chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, especially shoulder blades; tired/sleepy; tired/sleepy; chills; This is a spontaneous report from a contactable other HCP (patient). This 64-year-old female other HCP reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL128H), via unspecified route at right arm on 08Jan2021 07:45 AM at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included elevated blood pressure and atrial septal defect repair 2008. Concomitant medications included olmesartan medoxomil and hydrochlorothiazide. Historical vaccine included the first dose of BNT162B2 (lot# EH9899) on 18Dec2020 at age of 64 years old for COVID-19 immunization and having arm pain. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. On 08Jan2021 07:00 PM, patient experienced pain at injection site, swelling (size of her palm), warm to touch all over body and muscle aches, especially shoulder blades, very tired/sleepy with chills. No treatment was received. It was reported normal temperature for patient was 97.2 (+) or (-) 98.6. Outcome of events was recovering.
Rash & UrticariaPruritus TREATMENT: METHYLPREDNISOLONE, DIPHENHYDRAMINE, RANITIDINE
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received  16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).   This case involves an adult of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  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 the 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
SWOLLEN ARM/INJECTION SITE REATION. SEEN BY URGENT CARE FACILITY WHICH BELIEVED REACTION INITIALLY TO BE CELLULITIS HOWEVER LATER DETERMINED SEVERE INJECTION SITE REACTION TO VACCINATION,
As soon as the I/M vaccine was administered-within 1-2 seconds Pt became tense and went into a generalized tonic seizure lasting about 3.5 minutes.  Pt vital signs remained stable.  She was post icteal after treatment.  She was sent to ER via paramedics.
Patient couldn't walk or move his legs. Called pediatrician, told to monitor child. Twelve hours later the patient completely recovered.
Fatigue beginning about 3-4 hours after injection, lasting through about 28 hours, tenderness at site of injection but also entire upper arm which started mildly, got much worse around 8 hours after  injection, then became less severe about 30 hours after injection.
23 YEAR OLD admitted to hospital with chest pain and elevated troponin (5000).  Had received second dose of Moderna vaccine 4 days prior. Myalgia and fever from vaccine were resolving when chest pain and dyspnea started.  Normal angiogram, no coagulopathy, normal platelets, normal echo. Pain resolved.
Stroke; Anaphylactic shock; High blood pressure; A spontaneous report was received from a pharmacist concerning a 50-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, stroke/cerebrovascular accident and high blood pressure/hypertension.  The patient's medical history was not reported. The relevant concomitant medications were not reported.  On 18 Mar 2021, approximately five minutes prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 032M20A) via unknown route for prophylaxis of COVID-19 infection.   On 18 Mar 2021,five minutes after vaccination the patient experienced anaphylactic shock, stroke and was subsequently hospitalised. The patient also had high blood pressure. The events anaphylactic shock and stroke was life threatening. Treatment for the  events included steroids, diphenhydramine and epinephrine.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events anaphylactic shock, stroke and high blood pressure was not reported.; Reporter's Comments: This is a case of Anaphylaxis and Stroke in a 50-years-old female patient with no medical hx provided who was hospitalized  immediately after receiving first dose of vaccine. Very limited information has been provided at this time. Further information is expected
Day 7 of first vaccine mild to moderate Swelling of lymph nodes behind left ear and left side of neck and redness ,soreness of earlobe. Lasted 3 days.  Day 7 of second vaccine moderate to severe swelling of lymph nodes behind left ear, left side of neck , redness soreness of ear lobe . Fever and general malaise. At this time has continued off and one until todays date.
Swollen on left hand for 6 days, got some temperature the 1st 3 days. Hard touch on the left hand.
Headache CHEST TIGHTNESS, CHILLS, NAUSEA, WEAKNESS Narrative:
For 2-3 days after, fever/chills, nausea, extreme fatigue,  sore arm.  8-9 days after: arm swollen, itchy, and hot at the injection site, along with nausea; this has lasted  5-6 days so far.
Pt recv vax on unspecified day; within 6 wk post vax pt dx=Bell's Palsy
only had a sore arm and bruise @ site of vaccination for the first week.  Yesterday started with red area, itching and hot to the touch @ IM vaccine site left arm
mom became alarmed when pt abruptly woke w/loud screaming cry which lasted approx 15-20mins about 9PM of the same day recved vax; stated pt was very pale & didn't seem self; MD notified;
Positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. No Treatment information was provided.
Patient presented to emergency department on 8/26/2021 with weakness and leaking for urinary catheter. Patient was discharged on the same day from skilled nursing facility and son reported patient was very weak and could not stand or walk.  Upon screening for discharge to facility, patient was found to be COVID-19 positive.  Patient remained asymptomatic with COVID-19 infection during admission. He was discharged on home hospice on 9/17/2021.
7cm area of scattered macular erythema, not tender, and not raised. Seen in office on 02/08/2002.
Patient got vaccine on October, 6th. He started feeling dizzy on October 9th, then on 11th and 12th felt so dizzy he was bedridden and had to have spouse support him to walk to the bathroom. He describes it as vertigo, but had no vomiting. He self-diagnosed it as vestibular neuritis, but did not see a physician. On the 13th he  started to feel like he could stand up and move around the house again more on his own. He resumed driving on the 14th . He felt symptoms were resolved by the 15th.
swelling in rt leg; fever 102.7; difficult breathing 4-5 hrs p/vax lasted max of 12 hrs;
55 year old man with development bilateral lower extremity numbness and hyperreflexia consistent with myelopathy, found to have a longitudinally extensive spinal cord lesion consistent with transverse myelitis from C6-T4.
This spontaneous report as received from a nurse practitioner refers to a 19 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (strength, dose and frequency not provided). The patient was diagnosed with ovarian cancer while on GARDASIL. The patient was not given treatment for AE. The patient had not sought medical attention. The outcome of ovarian cancer was unknown. Therapy was not discontinued (also reported that the therapy was not reintroduced). Ovarian cancer was considered to be an other important clinical event. Additional information is not expected.
When I got my first shot of the vaccine , I had some of the symptoms mentioned including a headache but after 24 hours , everything went away, however a few days after after , my headache Came back and has not gone away ever since , yesterday , I went to get my second vaccine but thankfully my headaches haven?t gotten worst.
Patient received 2 doses of Rotateq. Hospitalized for severe diarrhea and dehydration at 6 months.  4/3/07 Received medical records from hospital which reveals patient experienced diarrhea, vomiting, fever & mild dehydration.  Admitted 1/31/07-2/4/07.  Patient experienced poor growth since birth.  Consults by endocrine, GI & immunology.  Condition improved although patient did not have steady weight gain & was d/c home to f/u w/immunology as outpatient.   FINAL DX: poor growth, rotavirus infection.
no additional AE; administration of MMR II post expiry; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 18-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, liverecombinant human albumin (rHA) (M-M-R II) 0.5 ml, lot # R036580, expiration date 17-DEC-2020 (route of administration was not provided) for prophylaxis. No adverse events were reported.
The patient had his initial shot of the Pfizer COVID Vaccine, then tested positive for COVID-19; The patient had his initial shot of the Pfizer COVID Vaccine, then tested positive for COVID-19; He and his work partner both work up feeling awful the next day with all the side effects that can possible happen; Their arms killed them for about a day; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on arm on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had his initial shot of the Pfizer COVID Vaccine, then tested positive for COVID-19. It was reported the patient and his work partner both work up feeling awful the next day with all the side effects that can be possible happen. His work partner he was speaking of also tested positive as well. As the patient work partner woke up with 103 fever, so the patient got tested because of him, since they shared a station for 24 hours. The other symptoms they experienced were that they felt like they got shot in the arm. Their arms killed them for about a day. The outcome of the event was unknown. Lot and batch number has been requested.
Child had rash in the diaper area of folliculitis at office visit- then last evening rash spread rapidly on to the torso and arms, child very fussy, fever over 101, decreased appetite and child biting at arm.
Patient had received two monovalent COVID vaccines, which was documented in database but not the internal medical record. Patient received monovalent COVID vaccine, thought to be primary series, when he should have received bivalent as a booster
Pain in left shoulder/arm EVERY time I reach, stretch or twist my arm in certain motions, especially stretching. It does not hinder me from daily activities, but each time it causes wincing pain for 3; On 10Mar2021, patient received BNT162b2  dose 1 and dose 2; On 10Mar2021, patient received BNT162b2  dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp.   A 65-year-old female patient  (Non pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6205 Expiry date UNKNOWN) dose 1 via an unspecified route of administration in arm Left on 10Mar2021 17:45 (age at vaccination was 65-year-old) and dose 2 (Lot number ER8732; Expiry date UNKNOWN) via unspecified route of administration in left arm on 10Mar2021 as single dose for covid-19 immunisation. The patient had no known allergies. Medical history included blood cholesterol from 2015 and 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. Concomitant medications received within 2 weeks of vaccination was atorvastatin taken for blood cholesterol from 2015 and ongoing. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021, patient received BNT162b2  dose 1 and dose 2 via an unspecified route of administration in arm Left and at on the same day at 22:00 had continuous pain in left arm when stretching or twisting-for 10-30 seconds, then it's gone. Occurs every time she twists or stretch-mostly in upper arm but sometimes radiates down entire arm. No treatment received for the event. Pain in arm is not disabling.The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) negative on 20Mar2021. The outcome of the event pain in left shoulder/arm EVERY time I reach, stretch or twist my arm in certain motions, especially stretching. It does not hinder me from daily activities, but each time it causes wincing pain for 3 was not recovered and rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
pt devel gen hives 1wk p/vax;pt was treated w/Pred & hives are resolving;
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was reported. No concomitant medication was reported.
The patient got her single shot Johnson and Johnson vaccine on 3/6/2021. Then, on or about 4/22/2021, she began to complaint of dizziness and left-sided weakness. She presented to emergency room on 4/29/2021 and was found to have a stroke via CT and MRI.
pulmonary embolism; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ep7534), via an unspecified route of administration, administered in right arm on 16Mar2021 15:00 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included verapamil. The patient previously took lisinopril and experienced allergies. The patient received first dose of bnt162b2 on 23Feb2021, 13:00 for Covid-19 immunization. On 19Mar2021, the patient started having challenges with shortness of breath. On 31Mar2021, after the challenge continued to grow he was checked into the hospital and was diagnosed with pulmonary embolism. Despite no travel nor history of family blood clots, nor was he was genetically dispositioned. The events resulted in emergency room/department or urgent care. Therapy for the events included Blood thinner. The patient had no other vaccine in 4 weeks, and no Covid prior vaccination. The patient was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab was negative on 31Mar2021. Outcome of events was recovering.
Information has been received from a medical assistant concerning a 17 year old female who on 03-MAY-2007 was vaccinated with first dose of Gardasil (lot # 657622/0388U) IM in the right gluteal muscle. There was no concomitant medication. On 04-MAY-2007, the patient developed redness, a bump, and itchiness at the injection site which was the gluteus muscle. Medical attention was sought. At the time of reporting, the patient recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a medical assistant concerning a 17 year old female with no illness at the time of vaccination and no history of allergies or medical conditions who on 03-MAY-2007 was vaccinated with first dose of GARDASIL (lot # 657622/0388U) IM in the right gluteal muscle at approximately 2 PM. There was no concomitant medication. On 04-MAY-2007, the patient developed redness, a bump, and itchiness at the injection site which was the gluteus muscle. Medical attention was sought. At the time of reporting, the patient had recovered. Additional information was received from a family nurse practitioner who reported that the outcome of the events was unknown (previously stated as recovered). No additional information is expected.
17NOV97 mom called  & stated pt having diarrhea 12NOV97;cont w/diarrhea & some vomiting through today;seen by MD morning;signs of dehydration;trying BRAT diet;some fluids;
Patient administered 0.5mL of the COVID-19 vaccine. He should have received 0.25mL of the COVID-19 vaccine according to protocol.
She initially had fever and redness tenderness and swelling of the left arm, site of administration the came to involve the entire circumference of the arm.  After about 2 days, she developed non pruritic evanescent urticaria-like rashes on the arms and legs, hands and feet, sparing the trunk and mucosae. No vomiting no difficulty in breathing.
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old female patient who received a 0.5 mL dose of QUADRACEL lot C5248AA via intramuscular route in the left deltoid on 27-Jul-2018, after the dose of KINRIX administered in Dec-2017. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was reported that QUADRACEL had been inadvertently administered to a patient for the purpose of polio immunization after KINRIX had been administered in Dec-2017. She reported the intention had been for the patient to receive dose 5 in the series for polio immunization. She reported no other vaccines were administered concomitantly. 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 holders 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. Documents held by sender: none.
This is day 6 of my 2nd Moderna vaccine.  I began coughing around 10 pm tonight. I noticed  3 days after  my 2nd vaccine that my breast are tender. And they still are. My 2nd vaccine was March 9, 2021.   Slight headache still persist.  All other body pains are gone. The cough is new. Seems like phlegm is trying to come up .
On the fourth day after vaccination, I noticed that my heart was racing and beating off rhythm. This got worse on the fifth day post vaccine. I was also somewhat short of breath, and since this was very atypical, I went to the Emergency Room. An EKG showed pretty constant PVCs. I was given metroprolol and seen by a cardiologist. I was sent home with metoprolol 12.5 mg/twice a day. I took as prescribed for a few days and then tapered off this medicine before cardiologist followup appointment. I was still having some PVCs at that point. A holter monitor soon after showed normal heart rhythm. I have had just a few episodes of PVCs since and for the last month, my heart beat seems normal.
left sided numbness (starting approx 12 hours after injection, resolved within 24 hours), fever resolved within 24 hours, seen in Urgent Care today for supraclavicular lymphadenopathy (worsening)
Non-expected: Facial swelling and itchy rash (on face) within 3 hours of getting vaccine. Difficulty swallowing, but no difficulty breathing.  Pain in bottoms of feet that woke me from sleeping twice. Inability to stay awake, lethargy, weakness. In addition to expected: loss of appetite, nausea, achiness, tiredeness, headache, hot and cold spells. Symptoms lasted 5 days until I felt better. Felt better for about 18 hours, and then all symptoms except rash came back. Facial rash, itchiness, and swelling lasted 3.5 days, despite taking Benadryl and Allegra. Still incredibly tired and weak, 7 days out.