chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt has syncopal episode 14-15 minutes after vaccine. Pt sitting in chair during observation and suddenly passed out. Pt was able to come out of syncopal episode within a few seconds (10-15 s) after RN approached him. Pt states he felt dizzy for 30 seconds and passed out. Pt was dazed /confused and pale when awaken. Pt states he did not have breakfast this morning and last had a meal yesterday evening. Pt denies having syncopal episode in the past related to blood draw or vaccines. Vital signs taken initially (at 1041) after syncopal episode were as followed: BP 84/47, HR57, SpO2 97%, pt given granola bar, ice water, and ice pack applied in back of head. After patient was able to regain skin color back, drink full cup of ice water, and eat whole granola bar, vital signs were taken again as followed at 1052 105/50BP, HR71, spO2 97%. Pt placed in gurney to be taken to treatment room. RN gave report to treatment room RN. Pt AOx4 when, able to follow commands.
Pain and numbness on site as expected the day of. Months later (July) I feel the same pain and numbness, my hand loses strength and feels fatigued. Pain starts at the injection site and runs down to mid forearm. This happened the morning after a hike, woke up with pain in the middle of the night, tried to sleep it off but woke up the next morning to more pain. Took Tylenol . It happened one other  time in July (19th) in the morning after waking up again. This time I took no medicine and pain went away during the day.
Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L020000 with expiration date 02-JUN-2017, 0.5 ml, frequency was not reported) subcutaneously. On an unknown date the patient missed a dose of VARIVAX (Merck). No adverse effect was reported. Product quality complaint (PQC) was filed. Additional information has been requested.
Mother reports child's arm got swollen and itching in area of shot - noticed 6 hours after shot given. Nothing has helped itching
everything had been tasting terrible (like rotten); lump; could not think straight/was not thinking clearly; exhausted; nausea; vomiting; pins and needles all over body; throat was closing but not a lot; felt sick; wheezing; lips swollen; diarrhea; This spontaneous case was reported by a health care professional and describes the occurrence of PARAESTHESIA (pins and needles all over body), THROAT TIGHTNESS (throat was closing but not a lot), ILLNESS (felt sick), WHEEZING (wheezing) and LIP SWELLING (lips swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (multiple allergies).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PARAESTHESIA (pins and needles all over body), THROAT TIGHTNESS (throat was closing but not a lot), ILLNESS (felt sick), WHEEZING (wheezing), LIP SWELLING (lips swollen), DIARRHEA (diarrhea), VOMITING (vomiting) and NAUSEA (nausea). On 26-Mar-2021, the patient experienced THINKING ABNORMAL (could not think straight/was not thinking clearly) and FATIGUE (exhausted). On an unknown date, the patient experienced TASTE DISORDER (everything had been tasting terrible (like rotten)) and VACCINATION SITE MASS (lump). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (pins and needles all over body), THROAT TIGHTNESS (throat was closing but not a lot), ILLNESS (felt sick), WHEEZING (wheezing), LIP SWELLING (lips swollen), DIARRHEA (diarrhea), TASTE DISORDER (everything had been tasting terrible (like rotten)), THINKING ABNORMAL (could not think straight/was not thinking clearly), VACCINATION SITE MASS (lump), VOMITING (vomiting), FATIGUE (exhausted) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided Treatment included nebulization.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-JAN-2021 Contains no new information
Sore throat the morning after injection (4/6/21) that progressively worsened, diagnosed with step throat on 4/8/21.
COVID positive  about three weeks after completing COVID Moderna vaccine series (received both doses exactly 4 weeks apart); no known positive contacts or exposure.
Employee had a seizure about an hour post vaccination.  EMS was called and employee was transported to ER.
Subsequently post vax, the pt experienced a really bad reaction. The consumer expressed a concern about this particular lot of vaccine.
Per patient after she was monitor for 30 minutes in clinic for COVID-19 vaccine, she felt fine.  Per patient one hour after she received the vaccine, she had tingling on left side of face that lasted for 1-2 hours and it went away.  Per patient she did not follow up with her provider.
After my J&J vaccine, I experienced fever, chills and a left sore arm and those symptoms resolved in 24 hours. On 04-06-2021 I experienced headaches on and off and on 04-07-2021, I had light headiness, an air-filled pressure sensation to my eyes, forehead, more like a sinus headache. On 04-14-2021, I went to see my PCP due to my headaches continuing, the doctor ran complete blood panel test were performed along with a D-dimmer test to rule out blood clots and he told me to take Advil as pain medication.  My D-dimmer test was normal. I noticed when bending down my headaches became worse. On 04-20-2021, an MRI of the brain was performed. On 05-01-2021, I experienced muscle body aches, fever and continued with headaches. I went to a walk-in clinic, where a Covid-19 test was performed and it was negative. I started taking antibiotics and the fever and muscle bode aches started to go away. I still have to this day headaches and an air-filled pressure sensation around my eyes and eyebrows.  As of today, my headaches are consistent, and they come and go.
Moderna COVID-19 Vaccine EUA                 Darker than normal urine for 2 days......I apologize if this is not considered an 'adverse event'. it is unusual for me.
Information has been received from a physician concerning a 64 year old female with blood pressure high cholesterol high who on 12-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR, AVAPRO, CARDIZEM CD and aspirin. On approximately 11-JAN-2008 ("3-4 days ago") the patient developed shingles rash that was mild that was mild confined to one finger of one hand. The shingles was painless and did not bring any discomfort. The patient described Valtrex 1 gr twice daily for 7 days. The patient is recovering and the rash is scabbing. Follow-up information received from the Herpes Zoster Questionnaire on 16-Jan-2008 indicating that the patient was vaccinated with ZOSTAVAX (Oka/Merck) (lot#658361/1090U). A rash did occur with an onset of approximately 09-Jan-2008 isolated to the one finger with 4 or 5 zoster like lesions. The patient had no fever and was experiencing pain rated as a "3" on a scale of 1 to 10. No other systemic symptoms reported. The patient had not yet recovered, still has lesions. Patient has a history of chickenpox in her childhood. No recent exposure to chicken pox or herpes zoster. Follow-up information was received from the VZV identification program indicating that the sample of the lesion was collected on 16-Jan-2008 and sent to the laboratory on 21-Jan-2008 and the source of the specimen was a "scab", did not mention the site. The specimens arrived at the laboratory on 24-Jan-2008. Results: Was VZV DNA amplified - No. Was B-globin DNA amplified - No. Interpretation: Inadequate specimen - No strain ID. Results reported on 04-Feb-2008. Follow-up information was received from the VZV identification program indicating that the sample was ran twice and the result was still "inadequate". No further information is expected.
Groin pain Swollen lymph nodes in groin and abdomen Left Testical pain Abdomin pain Sore left arm
Information has been received from a physician concerning a 65 year old male with no medical history or allergies won 04-AUG-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included LIPITOR and FLOMAX. On approximately 10-SEP-2007 the patient developed a papular rash all over the body that was mostly on both legs. it was reported that patient was vaccinated at another physician's office. Unspecified medical attention was sought. A biopsy showed that it was not suggestive of Herpes Zoster rash. At the time of report the patient had not recovered. A quality complaint was not involved. Additional information has been requested.
Pt initially reported right arm pain at/near site of injection beginning 2-3 days after injection. Occurs mostly when he touches the area or with certain arm movement. Pt consulted with primary care physician at an appointment that had been scheduled prior to the incident.
2 weeks after receiving 4th dose patient was noted to have A Fib and arterial thrombus in leg.; 2 weeks after receiving 4th dose patient was noted to have A Fib and arterial thrombus in leg.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 75-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: hypertension. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; VALSARTAN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant), ARTERIAL THROMBOSIS (hospitalization) all with onset Apr2022, outcome "unknown" and all described as "2 weeks after receiving 4th dose patient was noted to have A Fib and arterial thrombus in leg.". The events "2 weeks after receiving 4th dose patient was noted to have a fib and arterial thrombus in leg." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of atrial fibrillation, arterial thrombosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events atrial fibrillation and arterial thrombosis and the suspect drug BNT162B2 cannot be excluded. 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.
Low grade Fever Nausea Fatigue Symptoms resolved by the next day  10/22/09 ED records received service date 9/23/09 to 10/21/09. Assessment: Sinus infection? Low grade fever, nausea, fatigue.
Patient had a red raised wheel reaction at injection site on Saturday 09/30/23, that spread and was itchy and read, and warm to touch on sunday but styed localosed to the arm. Patient cjecked with pharmacist and MD and advised to use hydrocortisone 1% OTC and reaction is subsiding gradually, no oral meds required
red inflammed area 8 inches by 3 1/2 inches at L deltoid (injection site)   Injection given on 5/23/09
Severe left first toe/hallux pain, patient unable to bear weight, intermittent without redness, warmth, swelling.  Morning stiffness.  No risk factors, personal history, or family history for gout.
Moderna COVID-19 Vaccine EUA March 19: Received vaccine. Experienced only very minor muscle soreness in left arm.  March 20: In the evening, began to feel low level general muscle aches throughout body. March 23: Woke up with lower back muscles contracted. Very painful to move and stand up. Very difficult to walk. Could only walk very slowly and in a hunched over position. Changing positions from sitting to standing and vice versa was very painful and would take at least 7 or 8 minutes. Because of the extreme difficulty in movement and pain, went home to rest. Applied hot water bottle to lower back while lying down.  March 24: In the morning symptoms were better. Called the hospital but was told my symptoms were not a reaction to the Moderna vaccine.  March 25: Symptoms were greatly reduced. Able to walk nearly normal.
body aches, chills, headache, fatigue that began 15 hours after injection and escalated to severe for a few hours. Side effects subsided within 36 hours of vaccine.   9 days later- 3/20/2021- diarrhea for 72 hours, nausea, headaches, fatigue. 3/23/2021 severe bloating, constipation, irregular BM, that is still persisting 26 days later.  4/6/2021- menstrual cycle was due on 4/1/2021 history of very regular cycles, PMS symptoms ongoing for over 2 weeks and menstrual cycle is now 6 days late. Negative pregnancy test, not pregnant.
Second dose, massive diarrhea; severe fatigue; chills; diaphoretic; neck pain.; headache; This is a spontaneous report from a contactable Nurse (patient). A 50-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248) via an unspecified route of administration on 18Jan2021 at single dose in left arm for COVID-19 immunisation. He received the first dose (EL 3248) at age if 50-year-old on 28Dec2020 10:00 AM Intramuscular in Left arm for COVID-19 immunisation, and after first dose experienced nausea wanting to vomit, massive diarrhea, severe fatigue, with chills and diaphoresis, and bloody stool-diarrhea. Medical history included hypertension. There was no known allergies. Concomitant medication included acetaminophen. After the second dose, on 20Jan2021 10:00 PM the patient had massive diarrhea, severe fatigue, chills, diaphoretic, headache and neck pain. No treatment received for events. Events outcome was recovering.
The patient's father called me 6/30/07 and reported to me that his daughter had passed out briefly in the lobby outside my office (patient came to visit alone). She drove to a store where she met her father and he took her home. Patient is a veggan.
This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration on 30Jan2021 09:30 (at the age of 76-years) as 2nd dose, single dose in left buttocks for covid-19 immunization. Medical history included: slight high blood pressure and unspecified allergies. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included carvedilol 12.5 mg, vitamin d [vitamin d nos], pantoprazole sodium. The patient received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration on 09Jan2021 at 10:30 as 1st dose, single dose in Left buttocks for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 31Jan2021 at 05:00, the patient experienced fever 102.6, chills and aches, headache, soreness at site of injection with a 3 inch red circle. The patient underwent lab tests and procedures which included body temperature: 102.6 on 31Jan2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Rash/whelps, Lichtenification / Raised erythematous skin, scales on Extremites Back + sparing Belly. Keflex 500 TID X 10 #30 MM HCI % HC1% AAA BID Hydroxyzine 25 TID X10 #30/MR warm compress
Patient reported the need for a booster. However, the patient had already received a booster a month ago. No adverse signs or symptoms observed.
73-year-old male with significant medical history for diabetes mellitus type 1, history of DVT, GERD, hypertension, presented to the ED as he was recently diagnosed with COVID-19 and presented via EMS after a fall. He states that he has pressure on the left side of his chest without any radiation for the past 4 to 5 hours and he fell going into the bathroom as he usually sleeps in his living room. Admission dx: SOB, fall, NSTEMI, Troponin level elevated, AKI, COVID-19.  CT PE negative for pulmonary embolism.; Mild patchy round glass multifocal areas of airspace disease in the lungs & right basilar atelectasis and some infiltrative changes in the right perihilar region. D dimer 1,294.   Treatment:  Oxygen, decadron, remdisivir,  lovenox. Discharged
Information has been received from a physician concerning his female nurse who on approximately 07-MAR-2008 or 08-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 10-MAR-2008 the patient experienced an outbreak of herpes simplex virus (HSV-1). At the time of the report the patient's status was unknown. Additional information has been requested.
Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years,  as single dose for covid-19 immunisation.  Medical history included back disorder from an unknown date and unknown if ongoing.   The patient's concomitant medications were not reported.  Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown.  Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date.  Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator).  The patient died on 16Apr2021.  An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure
Patient diagnosed with chicken pox 9/23/07. Had vaccine and booster. Had 1st dose Varicella on 3/25/02 and booster on 4/27/07.
The entire week following the 2nd dose (occurring several times/day), I felt like my heart was fluttering.  I don't know how else to explain it as I've never experienced anything like it.  This fluttering feeling has since occurred less and less frequently.  As of today, July 5, 2021, it is only occurring maybe once per week.  Does not seem to matter whether I'm doing anything or just sitting.
Rash noted on the face and neck around 3:00 PM 7-7-15, moving to arms and legs. Urgent care visit 7-7-15 for rash. Dx contact dermatitis. Rash faded and patient had no other symptoms.
Patient complained of left leg limping/notice indention/white pigmentation on June 25, grandmother states a trauma/a injury.  History CP on dad sided/rtn on 07-30-07 - grandmother states notice when started walking and child walked at 13 months dragging of left leg.  States CP-Aunt-Dad side and son at 4 years.  Notice indention on 06-25-07 - x-ray normal.  09-14-07 left leg indention - lighter in color - not limping much.  Stopped dragging leg - recovered.  Small lipoatrophy left thigh - present.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with LIQUID PEDVAXHIB, lot # K008873, expiration datte: 06-FEB-2017 or lot # K008877, expiration date: 24-FEB-2017, (dose, administration route and site were not reported) after it was exposed to a supported temperature excursion of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Painful rash under left breast, pain resolved after a few days but rash is still present. Concerning for tinea corporis but given timing of vaccine, could not rule out vaccine side effect.
Breakthrough Covid case on May 18/2022, 5 -day fever resulting from illness and upper respiratory distress and high resting pulse. What I would describe as moderate. Not a result of the vaccine, but a result of breakthrough illness.
Red, swollen, itchy rash, very painful. Could not lift arm. Took ~36 hours before sxs subsided. Took Aspiring to help with sxs, helped somewhat.
Patient given Heplisav-B vaccine at 1012, IM in right deltoid. Hypertension as documented. Large fluid gain today. Patient reported sensation of having to have a BM and back pain. He then reported being nauseated and vomited approximately 200 cc bile mixed with his protein drink when he drank most of before treatment ended. Patient became diaphoretic after vomiting. Also reported his lips being numb. Patient refused any more interventions and left the unit.  Rn went to assess patient in his mother's vehicle at 1030. Patient even more diaphoretic and still reporting pain and numb lips. Mom asked, "What did give him?" I told her that he received his Heplisav-B vaccine. She stated, "I'm taking him to the E.R." Patient presented to ER with lip swollen, difficulty breathing, tachycardiac, and diaphoretic. Patient treated with IV fluids, prednisone, epinephrine, Solu-Medrol, and albuterol. at 1111. Patient was monitored for until 3:18pm. Patient was discharged to home with EpiPen.