chrisvoncsefalvay/vaers-outcomes huggingface dataset:
few minutes of  vaccine administration headache occurred , then lightheadedness .  nurse checked my vitals highest above 200/110  pulse above 100 .  then feeling of itchy throat , then both lower legs and lower arms felt cold.  all within 20 mins of administration. i was transferred to urgent care after given tylenol 1 gm.  in urgecare headache and dizziness worse.  toradol iv and normal saline bolus given. toradol iv helped  with headache but dizziness still . i was unable to drive home. came home still dizzy .  i asked for epi pen to be rx.     i took benadryl at bedtime to see if it helps with reaction.  woke up today with dizziness and body aches . tylenol helped with body aches .  night time dizziness minimal.
On the 16th, I woke up feeling unwell. I took a COVID-19 test. The result was positive. My wife called the doctor and requested PAXLOVID. They called it in the pharmacy. I received it within the hour, and I immediately started treatment. I took it twice a day for five days. During that five-day period, I had no symptoms. On Wednesday, the 21st, I tested negative for COVID-19. Immediately after I tested negative, I didn't have any other short-term effects. For the past month, I haven't had any lingering effects either.
A bad looking rash was spreading from the injection site on my left arm. I went to the drug store to look for some Benadryl, and a pharmacist there who saw the rash said I should definitely get it looked at by my doctor.
pt came back to clinic 16JUL96 c/o soreness in inj site;also c/o some numbness in rt arm off & on since 14JUL96;some redness & swelling noted in inj site;about 2 inches in diameter saw by clinician @ clinic advised to use cool compresses;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CHILLS; TIRED; This spontaneous report received from a patient concerned a 60 year old male and unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included: pollen allergy, dust allergy, allergic to Iodine and drug allergy (sulfamethoxazole/trimethoprim). On 09-MAR-2021 at 10:45 AM, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm for prophylactic vaccination. Age at time of vaccination 60 years old.  Concomitant medications included rosuvastatin. On same day, the patient experienced chills and was tired after vaccination about 3 hours after administration (dose number in series 1). On an unspecified date, the patient experienced suspected clinical vaccination failure (dose number in series 1). On 28-NOV-2021, at 10:00 AM, the patient received non-company suspect vaccine included: elasomeran (moderna) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 027H21B expiry: UNKNOWN), dose was not reported, administered to left arm prophylactic vaccination. Age at time of vaccination 60 years old.  On same day, the patient experienced chills and was tired after vaccination about 3 hours after administration (dose number in series 2).  On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2).  On 13-JUN-2022, the patient received non-company suspect drug: Paxlovid) (form of admin and route of admin were not reported, batch number: GA3594 expiry: UNKNOWN), dose was not reported, administered for treatment of COVID-19 and discontinued on 17-JUN-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and elasomeran was not applicable and with Paxlovid was drug discontinued. The patient recovered from chills, and tired, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220657867-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
inconsolable crying for 2 hrs rt p/shot then fell asleep okay p/resting; APAP given a/shot & 4 hrs p/1st dose;
Myalgia Dose 1: soreness at injection site, chills and body aches.  Narrative: Dose 1: soreness at injection site, chills and body aches.
Patient was in observation area after vaccine administration. Twelve minutes after vaccination, he fell to the floor and appeared to be having a seizure. Staff protected him from injury, and administered oxygen, and called EMS. He stopped seizing, then had another seizure before EMS came to transport him to the ER.
R thigh red and swollen. Benadryl elexir 1 tsp orally.
Patient called pharmacy to see if can still get her second dose Moderna COVID-19 that is due on 5/20/21.  She has tested positive with COVID -19 on 5/9/21.
got sick; tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick) and COVID-19 (tested positive for COVID19) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ILLNESS (got sick) and COVID-19 (tested positive for COVID19). At the time of the report, ILLNESS (got sick) and COVID-19 (tested positive for COVID19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-080039, US-MODERNATX, INC.-MOD-2021-080039 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080039:case of mother US-MODERNATX, INC.-MOD-2021-080039:case of mother
Eight days after the vaccine, my injection site became red, itchy, hot to the touch, and swollen.
onset @ MN fever, sweaty, nauseated, really ached; w/o vomiting, h/a, arm felt funny, red, sweat, & chills; lasted for weekend; didn't see MD taking PCN in exposure to strep throat;
Body aches, fatigue, mild headache, scratchy throat, ?foggy? feeling, sore arm
Pt with medical hx of PCOS and allergy to clindamycin and ciprofloxacin presented to vaccine site for vaccine. Pt received 1st does of moderna and 10 minutes later reported SOB, blurry vision, chest tightness, chills, nausea . vitals were WNLs with hR of 83-88, oxygen saturation of 98-100. unable to obtain BP. 4 minutes later pt reported her vision had improved but continued to have chest tightness, SOB, nausea. EMS was called and pt was taken to lenox hill for further treatment. Through out the event pt was coherent and responded to questions appropriately.
Anxious and has anxiety; Receives third dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxious and has anxiety) and ACCIDENTAL OVERDOSE (Receives third dose of Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced ANXIETY (Anxious and has anxiety) and ACCIDENTAL OVERDOSE (Receives third dose of Moderna COVID-19 vaccine). On 09-Jun-2021, ACCIDENTAL OVERDOSE (Receives third dose of Moderna COVID-19 vaccine) had resolved. At the time of the report, ANXIETY (Anxious and has anxiety) outcome was unknown.            Concomitant products were included medication for diabetes and high blood pressure . No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Pt was given Covid vaccine 16 days before turning 12 years old. Facilitator was back documenting due to WiFi problems and realized this patient was not 12 years old. She informed me and I went to the vaccinator that vaccinated this patient to ensure she knew the vaccine requirements. All staff was told before the clinic started the mandatory age requirements and told all DOBs were written in red on a sheet of paper on every table.
Chronic diarrhea 24/7 for 6 weeks until started Budesonide 9mg. Received two colonoscopies, results were undetermined colitis. Endoscopy was normal. CT showed evidence of colitis. After 3rd dose of vaccine on Dec. 3, 2021, I had diarrhea Monday Dec. 6 (isolated event) then Monday Dec. 13 for a day or two, then Monday Dec. 20 diarrhea started and didn't stop. I was going 20-30 times a day, all day, all night with urgency. I couldn't sleep for 6 weeks. I'm still taking Budesonide 9mg but I have a follow up appointment and it was planned to start tapering dose and see how I do. I've had isolated events of diarrhea but it doesn't go chronic now. I had to go on short term disability leave from work for 2.5 months. I'm still recovering from the ordeal, still have fatigue and was still in pain in my mid section until last week.
er hpi: 84 y.o. female who presents with HEMATURIA. FOR LAST 2 WEEKS.
Pt. became short of breath, felt weak and expressed a feeling of his throat tightening and tongue swelling approx. 40 minutes after receiving yellow fever vaccination.  Pt. was treated in clinic with 0.3mg 1:1000 epi, O2 and IV NS.  He received further tx with diphenhydramine and PO prednisone in ED after transport from clinic via ambulance. Pt. was released to home after ED treatment.
1/5/21, symptoms lasted 48 hours and then resolved.  Body aches, fever, tired, HA
Approx 5 mins after injection I felt very sick to my stomach, very hot, and began feeling faint.  Around 7 mins after injection I lost consciousness.   My blood pressure dropped to 52/32 according to the EMT on site.
Participant had face swelling, facial rash, vertigo, fatigue for a few after vaccine, participant couldn't get out of bed. All symptoms except for rash on face. Participant was prescribed cream for facial rash and still presently using.
sweating, increased heart rate- still, vomiting/ diarrhea, headache, fatigue, loss of appetite/taste,
One week after my vaccine shot, the area of the injection got very swollen and itchy and red.
Red raised bump, hot to touch at injection site. Also 5 days in bed with exhaustion, weakness and body pain.
Information has been received concerning a pt,  who after 2 days post vaccination returned to his physician with redness, swelling, and soreness in left arm and fever of 100.3 F.
Pt presented to the ER with shortness of breath  that had been worsening over a long period of time but had progressed to the point she was not able to able to take a few steps without significant shortness of breath.  She also had a cough productive of yellow to greenish sputum but no fever or chills.  She did been seen at a health facility about a month ago was prescribe steroids which did help but symptoms recurred.  Her potassium was noted to be 2.8.  Chest x-ray showed prominence of interstitial markings in bilateral lung fields some bibasilar atelectasis with no lower lobe consolidation.  She was admitted for COPD exacerbation and was started on steroids and antibiotics.  She was also found to be COVID-19 positive.  She is on chronic steroids of 40 mg daily.  She did complete a steroid burst to reduce adrenal insufficiency with improvement in her oxygen saturations.  Patient also received a dose of IV Venofer.  Repeat D-dimer improved.  Patient discharged in stable condition, on 3 L home oxygen.
In addition to a sore arm, patient reports legs would not work.  Patient had trouble walking.  Patient reports extreme lethargy on Friday, November 1st, 2019.
This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age. Current conditions and medical history were not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with improperly stored M-M-R II (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
At 2100 hours, I experienced menstrual bleeding. My menstrual cycle was over and ended the day before. I lost 7 ml of blood. I wear an internal menstrual cup that measures blood output. This has never happened to me before. After my menstrual cycle in January, the month I received my vaccine, my menstrual cycle was irregular the following month (February) and after that I did not have a menstrual cycle until June. So I did not have a menstrual cycle from February until June. In the months that my menstrual cycle was absent, especially at the end of February until April I experienced menopause symptoms i.e. hot flashes, night sweats, hair loss, weight gain. I had my hormones checked and my levels were off. This was odd because I was completely fine prior to the vaccine. My hormones have leveled since.
Shingrix shingles vaccine caused hives that have lasted for weeks. Doctor gave me a shot and 2 prescriptions after OTC meds did not work. Three weeks after the second dose and I still have hives. Very painful. What should I do now to end this nightmare? I do not have any other medical issues nor am I on any meds other than eye drops for glaucoma.
Chills, nausea, swollen & red rash on face cheeks. Chills subsided within 6 hours. Nausea till following day. Rash didn't appear until noon on 10/25. Took Benadryl when first started with the chills.
redness  at the spot of injection; Half golf ball sized lump at spot of injection; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on the left arm on an unknown date in Apr2021 at 09:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lisinopril dihydrate (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and atenolol (MANUFACTURER UNKNOWN) from an unknown date and an unknown indication. Patient was not aware if he had any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021 at 09:00, the patient experienced redness at the spot of injection and half golf ball sized lump at spot of injection. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events redness at the spot of injection and half golf ball sized lump at spot of injection were unknown at the time of this report.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information includes: Event coding updated from Injection site redness to Vaccination site erythema and Injection site lump to Vaccination site lump, and adverse event start time 9:00 added in narrative
Patient is hospitalized due to COVID-19. Patient is fully vaccinated. On supplemental O2, steroids, Decadron, Remdesivir, prednisone, ceftriaxone, azithromycin (8/4/2021)
This study case was received from the investigator (MILVAX) on 23 January 2012. A 36-year-old male subject received following vaccinations: ACAM2000 (lot number not reported) on 04 November 2011; ANTHRAX VACCINE (manufacturer and lot number not reported), HEPATITIS A VACCINE (manufacturer and lot number not reported) and HEPATITIS B VACCINE (manufacturer and lot number not reported) on 25 October 2011. The subject had no significant medical history. On 16 November 2011, the subject had an abnormal troponin I of 0.07. On 22 November 2011, the subject had a normal electrocardiogram (ECG). On 02 December 2011, the subject had a normal magnetic resonance imaging (MRI) of the heart. On 29 November 2011, the subject was diagnosed with myocarditis, unspecified. The outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
sore and achy throughout the body; This is a spontaneous report from a contactable consumer. A consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 22Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jul2021, the patient experienced sore and achy throughout the body. It was reported that the caller got the first dose of the Pfizer COVID 19 vaccine this morning and is sore and achy throughout the body. Is it okay to take aspirin and will it effect the effectiveness of the vaccine. The clinical outcome of event was unknown.  Information on batch/Lot number has been requested.
Mother called today and states that noticed yesterday red raised walnut area on left upper arm, where the MMR was given and was still red a raised this morning. Instructed to come into center to have area looked at, as this is closer to there home, states she will if not better when she picks him up at 3:30 today.
had suspected clinical vaccination failure; had suspected covid-19 infection (cough, head congestion/clogged head, Sinus pain and runny nose); experienced crackly ears; interchange of vaccine product; off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. Other Case identifier(s): 20220126728(0.0) (Janssen).  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Jan2022 (Lot number: FJ8762) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Drug allergy", notes: Drug allergy (Unk) (continuing: Yes): Ibuprofen. Vaccination history included: Janssen covid-19 vaccine (dose 1, lot number: 1805029), administration date: 16Mar2021, for covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Jan2022, outcome "unknown", described as "interchange of vaccine product"; OFF LABEL USE (medically significant) with onset 04Jan2022, outcome "unknown", described as "off label use"; DRUG INEFFECTIVE (medically significant) with onset 12Jan2022, outcome "unknown", described as "had suspected clinical vaccination failure"; COVID-19 (medically significant) with onset 12Jan2022, outcome "unknown", described as "had suspected covid-19 infection (cough, head congestion/clogged head, Sinus pain and runny nose)"; TINNITUS (medically significant) with onset 11Jan2022, outcome "not recovered", described as "experienced crackly ears". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Binax now antigen.  No follow-up attempts are possible. No further information is expected.
Symptoms started 4/17/11 - he broke out on arms legs, tummy and neck with red pussy bumps w/ white rings around them. Today 4/20/11 is the first day they look better.
patient was administered an expired does of daptacel with no adverse event; Initial information received on 08-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was administered an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine (Daptacel) with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) for Immunisation.  On 08-Jun-2022, the patient received a dose of 0.5 ml total, 1x(1 day), suspect Daptacel (form: Suspension for injection, lot C5743aa, 6-Jun-2022 via intramuscular route, administration site: right thigh, Strength = standard) for immunisation.  On 08-Jun-2022 the patient was administered an expired does of daptacel with no adverse event (expired product administered) (Latency: same day).  Action taken was not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a Family Planning Nurse concerning a 47 year old male his relevant medical history, past drug history and concomitant medications were unknown, who on 03-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) 0.65 mL subcutaneously. She reported that she ordered VARIVAX (Merck) from the pharmacy and was sent ZOSTAVAX (Merck) instead which she administered to this consumer about two a hours before the report. She did not realize this inadvertently administration until she was doing her records. It was unknown if any relevant laboratory test were performed. The patient's status was unknown at the time of reporting. No further information is available.
01/07/22  inpatient postoperative for "Exploratory Laparotomy, Low Anterior Resection with End Colostomy, Small Bowel Resection X2, drainage of pelvic abscess ". PMHx of "anxiety/mood disorder, COPD/emphysema, 2L NC at home, chronic hypoxic respiratory failure, GERD, prediabetes"
I did not feel good overnight. I woke up the morning following my vaccine with fever (100.6 F), sweating, chills, malaise, and back pain. It lasted about 24 hours, and cleared with time and Tylenol.
After 12 hours, patient was at home and had a syncopal episode; mom reported to the on-call doctor. Patient had become queasy. Denied nausea, vomiting, diarrhea. No cardiovascular disease history.
pt recv vax; urticarial rash 12 hr p/ vax w/ edema of hands;