events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The onset of events was 09Mar2021 07:00. The patient also reported that it was "Very scary" and "Thyroid was in rage during this event" on an unspecified date. Went to ER twice weeks apart. Lasted for 3 weeks. The patient underwent lab tests and procedures which included blood glucose: low on 09Mar2021. No treatment received for the adverse events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation) required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events "Very scary" and "Thyroid was in rage during this event" was unknown while for the rest of the events was recovered with sequelae (Recovered with lasting effects). Not diagnosed with COVID prior vaccination, not COVID tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship.  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.
Hearing ringing sounds in right ear. About from 4/15/21 to now continously.
Patient accidentally given a third dose of Rotarix. The second dose was not recorded on facilities certificate of immunizations nor the system immunizations record when the vaccines were verified by me on today's visit. Vaccine was ordered and administered to patient. Upon end of visit I asked the mother if she needed a copy of vaccines administered today and she stated she would like the vaccination card updated instead. At that time was noted that second dose was recorded on the card.  I immediately went to supervisor to report and came back to the clinic room to notify mother & father of incident.  No signs, symptoms or treatment at this time.
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown. The vial did not undergo any temperature excursions. Suspect vaccine expiry date was 11-May-2023.  It was reported that no adverse reactions have been reported by any patients.  No treatment medication was reported.  This case is reported for patient 16th out of 50 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Sore injection site, 102° fever, eyes hurting, sensitive to light, elbow, knee & ankle joint pain. Lasted about 10 hrs, 10 AM to 8 PM. Took 2 tylenol at 730 PM.
Swelling around injection site and spreading to elbow; red rash; patient took BENADRYL.
2ND DOSE WAS GIVEN AT 1 MONTH INSTEAD OF 6-12 MONTHS.
- Pt called clinic and later seen  on 3/30/09 for an urgent visit for complaints of non-pruritic red rash on left side of trunk - Per PCP physical exam: erythematous rash with some vesicles, some lesions coalescing over right upper trunk posterior around to anterior trunk - Pt treated with 7 days of famciclovir of note,  pt had truncal rash ant to post noted on 3/24 prior to receiving zostavax
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 26-JUN-2016, the pt was vaccinated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dosage schedule, route, lot number and expiration date were not provided). On an unspecified date, shortly after vaccination, the pt suffered hearing loss. As a direct and proximate result of ZOSTAVAX vaccine, the pt's symptoms resulted in in physical limitations, mental and emotional distress and severe, serious, progressive, incurable and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment. At the time of the report, the pt had permanent hearing loss (not recovered). The reporter considered hearing loss to be related to ZOSTAVAX. Upon internal review, the event hearing loss was considered disabling (due to sustained, severe and permanent personal injuries) and medically significant. Additional information has been requested.
pt recv vax 12MAR96 & 21OCT96 pt devel chickenpox consisting of scattered papules, a few vesicles & approx 20-30 lesions on trunk  & arms;MD reported chickenpox looked attenuated;
Pretty negative reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Pretty negative reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 VACCINATION COMPLICATION (Pretty negative reaction). At the time of the report, VACCINATION COMPLICATION (Pretty negative reaction) outcome was unknown.            No concomitant medications were provided No treatment medications were provided
Warm to touch; little redness/redness where shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH and VACCINATION SITE ERYTHEMA in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation on 03-Mar-2021 and Drug allergy to Accutane. Concomitant products included SERTRALINE for Anxiety, METOPROLOL for Blood pressure, ATORVASTATIN, CHLORTHALIDONE, POTASSIUM CHLORIDE, and FAMOTIDINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE WARMTH and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE WARMTH and VACCINATION SITE ERYTHEMA had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Allergic conditions which includes drug allergy to Accutane on unknown date. Concomitant medication includes Eliquix 5 mg for indication of blood thinner which is 1 tablet a day and vitamin once a day.  Non prescription medication which includes eye vitamin which is 2 tablets a day and Rogaine 2% topical cream with indication of apply to scalp at 1 time a day.   No treatment information was provided.   This case was linked to MOD-2021-376403, MOD-2021-376348 (Patient Link).
Vaccinated with shaken vaccine; Pain at the injection site; Mild fever; A spontaneous report was received from a pharmacist concerning a 56-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccinated with shaken vaccine, pain at the injection site, and mild fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, approximately 0 days prior to the onset of the event, vaccinated with shaken vaccine, and 1 day prior to the onset of the events, pain at the injection site, and mild fever the next day,  the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   During vaccine administration, the patient noticed the vaccinating technician shook the vial while administering the vaccine. One day after vaccination, the patient experienced pain at the injection site and mild fever. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, vaccinated with shaken vaccine, was considered resolved on an unknown date. The outcome of the events, pain at the injection site and mild fever were unknown.; Reporter's Comments: Company comment: This case concerns a 56-year old, male subject, who experienced a non-serious expected event of Injection site pain and pyrexia, and non-serious unexpected event of wrong technique in product usage process. The event of injection site pain and pyrexia occurred 1 days after the first dose of mRNA-1273, lot # unknown. Treatment details not available. Very limited information regarding this event/s has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-002862: US-MODERNATX, INC.-MOD-2021-002848: US-MODERNATX, INC.-MOD-2021-002858: US-MODERNATX, INC.-MOD-2021-002872: US-MODERNATX, INC.-MOD-2021-002858:
States she started feeling a bit of a headache after leaving the observation area, and by the time she got to her office in the same center, she had light sensitivity.  Has not taken any medications no known allergies.  Headache described as pulsating located in the front of her head.  States relief when eyes are closed.
Patient received COVID booster and Pneumovax during PCP appointment on 6/13/22. Later that day, awoke from a nap with a bad headache. Took Tylenol, and the next day complained of bilateral jaw pain and told to continue tylenol. Increased headache by Saturday 6/18 and patient presented to ED.  While in the ED, she had a deterioration of neurologic status and a head CT was performed with results as below. Started on clevidipine infusion, received tranexamic acid, mannitol, hypertonic saline. Unable to received transfusions per religion. Repeat head CT showed increased size of hematoma and vasogenic edema, with worsening mass effect and midline shift, as well as herniation. Unable to perform surgical intervention due to thrombocytopenia. Herniation on 6/19 and transitioned to comfort measures, with brain death on 6/20/22.
in the arm where she received the shot, her hand and wrist go numb with pins and needles; in the arm where she received the shot, her hand and wrist go numb with pins and needles; her arm is sore; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (left arm) on 20Dec2020 06:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  There was no other vaccine administered on same date of the Pfizer vaccine. The patient reported that she had the vaccine on Sunday (20Dec2020) and had a side effect that she didn't see listed. She stated that in the arm where she received the shot, her hand and wrist go numb with pins and needles, it was getting progressively less. She added that her arm is sore, but she expected that. She further stated that last night it just happened one time and it feels a lot better now. The patient asked if those were an expected side effect. The patent clarified that she received the COVID 19 vaccine on 20Dec2020 0600 in the left arm. On 21Dec2020 in the night at 0200 she woke up with pins and needles in her hand and wrist. It happened only when she was asleep and not moving her arm. She added that actually she feels it very faint off and on in the day but each night it has improved. She further clarified that the pins and needles are in her lower arm and wrist radiating up the arm. She added that she will be scheduled for the second dose. The outcome of event vaccination site pain was unknown, while the outcome of other events was recovering.
Passed blood clot. Called Dr. OB. Was seen in office 01/05/2011 Ultrasound showed no fetal heartbeat-had D/C.
Pt presented with "rash" - sudden onset, began on his back and also on abdomen. Endorses some pain, but states it is tolerable. Denies itching. The rash is constantly present. No drainage. -No hx of similar rash in the past. No recent exposure to animals/pets or plants. -Denies change in body products. No new foods or medications.  -Denies FH of known rheumatologic or autoimmune conditions.  3 vesicles with clear fluid on abdomen (over distal end of ribcage ). Multiple vesicles with clear fluid + drying vesicles on back (bottom of left scapula). No drainage or signs of infection.   Pt given script for Acyclovir  (1 tab 5x/day for 7 days) for presumptive shingles.
This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received GARDASIL (Lot Number: K009202, Expiry date: 17-DEC-2016) (dose, frequency were not reported) which was improperly stored. No adverse effects reported. Causality assessment was mot reported for the events. This is one of the several reports received from the same reporter. Additional information has been requested.
Rapidly progressive weakness, inability to concentrate or perform activities as Physician, tremulousness, extreme malaise, accelerated hypertension (BP 220/120, with no prior history of hypertension), low grade sinus tachycardia (108 bpm).  Admitted to Hospital for 48 hrs. 11/30/09 Medical Records received for DOS(hospitalization)11/20/09 DX: Acute Hypertensive Injection Reaction.  Pt. presented to ER c/o fatigue, weakness, rigor sensation, HTN, agitation. Admitted for observation.
On 6/4/21 at 11:30 am,  I went deaf in my right ear suddenly. It started with tinnitus and I went deaf over the course of a few minutes.  6/4/21 Urgent care visit: no sound detected in right ear 6/4/21 Emergency room visit: Oral steroid prescribed. 6/7/21 ENT specialist visit: Hearing test for baseline, diagnosed sudden onset hearing loss and additional oral Steroids prescribed. 6/14/21 ENT specialist visit: Hearing test shows no significant improvement: Steroid injections into ear prescribed and done in office 6/21/21 ENT specialist visit: 2nd steroid injection into ear done. 6/22/21 MRI of head done: (results not in yet) Future 6/25/21: ENT specialist visit: 3rd steroid injection into ear scheduled.
1130 started vomiting, 12noon eye lids swelling; 1210 large hives over entire body really bad rash all over cheeks; 1230 seen in ER, Prelone & DPH recvd;
Headache started at 8:00 AM, rash started after that when pt received Tylenol from mother
No adverse effects reported; patient received an expired dose of VARlVAX; This spontaneous report was received from a medical assistant referring to a 34 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies and medical history provided.  On 24-OCT-2019, the patient received an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX)(dose and strength unknown; lot # N023961, expiration date was 01-SEP-2019) with sterile diluent (lot# N026288, expiration date 08-FEB-2020) subcutaneously for prophylaxis. Varicella virus vaccine live (oka/merck)(VARIVAX) was stored properly. No adverse effects were reported.  This is one of the two reports received form the same reporter.; Sender's Comments:  US-009507513-1910USA015487: