chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in my hip and when she just lay down or rest also have the body; muscle pain; Joint pain/wrist will have all kind of pain/pain in my hip; Muscle weakness; headache; tiredness; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: EN6202) as 1st dose, single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had mild symptoms the next day (04Mar2021) which she was really not concerned about, just tiredness for about 6 hours and some headache. On day 7 after first dose (10Mar2021), she began to experience joint pain and muscle weakness; the patient was still experiencing the symptoms. It was not terrible pain but when she try to open a door and her wrist will have all kind of pain, pain in my hip and when she just lay down or rest also have the body and she also didn't have the joint pain in general. The first time of experience of muscle pain. The day when she reported makes day 10 do the symptoms listed. The patient saw that the symptom should resolve in 24 to 48 hours, so she was surprised after 7 days about having kind of like a joint pain. The outcome of tiredness was recovered in Mar2021, not recovered for joint pain and muscle weakness and unknown for the other events.  No follow-up attempts are possible. No further information is expected.
In less than 24 hours after my shot, I  sustained a fever of 103, and was peeing blood. I went to the urgent care, and was treated for a urinary tract infection.  I followed up later with my gynecologist, and then a urologist. I had a scan done of my kidneys and bladder camera. Everything came out normal.
Pt reported redness and ichness on his face, abdomen, bilateral arm. PT denied difficulty of breathing nor dizziness.  Consulted on-call Dr and requested to assess pt; IM Diphenhydramine 1mg  BP 147/101, HR 89, O2 100% at 320 pm. Pt reported decrease of itchiness at 325 pm. 500ml Oral fluid given. BP 143/101, HR 92, O2 100% at 330 pm.  BP 144/98, HR 83, O2 100% at 335 pm. Advised to consult with primary care about his high Blood pressure.
Patient reported that after multiple years of afib controlled on a pacemaker, patient had an event following reception of Arexvy and Fluzone HD vaccine on same date and was informed that pacemaker intervention was no longer viable and initiated on amiodarone (RX received 11/1/23)
Patient complained of 2 day fever, headache, joint pain, arm pain & redness at injection site.
Flu like symptoms - Fever up to 102, by ear. fever and symptoms started 2/24 and and fever lasted two days, second day up to 101. Headache, extreme fatigue, muscular aches. Pt. comfortable and symptoms gone mid morning 2/27. Treated with bed rest, drinking fluids and acetaminophen  as needed.
Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 05Feb2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231) on 13Jan2021 at 01:45 PM for COVID-19 immunization (in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 06Feb2021 at 02:00 AM, the patient experienced fever ranging from 100 to 100.9 accompanied by chills and moderate headache as well. Fever subsided by the morning of 07Feb2021 and headache was mild by then. The patient also experienced soreness at site of injection on 06Feb2021 at 02:00 AM only if she touches it. No treatment was administered for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.
My arm hurt for several days (it's normal for me), I got fever, body ache, I took TYLENOL, it last for 1-2 days. One week after my Lupus increased, affected my system, my face flushed, it lasted for a month. I saw my doctor and had lab work, which always abnormal due to my Lupus.
pt recv vax MAR95 & 11MAR98 pt devel 10-15 vesicles w/o fever;@ the time of the report, pt had a few new vesicles coming up;
? Experienced mild Covid symptoms (fever, fatigue/extreme exhaustion, weakness, headache, body aches, dizziness, no appetite, etc) after each dose of the Covid vaccine, with the 2nd round being more severe.  ? 2-3wks after 2nd moderna dose, I started bleeding profusely vaginally (I was not pregnant), and the bleeding continued for 5 weeks. Additional symptoms included?fever, exhaustion, inflammatory skin rashes/issues,  face/throat/neck and lymph nodes in the neck and underarms swelling to the point I could not lay down flat at night to sleep, had trouble swallowing, eating, drinking, and breathing with pulsating/throbbing pain around the clock.   ? Symptoms somewhat subsided after about ~6wks, but continue to reappear without rhythm or reason for days/weeks at a time usually accompanied by fever, and head pain.
Case number PHEH2015US026895 is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 61-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 12 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse reaction was experienced by the patient following the maladministration. Follow up report received from nurse on 26 Jan 2016: Updated reporters comments.
30 doses were drawn and administered from a 20-dose vial; 30 doses were drawn and administered from a 20-dose vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (30 doses were drawn and administered from a 20-dose vial) and PRODUCT PREPARATION ERROR (30 doses were drawn and administered from a 20-dose vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (30 doses were drawn and administered from a 20-dose vial) and PRODUCT PREPARATION ERROR (30 doses were drawn and administered from a 20-dose vial). On 04-Nov-2021, ACCIDENTAL UNDERDOSE (30 doses were drawn and administered from a 20-dose vial) and PRODUCT PREPARATION ERROR (30 doses were drawn and administered from a 20-dose vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-377749 (Patient Link).
Shortly after vaccine was administrated I became disoriented and nauseated. Felt off, wasn't severe, no injection site reactions
Pt recvd booster dose of MMR in JUL89 (WAES91101020) & w/Hep B vax on 31JUL91; On the evening of 31JUL91 pt devel a fever; following day exp fatigue, muscle weakness, h/a & joint pain;
1/8/2022- Chief Complaint: Lethargy- Source of Information: Available medical record. History of Present Illness:  This is a 69 y.o. female with PMH of being a conjoined twin, developmental delay, GERD, hyperlipidemia, hypertension, seizure disorder, and hypothyroidism presents to the emergency department chief complaint of lethargy and altered mental status. The patient has none nonverbal at baseline with occasional "yes "or "no". History is provided by the patient's first cousin who was the patient's guardian. Guardian states that the patient has had poor p.o. intake over the last 6 days. She states that typically the patient is able to ambulate on her own with a walker but has not done so over the past 6 days. She states that she is fully vaccinated against the coronavirus and is vigilant about cleaning the house every day with disinfectants. The patient has multiple family members who are healthcare providers and also take care of the patient. ED vitals: Blood pressure on arrival was 153/67, SPO2 90% on room air, heart rate 81. Patient did test positive for the coronavirus. Her last dose of the vaccine was in May 2021. Labs were remarkable for hemoglobin of 15.7, AST 79, creatinine kinase 1826, urinalysis 20 ketones, 2+ blood, greater than 20 RBCs, 11-20 WBCs, greater than 50 squamous cells, 2+ bacteria. CXR: No acute cardiopulmonary disease/process or significant change from prior given patient rotation. CT head: No acute intracranial process, re-demonstration of remote injuries involving the right parietal, frontal parietal regions.  Bilateral mastoid effusions with associated opacification of the middle ear, nonspecific white matter changes likely related to chronic ischemic small vessel disease
"sick" and not feeling right for the day and then died that night, labeled as cardiac arrest resulting in  death
Patient went to sleep on the night of 10/19/11, he woke up feeling that he could not move and his heart was beating fast. He thought he had a dream. Once awake the symptoms went away. Also was shivering. Sleep paralysis.
Normal expected reactions all weekend; Excruciating joint pain; Fever; Extremely Dizzy- can hardly stand; Extremely Dizzy- can hardly stand; A spontaneous report was received from a female HCP,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced normal expected reactions all weekend, extremely dizzy-can hardly stand, excruciating joint pain and fever.   The patient's medical history, as provided by the reporter, included COVID-19 (November 2020) . No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received the Moderna vaccine and experienced the normal expected reactions the following entire weekend. She was sick all weekend with everything except the loss of sense of smell. She also had excruciating joint pain and a fever that broke on 03 Jan 2021. On 04 Jan 2021 around 4:00am, the patient was extremely dizzy and could hardly stand. She stated that she knows it sounds like an inner ear issue but she has never had an inner ear issue before. The patient would like to know if this is one of the side effects. No treatment information was provided.  Action taken with mRNA-1273 in response to the events is not applicable.   Outcome of the events, normal expected reactions all weekend, extremely dizzy-can hardly stand, and excruciating joint pain, were not reported. The event, fever, resolved on 03 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pseudo-bowel obstruction. Could not eat. Tube through nose to stomach relieved pressure. Normal bowel function resumed after about 24 hours. Released after about 36 hours
Scratchy, sore throat, cough, SOB, asthma like symptoms (closing/tightness of esophagus/throat.  Lungs hurt with deep breath.
Patient had very bad pain in right arm moved to chest had SOB. Went to ER. Patient then diagnosed with Pericarditis. Had an MRI with Contrast had a Iodine allergy ended with patient in ICU x 3 days with anaphylaxis.
Approximately 5-6 post-vaccination, the patient developed pain in her neck on the same side of the vaccination site. On exam she had significant soft tissue swelling to the base of the left side of the neck extending to the supraclavicular area. Additionally, she had pain limiting the range of motion of her left shoulder extending from the left neck to the left lateral deltoid. The skin was warm to the touch, but showed no cutaneous erythema. The pain on palpation of the soft tissue swelling caused the patient to jump out of her chair.
I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 19-Feb-2021 for Myalgia, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (I had a sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.    Concomitant product use was not provided by the reporter.  Patient took her second dose on 18-FEB-2021 on left arm, lot number was 013M20A.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested   This case was linked to MOD-2021-288260 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Information has been received from a medical assistant concerning a 74 year old female patient who had an episode of shingles prior to receiving ZOSTAVAX (Oka/Merck). In May 2008 the patient was vaccinated with ZOSTAVAX (Oka/Merck) (no lot # provided), and subsequently, on an unspecified date in 2998, the patient experienced shingles again. Patient came into office seeking medical attention. Additional information has been requested.
Both eyes and lips were swollen. He had a round of Benedryl and steroids.
A pt received Pnu-Imune 23 on 11/28/00 and subsequently, was hospitalized overnight. The adverse event was not stated. As of 11/29/00, no further information was available. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Pnu-Imune 23.
ER visit for chest pain. Aspirin 324 mg administered. Nitroglycerin 0.4 mg q5 min ordered.
24 hours after receiving the injection the patient has an area of erythema and edema the size of a lemon. The tissue is firm at the sight.
muscle aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 09:30 (Lot number: EL9262) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperuricemia" (ongoing), notes: He produces too much uric acid and it causes kidney stones; "Dizziness" (ongoing), notes: Caller had some slight dizzy spells that the doctors couldn't isolate.; "Back pain" (ongoing); "Covid-19", start date: Dec2020, stop date: Dec2020, notes: Mentions Dec2020 he got COVID 19 but was cleared at by the end of Dec2020. Concomitant medication(s) included: DIAZEPAM taken for dizziness, start date: 1978 (ongoing); ALLOPURINOL taken for hyperuricaemia (ongoing); PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL] taken for back pain. The following information was reported: MYALGIA (non-serious) with onset 10Feb2021, outcome "recovered" (12Feb2021), described as "muscle aches".  Additional information: Patient states he noticed the day after muscle aches but nothing that he didn't expect. The patient did not receive any previous immunization with the Pfizer vaccine and also did not additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccine within four weeks prior to vaccination. The patient did not have any family history. The patient did not have any illness at time of vaccination. The patient did not perform any relevant test.  No follow-up attempts are possible. No further information is expected.
Early the next morning I woke up very very itchy all over my body. No hives but I was just extremely itchy and uncomfortable with lasted for about 24hrs. I took Benadryl that night and the next day I felt better.
Whole  Arm weaknesses and pain. Severe under arm/lymphatic soreness and headaches
Nystagmus started about a week after the vaccine dose.  It is still occurring as of 5/1/21 but not as severe.  No treatment has been given.   Also had a sore arm for two days starting the evening of the vaccine being administered.
I first had these red spots all over my palm and feet. Then I developed more rashes on my lower back and thigh. I also had these huge welts on my neck, lower back, and thigh.  I used Benadryl spray on the spots, which provided some relief. But when I took the Benadryl tablet, it did not help.
Feeling of tightness in chest as if there were an air bubble,  then tightening of throat with some difficulty of swallowing,  then several hours of  nausea, fever and body aches  over a period of 6 hours.   Took an antihistamine for the chest and throat reaction   and then in a couple of hours took ibuprophen for the fever and aches. After about 6 hours I began to feel  better but still weakness through the next day.
Severe Chills Fever 102 Hot burning whole body Dry Heaves Weakness Took Tylenol, pushed fluids--lasted 24 hours
Patient reported muscle spasms and pain in legs from the 27th lasting to present (8/2/21). Also reports pain in both arms with the arm opposite of injection site worse. Pain in the arms began on the 28th and seems to be getting worse. He reports only a couple hours of sleep per night since the shot.
Dizziness, Headache, Fever, ErythemaMultiform, lymphadenopathy, fatigue
Second dose of vaccine was given on day 22; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine was given on day 22) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine was given on day 22). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine was given on day 22) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Pt was thought to have had chickenpox in the past. Subsequent to being exposed to grandson who received one dose of varicella virus vaccine live the pt developed a shingles like rash. No further information is available.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old patient who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. The patient had COPD (Chronic obstructive pulmonary disease). Concomitant medication was not reported. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose as High Dose was given to a 60 year old with COPD. It was not reported that if any adverse reaction was experienced. 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. Documents held by sender: none.
Severe Nausea, Vomitting, and diarrhea that lasted for approximately 5 hours. Could not keep water down.
Patient experienced a seizure 2 hours post his second COVID 19 vaccination.  Patient has a history of seizures but had been seizure free for greater than 12 months according to the nursing staff.
Patient was given the pediatric dose and should have been given the adult dose.  Parent was notified of the error and was told the child will receive the adult dose on next vaccine which would be 3 weeks from first dose
BROKE OUT WITH  SHINGLES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-APR-2021, the subject experienced broke out with shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out with shingles was not reported. This report was non-serious.  .
Warmth and redness approximately 10 x 10cm around the injection site upper left bicep to deltoid region, and non tender area developed within 24 hrs and persisted for additional 36hrs. Required treatment course of Keflex for cellulitis.
I began getting chills and felt feverish. I also had body aches and pains as when ill with the flu. There was a sense of nausea initially but it went away. There was pronounced feeling of heat located subcutaneously on my right outer thigh. It came and went about every minute or so. (I counted the seconds in between each incident). I am still experiencing flu like symptoms (bodily aches, slight headache, mild chest pain, and general ill-feeling.) I will contact my primary care physician today about my concerns but felt it necessary to document these mild but disturbing side effects.
persistent sensory issues after HPV vaccine. Likely peripheral nerve issue but will report as adverse event. No treatment but will delay second dose until next year 2021.
My daughter received her MMR vaccine on 5/18/2017 and was not sick or symptomatic prior to vaccine. The following day I noticed she was more clumsy than normal. This progressively worsened over the next couple of days where she was stumbling, running into walls and look as if she were intoxicated. A couple of days after the vaccine she broke out in hives and rash all over her body with a fever. There were no new foods to her diet or changes in her environment. Took her to the pediatrician where the denied reaction to the vaccine.