chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10days earlier menstruation; Cold symptoms; Body chills; Fever; Headache; Aches; Insomnia; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism since and unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHYROID) for unknown indication, from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced 10 days earlier menstruation. On an unknown date, 12 hours after the second dose, the patient experienced body chills, fever, headache, aches, insomnia that occurred for 3 days and felt cold symptoms and was in bed for 3 days. The patient should have taken Tylenol right after the shot as it mitigated the symptoms a lot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included paracetamol (TYLENOL) on an unknown date and unknown if ongoing. The clinical outcome of the events 10 days early menstruation, body chills, fever, headache, aches, insomnia and cold symptoms was resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added, Duration for AE "body chills, fever, headache, aches, insomnia" added as 3 days.
DIZZINESS; SWOLLEN LIPS; UPSET STOMACH; NUMB LIPS; CHILLS; MUSCLE ACHES; HEADACHE; FEVER; NAUSEA; FATIGUE/TIREDNESS; SWEATS; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Vaccinated at left arm. No concomitant medications were reported. On MAR-2021, the subject experienced sweats. On 20-MAR-2021, the subject experienced fatigue/tiredness. On 21-MAR-2021, the subject experienced swollen lips. On 21-MAR-2021, the subject experienced dizziness. On 21-MAR-2021, the subject experienced upset stomach. On 21-MAR-2021, the subject experienced numb lips. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced muscle aches. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lips, upset stomach, numb lips, muscle aches, headache, and nausea, and had not recovered from fatigue/tiredness, dizziness, fever, chills, and sweats. This report was non-serious.
Pt w/ 50 mm red area over lt arm below injection site. Pt states the morning after the injection, the area was hot & raised but seems to be resolving now.
Vaccine received 1/4/2021, minor injection site tenderness and right shoulder joint pain resolved by 1/8/2021. On 1/12/2021, upon removing shirt at approximately 4:00 PM, silver dollar sized area of induration , hotness, pain and erythema noted at injection site.  No fever was observed. Contacted ID MD at employer and informed him of the findings.  He advised it could be an immune mediated response vs. cellulitis. Went to Urgent Care site on 1/13/2021 and was dx with cellulitis and was prescribed cephalexin 500 mg PO TID x 10 days.  By 1/16/2021, induration, pain, and erythema has resolved.  Interestingly, injection site is still a bit warmer than the surrounding tissue.
Patient came in from prenatal visit and stated she was given active seasonal FLUMIST at health center. Dr felt we should report. 11/20/09 Medical records received for date 6/11/09 to 11/17/09. OB records. Pt states given H1N1 flumist given approx 11/14/09. Pt pregnant EDC 1/26/10. On 11/17/09 (+)FM, no complications noted.
Numbness/tingling (whole body/lasting longest in hands/feet); drop foot; muscle weakness; fatigue; trouble concentrating; trouble walking. Symptoms improving but still some numbness/tingling in hands/feet.
Received a telephone on 1/11/2022 from client reports symptoms of dizziness, nausea, and clamminess two hours after receiving Rabies (Imovax) vaccine. Client was strongly advised go and be evaluated at an urgent care or ER. Client verbalized understanding. Telephone call with the client today 1/12/2022. Client reports he did go to an urgent care for evaluation yesterday. He stated the doctor said client probably had a mild reaction to the vaccination and client was given nausea medication. Client reports he is doing well today and is not experiencing any symptoms. Client states there is no swelling, redness, or pain at his vaccine injection site.
Patient presented to the ER for worsening diarrhea, coughing, shortness of breath and chills x 1 week. Patient was treated with solu-medrol, pepcid, lovenox, antibiotics for Covid pneumonia. Patients respiratory status got worse and she had to be intubated. Patients kidney function worsened and nephrology was consulted. Patient was placed on a Bicarb drip. Patients condition worsened and she was transferred to another hospital on 12.4.21.  Patient received one dose of Tocilizumab. Patient required a tracheostomy and PEG tube placement on 12.16.21. Patient had an abdominal CT scan on 12.20.21 that revealed dislodgement of the PEG tube. Patient underwent PEG tube replacement on 12.21.21. Pt was transported back to hospital on 1.10.22. Patient was discharged to SNU on 1.14.22.
10 x 10 cm lg red warm local rxn to varicella booster R arm.
Feet became numb and very painful. The sensation quickly spread up my legs and I became unable to walk. I sought medical services from my Family Dr. who then refered me to a neurologist who diagnosed GBS. I was not hospitalized and have been recovering slowly at home. GBS is not for the faint hearted as it has changed my life.
Severe Nausea; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 12-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 in the left arm on an unknown date in May2021 at 15:00 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021 at 22:00, the patient experienced severe nausea accompanied by a vomiting event. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea accompanied by a vomiting event was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
after being intimate with him, she started to have sore knee joints; after being intimate with him, she started to have sore knee joints; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that her fiance received both doses of Pfizer COVID vaccine and stated that after being intimate with him, she started to have sore knee joints. First she thought her knees were just acting up, but then it started being more sore. The patient asked why she was more sore and did she have the vaccine in her body now. The patient further asked what was the duration of immunity of the vaccine and if the next round of shots would be given next year. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hives developed to back, under both arms, torso and left arm covered in hives with purple discoloration. Went to ER and was administered Steroid shot and oral steroid s x 5 day and Benadryl .
This spontaneous report as received from a 86 years old male patient with colon cancer, breast cancer and drug allergy to naperson refers to himself. The patient was vaccinated with ZOSTAVAX (lot # unknown) subcutaneous 5 years ago (approximately in October 2007). No other co-suspects were reported. Concomitant medications included ZOVIRAX and cephalexin. On 10-OCT-2012 the patient experienced blotch on his left thigh, which was diagnosed by his physician as shingles. The patient had not had shingles prior. There was no treatment information and no lab was given for the event. The outcome of shingles was unknown. Additional information has been requested.
Injection given of Friday 4/28/17 and pt. called Monday 5/1/17 with c/o weaken joint and muscle aches, and abd cramping, diarrhea, testicular pain. Able to get relief from TYLENOL P.M. Is beginning to feel better today 5-1-17 but continues to have random joint and muscle pain.
About 1 hour after nausea, pain at the site of injection, headache. About 2-3 hours after joint pain, fatigue, and low grade fever + earlier symptoms mentioned above.
Left shoulder/joint pain; left shoulder partial immobility; left hand/finger tingling; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK417J, expiry date: unknown), via an unspecified route of administration from on 05Jan2021 10:30 at single dose (Left Deltoid) for COVID-19 immunization.  The patient medical history was not reported.  Patient is not pregnant. Patient had no covid prior vaccination, patient had no covid tested post vaccination, and no known allergies. Concomitant medication included paroxetine (PAROXETINE).  The patient received first dose of bnt162b2 (lot number: PAA156051) on 12Dec2020 at Left Deltoid for COVID-19 immunization at 35 years-old. Vaccination facility type was Hospital. The patient experienced left shoulder/joint pain, left shoulder partial immobility, and left hand/finger tingling that has not gone away; all on 08Jan2021 08:00. The outcome of the events was not recovered. No treatment for events was given.
When I was getting dressed I noticed that I had a few bumps on my back. They felt raised like a mosquito bite, but did not itch or hurt. Over the next few days, more bumps appeared, and they developed large round scabs, like a burn from a cigarette. A few scabs have now fallen off, and the scab area remains red. But they do not hurt at all.   I?m not entirely sure when the bumps initially formed because I can?t see them well and do not feel them at all.  At the moment I have 8 scabs/red areas running down my back on the left side.
mixed connective tissue disease; This is a spontaneous report from a contactable Nurse (patient) reported for herself from a Pfizer sponsored program. A 71-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot Number: EM9810) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 71 years old.  Medical history included ongoing immune thrombocytopenia (ITP) diagnosed probably 10 or 15 years ago. The patient's concomitant medications were not reported. Historical vaccine included first dose of Pfizer Covid Vaccine on 18Jan2021 (LOT: EL3249) at left arm for covid-19 immunization. The patient experienced mixed connective tissue disease (medically significant) on 08Apr2021 with outcome of not recovered.  Therapeutic measures were taken as a result of mixed connective tissue disease. Reported patient recently diagnosed with mixed connective tissue disease on 08Apr2021, in the past month. She currently has been placed on prednisone and  Plaquenil and wanted to know if that will affect her vaccine. Caller stated she started medications this Month in May. She received both of the Pfizer vaccines in Jan and Feb of 2021.  Information about lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Mixed connective tissue disease  . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Motrin taken prior to Vaccination.  Pain in shot arm.  Tingling sensation in shot arm.  Pain in neck on side with shot in arm; small knot developed; sensitive to touch.  Headaches increased as Motrin wore off.  Pain in neck decreasing over time; knot in neck becoming less sensitive.
On 3/10/08, pt was given Infanrix and MMR vaccine in left arm. Deltoid and tricep area of arm-red and warm and swollen. Pt is to return to office 3/13/08 to re-evaluated arm for infection
Pain sore arm for about 48 hrs. Light headache for about 24 hours. Weekend after big sore lump in underarm. Exactly a week later, tonight my arm is hot and itchy. Has big lump looks like big bug bite. Feel prickly and hot and slightly headache/nauseous.
Initial and follow up information has been received from a registered nurse and a nurse in the physician's office, concerning a 37 year old female who on an unspecified date received an accidental eye splash with the vaccine measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live as it was being prepared to be administered to her child.  It was reported that the poison control was contacted and an incident report was filled out.  The nurse considered the event to be non-serious and reported that the patient was fine, however, had some burning in her eye.  It was reported that the patient was administered an eye flush.  It was reported that the patient was instructed to call the doctor's office if she had any problems, however, at this time, the patient had not contacted the physicians office.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
organ failure; rash; Dress syndrome; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome), ORGAN FAILURE (organ failure) and RASH (rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 100006) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid disorder.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) 1 dosage form. On 17-Apr-2021, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced ORGAN FAILURE (organ failure) (seriousness criterion hospitalization prolonged) and RASH (rash) (seriousness criterion hospitalization prolonged). At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome) had not resolved and ORGAN FAILURE (organ failure) and RASH (rash) outcome was unknown.            Patient taking thyroid medication .Treatment history was not reported .  Patient was hospitalized due to organ failure, rash and multiple other issues.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient began not feeling well the day following vaccination, with vomiting, diarrhea, and fever. Patient became confused today, family called EMS.  He was found to have multiple areas of hemorrhage in his brain (SAH) with a critically low platelet count of 24.  He is currently in ICU intubated and sedated.
So sometime after the vaccine I got joint pain in my wrists for no apparent reason at all. I saw my DR and I can't remember if they did x-rays or an MRI but it lasted for a few weeks before I had even went in to see her. I honestly cannot even give a time frame because it was so long ago, this happened in the beginning of the year.
Entire chest hurt, was hard to breath, dry heaving since there was no food to vomit and felt like I was having a heart attack spanning from early morning till late in the evening March 18, 2022(8am-5ish pm). Went into the er around 11:30 am stayed till about 8pm in the night. The hospital only gave me pain meds, I believe Tylenol.
body ache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medication was provided.  No Treatment Medication was provided.   This case was linked to MOD-2021-013573 (Patient Link).
Lg bruised, red area, 4 inches in diameter. Hot to the touch. Hard & painful for 4 days.
Received vaccine 3/25/19 in office at 12 year well check, GARDASIL #2 and Hep B #4 (due to timing). Developed sharp pain under (R) arm with swelling the next day. No redness, no fever used Ibuprofen prior to visit.
Arm soreness only for 36 hours.  Occasional heart palpitations noticed approximately three weeks laters.  Second dose 6/15/2021.  Arm soreness and mild fever, aches, fatigue for 48 hours.  Occasional palpitations continued.  ER for treatment. Diagnosis: sinus arrhythmia with occasional premature ventricular complexes.   Patient had normal ECG pre-vaccine (5/5/2021) based on annual wellness exam.
mom reported while driving, child in back seat exhibited garbled speech, lt facial droop & drooling; mom stopped car & incident was over;child's speech back to nl & only complaint from child was lt face felt funny;to MD-MRI ordered;
I have had very very mild tinnitus for a few years now, where it is only noticeable in dead silence. I sleep with a sound machine and that fixes the problem completely. But after getting the vaccine, I have ringing in my left ear that is 10x louder than it ever has been before. My ears feel clogged. It is taking over my life. I can't focus. I can't sleep.
they administered 15 ml instead of the full dose of 30 ml; they administered 15 ml instead of the full dose of 30 ml; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EL9265) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "allergic to Fentanyl". The following information was reported: PRODUCT PREPARATION ISSUE (non-serious), UNDERDOSE (non-serious) all with onset 26Feb2021, outcome "unknown" and all described as "they administered 15 ml instead of the full dose of 30 ml"; VOMITING (non-serious) with onset 26Feb2021, outcome "unknown", described as "vomiting". Additional information- It was reported that  patient got the first dose yesterday; and since she is allergic to Fentanyl they administered 15 ml instead of the full dose of 30 ml; asked if she will be receiving the full dose of 30 ml on her second and make up for the deficit from her 1st dose' coded as 'no adverse effect' and 'vomiting' coded as 'vomiting'  No follow-up attempts are possible. No further information is expected.