chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Felt tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and FATIGUE (Felt tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and FATIGUE (Felt tired). At the time of the report, NAUSEA (Nausea) and FATIGUE (Felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter stated that she had a lots of friends who experienced the events after receiving Moderna COVID-19 Vaccination.  No relevant concomitant medications were reported. No treatment information was reported.
Pt recvd vax on 13MAR91, post vax exp fever 103.6 r, high pitched cry, grouchy, would go to sleep only on mom's chest or sleep 1/2hr @ time; awaken w/jump or squeal;
INJECTION SITE MASS; INJECTION SITE PRURITUS. Information has been received from a registered nurse concerning a patient who on 15-May-2003 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast )(lot # 643165/0217M). Subsequently the patient developed a 'welt', about the size of a 50 cent piece, raised and itching". The patient sought unspecified medical attention. Additional information has been requested.
Red swelling about 4 inches in diameter. Patient complained of soreness and itching. Advised to use lanocane.
pt recvd vax & w/in 1 hr post vax pt exp excruciating pain @ inj site which radiated down arm,& nausea;sx come & go;
PATIENT 15 AT TIME OF IMMUNIZATION WHEN EUA FOR 16 AND OLDER
Pt got J&J vaccine around 1:25pm.  After shot administered, while talking to me, patient suddenly slumped over into my arms and eyes rolled back and lost consciousness for about 10 seconds and he was making some gurgling noise. Some excretions came out of his nose and he came to and was able to lie on floor to elevate his feet, but still was very dizzy.  First responders showed up and his vitals were WNLs, but pt continued to look pale and struggle to come to upright position for another 15-20 min. Pt's friend showed up to pick him up and he was able to walk out to the car without issue.
Started having swelling, itching, pain, welting at injection site. Patient's husband is an MD and treated patient at home. Swelling reached up to 5" wide and 4" long
Couldnt keep anything down.; 5 hours after receiving the 2nd dose had a headache; vomiting every hour; Spent sleeping; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 08Apr2021 at 15:15 (at the age of 57-year-old) as a single dose for COVID-19 immunization. Medical history included asthma since unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. Concomitant medications included ADVAIR (MANUFACTURER UNKNOWN since unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 11Mar2021 at 15:15 (at the age of 57-year-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 20:00, 5 hours after receiving the 2nd dose the patient had headache and at 7 hours vomited., rest of the night was spent with a horrible headache and vomiting every hour, couldn't keep anything down. On an unknown date in Ap2021 (next day) spent sleeping, next day woke up with headache still had headache, next morning woke up with headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported adverse events, however the patient took Tylenol for the headache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and at 7 hours vomited, rest of the night was spent with a horrible headache and vomiting every hour, couldn't keep anything down, spent sleeping was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Hearing loss right ear 12/4/03 7pm. Vertigo and nausea 12/5/03 2am. Hospitalized 12/5 to 12/8/03. Hearing loss, vertigo remain. The medical record received on 2/17/04 states tinnitus, and beating nystagmus. Permanent hearing loss one ear. Persistent vertigo. Per annual report- permanent hearing loss (deafness) in one ear and residual vertigo. Discharge summary sttes viral infection. msv
On Monday, 11/01/22 I had a very bad headache and constant nausea, on the 11/2/22 I had a runny nose, stuffy head, body aches, no energy, chills with no fever, I still had the headache. By Wednesday 11/3/2022 I pulled a muscle in my back from coughing so much, I took a home COVID-19 test, it came back positive. I went to a clinic on Friday to have them do a test and it also came back positive. I was prescribed Paxlovid for five days, prednisone, nasal spray and benzonatate. It took me until 11/11/22 to test negative, the fatigue lasted for another two weeks. I am feeling much better. I have asthma and did not have to use my nebulizer more than once a day. That is amazing.
I was tested positive for Covid-19.; I was tested positive for Covid-19.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Not reported), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient had the first shot on 11Feb2021 and scheduled to get the second dose on 04Mar2021. However, the patient was tested positive for Covid-19 in 2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Administered 4 yr old vaccines to child hours later mom calls clinic and tells nurse that child is crying and full of rash. Advised mother to take child to Doctor. F/u later with mother. She voiced child was better. She gave him Benadryl and milk. *NOTE: 0 PREVIOUS DOSES OF PCV13 GIVEN. 4 PREVIOUS DOSES OF PCV6 GIVEN.
After administering the vaccine, patient was waiting in observation area for 15 minutes. Suddenly the mom told us that the patient fainted. He was unconscious for a few seconds, after which he was fainting on and off while sitting on the chair. We gave the patient some cold water, placed ice pack behind his head and placed support for his head as well. The mom told us that the patient had a history of fainting. We called 911, which arrived in about 5-7 minutes. When paramedics came, they ran several tests on the patient and offered the mom to take her son to the hospital. The mom refused. The patient and the mom rested for another 10 minutes, then they left
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. Health Professional reported that they administered expired FLUMIST for 11 patients. The outcome of the event of administered expired FLUMIST is unknown. The report was considered to be non-serious.
pt recv vax 23OCT98 & pt exp dizziness & became lightheaded;vital signs were monitored & BP dropped 60/100;pt recovered;
pt recvd vax; redness marked edema at inject site 3 days after vax;
Left arm: swelling, lump, and redness surrounding injection area beginning 12 hours post injection and continuing with a broader redness area by 48 hrs. At 17 hours post injection: severe headache and general malaise and fatigue, lasting 24 hours. 48 hrs post injection, swelling and a painful lump in left clavicle region noted. Currently at 56 hours post injection: still swollen painful left arm with a knot and redness; still painful lump and swelling in left clavicle region
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced COVID-19 (COVID-19). In 2022, COVID-19 (COVID-19) had resolved.            Concomitant products were not provided. Treatment medication were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  In Jan 2022, patient got COVID and had high fever, sore throat, fatigue and headache. fever lasted five days and symptoms coughing lasted about a month.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID was not provided.
vaccines being given post temperature excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old female patient whom influenza quadrival A-B vaccine [Fluzone QIV] was given post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-May-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine, suspension for injection (lot UT7376NA expiry date : 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination was given post temperature excursion with no reported adverse event (intercepted product storage error).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event vaccines being given post temperature excursion with no reported adverse event.   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.; Sender's Comments:  01092869: 01092879: 01092814: 01092832: 01092891: 01092687: 01092746: 01092709: 01092741: 01092787: 01092850:
Case number PHEH2013US022526 is an initial spontaneous report from nurse received on 24 Oct 2013. This case refers to 64-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1308101, expiry date: Mar 2014) 0.5 ml intramuscularly on 15 Oct 2013. On the same date of vaccination, the patient developed softball size red, raised and hot reaction at injection site. She came back on 17 Oct 2013 with soccer or football size reaction area. She was treated with SOLUMEDROL 40 mg for the events. The outcome of the events was reported as resolved. The seriousness and causality of events was not reported. Following internal review, for the information received on 24 Oct 2013, the following correction was done. The event verbatim was updated as "soccer or football size reaction area" and coded to extensive swelling of vaccinated limb.
When injected,  felt the burn of the vaccine. A few minutes later started sweating, dizzy, blurred vision, ears ringing and sound start fading.
Flu symptoms immediately.  1 week +1 day post injection, severe body aches, fever, 1 week + 2 days seizure requiring hospitalization, ICU and vent for 4 days.
On first day set off my asthma and then had several days of aches, pain, and a general feeling of illness. After 10 days spoke to my doctor as was feeling so very week and ill.  Continued to feel poor and had  numbness in the fingertips and toes so did a video visit with Dr. on the phone on March 2.  The weakness spread into arms and legs so doctor admitted to the hospital on March 10th where I was diagnosed with Gillian Barre.  I spent a week in the hospital including 5 days in the ICU and then 2 and a half weeks in the rehab center.  I still continue to work with in home PT, speech, and OT.
Fever greater than 100°F, extreme chills, cold extremities, muscle aches, hard breathing, and difficulty sleeping. I took 2 tablets of Acetaminophen 650mg when started to fever around 10pm, drank lots of warm uncaffeinated  tea, and slept on a heated bed. Slight fever of about 99°F and muscle ache the day after, took another 2 tablets of 650mg acetaminophen at 10am.
Chills, fever, body aches, headache starting almost exactly 12 hours after shot. Severe symptoms lasted about 18 hours after they started.
My tinnitus, which I've had for about 3 months now, became much more intense beginning in the evening and through the night, and continues to be extra intense today.
Localized erythema with redness/swelling measuring 19 cm x 14 cm
Immunized on 9-9 at approx 28 weeks of pregnancy - EDD 12-1-20 Seen in EC on 9-10 with lump, redness, swelling of left arm.  Pain 7/10.  Red circular area on left deltoid.  Presumed localized reaction with f/u by OB clinic.  Pt seen in OB clinic on 9-11 and rx'ed Bactrim DS for possible cellulitis.  Advised to use Tylenol for pain.  Patient returned to clinic on 9-14 with minimal improvement.  However pt admitted to only taking one dose of antibiotic due to GI upset.  Med changed to Keflex.  Pt returned on 9-17 - arm was improving with less discoloration and no pain.  No subsequent mention of any ongoing problems.
Pfizer-Biotech COVID-19 Vaccine EUA Patient experienced nausea 30 minutes post vaccine administration.  Patient states feeling better 10 minutes later.
This spontaneous report as received from a pharmacist refers to a female patient of 60 years old. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneously left arm, lot # not reported) on 18-AUG-2012 and had injection site reaction. Pharmacist stated the patient came into pharmacy today (20-AUG-2012), with hard, red, sore bump and rash at injection site of left arm. No other co-suspects were reported. No concomitant medications were reported. At the time of report the outcome was reported as not recovered/not resolved. The patient sought medical attention via coming into the pharmacy. Additional information is not expected.
After immunization given, patient experienced more than usual bleeding. I was able to control bleeding with extra cotton ball and bandage. After bleeding subsided, patient's arm had swelling at injection site. I advised the patient to stay with us for 15 minutes to make sure no other adverse reaction occurred. After 15 minutes, bleeding has stopped but swelling at injection site was still present.
Pt had severe swelling at injection site with pain. She was admitted to the hospital on 9/25 and given a steroid, pain reliever and Benadryl. She was released on 9/26.
Left upper arm soreness never went away. Aches upon lifting arm over head. (Note: I also had a DTAP shot in the same arm on 5/25/21. Don't know if the this also impacts the continued aching in the upper arm.)
ALLERGIC REACTION AT INJECTION SITE. DEVELOPED BIG, INFLAMED LUMP AT AND AROUND INJECTION SITE.
0.3 mls of undiluted pediatric pfizer covid vaccine was administered resulting in an approximate dose of 42 mcg instead of the recommended 30 mcg . The patient has not reported any unexpected side effects due to the higher dose.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was sitting after giving both vaccinations, 5 minutes later fell over in his chair, was still conscious, was able to slowly get back up into sitting position. Caregiver stated that patient was OK after waiting about 10-15 minutes
she believes the rash to be a shingles infection; the patient developed an itchy, painful rash; the patient developed an itchy, painful rash; This spontaneous report was received from a female adult patient of unknown age. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were unknown.        On an unknown date in 2012 (also reported as approximately 8 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injectable (dose, strength, frequency, lot# and expiration date were unknown) for prophylaxis.         On unknown date, the patient developed an itchy, painful rash. she believed the rash to be a shingles infection. The outcome of the events was unknown. The causality assessment between the event and zoster vaccine live (ZOSTAVAX) was not provided.
After a night of being up with flu like symptoms, when I got out of bed at 7 am to start my day, I had a precipitous fall in body temperature.  At this time, I also had profuse cold sweats, my limbs started getting cold, I could not see or hear and had ?stars? like I was about to pass out.  My wife helped me downstairs and after some water and Tylenol, symptoms reversed themselves in about 15 minutes.  My body temperature was not recognized by the thermometer and then registered 93.4
Developed local swelling, itching, and redness initially.  Now has associated cellulitis.
Janssen-Covid19-EUA Incident # 2021-033197  The client was sitting in observation and had a syncopal episode. He was immediately assessed and felt better while waiting for the ambulanceto arrive.  The client signed out AMA.  See paramedic PCR for further.
lower abdominal pain; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (lower abdominal pain) and DIARRHOEA (diarrhea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Diarrhea and Cholecystectomy (5 years ago his gallbladder was removed). Concurrent medical conditions included Diabetic.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 18-Mar-2021, the patient experienced ABDOMINAL PAIN LOWER (lower abdominal pain) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN LOWER (lower abdominal pain) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Extremely tired and have a wore out feeling of having no energy to move around or do anything.  Have a body temp  of 96.1     Other than that I feel fine.
Developed acute severe nausea, vomiting and ataxia on 12/12/22. Presented to the ER and administered IV fluids. EKG showed prolonged QT interval and labs were normal.  Symptoms of N/V continued with several near syncopal episodes and ataxia. Admitted to the hospital on 12/30/22 after head CT revealed mulitple cerebellar infarcts.  Placed on aspirin and statin dose was increased.  Continuous cardiac monitoring ruled out Atrial fibrillation, but did show intermittent PVCs and bradycardia. There was no evidence of coagulation disorders. Cholesterol was normal as were all other labs (including normal CRP, ESR, WBC).  Severe fatigue and nausea continues as of 1/16/23. No etiology for CVAs identified.
Redness, hives around injection site measuring about 2 inches in diameter, itching and the area is swollen. Patient states pain since initial injection but that it increased this morning after waking and that's when itching started. He took off bandaid ten min post injection.
Information has been received from a physician concerning a 32 month old female who in October 2004 was vaccinated with a dose of Varivax. Subsequently the patient experienced breakthrough varicella rash. It was reported that the patient had not recovered. Unspecified medical attention was sought. No further information available. There was no product quality complaint involved. Additional information received indicated that there was no further information available. No additional information is expected.
Neuropathy- starting in bilateral toes now intermittently affecting all 4 limbs
Client was vaccinated at 1500, ad while in observation she reported having tingling in mouth, throat, and cough. She described it as asthma attach. PN and EMS attended her at 1526. VS: 168/81, Res 24, Pulse 115, Ox 98%. Patient was administered Benadryl 25mg at 1530. Client reported not to feel the above feelings. She signed the refusal to transport. Released at 1600. She felt awake and fine before her vials taken and released. 145/84, pulse 104, Ox 99%.
Actually vaccination time and adverse event time unknown as this was during a vaccination clinic located at a local middle school. It was reported that the client had a syncopal episode in the gymnasium after she had been vaccinated. The client recovered and returned to class after her parent was notified.