chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills for appx 36 hours from onset of symptoms.  Fever 100°, 102°, 100.4°, 100.3° starting midnight 12/2 through 11:30 am 12/3. Body Dizziness, sensitivity to light, 10:30 am - 2pm 12/2. Body aches 12/2 through current. Muscle weakness, inability to stand, 10:30 am 12/2. Shallow breathing,  cough withe deeper breathing.
Patient complains of arm soreness on exertion. Sometimes radiating up toward neck on left side and down left arm to elbow. Pain is more noticable in night while trying to sleep. Ice and ibuprofen have been used and are effective in reducing and temporarily eliminating pain. Today is 23 days since vaccination and patient is still experiencing intermittant pain. It isn't getting worse, but isn't getting better to the extent that the patient hoped.
Redness, Swelling and Itching at Injection Site - has continued to get worse through the weekend. Recommended that patient try an oral antihistamine and follow up with primary physician if not improved by tomorrow.
Anaphylaxis symptoms starting about 45 minutes after injection. Initial symptoms were severe light headedness and tachycardia.  Epi-pen self administered 5 minutes after onset of symptoms.  Symptoms resolved within 30 minutes of Epi-pen administration.
This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on 16-MAR-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # L033690, expiration date 14-JUN-2018; dose and frequency was not reported) intramuscularly, for prophylaxis. On that date the patient was also vaccinated with a dose of an also improperly stored ROTATEQ, orally (lot number: M014755, expiration date: 30-OCT-2017). This information was discovered as a digital data logger measured temperatures of 47.5 °F, 47°F to 77°F for a total time frame of 16 hours. There was no previous temperature excursion. No adverse side effects were reported, and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013286: US-009507513-1703USA013277:
Low back pain, myalgia, 10cm erythematous plague (hot) at site of injection. Almost certainly due to anthrax vaccine. TX prednisone and Naprosyn.
Information has been received from a physician assistant concerning a 21 year old female with a history of papilloma viral infection (unspecified onset) and no drug reactions and allergies who on 10-JAN-2008 was vaccinated IM with the first dose of GARDASIL. Concomitant therapy included DEPO-PROVERA. It was reported that the patient's HPV status was not confirmed prior to the first dose. On 14-JUL-2010, a Papanicolaou (PAP) smear was done and it came back positive for HPV. It was reported that the patient upon hearing the positive HPV test stated that she has a history of HPV, but the practitioner was unable to confirm when or how this was determined. On 28-JUL-2010, the patient received the second dose of GARDASIL. At the time of the report, the patient status was reported as HPV positive. The patient did not seek medical attention. Follow-up information has been received. It was reported that there was no adverse reaction. Additional information has been requested.
redness; had brain fog; alike an unclear head; difficult to stand; dizziness; tiredness; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness), BRAIN FOG (had brain fog), HEAD DISCOMFORT (alike an unclear head), DYSSTASIA (difficult to stand) and DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dizziness and Rheumatic fever.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), BRAIN FOG (had brain fog), HEAD DISCOMFORT (alike an unclear head), DYSSTASIA (difficult to stand), DIZZINESS (dizziness) and FATIGUE (tiredness). At the time of the report, ERYTHEMA (redness), DIZZINESS (dizziness) and FATIGUE (tiredness) had not resolved and BRAIN FOG (had brain fog), HEAD DISCOMFORT (alike an unclear head) and DYSSTASIA (difficult to stand) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. It is unknown when her most recent dose was or how many doses she had received. She was unsure if her most recent dose was a monovalent or bivalent product. Since she had the last shot she had brain fog. This is alike an unclear head. It's very hard to get rid of if at all. Had a problem with dizziness regularly that had been ongoing since before the vaccine. The dizziness coupled with the brain fog can make it difficult to stand. Drinking ginger dissolved in boiling water seems to help with the brain fog. She had also been having some issues with tiredness and redness. She was told prior to receiving her most recent vaccine she should not receive it because of her continued dizziness symptoms. She received this dose anyways. She just spoke with her pharmacist who was concerned that her symptoms had lasted so long. Unknown how long after receiving this dose symptoms started. Unknown how long symptoms had been ongoing. She never had covid. History of rheumatic fever.
swelling and pain at injection site; swelling and pain at injection site; This is a spontaneous report from a contactable consumer (patient himself). A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Feb2021 (yesterday) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in February2021, the patient experienced swelling and pain at injection site. The nurse gave him the injection, he didn't even feel it. The patient wanted to know how long it may last and if there is any treatment for it. The outcome of the events was unknown. There was no product quality complaint (PQC) present.   Follow-up attempts are completed. No further information is expected.
Fever onset the morning after vaccination, lasted until the late evening on 5/11. Fever was 102.5 for roughly 6 hours before it broke at 8PM and started dropping. Accompanied by chills and joint pain. At time of vaccination, arm pain at the site. Arm pain developed by the next day, very sore but able to move it. Injection became swollen, and the arm developed a red, itchy rash similar to previous "Moderna" arm experienced in the first vaccine, but this one is the day after, and not 8 days after the vaccination. As of 2PM 5/12, fever is gone, swollen itchy rash is still there and fatigue continues. Treated fever with 400mg ibprofen starting at 7AM 5/11, again at 2:45PM and again at 6:45PM. Ibprofen continues on 5/12, 400mg taken at 7AM and again at 11:25AM
Patient reported via email that he had a bruise/rash at the injection point. Patient reported that this spread in two line to the underarm area looking like an infection was spreading. Pt reported that it was quite painful on 3/2/2019, a little better on 3/3/2019, and was still tender on 3/4/2019. We have reached out in an effort to have patient return to clinic for an evaluation but have not heard back yet.
Fingers / tongue / feet neuropathic pain starting Dec 2008 - with continual pains past 7 months.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL injection, lot # J002641, expiration date 10-Dec-2015 (dose and route not reported). Concomitant therapies were not reported. The reporter stated that GARDASIL vaccine was exposed to a highest temperature of 11.5 degree centigrade for a time out of range of 123.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Information has been received from a healthcare worker, concerning a 37 year old female patient with allergy to penicillin. The patient had no pertinent medical history. On 01-OCT-2012, the patient was vaccinated with a dose of VARIVAX (Merck), subcutaneous (dose was not reported) (Lot #: G007060; expiration date: 24-FEB-2014). There were no concomitant medications reported. On 14-OCT-2012, the patient developed chickenpox, after receiving VARIVAX (Merck). Healthcare worker stated that patient developed itchy vesicles all over the body. The patient sought medical attention through office call. No treatment was given for the event. No lab diagnostic studies were performed. At the time of the report, the patient's outcome for chickenpox was reported as not recovered/not resolved. The relatedness for chickenpox was unknown for VARIVAX (Merck). Additional information has been requested.
redness over legs, arms, face, chest. Feels hot "like I'm burning from the inside".
The pt visited the clinic 10/27 reported that the day after he received the PPV vaccine he woke up with redness, swelling and tenderness Lt arm. He was seen by his doctor and was advised to go to the ER on 10/23, started on KEFLEX. Redness, swelling totally resolved.
Bells Palsy to the right side of the face. starting 03/06/2021 and continuing as of 07/28/2021 Pain control with medications
Information has been received from a registered nurse concerning adult patients who were recently exposed to their child (WAES # 0712USA02913) who was vaccinated with a dose of Rotateq (lot# 656659/0942U) on 20-NOV-2007.  Subsequently the patients experienced gastrointestinal symptoms (unspecified) one day after the patient was examined in the emergency room on 24-NOV-2007.  The parents' symptoms lasted 48 hours and then resolved.  This is one of several reports from the same source.  Additional information has been requested.
At night I had really bad  congestion and sinuses so I called my doctor this was 12/13/2022 after a positive home COVID-19 test, my doctor called in a prescription for Paxlovid which I began taking on the fifteenth of December 2022 I then began to use my inhaler more, on the fifteenth of December 2022 I was feeling better everyday with lingering congestion, as of the reporting date I was feeling better.
9 year old female with acute onset of a itchy rash of her right arm the day she received a Td for a puncture wound of her foot. Her Td was given 3/6/2012. Rash treated with Hydrocortisone cream and oral BENADRYL at home. Pt seen in office 3/12/2012 & treated with 5-day course of Prednisone.
Dizziness, Headache, Myalgia, CoughWheeze, Rash, NauseaVomiting, Syncope, SEVERE FATIGUE Narrative: RASH ON UPPER BODY FROM WAIST TO NECK. WHITE RING AROUND SITE OF INJECTION AT LEFT DELTIOD
After my first dose I had pain, scaling on my right outer ankle bone. I went to urgent care, and they put me on antibiotics, and it didn't help. Then I went to my PCP, and they gave me a different antibiotic that also didn't work. They sent me to wound care specialist nothing worked there either. I was sent to rheumatologist who injected the area with steroids that only helped a little. I have been seeing the rheumatologist and a dermatologist for this ongoing problem that is getting worse. It is believed to be an autoimmune ulcer. I have been injected with steroids multiple times given oral steroids as well and it is getting worse.
FLUBLOK was administered to 37 month old female patient (Drug use in unapproved age group) with no reported adverse event; Initial information was received on 14-Feb-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.  This case is linked to case 2022SA054691(CLUSTER).  This case involves a 37 months old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (drug use in unapproved age group) with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Feb-2022, the patient received 0.5 ml of suspect influenza quadrivalent recombinant vaccine suspension for injection for 1 day via Intramuscular route in right quadriceps, lot-QFAA2152 (with an unknown expiry date) for immunization.   On 14-Feb-2022,the patient developed a non-serious event "FLUBLOK was administered to 37 month old female patient (Drug use in unapproved age group) with no reported adverse event (latency same day) following the administration of influenza quadrivalent recombinant vaccine.    Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event flublok was administered to 37 month old female patient (drug use in unapproved age group) 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.
pt recv vax 4MAR97 & devel arthralgia in the first 3 wk of March;event spontaneously resolved;
States this was each patients booster dose; undiluted thawed vaccine was moved from refrigerator to cooler, then to freezer, stored for 24 hours, moved back into cooler where it thawed, then diluted; undiluted thawed vaccine was moved from refrigerator to cooler, then to freezer, stored for 24 hours, moved back into cooler where it thawed, then diluted; undiluted thawed vaccine was moved from refrigerator to cooler, then to freezer, stored for 24 hours, moved back into cooler where it thawed, then diluted; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Nov2021 (Lot number: FE3590) at the age of 44 years as dose number unknown (booster), 0.3ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Nov2021, outcome "unknown", described as "States this was each patients booster dose"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 14Nov2021, outcome "unknown" and all described as "undiluted thawed vaccine was moved from refrigerator to cooler, then to freezer, stored for 24 hours, moved back into cooler where it thawed, then diluted".  Additional information: Caller stated that he worked in medical clinic and he was a physician reporting a temperature excursion of the Pfizer Covid vaccine (Adult). Caller stated that they had the Pfizer Covid vaccine for ages 12 and up, and they had an incident over the weekend. There was an event outdoors at a church on Sunday 14Nov2021, stated that the clinic he worked at was closed on Sunday. Someone who was going to the event who was going to be administering the vaccines, took the vials of vaccines out of refrigerator on Saturday 13Nov2021 and transported them in a cooler to their own freezer. Caller reported that the vials were placed into the freezer over night and moved back to a cooler on Sunday the day of the event, stated that they were then thawed again to be administered at the event. Caller clarified that the vials were what was stored in the cooler, that they were diluted and drawn up at the time of the event and administration. The undiluted thawed vaccine was moved from the refrigerator to a cooler, then placed in a freezer, stored there for 24 hours, moved back into a cooler where it thawed, then diluted and given to 16 patients. There were some vaccines likely involved in a temperature excursion. Caller wanted to know if the vaccine was stable or do the patients need to be revaccinated.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101595916 same reporter/SD/AE, different patient.
A report has been received from a Health Professional via Medical Representative concerning, a subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced fever and sore throat. The outcome of the event of fever and sore throat is unknown. The report was considered to be non-serious by the reporter.
Shot was given much higher on my arm than normal.  Since then, I have been in pain and unable to sleep on that side or lift my arm without hurting.
Reported death due to Guillain Barre Syndrome. Transferred to Hospital on 11/18/06 with severe pain to spinal stenosis, low grade fever, and possible Guillian Barre Syndrome. Dies at hospital. 1/8/07 Received medical records from hospital which reveal patient admitted 11/18/06-11/29/06 for LE pain with ascending paralysis & studies positive for GBS.  Treated with IVIG x 4 days. on 11/25, had PEA & coded.  Responded well initially then coded several additional times before expiring on 11/29. Consults of pulmonology & neurology included.  D/C summary indicates COD as secondary to GBS, causing severe autonomic dysfunction & cardiac arrhythmias. PMH: CHF LABS: EMG/NCS 11/20/06, c/w GBS; CT of head 11/18, showed mild atrophy; fluoroscopic LP on 11/18, revealed elevated protein, normal WBC & RBC. FINAL Dx: Guillain Barre Syndrome; CHF w/ejection fraction of 35%; aspiration pneumonia; BPH; anemia; & CAD. 1/9/07 Received copy of Death Certificate from family which reveals COD as GBS with contributing factors of CAD & spinal stenosis.
The same night of vaccination patient experienced rash in both arms, hands and face. She took Benadryl and topical cream he had at home for dermatitis and problem resolved by noon the next day.
Chills; Fever 101.6 degree F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever 101.6 degree F) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever 101.6 degree F). At the time of the report, CHILLS (Chills) and PYREXIA (Fever 101.6 degree F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 101.6 (Inconclusive) Fever 101.6 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Reporter'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. Further information has been requested.
Severe pain in right arm. Numbness in fingers. Vaccination area was warm/hot.
"Left arm swollen, red, area size of golf ball, feels warm to touch, no difficulty breathing, but state does not feel well, no emesis." All info by report to triage line at clinic.
Information has been received from a registered nurse concerning a child who recently, in approximately April 2006, was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot 652545/0926R). In approximately April 2006, the patient experienced a fever equal to or greater than 102 degrees F. A product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Patient complains of muscle and bone pain, later uncontrolled diarrhea, fever, vomiting on 10-22-15, feeling better 10/23/15.
My period has not come. The first day of my last period was 17May2021.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 09:00 (Lot number: EW0169) as dose 1, single and administered in arm left, administration date 2021 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 17May2021, outcome "not recovered", described as "My period has not come. The first day of my last period was 17May2021.". The event "my period has not come. the first day of my last period was 17may2021." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of oligomenorrhoea. Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 vaccine inadvertently given to 17 year old as first dose. Recipient of vaccine and parent notified by  Manager before leaving the facility. Appointment scheduled for recipient to receive the second dose of Moderna after 28 days as off-label use. Recipient left facility after the 15 minute monitoring time, no adverse events reported at that time.
pt recv vax & exp soreness & heat @ the inj site, devel redness @ the inj site & exp muscle aches to a point where could not lift arms;
pt recv vax 1APR99 & on 14APR99 appeared 2-3 papules around inj site, redness also around site-(rt thigh);mom called office & MD requested mom bring pt to be seen on 15PR;one spot or papule on upper lip;no tx given;
Patient came in on 12-22-12 with mother. Left arm red, itching and swollen. 4x2 red area above elbow. Mom instructed to give BENADRYL & TYLENOL by mouth & apply cool compress. If worsens or new sx to call or return to clinic.
Chills, temperature, swollen lymph nodes. Tiredness, headaches, nausea.