chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed new onset AFIB within days after administering the PFE vaccine; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Patient developed new onset AFIB within days after administering the PFE vaccine".  Clinical course: Description of Event reported as Patient developed new onset AFIB within days after administering the PFE vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Atrial Fibrillation and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
PT CALLED TO REPORT SOB BUT SAID SHE ALSO HAS PANIC DISORDER AND HAD FREQUENT SOB BEFORE HER MODERNA SHOT BUT FEELS IT HAS GOTTEN A BIT WORSE SINCE THE SHOT. SHE SAID SHE HAS SEEN DR SINCE HER SHOT AND DR ADVISED PT TO GET 2ND DOSE AND TO SEE HER PSYCH DR REGARDING THE SOB. SHE ALSO REPORTED SORENESS IN THE LEFT ARM FOR 10 DAYS. PT WAS COUNSELED REGARDING POSSIBLE SIDE EFFECTS OF MODERNA AND TOLD TO SEEK IMMEDIATE MEDICAL CARE IF SHE IS EXPERIENCING TROUBLE BREATHING. SHE WAS TALKING NORMALLY AND DISPLAYED NO SOB WHILE ON THE PHONE. SHE ALSO SAID THE SOB "COMES AND GOES" BUT HER CLONAZEPAM AND MIRTAZEPINE RESOLVE IT. SHE DID NOT HAVE ANY SWELLING OF THE FACE OR TONGUE, RASH OR OTHER CONCERNS.
Severe fever, chills, sweating, body aches, dehydration, joint and muscle aches, fatigue, weakness, lightheadedness, dizziness, headache. No effect from meloxicam 15 mg taken once daily or additional advil 400 mg taken every 4 hours.
pt recv vax 28JUN96 & approx DEC97 pt devel moderate case varicella;
Patient presented to hospital with history of fever, chills and body aches. Her symptoms started 5 days ago, she tested positive for COVID two days after developing the symptoms. One day after testing postive, she gradually developed bilateral lower extremity weakness and loss of sensation.  Conservative treatment.
MUSCLE PAIN(EVERYWHERE), FEVER (39.9 C), FATIGUE, HEADACHE TIMES 2 DAYS; IBUPHROFEN 800MG X 2, TYLENOL 500MG, X 2, WATER;
3 wheals,  they are pink and itchy; wheal to the side of the injection site; like a mosquito bite above the injection site; lots of pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (lots of pain), PRURITUS (3 wheals, they are pink and itchy), INJECTION SITE URTICARIA (wheal to the side of the injection site) and INJECTION SITE ERYTHEMA (like a mosquito bite above the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.    Concurrent medical conditions included Hashimoto's disease.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (unknown route) at an unspecified dose. On 12-Jan-2021, the patient experienced PAIN (lots of pain). On 18-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (like a mosquito bite above the injection site). On 19-Jan-2021, the patient experienced INJECTION SITE URTICARIA (wheal to the side of the injection site). On 20-Jan-2021, the patient experienced PRURITUS (3 wheals,  they are pink and itchy). On 13-Jan-2021, PAIN (lots of pain) outcome was unknown. At the time of the report, PRURITUS (3 wheals,  they are pink and itchy), INJECTION SITE URTICARIA (wheal to the side of the injection site) and INJECTION SITE ERYTHEMA (like a mosquito bite above the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
PATIENT REPORTED FEELING THE VACCINE 'TRAVEL' THROUGHOUT THE WHOLE RIGHT SIDE OF HER BODY IMMEDIATELY AFTER THE VACCINE WAS GIVE. APPROXIMATLEY 5 MINUTES AFTER THE VACCINE, THE PATIENT SHOWED SIGNS OF REDNESS AND PERSPIRATION. AT THE SAME TIME, THE PATIENT REPORTED FEELING NAUSEA AND DIZZINESS. EMS WAS CALLED AT THIS TIME. EMS CLEARED THE PATIENT, NO MEDICATION WAS ADMINISTERED TO PATIENT.
A slow decline into autism. Not fully noticeable until about 2 years old. Started with gross motor and oral motor problems and now full blown immune problems.
loss of taste and texture; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (medically significant), outcome "unknown", described as "loss of taste and texture".  Clinical Information: It was reported that, the patient received the dose of covid vaccine and experienced loss of taste and texture in 9 months.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. Since an unspecified date in 2015, an unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX, subcutaneously (lot# reported as K015994, dose, strength and frequency were not provided) which underwent supported temperature excursion. Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Slept for 13 hours; Arm hurt after the booster; 7 weeks since booster dose and lymph node was tender; Lymph node was still swollen; She was tired; Lymph node was size of golf ball in the underarm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for 13 hours), PAIN IN EXTREMITY (Arm hurt after the booster), LYMPH NODE PAIN (7 weeks since booster dose and lymph node was tender), LYMPHADENOPATHY (Lymph node was still swollen) and FATIGUE (She was tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept for 13 hours), PAIN IN EXTREMITY (Arm hurt after the booster), LYMPH NODE PAIN (7 weeks since booster dose and lymph node was tender), LYMPHADENOPATHY (Lymph node was still swollen), FATIGUE (She was tired) and LYMPHADENOPATHY (Lymph node was size of golf ball in the underarm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept for 13 hours), PAIN IN EXTREMITY (Arm hurt after the booster), FATIGUE (She was tired) and LYMPHADENOPATHY (Lymph node was size of golf ball in the underarm) outcome was unknown and LYMPH NODE PAIN (7 weeks since booster dose and lymph node was tender) and LYMPHADENOPATHY (Lymph node was still swollen) had not resolved.            No concomitant medication were reported. It was reported that the patient visited healthcare professional about 2 weeks ago and encouraged patient to get mammogram.   Reporter did not allow further contact
Administered Novartis H1N1 (4 yrs & older) vaccine 0.25ml IM right deltoid. Should have given Sanofi Pasteur H1N1 (6mo & older) 0.25ml IM. No signs or symptoms of distress noted.
patient appeared to passout and possibly have a seizure . We called his name and his eyes rolled in his  head. he awoke disoriented. He threw up a couple of times . ems was called and patient was monitored in store over an hour as he refused medical treatment. Patient was sweaty with low bp pale 108/78 patient later claimed to have ptsd with vaccinations since age 2
30 year old patient comes to the COVID-19 vaccination area in the Hospital to administer his second dose of PFIZER vaccine. When obtaining information patient informs having an allergic reaction to the first dose of COVID vaccine PFIZER; he refers "after getting the first dose vaccine of PFIZER I began to present the next day with a rash on my arms and back with itching and redness in my skin, this happened to me before with the influenza vaccine". It is recommended to visit his primary doctor before administering his second dose. He wants it and authorizes the administration of the second dose and signs a consent. He is advised in case of presenting a rash, redness in the area and itching again to visit the nearest emergency room. He understands and we administered the second dose with aseptic measures. Patient did not have an adverse reaction during the 15 minute wait and returns home.
24 hours later dizziness, fatigue, headache bleeding nose, sinuses swollen and plugged, bloody mucus, bloody gums/tongue the next morning(heavy).  Sinuses went down, bloody nose stopped in 3 hrs, and teeth stopped bleeding a few hours later.  No more bleeding now, but still have a little headache.
got vac at 12:30 pm 2/20/21, started feeling flue like approx 5:00 pm 2/20/21,sore arm running up my neck and shoulders, body aches w/ no thermometer but felt like I had a fever with chills, fatigue, wheezing, head ache that was not constant but hit spuratic from temples to back of head, thought I was feeling better 2/21/21 but symptoms returned and are continuing to current 2/23/21. My current symptoms; I woke up in the night w/loud wheezing continuing through the night and current worse at times when I'm up, some shortness of breath, some cough, some heavy chest feeling, I feel like I have a fever w/chills, fatigue, spuratic headache, cough, some blurred vision w/watery eyes and some crusting. I just feel flue like and want to rest. I have a doctor appt tomorrow 2/24/21 to get checked out. Just wanted to let you know my symptoms. I am healthy and do not take meds of any kind.
Rash red itchy rash on chest between and underneath breasts and on lower abdomen, tickle/irritation in back of throat starting second morning after receiving vaccine
I had my menstrual cycle a few days before the vaccination.  I am regular every month.  After the vaccine, I had the menstrual cycle again and a few weeks later again, and then nothing for several months, and then drops of red blood but no complete cycle.  I reported this to my obgyn, who confirmed that she knows of many cases that the vaccine does cause interferance with a women's reproductive system.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On 10-JUN-2014, an unspecified number of patients were administered PROQUAD (lot#, expiration date, dose, route and indication not reported) that were exposed to improperly stored temperatures outside the product insert. No adverse effects reported. This is one of several reports received from the same source. Follow up has been received. A phone call was placed to physician. The phone call was transferred to the Medical Assistant. The medical assistant stated that she had no patient identifiers or specific dates of vaccination because the Merck National Service Center offered information that her vaccines were within temperature stability data and she did not need to keep that patient data for any re-vaccinations. The medical assistant had the lot numbers available (no expiration dates). The Lot Numbers - J015595 and J011330 were provided for PROQUAD. The lot # J011330 (expiry date: 13-MAR-2105) was validated for PROQUAD. This case is linked to case # 1406USA006736 and 1406USA006998 (same reporter link). Additional information has been requested.
Sore left arm after 2 days. Continued after a month. After a MD appointment a MD diagnosed as SIRVA.
Pt stated she had dizziness, nausea, weakness on 1-28-02. Called pt back 1-29-02, pt stated she felt better. Pt was advised to seek medical attention if she needed too.
Pt recv vax on 8/17/98; on 8/19 pt exp rash; on 8/20 pt exp fever(101); 8/21 pt saw M.D.; pt fussy, purple lips,pale face, blotches on face&trunk;pt saw E.R., edema over body; tx=   Hydroxyzine.8/26 pt imp
Pt felt pain across back of neck/shoulder about 2-3 hours after vaccine. Used inhaler and felt lousy. Next AM called Rph & suggested rest & APAP. 36 hours after vaccine pt felt fine.
Sharp Headache began that night 03/18/2021. The next day my body was achey and I felt sick the next 3 days. To be sure, I scheduled a covid test just to be sure. I am still having a hard time breathing and feel sick. Mucus and raspy throat. Kind of like something is stuck in my throat.  Today is 03/25/2021 and I still feel raspy with Mucus and cough.
On 4-1 2021 My husband started with lightheadedness and unsteady on feet went to AAGH ER in Annapolis MD ruled out a stroke and diagnosed with ataxia and given antivert.  Two days later 4-3-2021 he developed right side of face drooping .   MRI was re-done with contrast and without and no stroke.   Diagnosed with possible Bell Palsy started on prednisone and antiviral drug.   Is now 4-14-2021 he feels better but right side of face still drooping.   But he feels better.   Only reporting as saw Bell Palsy was seen in trials for Moderna.
The patient is a healthy 21 yo male with dx myocarditis with symptom onset 12 OCT 2019 after receipt of HPV9 (R017624) on 01 OCT 2019 & IIV Fluarix (SKB 454G3) 19 SEPT 2019. Symptom onset to vaccine receipt would be 23 after IIV & day 11 after HPV. He was seen in ER for severe SOB, nonproductive cough, exp wheezing, R sided pleuritic CP, pain with breathing effort, and tachycardia. He had positive troponins I at 0.068 , 0.072, peaked at 0.115 and were 0.015 on 16 OCT 29; K+ 3.10, Cr 1.4 BUN 20; WBC 13 with ABS neuts 11.6. EKG showed Sinus tach at 115 & RA enlargement. Only viral studies were RSV & flu which were negative. CXR & chest CT were WNL. Cardiac echo on 16 OCT WNL EF 60-65%. He was discharged on 16 OCT, and no medications were initiated. Of interest, he has a history of CP and 2018 workup was negative. Today I am telephoning for f/u.  The patient reports he noted the pain about OCT 12. It was intermittent. On 15 OCT they ran a mock PT test and he had severe SOB and prolonged recovery. He had chest pain and drove to the ER when able. He was kept overnight and discharged. He reports he currently is feeling better. He continues intermittent mild sharp CP episodes 3-4x week and has pulmonary referal Followup EKG, troponins WNL.  f/u CT Cardiac morphology WNL 03 DEC 19
blood in my urine; back pain; This is a spontaneous report from a contactable consumer. A 20-Year-old male patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EN6203, Expiration date: Unknown, Solution for injection), on 22Feb2021 around 10:00Am on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 20-Year-old). Medical history included IgA Nephropathy. Concomitant medications were reported as unknown. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL9262) around 02:15 PM on left Arm as Dose 1 single for covid 19 immunization on 26Jan2021. The patient had not received any other vaccine in four weeks. The patient had received unspecified other medication in two weeks. The patient had not affected with covid19 before vaccination. On 23Feb2021 (night after patient received second vaccination) around 10:00PM he started to feel some back pain and observed blood in his urine and somewhat unsurprising to him as he had IgA Nephropathy, and such a reaction to a vaccine would make sense within the mechanisms of his condition. However, this was still the first time in about a year that he had experienced these symptoms, and there was not very much information about the potential relationship between the vaccine and this disease on the internet, so it was still a bit shocking, and if he had receive a response from this report he would appreciate any information we have on whether or not similar incidents have occurred in IgA patients. None of the Allergies were reported. No therapeutic treatments were received. It was reported that patient had tested covid after vaccination. On 22Feb2021 the patient laboratorial test included Covid test (Nasal Swab) which had shown negative result. The outcome of the events were reported as unknown.  Follow-up attempts completed. No further information expected.
Consistent burning sensation in my arm. Suddenly after the last 48 hours.   Extremely tired
Tingling at the right side of her face; Swelling at the right side of her face; Redness in the right side of her face; A spontaneous report was received from a Healthcare Professional concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, swelling and tingling .  The patient's medical history was not provided. The patient was allergic to a bird. Concomitant medications reported were Aspirin.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On unknown date the patient reported experienced redness, swelling and tingling in the right side of the face for 5 days  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome redness, swelling, tingling was not reported.
Pt received Hep B and TDaP on 2/15/17. Took 1st dose of oral typhoid on 2/16/17. Took 2nd dose on 2/18/17 and had upset stomach. Had pain and cramping that day. Diarrhea began at 8AM on 2/19. Diarrhea x 6 that day and severe stomach pain. Body aches. Watery diarrhea of 10-15 min. 5x continued and began to subside on 2/22/17.
Tdap was administered to the patient accidently instead of DTaP which is age appropriate. No reaction was noted or has been reported.
Severe red swollen hard arm almost to elbow. Also terrible body aches felt like Mac truck hit me. Going on 4th day and arm still very sore, red and swollen. Also baseball size lump under arm and hurts.
Pt had a vasovagal syncopal episode approx 10 mins after vaccine administration-pt fell in office and hit the back of her head-recovered quickly in the office but was sent to ER for eval for head trauma on an precautionary measure-uneventful ER visit.
PAIN MOVED FROM CENTER OF BACK AND MOVED BACK AGAIN TO CENTER OF CHEST; PAIN GOT WORSE EVERY TIME WHILE BREATHING AND FEELS LIKE IT IS BETWEEN TOP LAYER OF SKIN AND RIBS; PAIN UNDER LEFT ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: disabled, and other pre-existing medical conditions included: Patient took the product as directed. Patient had no marks or lesions on skin. Patient reports that she did not fall and there is no other reason for any pain being caused. Patient did not left her apartment in 5 or 6 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced pain moved from center of back and moved back again to center of chest, pain got worse every time while breathing and feels like it is between top layer of skin and ribs, and pain under left arm. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Mammogram (NR: not provided) Normal, and Sonogram (NR: not provided) Normal. Treatment medications (dates unspecified) included: paracetamol/tramadol hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain under left arm, pain moved from center of back and moved back again to center of chest, and pain got worse every time while breathing and feels like it is between top layer of skin and ribs. This report was non-serious.
Covid19 breakthrough.  1st vaccine received on 03/05/2021.  92 y/o with PMHX CABG/AVR, Arthritis, Afib, DM2, GI tract CA, HTN, HLD, Bilat carotid artery stenosis presents to ED with 1 week c/o wheezing and SOB.  Pt afebrile with room air O2 sat 96%.  CXR reveals Bilat pleural effusions with underlying atelectasis.  Plan for thoracentesis.  Treated with IV ABX.
Client states that as the day progressed after her vaccination, she began to swell...hands, face, legs.  States "I looked like I had gained 30 lb. "  She called and notified her MD and was advised to not take anymore COVID vaccine.  She was not seen by a MD for evaluation.  States swelling resolved by evening of 5/27/2021 and has had no more problems.
Administered vaccinations about 3:17pm. Hep A in the left deltoid and HPV in the right deltoid. Pt had left the room to go into waiting room and then fainted. He awakened, responded to us, was assessed then was able to be put in chair for further evaluation. Totally recovered by 3:25pm.
2-inch area of itchy, slightly raised red area around injection site, sore to touch. Itch is not alleviated by topical hydrocortisone cream.  Itch started 24 hours after injection.
Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0158) via an unspecified route of administration in the left arm on 08Apr2021 at 15:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Factor V Leiden, ADHD and interstitial cystitis. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), cetirizine hydrochloride (ZYRTEC), fexofenadine hydrochloride (ALLEGRA), levonorgestrel (MIRENA IUD) and curcuma longa rhizome (TURMERIC PWD); all from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 07:30, the patient experienced soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event soreness at injection site was unknown at the time of this report.    No follow-up attempts are needed. No further information is expected.
09/04/2012 at 5:37 pm MENACTRA vaccine was administered by physician.
Headache beginning 3 or 4 days after, dry rasping cough beginning at 6 days after shot, some muscle fatigue and very tired.
Patient came to pharmacy on 10-19-18 in the evening and complained that her arm has hurt since she received her immunization in August. Have been unable to contact patient to get additional information needed at this time. Have message in to primary care doctor.