chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About two weeks ago, I had exacerbation (extreme) of Gerd symptoms and there was no relief with my medications. And with that exacerbation, I had severe reflux, chest tightening, dizziness. I already had an appointment scheduled with the GI clinic for a follow up so I waited until then and that was last Wednesday (the 27th). I had quit taking the Nexium and I was put on Protonix. I started on that on Thursday, the 28th. I am still waiting for the meds to take effect. I have been pretty miserable for the first couple of weeks. I have only noticed slight improvement of symptoms, but I know it's a couple of weeks for it to fully take effect. If my symptoms don't subside, my practitioner my wants to do a CT scan done just to rule things out.
15 year old child presented very sick with high fever and red painful eyes. Fever was 103 for three days. No lowering. Condition worsened with headache, fever of 103.8, fatigue, and rash in vagina, thought to be from maxi pads.  Saw urgent care after virtual dr. appointment. Urgent care said it was viral or covid. I asked for urine test for UTI. Came back blood in urine, but not UTI. Refused Covid test as I had done three already that were negative. Sent home and said was viral. SHe got much worse so I called and asked for antibiotics. They called in and said if not improve call. I called after 2 days of no improvement and getting worse. The on call dr. suggested we go to hospital. After day6 of fever of 1 103.8 the er was very concerned. They suggested herpes or another STI. we were nortified. CHild was not sexually active and they said it did not matter. They tested for EBV, CMV and many others. so they called specialist OB GYN. She came and said it was Lipschutz Disease. They needed to wait for tests. She was in extreme pain and could not move. We were admitted and continued for 5 days. SHe was in extreme pain. They took pictures to document her recovery. She was sad and embarrassed. SHe mentally was struggling. COuldn't drink or eat out of fear of using the restroom. She was very ill and feared dying. She had blisters covering the inside and out. She had many doctors looking daily at her progress. She tested negative for all viruses that could have caused this including COVID-19. No antibodies. No EBV, CMV or Mono, or many others they tested. No flu. Her liver enzymes were high and her blood showed her body had inflamation. My child is still in extreme pain and suffering and can barely walk. Is afraid to use the bathroom and is struggling in school now.
Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022; No adverse event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 55-year-old 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. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperature excursion).    Concomitant medication not reported. Treatment medication not reported.
I had a mild dizziness that started on the 20th of May and has been ongoing ever since (stops and starts). I saw my Dr. the week after that and she ordered tests.
Patient received 4 vaccines and after a few minutes started feeling, week, shaky, cold and lethargic. She was advised to sit down. She was given water and a cold pack was applied to the back of the neck. After 10 minutes, she was still feeling the same, so 911 was called. Paramedics came and assessed the patient. Vital signs were normal. She started feeling better so paramedics did not take her to the hospital. She was advised not to drive herself so she contacted a family member and she was picked up. We tried to follow up with her a few days later but she didn't respond to our call.
Abscess formation on left thigh for 1 day, redness, tender, warm to touch started on BACTRIM and neosporin applied.
No additional adverse events; Caller is medical assistant who reports administered doses of vaccines to 5 patients following temperature excursion. No additional adverse events/No Product quality complaints. See AE cases for other patients:   Patient 1: 02192565  Patient 2: 02192; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 25-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 1 dose, lot number U007505, expiration date: reported as 04-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) after temperature exposure (product storage error). No additional adverse event was reported.; Sender's Comments:  US-009507513-2206USA007849: US-009507513-2206USA007854: US-009507513-2206USA007852: US-009507513-2206USA007701:
pt recv vax;cellulitis;very large area of redness (elbow to shoulder),inflammation&hardness dx as cellulitis;pt can't lift arm;tx in ER;
Varicella rash/illness with recovery in approx. 8 days. No further symptoms as of 2/14/02.
Information has been received from a physician concerning a 33 year old white female with increased liver function tests, headaches, hypertension, and shellfish, penicillin, and seasonal allergies who in June 2003 and on 14Jul03 was vaccinated in the left deltoid with the first and second dose of hep B virus vaccine rHBsAg (yeast) (lot640335/1255L for both doses). On 16Mar04 at 10:00AM, the pt was vaccinated in the left deltoid with a third dose of hep B virus vaccine rHBsAg (yeast) (lot 640335/1255L). The pt experienced a dime sized area of redness at the injection site. Four to five hours later, the pt had a fever of 101 degrees F. That night, the fever went up to 102. 5 degrees F. At the time of the report, the fever persisted. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from a health professional in the physician's office who indicated that on 17Mar04 at 9:00PM, the pt developed a fever and chills. She felt awful with aches and pain. There was a dime sized area of erythema at the injection site. It was noted that the pt recovered on 19Mar04. No further information is expected.
Left arm with moderate edema from elbow to mid arm, mild increased heat. No edema or erythema at shoulder. Left hand, forearm. Local reaction only,treatment hydroxyzine
Finished Pfizer series on 1/8/2021. Tested + for Covid-19 on 4/4/2021. Sxs started on 4/1/21 including diarrhea, f/c, SOB/dizziness, nausea. Improved quickly.
Extreme soreness at injection site, low fever, chills,  body aches, especially in my legs, fatigue, headache.
This is the case of a young man I saw on rheum consults in March 2021. He was vaccinated with Pfizer #1 on March 11, was febrile March 18th, and presented here on March 22 with what we diagnosed as MIS-A (+PCR, febrile, low platelets, carditis - responded to glucocorticoids, IVIG). He followed up and has recently been released from cardiology with return of normal cardiac function. He was told by his cardiologist he could get the vaccines, but patient wanted a second opinion and reached out. He is well now and without symptoms.  27 y/o M, Feb COVID. Rheum 3-21. Pfizer #1 on 3/11, febrile (103) 3/18, & 3/22 dx MIS-A (+PCR, febrile, low platelets, carditis ? responded to glucocorticoids, IVIG). Followed up; released from cardio (return normal cardiac function).
right leg  was getting paralyzed, this occurred after his first shot and second shot; affected lower back and left side going down left leg; soreness in left arm and tenderness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Oct-2021 and was forwarded to Moderna on 11-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (right leg  was getting paralyzed, this occurred after his first shot and second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery in October 2020. Concomitant products included WARFARIN, ATORVASTATIN, OMEPRAZOLE, HYDROCODONE and TESTOSTERONE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MONOPLEGIA (right leg  was getting paralyzed, this occurred after his first shot and second shot) (seriousness criterion medically significant), VACCINATION COMPLICATION (affected lower back and left side going down left leg) and VACCINATION SITE PAIN (soreness in left arm and tenderness). At the time of the report, MONOPLEGIA (right leg  was getting paralyzed, this occurred after his first shot and second shot), VACCINATION COMPLICATION (affected lower back and left side going down left leg) and VACCINATION SITE PAIN (soreness in left arm and tenderness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications Senclanide 150mg twice a day. Patient discontinued testosterone shots because of his right leg was getting paralyzed after 2 doses and after 1st dose patient stated that he used cane due to problem with legs.That affected his lower back and a little bit in the left side going down his left leg.The patient side effects went away in 4-5 days. No treatment medications were reported.   This case was linked to MOD-2021-349075 (Patient Link).; Sender's Comments: This case concerns a male patient of unknown age with medical history of back surgery, who experienced the unexpected serious event of Monoplegia. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge is positive since this event occurred after the first and second doses. The history of back surgery for unspecified indication remains a confounder considering that the underlying pathology may have contributed to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
She does not have energy to do anything; She was hot and cold; Headache; Chills; Joint pain; Nausea; Tired/tiredness; Not feeling too well; This is a spontaneous report from a contactable consumer, other non HCP (patient reported for self). A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 24Mar2021 at 16:20 (at the age of 49-years) as dose 1, single for COVID-19 immunization. The patient relevant history included none. The patient medical history included heart condition diagnosed in 2014. Family medical history relevant to AE(s) were none. The patient's concomitant medications were not reported. The patient had not received any vaccination within 4 weeks prior to Covid vaccine. There we no AE reported following prior vaccination. The patient did not have a history of previous immunizations with the Pfizer vaccine considered as suspect (reported as none). It was reported that, patient got the vaccination from Pfizer last Wednesday and she was having some side effects that have been going on since Monday.  Patient adds that it has been going on early Monday morning.  She was just wondering if it is side effects from the Pfizer vaccine or should she be contacting her doctor. After vaccination, the patient was not feeling too well (unspecified date in Mar 2021). On 28Mar2021, the patient had experienced Tired/tiredness, chills, joint pain, nausea; on 29Mar2021 had headache and on 30Mar2021 she did not have energy to do anything, she was feeling hot and cold. The patient adds that she has already talked to her physician and the physician said it could be like a week so if caller was not feeling better within 72 hours to give the physician a call. Relevant tests: patient stated as, no not yet. Therapeutic measures were taken as a result of headache which included treatment with alternates Ibuprofen and Tylenol and for nausea included Zofran and so it was under control. The patient did not receive any additional treatments. The outcome of the event nausea was recovering; Tired/tiredness, headache, chills, joint pain was not recovered while Energy decreased, asthenia feeling of body temperature change was unknown.   No follow-up attempts are needed. No further information is expected.
day 1 immediately following vaccine - metallic taste in mouth; some arm fatigue (similar to influenza injection reaction), slight headache  day 7 - left armpit lymph node discomfort; rash developed throughout the day in area about 1-2 inches to the right of the injection site on left upper arm; rash was initially blotchy and itchy but as the day progressed, it became much large and "filled in" as similar to a very large hive (approx 4x7 inches). Rash is itchy and hot/inflamed.  Metallic mouth taste also returned along with increased salivation.  day 8 - rash still present - hot and itchy but has not enlarged beyond day 7 size; armpit lymph still uncomfortable but less so than day 7; metallic taste and increased salivation remain.
Swelling on ankle; Redness on ankle; Pain on ankle; This spontaneous case was reported by an other health care professional and describes the occurrence of JOINT SWELLING (Swelling on ankle), ERYTHEMA (Redness on ankle) and ARTHRALGIA (Pain on ankle) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Gout.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced JOINT SWELLING (Swelling on ankle), ERYTHEMA (Redness on ankle) and ARTHRALGIA (Pain on ankle). At the time of the report, JOINT SWELLING (Swelling on ankle), ERYTHEMA (Redness on ankle) and ARTHRALGIA (Pain on ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
pt recvd vax;approx 4mo later exp pain in shoulders & arms,wrist edema,weakness & numbness;dx w/ tendinitis approx 5 mo p/ dose 2; unresolved
No signs or symptoms reported; Temperature excursion that ocurred on 2/3/2021 on Gardasil 9. Gardasil 9 was given; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 03-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml, lot# 1614898 and expiration date 15-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported). No signs or symptoms reported.  The temperature excursion was of 31.3 Fahrenheit degrees (°F) for 0 hours 15 minutes and 0 seconds, 33.4°F for 0 hours 15 minutes and 0 seconds. Time frame 30 minutes total. A previous temperature excursion was not reported. A digital data logger was not involved.  This is one of 3 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001253: US-009507513-2104USA001082:
2 inch by 2 inch welt around injection site on arm itchiness;  That whole area has felt harder/firmer on the left arm compared to right arm ever since the injection.  The itchiness and red welt showed up a couple of days ago.
Both arm red, hard and swollen at injection site, left arm measured 75mm wide and 68mm long around injection site. right arm measured 42 mm wide and 35mm long around injection site. Pt ran small low grade fever, advise give pt ibuprofen and Benadryl, per Dr.
Positive test; Positive test; This is a literature report for the following literature source(s).  A 67-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and 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.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive test".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200740728 Same article, other patient;US-PFIZER INC-202200833096 Same article, same patient, other product;US-PFIZER INC-202200833097 Same article, other patient;US-PFIZER INC-202200833098 Same article, other patient;
Improperly stored dose of VARIVAX were administered to a patient; No adverse affects reported; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and previous medical history were not reported.  Information was extracted from data logger.  On an unknown date, the patient was vaccinated with one dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032355 and expiration date  14-OCT-2021 for prophylaxis  (strength and patient route of administration were not provided). The storage temperature was reported to be 7.1°F for a period of 30 minutes. No additional adverse effects were reported.   At the time of reporting, the outcome of product storage error was unknown.
Patient was given his second Moderna vaccine 3 weeks after his first dose instead of 4 weeks.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2012, the patient was vaccinated by a healthcare provider with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) prescribed by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Local erythema at site of injection, arm red and swollen and hot to touch. Nausea & Vomiting, red blotches on arm - Client applied heat to area.
Per MD & RN notes from Emergency Dept Records:  "Of note, patient received first COVID vaccine two days ago 1/14/21 and has had chills, sweats, and malaise over the past 24-48 hours." Pt also reports "not drinking enough water" leading to dizziness & syncopal episodes x3, with T-spine compression fractures secondary to at least one of these falls.  Denies loss of consciousness, headache, vision changes, tinnitus, Nausea/vomiting, numbness/tingling/weakness in extremeties except for brief feeling of knees "giving out" just prior to falls. Pt admitted to Medical Ctr on 1/16/2021, w/ T7, T9 & T11 fractures, & comorbidities. Planned discharge for 1/25/2021.
Patient reported itching, redness, and warmth at the injection site beginning a couple of hours after vaccination.
irregular heart beat/his father in law experienced the exact same thing she did; pulse rate was high/his father in law experienced the exact same thing she did; would wake up in the middle of the night with her heart pounding like crazy/the same happened to his dad; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number; NDC number; Expiry Date: Unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced irregular heart beat/his father in law experienced the exact same thing she did, pulse rate was high/his father in law experienced the exact same thing she did, would wake up in the middle of the night with her heart pounding like crazy/the same happened to his dad. The patient underwent lab tests and procedures which included heart beat/pulse rate were irregular and high. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021294406 same drug/event, different patient; PFIZER INC-2021297869 same drug/event, different patient