chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Worsening joint pain generally; over following month developed right supraspinatous tear, documented impingement signs (Physical Therapist). Currently undergoing physical therapy.  Same timeframe developed left hip pain, possible greater trochanteric bursitis.
Patient stated rash (softball size) warm and tight. Talked to patient 5 days post administration and she states moved down to elbow and feels like it is "getting better". Counseled patient to ice, use an antihistamine and can use TYLENOL. Patient also states soreness is gone.
The night I received the second dose, probably after 11pm, I had body aches, chills, headache, probably a fever. In the morning, still feeling poorly, I took ibuprofen, which helped ease the symptoms. When that wore off, around 11 am on 05/18/2021 the body aches and chills returned. I checked my temperature, and it was 102.3. Later that evening, I'm not sure what time, my arm started itching at the injection site. The fever and body aches continued overnight. On 05/19/2021 I woke up with the fever gone but body still achey, plus sensitive skin. The injection site is still itchy, is slightly swollen, and has a large red patch around it.
Pt received 5th DTAP and 4th IPV on 4/22/02 in the left upper arm. On the morning of 4/23/02, redness and swelling was noted and by 4/24/02, seen in office for redness and swelling of an area from shoulder to elbow 20cm X 11cm of redness and swelling. Treated with Benadryl q 6 hours and resolved after Benadryl.
My breast implants swelled up at top of my chest and an intense itchiness occurred that was painful.; My breast implants swelled up at top of my chest and an intense itchiness occurred that was painful.; My breast implants swelled up at top of my chest and an intense itchiness occurred that was painful.; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 12Mar2021 08:00 (age at vaccination: 54 years) as 1st dose, single for covid-19 immunisation. The patient was administered vaccine in Clinic facility. The patient medical history included covid-19. Prior to vaccination, the patient diagnosed with COVID-19. The patient did not receive other medications within 2 weeks of vaccination. The patient was allergic to ampicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 21:00, the patient breast implants swelled up at top of chest and an intense itchiness occurred that was painful. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received anti-inflammatory medicine as treatment for the adverse events. On an unknown date, the patient underwent sars-cov-2 test which was positive. Since the vaccination the patient was not tested for covid-19. The outcome of the events was not recovered.
Felt great and then all of a sudden diarrhea started around 11 pm. Went to bed and became extremely cold - teeth chattering, chills and fever at 11:30pm - approx. 8 1/2 hours after injection.  After that vomiting, soreness, headache body aches, fever of 100 degrees.  When awaking the next morning, still had fever of 99.8, chills, nausea, headache.  Finally felt like myself by 3pm on Tuesday, March 16.   I am not a chronic complainer.  After receiving my flu shots every year for many years, this was the first reaction I've ever had to any immunization - ever.
Began within 3 hours, redness, swelling, knotty & itchy at the injection site
I had a strong dull ache in my RT deltoid into my neck. Followed by numbness into my RT jaw maxillary sinus and rt and eye. I went to urgent care and my symptoms were consistent with bells palsy. All these symptoms happened within a 45 minute perid directly following my shot.  I was seen by MD. The observation nurse at Hospital where I recieved my injection was RN
Case number PHEH2015US000674, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 10 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided.
injection site redness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 01-Mar-2021, VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Patient called on 10/10/19, then came in to pharmacy. Severe and significant redness and swelling over entire bicep and tricep area reaching down to elbow from injection site. Patient reported radiating pain, high heat, fever, chills and feeling very clammy. Advised patient to go to clinic or urgent care. Also to take ibuprofen and use a cool pack. Pt states he has no PCP
ON 08/03/05 MOTHER AND FOUR YEAR OLD PATIENT SHOWED UP TO THE CLINIC, COMPLAINING  THAT CHILD HAD SWOLLEN  LEFT DELTOID.  WHERE CHILD RECEIVED DTAP.  ON ASSESMENT CHILD HAD SWOLLEN UPPER ARM TENDERNESS, WARM TO TOUCH, NO REDNESS, NO COMPLAIN OF FEVER OR OTHER COMPLAIN.
First shot arm hurt for days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced first shot arm hurt for days and mild symptoms. Second shot nothing. No symptoms. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received dose #1 Moderna COVID Vaccine 1/12/21 Clinic. 1/15/21 presented to  ED for left upper arm redness/swelling, fever, body aches, new cough, decreased appetite, and fatigue . Had been treating w/OTC Tylenol. Developed sepsis, leukocytosis from LUE cellulitis, currently admitted to hospital for treatment. Entered by PSS for tracking.
States she awoke 10/29/2014 with very swollen face. Used Benadryl for the swelling. Face remained swollen until 10/30/2014 afternoon.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Tingling, weakness, numbness and muscle ache started on 02/25/2011 and it lasts for couple of weeks. On February 26 & 27, 2011 Urine Retention problem that means I couldn't urinate. First ER then I admitted to the hospital after that they diagnosed me Guillain-Barre Syndrome. I got IVIG treatment.
Pt recvd vax & exp a steady ache below lt knee cap; pt stated that limped all the time; No further details were provided;
pt recvd vax & presented in ER per ambulance 445PM temp R 99 sz prior to arrival; unresponsive 02 bagging changed from amubu to mask @ 505PM;
No side effects were reported.; HCP reports PROQUAD was expired and administered to patient. No side effects were reported.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-JUN-2023, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, as prophylaxis (lot number: U039957, which was determined to be valid, with an expiration date on 14-JUN-2023) (strength, dose, scheme, route and anatomical location of administration were not reported) (expired product administered).  No side effects were reported.
Patient's arm is red, slight inflammation, and warm to the touch. Area extends from deltoid to near elbow. Did not obtain specific time of onset, but has had symptoms for 7 days. Has not received treatment, but recommended her to see physician or go to urgent care.
lyme disease flare (swollen joints), first flare in many years, occurred 7/30/21, still resolving menstrual cycle previously normal, now with 50 day long cycles (delayed ovulation), still resolving
Re rash on Right side only (same side vaccine was given.) Rash was reported as an itchy, red rash noted on right leg, neck, inside of right arm. Rash occurred about (3) hours after vaccine was given.  Mother reports she was just keeping an eye on it to see if it got worse. Advised her to reach out to PCP for follow up .
After 1st injection, mild chills, slight exhaustion 24-48hrs after, and diarrhea at 72hrs. About 1 week later, hands/feet/joints started to hurt and feel tight and stiff.   After 2nd injection, woken up with severe body pain the next morning lasted like that pretty much until 72 hours later when I also have nausea, vomiting and terrible headache.  Those symptoms passed and I was left with very bad joint pain especially in my hands/arms up  - joint pain and stiffness is starting to get better 3.5 weeks past 2nd injection.
One day, post vax, pt noted pain, redness, itching and warmth in the right triceps of injection site. Pt sought medical care for 10cm X 10cm of indurated area of swelling. Cold compresses applied. Atarax  and Motrin.  Follow up 10/19/2000: "Patient recovered from adverse event.  3 days missed from work.  Did not receive any more shots since the reported event."
24 hours after receiving vaccine developed shortness of breath, tight chest, light headed, coughing, congestion, expectorating phylum, hot & cold spells.  Internal/ external itching.
Pt given 2nd dose vaccine 05/19/2021.  2nd dose was due 05/24/2021.
Pt states she was diagnosed with Guillain-Barre syndrome approx. 2 weeks after receiving vaccine.
Temp to 103 degrees started at 6pm, rash started at 5pm and crying from 10pm - 2am
Urticarial-like lesions over entire body.  Patient also noted a decrease in appetite.
Rash on ears and neck and shoulders. Pin prick like. Showed 2 hours after shot and went away after approx. 24 hrs.
a 6 x 10 x 6 ovarian endometrioma settled in front of bladder; Ovarian cyst ruptured; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Beta-thalassemia" (unspecified if ongoing); "Covid", start date: 11Dec2020, stop date: 11Dec2020. Concomitant medication(s) included: ESCITALOPRAM; CLONAZEPAM; MUSHROOM COMPLEX [ALLIUM SATIVUM;GANODERMA LUCIDUM;HERICIUM ERINACEUS;INONOTUS OBLIQUUS;LENTINUS EDODES]. Vaccination history included: BNT162b2 (DOSE 1,SINGLE, Batch/Lot number: ER2613, Anatomical location: Left arm), administration date: 17Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: ER8730, Anatomical location: Left arm), administration date: 07Apr2021, for COVID-19 immunisation, reaction(s): "Ovarian cyst ruptured"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number 3302688), administration date: 17Nov2021, for COVID-19 immunisation. The following information was reported: OVARIAN CYST RUPTURED (medically significant) with onset 07Apr2023, outcome "unknown"; ENDOMETRIOSIS (medically significant), outcome "unknown", described as "a 6 x 10 x 6 ovarian endometrioma settled in front of bladder". The patient underwent the following laboratory tests and procedures: Carbohydrate antigen 125: (unspecified date) 120, notes: CA-125 = 120; Computerized tomogram: (unspecified date) Unknown results; Magnetic resonance imaging: (unspecified date) 6 x 10 x 6 ovarian endometrioma, notes: settled in front of bladder, location unusual, Unknown if malignant. No lymph node inflammation. No ascites; SARS-CoV-2 test: (Feb2022) Negative, notes: Nasal Swab; (Sep2022) Negative, notes: Nasal Swab; (11Dec2020) Positive, notes: Other; Ultrasound scan: (unspecified date) Unknown results. Therapeutic measures were taken as a result of ovarian cyst ruptured, endometriosis. Clinical course: Never had cysts prior. Bilat salpingo-oophorectomy w/ hysterectomy scheduled 08May2023. Tramadol Aug2021 & Apr2023. Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Ovarian cyst ruptured, Endometriosis and the use of suspect product Comirnaty cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-202300185334 same patient and reporter, different doses and event.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications are not provided. Treatment medications are not provided. The date of vaccine refrigeration was reported as 19-Aug-2021.
This spontaneous report as received from a physician refers to an over 65 years old male patient with a history of coronary artery disease (CAD) and exposed to chicken pox, who on an unspecified date was vaccinated with a dose of ZOSTAVAX 0.65 ml subcutaneously (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 26-OCT-2012 the patient developed a case of full blown chickenpox as of today. The physician had checked the patient for varicella titers prior to vaccination and the titers were low. The patient was treated with VALTREX for the adverse event. At the time of the report, the patient had not recovered from adverse events. The patient sought medical attention: office visit. The relatedness for the adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Pt recvd 2nd dose of vax & exp some arm pain & recovered the next day; pt recvd 3rd dose of vax & lab eval revealed neg titer for anti-HBS; No further details were provided;
Terrible pain; Rash across her right abdomen, side, and around her back; Shingles; Information has been downloaded from Agency (US-CHIRONMA-PHHY2015US059987).    This spontaneous report was received from a health professional referring to a 63 years old female patient. The patient's concomitant medications included losartan potassium (+) hydrochlorothiazide (HYZAAR), amitriptyline hydrochloride, fish oil, potassium, vitamin d and aspirin. No information regarding the patient's concurrent conditions and medical history was provided.   On 11-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (1 dosage form, lot # K018176, has been verified to be a valid lot number, expiration date was not reported, but upon internal validation established as 10-JAN-2016, strength and exact dose were not reported) subcutaneously for immunization and influenza virus sag 3v vaccine inactivated (FLUVIRIN) (1 dosage form, lot # 146604, strength, expiration date and exact dose were not reported) intramuscularly for immunization.   On 17-FEB-2015, the patient experienced rash across her right abdomen, side, and around her back (rash) and shingles. On an unknown date, the patient experienced terrible pain. The outcome of all events was reported as not recovered. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was not provided. The primary reporter suspected all the events related to influenza virus sag 3v vaccine inactivated (FLUVIRIN).      The events of rash, shingles and pain were considered as medical significant by the agency.
7-24-12 polymyalgia rheumatica on neck, back & shoulders. 7-30-12 still ongoing today. Received  rx MEDROL dose pack.
Generalised fine erythematous rash, morbilliform on trunk and intraarticular.
No reaction until the 6th day, Sunday.  Expected reactions on Day 6: temperature 100.4, tiredness behind eyes, slightly achy body.  Massive headache by Monday and ringing in ears.  Took Naproxin and Mucinex Monday morning before going to work.  At the end of the day I took Naproxin and Mucinex in order to sleep.  By Tuesday I had chest congestion which has gotten only worse along with needle-like pain in the chest upon coughing. I spit up yellow phlegm, tiredness behind eyes returned, sneezing, choking on phlegm, and constant runny nose and ringing in ears.  This has made working difficult, but not impossible.  Please ignore if these are normal reactions.  I'm just not sure.
Low grade fever to 100.1 the morning after receiving the vaccine, mild body aches and headache. Symptoms dramatically improved within 12hrs and by the following morning (48hrs post receipt of vaccine), I was symptom free.
PAIN AT INJECTION SITE when given gardasil vaccine lot # 0072 excoriation was 10/24/2010 im - was 2nd gardasil -no adverse reaction from first vaccine - causing pt to cry, hold her arm, swelling at injection site 1/4 inch raised bump (declined within a seconds) redness that radiated to 1 1/2 inches from injection site (gone within 15 minutes ) had pt lay down, monitor vital signs - stayed within normal limits except temp was 98.6, 15 minutes later was 99.0, got out emergency first aid benedryl but did not need it, pts color remained the same - ARNP check pt and injection site - pt remained in clinic for 30 minutes after injection - pain had decreased in arma and pt had mobility in arm and she left in good condition.  Called pt at home 3 hours later and pt stated she felt much better and that her arm felt better than it had after her first gardasil vaccination after 3 hours.
headache; muscle pain; low grade fever; weakness; nausea; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (lot number and expiry date: unknown) as dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 05Mar2021. For the last 3 days (in Mar2021), the patient experienced headache, muscle pain, low grade fever, weakness and nausea. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
This is a  83 Years old  Male  presenting with syncopal episode today after he got his flu shot. The patient is not feeling unsteady and off-balance when attempting to walk. He had a cholecystectomy late July, early August. He still has 2 drains in. He went last week and had abdominal pain. They did a CT which showed a possible abscess. He denies any abdominal pain currently and he denies any recent fevers.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (route of administration and lot number were not reported). The patient experienced swelling and redness on her arm after receiving PNEUMOVAX 23 (date unspecified). The patient did not seek a medical attention. The outcomes of the events were unknown. The causality between PNEUMOVAX 23 and the events was not reported. Additional information is not expected because the physician did not give a consent for further contact.
Patient has shortness of breath. He called 9-1-1 twice. The first time they didn't take him to the hospital. The second time they took him to the hospital and they released him after several hours.
Rt leg red, swollen, itchy, hot to touch for 5-6 days.
More fatigue than usual at noon through 1:30 on two  consecutive days.  I felt I had to nap.  One nap on 4/23 was 1/2  hour but the other on 4/24 was 1 1/2 hours.  That is far more fatigue than I ever experience at that time of day.