chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upset stomach; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills) 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) dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. /unknown.  Concomitant product use was not provided/unknown by the reporter.
Patient given H1N1 and hives developed red blotchy rash.  to trunk, back and arms within seconds, no difficulty breathing, lungs CTA, 1 tsp BENADRYL given.
HCP put a needle on the syringe, did not use the vaccine, placed it back in the refrigerator, gave the vaccine next day to patient, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of an unknown demographics who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (prefilled syringe) (lot number, expiry date, dose, route and site of administration were not reported), which was stored with attached needle for a day.  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 Device stored with needle attached.   It was reported that HCP put a needle on the syringe, did not use the vaccine, placed it back in the refrigerator, gave the vaccine the next day to a patient.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Patient presented to the emergency department with complaints of an abnormal laboratory result. She was subsequently admitted for further management of C. diff colitis, abdominal pain, diarrhea and leukocytosis. She remains admitted at this time.
Erythema and itching present to left deltoid area 17cm x 20cm. Erythema and itching present to right deltoid area 10cm x 13 cm.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth and red blotches. On an unknown date, the outcome of the injection site pain, injection site warmth and red blotches were unknown. The reporter considered the injection site pain, injection site warmth and red blotches to be probably related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with SHINGRIX a little over a week ago, before the date of reporting. The patient came to the pharmacy before the date of reporting because the injection site was still sore and warm. The patient also experienced red blotches under the injection site. Other information was not available at the time of reporting.
About 2 to 3 hours after received the vaccine the patient says her left arm starting to swell up and become red. It became worse throughout the evening but was improving by the next morning but was still swollen and red. When she went to the pharmacy the next day the pharmacist recommended taking BENADRYL.
ITCHY, SWELLING, LUMP AT INJECTION SITE Narrative: EMPLOYEE STATES: SWELLING, ITCHY, WARM TO TOUCH, RED, HUGE LUMP OF 8CM X 9CM AT INJECTION SITE
Patient broke out into hives with throat closing 3 hours after receiving the flu shot. He was diagnosed with Stevens Johnson Syndrome.
From 12hrs post-injection until 72 hours stomach pain and upset.  At 72 hours colitis hit without warning ( I always have warning before it starts)
After getting the COVID 19 vaccine the lady was diagnosed with cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (After getting the COVID 19 vaccine the lady was diagnosed with cancer) in a female patient of an unknown age 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. On an unknown date, the patient experienced NEOPLASM MALIGNANT (After getting the COVID 19 vaccine the lady was diagnosed with cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (After getting the COVID 19 vaccine the lady was diagnosed with cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Mammogram: normal (normal) Mammogram done three months prior and was fine.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.  Patient had no history of breast cancer in her family as per the reporter.  Assessment is limited due to very scarce information regarding the patient age, medical history, habits, familiar history, exact vaccination date, concomitant medications, type of malignant neoplasm and other risk factors.  Company Comment - This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of neoplasm malignant of unknown type and location. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case.; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of neoplasm malignant of unknown type and location. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case.
Hot at the injection site; Hardness at the injection site; Itchy at the injection site; Redness increased to a size of 2 silver dollar size coin 2 weeks after the vaccination; Patient stated that 2 days after the vaccination, she had dime size redness at the injection site; Patient stated that 2 days after the vaccination, she had mild flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), INFLUENZA LIKE ILLNESS (Patient stated that 2 days after the vaccination, she had mild flu like symptoms), VACCINATION SITE INDURATION (Hardness at the injection site), INJECTION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Patient stated that 2 days after the vaccination, she had dime size redness at the injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Patient stated that 2 days after the vaccination, she had mild flu like symptoms) and VACCINATION SITE ERYTHEMA (Patient stated that 2 days after the vaccination, she had dime size redness at the injection site). On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness increased to a size of 2 silver dollar size coin 2 weeks after the vaccination). 22-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy at the injection site). At the time of the report, VACCINATION SITE WARMTH (Hot at the injection site), INFLUENZA LIKE ILLNESS (Patient stated that 2 days after the vaccination, she had mild flu like symptoms), VACCINATION SITE INDURATION (Hardness at the injection site), INJECTION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Patient stated that 2 days after the vaccination, she had dime size redness at the injection site) and VACCINATION SITE ERYTHEMA (Redness increased to a size of 2 silver dollar size coin 2 weeks after the vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided.  No Treatment information  provided  Patient stated that she had dime size redness which increased to a size of 2 silver dollar size coin 2 weeks after the vaccination.   This case was linked to MOD-2021-256850 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: updated outcome of the events and 2nd dose and its events information
Pt contacted Health Department on 1/18/22 stating that her and her husband have been experiencing tachycardia and a-fib in the middle of the night and early morning off and on. Per pt, the symptoms started about a month after recieving the second Moderna vaccine on 02/26/21. Pt stated that she uses an app on her phone that she places her fingers on the back of and it shows an EKG. She states that her EKG results show up as tachycardic, PVCs, and A-fib at different times. She states that these episodes wake her up in the middle of the night or occur early morning when she is at rest. When asking what her heart rate runs while experiencing this she stated it runs in the 160s. Per pt, she has no underlying health conditions and does not take any medications. Asked pt if she had seen a primary care or any physician since these symptoms started and she stated that she has not seen a doctor. Pt stated that she did not consult with a physician before recieving her Moderna booster on 12/21/21 and that cardiac episodes are still occuring. Educated patient on the importance of seeking a primary care physician to further investigate cardiac symptoms.
Chills, flushing headache, moderate site injection pain, arthralgias, myalgias
Fever; In my vaccinated arm, under my arm started to swell and it is still swollen under my arm; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that, A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Reason for not providing lot number of Covid-19 Vaccine: Other: Consumer stated, it is PP136782 something like that, it is the only number on this paper and expiry date was unknown.The patient medical history and concomitant medications were not reported. The patient experienced fever and in my vaccinated arm, under my arm started to swell and it is still swollen under my arm on an unspecified date. The number of Covid-19 Vaccine is Unknown. When probed for the concern, consumer stated that, I received my second dose of Pfizer on Tuesday and like I had fever like that stuff that it's ok now, however since yesterday afternoon under my arm in my vaccinated arm, it started to swell and right now when I woke up it's still swollen under my arm. I do not know if it's like one of the side effects of my vaccine or not, this is the first time happened. My arm didn't swell or anything before, so I would like to know if it is ok. When paraphrased the concern, consumer stated, Yes, just after (vaccination) like the next day. Consumer was informed about the Role of Pfizer Drug Safety and Pfizer Medical Information Department and stated, I just need to know why it is swollen and if it is okay or not. Consumer was provided with the number of Pfizer Medical Information # #and was requested to select option 3 and timings as 8 am to 8 pm from Monday to Friday as per (EST). As consumer was not willing to proceed the call. Product details (Expiration date, number), Pharmacy details and treatment could not be probed over the call. Limited information available over the call. This report is not related to a study programme. When probed for vaccine LOT#, consumer stated, it is PP136782 something like that, it is the only number on this paper and When probed for consumer's mailing address, consumer stated, it is 2237, why do need that, I don't want to provide my any personal information. Vaccine name (Both doses vaccine): Pfizer, Covid-19 Vaccine. Outcome of the events was Unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Hours after injection of PNEUMOVAX patient states the arm was quite painful to move, states the injection site was fine but below it was red, warm, hard lasted 2 days.
Headache, Myalgia, Fever, Lightheadedness, fatigue Narrative:
after 1st shoot got  dizzy. after 5 or 6 days  .after .secound shot  got so dizzy  on the7 day after the shot . I went in to hospital.
SORENESS, ACHY, CAN NOT LIFT UP LEFT ARM, EXTREME PAIN.
to er due to altered mental status and acute on chronic subdural hematoma .  tested + for covid.  12-6-22    was placed on nonheroic measures and comfort care and hospice and deceased on 12-13-22 at in patient hospice medical center  Presented to the er initiallly with altered mental status
Rash appeared on arm one week after the injection. It was approx 6x4 inches. The area was  red, raised, hot to the touch and extremely itchy. Treated with ice packs, cortisone cream and Benadryl. As of today area is much improved but not completely resolved.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates in 2017, reported as since 11-JAN-2017, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot number: M038226, expiration date: 07-SEP-2018 and lot number: M035688, expiration date: 10-AUG-2018; dose and route of administration were not provided). Other suspected therapy included sterile diluent (also reported as "diluent that was used to reconstitute the doses") (manufacturer unknown) (strength, dose, route of administration, lot number and expiration date were not provided). The nurse reported that there were multiple unspecified temperature excursions on unknown dates. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015097:
on the day 04/09/2021 i had vaccine done 11:AM.On 04/09/2021 that night after i got home from works around 6:30pm i felt a little headache then right after i took shower i was chilled and shaking then i crabbed a thick cloths to wear and took an Advil  and it slow down until mid night it stared one more time its chilling.The next day on 4/10/2021 i feel fine but some miner headache here and there and today too on 04/13/2021.i am worry incoming years how will it ends.
5 day history of congested sinuses, headache, running nose, post nasal drip, throat irritation and minimal productive cough without fever SOB or CP starting on 9/5/21
Feeling hot; Nausea; A spontaneous report was received concerning a 56-year old, male patient who received Moderna's COVID-19 vaccine and experienced nausea and feeling hot.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 05 Jan 2021, during his 15-minute waiting period after the injection, the patient began to experience nausea and feeling hot. The patient was assisted in the emergency bay area and monitored for severe reaction symptoms. The patient drank water and was feeling better within a few minutes.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, nausea and feeling hot, were considered as recovering.; Reporter'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.
Migraine, Dizzy, Nausea, Rash across chest, extremely sore arm at injection site, flush fever like
onset of intense lt arm pain hrs p/vax in that arm; by evening pt had severe total body myalgias & fatigue; hospitalized in our infirmary for 2 days;
chest tightness and voice change 15 mins after the booster dose. pt received 2 doses of epinephrine (10 minutes apart)
His left thigh started with a small local reaction and now 2/3 of his thigh is red, swollen and warm to the touch.    Per PCP, these reactions are self- limited and are generally treated with cold or warm compresses, symptomatic treatment with antihistamines if itching, and corticosteroid topically to reduce warmth, erythema and tenderness, particularly if the reaction progressed over several days. Oral steriod was prescribed. Outcome unknown at this time.
Heaviness all over--more pronounced in the chest.  Next day sore throat, stuffy nose and thick mucus
Have had a headache since a day or two after the vaccine which I have been treating with acetaminophen and ibuprofen. I also have had difficulty breathing. I have asthma and have had to use my emergency inhaler multiple times a day with very little relief. I had to start using my nebulizer for better relief.  I reached out to my doctor and am waiting to hear back.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-DEC-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about "September 10, 2014" (note this is prior to reported vaccination date), the patient was treated at a health center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt stated he started to have weakness starting from right leg and then the right arm. Pt was taken to Medical Center by his father on 10/25/11 and had CT scan of head, CBC, and CMP done, results normal.  Pt was referred to another Medical Center to follow-up with Pediatric neurology and for MRI of spine for 11/9/11 for further evaluation.
Started getting a bad sore throat on Sunday, March 21st that lasted through Wednesday, March 24th.  Was tested on Tuesday, March 23rd for covid and strep and both were negative. On the 24th I noticed white/yellow spots on my tongue and was diagnosed with oral thrush on March 25th. I have never had oral thrush in my life and the urgent care said it might have been the way my body reacted to receiving my first dose of the vaccine.
PATIENT STARTED TO EXPERIENCE LOWER EXTREMITY LEG PAIN SHORTLY AFTER RECEIVING BOOSTER PFIZER DOSE.  HE WENT TO THE ER 5 DAYS POST VACCINE AND WAS DIAGNOSED WITH LOWER LEFT LEFT DVT. PATIENT CONTINUED XARELTO THERAPY 20MG DAILY. PATIENT WAS ALREADY ON XARELTO 20MG DAILY FOR PREVIOUS DVTS (SINCE 2007).
A minute later after flu vaccination patient had a muscle knot at injection site. Patient was instructed to see a RN at health office right away and asked to put an ice pack on injection site. RN from health office has notified RN hosting the Flu Clinic, that patient's muscle knot has gone down and patient feels fine.
I went to do my annual physical on 5/31/21 and the following symptoms got worse: Nausea, muscle pain, high temperature, cough, chest pain, and pain in the left side of the stomach.
Injection site reaction: pain swelling and redness, Difficulty moving the shoulder, Pain upon movement  Next day it started getting worse, Unable to move torse and hips, During the 1st week of november the patient was also being treated for UTI and received a Rocephin injection from the doctor's office. Patient is now hospitalized as she was unable to walk, trouble balancing, and having tingling and numbness upon touch to her labs.
Employee reports diarrhea and bruising to site where she received her flu shot.  Per agency have the employee follow-up with panel provider.  vaccination was received approx 2 weeks prior to report.  Now reports all symptoms resolved.
Extreme arm pain- cannot move arm- could not sleep due to pain- cannot get himself dressed- took motrin to help the pain but over 24 hours later and still in a lot of pain
redness and swelling around both eyes.   the swelling became visually evident 3 days after the vaccine was administered and has gotten progressively worse since then.
COVID 19; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 12Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "COVID 19"; COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.