chrisvoncsefalvay/vaers-outcomes huggingface dataset:
children were prescribed unknown antibiotics and then developed thrush; children ended up in unknown emergency rooms with high fevers; This spontaneous report was received from a registered nurse and refers to a child patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, frequency, lot #, and expiration date not reported) for prophylaxis.  On an unknown date, also reported as "after receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)", the child ended up in an unknown emergency room with high fevers (pyrexia). Subsequently, the patient was prescribed unknown antibiotics (antimicrobial (unspecified)) (strength, dose, frequency, lot #, and expiration date not reported) for an unknown indication. On an unspecified date, the patient developed thrush (candida infection). It was noted that the reporter inquired about the availability of measles virus vaccine, live (Enders-Edmonston) (ATTENUVAX) and mumps virus vaccine live (MUMPSVAX). The action taken with antibiotics (unspecified) regarding the events was not reported. The outcome of the events was unknown. No further information provided.  The causal relationship between pyrexia, candida infection and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA011146: US-009507513-2002USA008445:
Numbness, tingling, pain swelling in both legs 10 or so days after vaccine. Went back to the clinic and being treated for pinched nerve in her back. She is a jogger and she has not been able to run because her feet are numb and swollen.
Diagnosis: Acute myopericarditis. Presentation: Pt had typical post-vaccine side effects on 6/7/21 including fever and malaise. Also had intermittent mild substernal chest pain starting 6/7/21. Malaise and fever resolved by 6/8/21 but intermittent chest pain continued to occur. Vomited x1 on 6/9/21 in early morning hours, which was followed by severe constant substernal chest pain, pain worse when lying down. Presented to medical care on 6/9/21, seen first via phone visit, then pediatric office visit, then sent to ED and admitted to hospital. Treatment: Naproxen 250 mg PO BID starting on 6/9/21, continues on this treatment as of 6/17/21. Outcome: Symptoms resolved on 6/9/21 after naproxen started, discharged home on 6/10/21. Doing well in outpatient without any complications.
I had a headache and sore arm the day after the vaccine. On 06/12/22 I started feeling symptoms. I had chills and as the day progressed I felt congested and by the afternoon I had a fever with a bad headache and hurt all over. I also had severe stomach pain and nausea. I took a home test for COVID-19 and it was positive. I alternated ibuprofen and TYLENOL for the fever and headache. I had a telehealth visit with the emergency room. I was advised to contact my primary care doctor and with my rheumatologist for the prescription PAXLOVID. I did start feeling better after taking it. Two weeks later I developed pleurisy and in the emergency room. I was not admitted to hospital and was sent home with medication.
Pt flushing/sweating and dizziness 8 mins after vaccination. Pt w/ hx of fainting w/ needle sticks and blood draws. Taken by w/c to lay down in med room. Given water and orange juice. Felt back to normal after 25 mins. Appeared to have moderate vasovagal event.  Pt stable and released from vaccination site.
pt recvd vax & 10mins later pt devel a body rash on chest, shoulders, & upper back; The next day the pt exp a fever of 101, malaise, soreness in rt arm, tongue swollen & welts;
Heavy menstrual bleeding for 15 days, usually is medium bleeding and only lasts 4-5 days. Menstrual cycle seems to have also shortened.
Patient was administered vaccine by medical assistant student. Through a recent audit, it was identified that this patient likely received a Menveo dose that erroneously diluted with sterile water rather than the diluent that comes with the vaccine powder.
Bumpy rash on bilateral thighs. No redness noted. No open area, no drainage. Mom denied fever or any other symptoms.
Fever spike 102.7 after Tylenol was taken, Extreme chills causing severe body shivering, teeth chattering, and goosebumps even while under covers, Severe headache, Nausea, Slight numbness in hands and arms, Body aches, Lightheaded and dizzy
Nose bleed; Sleepy; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleed), SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (SORE ARM) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-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 ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. In 2021, the patient experienced SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (SORE ARM). On an unknown date, the patient experienced EPISTAXIS (Nose bleed). In 2021, SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (SORE ARM) had resolved. At the time of the report, EPISTAXIS (Nose bleed) had resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were 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.
9-10 days after the vacc my injection site began to get red, hardened, very sore, itchy, & warm to the touch (I had this reaction for a few days immediately after vacc as expected) But this was a second site reaction over a week after vacc.
Sore arm; A spontaneous report was received from a consumer concerning herself, a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) in the right arm for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced arm soreness.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event sore arm was not resolved.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event,  a causal relationship with the event cannot be excluded.
Body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and PYREXIA (fever) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder. Concomitant products included LAMOTRIGINE (LAMICTAL) and ASENAPINE MALEATE (SAPHRIS) for Bipolar disorder, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced MYALGIA (Body ache) and PYREXIA (fever). At the time of the report, MYALGIA (Body ache) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-386577 (Patient Link).
Patient reported redness, swelling and tenderness at injection site of Pneumococcal polysaccharide vaccine. Patient was examined by a doctor 2 days followning injection and treated with cold compress and Ibuprofen. Patient examined again the next day by the doctor and discharged.
Roughly 36 hours post vaccination, patient's right arms is red and extremely swollen all the way down the arm to the elbow.
I suffered Tachycardia for about 2 and a half days after I got the Covid vaccine.  When I say Tachycardia, I mean Tachycardia.  That means my heart rate went crazy fast and I almost fainted every time I got up.  Although the most acute symptoms lasted only 2 and a half days after I got the shot , for up to 2 months after I got the NovaVax vaccine, I struggled to return to my normal workout routine (running) as my heart kept feeling funny every time I exerted myself.  Even just a little.   I'm an athlete, and normally run 5 miles daily without breaking a sweat. That makes all of this even more of an aberration for me.
Nausea, eye twitching, eye swelling, back itchy, lip and tongue went numb, fatigued and weakness, dizziness, 'trouble breathing', feeling of 'lump in throat'.
Within 48 hours after receiving the vaccine, I had reduced mobility in my right arm.  I have pain in my arm when it is cold but when it is warm, I have full mobility.   It is the opinion of my orthopedic doctor that I received the vaccine in a tendon instead of the muscle. I have a steroid injection that helped. At this time, it is recommended that I use my arm as much as possible.
COVID-19; COVID-19; Occasional brain fog; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4325345-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jan2022 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single, intramuscular, administration date 31Jul2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154587) at unk (citrate free). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "COVID-19"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "recovering", described as "Occasional brain fog". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the ["covid-19" and "occasional brain fog"] with the suspect product was not provided at the time of this report. Since related determination has been received, the case is managed based on the company causality assessment.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Two days after vaccine developed bad tinnitus in left ear. I went to ENT and they treated me for sinus infection with Amoxicillin. Has been 4 weeks and not any better. Have never had tinnitus before this vaccine.
COVID-19; COVID-19; This is a solicited report from a non-Pfizer sponsored program entitled (marketing program name from a contactable consumer (patient), based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3898481-00). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 vaccination; and adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date and ongoing at "Citrate Free" (as reported), for Moderate to severe rhematoid arthiritis and Moderate to severe chronic plaque psoriasis. The patient's medical history, other relevant history, concomitant drugs were Not Reported. It was unknown if patient was enrolled in a covid-19 Vaccine Trial. On an unspecified date, the patient experienced non-serious covid-19. The patient underwent lab tests and procedures which included covid-19 test: Positive on an unknown date. The action taken in response to the events for adalimumab was Dose Not Changed. The outcome of the event covid-19 was resolved on an unknown date. The reporter's causality for the event of covid-19 with adalimumab and bnt162b2 was not reported.   The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective and Covid 19  cannot be completely excluded.
Case number PHEH2015US024823, is an initial spontaneous report received from a health care professional on 23 Nov 2015. This report refers to a 56-year-old male patient. Past medical history included metabolic disorders. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) multi dose vial (MDV) at a dose of 0.5 ml intramuscularly in left deltoid on 23 Nov 2015 at 10:34 AM. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse events were reported following the maladministration. Follow up report received from healthcare professional on 21 Jan 2016: Updated medical history (metabolic disorder) and suspect drug information (batch number, anatomical position of vaccination and time of vaccination).
developed light case of Shingles; This is a spontaneous report from a contactable other hcp (patient herself). A 68-years-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in left arm on 26Feb2021 16:30 (at the age of 68-year-old non-pregnant) (Lot Number: en6198, Expiration date: unknown) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroid. Concomitant medication included unspecified medication. Patient has not covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced developed light case of shingles on an unspecified date. Patient was not tested positive for covid-19 after vaccination. Outcome of event was recovering.   No Follow-up attempts are possible. No further information is expected.
T102 day p/shots mom gave APAP excessive high pitched crying for approx 2 hrs in afternoon; p/shots MD instructed mom to place pt in tepid bath & keep giving PAPA; t102;
Staring spells with in 2 wks after vaccinations also eye rolling, eyes gently close then tremors lasting up to 3 sec, 1 spell resulted in falling backward. EEG done consistent with generalized cortical irritability. MRI nl, F/U EEG x 4 hours back to normal.
covered their throats, they lose their breath; dizzy; feeling bad; nauseous; he has a fever (104-103 ° F), a lot of fever; headache; body aches ( body hurts a lot); This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (covered their throats, they lose their breath), DIZZINESS (dizzy), FEELING ABNORMAL (feeling bad), NAUSEA (nauseous) and PYREXIA (he has a fever (104-103 ° F), a lot of fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014cz14) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (covered their throats, they lose their breath), DIZZINESS (dizzy), FEELING ABNORMAL (feeling bad), NAUSEA (nauseous), PYREXIA (he has a fever (104-103 ° F), a lot of fever), HEADACHE (headache) and MYALGIA (body aches ( body hurts a lot)). At the time of the report, DYSPNOEA (covered their throats, they lose their breath), DIZZINESS (dizzy), FEELING ABNORMAL (feeling bad), NAUSEA (nauseous), PYREXIA (he has a fever (104-103 ° F), a lot of fever), HEADACHE (headache) and MYALGIA (body aches ( body hurts a lot)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 104-103 f (High) 104-103 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-103344 (Patient Link).
blood pressure going high; Leg started swelling up; right leg is swollen and painful; could hardly walk / couldn't walk for weeks; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Leg started swelling up), PAIN IN EXTREMITY (right leg is swollen and painful), GAIT DISTURBANCE (could hardly walk / couldn't walk for weeks) and HYPERTENSION (blood pressure going high ) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (Leg started swelling up), PAIN IN EXTREMITY (right leg is swollen and painful) and GAIT DISTURBANCE (could hardly walk / couldn't walk for weeks). On 27-Feb-2021, the patient experienced HYPERTENSION (blood pressure going high ). The patient was treated with DICLOFENAC SODIUM for Leg pain, at a dose of 1 UNK. At the time of the report, PERIPHERAL SWELLING (Leg started swelling up), PAIN IN EXTREMITY (right leg is swollen and painful), GAIT DISTURBANCE (could hardly walk / couldn't walk for weeks) and HYPERTENSION (blood pressure going high ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood pressure measurement: 202/94 (High) 202/94.         No Concomitant medications were reported.  Action taken with mRNA-1273 in response to the events were Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Live FU added to Initial case where new events added and case upgraded to due addition of event blood pressure is really high. 202/94. This FU line was not ticked as significant because this leads to change in Regulatory Clock start date. On 21-Jun-2021: Follow up received on 21-06-2021 and treatment medication was updated
March 31, I woke up with very stiff joints, making walking and doing household chores exceedingly difficult. This lasted for 5 days.  Beginning on April 5th I felt like I could not catch my breath, so I called my doctor?s office for an appointment; I saw the PA and she felt I needed to have an EKG. I called them and the earliest I could see them was the 20th. I contacted my Doctor?s office, and they sent an order for the testing ASAP, I never received a call from them to reschedule. As the week continued, I got worse and went to the ER. After numerous tests and blood draws, I was admitted to the hospital. I spent 2 days in the hospital, 24 hours on oxygen.
really sick; a feeling "like 2 trucks hit her," and her body hurt all over; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), PAIN (a feeling "like 2 trucks hit her," and her body hurt all over), HEADACHE (headache) and PYREXIA (fever) in a 21-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick), PAIN (a feeling "like 2 trucks hit her," and her body hurt all over), HEADACHE (headache) and PYREXIA (fever). At the time of the report, ILLNESS (really sick), PAIN (a feeling "like 2 trucks hit her," and her body hurt all over), HEADACHE (headache) and PYREXIA (fever) had resolved.            Patient reported no significant past medical history and no previous diagnosis of covid-19.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-475933 (Patient Link).
104 fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (104 fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (104 fever). At the time of the report, PYREXIA (104 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Patient had underlying b cell lymphocytosis after 2nd dose of Pfizer Vaccine, patient developed autoimmune hemolytic anemia  and shortly after developed a pulmonary embolism.
Started to experience leg, foot and ankle cramps during sleeping time, occurs randomly 4 -5 times a weekly, Never experience these type of symptoms before.  The cramps will last from a few minutes to a couple of hours, they always wake me up while I'm sleeping.
This spontaneous report was received from a pharmacist and refers to multiple, unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.   On unknown dates, the patients were vaccinated with improperly stored VARIVAX injection (lot#, expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237:
Chills, joint pain, body aches, fever of 102 degrees, headache, dizziness
ACUTE RESPIRATORY FAILURE 8/4/2021 ABNL CHEST CT SCAN  ACUTE RESPIRATORY FAILURE 8/4/2021 ACUTE RESPIRATORY FAILURE