chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days after shot I had fever, my left ear swollen and pain, throat sore. I couldn't walk, eat or drink anything.  Vomiting and diarrhea.  Bedridden  with high fever. Sunday, August 21, 2022 felt lousy,  stayed in bed most of the time. Infection and pain in left ear. Numbness on left side of face. My ear was almost twice the size, very swollen.
Pt felt her blood pressure going up and dizzy. feeling hot and anxious.  Pharmacist called 911 and paramedic team came and checked her condition. Pt stayed with paramedic team for 30 minutes in the pharmacy parking lot then pt felt ok after 30minutes sent home.  On the next day 04/14 we called pt to check her status at 5 pm, pt got no symptoms anymore and feel good.
Suspected Yellow Fever Vaccine Associated Viscerotrophic Disease: Admitted with persisting fever, chills, sweats, myalgias, nausea, and mild headache which started 2 days after immunization. Diarrhea with C-diff positive PCR started on day #2. Briefly admitted for IV fluids from 4/7 to 4/8. Readmitted with persisting fever on 4/10.  Has worsening thrombocytopenia, liver function elevations, AKI. Remains hemodynamically stable and no bleeding on hospital day #4.
Severe heart pain; Shortness of breath; Got her third vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST PAIN (Severe heart pain) and DYSPNOEA (Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leukopenia.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Severe heart pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and OFF LABEL USE (Got her third vaccine). At the time of the report, CHEST PAIN (Severe heart pain) and DYSPNOEA (Shortness of breath) outcome was unknown and OFF LABEL USE (Got her third vaccine) had resolved.            Concomitant product use was not provider by the reporter.  Treatment information was not provided.   The patient received vaccine in  a Wednesday.  Company comments:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The causality for OFF LABEL USE  is not applicable. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The causality for OFF LABEL USE  is not applicable. Further information is expected.
Site: Pain at Injection Site-Mild, Additional Details: Patient described that the vaccine "hit in weird spot of the arm, it hurt."
It was itchy and burning on my left breast, the same breast where I had radiation as well as a rash that looked like an irritation, red skin rash. This began April 9, 2021 approximately. I saw my DR, but it was getting better by then. I saw a different doctor on April 13, 2021 to confirm it wasn't an infection. I did not get any medication, I just waited it out and used over the counter itch control type medication - I took Benadryl pills and a topical cream.
Patient reported fever and headache x 2 days after immunization. Patient treated with APAP.
recipient complained of feeling lightheaded and thought she would pass out.  gotten a snack and drink and then laid down on stretcher.  vital signs stable but then symptoms did not improve and began to complain of numbness and tingling in her left arm.  transferred to the ED
Patient reported pain in shoulder area of left (administration) arm, fever of approximately 100 - 100.3 * F, and nausea. Fever and pain have persisted from 2/22/20 and continue as of today (2/24/20).
Fever began to rise within 18 hours and spiked to 103.8 and stayed within .5 of that level for approximately 24 hours. Acetaminophen was not effective in reducing fever and ibuprofen was not able to be used due to other meds.  Patient previously had COVID in October 2020 and had fully recovered within one week of diagnosis of COVID. Fever during COVID symptoms peaked at 101.5 and all other symptoms were mild and complete abated by October 20.
Client completed COVID 19 adult Pfizer series on 04/09/21 (lot# ER8737, expiration date 07/21).  Approximately 15 minutes after receiving 2nd dose, client states "blood was boiling" and complained of nervousness, burning sensation, nervousness, and increased heart rate.  Burning sensation started in her legs and spread through entire body.  Symptoms lasted approximately 5 minutes.  Client admits to history of anxiety and that symptoms consistent with what she experiences during panic attacks except for burning sensation.  Client self administered Xanax at home after episode and denies following up with primary care provider regarding incident.     Client self administered Xanax before adult Pfizer booster appointment 12/13/21.  Medical history includes hypertension, hypothyroid, and anxiety that client reports are controlled with medications.  12/13/21, 1310:  Approval to administer COVID 19 adult Pfizer booster received.  1319:  COVID 19 adult Pfizer vaccine booster (lot# FF8841, expiration date 01/03/22) administered to right arm.  Client went to Observation Area and advised to remain for 30 minutes. Client agreed to advise staff if side effects or symptoms occurred while in observation.  1415: Client went home.
Covid; Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies were reported as No. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
signs and symptoms of COVID began on or around 11/20/2021. Signs and symptoms included increase weakness, dizziness, light headed, and hypoxia with SpO2 at 80% on room air. Was hospitalized 11/27/21 - 12/2/21
Pt suffered generalized seizure around 12 hrs after vaccine. Temp at time of seizure 98 degrees; by time paramedics arrived 99 degrees in ER 100.2 (max). Dxd with febrile seizure by ER.
Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn,  nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours.   Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday.  Nausea and diarrhea on and off until Tuesday.  Fever until Sunday afternoon.  Pain in back rt side.  About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.
CONDITION RETURNED WITH SKYRIZI (RISANKIZUMAB); NEGATIVE REACTION/NULLIFIED THE EFFECTS OF SKYRIZI (RISANKIZUMAB); This spontaneous report received from a patient concerned a 6 decade old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 04-JUN-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Age at time of vaccination 58 years old. No concomitant medications were reported. On an unspecified date, the patient experienced condition returned with skyrizi (risankizumab), and negative reaction/nullified the effects of skyrizi (risankizumab). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient had not recovered from condition returned with skyrizi (risankizumab), and negative reaction/nullified the effects of skyrizi (risankizumab). This report was non-serious.
On day 2 after vaccination, red localized swelling to left arm. Tender, pruritic, erythema, warm to touch. Decrease in all symptoms seen 24 hours later in office with remaining localized erythema and mild edema, still tender and warm to touch. Instructed to treat with ice packs and warm compresses, NSAIDs for pain relief and anti-inflammatory effects.
flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient to whom influenza quadrivalent recombinant vaccine [Flublok] inadvertently ordered, staff administered to six patients, should have been influenza trival A-B subvirion no preservative vaccine [Fluzone] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  On 04-Jan-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (lot UJ93AA; strength, formulation, frequency, expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 04-JAN-2023 the flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency:same day).  It is unknown if there were lab data/results available  Action taken : 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 guidelines. 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.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a RN concerning a kindergarten male pt who on 04/29/99 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up information was received from the registered nurse who indicated that the physician diagnosed the patient with chickenpox on approximately 17-Jan-2004. No further informatin is expected. It was noted that pt's from the same source had a similar experience. (WAES # 0403USA02088, 0403USA02109, 0403USA02110, 043USA02111, 0403USA02112, 0403USA02114, 0403USA02115).
My son became ill on 6/26/18. We were told it was strep throat. On 6/27/18, my son began to complain of his legs hurting and not wanting to walk. We took him back to the Dr. on 6/28/18. They sent us to ER. Where they did blood work and took a urine sample. They gave him a IV saying he was dehydrated. And sent us home saying it was the Strep making him not want to walk and his muscles hurt. Friday 6/29/2018, we took him back to his pediatrician who again said this is just Strep throat and it could get worse before it gets better. On Sunday 7/1/2018, my son was up all night screaming in pain. We took him back to the Dr. who finally said something neurological is going on take him to the ER. We decided to take him to Hospital, where they finally diagnosed my son with Guillain-Barre Syndrome; through a 2 1/2 hr long MRI and a spinal tap. He was admitted to the hospital on 7/2/2018. He received four IVIG treatments over the course of 4 days and is now in the recovery stage. We hope to be release on 7/31/2018, with continued Outpatient Physical Therapy which could last anywhere from 6 months to a year.
Patient presented to the ED on 3/9/21, then was hospitalized 3/27/2021 after receiving COVID 19 vaccination.
This case was reported by a consumer and described the occurrence of diarrhea in a 34 year-old female subject who was vaccinated with BOOSTRIX GlaxoSmithKline. A physician or other health care professional has not verified this report. Concurrent medication included Oral contraceptive (Birth control pills) and M.V.I. On 1 April 2009 the subject received 1st dose of BOOSTRIX (0.5ml, unknown, left arm). On 1 April 2009, within 3 hours after vaccination with BOOSTRIX, the subject was self-treating with IMMODIUM. At the time of reporting the event was unresolved.
first attempt to adminster vaccine at the top of shoulder, health care provider bent needle. the needle was replaced and the vaccine was injected at top of shoulder and collarbone. after injection, I went home awaken about 2:30am with pain in the intire left arm. I still have pain after one month. for about 10 days I could not use arm. I am now 85% pain free. I still can not lift arm above head I did not want my friends and family to know how servere my pain was for fear they would not want to get the vaccine. I have never had vaccine of any type in the area that this vaccine was injected. I did not go to doctor's office due to weather 14 inches of snow. however, I did make my primary physican aware of issue...
Injection site redness, swelling, and itching which did not occur until day 8 post injection.
I had a sore arm for about a day.  In 05/2021, I developed hives at the scalp line. The hives have progressed since then to all over the body.  I am currently taking four Zyrtec daily. This is helping but they still occur.  It shows up on areas that are covered. I have rarely had them on my face.
Intermittent hives on palms/wrists starting day after first shot'; This is a spontaneous report received from a non-contactable consumer (patient). A 38-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Lot Number: EN6208, Expiration date was not reported), via an unspecified route of administration, on 12Mar2021 15:45 on left arm as single dose for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. Allergies to medications, food, or other product reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received within 2 weeks of vaccination: Allegra, Advair. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced Intermittent hives on palms/wrists starting day after first shot on 03Apr2021 09:00. Patient did not receive treatment for the event. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Patient received 2nd dose 15 days early. Attempted to reach patient and was unsuccessful.
Aches; Chills; Fatigue; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma chronic. Concomitant products included LORAZEPAM (ATIVAN) for Sleep disorder, METOPROLOL, MONTELUKAST, SERTRALINE and ZOLPIDEM for an unknown indication.    On 12-Mar-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 PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Low grade fever). At the time of the report, PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Low grade fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter.  It was reported that the patient had aches, chills, fatigue, nausea, and a low grade fever.  Reported that patient was grateful that he received the Moderna Covid-19 vaccine.   This case was linked to MOD-2022-455495, MOD-2022-455496 (Patient Link).
Headaches,chills, fever, joint aches, shakiness, reddness to area of injection site and rash and heat of left arm with some swelling.
2hrs after my son would not stop vomiting (when he had not vomited at all previously before this, not even the day before), He passed out and I could not wake him up (when he was a light sleeper before this shot was given and did not have issues waking up before this shot was given). He also had injection site redness. I now believe it's possible that my son may have had brain swelling after this vaccination. Today he has a severe speech delay that is not due to tongue tie... I consulted in nurses and they brushed it off. I consulted in the pediatrician (when she came to our room) as she was getting ready to sign us out of the hospital and she said to me and I quote "weird". His temp was monitored during our stay.
Developed swelling and itchiness on right ankle. Doctors say it?s cellulitis. Have taken three rounds of antibiotics to try and clear it.
Developed multiple blood clots in both lungs became extremely short of breath with any activity, heart palpitation, tachycardic
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound of covid symptoms in 7 days after ending Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient took other medication in 2 weeks. Patient took COVID 19 Treatment (Paxlovid) from 25Jun2022 to 29Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Covid 19 and Drug ineffective and suspect drug BNT162B2 cannot be excluded.
swelling in her left cheek; redness; swelling right beside her eyes; swelling right beside her nose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling in her left cheek), ERYTHEMA (redness), SWELLING FACE (swelling right beside her eyes) and SWELLING FACE (swelling right beside her nose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Heart valve operation in November 2020. Concurrent medical conditions included Penicillin allergy, Drug allergy (SULFA DRUGS, ) and Drug allergy (allergic to ACE INHIBITORS). Concomitant products included ATORVASTATIN for Cholesterol.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced SWELLING FACE (swelling in her left cheek), ERYTHEMA (redness), SWELLING FACE (swelling right beside her eyes) and SWELLING FACE (swelling right beside her nose). At the time of the report, SWELLING FACE (swelling in her left cheek), ERYTHEMA (redness), SWELLING FACE (swelling right beside her eyes) and SWELLING FACE (swelling right beside her nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken were Atorvastatin, Baby Aspirin, Ensure Milk. Treatment medications taken were Benadryl.
Was in perfect health have been very tired and discovered I have fibrosis of liver level2-3
PATIENT RECEIVED 0.3ML DOSE AT 9 YEARS OLD. SHOULD HAVE RECEIVED 0.2ML DOSE. PER CDC, DOSE DOESN'T HAVE TO BE REPEATED.
Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Patient received Moderna vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Not known drug allergies.  Previously administered products included for COVID-19 vaccination: J&J (Dose one Lot number: 1805031) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  It was found out that the vaccine had been expired for 2 weeks  It was reported that since the expiration date was not written on the vial they did not noticed it had already expired.  On an unknown date the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  The vaccine stored in fridge on 17-May-2022.  No treatment drugs were reported