chrisvoncsefalvay/vaers-outcomes huggingface dataset:
passed out. Shaking like he has Parkinson's disease, fever, chills, throwing up. Rash on arm it was injected.
I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.
On 05/14/2002, the pt developed low grade fever for two days. macular-papular erythematous rash on face, extremities, trunk and scalp also developed.
Loss of taste, smell, appetite.  Fever, chills, fatigue.  Symptoms lasted a total of 2 weeks, but most severe for 4 days.  During this time, I had a negative PCR and rapid COVID test 1 week apart from each other.
Patient was scheduled to receive 2nd dose Moderna COVID vaccine and was inadvertently given Pfizer by mistake.  Incident was discovered shortly after patient left the mass vaccination site and after an uneventful observation period.  Patient was contacted by site manager immediately and was informed of Agency guidance regarding administration error.  Incident report was submitted immediately to health and hospital systems.
Swelling, raised area 6x5 hot to the touch, "felt sick" fever.
2.5" X 3" REDDENED AREA ON RIGHT DELTOID, SORE TO TOUCH
Had serious hive, rash, swelling of tongue, lips, throat, beginning on 3/1/21 early am. Ended up in hospital on 3/1/21 as throat closed up, needed medical attention. Was hospitalized over night and then had another severe attach where breathing was obstructed and was taken to hospital by squad on 03/04/21 was treated and given an EpiPen.was on Prednisone, Benadryl,  Xyzal etc.
This is a cluster of two patients who had received ADACEL, lot number C4008BA and experienced cellulitis. One patient is captured in this case and the other was captured in case number 2012-03108. A 38-year-old female patient had received an intramuscular injection in the right deltoid of ADACEL, sanofi pasteur Ltd., lot number C4008BA on 08 March 2012 and an unspecified amount of time later in March 2012 developed cellulitis at the injection site with swelling, redness and pain. The patient was evaluated in the emergency room (ER). No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Information has been received from a registered pharmacist concerning a over 60 year old male with atrial fibrillation and a history of chickenpox and shingles and not known drugs allergies, who on 20-DEC-2008 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Oka/Merck).  There was no concomitant medication.  After receiving the ZOSTAVAX (Oka/Merck) the patient had an allergic reaction.  Patient developed itchy red welts on the back of his arm and neck with lip swelling several hours after vaccination on 20-DEC-2008.  Initially he was treated with BENADRYL but lack of response caused the physician to give the patient MEDROL, ZYRTEC and ZANTAC.  Patient improved after taking MEDROL but still had an intermittent rash that had not resolved and changes location.  It had been on his buttocks and currently he had 3 small mildly itchy welts on his back.  Patient said the current rash was not "weepy and did not seem like his shingles rashes pre ZOSTAVAX (Oka/Merck).  The patient had a tuberculin skin test 30 days prior to received the dose of ZOSTAVAX (Oka/Merck).  The patient sought medical attention through an office visit.  At the time of this report the patient had not recovered.  Additional information has been requested.
pain in unknown arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 86-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208), on 07Apr2021 as dose 2, single (Lot number: EW0153) and on 30Oct2021 as dose 3 (booster), single (Lot number: SH8028) at the age of 86 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021, outcome "recovered", described as "pain in unknown arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: first dose: pain in the unknown arm, second dose: pain in unknown arm and first booster: pain in unknown arm. Is report related to a study or programme was No. No Other Conditions, No Investigations, No Other Products. Patient Stated that the others were last Oct and Apr and she does not recall which arm. Stated that the next day that she got a little bit of pain in the arm but no bad effects. Event details Stated that the pain only lasted one day with it. Later clarified that the pain in the arm happened on the day of the shots. Treatment was None.   Follow-up attempts are completed. No further information is expected
I experienced and continue to have buzzing and humming in the ears within 2 weeks of 1st dose of Pfizer vaccine. Buzzing is annoying and can be louder for short periods of time, otherwise is noticeable and constant. Never had this buzzing until after receiving the Pfizer vaccine 1st dose on 04/28/21. Had 2nd dose 05/19/21- exactly 3 weeks following first dose as specified and buzzing sound continues.  Both doses received at a local Walgreens.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of properly stored M-M-R II therapy type rHA, lot # N013868, expiration date 04-MAY-2019 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with improperly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse events were reported. The sterile diluent had been improperly stored at a temperature of -1 degree Celsius or colder (-10 degrees Celsius) for 6 days, through unknown number of cycles. There had been no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA003734:
Patient verbalizes "lot of pain at the injection site, moderate swelling of the left arm, erythema (5.5 (l) x 2.5 (w)), joint pain mostly in her fingers, left hand stiffness, knots beneath the skin of her left arm.
Site reaction, seemed almost like a bug bite, itchy and swollen area about 2 inches in diameter, went away gradually over a couple days.
Patient received (IM) Flu injection in left deltoid muscle on 10-1-08, Patient reports that since that day she has difficulty lifting her arm to do normal AOL'S, such as putting her hair up. Patient has seen her pcp who recommended, per patient, physical therapy. symptoms persist to 10-21-08.
Patient's arm was tingling, chest began to tighten. She began to black-out. Gave two 0.3 EPI pen shots. The adverse events began 3-4 minutes after the shot.
nausea; vomiting; diarrhea; large GI bleed; PEA (Pulseless electrical activity); This is a spontaneous report from a contactable physician. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Apr2021 (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included coronary artery disease (CAD), cardiomyopathy, hyperlipidemia, and hypertension. The patient had no covid prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN EC); atorvastatin (LIPITOR [ATORVASTATIN]); carvedilol (COREG); fluocinonide (LIDEX-E); sacubitril valsartan sodium hydrate (ENTRESTO); and warfarin sodium (COUMADIN). The patient had nausea, vomiting and diarrhea since getting the vaccine which progressed to a large GI bleed, had PEA (Pulseless electrical activity), was resuscitated and was currently in the ICU intubated. The events occurred on 14Apr2021 and all events resulted in hospitalization, considered as life threatening illness (immediate risk of death from the event). The patient received treatment for the events which included transfusions, resuscitation, and current intubation. The patient underwent lab test which included Roche cobas SARS-CoV-2 assay: negative on 19Apr2021. Outcome of the events was not recovered.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded considering the temporal association. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient came to see PA on 12/10/20 for left arm pain- described as a dull soreness with sharp pain  when she moves her arm. Tried to take Ibuprofen for the pain without relief along with heat and ice. Feels like pain has spread to her left upper back.  Patient was rx Mobic for the pain .  Came back to office on 4/7/21- and she had been doing physical therapy. Reports that an MRI showed inflammes bursa, torn biceps tendon/rotator cuff tendon. She was told that the injection might have been given a little high. She is seeing hand and shoulder specialist.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 4-year-old subject of unspecified gender who was vaccinated with influenza virus vaccine (unspecified), manufacturer unspecified. The subject did not receive any concomitant vaccine. No egg allergy was reported in this patient. On an unspecified date the subject received unspecified dose of Influenza vaccine (unspecified) (unknown). Less than one day after vaccination with Influenza vaccine (unspecified), the subject experienced anaphylaxis with respiration problem (chest tightness or wheezing) and skin reactions. The patient was either hospitalised or treated at the emergency ward and further referred for allergy testing. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case is linked to cases B0695522A and B0695523A. It was not possible to attribute some of the information provided in the article to one or the other patient. Therefore this report contains only the generic information. All other details can be read in the article.
myopericarditis causing pleuritic chest pain for several hours, starting 8/22. patient admitted and treated for pericarditis, symptoms improved.  cardiac MRI with signs of myocarditis as well.   Note that patient also received inactivated poliovirus vaccine 8/19/22 at Clinic - R deltoid IM route, lot V1A024
She got her vaccine, she didn't notice anything at first.  Her foot kept hurting, thought it was her tennis shoes and fell in a Department Store and then had to use a walker to get around, and then it started to get worse.  She was bouncing up against the cabinets and did not realize it was a stroke, then her daughter and son-in-law took her to the hospital and she was diagnosed with a stroke on 9/4/2021 and stayed there until 9/7/21.  Now she is going to therapy to build up her strength.  She can walk on some days and then on some days she cannot walk.    This is her third session of 10 days for an hour, and now will have to do 20 sessions for 1/2  hour.  She still needs assistance on same days.  She feels that it is helping and does not know how long it's going to be, and her voice due to the stroke or after effects from the stroke she looses her voice and then it will come back.
headache; an inflamed right side of the face /it is swollen enough to be noticeable; Feeling Numb /I felt like my face was numb in a weird way; one part of her face seemed a little more inflamed; my face got in pain on the right side /it kind of feel like I had an anesthesia and it was wearing off; This is a spontaneous report from a contactable pharmacist (patient). A female patient of (Age:32, unit not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date on Jan2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, an inflamed right side of the face /it is swollen enough to be noticeable, feeling numb /i felt like my face was numb in a weird way, one part of her face seemed a little more inflamed, my face got in pain on the right side /it kind of feel like i had an anesthesia and it was wearing off on an unspecified date on 2021. The case was reported as non serious. Reported as, patient received the first dose of the Covid vaccine and states that she experienced the typical side effects of a headache, but also is experiencing "an inflamed right side of the face." She states that it was swollen enough to be noticeable and it feels as if she has received anesthesia and it was wearing off. She was scheduled to receive her second dose of the vaccine a day after. She was calling because she got the COVID vaccine a month ago on friday. She states that after she got it, a few hours later one, part of her face seemed a little more inflamed, and it felt like anesthesia was wearing off on one side. The feeling lasted a few days, and she felt it go down little by little. It took a few days to go away but I felt like my face was numb in a weird way. Not completely numb but just feel like coming off of anesthesia". Outcome of all the events were unknown.  Follow-up attempts completed. No further information expected.
Pain in left side of neck, shoulder and arm soreness, with movement in left arm. Left arm soreness at site of injection 2-3 days. After injection and then about 2 weeks ago more symptoms. Temp 99.9 slightly less grip on left than right when asked to squeeze had swollen arm noted on deltoid area. No nodules on palpitation on neck. To see physician for consult. MRI ordered.
Pt. experienced redness, hotness and pain at injection site. Swelling was also reported. No fever.
Patient was given less than a quarter of the dose; A spontaneous report was received from a pharmacist concerning a unknown patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient was given less than a quarter of the dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly prophylaxis of COVID-19 infection.  Reporter who was a pharmacist stated patient was given less than a quarter of the dose. Pharmacist was wondering if another dose should be given. This was the patient's second dose of the series. No further information was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273 (lot # unknown) with no associated AEs.
Pfizer-BioNTech COVID-19 Vaccine EUA  Drive Thru Vaccination clinic - Within 10 mins of getting the vaccine, patient reports numbness to her central lips and tip of tongue. Diaphoresis and chest discomfort. Vitals were 157/78, 99, 16, 98% RA. Symptoms slowly started to resolve. 911 called and pt sent to ED. Pt takes Allegra (fexofenadine) daily. Symptoms resolved at 1:15pm. Troponins were normal - low concern for ACS. Diphenhydramine 25mg po on 1121 and prednisone 40mg at 1214. Discharge prescription for  prednisone 40mg daily x 3 days.
C/O head ache, dizzy, abd pain, given juice, crackers, water, monitored, parent called to pick up related to irregular HR and increased temp. Father came and picked up child, stated would call pediatrician.
Pt reported she experienced a reaction from vaccine. A welt the size of her hand formed at the injection site. Pt was vacationing with a physician and area was assessed. Pt took ibuprofen and applied ice packs. Welt has resolved.
slept much of the afternoon; Extremely tired; had chills through the night; Did not feel well; Rash under the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well), SOMNOLENCE (slept much of the afternoon), VACCINATION SITE RASH (Rash under the injection site), FATIGUE (Extremely tired) and CHILLS (had chills through the night) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 016M204) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy and Allergy to plants (Allergy to poison oak).   On 11-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash under the injection site). On 12-Mar-2021, the patient experienced MALAISE (Did not feel well), FATIGUE (Extremely tired) and CHILLS (had chills through the night). On 13-Mar-2021, the patient experienced SOMNOLENCE (slept much of the afternoon). On 14-Mar-2021, MALAISE (Did not feel well), SOMNOLENCE (slept much of the afternoon), VACCINATION SITE RASH (Rash under the injection site), FATIGUE (Extremely tired) and CHILLS (had chills through the night) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The action taken with mRNA with the events was considered as not applicable.   This case was linked to MOD-2021-018361, MOD-2021-018361 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up was received on 11-AUG-2021 and Relevant history added. Site of vaccine administration updated for dose 2. Onset latency updated.
The night of the vaccine he lost use of his arm. Arm became very painful warm and swollen. On Sunday (48 hours) after receiving the shot the patient came to the pharmacy. His entire upper arm (shoulder and bicep) were swollen, red, erythematous, and painful.
received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
On Friday 8-17-12 woke up stiff with joint pain in all joints, including neck and fingers.  Had sharp pains in joints with movement.  Joint pain continued for a week.  Had trouble sleeping due to pain and stiffness in joints.  Monday, 8-20-12 missed work due to joint pain.  Throat felt sore and swollen.  Neck was also painful, unable to turn head.  Unable to raise both arms above shoulder level.  Took ibuprofen for pain but reports it did not help.  Denies fever or other symptoms.  On 8-24-12 felt a little better but still not back to normal.
Information has been received from a physician concerning a six year old female patient who was vaccianted with varicella virus vaccine live (lot 622752/0183B). The physician reported that last week. On 5/3/2005 the patient came into the office with a very mild breakthrough case of chicken pox. No treatment was given. There was no other information regarding the adverse experience. There was no product quality complaint reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006. Information has beenreceived from a physician concerning a six-year-old female patient who on 03-feb-1998 was vaccinated with VARIVAX (Merck) (Lot # 622752/0183E). There were no concomitant medication.The physician reported that last week, on 03-MAY-2005 the patient came into the office with a very mild breakthrough case of chicken pox. No treatment was given. There was no other information regarding hte adverse experience. There was no product quality complaint reported. Follow up information received from the physician reported the patient did not undergo any lab/diagnostic tests. The only reported adverse reaction were the vericella lesions, a few lesions wiht no fever or pruitis. Additional information is not expected.
PATIENT STATED SOFTBALL SIZE LUMP DEVELOPED IN ARMPIT AREA, VERY SENSITIVE TO THE TOUCH. HE WENT TO URGENT CARE AND THEY THOUGHT HE HAD AN ALLERGIC REACTION AND PRESCRIBED ANTIBIOTICS.
The patient is an 8-year-old female who received the COVID-19 Pfizer vaccine on 6/30/2021. At this time, there are no reported symptoms by the patient or guardian.
Patient was given wrong wrong dose of Hep B vaccine, she received 0.5 ml but should have received 1 ml of this vaccine.
I felt a pressure at the posterior  base of my neck moving up and to the right of my head. I was not losing conscientiousness. However, I felt as if I was being pulled down to the ground. I grabbed the hand rail next to me and pulled myself up before falling to the floor. After the event, I became light headed and very fatigued. I sat down from an hour and the side effects went away. I did not seek medical attention. I work in a hospital and emergency help was only a code button away should I have experienced a medical emergency.
Post vax, the patient developed erythema, induration, warmth and tenderness in an area 6x8cm at the injection site.