chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he received his booster dose of Pfizer BioNtech covid 19 vaccine; shooting pains in his left foot occuring every 15 minutes; he tries to walk his foot goes out on him and ankle won't work; he feels like he "shot his foot"; if it could be a blood clot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A 59 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Dec2021 (Batch/Lot number: unknown) at the age of 59 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, unknow dose number), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Dec2021, outcome "unknown", described as "he received his booster dose of Pfizer BioNtech covid 19 vaccine"; THROMBOSIS (medically significant) with onset Dec2021, outcome "unknown", described as "if it could be a blood clot"; PAIN (non-serious) with onset 19Dec2021, outcome "unknown", described as "shooting pains in his left foot occuring every 15 minutes"; GAIT DISTURBANCE (non-serious) with onset 19Dec2021, outcome "unknown", described as "he tries to walk his foot goes out on him and ankle won't work"; FEELING ABNORMAL (non-serious) with onset 19Dec2021, outcome "unknown", described as "he feels like he "shot his foot"".  The clinical course was reported as follows: he received his booster dose of Pfizer BioNtech covid 19 vaccine yesterday and last night he left to go home before 22:00, he went home and tried to go to bed. He laid down and he started feeling shooting pains in his left foot occuring every 15 minutes,he feels like he "shot his foot" and when he tries to walk his foot goes out on him and ankle would not work. They are wondering if it could be a blood clot. Caller says she told him to take aspirin. No Emergency Room,No Physician Office.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Not an adverse event however, wrong drug was administered to the patient. Patient was supposed to receive Pfizer monovalant 12+ second dose to complete their series vaccine. Patient was instead given pfizer biavalant 12+. Supervisor contacted on call MD and he recommends that this patient would receive another bivalant dose as long as the 2 months have passed.
HiB vaccine administered on 08/15/2023 was expired on 08/12/2023. I explained to her that that vaccine dose cannot be counted so revaccination at any time is indicated. Mother confirmed child is doing well, no fever and no adverse effects from vaccine reported. Mother agreed to go to office on Monday 8/28/2023 at 11 am to revaccinate child.
I started having a rash on 11/4/21, I went to urgent care 11/6/21 and was diagnosed with hives. I have never had hives before; the urgent care is not sure what caused them. On 11/7/21 I started having weird feeling in my chest, so I went to the ER and they did a bunch of test and diagnosed it as heartburn. The hives have cleared up and the heartburn is much less, but I have never had either one of these before.
Heart rate went to 133 at 12:45pm for 6 minutes; face and ears were swollen; face and ears were swollen; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration at the left arm on 29Dec2020 11:15 at a single dose for COVID-19 immunization. The patient was obese with BMI of 32, known allergies were tree nuts, sunflower seeds sesame seeds. The patient was not pregnant at the time of vaccination. Concomitant medication includes vitamins nos (DAILY MULTIVITAMIN). On 29Dec2020, heart rate went to 133 at 12:45pm for 6 minutes. The patient took TYLENOL and BENADRYL and went to sleep. When she woke up her face and ears were swollen, heart rate is back to normal (29Dec2020). The patient also added that swelling was a reaction she normally gets when she eats something she was allergic too. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events face and ears were swollen was recovering; heart rate went to 133 at 12:45pm for 6 minutes recovered on 29Dec2020.
This is a 74y.o. female with history of COPD, a-fib on xeralto, who presented on 9/25/2022 with occlusion at the level of the bilateral external iliac arteries and severe luminal caliber narrowing of the SFAs to the level of the mid popliteal arteries bilaterally..  Pt underwent procedure listed above which they tolerated well without complication, see operative report for full details.  Patient recovered well. Hospital course significant for left wound that required operative groin washout and debridement.  On HD#33, pain controlled, pt tolerating diet, voiding and ambulating independently, ready for discharge to home care with instruction to follow up as indicated below. Pt was educated on pain expectations.
10/12: Tues evening felt sensation of pin pricks on my back while lying down 10/13: Wed evening felt sensation of many stabbing pin pricks in my back while lying down 10/14: Thurs morning, red hive dots appeared all on back, side, breasts & inner thigh 10/14: Thurs afternoon, red hives spread into red raised rash and became very itchy 10/14: Thurs night, red symmetrical hive rash spread to cover 50% of back, side and front of abdomen, breasts, inner thigh, very itchy. Also had swollen eye lids 10/15: Fri early morning at 1:00 am itchy hive rash continues and nausea and diarrhea started. 10/15: Friday morning 6:00 am itchy hive rash and swollen eye lids continue, nausea, diarrhea, and chills 10/15: Friday morning 9:15 am itchy hive rash and swollen eye lids continues, chills (nausea subsides).
FEELING DIZZY/LIGHT HEADED/FEELING GOING TO PASS OUT; SWEATY HANDS; SHORTNESS OF BREATH; NAUSEA THAT COMES AND GOES IN WAVES; HEADACHE THAT COMES AND GOES IN WAVES; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lyme disease, and concurrent conditions included: thyroid, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04321A, expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-SEP-2021, the patient experienced nausea that comes and goes in waves. On 03-SEP-2021, the patient experienced headache that comes and goes in waves. On 11-SEP-2021, the patient experienced feeling dizzy/light headed/feeling going to pass out. On 11-SEP-2021, the patient experienced sweaty hands. On 11-SEP-2021, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache that comes and goes in waves, nausea that comes and goes in waves, feeling dizzy/light headed/feeling going to pass out, sweaty hands and shortness of breath was not reported. This report was non-serious.
I had whole body aches, extreme fatigue, chills, fever,  tachycardia (well over 100 beats per minute), unable to hold any item in my hands without it moving to and fro about 8 inches, some headaches, unsteady gait when ambulating. Almost felt like falling.   I didn't want to move in bed since it would only exacerbate the body aches and make it worse. Horrible time   1st dose 02/03/2021  Negligible side effects  (only sore injection site)  Date of 2nd dose 03032021
High fever after given vaccines 8/5/16. Fevers of 103 started 8/12/16 and have persisted for the last 2 days.
Immunization certified technician gave injection following proper technique. After finishing the injection, a red bump appeared at injection site. Patient complained of no pain or issues breathing. Gave patient a benadryl 25 mg tablet in case of reaction and monitored for 30 minutes. Bump seemed to go down in size throughout waiting period. Patient had no other complaints.
Outpatient cath identified blockage. CABG, shortness of breath (prior to admission), acute hypoxic, respiratory failure and also concerns for aspiration pneumonia.
This is a 73y.o. female who presents to the ER due to shortness of breath. The patient has a longstanding history of COPD, and has multiple prior hospitalizations due to exacerbations.  She is on home oxygen, 3 L/min at rest and 4 L/min with exertion. She has been vaccinated against COVID-19 with the Janssen vaccine on 6/2/2021, with no booster shot recorded in the system.   In the emergency department she was found to be positive for COVID-19.  She was also hypoxic, requiring the use of heated high flow, currently at 41% FiO2.  At the time of my examination she reported that her shortness of breath had improved.  Also, she was noted to have an intermediate troponin which has trended upward overnight.  She has seen Dr. in the past.
Patient experienced what seems to be an allergic reaction.  Edema and redness occurred over almost the entire arm. Symptoms improved when patient took diphenhydramine.
After two weeks of pain a doctor was contacted.  I ended up going to an orthopedic specialist who stated I have rotator cuff impingement syndrome (M75.42), post-injection adhesive capsulitis of left shoulder (M75.02) and frozen shoulder.  I have been in physical therapy since.  I also was not able to work normally and have been on light duty/work comp since October 30, 2018.  I am a mental health nurse and am unable to work with this patient population so I had to reluctantly find a new job.  I am continuing PT and still have lifting limits.  Rotation in my left shoulder is diminished and I struggle to lift over my head.
tired the next day; 99 temperature which lasted 1 night; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (99 temperature which lasted 1 night) and FATIGUE (tired the next day) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced PYREXIA (99 temperature which lasted 1 night). On 17-Sep-2022, the patient experienced FATIGUE (tired the next day). On 17-Sep-2022, PYREXIA (99 temperature which lasted 1 night) had resolved. At the time of the report, FATIGUE (tired the next day) had resolved. No allergies were reported. No concomitant medication information was provided. Lot number reported as AS7140C or A57140C (handwritten). No treatment information was provided.  Patient never had COVID+ test or diagnosis. Did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #).   This case was linked to MOD-2022-648275, MOD-2022-648106, MOD-2022-648153 (Patient Link).
I got Covid again December 28th, I was given PAXLOVID. I had just gotten over it and I started getting sick on the 19th of January. My upper respiratory felt like I was getting Covid again but tested negative. I went to the ER, and I had bronchi's spasm really bad. A nurse came and put me in the resuscitation room, and I don't remember much after that. I was on bypass and respiratory support as well as breathing treatments. After that I was discharged on Sunday.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 24-APR-2014 the patient was inadvertently administered a dose of PNEUMOVAX 23 (lot # H014283) that had expired on 17-APR-2014. No adverse effects reported. Additional information has been requested.
Information has been received through the Merck pregnancy registry and from a physician concerning a 16-year-old female with no pertinent medical history or allergies, who on 09-FEB-1998 was vaccinated with a first dose of VARIVAX (Oka/Merck). On 05-OCT-2007 the patient was vaccinated subcutaneously with a second dose of 0.5 ml of VARIVAX (Oka/Merck) (658424/1181U). There was no concomitant medication. The patient had a negative pregnancy test on 05-Oct-2007, and a positive pregnancy test on 20-Nov-2007. Unspecified medical attention was sought. No other symptoms were noted. No product quality complaint was involved. Follow-up information has been received from the Merck pregnancy registry which indicated that the patient is a female with a history of 0 pregnancies and 0 live births whose last menstrual period was on 20-Sep-2007. Her estimated date of delivery is 16-Jun-2008. On 20-Nov-2007 she was prescribed pre-natal vitamins daily. Studies included: 30-Dec-2007 an ultrasound for dating purposes, 13-Dec-2007 a "first TM integrated section" which was normal and on 30-Jan-2008 serum alpha-fetoprotein test with the results pending. It was reported that there was no local reaction at the vaccination site, no varicella (chickenpox) symptoms post vaccination and no herpes zoster symptoms post vaccination. Follow-up information has been received from the Merck pregnancy registry concerning this 16-year-old female with a history of depression and adjustment disorder with meds and counseling in the past who on 05-Oct-2007 was vaccinated subcutaneously with a second dose of 0.5 ml of VARIVAX (Oka/Merck) (658424/1181U). It was noted that the patient had the following complications during pregnancy: chlamydia (05-OCT-2007 and 24-DEC-2007) and depression (date unspecified). The patient was treated with azithromycin 1 g, 1 dose taken (20-NOV-2007 and 24-DEC-2007) for chlamydia. The patient did not receive any medications for depression. The patient was also treated with clotrimazole 1 app. QHS, 7 doses taken (29-JAN-2008) for vaginal candidiasis. On the following dates the patient had ultrasounds performed: 03-DEC-2007 (12.0w CRL with EDC 16-JUN-2008, suggestive of significant bladder outlet obstruction), 13-DEC-2007 (13.4w, nl FM, nl cardiac activity, nl AFI, posterior placenta, nuchal translucency 1.7mm, nl fetal bladder, nl fetal renal pelvises, rec extended anatomic survey at 18-20 weeks) and 19-JAN-2008 (18.7w, nl anatomy, AFI 13.8 placenta posterior). On 22-JUN-2008, 40 plus weeks from LMP the patient gave birth to a 7 lb 3 oz normal male baby. The baby has a congenital anomaly of pyloric stenosis. There were no complications during labor and delivery. At the time of the report, the outcome of the baby was unknown. It was noted that there was no feature of congenital varicella zoster syndrome (cutaneous scars, limb hypoplasia, eye and CNS malformations, neurologic deficits) noted. The reporter considered pyloric stenosis to be a congenital anomaly. Additional information is not expected.
Mom saw rash at site of vaccine inj. in morning after given. Dad saw rash spread in afternoon and baby cranky. No other S or S.  Dad advised by provider to give Benadryl & to watch for signs of further allergic rxn.
This spontaneous report as received from a physician via a field representative referred to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose/frequency, route and duration were unspecified) for shingles vaccination. Then the patient experienced irritation, swelling, redness and tenderness at the injection site on an unknown date. The outcome of irritation, swelling, redness and tenderness at the injection site were unknown. The relatedness of irritation, swelling, redness and tenderness at the injection site were unknown for ZOSTAVAX. This was one of several reports that received from the same source. Additional information is not expected.
Within one minute of receiving the vaccination, he developed lightheadedness. He single pies from the sitting position and struck the left side of his forehead. He was taken to a private section of the arena and monitored. Initial blood pressure was 75/50s, and subsequent monitoring show that his blood pressure was in the  136/85. No itching, rashes, shortness of breath, facial swelling, tongue swelling, or anaphylaxis.
Student c/o "heart pounding" and not feeling well after H1N1 vaccine. Did not eat b'fast and got sick riding bus this a.m. No SOB, rash or itching reported. Sprite and crackers given and student feeling better.
positve for COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positve for COVID 19) in an 88-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (positve for COVID 19). At the time of the report, SARS-COV-2 TEST POSITIVE (positve for COVID 19) outcome was unknown. Not Provided          This case was linked toMOD-2021-118288 (E2B Linked Report).; Sender's Comments:  MOD-2021-118288:
Approximately 3 months post 3rd dose, the pt began experiencing severe headaches and fatigue. She has not sought medical attention. The headaches and fatigue persisted as of 12/06/00. A 15-day follow up report received 01/12/2001 adds: Report 2000035173-1 describes headaches in a 16-year-old female who received Lyme disease vaccine (Lymerix). This report was received from the pt's father and has been confirmed by a physician. Concurrent medical conditions include recurrent right knee offusion subsequent to an injury with hemarthrosis in April 1999. The pt is allergic to penicillin. She was taking no concurrent medications at the time of immunization. Theh pt's father stated that family history is significant for headaches in this pt's sister following receipt of Lymerix. This pt received her 1st injection of Lymerix (lot LY12009) on 04/14/1999 and her second injection of Lymerix (lot LY12079) on 05/29/1999. She had no adverse experiences following receipt of her first 2 doses of vaccine. She received her 3rd injection of Lymerix (lot LY23609) on 04/17/2000). The pt's father reported that the pt began experiencing severe headache and fatigue in July 2000 (precise date unknown) approx 3 months post-immunization. The vaccine provider stated that the pt underwent a routine, annual physical examination on 07/06/2000; she had no complaints at that time. Subsequently, the pt's mother reported to the vaccine provider that the pt began experiencing fatigue in May 2000. The mother reported that headaches began in August 2000, and became severe on 08/20/2000. The father indicated that the pt had not sought medical attention. However, the vaccine provider stated that the pt was seen by 2 pediatric neurologists. Each neurologist prescribed unspecified antidepressants, however the mother did not give the antidepressants to the pt. The vaccine provider reported a diagnosis of possible psychogenic headaches and stated, "I don't think headaches are due to Lyme disease vaccine." The pt has been treating her headaches with ibuprofen (Advil) 400 mg every six hours. The vaccine provider considers the headaches to be disabling/incapacitating. The most recent info, received on 01/02/2001 from the vaccine provider, indicated that the headaches persisted. On 01/02/2001, the vaccine provider also reported that the pt has been under the care of an orthopedic surgeon for the management patellamodal arthralgia of the right leg. The vaccine provider did not provide the onset date of the arthralgia, nor assess its relationship to Lymerix administration. ANA (Hep-2) titer and assay for RA factor performed by the orthopedic surgone on 07/31/2000 were negative. Erythrocyte sedimentation rate measured on 07/31/2000 was 5mm/hr. Lyme IgG and IgM by BIA was positive. Western blot for Lyme IgM, IgG and IgA was performed, the pattern of observed reactivity was interpreted as consistent with a response to OsoA Lyme vaccine. As a result of follow-up info received 01/01/2001, this report has been reclassified as serious, unexpected.
Initial report received from a healthcare professional on 03 September 2013. A 30-year-old female patient had received intramuscular first dose of ADACEL vaccine (lot number: C4313AA, expiry date: 22 March 2015, anatomical site of administration was not reported) on 03 September 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 20 January 2013 and the estimated date of delivery was reported as 27 October 2013. The patient's health during pregnancy, risk factors (e.g.: alcohol, tobacco or recreational drugs), concomitant medications and treatment for infertility were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by the sender: none.
Long Haul Covid; Long Haul Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4370040-00 (Agency).  A 49-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown), in Oct2021 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Heart Attack", start date: Apr2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Long Haul Covid". The patient underwent the following laboratory tests and procedures: Weight: Lost 60 Pounds. The action taken for adalimumab was unknown.  The reporter's causality for the event of long covid with Pfizer BioNTech COVID-19 Vaccine and Humira was not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the Limited information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
12/1/2022- Presents to ED, fall at rehab s/p spinal fusion surgery. C/o fatigue and chills. T-99, BP-139/94. Spo2 96% on RA. Covid + test. CXR- no infiltrates. Ordered bebtelovimab, IV ceftriaxone given in ED, IV decadron and IV remdesivir. Admit generalized weakness l/t mechanical fall Covid. WBC-7.0, D Dimer 345. 12/4/2022-WBC-3.7, continue doxy and ceftriaxone. Spo2-95% on RA. 12/6/2022- WBC-9.7, completed 5 day course remdesivir. Maintained sat of above 95% on RA. Continue deadon Po for 6 more days. Was on ceftriaxone and doxy, will take cefdinir and doxy at home.  Discharge to Home.
Patient was seen for an office visit and offered/administered a booster of the COVID-19 vaccine. Post administration it was discovered that the patient had recently received a booster at a retail pharmacy on 4/22/2022.