chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1-2 days after the second vaccine, all joints became extremely painful/hips, shoulders, elbows and wrists extremely painful. Pain did not subside.; Hands became swollen; This is a spontaneous report from a contactable consumer or other non hcp.  A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Right on 22Mar2021 (Age at vaccination: 60 years) as DOSE 2, SINGLE for covid-19 immunisation at hospital . The patient medical history was not reported. Concomitant medication(s) included aspirin [acetylsalicylic acid] 81 mg/day, taken for an unspecified indication, start and stop date were not reported: Rosuvastatin 5 mg/day. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunisation on 12Feb2021 with lot number EM9809 taken in right arm.  Patient did not receive any other vaccines in 4 weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. The patient experienced 1-2 days after the second vaccine, all joints became extremely painful/hips, shoulders, elbows and wrists extremely painful. pain did not subside, and hands became swollen on 23Mar2021. Therapeutic measures were taken as a result of 1-2 days after the second vaccine, all joints became extremely painful/hips, shoulders, elbows and wrists extremely painful. pain did not subside. (arthralgia), hands became swollen (peripheral swelling). Adverse event resulted  in doctors' office visit. Subsequently prescribed steroid for relief Methylprednisone (50 mg/day). Realized some relief, condition persists. The outcome of the events was recovering.   No follow-up attempts are required. No further information is expected.
Severe gout flare-up after two and one half years without any gout flare ups.  The pain lasted in excess of three weeks and seemed to be clearing up as I headed for my second dose.  A day after the second dose the flare-up returned at a less severe level and continues to this day.
I have what looks like "COVID arm." There is a pink/red, slightly raised patch on my upper left arm. It is about 3-4 inches in diameter.  It is slightly sore and slightly itchy. The outer edge is darker red. No other symptoms. I did not seek medical attention.
Ten days after first dose patient developed NAION and edema of superior optic nerve left eye, had inferior visual field defect. Ten days after second dose of vaccine developed NAION to left eye a second time, with vision loss of superior visual field. This resulted in count fingers vision in the left eye. Treated with inpatient hospital stay, IV steroid infusions. Pt is now on steroid taper and has 20/200 vision in left eye. Patient is still legally blind in that eye. Work up including MRO of brain and orbits, CT angiogram were normal. Labs, ESR, CRP and platelets were also normal.
Itchy rash; Muscle pain; Red; Pain worse going up neck and into back of head; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 15:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcerated colinitis and heart stent. The patient received unspecified medication within two weeks of vaccination. The patient did not have allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 07:00 the patient experienced red, itchy rash, muscle pain and on an unknown date in Apr2021 patient experienced pain which got worse and goes up to neck and back of head. The event resulted in doctor or other health care professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with cream, over counter pain medicine and heating pad. The clinical outcome of the red, itchy rash, muscle pain and pain which got worse and goes up to neck and back of head was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: amended medical history data and event data.
pain at injection site. pain radiating down arm. pain at elbow. pain at wrist.
Huge bruise on upper/inside calf of left leg with no injury to cause it. Hematoma underneath. Still present more than 3 weeks later.
Most dramatic symptoms were a heart arrhythmia where my heart missed beats and inflammation of my lungs. This started 11.5 hours after my vaccine dose. The heart arrhythmia continued  daily for 8-9 months. And the lung inflammation continued for 12 months, centering in my right upper lobe causing rhonchi and an audible wheeze.  Both of these complications still happen but are much less often now. Along with these major complications I also had the usual sore arm and exhaustion experienced by many other vaccine recipients.
No adverse event; Adult patient received 2 child shots instead of Bivalent adult shot.; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Adult patient received 2 child shots instead of Bivalent adult shot.) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Adult patient received 2 child shots instead of Bivalent adult shot.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Adult patient received 2 child shots instead of Bivalent adult shot.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The patient was taking concomitant medication but did not specified on which medication exactly.  The patient had no allergies.   When the patient got the shot, the person that gave the shot made a mistake and gave the juvenile dosage and so on same day they gave patient a second shot of the MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) with batch no. AS7145B. The patient went there to get the BA5. The patient did not know what patient got so patient got two shots.   Reporter stated that the pharmacist said gave the patient received wrong shot, they gave patient the juvenile shot. The patient wanted to know if 2 shots of the Moderna Covid-19 vaccine bivalent are equivalent to 1 adult dose of the bivalent vaccine.  The patient was not tested positive for COVID-19.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2022: Live follow-up received. Updated narrative.
On 30 Apr, 2nd day after vaccination, I an episode of heart palpitations ("ventricular premature complexes in a pattern of bigeminy").  These were captured on an EKG during a VA disability exam, and started shortly after providing a blood sample (I'm nervous with needles).  Previous day (1st day after vaccination) I had a fever of 101.5 F and was fatigued.  Suspect the stress of the fever, immune response, and then blood sample caused a stress event that triggered an abnormal heart rhythm.  Palpitations not accompanied by light headedness or shortness of breath, so no immediate medical care directed.  Episodes of palpitations continued for 4 days, but have mostly disappeared since.
week after getting the vaccine she starting to get severe joint pain in shoulders and hip which made her very weak. it increased day by day, bad headaches, hard to sleep and cant focus
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 68-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.  No treatment medications were reported.
Mother of patient arrived to clinic today for vaccination of another child and mentioned to this RN that pt developed redness and swelling to vaccination sites, have facial swelling, generalized hives on the evening of 9/22/23, several hours after receiving vaccines. Did not take to ER. Informed provider during pt's physical exam on 9/29/23 and was prescribed prednisolone for the facial swelling.
injection site area skin and underlying muscle feel numb to the touch.  Not completely numb, but significant reduction in sensation when rubbed or otherwise stimulated.  About 5" in diameter centering on injection site.  All injections in series given in the same location.
Area/injection site became red and inflammed on Saturday 2-23-08 after injection on 2-22-08.  Entire upper left arm, medial and posterior aspects is erythematous and warm but not raised.  Diagnosis: Cellulitis of upper arm.
Patient complained of pain at the injection site immediately after vaccine. Arm was "super sore over the weekend. Starting on 2/9/23, patient was describing pain as sharp and felt like something sharp was moving around in her arm. Left deltoid area became red, painful, and slightly swollen. Area was warm to touch on day of exam, redness spreading. Treated for cellulitis.
Sores on the back of tongue; High fever; Migraine; Fatigued beyond comprehension; Body aches so bad nothing helps.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jul2021 at 15:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had known allergies to azithromycin (ZITHROMAX). Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021 at 06:00, the patient experienced every symptom severely over a week. The patient experienced sores on the back of tongue, high fever and migraine that won't let up. The patient stated she would not be getting the second dose as she was fatigued beyond comprehension and her body ached so bad nothing helped. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sores on the back of tongue, high fever, migraine, fatigued beyond comprehension and body ached so bad nothing helped was not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Blood pressure has been 145/80 p.60 since 12/24.  I do not have high BP normal pressure for me 110/75  Extreme muscle strain experienced 48 hrs after vaccine given.
Pruritus ( 1 day post vaccination), generalized macular rash trunk, extremities. No fever, arthralgia, shortness of breath or cough. Metallic taste in mouth.
10/12/04 In office for vesicular rash that started on 10/9/04. Located on left shoulder, down arm and wrist. Tylenol/Advil for pain DH 72hrs from onset.
Child reported to our office 5/5/06 with scattered clusters of vesicles. Dx as chicken pox. Treated with Zovirax 200/5 1 1/2 tsp qid x 5 days.
10Dec97 & 12Jan98 Pt recv 1 & 2nd dose vax. Concomitant meds: Decadrol & Thorazine. 13Jan98 Pt devel itchy generalized lesions, 10-20 scattered over body. Reporter noted lesions not "true vesicles".
Can hear blood flow and heart beat in left ears. I believe it?s called Tinnitus.
headache; felt sluggish; This is a spontaneous report from a contactable consumer.  A 77-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration on  an unknown date as single dose for COVID-19 immunisation. The patient had received the first dose of  BNT162B2 on 21Jan2021 and experienced numbness at injection site, swelling and itchy, then dizziness and little taste in mouth. There were no medical history and concomitant medications. It was reported that the night of second vaccine the patient had headache that lasted overnight and felt sluggish the whole day the day after.  Admission to hospital due to the event was reported. Treatment was not received. The patient was fine at the time of reporting.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021100456 Same reporter/patient/product, different dose/AE.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 08-Dec-2010. On 13-Dec-2010, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 03-Mar-2011 and incorporated into case: no late occurring adverse events.
Information has been received from a health professional concerning a 31 year old female who on 10/18/2005 was vaccianted with a 0.5ml dose IM in the left deltoid of Pneumococcal 23v polysaccharide vaccine, (lot 640453/0791P). Concomitant therapy included atorvastatin calcium Lipitor. That night, on 10/18/2005, the pt experienced a red and swollen left arm and she had pain in her shoulder blade and arm pit. The symptoms subsided on their own and she received no treatment. No medical attention was sought. The pt was considered recovered on 10/6/05. No further information was available. Additional information has been requested.
My reaction to the Shingrix vaccination was full body debilitating pain primarily in joints.  Became noticeable about 2 hours after injection and kicked in full force by about 8 PM that evening.  Lasted for about 20 hours before subsiding.  Initial sign was the expected muscle pain at injection site, which occurred within the first hour.   I don't recall how the pain progressed, as I was preoccupied.  I was up the entire night in severe burning, searing  head-to-toe pain.  Difficulty walking or sitting due to pain.  Remained flat in bed, in and out of sleep,  the remainder of the day on 08/18 until the pain subsided to a tolerable level in the early evening.  Called my physician.  No treatment.  She suggested that I do not get the 2nd shot, but I am leaning toward getting the shot as other family members have had shingles within the past 3 years.  Outcome:  No residual effects.
Monday AM (swelling in right armpit, right side of face looked odd - slightly puffy/stiff) Tuesday AM (swelling  increased still in right armpit, uncomfortable, facte still off) Wednesday AM (swelling still in right armpit, slight decrease, ache developed in right shoulder along collarbone area to right side of neck, tickle on right side of throat and numbness/tingling on right side of mouth.  Right side of face more stiff and when I tried to smile, right side of mouth would not turn up.  I would try to force it and right side would quiver and shake.  Sent notice to my primary and was advised to call 911 if emergency or get a face to face with urgent care.  Went to urgent care and was diagnosed with slight case of Bell's Palsy, was prescribed Deltasone & Valtrex.  I did NOT take either drug. Over the course of the next week, armpit swelling reduced  and face puffiness/stiffness seem to subside.  Have tightness on right side when I force mouth movement to right side .
Starting around noon of the fourteenth, had flu like symptoms including headaches and sore muscles. Woke up the fifteenth feeling better but not 100 percent.
Slight redness in shoulder - left slight itching in shoulder - left at this time redness is going down.
This spontaneous report was received from a pharmacist referring to a 39 year old patient of unknown gender, who on 09-DEC-2051, was vaccinated with a dose of ZOSTAVAX unknown administration route, lot # L032402, expiration date 26-NOV-2016. The pharmacist also reported that the patient had a history of previous shingles outbreaks prior to vaccination. No adverse effects were reported. Additional information has been requested.
Patient was complaining of chest tightness and increased heart rate around 15 minutes of receiving the vaccination. Was given 50 mg Bendadryl IM for treatment and patient was monitored for an additional 30 minutes. Symptoms were relieved upon patient exit.
Pt recvd vax 24OCT91 1030AM & @ 6PM pt cried-screaming for several hrs t102 R; pt given APAP & cool bath; 930PM t101; 2AM awake screaming t104;
Swelling, heat, pain, redness at injection site spread to elbow. Dr. prescribed steroids, BENADRYL, hydrocortisone cream.
Fatigue; Achiness; Booster; other_vaccine_same_date_product=Flu Shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 18Nov2021 (Batch/Lot number: unknown), single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 74 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available to reporter at the time of report completion), administration date: Mar2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 18Nov2021, outcome unknown; PRODUCT USE ISSUE (non-serious) with onset 18Nov2021, outcome unknown; FATIGUE (non-serious) with onset 20Nov2021, outcome recovered (Nov2021); PAIN (non-serious) with onset 20Nov2021, outcome recovered (Nov2021). It was unknown if therapeutic measures were taken as a result of fatigue, pain. The lot number for bnt162b2 was not provided and will be requested during follow up.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
lowest temperature it reached was 1.4C and the highest temperature it reached was 9.0C for a total duration out of range of 1 hour and 54 minutes,with no reported adverse event; post administration to patients without reported adverse event; Initial information received on 04-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves vaccine IPV (VERO) [IPOL] where temperature reached was 1.4c and the highest temperature it reached was 9.0c for a total duration out of range of 1 hour and 54 minutes and was post administration to 2 years old male patient without reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor  On an unknown date the reporter reported that the lowest temperature it reached was 1.4c and the highest temperature it reached was 9.0c for a total duration out of range of 1 hour and 54 minutes,with no reported adverse event (product storage error) and post administration to patients without reported adverse event (poor quality product administered)  (unknown latency) following the administration of IPV (VERO) (Suspension for injection) (strength: 5 mg) (lot number: V1A024M and expiry date: 17-feb-2024) via intramuscular route in unknown administration site for Immunization.  It was reported "MA reporting a temperature excursion due to a refrigerator malfunction at their facility. The lowest temperature it reached was 1.4C and the highest temperature it reached was 9.0C for a total duration out of range of 1 hour and 54 minutes. The products open was IPOL. MA calling for stability information. Extended stability data does not cover open IPOL. MA requests for stability information be emailed. Submitting to PV due to post administration to patients."  Action taken: not applicable.  Outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 08-Mar-2023 via other health professional: case was updated from non-valid to valid case. Patient's demographics were added, strength was added, narrative amended accordingly.
Skin, swelling, erythema and induration at left deltoid around injection site measuring 4x4 inches warm.
The first 3 days immediately following shot I had chills, hot flashes, headache, nausea, dizziness, and extreme fatigue. Pain, inflammation and swelling started around 2 weeks after shot. Currently still dealing with symptoms for a total of 7 weeks.  Pain and inflammation in both hands. Pain and inflammation in both knees. Inflammation and soreness in right elbow and right ankle. Went to primary care doctor, got blood work. Recommended to see Rheumatologist. Meloxicam prescribed and have been taking that for 4-5 weeks. Going back to Rheumatologist for follow up appointments. Symptoms are still present today.
PATIENT STARTED LOSSING HAIR EXCESSIVELY 3 MONTHS AFTER THE SHOT ON 5/1/2022.