chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joint pain on my left hand, left elbow, and left knee.  Started occurring after the first shot. I have not sought any treatment at this time. The joint pain on my left hand (specifically the "pointer" and "middle" finger) still persists.  The pain occurs when I make a fist.  When the fingers are extended there is still a slight pain. The pain on my left elbow and left knee has subsided, but the pain is still there though not as severe.   The pain stills persists over three weeks since I took the first shot and after I took the second shot.
Information has been received from a healthcare worker concerning a number of employees at their office (office unspecified) who was vaccinated with the series of HepB. (Manufacturer unknown, route and Lot# not reported). After the patients completed the vaccine series and they had low titers. At the time of the report, outcome was unknown. This is an amended report. The lower level term and preferred term of AE of "low titers" was changed to "hepatitis B surface antibody negative". No further information is available.
The first two days only injection site pain. On 03/17/21 I noticed splotchy redness at the injection site and it is a bit swollen and warm to the touch.  I completed my v-safe check ins via my phone with no other symptoms because this is the first time it has occurred since I received the shot.
woke up at 0400 on 1/7 with headache, low grade temp (99.8), chills, and as day went on I became nausea, tired and my joints in my hips ached along with my back and neck. I got home from work took 2 Tylenol and slept from 7pm till 4am on 1/8.  on 1/8 I woke feeling back to normal minus some arm tenderness and a small red circle at injection site.
A few days after injection, she developed a severe rash on chest and armpits and then spread to creases of arms and legs. Painful and itchy rash- she saw her primary care doctor first- oral steroids did not touch the rash. Then the doctor referred her to the dermatologist, at which point they did a biopsy and it showed that she is still having a severe allergic reaction. They prescribed and administered a steroid injection and topical tacrolimus.
Patient began having discoloration  on right upper arm that was purple/red in color, itchiness, pain , dizziness. Benadryl given to patient in office, patient transported to hospital to be evaluated.
Moderna, Dose: 3 / Pfizer, Dose: 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Activity induced asthma" (unspecified if ongoing), notes: Activity induced asthma; "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 26Jun2023, stop date: 29Jun2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Dose: 3 / Pfizer, Dose: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2023) Positive, notes: Positive  antigen tests through 04Jul; (05Jul2023) Negative, notes: Antigen test negative 05Jul; (06Jul2023) Positive, notes: Positive test again 06Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
9x13 cm area of erythema, induration, swelling & inc warmth around site of inject-local inflammatory response (no allergic) rt arm;
lost the ability to see well.; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (lost the ability to see well.), DIZZINESS (dizziness) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VISUAL IMPAIRMENT (lost the ability to see well.), DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, VISUAL IMPAIRMENT (lost the ability to see well.) had not resolved and DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported. Action taken with mRNA-1273 in response to the events was not Applicable
Pt experienced swelling and pain. Pt refused to walk, had moderate swelling of thigh and knee, tenderness over out thigh where injections given.
arm swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swelling around the injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm swelling around the injection site). At the time of the report, VACCINATION SITE SWELLING (arm swelling around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered once on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced fever, headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and tiredness was not reported. This report was non-serious.
Nausea; DIARRHEA; METALIC TASTE; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 11Mar2021 at 16:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received an unspecified booster dose within 4 weeks on 04Feb2021 prior to the COVID vaccine. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date and unknown if ongoing. On 12Mar2021 at 06:00, the patient experienced nausea, diarrhea and metallic taste. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result if the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nausea, diarrhea and metallic taste were resolved on 12Mar2021.   No follow-up attempts are needed. No further information is expected.
Initial report received from a healthcare professional on 03 June 2013. A 58-year-old female patient had received an intramuscular second dose of MENACTRA vaccine (lot number- U4588AD) in right deltoid on 29 May 2013 at 11.00 AM. On 29 May 2013 at 01.00 PM, the patient had developed pain and edema to right deltoid and presented fever the following day. The patient also had right shoulder joint pain now. The patient had no concomitant medications, illness and no known allergy at the time of vaccination, and the patient's past medical history includes asthma. The patient had not experienced any adverse event following prior vaccination. The corrective treatments were not reported and no laboratory investigations were done. The patient's outcome was not recovered. Documents held by sender: none.
pt. came in on 09/18/2008 c/o redness,swelling,itching and hot to touch @ injection site 2 days after receiving varicella vaccine.Dr. noted are to be 4-5 cm in diameter with hard center and no fluctuant noted. pt. put on benedryl/zyrtec and advised on cool compresses and motrin prn. pt to return to office if no improvement.
An 18 month old patient received Quadracel, no AE; An 18 month old patient received Quadracel in the left thigh, no AE; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves an 18 months old female patient who received 0.5ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C588AA, expiry date: 26-Nov-2021, form: Injection) once via unknown route in the left thigh for prophylactic vaccination on 08-Sep-2020 (product administered to patient of inappropriate age and product administered at inappropriate site).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was a case of an actual medication error due to product administered to patient of inappropriate age and vaccine administered at inappropriate site (latency same day).  At the time of report, no adverse event was reported.  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 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.
Pain and swelling about 60 mins after vaccine admin, color and induration, and vomiting about 5 hrs after vaccine admin.
Beginning four hours after injection and continuing, on and off in waves, for 3 more days (until 01/22/2021):  chills (with no fever), significant body aches, fatigue, mild nausea, mild headache
Eye inflammation; Contact with individuals who tested positive for COVID with Humira; Contact with individuals who tested positive for COVID with Humira; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4237205-00 (AbbVie).  A 25 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single, intramuscular, administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as cf for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Contact with individuals who tested positive for COVID with Humira"; EYE INFLAMMATION (non-serious), outcome "unknown", described as "Eye inflammation". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2022) positive. The action taken for adalimumab was unknown.  Clinical information: Solicited report by a consumer of an adult female with events of non-serious Eye inflammation and contact with individuals who tested positive for covid with HUMIRA (ADALIMUMAB). On unknown dates, the patient experienced eye inflammation and contact with individuals who tested positive for covid. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 23Mar2021, the patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 13Apr2021, the patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Eye inflammation and contact with individuals who tested positive for covid with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test, vaccination failure and Eye inflammation
Fever up to 102.4 degrees Fahrenheit. Was very tired and wouldn't eat. Drank very little. Started to stare off, then her eyes rolled back in her head. She arched her back and her legs and arms would shake off and on. This lasted for 15 minutes, after 15 minutes she very slowly became alert and responsive. Taken to ER. She was given Motrin and Tylenol for fever. Did blood work and she was given Cephalexin for 7 days for local reaction/infection in right leg where she had one shot.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 21-JUL-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
The vaccine hit my nerves system/damage is already been done/effect my nerves system; A rash on my body/put a rash on on my body; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (The vaccine hit my nerves system/damage is already been done/effect my nerves system) and RASH (A rash on my body/put a rash on on my body) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVE INJURY (The vaccine hit my nerves system/damage is already been done/effect my nerves system) and RASH (A rash on my body/put a rash on on my body). At the time of the report, NERVE INJURY (The vaccine hit my nerves system/damage is already been done/effect my nerves system) and RASH (A rash on my body/put a rash on on my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Developed chronic urticaria with the same symptoms after taking the first Moderna booster. Intense itching at random parts of the body all day and night. Itching was severe enough to prevent normal daily functions and sleep. Hives and itching would crop up at multiple parts of the entire body and last for approximately 30 minutes to 2 hours at each spot. Also accompanied by dry skin.
Received MCV4 + MenB. About 1-2 hours later had "burning under his skin", difficulty swallowing, + Hyperventilating. Went to Urgent Care - gave Benadryl 25 mg - seemed better but about 1 hr later became pale + BP dropped - ER BP in ER 86/56. Given IV fluids, Pepcid, decadron + IV Benadryl A few hours later he felt better and was discharged home
Right side of her neck was swollen, tender, and painful to touch; Right side of her neck was swollen, tender, and painful to touch; Right side of her neck was swollen, tender, and painful to touch; Hurts upon movement; Tenderness of the site; A spontaneous report was received from a nurse concerning a 38-years-old female patient who experienced right side of her neck was swollen, tender and painful to touch, hurts upon movement and tenderness of the site.   The patient's medical history included diabetes. Concomitant medications included unspecified medications for diabetes.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20A) in the left arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient had usual tenderness of the site. On 25 Dec 2020, the patient experienced the right side of her neck was swollen, tender and painful to touch. It hurts upon movement. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events right side of her neck was swollen, tender and painful to touch, hurts upon movement and tenderness of the was not reported. The outcome of the event hurts upon movement was not recovered (still hurts).; Reporter's Comments: This case concerns a 38-year-old female who experienced NS unexpected events of pain, neck pain, neck swelling, musculoskeletal discomfort and NS expected event of injection site pain.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Pain event ongoing, other outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
paresthesia and neuropathic pain in the arm (left) that vaccination was delivered, temporally related to vaccine administration. pain radiated down his entire arm and was debilitating.
A couple of days later after the vaccine, I started with a runny nose, sneezing, nausea, itchy throat, painful cough, chills. No fever. On 01/01 I woke up and had no voice. I went straight to the UC and they diagnosed me with upper respiratory infection, I was treated with azithromycin and something else for nausea. About  days later I was totally fine.
This is a spontaneous report from a contactable consumer. A 07-year-old female non Pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via Intramuscular Left arm on 04Nov2021 03:00 PM at age of 07-year-old (Batch/Lot Number: FK5127) as DOSE 1, SINGLE (Lot number: FK5127) for covid-19 immunisation and influenza vaccine (FLU VACCINE VII) on 13Oct2021 Left arm as DOSE 1, SINGLE for immunisation. No covid prior vaccination. No Known allergies. She experienced very sore arm at injection site on 05Nov2021 with outcome recovering. No covid tested post vaccination. No treatments received for Very sore arm at injection site.  Follow-up attempts are completed. No further information is expected.
Itchy red spots arms, face buttocks crease, chest, light.  But itchy. Not too bad. Not as bad as skin fungus I had last year. This, just annoying.  Panicked, at first, thought horrible fungus was back.
Adverse effects started on 03/13/2021. Not able to sleep more than an hour or two at a time for eleven consecutive days. Could not lay down to sleep. When lying down I would stop breathing. I would sit up to catch breath. I would sleep 3 to 4 hours a night over an 8 to 9 hour period of time. Called the Physician Assistant on 03/25/2021 and he sent orders to have blood drawn at hospital, where we were vacationing. Also had x rays taken. On 03/26/2021 he ordered that blood be tested again because of enlarged heart. On the way back home that day, I received a call from my Physicians office telling me to go to the nearest emergency room as tests showed that my heart was shutting down and that I would go into cardiac arrest if not treated. Treatment: I checked into hospital upon returning to town on the evening of March 26th. After some testing there, my triponin levels were 10x the normal range at 4.5. The staff started me on water pills and I lost 12 lbs. within 24 hours, 16 within 48 hours. They did a heart cath. on 03-29-2021 and put stints in for arteries that now had 80 and 70 percent blockages. My Ejection Fraction at that time was 25%. After observation, I was sent home late in the day of 3-30-2021. I am now taking 10 pills a day for the heart and bladder. Brilinta 90 mg x 2, Entresto 25 mg x 2, Carvedilol 3,125 x 2, Atorvastin 20 mg, Furosemide 20 mg, Potasium 20 meq, and Aspirin 81 mg. My Ejection Fraction was last checked in July and I was at 45%.
Patient received the 2nd dose of the Pfizer vaccine on 5/7/2021 in the afternoon. Shortly after she developed low grade fever. Later that evening she developed diarrhea, HA, congestion and some chest pain/tightness. She presented to ER Early Saturday, was given dex and injections for HA. Was better shortly after, monitored the rest of the day and released to home. using flovent and proair only as needed for some lingering wheezing.
I began having shortness of breath-mild and used albuterol MDI and Flovent MDI at 1430. General malaise with low grade fever began about 1530. At 1830 I had rigors that lasted for 3 hours and I began having chest pain that I interpreted as cardiac. My heart rate was rapid and difficult to count (about 200 bpm). I asked my husband to transport me to the hospital at about 2130 at which time I began projectile vomiting. I began sweating and my rigors stopped. My heart rate returned to normal and I went to bed and slept for about 11 hours. I had mild flu-like discomfort for about 24 hours after that. I also noticed my urine to be foul smelling and dark but am not sure if that is related to the injection itself or not.
PATIENT ARRIVED FOR HPV #2, STATED LAST MENSTRUAL PERIOD WAS LAST DAY OF MAY 2009 AND SHE WAS NOT PREGNANT.  COPY OF CONSENT MAILED.  MOTHER INFORM TODAY 7/17/09 AT 11:15 AM PATIENT WAS PREGNANT.  MOTHER REQUEST TO BE PLACE IN THE LIST OF HPV BY MERCK.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 07-AUG-2014, the patient inadvertently received an expired dose of PNEUMOVAX23 (dose, dose number and route were not reported) batch number H022064, lot number 0291AEm expiration date 25-JAN-2014. No adverse effect was reported. Concomitant medications were not specified. Additional information has been requested.
1 WEEK AFTER I WAS GIVEN THE VACCINE I DEVELOPED A 4X4 CM  RAISED, PAINFUL, WARM, AND  RED AREA WHERE THE VACCINE WAS GIVEN.
A week after the second does of Pfizer COVID-19 vaccine, I start developing a very itchy rash on various parts of my body (forearms, ankles, torso, etc.).
Redness/swelling of arm 24 hours after shot.  Fatigue/tiredness next morning (12 hours after).  Flu-like symptoms (nausea headache) and body aches next afternoon (24 hours after).