chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with PEDVAXHIB lot # J006418, expiration date 06-MAR-2016 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as improperly stored PEDVAXHIB was administered to unspecified patients. There was no adverse event. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
sudden onset of lightheadedness, dizziness ,. fatigue and intermittent chest tightness
Moderna COVID-19 Vaccine EUA Headache, dizziness, lightheadedness, nausea, diarrhea, fatigue, head pressure, night sweats
Second dose was not administered till now; A spontaneous report was received from a other healthcare professional concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA -1273) and due to the relocation issues second dose was not administered till now marking 60 days/product dose omission issue.  The patient's medical history was not provided. Concomitant medications were not reported.  On 11 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.   The patient got vaccinated and due to the relocation issues second dose was not administered till now marking 60 days.   Treatment details were not mentioned.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event due to the relocation issues second dose was not administered till now marking 60 days was resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
This case was reported by a physician (spouse of subject) and via a patient assistance program described the occurrence of injection site pain in a 62-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). On 21 May 2013, 2005, 2000, and 1995 the subject received 7th dose, 6th dose, 5th dose, 4th dose of ENGERIX B adult (unknown details) and experienced extra dose administered and off label use. The physician "was advised that an additional dose was required every 5 years." In 1990, the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B adult (unknown details). On 21 May 2013, immediately after vaccination with the 7th dose of ENGERIX B adult, the subject experienced injection site pain. The physician stated there was "no redness or swelling noted." At an unspecified time after vaccination with 6th, 5th, 4th, 3rd, 2nd, and 1st doses of ENGERIX B adult, the subject experienced injection site soreness (described as "some soreness"). In 2013, the subject was treated with CIPRO, ADVIL, ALEVE, BACTRIM and Fluconazole. The physician stated that the treatments did not relieve the injection site pain. At the time of reporting the outcome of the event of injection site pain following the 7th dose of ENGERIX B vaccine was improved and still present. The physician stated that the soreness following previous ENGERIX B injections lasted for a few days. The physician considered the event of injection site pain with the 7th dose of ENGERIX B was probably related to vaccination with ENGERIX B adult; however, he did not specify relationship with the previous doses of ENGERIX B.
After the first dose of the series, the pt reported constant diarrhea, stomach upset for three weeks. After second dose in series, pt reports recurring episodes of diarrhea at three week intervals. Pt reports intolerance of dairy even with use of Lactaid; fermented foods; richer, fattier foods such as meats.
Pt c/o feeling dizzy after shot.  Pt told to sit-  down - given a cold compress.  Pt LOL for under 1min with some jerking movements ammonia inhalant used  with little effect Pt cont.  to go in and out of consciousness.  MD call to Pt.  911 called as per MD.  O2 given.  Pt taken to hospital via amb.
GUILLAIN-BARRE-Syndrome onset 5-7 days after H1N1 vaccine injection. Diagnosis - Clinical and EMG/NCS. Treatment IVIG 0.4 gram/kg x 5 days - Rehabilitation.  12/3/09, 12/21/09, and 12/22/09 Hospital records and discharge summary received. Service dates 11/21/09 to 11/30/09. Assessment: Guillain-Barre Syndrome, Cervical spinal cord stenosis, Recurrent bladder cancer. Recently discharged from hospital where he was treated for pneumonia and received H1N1 vaccine. Developed pain in neck, muscle weakness, observed and discharged at another facility. Difficulty walking. Legs gave out and fell. Patient presented with ascending weakness of his extremities. Cough. Diminished breath sounds. Deep tendon reflexes hypoactive. Tremor upper and lower extremities. Umbilical hernia. IVIG administered. Developed acute renal failure. Anemia. Hypercapnia. Transferred to rehabilitation.
I develop  thick rushes on the injection site  like a map and I feel  my right arm is a bit heavy. I also feel  some pinching inside my head and a  knife stab feeling from my left chest going to my stomach the other day.
Aproximately 3hrs after recieving vaccine for covid my heart rate spointaniously jumped into the 180 and stayed rapid tachycardiac for about 12 hous . i went to a walkin in and was sent by emt"s to  hospital. had blood tests multiple ekgs and a chest xray. administer fluids and vit k as well as diltiazem. and at some point my heart rate just  flipped back to a normal sinus rythem. was admitted for 24 hrs then discharged to follow up with my pcp and a cardioligist
Patient Received vaccine 10/13 called teledoctor on 10/17 reported cramps in upper right leg muscle, did not report back to pharmacy until 10/27 per MD. Said symptoms started a few day after vaccine and lasted about 9 days. Along with cramping also felt stiffness. Teledoctor confirmed on conference call on 10/17 prescribed Diclofenac 75mg Tablet BID and also reported event Case. Patient did not report any bruising, redness at vaccine site only a day of some soreness at site. Thanked patient for reporting and explained the report will be sent in event others had similar reactions with same manufacture/lot.
Colitis ulcerative aggravated; This is a solicited report based on the information received by Pfizer from a company (Mfr. Control No: 21K-163-4052708-00).  A non-contactable consumer (patient) reported a 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 15Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 22Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for moderate to severe ulcerative colitis.  The patient's medical history and concomitant medications was not reported. The patient experienced ulcerative colitis flare (Colitis ulcerative aggravated) on an unspecified date with outcome of unknown.  The action taken in response to the event(s) for adalimumab was unknown. Causality as per reporter of bnt162b2 was possible.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of serious event Colitis ulcerative aggravated cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
J96.00 ACUTE RESPIRATORY FAILURE 4/5/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION R09.02 HYPOXIA 4/5/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION
Patient is a 17 year old male with history of Duchenne Muscular Dystrophy,  chronic respiratory failure, heart failure , incontinence, and chronic malnutrition presenting after cardiac arrest. Pt transferred from community hospital.    Patient taken to PCP on 3/1/22 reported recent cough, congestion, and thick secretions with difficulty clearing secretions. He and his PCP made plans to  re-start cough assist BID, also received second COVID vaccination. Pt returned.  Later that day reportedly 911 was called and patient was taken to community hospital.  He was in full arrest, stabilized and transported to Hospital
Erythema and pain results in cellulitis. Tx with NSAIDs and KEFLEX.
Pt received FLUZONE shot on Thursday Oct 20th 2011 at a school based clinic that day. Pt is autistic. Parents noted he was less fussy that night. Saturday and Sunday he had a fever. Monday he was slow having flu-like symptoms. Patient also began suffering with "ST" words. This has been his major symptom the last 3 weeks. Patient had shot last year also. Parents did not take him into the provider to be examined.
Pain in muscle around injection site ~2.5hrs in spread thru my entire upper arm and shoulder; Dose 2: Pain in muscle around injection site ~2.5hrs in spread thru my entire upper arm and shoulder; pain in my chest wall and around the lymph system surrounding left breast, started first near sternum, then spread above left breast implant.; soreness and tenderness in addition spread up to armpit and along to left side along breast; Dose 2: Pain in muscle around injection site ~2.5hrs in spread thru my entire upper arm and shoulder; lymph swelling; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Apr2021 11:30 (Batch/Lot Number: EW0153) as single dose for covid-19 immunisation.  Medical history included hypothyroidism, autoimmune thyroiditis, Hashimoto's, asthma, fibromyalgia, arrhythmia, hypersensitivity to Norco, Rondac Cough Syrup. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included levothyroxine sodium (TIROSINT); levocetirizine dihydrochloride (XYZAL); salbutamol (VENTOLIN [SALBUTAMOL]); iron (IRON); ascorbic acid; cholecalciferol; magnesium sulfate; zinc chloride. The patient previously took dose 1 bnt162b2 on 12Mar2021, , lot number: EN6199, in left arm for covid-19 immunisation. The patient experienced pain in muscle around injection site, 2.5hrs in spread thru my entire upper arm and shoulder, (like simultaneously pulled all muscles & got punched in shoulder joint; hard to lift arm or pick anything up for 2 days). Then 7hrs in, pain in my chest wall and around the lymph system surrounding left breast, started first near sternum, then spread above left breast implant. Came and went for 4 days, then soreness and tenderness in addition spread up to armpit and along to left side along breast. It is been 9 days now. Have not had appointment with physician yet, but am booking today and wanted to report here first. Event onset time was 09Apr2021 06:30 PM. Checking to see if Pfizer will cover the cost of CT ordered by physician following weeks of lymph swelling and pain which prompted CT to be ordered. Outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Nausea; 20 hrs after second shot severe shaking chills; fever 103F; chest burning; severe headache; severe weakness; This is a spontaneous report from a contactable consumer (patient). A 63-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiry date: unknown) via unspecified route of administration on right arm on 26Jan2021 as single dose for COVID-19 immunization. The patient medical history includes chronic lymphocytic leukemia, hypertension, type 2 diabetes, metastatic thyroid cancer, pulmonary metastases and allergic to Keflex and clindamycin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1263) in right arm on 07Jan2021 15:00 as single dose for COVID-19 immunization. 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. Post vaccination, the patient was not tested for COVID. On 27Jan2021 at 03:00, 20 hours after second shot, the patient experienced severe shaking chills, fever 103F, chest burning, severe headache, severe weakness and nausea. The patient did not receive any treatment for the events. The outcome of events was recovering.
Felt very sick like the flu even beyond 72 hours from receiving dose.  Green mucus. Bad cough, body aches.  Much worse reaction then after 2nd dose of vaccine.
Information has been received from a certified medical assistant referring to a 23 month old female patient with gastric esophageal reflux disease and no drug allergies. On 17-MAY-2013 the patient was vaccinated with a dose of ROTATEQ (lot # J000035, expiration date 24-APR-2014), 2 ml, orally for the prevention of retrovirus. On unspecified dates, the patient was vaccinated with the rest two doses of ROTATEQ, 2 ml, orally. The lot numbers of these two doses were lot# H012252 with expiration date 29-JAN-2014, and lot#H016250 with expiration date 27-MAR-2014. On 05-MAR-2015 the patient who had received ROTATEQ series, experienced diarrhea, nausea, vomiting and ear infection. On 09-MAR-2015, after experiencing four days of the above events, the patient was seen in the physician's office. A stool sample was collected and did test positive for Rotavirus. A basic metabolic panel was performed on the patient as well. The patient was treated with oral fluids and an unspecified antibiotic. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was reported.     On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 10-Mar-2021, PAIN IN EXTREMITY (arm pain) had resolved. Not Provided      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.
atrial fib/erratic heart beat/rapid heartbeat in chest and throat/Alternating episodes of rapid heartbeat in chest and throat that were so strong; A lump in left breast that was the shape and size of a new erase on a #2 pencil; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 20Mar2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable consumer (patient), Program ID. A 71-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 2, single (Lot number: EN6198) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EL9269), administration date: 13Feb2021, when the patient was 71-year-old, for COVID-19 immunization. After many months of dealing with an erratic heart beat, following the second initial COVID shot, Patient had developed atrial fib and have been put on Eliquis. Her reaction to these vaccines resulted in a previously strong heart now requiring drugs to treat the resulting atrial fibrillation. Patient stated she could not afford Eliquis due to financial reason, which was initially prescribed for her during her emergency visit. Following the second vaccine in Mar2021, patient had the following symptoms: 1. Rapid, thumbing pulse in the back of neck at the base of the skull. 2. Alternating episodes of rapid heartbeat in chest and throat that were so strong, she felt them without using hand or an instrument. Response: Her primary care doctors conducted and electrocardiogram, results showed no problems: she ordered a brain scan, result showed no problems. 3. A Lump in left breast that was the shape and size of a new erase on a #2 pencil. Even though it had gone away before the scan, the center said it probably was a result of the second COVID shot: cancer was not indicated on the breast exam. Initial assessments: patient saw her primary care doctor with complaints of rapid pounding heartbeat in lower skull/ back of neck throbbing. The patient underwent the following laboratory tests and procedures: Breast scan: (28Apr2021) Lump in left breast temporary, notes: gone away before the scan; Electrocardiogram: (23Mar2021) no problems; Heart rate: (Mar2021) High/Rapid; Physical breast examination: (Mar2021) A Lump in left breast that was the shape, notes: and size of a new erase on a #2 pencil; Scan brain: (24Apr2021) no problems. Outcome of atrial fibrillation was not recovered, outcome of lump in left breast was recovered.
EE RECEIVED BOTH PFIZER COVID-19  VACCINE DOSES AND TESTED POSITIVE TO COVID ON 8/19/21
Increase in muscle fatigue with repetitive motion to the point it now occurs when performing ADLs (brushing teeth, washing hair, etc.) Sensation of not having enough respiratory capacity to the point that I am unable to finish sentences due to loss of air and sensation that I need to purposefully take large breathes intermittently to have enough oxygen
She was walking unassisted before the vaccine, After the shot she didn't have the strength to stand from a chair. Now she has to have help just to walk and she walks very slowly when she does walk. And she can not walk outside at all.
Chills, fever,  migraine like headache without sensitivity to light or sound, sore arm.
This spontaneous report was received from a 80 year old female patient regarding herself. The patient had no medical history, drug allergies/reactions and was not on any concomitant medication. On 26-JUL-2017, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, frequency and lot# not provided) for prevention of shingles. The patient stated that about an hour after receiving the ZOSTAVAX (reported as on 26-JUL-2017), the patient experienced nausea, sweaty, the palms of her hands turned red, pain in her shoulder blades, dizziness, and began to vomit a clear gelatin type fluid, hot and sweating, lump in back, redness, rash to hands. The patient called back to the pharmacy to inquire if this was normal. The whole ordeal lasted about an hour. The patient notified her physician by phone, but did not go to the hospital to visit her physician. The patient was recommended by the pharmacy to take some BENADRYL for her symptoms. The patient stated that once her symptoms stopped (an hour later), she felt much better. The patient thought she was having an allergic reaction to ZOSTAVAX. No laboratory tests were performed. The outcome of vomiting, hypersensitivity, dizziness, musculoskeletal pain, palmar erythema, nausea, rash, erythema, mass, hyperhidrosis and feeling hot was reported as recovered on an unknown date in July-2017. Causality assessment was not provided. No product quality complaint (PQC) was involved. No other information provided on this matter.
Information has been received from a physician assistant concerning a 24 year old female patient with no medical history or allergies who on 08-JAN-2007, was vaccinated IM with a first dose of Gardasil (Lot # 655165/1425F). On 15-MAR-2007, the patient was vaccinated with a second dose of Gardasil (Lot# 655324/0088U). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, after both vaccinations the patient experienced shooting pains in the arm and neck on the side of the injection. The pain lasted for about a month each time. The physician assistant did not know which arm was used for the injections. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested.
Red hive like spot in 10-15cm surrounding injection site on left arm. Spot is itchy periodically.
PROVIDER PROGRESS NOTE 2/8/2022 87 yo, covid positive start of January. Hospitalized 1/31 - intubated 2/6   1. Pulmonary:  1. Hypoxic resp failure due to covid. 1. Intubated 2/6 2. 20/450/80/12 + flolan + paralysis 1. Trying to limit MV given PTX/subQ emphysema. Dropped peep to 10 2. I'm fine with premissive hyeprcapnea and ph > 7.10.  1. venous 7.15 acceptable this am  2. Signs of barotrauma - subQ emphysema and L sided PTX. Latter not large enough for CT. Monitoring with daily cxr 2. Cardiac:  1. Septic shock - on repi and vaspressin. Added norepi to use as primary pressor 2. Afib - on amiodarone. Looks to have converted to sinus this am 3. Renal:  1. ARF - likely ischemic or prerenal ATB, on top of contrast nephropathy. Numers progressive today. Likely will need to start HD in next 24-48h. 4. ID:  1. Leukocytosis - likely stress infection post intubayion etc, but can't r/o 2ndry infection 1. On cefepime/vanco 2. Cx's pending, but ngtd 2. Covid  1. On steroids 2. Out of time window for Toci/Bari  5. GI: no issues 6. Nutrition: TF's on hold due to high residuals 7. Heme:  1. Leukocytosis as above 8. Neuro: no issues 9. Sedation/Analgesia: versed, dilaudid Restraints: Not indicated 10. Endocrine: accuchecks and ssi 11. Prophylaxis: h2b, lovenox 12. Lines/Site: PICC 13. Code Status: DNR/may intubate 14. Family Communication: with DIL yesterday, and son today. My message was despite full support, he has declined over the past 48h. If we were to continue full support, we need to decide about dialysis. My recommendation was that given his trajectory, The patient is unlikely to survive, and even if he did would be looking at prolonged recovery (trach, peg etc). My recommendation was given his age, we could feel comfortable about honoring his wishes and trying full support as we did, but I would transition to comfort cares
12/22 vaccination 12/27 8AM started feeling going on with TMJ. Had appt with audiologist. Wondering if it was in ear. Ran along facial nerve.  12/30 pain increased tremendously, exploded. Weird, yucky lesions on face and mouth. My husband asked if could be shingles; positive.  1/12 Neurology.  2/7/2021 Major pain has subsided.  Still recovering from Shingles.  *2nd vaccination 1/12/2021 7:30 R arm
Fever blisters on mouth....now extreme fatigue, light sensitivity, muscle weakness has presented in last 4 days.
About 5 minutes after receiving the vaccine the patient passed out in the waiting area. Patient went pale and fainted. The mother caught the patient. Within 30 seconds the patient became aware of her surroundings and all vitals were within normal range. She ate some crackers and was stable.
I had shaking chills with a fever of 101.0 the evening of shot injection then extreme fatigue . The fever/chills lasted 2 days. Took Tylenol. Did not feel better till day 4 after shot.  The first shot did not cause any reaction but this second shot was given 2 months after first shot and caused these reactions. I know these are listed as normal reactions but maybe second shot should be given at 6 months.