chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; fatigue; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02NA21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, CEFUROXIME (MAXIM [CEFUROXIME]) for Indigestion.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever). At the time of the report, MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101 degree f (abnormal) 101 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information regarding corrective treatment was reported by the patient.
Hep-B booster received at 19:30. At 01:00, child awoke yelling "everything hurts" and fever of 102.5F. Fever continued at 101F for 3 days with nausea. Fever came back over 2 weeks. Also had headache and weakness for 3 weeks and sleepiness.
Hearing Issues ranging from Simple to Serious  after vaccination; Ear Infections ranging from Simple to Serious  after vaccination; Fluids in the Ear ranging from Simple to Serious  after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOACUSIS (Hearing Issues ranging from Simple to Serious  after vaccination), EAR INFECTION (Ear Infections ranging from Simple to Serious  after vaccination) and MIDDLE EAR EFFUSION (Fluids in the Ear ranging from Simple to Serious  after vaccination) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HYPOACUSIS (Hearing Issues ranging from Simple to Serious  after vaccination), EAR INFECTION (Ear Infections ranging from Simple to Serious  after vaccination) and MIDDLE EAR EFFUSION (Fluids in the Ear ranging from Simple to Serious  after vaccination). At the time of the report, HYPOACUSIS (Hearing Issues ranging from Simple to Serious  after vaccination), EAR INFECTION (Ear Infections ranging from Simple to Serious  after vaccination) and MIDDLE EAR EFFUSION (Fluids in the Ear ranging from Simple to Serious  after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information was not provided
SEVERE HEADACHE ON LEFT SIDE OF HEAD STARTED ABOVE LEFT EYE MOVED TO LEFT EAR.
I started feeling dizzy on Wednesday March 17th. I took meclizine over the counter then saw an online dr on Wednesday the 24th and was prescribed meclizine. I am still feeling dizzy on the 26th.
Information has been received from a physician concerning a 9 year old male patient with a history of seizures who was vaccinated with a dose of VARIVAX (Merck) (route and dose not reported). The patient came back in the office with eye issues on an unspecified date. The outcome of eye issues was not reported. Additional information has been requested.
LEFT ARM WITH LOCAL REACTION- 5 1/2CM X 5 1/2CM AREA OF REDNESS AND INDURATION; WARM TO TOUCH, LOW GRADE FEVER
aches and pains (headache/hips), fever (101.6), loss of smell, nausea, low temp (95.5)
7-12 Received vaccine. 7-13 - 7-15 c/o nausea vomiting once a day, stomach pain with h/a's no dizziness or fever present.
2 days after vaccine administered 10/28/09, reaction at site of administered muscle L deltoid, red, swollen, pain, induration, warm compress. Seen 11/6/09 with all except slight induration resolved.
FEVER 102.8, CHILLS, HEADACHE AND BODY ACHES LASTED 48 HOURS LEFT ARM SWOLLEN FROM SHOULDER TO ELBOW, BRIGHT RED, PAIN AND ITCH STILL SWOLLEN, RED , PAINFUL AND ITCH
No adverse event reported. Patient received TWINRIX on 10/26/18, 12/26/18, 12/31/18.
Patient diagnosed with COVID-19, confirmed by PCR; Patient diagnosed with COVID-19, confirmed by PCR/ Vaccine Failure; This is a spontaneous report from a contactable physician. A 74-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on an unspecified date as single dose, then second dose on 19Feb2021 (lot number and expiration date not provided) intramuscular, administered in right arm on as single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. On 14Apr2021, the patient was diagnosed with COVID-19, confirmed by PCR. The patient was hospitalized for four days and received steroids and Remdesivir as treatment medication. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.
Painful lymph nodes on the armpit and neck 24 hrs after the vaccine; rash on the left flank within 48 hrs that later on diagnosed as shingles; rash on the left flank within 48 hrs that later on diagnosed as shingles; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 10:00 (Lot number: 30155BA) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chicken Pox" (unspecified if ongoing); "Post Partum Depression" (unspecified if ongoing); "Epicarditis" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 20Nov2021 10:00, outcome "recovering", described as "Painful lymph nodes on the armpit and neck 24 hrs after the vaccine"; HERPES ZOSTER (non-serious), RASH (non-serious) all with onset 20Nov2021 10:00, outcome "recovering" and all described as "rash on the left flank within 48 hrs that later on diagnosed as shingles". The events "painful lymph nodes on the armpit and neck 24 hrs after the vaccine", "rash on the left flank within 48 hrs that later on diagnosed as shingles" and "rash on the left flank within 48 hrs that later on diagnosed as shingles" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymph node pain, herpes zoster, rash.  Additional information: The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient did not have any known allergies. The patient was tested for covid-19 since vaccination and results were unknown. The patient received treatment with Valtrex, Norco, Gabapentin, Prednisone, Advil for reported events.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker-Office Manager refers to an unspecified number of patients. The office manager reported that multiple unspecified patients received MMR II injection (confirmed Lot# K021152 and exp. 02-JAN-2016) (dose and route of administration not reported) that were improperly stored. No adverse effects reported nor PQC was involved. Additional information has been requested.
Immediately following vaccine (about 4 mins) patient passed out - hit her head on a table then concrete floor. health Unit called emergency and she was taken to local hospital. Doctor stated no internal injuries but she still has bruising on body and a lump on her head.
SWELLING OF LIPS . BILATERAL ARM ITCHING. TOOK OTC BENADRYL AT HOME. LIP SWELLING DECREASED BY OFFICE VISIT 10/30/2009.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient (greater than 65 years of an unknown gender) who received an expired dose of vaccine FLUZONE HD lot number not reported (dose, expiry date, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Expired vaccine used. It was reported that gave High dose vaccine to a patient greater than 65 but then realized it was from last year's stock (expired date High Dose vaccine from last year). Did not report any adverse event with the vaccine. 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 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.
Patient developed pneumonia Admitted to hospital on 12/25. Determined to have pseudomonas bacteremia and passed away on 12/27.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache".  Additional information: Caller had 1st shot yesterday and was told not to take any aspirin. Now has headache and wondering if she can take aspirin. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4/30/19: The patient's mother noted a red rash which developed the morning of the visit on his face and body.  The rash is blanchable, ~.5cm, erythematous papules, scattered distribution, no palm or sole involvement, no oral lesions. No fever, no cough, no conjunctivitis.  Afebrile today.
This spontaneous report as received from a physician refers to approximately 9 patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (dose, route and lot # not reported) that were out of temperature range for 7 days. No adverse effects were reported. Additional information has been requested.
Vigorous local reaction with arm swelling and erythema, subjective fever, myalgias, general malaise. Noted symptoms within a few hours of injection. Eval 9/26/04 when progressive symptoms. Treated with Keflex/oral Prednisone.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 17-SEP-2014 expired sterile diluent (MSD) (lot #: G012930, expiration date March 2014) was used to reconstitute ZOSTAVAX and was administered to a patient (dose, dose number, route, anatomical location, lot number and expiration date were unspecified).  No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
itching at the injection site; swelling at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) 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 14-May-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 INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Patient states received MMR and Hep B vaccines on Oct 6, 2006.  In the next 48 hours her joints felt stiff, achy and she felt dizzy.  On Oct. 9 she began to have numbness entire length of left lower extremity, with her knee feeling weak.  She has a history of Multiple sclerosis with a remote episode in the past affecting the R lower extremity.  She is on no treatment for MS.
experienced a headache; This is a spontaneous report from a contactable consumer (Patient's wife).   A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 05Apr2021 as 1ST DOSE, SINGLE for a covid-19 immunisation (Age at the vaccination 81-years). The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. Reporter wanted to know if her husband can take any pain reliever. It was reported that she called doctor's office and they said it was ok. It was also mentioned she went to have her second Pfizer vaccine today and they told her to wait 24 hours before taking any Advil/Aleve/Tylenol. It was reported that patient took Motrin 5 hours after he had the vaccine. The outcome of event was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Headache began 9/13/21, dull and continuous, then fever started 9/17/21 (still had headache). On 9/22/21 my head started to "buzz" and will not stop. Fever stopped around the same time as buzzing started. Headaches now come and go. Other symptoms currently experiencing are brain fog, unable to focus/concentrate, poor sleep waking up often and unable to get back to sleep. Unable to work at my job. Applied for short term disability for now.
Patient lost color in his face and felt very dizzy/lightheaded immediately following vaccination. Patient displayed symptoms of sweating and physical chills. He also complained of slight nausea intermittently.
Influenza vaccine given at 0900, employee reported history of anxiety with shots.  Sat for 2 minutes after shot, reported feeling fine.  After walking back to the unit, employee reported feeling dizzy, weak and lightheaded for about one and a half hours.  BP was 70/? when checked. Employee does not remember diastolic.  Employee reports symptoms resolved spontaneously and at 12:30pm when speaking with employee to f/u no symptoms noted at all.
5 hrs after receiving this flu shot I had severe chills and went to bed. My husband covered me with 4 blankets and it didn't help at all. My temperature at that time was 100.4. As time progressed my fever increased to 102.4, and I began vomiting and having breathing issues. I vomited everything I had eaten that day. I was laying on raised pillows and had difficulty breathing for about 45 minutes. The next morning my temperature was 100.0. I get the flu vaccine every year. I've never had such a reaction to flu vaccine before, just a little achy if anything. Nothing like this, and this is why I didn't hesitate to have the vaccine.
Information has been received from a physician who heard from another physician in another city, concerning a patient vaccinated with a dose of GARDASIL (route, site, dose# and Lot# not provided). Subsequently the patient experienced anaphylactic reaction. The patient sought unknown medical attention. The patient's outcome is unknown. Additional information is not expected.
felt really super fatigue; Chills; Headache; arm was a little sore/there was tenderness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (arm was a little sore/there was tenderness at injection site), FATIGUE (felt really super fatigue), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE and VITAMINS NOS for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was a little sore/there was tenderness at injection site). On 26-Mar-2021, the patient experienced FATIGUE (felt really super fatigue), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 26-Mar-2021, FATIGUE (felt really super fatigue) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was a little sore/there was tenderness at injection site) was resolving and CHILLS (Chills) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021 contain no new information
Patient presented with weakness, and eventually Lhermitte's sign - She soon developed bilateral lower extremity sensory loss from T10 dermatome down. Gait instability has continued, as well as stool incontinence.
Patient presented on 6/25/12, with complaints of arm pain after receiving ZOSTAVAX injection 6/21/12. The area was red and warm to the touch. The red area was spreading, itching, and painful, treated with Antibx, ALLEGRA and cold packs.
Last week, I woke up on Thursday morning, with a sore throat and head pressure. Also my voice was gone. I went to Urgent Care and had a visual exam. I was diagnosed with a sinus infection - they saw the post nasal drip. They prescribed me amoxicillin and Prednisone that I took for five days and I'm still on amoxicillin (had a 10 day course of that).
Rash x 5 days generalized lower extremities, burning right thigh, raised blisters away from site.
o Full body violent chills lasting from 3:15PM-4PM. o Temperature reading of 100.8ºF at 3:35PM, 101.8ºF at 4:15PM, 101.8ºF at 5PM, 101.1ºF at 5:25PM o Took 3-325mg Extra Strength Tylenol at 3:55PM and have been drinking Gatorade and water. o Oximeter at 3:45PM was 94 and then climbed up to 98 after 5 minutes. Took a while to get a reading due to the violent chills. o Blood pressure: 103/72 pulse 69 at 3:56PM, 95/57 pulse 68 at 4:44PM, 97/60 pulse 76 at 5:35PM.
dementia; Alzheimer; Loss of memory; Loss of energy; chills; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia) and DEMENTIA ALZHEIMER'S TYPE (Alzheimer) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (dementia) (seriousness criterion medically significant), DEMENTIA ALZHEIMER'S TYPE (Alzheimer) (seriousness criterion medically significant), AMNESIA (Loss of memory), ASTHENIA (Loss of energy) and CHILLS (chills). At the time of the report, DEMENTIA (dementia), DEMENTIA ALZHEIMER'S TYPE (Alzheimer), AMNESIA (Loss of memory), ASTHENIA (Loss of energy) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  As reported, the patient was healthy, extremely active, a professor (still teaching), he was biking. Almost overnight, he went into dementia/Alzheimer's with loss of memory, loss of energy, chills. The symptoms had not gone away.  Company comment: This is a spontaneous case concerning an elderly male patient with no medical history reported, who experienced the unexpected serious events of Dementia/ Dementia Alzheimer's type with unexpected non-serious events of Amnesia and Asthenia and expected non-serious event of Chills after the unspecified dose number of mRNA-1273 vaccine. There were no diagnostic findings to support the reported events. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-449363 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an elderly male patient with no medical history reported, who experienced the unexpected serious events of Dementia/ Dementia Alzheimer's type with unexpected non-serious events of Amnesia and Asthenia and expected non-serious event of Chills after the unspecified dose number of mRNA-1273 vaccine. There were no diagnostic findings to support the reported events. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No adverse effects reported; patient was inadvertently administered one dose of Varivax concomitantly with Proquad; patient was inadvertently administered one dose of Varivax concomitantly with Proquad; This spontaneous report was received from a pharmacist and refers to a 17-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-OCT-2019, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one dose, lot # S019461 and expiration date 24-JUN-2021 (exact dose, site and route of administration were not reported) concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot # S017245 and expiration date 01-DEC-2020 (exact dose, site and route of administration were not reported) both for prophylaxis. No adverse effects were reported.
01/10/22 presents to ED for "cough shortness of breath". PMHx of " type 2 diabetes, renal transplant, hypertension, peripheral vascular disease status post right BKA"
rash all over body (giant hives) also on face swelling of both knee joints, tender to touch elevated temp 102; rx w/DPH;