chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hands and feet felt arthritic, nausea before eating, all over body & joint pain, then a debilitating migraine that lasted all day, sinus pressure in ears, around eyes,    lethargy
Developed a 10x6 cm round red area I (L) thigh. Treated with BENADRYL Dx fat necrosis.
Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient was found to be deceased at 3:00 am. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 13 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided. .; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
pt recvd vax & devel urticaria w/in 24 hrs of vax; No further details were provided;
100 degree temp; swollen lymph nodes under arm; This is a spontaneous report from a contactable other health care professional (patient herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 12Mar2021 at 12:15 as dose 1, single (at the age of 47-years-old) for COVID-19 immunisation. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 59267-1000-01, Expiration date: Unknown), via an unspecified route of administration on 09Apr2021 at 12:15 as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included blood pressure abnormal, allergy to cephalosporins and ob/gynae issues (gynaecological examination abnormal) from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications included iron, vaccinium macrocarpon (CRANBERRY), vitamin D, birth and blood pressure medications taken for an unspecified indication, start and stop date were not reported. On 03Apr2021 at 12:30, the patient experienced 100 degree temp and swollen lymph nodes under arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: 100 degrees on 03Apr2021. Therapeutic measures were not taken as a result of the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Patient received Td on 2/25/08, reported increasing pain, fever, swelling, induration left injection site 1 day after receiving vaccine.  Doctor diagnosis cellulitis.  Treated with Levaquin 500mg for 7 days.
A patient was administered three doses of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (A patient was administered three doses of the Moderna COVID-19 vaccine.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced EXTRA DOSE ADMINISTERED (A patient was administered three doses of the Moderna COVID-19 vaccine.). In June 2021, EXTRA DOSE ADMINISTERED (A patient was administered three doses of the Moderna COVID-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Patient demographics and vaccine information updated
arm pain at site of injection on first vaccine. lasted about 1 week  left arm pain at site or injection, severe fatigue, myalgias and low grade fever after second vaccine that lasted for 48 hours
suffered a stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) (Batch/Lot number: unknown) at 11 mg daily (11 mg, daily); methotrexate sodium (METHOTREXATE SODIUM) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "suffered a stroke". The action taken for tofacitinib citrate and methotrexate sodium was unknown. Clinical course: Patient takes Xeljanz XR 11mg 1 daily. Patient stated after she took the 1st Pfizer Covid-19 injection she had a stroke. caller takes xeljanz and methotrexate. She recently had the pfizer covid vaccine (1st dose) and suffered a stroke after receiving vaccine  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 available information the causality between the  event cerebro vascular accident and the suspect product ,comirnaty cannot be ruled out , with tofacitinib is unrelated , methotrexate sodium is unrelated
Experienced a significant panic attack morning of December 10, followed by two weeks of significant anxiety that was not fully controllable by the citalopram being taken before and after. Additional, significant changes in irritation of GERD and bowels developed rapidly - reducing known irritants, such as tomato sauce and carbonated beverages, has made management of symptoms easier following several months of experimentation. However, symptoms and irritation still persist, though are better managed at this time.
pt recv vax; arm sore; lt arm started to ache; depends on position and movement of arm; lateral movements hurt the most; reports inc pain w/ immobility;
patient reported that she lost sense of smell and taste with each vaccine, temporarily.  She also reports swollen lymph nodes under each arm that continues with no relief.
received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were provided.
"72 hours after the injection I started bleeding from my nose"; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left  arm on 11May2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had] not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021, 72 hours after the injection, the patient started bleeding from her nose. she had never had a nose bleed in her life.  It lasted a few minutes with a clump or clot coming out of her nose and then the bleeding stopped. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event "72 hours after the injection I started bleeding from my nose" was resolved on 14May2021.  No follow-up attempts are needed. No further information is expected.
large local rxn w/fever of 104 & achiness;seen in ER on 12MAY95;
Patient developed a rash at the injection site, firm and warm to the touch. She was afebrile, but the area became increasingly itchy. After seeing her PCP, she was diagnosed with a bacterial infection and prescribed Cefadroxil.
1/8/10 6:00 am upon awakening - noticed red swollen, irritated eyes. Self - treated with ZADITOR eye drops. Also soreness/swelling at injection site. 1/10/10 11:00 am (approx) - became dizzy, head was spinning when turned over in bed to rest. Lasted several hours till early evening, then headache. Still have low grade headache 1/11/10.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Fever-Severe
Headache, Arthralgia, Fever, tight sensation in face eyes and tongue, sweating , sleeplessness... spotting with urination , soreness at injection site ,
tiredness; Body ache; Just general body aches all over/pain; weakness; a very low temperature fever; This is a spontaneous report received from a contactable consumer via Pfizer Sponsored Program. A female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9263) via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. Reporter stated that her mom developed lots of side effects of tiredness, body ache, just general body aches all over/pain, weakness, very low temperature fever after she received the 2nd dose of vaccine on an unspecified date in Jan2021 (reported as last night) and was wondering is it okay to give Tylenol or Advil something for her symptoms. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare for shingles. And on an unknown date, the patient was hospitalized. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
52 Y.O. female patient received Pfizer booster vaccine Lot# FK9729 on 1/27/22 at 1150. at 1155 patient started having tingling throat and itchiness. Patient's BP: 126/86 HR: 77, O2: 98%. Patient didn't complain from any shortness of breath. Benadryl 50mg/1ml IM administered on her right deltoid. Patient monitored for 30 min and stated that she doesn't have a tingling sensation or itchiness. Patient was instructed to seek an emergency services if her symptoms gets worse. Patient lefty the clinic with a family member at 1230.
***BREAKTHROUGH CASE*** Patient Covid - on 10/08/2021. Patient received Pfizer vaccine with 1st dose on 03/31/2021 and 2nd dose on 04/21/2021. Patient hospitalized.  Per ED Note:  History of Present Illness     This is 64-year-old male past medical history of pulmonary fibrosis on home oxygen of 4 L as needed is presenting to the emergency department today with complaints of low oxygen level.  States that he was diagnosed 2 days ago with Covid when he went to an urgent care because he had some nausea and vomiting.  He overall has been having diffuse myalgias.  He states that he tried to get up to make breakfast earlier today and felt increasingly short of breath anytime that he was trying to ambulate.  He has been taking Tylenol for his headache which is mostly left-sided in nature nonradiating and described as a throbbing.  Currently rated a 5 out of 10.  Denies any fevers, chest pain, shortness of breath, pleuritic pain, numbness or tingling or weakness or dysuria.
Information has been received from a physician and a consumer concerning herself who on 02-NOV-2007 was vaccinated with her first dose of Gardasil (lot# 654540/1209U).  On 22-JAN-2008 the patient was vaccinated with her second dose of Gardasil (lot# 655327/1287U).  About a day and a half after receiving the first dose, the patient's lymph node was swollen on her left side near her neck.  The patient indicated it hurt for a couple days.  Also after receiving her second dose of Gardasil, the patient's lymph node had swelled again and it was hurting.  The patient's swollen lymph node in her neck persisted.  The patient indicated she has an appointment in February to have a biopsy done on the swollen lymph node.  It was unclear whether the patient would have the third dose of Gardasil.  Additional information has been requested. This is follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a physician and a consumer concerning herself who on 07-NOV-2007 was vaccinated with her first dose of GARDASIL (lot# 654540/1209U). On 22-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (lot# 655327/1287U). About a day and a half after receiving the first dose, the patient's lymph node on her left side near her neck. The patient indicated it hurt for a couple of days. Also after receiving her second dose of GARDASIL, the patient's lymph node had swelled again and it was hurting.The patient'sswollen lymph node in her neck persisted. The patient's PCP felt the swollen lymph node was not related to GARDASIL and sent her to an oncologist. She had an ultrasound on 18-JAN-2008. The patient indicated she has an appointment in February to have a biopsy done on the swollen lymph node. The biopsy was benign. It was unclear whether the patient would have the third dose of GARDASIL. Additional information has been requested.
Vision started really blurring out; it was going completely black in and out.; Body aches; I did not develop a fever but a random temperature; headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, So I am experiencing some symptoms with this vaccine. I had my vaccine done yesterday. The body aches started yesterday in the evening. Overnight I did not develop a fever but a random temperature. I had like 99 point (incomplete sentence) so it was like up and up there, but it was not like a full on fever. I was fine. I did not get the fever just had the body ache. I woke up this morning. I got to work and then my vision started really blurring out. I keep seeing 'spotty glossy' black and my 'vision' (Not further clarified) was completely blurred. When paraphrased the above concern, consumer stated, Yes, I just want to know if that is something that happened or expected the vision thing and now, I just have like a really major headache I have taken Tylenol (Intent: treatment) today. I have never had that issue or like my vision. I was worried because it was my vision, it was going completely black in and out. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
reconstituted ACTHIB with sterile water/no AE; Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and physician via call center via Global Medical Information (GMI) (Reference number- 00708161).  This case involves a 4-year-old female patient who received HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile water (product preparation error).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (QUADRACEL) for prophylactic vaccination.  On 30-Jul-2021, the patient received a fourth dose of 0.5 mL of suspect HIB (PRP/T) VACCINE (lot number: UJ526AAA and expiry date: 30-Jun-2022) via unknown route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  It was reported that, "Caller reports that a nurse administered ACTHIB to a patient without reconstituting with proper ACTHIB diluent."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recv vax on 9/17/97; on same day pt exp night sweats x 24hr, hair loss
Local redness at vaccine site with low grade fever of 100.5 and crankiness since night before
Approx 24 hours after 2nd Covid vaccine, pt experienced extreme pain in knuckles, had chills and vomited, extreme fatique
Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s.  Also, headache, mild muscle aches, chills.  After about 2 hours, did not improve therefore was directed to the ED.  EKG was normal.  CBC, CMP, TFTs all normal.  Was monitored for a couple hours and HR improved.  At home it took until 17:40 for HR to consistently be 100 or less..  still feel fatigued, headache, and achy.
Amenorrhea. She had previously had normal menses, but has not had her menstrual period since the vaccine (4 months)
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech start date: 26May2022/ Treatment of COVID-19 start date: 20Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Report about COVID treatment was yes. The patient did not receive other medication in 2weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had the shot @ 3:30 on Saturday 3/6/2021, woke up Sunday 3/7 with a fever and chills.  Fever went to 102.8... Chills went away after several hours, then nausea began later in the day Symptoms lasted all day Sunday and then  Monday fever went down to 100 for most of the day...  No naseau on Monday... Tuesday temperature back to normal...   This was a first dose of Moderna   don't know if this was an adverse event, but thought I should report it to you
Upper Stomach pain; Pain at injection site; Fatigue; This is a spontaneous report from a contactable pharmacist. A 59-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3248, expiry date not reported), intramuscular on 15Jan2021 13:30 at a single dose in the left arm for COVID-19 immunization. Medical history included diabetes, HBP (high blood pressure), and cholesterol. The patient had no allergies. The patient had no covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 16Jan2021, the patient experienced upper stomach pain, pain at injection site, and fatigue. Therapeutic measures were taken as a result of the events reported which included esomeprazole 40mg and rantidine 150mg. The patient was not tested for covid post vaccination. The outcome of events upper stomach pain, pain at injection site, and fatigue was recovering.