chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after the initial swelling and tenderness at injection site, a few days later, I noticed what looked like black specks at the injection site; dalys later, the black specks started being replaced with a lack of melanin - (white spots), and soreness in the upper arm and elbow; I reported this to my pcp while at a regular checkup; fast forward to the present day and the lack of melanin has spread to a starburst like effect of 2 inches in diameter and the pain in my arm is still present but in a greater area - in the upper arm, my shoulder and the bend of my elbow.
Nausea, vomiting, pasted out twice at the pharmacy, Dizziness, Muscle Weakness, Shortness of breath, chest pain and tightness.
lost some ability to hear as well as I could before the vaccination; Right ear congestion; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0180), via an intramuscular route on 13Jul2021 (at the age of 70-years) as dose 2, single in the left arm for COVID-19 immunisation. The patient medical history was not reported. The patient had no known allergies. The patient concomitant medications included Meloxicam, ginger, B12 and vitamin C from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single in the left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Jul2021, the patient experienced right ear congestion the next day after 2nd dose vaccine and it still persist today and also lost some ability to hear as well as he could before the vaccination. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient did not received treatment for events (as reported). The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
RECEIVED LESS THAN 0.5 ML OF THE VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 45 year old white, not Hispanic or Latino male. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received additional dose with covid-19 vaccine ad26.cov2.s (dose in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022) dose was not reported (approximately around 0.3 mL), 1 total, administered on 01-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that the patient received less than 0.5 ml of the vaccine as a booster dose approximately around 0.3 mL of dose (vaccine underdose and off label use). As per the report, "the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL"  (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5 ml of the vaccine as a booster dose  and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211210058, 20211209976, 20211210160, 20211210588, 20211210610, 20211209775, 20211210159, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211209706, 20211209912, 20211209921, 20211210019, 20211210112, 20211209798, 20211209874, 20211209884, 20211210549, 20211210106, 20211210107, 20211210141, 20211210143, 20211210180, 20211210334, 20211210585, 20211210590, 20211210590, 20211210684, 20211210385, 20211210165 and 20211209843.
Shingrix vaccination shot. Caused fever, aches, exhaustion, general feeling of nauseousness.  Unable to sleep and unable to feel well
During first week, left arm sore at site where seasonal flu shot was given.  Then entire arm sore, weak. Still (now 11/4/2009)arm has tingling (pins and needles) feeling, entire arm feels heavy with prickling sensation from top of arm to finger tips.
Fever and chills for from day 2 through day 6; pain in arm beginning on day 2 through day 6; fatigue, muscle pain, headache, dizziness starting on day 2 continuing through today (day 13), tinnitis beginning day 2 continuing & getting worse through today (day 13), especially severe days 9-13.  Tinnitis is interfering with ability to concentrate & sleep.
Vaccine administered 4-6-13. Notified of "chicken pox-like" rash on arms / legs on 4/9/13 4:30pm. Contacted MSD to report rxn - advised patient to notify MD. Followed up with patient 4/10/13 4:45pm rash ? coming to "blister" head.
This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (Breakout in rash and blisters), URTICARIA (Hives) and RASH (Breakout in rash and blisters,rash all over body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced BLISTER (Breakout in rash and blisters), URTICARIA (Hives) and RASH (Breakout in rash and blisters,rash all over body). The patient was treated with PREDNISONE ongoing since an unknown date for Rash and Hives, at an unspecified dose and frequency. At the time of the report, BLISTER (Breakout in rash and blisters) and RASH (Breakout in rash and blisters,rash all over body) had not resolved and URTICARIA (Hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Followup reiceived :Live Follow Up Appended- patient info updated.Primary reporter type updated as per recent data received.Lot no.updated,treatment drug added.Event onset date updated
1) moderate arm pain, slight swelling, redness and bruise at injection site  starting 9/15/22 @ 3:00pm until 9/17/22 @ 9:00pm. 2)Tiredness, muscle pain and headache starting  9/16/22 4:00am until 9/17/22 @ 12:00pm
Patient came into pharmacy on 9-18-2010 to show her arm.  There was a half dollar size bruise at site of injection of Pneumovax vaccine.  There was a 4 inch strip of redness below the bruise which wrapped around the arm.  Patient complained of tenderness under the arm.  She took Benadryl 50 mg that evening.  On 9-19-10 she said it was getting a little better and was going to take Benadryl 25 mg every 6 hours.
Wrong dose given.  My child is 10 years old and he was given the booster for 12 years and up.  I told pharmacist at check in that he is 10 years old.  I handed same person the Vaccination Record Card with correct birthdate.  The confirmation materials received online included warnings/info about the booster for 5-11 years old.  The same pharmacist asked my son his birthdate at moment before injection and he stated it correctly.  Still, the wrong shot was given.  My son felt fatigue and pain in his arm last night.  This morning still complaining of pain in his arm and throat pain.  He felt fine enough to go to school.  We've given him Tylenol for the discomfort.
Client received 1st dose in seriers of Pfizer on 5/18/2021. Client started with itching and hives on 5/25/2021 and treated by parent with OTC ibuprofen and benadryl. No improvement noted and symtoms progressed on 5/26 and 5/27. On 5/27 symptoms worsed with swelling of lips and tongue and finally difficulty breathing. Parent took client to Hospital ER on 5/27 where she was treated with IV benadryl and steriods. Symptoms have not re-occurred. Client given EpiPen and has not used. Parent denies any other ideas of what could have triggered this allergic response.
Swollen right eye; Swollen left hand; This case was reported by a pharmacist via call center representative and described the occurrence of eye swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7A7H4, expiry date 10th December 2021) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, less than a week after receiving Shingrix, the patient experienced eye swelling and hand swelling. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the eye swelling and hand swelling were unknown.   It was unknown if the reporter considered the eye swelling and hand swelling to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient experienced swollen right eye and left hand after vaccination. The reporter stated that when she was unable to withdraw the medication from the vial, so she had to open a new vial for reconstitution of a dose. The pharmacist also reported that the patient went to see her HCP and that he gave her 20 mg of Prednisone, in case she is allergic to Shingrix. The pharmacist reported that patients will potentially be late for the 2nd dose of Shingrix due to a reconstitution PQC and a supply issue with restocking the vaccine. The reporter consented to follow up. This case has been linked with case US2020042784(Husband's case), reported for same reporter.
Early next morning after shot, my shoulder was in high pain while at rest and in use. I though the pain would go away, so I continued my normal activities and exercises, but the next day the pain intensified and I started losing strength and mobility in shoulder and arm movement. Dr. prescribed OTC anti inflammatory pills, topical rub, exercises. The Physical Therapist provided TENZ unit, exercise techniques and regimen, and cortisone electric pad treatment.
Excessive tiredness after first dose and second dose. Getting worse  Low energy Increased joint pain and muscle weakness  Headache 5/7 days a week Brain fog
Immediate neck stiffness and woke up 12 hours later with pounding heart and ringing and pounding in ears, tingling hands and feet and light headedness   This continued for a week. The lightheadedness subsided after one week but ringing and pounding in ears remains. Resting heart rate remains elevated as well.
PATIENT WOKE UP AND FELT VERY DIZZY, ALMOST PASSED OUT, VERY WEAK, HAD A HEADACHE. FELT LIKE GETTING THE FLU, HAD TO LEAVE WORK D/T SEVERITY. AFTER 1ST DOSE ONLY HAD SORE ARM.
Chills, fatigue, soreness, dizziness, and sinus headache overnight after receiving vaccine. Chills, fatigue, soreness, dizziness, chest pain, and difficulty breathing the day after receiving the vaccine.
about 8-9 hours after site injection a swelling about the size of small apple accoured. kind of round and slightly SLIGHTLY red. this morning swelling less but injection site tender
Sharp shooting pain down arm; pins and needles on right side of hand/forearm which then became numbness; followed by severe muscle weakness.
redness- intermittent; injection site pruritius; Swollen, like a mosquito bite - intermittent; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness- intermittent), VACCINATION SITE PRURITUS (injection site pruritius) and VACCINATION SITE SWELLING (Swollen, like a mosquito bite - intermittent) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021 at 4:00 AM, the patient experienced ERYTHEMA (redness- intermittent), VACCINATION SITE PRURITUS (injection site pruritius) and VACCINATION SITE SWELLING (Swollen, like a mosquito bite - intermittent). At the time of the report, ERYTHEMA (redness- intermittent), VACCINATION SITE PRURITUS (injection site pruritius) and VACCINATION SITE SWELLING (Swollen, like a mosquito bite - intermittent) 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.   Patient reported all symptoms appear to be intermittent in frequency No concomitant medications were reported No treatment medications were reported
Syncopal episode lasting approx. 30 seconds. BP 80/40. P 40. Given PO fluids and carbohydrate snack, elevated feet. VS stable within 5 minutes (116/70, P 64).
Pt recvd Heptavax B in 1989 & pt was determined to be a non-responder; pt recvd a booster (4th) dose of Engerix-B on 26JUN91 & was determined to be a non-responder on 14NOV01; pt recvd Engerix-B 2nd dose of 2nd series on 2DEC91;
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: pt noticed redness at injection site was not getting any better .. patient came into pharmacy on 8/24/2021 and pharmacits instructed her to call her dr to ask if she needs to be seen.. patient noticed itching, warm at site..she stills has complete mobility of arm just itching, redness and swelling not reducing
Information has been received from a physician concerning a 72 yr old retired male pt with an allergy to lidocaine who on 27Sep05 was vaccinated in the left upper arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot650454/0751P). On approx 27Sep05 the pt developed left upper extremity with cellulitic type reaction ie swelling. He was afebrile. The pt's outcome was unk. No further information is available.
shot was given in the am...around 8-9 pm started feeling achy, tired, fever, freezing...took ibuprofen, put on socks, sweatshirt and gloves because I couldn't get warm...went to bed...woke up at 2-3am drenched in sweat....took off gloves, socks, sweatshirt, went to bathroom...stood to pull up pants with right arm (still very sore from injection)...everything went dark...my husband came into the bathroom and I was laying on the floor....I couldn't stand... I had to crawl to the living room where my husband helped me into a chair...he got me cold wet towel, more ibuprofen and water....I slept most of the day...I was scheduled to work the weekend but missed all three days (F, Sa and Su)
Initial literature report received on 20 Dec 2010: This report consisted of cases retrieved from the database. A query of the database was conducted to identify potentially relevant cases based on a claimed injury of shoulder pain, arm pain, shoulder dysfunction, frozen shoulder, adhesive capsulitis, or shoulder bursitis. Brachial neuritis was also included since this injury was frequently claimed when the arm was involved regardless of the actual diagnosis. Case histories of all submitted medical records were reviewed in detail to verify vaccination date, symptom onset and clinical course. This patient with no history of shoulder dysfunction, was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) on unknown date. It was reported that the vaccine administration led to shoulder injury with significant shoulder pain and dysfunction. The symptoms lasted for more than six months. The outcome was not reported. The authors commented that they believe that this type of phenomenon is not due to a specific vaccine but results from injection of a vaccine antigen to which a person has previously been sensitized as a result of previous naturally occurring infection or past vaccination. This concept is consistent with the vaccines which were given in this case series, namely INFLUENZA and TETANUS which are given repeatedly over time. This clinical case series provides additional evidence supporting that the vaccine administration in the upper third of the deltoid area can have long-lasting consequences unrelated to the specific vaccine administered.
Narrative: A 58yo female with PMH of obesity. The attending physician reported the patient had a historical ADR of J&J Covid-19 vaccine induced Joint Pain explained as back pain and leg pain. four days following the vaccine. No other detailed information was provided regarding the vaccine and whether the patient received any treatments or not
Patient reported feeling feverish the night after receiving the shot, could not sleep at night due to the overwhelming pain at the injection site. Since receiving the shot two days ago, she developed a hard lump at the injection, has been in bed from feeling wiped out from it, skin is hot to touch, very painful to the touch, and swelling that has extended down to her elbow and is wrapping to the inside of her arm and up to the top of her shoulder.
Redness, swelling, irritable, crying inconsolably, warm to touch at approximately 3 hours, post vax.
Measle like rash. Daily I get a couple more bumps that pop out and itch like crazy. These appear on either my arms or legs.  This has been going on for almost 3 weeks.
Information has been received from a health professional that a high percentage of patients vaccinated with Gardasil subsequently experienced intense pain at the injection site at the time the vaccine was administered to them. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a health professional that a high percentage of patients vaccinated with GARDASIL subsequently experienced intense pain at the injection site at the time the vaccine was administered to them. It was reported that "at least 90% of patient's receiving the vaccine complained of intense pain at the injection site." The patient's complain that their arms feel heavy. Additional information has been requested.
Elevated BP (mostly systolic of +15 to +35) 10 of the past 12 days since receiving the shot; Day 1 & 2 fatigue. Got better by day 3. Gone by day 4. Reoccurred day 10 and gotten progressively worse; This is a spontaneous report from a contactable consumer. This 62-years-old non pregnant female consumer received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number ewd150), via an unspecified route of administration, administered in Arm Right on 02Apr2021 11:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypertension. There were no concomitant medications. No other vaccine in four weeks. Other medications in two weeks yes. No covid prior vaccination. No covid tested post vaccination. No known allergies. On 02Apr2021 19:00 patient experienced elevated blood pressure (mostly systolic of +15 to +35) 10 of the past 12 days since receiving the shot, day 1 & 2 fatigue. got better by day 3. gone by day 4. reoccurred day 10 and gotten progressively worse. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 02Apr2021 Also had elevated BP (mostly systolic of +15 to +35) 10 of the past 12 days since receiving the shot. No treatment was received for AE. The outcome of both events was not recovered.  No follow up attempts are needed. No further information is expected.
Pt noted with tearing, difficulty of breathing and itching. Epinephrine 0.ml given. Albuterol by nebulizer. Benadryl 25 ml po 10 am, 2nd dose Epi 0.1 ml @ 10am.
10/11 days after vaccination I developed a red circular  spot on my arm where the injection was given.  About the size of a lemon.  Only symptom was redness. No pain, swelling, heat,or itching. Now day 3, and beginning to fade. Have read about ?COVID vaccine arm?. Wanted to still report my symptoms. Feel fine. Plan to get  2nd shot in opposite arm.
Neurological side effects (dizziness, double vision, extreme brain fog, confusion, low blood pressure). Eventually diagnosed with dysautonomia and POTS. Vaccine discussed as very possible trigger by multiple doctors.
Given vaccine after sitting out punctured for a day.; Given another dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not reported.  It was reported that vaccine had been punctured on 10-May-2021 and left on the counter overnight before 3 doses were administered and the vaccine given to the patient was expired.  Reporter also stated that concerning dose of vaccine had not experienced any previous temperature excursions.  Patient did not experience any known symptoms on receiving 3 doses of the vaccine.
Narrative: Patient received Moderna Bivalent Booster Vaccine on 11 October 2022. The patient experienced redness and itching that was initially 2.5cc on the day of injection and spread to cover approximately 15x15cm on the lateral arm. The area was bright red and tender to the touch. The patient was treated with diphenhydramine.