chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe fatigue; Vaccination site pain; This is a spontaneous report received a contactable consumer, the patient. A 62-year-old adult male received the second dose of intramuscular BNT162b2 (solution for injection; Lot EL3248 expiry information not reported) as a single dose in the right arm on 05Janr2021 (at 62-years-old), for COVID-19 immunisation.  Relevant medical history included ongoing Hypertension (HTN; 2013), and ongoing Coronary Artery Disease (CAD; Aug2020) with coronary stent. Concomitant medications included sans indications and posology included ticagrelor (BRILINTA) ongoing rom 30Aug2020; lisinopril; acetylsalicylic acid (ASA) ongoing rom 30Aug2020; ergocalciferol (VIT D); and magnesium ongoing from 01Apr2020. The patient previously received COVID-19 immunisation with the first dose of intramuscular BNT162b2 (Lot EK5730) in the left arm on 16Dec2020. The patient reported that on 05Jan2021 he experienced injection site pain and that same day at 13:00 he developed severe fatigue. Treatment for the events included oral paracetamol (ACETAMINOPHEN) 1000mg from 05Jan2021 through 06Jan2021. The outcome of the events injection site pain, and severe fatigue was recovered on an unspecified date in 2021.  No follow-up attempts are possible; No further information expected.
Beginning about 60 days following May vaccination  I recognized a continuing decline in my ability to recall words.  Such as names of persons I know well,  activities I do often and general vocabulary.  I also have noticed my ability to organize thoughts and ideas are in rapid decline as well as my ability to manage projects.  It is greatly interfering with my ability to perform my job.
Patient received novel H1N1 vaccine and seasonal influenza vaccine 2 pm 10-29-09. Developed edema in eyelids, redness in conjunctiva and itch around eyes in 2 hours. Also mild headache and sore throat.
watery eyes; runny nose; slight headache; This is a spontaneous report from a contactable consumer.    A 74-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 25Feb2021 for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2) on 01Feb2021 for COVID-19 immunisation and she experienced she passed out and fell to the floor before daylight and dizziness on 01Feb2021.  The patient experienced watery eyes, runny nose and slight headache in 2021. No treatment was received. No admission to hospital due to the events. The outcome of events was recovered in 2021, she was fine now.  Information about lot/batch number has been requested.
stomach ache; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of Pfizer Covid 19 Vaccine on an unknown date. The patient experienced stomach ache in Apr2021. It was reported that the patient had the second dose last Thursday 22Apr2021. She is currently experiencing stomach ache after the dose. She wants to know if this is an adverse event of the vaccine. Outcome of the event was not recovered.                    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a Registered Nurse via Company Representative refers to a 19 month old infant. The patient was vaccinated with the first, second and third dose of LIQUID PEDIVAXHIB) (lot# not reported) (dosage and route not reported) approximately in August 2012 "at 2 months age", approximately in October 2012 "at 4 months age", and on 14-JAN-2014 at 19 months age, respectively. The nurse informed the representative that the patient had received two doses of LIQUID PEDVAXHIB at 2 months and at 4 months of age (dates unspecified), but had never returned for the booster dose (third dose) until today (14-JAN-2014) at 19 months of age. It was unknown if the third dose of LIQUID PEDVAXHIB was administered to the patient  at 19 months of age. No adverse event reported. Additional information is not expected.
Information has been received via a company representative, from a 22 year old female nursing assistant, who on 19-APR-2007 was vaccinated IM in the deltoid, with the first dose of Gardasil. The nursing assistant report she experienced pain in her deltoid muscle at the injections site, and pain that was radiating down her arm. At the time of this report, the nursing assistant had not recovered. The patient did not seek medical attention. No further information is expected.
2/2  8 am  to 2/3 8 am . After a restless night, I woke up feeling achy all over. It was hard to get up but I went to the couch for the rest of the day. I ate nothing. I took no meds. I sleep intermittently. At 6 pm I had a fever of 100.1 that lasted about 2 hours. No headache, no actual pain on body or at shot site. Just achy.
Weakness/dizziness. Shoulder pain and back pain at injection site. Hives.
Severe vomiting  intermittently over several hours, beginning the evening after COVID vaccine (shot 2). Stopped overnight.
After receiving a routine flu shot, I began to feel extreme pain in the effected shoulder, which continued to get worse for the following week. I experienced severe pain and limited mobility. Upon returning to doctor I was administered a cortisone shot which helped ease the pain.
Left thigh "lump" and redness reported by Mother 12/1/20 via phone call. Mother states that she believes this was where subcutaneous injection was given on 11/20/20. Mother noticed this on 11/30/20.  Patient was seen by PCP on 12/1/20 and reported back to writer that the PCP feels this is a deep tissue bruise. Patient's mother to monitor at home.
Interrupted menstrual cycle- unusual hormonal changes not caused by pregnancy, menopause, other health conditions or stressors. First day of preceding period to first day of first period after vaccination was 50 days (patient?s average cycle lasts 28-32 days). Pre-menstrual symptoms leading up to first period after vaccination such as fatigue, body aches, breast tenderness, and mood swings were more intense and lasted for longer. Chose to ?wait and see;? period eventually started on it?s own, albeit much heavier than on average.   I am unsure how else to report this information, so please forgive me if this is inappropriate: I contracted COVID-19 sometime in mid-January of 2021 and spent the last two weeks of the month quarantining at home. The illness itself was mild, the kind that during a typical cold and flu season you might call ?the sniffles? and carry on with normal activities. However, a similar, extended portion of time between the period before contracting COVID-19 and the one after occurred.  Therefore, I am not filling this report to suggest a link between the Moderna vaccine and a ?late? period, but rather I?m reporting to suggest there may be a link between either COVID-19 or it?s affects on the immune system and a ?late? period. Other people who menstruate have mentioned similar effects via social media, so I know that I?m not the only one, even if this information is only anecdotal. I realize that COVID-19 and the vaccines against it are still very new to the medical world, but I feel that this is a topic worthy of further research and scrutiny.
severe pain and weakness in the u=both upper arms, progressed as severe inflammation throughout the entire body that lead to immobilization, hospial visits, home care and treatment with 40 mg prednisone - later 6mg dexamethazone for 40 days and ongoing.  The inflammatory reaction continues, loss of fine motor function, weakness, rigidity and pain in skeletal muscles. Sudden drops of blood pressure with decrease heart rate (90/40 hr 59) - manifest as severe fatigue, chest compression.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were inadvertently administered with improperly stored doses of PNEUMOVAX 23 (lot#R002354, expiration date: 17-DEC-2019) and VAQTA (lot# N031940, expiration date: 23-NOV-2018) for prophylaxis which had a temperature excursion of 32°F to 35°F for 57 minutes. The previous temperature excursions were 47°F to 77°F for 33 hours, 52 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. This is a non-valid case due to lack of patient identifiers.
Started feeling light-headed, dizzy, shortness of breath, breathing became very shallow, felt faint.  Symptoms started about 20 to 30 min. after receiving flu shot/Influenza Vaccine. I went to the E.R. and was given a breathing treatment, hooked up to EKG, Chest X-Ray and was told my bronchial tubes has inflamed and had a bronchospasm and acute allergic reaction in response to the flu shot. Was prescribed Methylpred 4MG, Xopenex HFA Inhalation Aerosol & 25 Mg Benadryl Oral Tablets
Described to mom "tingling" in chest , then itching HR, Pox normal  Denies discomfort to provider
RASH (HIVES) ALL OVER BODY  60 HRS (APPROX. 2.5 DAYS AFTER SHOT ADMINISTERED
Client c/o HX of rash and itchy throat post previous vaccination. Client initially requested to monitor for 30 minutes by MD on site. At 15 minute mark, client's husband approached writer to request assistance for itchy throat. Writer noted redness to clients chest. Writer requested assistance from MD onsite, safety team and immediate supervisor. Client visited EMT and sat in ambulance for monitoring. V/S WNL for client, per client, at B/P 145/81, HR 67, and 98% O2 on RA. MD recommend continue monitoring. Client discharged by MD at 3:35 pm with no further c/o itchy throat or redness to chest.
Full body hives - diagnosed dermatographic urticaria. Lasted from November until current (April)
This is a spontaneous report from a Pfizer-sponsored program. A non-contactable nurse reported for herself. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) at single dose in 2014 for immunization. Relevant medical history and concomitant medication were unknown. On unknown date in Jan2016 the patient experienced pneumonia. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. Sender's Comments: Based on the information provided in the case, a lack of efficacy withpneumococcal 13-val conj vac (dipht crm197 protein) in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Turned 12 on 10-31. Should have received the adult dose.  Given the Peds dose.
This spontaneous report as received from an immunization official refers to multiple patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant medications were not reported. From 01-MAY-2017 to 31-JAN-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # N004817, Expiry date: 06-OCT-2018, Lot # N010706, Expiry date: 02-DEC-2018, Lot # N011647, Expiry date: 17-NOV-2018, Lot # M040268, Expiry date: 14-MAY-2018, Lot # M041765, Expiry date: 05-MAY-2018, Lot # M041768, Expiry date: 25-JUN-2018, Lot # M045546, Expiry date: 12-JUN-2018, Lot # M046000, Expiry date: 27-JUN-2018, Lot # N004817, Expiry date: 06-OCT-2018, Lot # N010706, Expiry date : 02-DEC-2018, Lot # N010707, Expiry date: 03-DEC-2018, Lot # N011647, Expiry date: 17-NOV-2018), M-M-R II recombinant human albumin (rHA) (Lot # L039613, Expiry date: 08-OCT-2017, Lot # M032487, Expiry date: 05-JUL-2018, Invalid Lot # M019233, Expiry date: 17-OCT-2017, Lot # M032487, Expiry date: 05-JUL-2018, Lot # M040558, Expiry date: 30-OCT-2018, Invalid Lot # M042497, Expiry date: 17-APR-2018, Lot # M042498, Expiry date: 17-APR-2018, Lot # M045101, Expiry date: 20-NOV-2018, Lot # M045402, Expiry date: 14-NOV-2018, Invalid Lot # M046368, Expiry date: 27-MAY-2018, Lot # M045402, Expiry date: 14-NOV-2018, Lot # N008366, Expiry date: 13-MAR-2019), PROQUAD (Lot # M046368, Expiry date: 27-MAY-2018, Lot # N002325, Expiry date: 19-JUL-2018, Lot # N010865, Expiry date: 01-OCT-2018, Lot # N014949, Expiry date: 11-NOV-2018, Lot # N019250, Expiry date: 20-DEC-2018, Lot # N020012, Expiry date: 13-JAN-2019, Lot # N021726, Expiry date: 06-FEB-2019) and VARIVAX (Lot # M005972, Expiry date: 02-FEB-2018, Lot # M010484, Expiry date: 01-MAR-2018, Lot # M025870, Expiry date: 24-MAY-2018, Lot # M039318, Expiry date: 20-SEP-2018, Lot # M041079, Expiry date: 06-OCT-2018, Lot # N014632, Expiry date: 11-MAY-2019) for prophylaxis. It was reported that M-M-R II and ROTATEQ vaccines experienced a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 509 Hours 30 minutes, PROQUAD and VARIVAX vaccines experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 112 Hours 36 minutes. There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint reported. It was reported that this call was reported due to a digital data logger. Follow up information has been received from the physician on 08-MAR-2018. The following lot numbers M046368, M042497 and M019233 were deleted from M-M-R II as it was confirmed that they belong to in the PROQUAD vaccine.
Paresthesia and burning sensation in limbs and face, fatigue, exercise intolerance, calf pain, internal tremor, dizziness; This is a literature report.   An adult female patient received BNT162b2 (BNT162B2), as dose 1, 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: NEUROPATHY PERIPHERAL (medically significant), 7 days after the suspect product(s) administration, outcome "unknown", described as "Paresthesia and burning sensation in limbs and face, fatigue, exercise intolerance, calf pain, internal tremor, dizziness". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Mildly positive; Biopsy skin: Low small fiber density in distal leg; 1.2; Electromyogram: Mild left Ulnar neuropathy and, notes: mild Rt median neuropathy; Autonomic testing: Normal; Neurological examination: Mild decreased vibration sense in toes bilaterally; Rheumatological examination: negative.  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 be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/patient different drug/event
Pt was a non-responder p/receiving 3 doses of Engerix-B; recvd 4th dose & did convert;
Information has been received from a physician via medical records concerning 21 year old female patient who on 09-AUG-2010, in the afternoon, was vaccinated with the first dose of GARDASIL (Lot # 662765/0821Y) into her right deltoid. Concomitant therapy included ACIPHEX and LOESTRIN 24 FE. There were no illnesses at the time of vaccination. It was reported that on 11-AUG-2010, the patient presented with low grade temperature for 48 hours, nausea, headache and temperature of 99 F. On 12-AUG-2010, the patient had temperature of 100 F. The diagnosis of posterior cervix lymphadenopathy. Laboratory diagnostic tests performed included: CBC which showed an increase in monocytes 11.8% (high). It was reported that on 19-AUG-2010, the patient saw a physician of infectious diseases for his evaluation. The patient had a temperature of 97 F on that day, and had soreness in submandibular lymph node which persisted. The physician placed her on CEFTIN. Additional information has been requested.
Pt. experienced 2 episodes of "going limp that lasted about 2-4 seconds" per episode on 9-18-08; per mother, recovered quickly.
This spontaneous report as received from a nurse via company representative, refers to a two female patients of unknown age. On an unknown date the patients were vaccinated with the dose of ZOSTAVAX (dose, route of administration and lot number were not reported). On an unknown date, the patients developed shingles after vaccination. The patients sought medical attention via office visit. The outcome of shingles was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Ulcerative colitis symptoms came back; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4206425-00 (Agency).  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Aug2021 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 15Aug2021, outcome "recovered" (2021), described as "Ulcerative colitis symptoms came back". The action taken for adalimumab was unknown.  Additional Information: The reporter's causality for the event ulcerative colitis symptoms came back for HUMIRA(ADALIMUMAB) and Pfizer BioNTech COVID-19 Vaccine (Tozinameran) of was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported event Colitis ulcerative and suspect drug BNT162B2 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.
Pt is a previously healthy 76 year old woman who received her covid vaccine 2 wks ago. She received Moderna vaccine on 3/8/21.  On 3/16/21 She developed symptoms of fatigue, chills,  body aches, decreased exercise tolerance. 3/19/21 exercised at YMCA as she does regularly. She was not able to do her usual level of activity and was only able to exercise low level for 10 minutes. Yesterday was very sob and after washing 2 windows had to lay down and rest.   In my office the nurse rooming the pt noted the pt to be very winded and sob just ambulating from waiting room to the exam room. Pox was down to 89% and took a while to come up to 94%. Transferred to Hospital ED. DiagnosedDiagnosis: Acute hypoxic respiratory failure secondary to massive Pulmonary Emboli, DVT without known precipitating factors. pt without previous history of clotting disorder, no known neoplasm, no recent travel or sedentary period. unprovoked DVT with MASSIVE PE.  patient did not have previous pulmonary disease.  Additional information for Item 19: studies: PO Chest Final Result  Stable chest. No new opacities are identified in this  patient with known extensive bilateral pulmonary embolus.   US Venous Duplex Lower Extremity Bilateral  Final Result  1. Acute DVT involving the right popliteal and posterior  tibial veins.  2. No acute DVT involving the left lower extremity.   CT PE Protocol WITHOUT legs  Final Result  1. Positive exam: Large-volume central pulmonary emboli seen  in both main pulmonary arteries with extension bilaterally  into all lobes. Dilated right heart chambers suggesting  acute right heart strain.  2. Peripheral groundglass opacities in the right upper lobe  may represent small area of pulmonary hemorrhage or  developing infarct.  Red Level 1 findings were entered into the system.  | Actionable Findings system for documentation and  communications on 3/22/2021 4:31 PM, Message ID 191499.  3. Pulmonary nodules in the right lower lobe measure up to 4  mm maximally. See below consensus guidelines.   TTE -  INTERPRETATION SUMMARY:  Left ventricle is normal in size.  There is normal left ventricular systolic function.  The quantitative LVEF based on modified Simpson's method is 62%.  There is asymmetric septal hypertrophy with maximal wall thickness of 1.3 cm.  There is mild (grade I) diastolic dysfunction with normal left atrial pressure.  Right ventricle is normal in size.  There is normal right ventricular systolic function.  No previous echocardiogram in Froedtert Health system for comparison.
Patient received covid vaccine BUD. Vaccine expired on 7/7/22 and was given the vaccine on 7/9/22
Body aches, bad chills, shaking, balance was off, nausea/vomiting. Took two advil during the night. Lasting about 24 hours total
Red skin; mottled skin on left (more) and right (less) shin; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 18Apr2021 at 11:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, obstructive sleep apnea and penicillin allergy. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and octinoxate, octocrilene (SOLARIS); all taken on an unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 09:00, the patient experienced red skin, mottled skin on left (more) and right (less) shin, not itchy. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red skin, mottled skin on left (more) and right (less) shin was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax 4FEB92 & anterior rt thigh & lower rt leg, foot, & sole became warm & red; this persisted until 10 minutes p/an oral dose of Hydroxyzine; When pt calmed down, inject site was not red or tender; (Idiosyncratic rxn to HIBTITER);