chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever between 103-105 degrees F for 5 days, extreme exhaustion, muscle weakness, pain head to toe, dizziness, heartbeat racing, sweating profusely, chills, very off balance. This is day 6, still dizzy, off balance, fever down to 100.8deg F. Took Tylenol whenever awake, to no avail.
Patient passed out from returning from bathroom after receiving shots.  called for assistance and lost sight.  Regained conciousness and was put on gerny, feet raised for 15 min until vitals returned to normal.  no other adverse effects.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 91-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 19-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805440 was crossed linked to original cases 201804863 due to same reporter.
Caller says she felt pain in her arm afterwards as well.; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#:not provided), via an unspecified route of administration from on 27Jan2021 (at the age of 74-year-old) at SINGLE DOSE for COVID-19 immunization at the hospital and paracetamol (TYLENOL), via an unspecified route of administration and dates at 2 DF, daily (every morning) for aches and pains. Medical history and concomitant medications were not reported. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot#: not provided) on an unknown date at SINGLE DOSE for COVID-19 immunization and says that she had no reaction to the first shot. The patient received the second dose and had a sore arm (in Jan2021) that was better today. She stated that in the morning she always took two paracetamol for aches and pains; and after she got the first and second shot she read three articles to do not take paracetamol  before you get the vaccines as it might affect antibodies. However, no one published about this or said this at the hospital when she went to get the shot, they just asked what she was allergic to it. She would like to know if now she was not so protected because she took paracetamol and if this was a problem. The action taken in response with the adverse event for paracetamol was unknown. Outcome of the event was recovering  Information on the lot/batch number has been requested.
Pt become pale color drained from lips placed him on bed- within 1 min Pt got color back.
Patient was given a vaccine that was beyond "use by" date of 8/16/22. Patient was contacted by pharmacy supervisor and was not reached.
Approximately 30 minutes after receiving vaccine patient experienced numbness on the left side of her tongue and cheek.  This lasted about one hour, but the numbness progressed to her left jaw and left cheek and then her whole head.  The next morning the numbness was at the base of her skull and lasted most of the day.  All symptoms resolved within 48 hours of the vaccine.  On 3/16/2021 patient reported slight numbness of her whole head during the day.  This resolved within a few hours.
She presented to her primary care March 11th with complaints of left hand and right ankle swelling and right shoulder discomfort. She primarily had swelling over the 2nd finger of the left hand.  She felt this abruptly started on March 8th with a palindromic presentation moving from both hands, both shoulders, and her right ankle. CRP was done at that time was 154.7.  She was started on 40 mg of prednisone for 3 days and then 20 mg of prednisone for 4 days which was helpful for her overall discomfort and swelling.  Off of prednisone she developed increased joint pain and stiffness.Prior to this episode she had been healthy and had not taken any new medications within the last 6 months. She was on vitamin-D, multivitamin, biotin, and vitamin-C which she stopped around 1 month ago.  She last took ibuprofen and meloxicam 1 year ago for chronic back discomfort.  We found that the patient had an inflammatory arthritis, with nephrotic syndrome.  She was found to have a membranous glomerular nephritis which has improved with prednisone therapy.  It was thought that perhaps her membranous glomerulonephritis was associated with a recent COVID vaccination.  As patient taper down on prednisone she had a marked flare of increased joint pain and swelling.  She increased prednisone back to 20 mg daily but had persistent pain stiffness and swelling.  She noted some gelling phenomenon as well.  She has noted erythema over the areas where she has pain, but no distinct rashes have been noted.  1/5/2022-  Acute onset of inflammatory arthritis with recent membranous nephropathy-seronegative rheumatoid arthritis, positive ANA and scleroderma antibody with recent respiratory symptoms may point to an early interstitial lung disease.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. Patient received under dose of 0.25 ml of Moderna Bivalent Booster.  It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.
The time prior to the vaccine, I had no pelvic pain or limitations in physical activity.   1/7/2021 Received Pfizer Vaccine #1 experienced left arm soreness at the injection site. The evening of 1/7/2021 following the injection, developed dull lower pelvic pain.  Pelvic pain worsened over the next two days   1/9/2021 Symptoms of pelvic pain intensified to now excruciating, sharp pain  1/10/2021 Seen at nearby urgent care and evaluated by healthcare provider; referred to nearby emergency department for further evaluation, work up and recommended imaging. Evaluated by emergency room physician, lab work collected and imaging were completed. CT scan showed 7cm mass in the right pelvis, small amount of pelvic fluid. Pelvic ultrasound was also completed and confirmed 7 cm round lesion in the right adnexa. Discharged home with pain medication and instructions for outpatient follow up.   1/12/2021 Seen by PCP and referral sent OB/GYN; Symptoms are now as dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and weight loss.  1/14/2021 Seen by OB/GYN, repeat pelvic ultrasound ordered  1/22/2021 Repeat pelvic ultrasound completed showed 7.4 cm right adnexal cystic lesion increased in size  1/28/2021 Received Pfizer Vaccine #2, staff at vaccination clinic informed of pelvic pain onset after Vaccine #1 injection. Approximately 4 hours after Vaccine #2, I developed severe sharp pain again similar to after Vaccine #1 which required pain medication for relief.   1/29/2021 Pain improved with medication   1/30/2021 Symptoms have now returned to dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and continued weight loss until scheduled surgery 2/26/2021.  2/12/2021 Seen by PCP, cleared for surgery; labs completed 2/17/2021 Seen by OB/GYN for preoperative visit  2/23/2021 Seen at hospital for COVID Preop Testing  2/26/2021 Surgery completed under general anesthesia ? Laparoscopic myomectomy with mini-laparotomy, lysis of bowel adhesions to degenerating fibroid tumor   The time prior to the vaccine, I had no pelvic pain or limitations in physical activity.
fever; chills; aches; I felt really crappy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ovarian cancer", start date: 2014 (ongoing), notes: cancer for seven years.; "irregular heartbeat" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "chemo" (unspecified if ongoing), notes: She said she was having her chemo before the 1st dose. She had her chemo 2 days before having the 2nd dose. Concomitant medication(s) included: TAXOL; DOXIL [DICLOXACILLIN SODIUM MONOHYDRATE]; METOPROLOL TARTRATE taken for hypertension. Vaccination history included: Covid-19 (1st dose), administration date: Mar2021. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "aches"; MALAISE (non-serious), outcome "unknown", described as "I felt really crappy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller undergoing chemotherapy. I have been on chemo about a year and a half. No information. She said she was having her chemo before the 1st dose. She had her chemo 2 days before having the 2nd dose. I am concerned via the media pullback for safety reasons. Safety of third dose but it was ok to give to immunocompromised. What is the safety issue of not letting anyone have the third dose. That one I was getting Doxil, monthly. Totally off during the first vaccine. Second dose I had Doxil on a Monday and vaccine on a Wednesday. I do take a blood thinner. Two weeks of chemotherapy in a row. Most of my blood work is pretty solid, I am in the normal range.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ears-ringing, and headaches started after about a week of second vaccine. Still occurring off and on 20 days after vaccine.  Not continual and some days worse than  others.
Patient developed area of erythema over site of injection and approximately 10 days after injection, vesicles formed on the erythematous area. Patient had 4 vesicles on an erythematous band approximately size of a quarter. (15cmx2cm).
Received MMR vaccine 8/19/22. Symptoms of chills/sweats, L jaw swelling/pain,  L ear pain,  erythema to skin over mastoid process began 8/24/22.  Diagnosed with acute sialoadenitis. Treatment included amoxicillin/clavulanate 875/125 PO BID x 10 days, ceftriaxone 1 g IM x 1, naproxen 500 mg PO BID x 7 days.   Noted improvement by  8/29 with complete resolution by 9/6/22.
Response (1/27) after receiving 2nd dose of Moderna COVID-19 vaccine (~1840), c/o itching, throat swelling, SOB, racing heart & nausea about 50min after vaccination. S/p IM Epi, Benadryl, Pepcid, Solumedrol & Racemic Epi. CCM consulted. Close monitoring in ICU overnight. (1/28) Symptoms resolved, plan to discharge home with Rx for Epi pen.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 15-JUN-2017 the patient was vaccinated with GARDASIL 9 lot # M014929, expiration date 27-MAY-2017, for prophylaxis. On 15-JUN-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL 9.
first dose was Pentacel, 2nd dose Daptacel then 3rd dose was Pentacel then 4th dose was Daptacel then came back in and gave another dose Pentacel with no AE; Initial information received on 16-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00901547).  This case involves a four-year-old male patient who had first dose was pentacel, 2nd dose daptacel then 3rd dose was pentacel then 4th dose was daptacel then came back in and gave another dose pentacel of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (interchange of vaccine products).  The patient past medical history, medical treatment, vaccination and family history were not provided.   On 09-Dec-2021, the patient received a fifth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ570AA and expiry date: not reported) via intramuscular route in right leg for prophylactic vaccination and also received first and third dose of same vaccine via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a second and fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to interchange of vaccine products.  It was reported "the office gave a child that is 4 years and 2 months this series of vaccines: first dose was Pentacel, 2nd dose Daptacel then 3rd dose was Pentacel then 4th dose was Daptacel then came back in and gave another dose Pentacel. Is this OK?".  At the time of report no adverse event was reported.
Patient stated they were on therapy with Gilenya for an estimated 10 years. During this time, they experienced multiple relapses and possible growth in lesions. Patient also experienced arthritis pain in their hands while on this medication after receiving their Moderna COVID vaccines; reported by patient
Immunizations given on 9/17/16. Reported on 9/18/16 with c/o burning tongue. Denies any sort of tightness, swelling, diff. breathing. Symptoms resolved after 4 days, stain on tongue until slough off on the 4th day. No further symptoms noted. Pt. evaluated 11/5/16 by Doctor.
Patient reported that he was blacked out while driving after receiving two vaccinations--FLUARIX QUAD and PNEUMOVAX. Patient hospitalized due to accident.
This was the Moderna booster. I briefly had the same symptoms as my first vaccine rounds- chills, slightly sore arm. But no nausea this time. Physical side effects are better with the booster, but this time I am experiencing severe BRAIN FOG starting about 17 hours after the booster and on going.
Chills Extreme headache Extreme body ache Fatigue Loss of appetite Soreness @ vaccine site
after my 2nd shot, At 3Am the following morning I experienced flu-like symptons, bad headache, body aches, and a little nauseous. This continued the following day.  I was taking tydelnol immediately after the shot till I went to bed that night.   The next day took tydenol and then advil.  Finally started to feel better the next morning
Menstrual bleeding for 6mths. My cycle would stop for 2-3days max then I would start bleeding again.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 23-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
No side effects with dose 1. After dose 2 at about 55 hours post injection, I woke up covered in hives head to toe. I took pictures if you need them.
Passed out twice - at 5pm on 12/26 & 8:30am on 12/27
Patient presented for induction of labor at 37w3d gestation due to diagnosis of IUGR (1st percentile). Pregnancy also complicated by velamentous cord insertion, 2 vessel cord, fetal cleft lip/palate, bi-lobed placenta, and GDM. She did also have COVID-19 infection in 3rd trimester with positive test on 1/6/22. Normal labor and delivery on 1/22/2022. Birth weight 4 lb 14.1 oz. Hospital admission within 6 weeks of receiving the COVID vaccine.
Child given DTP on 11-DEC-89.  Four Hrs later at home turned pale, eyes rolled back, became limp, bumped chin on high chair.  No seizure activity.  Examined in office; temp 102, otherwise fine.  Child hospitalized and place on monitor.
fever, body aches, headache, tiredness, injection site tenderness Narrative:  Took OTC Tylenol and Motrin  Other Relevant History:
9 Month following vaccination in left arm, the smallpox scab area erupted again resulting in itching and discomfort.
Covid monitoring documentation. PT admitted 1/16/22 documented to have positive covid. PT received Moderna 04/14/21 Lot 037A21B for dose 1. Dose 2 was Moderna given on 5/12/21 Lot 016C21A.
This case was reported by a pharmacist and described the occurrence of injection site reaction ion a 14-year=-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline) for prophylaxis. On 4 June 2007, at 15:00, the subject inadvertently received 1st dose of HAVRIX (720 elisa unit, left arm) subcutaneously, rather than the indicated intramuscular route. At an unspecified time after vaccination with HAVRIX, the subject experienced injection site reaction and sought medical attention at the physician's office. At the time of reporting, the pharmacist was not able to provide further details about the event. At the time of reporting the outcome of the events was unspecified.
My son experience after the vaccine around 03:40pm, he felt dizzy, started to black out and passed out. I gave him fluids and called his PCP. I made him eat since he did not eat earlier that day. He states he felt off, I gave him some Tylenol medication. He also had a headaches and started with diarrhea. The next day he stayed in bed, continued with flushed bright red cheeks, diarrhea and the headaches. The day after that he started to feel bit better, I think his symptoms lasted between 36-48 hours.  His glucose level was 90.
Patient experienced a syncopal event.  Patient was lowered to the floor, legs were elevated, and vital signs were monitored. Provided ice packs and fluids. Patient returned to a sitting position, and then standing position. Patient was monitored for an additional 30 minutes after event.
Pfizer BioNTech Covid-19 Vaccine Adverse Effect. Upon submitting the completion of his Pfizer vaccine series to the state registry, the Pharmacist on Duty checked to ensure the administration was properly reported.  At this time, he realized the patient had received the Janssen Covid-19 Vaccine on 3/5/21 Lot #1805025. When asked prior to administration if he had received a previous COVID-19 vaccine, the patient denied previously receiving any doses of Covid-19 vaccines.  When the pharmacy manager called to follow up with the patient and inquire about the J&J vaccine, the patient's daughter stated her father didn't speak English and she would have to look for the paperwork and get back to the pharmacy about whether or not he received the J&J vaccine. She stated he was not experiencing any additional side effects beyond a sore arm at this time.
Crying without interruption over 3 hours starting 8-9 hours after vaccine. DTAP and pneumococcal vaccines administered. Given paracetamol 12 hours after. She has dairy allergy and gluten intolerance now.
Initial report received from Non-Health Care Professional on 30 April 2012. A female patient, whose medical history and concomitant medications were not reported, had received a intramuscular dose ADACEL in right deltoid (lot number - unknown) on 23 April 2012. It was reported that on 23 April 2012, the patient experienced pain in arm and fingers of right hand 6 hours post vaccination. The reporter stated that 8 days later the patient continued to had pain which was worsening, extends from arm to shoulder to back and from arm site down to finger of hand. The outcome of events was reported as not recovered. Documents held by sender: none.
Pt was running fever around 103 felt very warm & clammy & seemed very ill; was taken to ER & MD felt was combination of DTP & UTI dx in ER caused the illness; ATB prescribed;
HCP administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered expired vaccine to the patient, after the manufacture date of expiration) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The live follow-up information was received on 08-Jun-2022 which contains non-significant information.