chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm hurt; Sinusitis; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE PAIN (Arm hurt) and SINUSITIS (Sinusitis) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Sinusitis.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever). On 11-Jan-2021, the patient experienced SINUSITIS (Sinusitis). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt). The patient was treated with GUAIFENESIN (MUCINEX) ongoing since an unknown date for Sinusitis, at a dose of 1 dosage form and PREDNISONE ongoing since an unknown date for Sinusitis, at a dose of 1 dosage form. On 09-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm hurt) outcome was unknown and SINUSITIS (Sinusitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Existing current sinus disorder prior to vaccination is considered a confounder for the event of sinusitis.
I developed chills 14 hrs after the 2nd dose of the Covid-19 vaccine, then later also experienced a low grade fever of 99 degrees F. Throughout the second day, I experienced headache and fatigue that did not alleviate until the morning of the third day.  After the headache and fatigue alleviated, I noticed a large swollen gland under the left armpit.  This slowly diminished over time and was mostly gone by the fourth morning.
Expired vaccine was administered. Patient was notified 8/18/22 and offered repeat dose per CDC recommendations. This was his 4th dose.
I started getting a little horse and congestion and then headache and sore throat followed with light chills. No fever just elevated, I never had any problems sleeping but I still have a cough. I had the symptoms a couple days and I took a home COVID-19 test and I went to the urgent care clinic and they gave me a COVID-19 test there and I was positive and they prescribed PAXLOVID for 5 days. I gave it to my wife and she was not happy about that so after 5 days I went to our lake house and stayed there.
he experienced arm soreness.; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EL9264), dose 1 via an unspecified route of administration on 30Jan2021 (at the age of 48-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included eczema and rosacea. Patient's concomitant medications were not reported. The patient experienced arm soreness on 30Jan2021. Patient did not receive any other products. It was reported that, patient took supplements and vitamins. He added that he had medication and creams for eczema and rosacea. He has had them for years. They were as needed only. He has not used them recently. It was also reported that the Lot is handwritten on the vaccine card and the last character is a bit off. It is either a U or 4. NDC and expiry are not documented on the vaccine card.  Outcome of event was recovered on 01Feb2021.   No follow-up attempts are needed. No further information is expected.
Patient tested positive for COVID 19 on 7/10/2021 in the Ed and was discharged home with instructions to return if his respiratory status changed. He came back into the ED on 7/13 and was admitted to our PCU for fevers, chills, fatigue cough and worsening SOB.  This patient live half of the time in a different state where his PCP is located.  He is still currently hospitalized and requiring heated high flow oxygen at 100% FIO2 at 70L.  O2 saturations between 92-88.  Patient was upgraded to ICU on 7/16 and vented. 7.23.21: Patient is still admitted at the time of this form submission.
Case number PHEH2013US017431 is an initial spontaneous report from the pharmacist received on 14 AUG 2013. This report refers to a patient of unknown age and gender. On 14 AUG 2013, the patient was accidentally  vaccinated with Men A lyophilized conjugate of MENVEO (batch number: M12009) mixed with sterile diluent instead of MenCYW-135 liquid component. No adverse reaction reported following this medication error. No other information was available.
He has like crippling arthritis; He is in pain; can hardly bend or walk.; This case was reported by a consumer via media and described the occurrence of arthritis in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2021, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced arthritis, pain and walking difficulty. On an unknown date, the outcome of the arthritis, pain and walking difficulty were unknown.   It was unknown if the reporter considered the arthritis, pain and walking difficulty to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient´s cousin. The age at vaccination was not reported but patient was in his 50's. The patient received shingles vaccination about a month ago of the reporting date and had a bad reaction a few days after the shot. The patient had like crippling arthritis, He was in pain and could hardly bend or walk. The patient did not have this before the shot.  The patient could not get in to see a specialist for five months. The follow up would not be possible as no contact details were available.
First 3 days felt like "Tetanus shot" - hot and painful, red. On 4th day, noticed a tiny dimple in middle of (L) deltoid. Started getting bigger and remained sore. Presently 2 cm deep and 2 1/2 in round. Saw ID doc - no infection. Seen at urgent care. US on 12/14.
Received Pfizer vaccine left arm on Friday 11/19/21 at 2:30pm that evening around 11:00 pm on 11/19/21 started with a small itch.  Over the period continued to itch in arm site and then it went over my upper body to top of legs. i continued to try to treat self with OTC products even treating it like dry skin.  Nothing had helped.  By this time i have rash and hives and sever bruising in upper and lower body with pain due to allergic reaction.  I went to urgent care and dx with allergic reaction to the COIVD Vaccine.  Was prescribed high dose of prednisone, Prednisone cream and Hydralazine for 14 days
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, lot number, expiration date were not reported). On an unknown ate, the patient's mother in law broke out in shingles. Then the patient broke out in shingles (date was not reported). The outcome of the event was not reported. Causality assessment was not provided. Additional information has been requested.
Patient came to the pharmacy and reports a rash migrated 2" below the injection site. Patient came to the pharmacy and showed the  rash and it was 2" below the injection site with 2" perimeter, round, and warm to the touch. Patient reported that it did not hurt, but felt warm. Recommended patient to put cold compress onto the area and report the emergency room if severe symptoms occur.
pt recvd vax; devel severe local rxn & redness at inject site; also exp fevers & body aches;
2-3 days after receiving the Johnson and Johnson vaccine, the muscle underneath my right eye began twitching and it has twitched continuously since then without ceasing.  It twitches all day and night and has not stopped even for a short period of time.
I was hospitalized for having a stroke; Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:00 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 28Sep2022 at 17:00, outcome "recovering", described as "I was hospitalized for having a stroke"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2023, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2023) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident included anti-coagulant Aspirin.  Clinical information: Patient had no known allergies. No covid prior vaccination. No other vaccine in four weeks.
ECZEMA OUTBREAK WORSE THAN USUAL THAT LASTED A COUPLE OF MONTHS INSTEAD OF A FEW DAYS; SORE ARM ABOUT TWO DAYS; FEVER THE NEXT DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included mild eczema outbreak. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per Procedure, no follow up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the subject experienced eczema outbreak worse than usual that lasted a couple of months instead of a few days, sore arm about two days, and fever the next day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eczema outbreak worse than usual that lasted a couple of months instead of a few days, sore arm about two days, and fever the next day. This report was non-serious.
Adverse Event: Patient was given 3rd covid dose, vaccine was expired by one day. Per Pfizer there is a 2 day window for expiration date. Team was notified about expired medication on 4/11/2022.  Patient reports not signs or symptoms of adverse reactions.
pt recv vax 29JUL97 5PM & in AM 30JUL97 pt awoke w/hives;no tx given;
At 07:00, on 7/6/02, temperature was 105F (ax) (digital reading) and gave Tylenol. Two hours later, it was 105.4F and gave Motrin. Four hours later, at 13:00, it was 105F again and gave Motrin throughout the day. Fever on 7/7/02 was 100.6F. The next day, no fever.
Receive vaccination 1:00 p.m. April 21st 2021. No adverse effects until waking the next morning. Sore, itchy arm at injection location. Unable to move arm up or down. Flu-like symptoms, nausea. Body and joints sore. Lack of energy. All symptoms gone within 48 hours.
Fever, chills, body ache, redness on arm that spread to entire upper arm over the course of 3-4 days
Pt came into clinic 2 days after receiving shingles vaccine. She had redness, swelling and heat at injection site.
Sore around infection site, started the next day after vaccination (2/17), no treatment, lasted about 4 days. Minor headache, started one day after vaccination (2/18), no treatment, lasted about 4 days. Vomited once, the morning one day after vaccination (2/18), no treatment. Nausea, started one day after vaccination (2/18), no treatment, lasted about 2 days.
Severe left arm pain, myalgias, weakness, fever, fatigue. Treated with Tylenol, Motrin and rest. Missed 1 day of work.
Swelling and redness covering entire lateral aspect left upper arm, from shoulder to elbow. Warm to touch. Cool compresses applied by pt.
This spontaneous report as received from a registered pharmacist refers to a 64 year old female patient with Thimerosal allergy. On 05-Sep-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001698, Exp date 08-May-2014), subcutaneous, dose and frequency unspecified. Concomitant therapies included amoxicillin. In September 2013 the patient developed a rash at the injections site of the ZOSTAVAX vaccination. The rash was described as a bright pink, raised oval area at the injection site of the ZOSTVAX vaccination about 2 ¼ inches across, not blistered and not itchy. There was no lab diagnostics studies performed. Patient contacted pharmacist and their physician for medical attention. The outcome of the event was reported as recovering/resolving. The patient informed the reporter that they were to get a Computed Tomography (CT) scan on 06-SEP-2013, but the CT scan was canceled due to the rash. The patient informed the pharmacist that they went to their physician (name of physician unspecified) on 06-SEP-2013 after the CT scan was canceled. This is one of several reports received from the same reporter. Additional information has been requested.
tingling feet; Experiencing sore arm; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer sponsored program COVAX US support.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported; Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tingling feet and experiencing sore arm. The patient reported she has no doctor or no insurance as also their ER is full with unvaccinated people. Told (withheld) that a nurse or Pharmacist could also call Pfizer regarding this concern. She did not want to provide any further information. She just wanted to know if the events were normal and if they have any report on sore arm and tingling feet. She denied providing her birth date, address and email. Reporter seriousness for the events were unspecified. Outcome of the events were unknown.  Follow-up (26Aug2021): This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable female consumer (patient) reported for herself included clinical information.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Platelets dropped to 98,000 and white blood count dropped to 3.0 less then 48 hours after vaccination  Routine blood work had been scheduled and revealed the changes noted. Left arm soreness, no fever, slight fatigue reported. 7 days later CBC was repeated and platelets now 159,000 and white blood cells 5.4 No treatment.      Full recovery
Patient describes the onset of sharp stinging pain in the left elbow when bending/extending the elbow.  Pronating and supinating forearm did not cause pain.  Pain was described as intense, "lightning bolt" pain severe enough to cause tears.  No redness, swelling of joint was observed.  There was no redness, inflammation or tenderness at the site of the injection.  She was treated with ibuprofen and limitation of use and symptoms had resolved by 8/19/2021.
Information has been received from a 55 year old male who on approximately 19-OCT-2010 (6 month ago") was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) into his non dominant left arm. The reporter stated that he had a "very benign headache" after getting vaccinated with ZOSTAVAX (Merck) 6 months ago. He stated he did not need to take any medication and the headache resolved. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Disness, diarrhea,  headache (very intense), fever, vomiting, shaking chills, body ache (very intense, can't barely stand)
4/29/21 Emergency room visit-Chest pain, fluid in pleural cavity, inflammation of the covering of the heart. Discharged from the ER with Colchicine 0.6mg tablet (2x/day), indomethacin 25mg capsule (3x/day), pantoprazole 40mg (1/day).  Visited primary health provider  on 5/25/21 who added prednisone to help with the inflammation.  Visited the ER on 6/4/21 with chest pain and atrial flutter.  Admitted to hospital to control the heart rate with Eliquis 5mg(2/day), colchicine 0.6mg (2/day), digoxin 125mcg 1x/day, diltiazem 180mg 1/day, indomethacin 25mg 3xday, metoprolol 50mg 2/day, pantoprazole 40mg 1xday.
Moderna Covid-19 Vaccine. Between 24 and 48 hours after the shot, about 3 inches below the injection site, I noticed my arm began swelling, getting very red, and radiating heat in patches. Over the next few days, it grew until it completely covered from the middle of my upper arm to my elbow. Sunday, March 28th, the redness and swelling is fading finally but still noticeable. Also the 3 nights following my shot, I dealt with severe lightheadedness and dizziness, but only at night
No adverse event; Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine)).    No concomitant medication was reported. Suspect vaccine was Bivalent BA.4-5 Blue Cap. It was reported that suspect vaccine might administer on another date in Jun-2023.  Vial size was reported as 2.5 ml.. Vial was initially stored in the refrigerator on 07-Jul-2023 which was less then 30 days of administration of vaccine. Vial did not undergo any temperature excursions. Expiry date was reported as 01-Jun-2023.  Suspect product dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 4th out of 5 patients.      This case was linked to US-MODERNATX, INC.-MOD-2023-732775, US-MODERNATX, INC.-MOD-2023-732775 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732775:master case US-MODERNATX, INC.-MOD-2023-732775:case for Patient 4
We had wellness day and had a vaccine drive. During the event we gave a Flublok to a 14 year old teen. She told me she had an egg allergy and I asked if she got the shot before and she said yes.  I assumed it was Flublok, and went back to the pharmacy to get it and gave it to her. Then after the event it dawned on me that Flublok is 18 years of age and up. I looked it up and it has been tested in children but not approved.  I contacted the father of the child to let him know about the situation. I also contacted the manufacturer to get more information about the use of Flublok under the age of 18. The manufacturer confirmed that it is comparable to the original, well-tolerated to the fluzone quad, and no adverse event had occur in patients under 18. The manufacturer also confirm that it does not need to be repeated.  No real medical adverse event occured.
pt returned to clinic about 2hrs after vaccination with complaint of pruritis and rash on face, trunk & arms. Pt devloped erethematous macular rash & discrete wheals on face, chest, back, abdomen and upper extremeties & wheals on lower extremities.  Pt received 50mg Diphenhydramine IM and was sent home with diphenhydramine 25-50mg po q6h prn.
Information has been received from a consumer concerning his approximately 78 year old wife with lymphoma diagnosed in February 2007. The patient was underwent chemotherapy and radiation. In December 2007 she experienced a recurrent lymphoma and was prescribed oral chemotherapy from January 2008 to May 2008. In October 2008 she was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Several weeks later, she was diagnosed with leukemia and experienced recurrence of lymphoma. On an unspecified date she was hospitalized. She received unspecified treatment which was unsuccessful. The patient died on 01-JAN-2009. The cause of death were Lymphoma and leukemia. No further information is available.  10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. DC DX: Lower back pain-resolved, fever-resolved, UTI-resolved, dental abscess, malnutrition. Presenting SX: pt c/o pain in back and both hips. Assessment: Pt found to have fever. Pt treated for current medical conditions and acute conditions and DC to rehab facility.    10/15/09 Medical records received for date of service 10/9/08.  Shingles (Zostavax) vaccine administered on 10/9/08.  Physician reports that pt. did not call office to report an adverse reaction.  10/21/09 Death Certificate DOD 1/1/2009. Myelodysplastic syndrome. Acute myelogenous leukemia. Anemia.
Narrative:  Patient admitted from nursing home to hospital floor due to COVID+ PCR. Patient presents with mild sore throat. Treatment includes throat lozenge PRN sore throat.