chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; fatigued; lightheaded/dizzy(the room was spinning); nauseous; chills; hot flashes; This is a spontaneous report from a contactable nurse reported for herself. A 24-year-old adult female patient (pregnant: no) was received the first dose BNT162B2 (brand: Pfizer, Batch/lot number: EK5730) via unspecified rout of administration on left arm on 23Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma, Bipolar Disorder, known allergies: Latex, milk, bananas, blue dye 2&, COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19? :Yes). Concomitant medication in two weeks included lamotrigine (LAMICTAL), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ascorbic acid, ferrous fumarate, folic acid, retinol (PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]). No other vaccine in four weeks. After the vaccination patient became lightheaded, dizzy (the room was spinning), nauseous and got chills and hot flashes. After 30minutes or so she began to get a headache while the other symptoms wore off and then became fatigued. Adverse event start date was 23Dec2020 01:00 PM. the most recent COVID-19 vaccine was administered in Hospital. Since the vaccination, the patient has not been tested for COVID-19. Treatment received for the events included ibuprofen (MOTRIN), Meclizine, ondansetron (ZOFRAN) and paracetamol (TYLENOL). Patient was recovering from the events. It was reported as non-serious. No results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.
Administering vaccine 11 days apart; A spontaneous report was received from a nurse concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of inappropriate schedule of product administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient received the first dose of the vaccine. The nurse reported that she administered the second dose on the same patient on 16 Jan 2021 and dose 1 and 2 were administered 11 days apart instead of 28 days interval.    No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, inappropriate schedule of product administration, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Itching of chest & injection site. Chest pain, cough, mild flush ant chest & injection site. No urticaria, stridor, retractions, SOB. Responded to 1 tsp oral BENADRYL. Mild wheezing noted after BENADRYL, O2 sats 95 to 98. Improved within 20 mins.
Patient came to pharmacy for her second dose of COVID-19 Moderna vaccine.  Pharmacist administered 0.25 ml instead of 0.5 ml. Error was caught several minutes after administration, but patient had already left the premises. Patient was immediately contacted over phone to come back to pharmacy. Per guidelines, pharmacist administered another 0.25 ml at a site 1 inch away from first injection to make total dose 0.5 ml. This second injection was done about 20 minutes after the first.
A week post vaccine, 12/20/2021, I got TIA. I lost memory and the ability to speak for 45 minutes. I did not have any weakness, I did not hit my head. I did not know my name, my husband's name or my kids' names. I went to the local ER, I had an MRI CT Scan, and an EKG and they did not show anything.
Fever 102F, chills, body aches, fatigue, injection site soreness/pain
Information ha been received from a registered nurse concerning a 66 year old female patient with no medical history but with allergies to sulfonamide and levofloxacin who on 17-AUG-2009 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot # 662748/1088X). Concomitant therapy included levothyroxine Na, fexofenadine hydrochloride, simvastatin (manufacturer unknown), NEXIUM, DIOVAN and ibuprofen. On the same day, after receiving the vaccination the patient developed an injection site reaction. The patient complained of pain and swelling. She applied some ice but later that day she started to have joint pain in her elbows, shoulders and wrists. The symptoms subsided after 24 hours. The patient called the office. No lab diagnostics studies were performed. At this time of reporting, the patient was recovering. Additional information has been requested.
I experienced diarrhea and suddenly became lightheaded, my heart started to race and I became shaken. The heart racing was so severe I thought I might be experiencing a heart attach or some other form of cardiac attack. My co-workers called an ambulance and I was taken to the hospital for further testing. While in the ambulance I began to have a fever of 100.4 and was shaking uncontrollably while still experiencing my heart racing.
Very loud tinnitus developed in left ear. Have always had low grade tinnitus, but never to this degree.
Three days after I received the vaccine, I felt shortness of breath and a rapid heart rate. I went into the ER and they ran test that came back normal and I was sent home. Over the next 3 weeks I was unable to walk a block without being very winded and fatigued. I am usually a very active person. I went back into urgent care to have more testing done which all came back normal. I was not prescribed any treatments. Over the next 5 months I experienced brain fog, rapid heart rate, night sweats, unable to sleep at night, food sensitivities, and increased anxiety. This condition is still ongoing, and I am still being seen by my providers. I have taken a month off work to recover and notice slight improvement.
Swelling and erythema in arm around inject site of Anthrax, extending past elbow. Tx'd in a medical center in a.m. of 2/5/03 w/Triamcinolone cream, Keflex, and Motrin. Increasing swelling and erythema during night, PT presented to ER. Tx'd w/Solumedrol and given Atarax.
Raised red rash in arm larger than a half dollar. Itchy and painful. Had to take Benadryl.
Patient presented to the ED on 4/15/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. She also had an ED visit on 4/13/21.
Within 24 hours after vaccination, pt developed perioral cyanosis and apnea CPR. Seizure like activity. No fever, witnessed desats in hospital D/C'd home with apnea monitor. 10/10/06-records received for DOS: 9/2-9/7/06 2 month old presented to ER with one episode of circum oral cyanosis of fingertips and toes turning blue and baby not breathing, mother administered CPR for 2-3 minutes with baby responding and breathing again. During apneic episode mother noted that baby was shaking and had eye twitches and eyes rolled back. Once baby awakened mother noted increased stiffness, unable to extend arms and stiff straight legs. On day of admission mother noted decreased responsiveness and increased sleeping. Also had congestion and cough. No fevers, decreased intake on day of admission. Urine output good, no vomiting no diarrhea. One sick contact with a 3 year old brother. IN ER PE WNL. UA: 10-20 protein, 300-500 glucose, negative nitrites, negative leukocyte esterase.  Hospital Course: Treated with Ampicillin and Cefotaxime. Initially had episodes of apnea and bradycardia with desaturations in 60s. One witnessed episode while patient was apneic and began having circum oral cyanosis and required stimulation and blow by O2. No further recorded episodes but was having respiratory rates as low at 10-12. DC with apena monitor.
After one shot, significant flare up of localized chronic psoriasis on buttock. Started spreading to other buttock, down inner thigh and scrotum. After second shot, his back, neck, underarms and face are covered with psoriasis and it has spread less in less severe form to legs, arms, abdomen, and probably other places I don?t know about yet. We are using sunlight, clobetisol and low gluten/no nightshade diet to try to control. Also one dose of 20 mg prednisone at ER, oral
Blood vessels that bursts for two weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PURPURA (Blood vessels that bursts for two weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history was not reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PURPURA (Blood vessels that bursts for two weeks) (seriousness criterion medically significant). At the time of the report, PURPURA (Blood vessels that bursts for two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information was not reported.  Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-080340, US-MODERNATX, INC.-MOD-2021-080364 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested. US-MODERNATX, INC.-MOD-2021-080340: US-MODERNATX, INC.-MOD-2021-080364:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 7 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient received Paxlovid from 09Oct2023 to 13Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
The second dose was administered on June 3, 2021. On June 29, I developed severe vertigo that has lingered into a chronic feeling of motion sickness and nausea for the past 8 months. A full GI workup and CT of head did not show any suspicious abnormalities.  The neurologist suspects this is a form of chronic vestibular migraine. I have kept a detailed tracking sheet to see if there are any triggers, and the only outlier is the COVID vaccine. I am not sure if the vaccine caused this, but I do think it is worth reporting.  I am due for a booster, but am hesitant given this unknown.
Initial report was received on 22 September 2009 from another manufacturer (document number 45225402) who received the report from a consumer, who is the patient's parent. A male patient (age not reported) had received an Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported). According to the reporter, her son had a reaction to the flu vaccine and experienced seizures afterwards. The patient's recovery status was not reported. The reporter declined to provide contact information and no additional information was provided. Documents held by sender: None.
Shortly after receiving shot patient started to feel sweaty and hot, patient was observed that her head was falling back and she was passing out and her friend caught her as she was passing out she was lowered to the floor and placed on a back board and placed on a litter and taken to medical observation, vital signs obtained and her blood pressure was 108/75  @ 11:11 Heart rate 75, follow up blood pressure was 101/66 HR 77 pulse ox was 98% on room air, patient was observed and she was discharged to home she was escorted out via wheelchair.
Initial report was received on 16 June 2010 from a health care professional. This report involved one patient out of a cluster of two patients who experienced an adverse event after receiving DT ADS PED USP. The adverse event experienced by the second patient has been captured in case number 2010-03424. A 3-year-old male patient had received a third dose intramuscular injection of DT ADS PED USP (site not reported), lot number U2630AA and a dose of IPOL, lot number D0122-2 (route, site and dose number not reported) on 09 June 2010 and immediately after vaccination, the patient developed extensive redness, swelling and discomfort in his entire thigh down to the knee. A few days later, the patient developed a rash on the groin and torso and under his arms. The patient was evaluated by their physician (date and results not reported). The patient had no history of adverse events following prior vaccinations. Outcome was entered as unknown on the VAERS form; however, the reporter stated the symptoms of extensive redness, swelling and discomfort in the entire thigh down to the knee persisted at the time of the report. Documents held by sender: None
Red area at injection site that increased in size and redness for one week. Became Slightly warm and indurated 2x5 cm. Febrile on days 5-8 after vaccination to 102 deg.
Pt received JSN COVID vaccine. He stayed in the LHU foe approximately 20 minutes after receiving vaccine and reported no reaction. Pt returned to LHU on 8/10/2021 and he had a rash on both arms and his left eye was swollen. He reported that the reaction occurred later that evening after the shot. Pt denied shortness of breath but he did use his Epi Pen that he had at home when he started having a reaction. Pt reported that in the past he had had severe allergic allergy reaction to CT/MRI dye and hydrocodone/codeine. Pt left the clinic after reporting this to a staff nurse. Upon trying to contact the pt later to discuss the VAERS form it was discovered that he did not list a phone number. After I was unable to locate a phone number from various sources at the LHU. No more information is known about this pt's medical history or background. He did not state if he went to see his PCP or any other provider because of this reaction.
Bruising at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 15Nov2021. Vaccination history included: Bnt162b2 (Dose 1, single, Location of injection: Arm Left), administration date: 09Nov2021, when the patient was 9 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 03Dec2021, outcome "recovering", described as "Bruising at injection site". Therapeutic measures were not taken as a result of vaccination site bruising.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 12-SEP-2014 the patient was vaccinated with PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
The vaccine was administered on 5/11/2021 but was expired by 30 day rule. We received the vaccine on 4/6/2021.
Received injection approximately 9:20 A.M.  Approximately 5 hrs later felt sleepy.  Around 4 P.M. started having a headache (normally do not have headaches).  By 5 P.M. the headache was severe (thought I was having a stroke) had chills.  Might have had a fever.  Went home from work - directly to bed - took 2 Ibuprofen.  Slept.
pt recvd vax & devel a macular rash 5 to 7 days later x 2 to 3 wks; pt was seen by a dermatologist who thought it was an allerg react to the vax; on f/u pts husband MD noted that pt recvd flu vax w/o incident felt rash of unk etiology;
Rash started on bilateral feet after receiving the vaccine for 1-2 hours with itching and burning throughout the body on 10/24/2011. Went to ER on 10/26/2011 and received a "shot", prescribed diphenhydramine and prednisone.
I went for a hair cut and when I got home i noticed a bald spot on my head.  I scheduled a doctor visit, she took a biopsy and diagnosed I have LLP.  The date was July 2021, 3 months after vaccine.  I am currently on Docicylin and cannot be in the sun.
16APR p/ leaving clinic pt began shaking, gagging, & vomiting; 17APR t102; ER t99/9. R32. P124. chest sound & breath good; poss due to vax & refer to family MD; inject site not red, swollen or hot; tx APAP & Pedicare; 18APR pt nl;
Cough, Phlegm, Fever, DX pneumonia and staph infection.
The day after both vacvines I had severe pain in groins and couldnt walk. I thought somehow I hurt myself. Was given a course of 60mg prednisone after 2 weeks of pain. This helped. Got my 2nd vaccine May 13th. The next day my groins shoulders all fingers and wrists and left foot were in severe pain. Could not walk or move for 2 Dr. referred me to Rheumatoid Dr. who agreed I had symptoms of Rheumatoid Arthritis. Simething I had never experienced before. He took multiple exrays to confirm. Inflammation tests were high. RA factor too high among other items. It has been 6 months and I still have severe pain most days until 3-4:00 pm. Am currently raking Hydroxichloriquin and prednisone since June 2021. It never goes away.  Now I have pain in my beck and lower back as well. My head is foggy, memory loss and geadaches every night. I cannot take other RA reluef meds due to lung disease that has been well controlled for 3 yrs.
I started to feel chilled around 7pm friday evening. I laid down and began to feel nauseous and hot; my skin was sensitive. I soon had a 103.7 fever with chills and a terrible splitting headache. My symptoms lasted through the night. I took one 200mg Ibuprofen at 03:30 saturday morning/it didn't seem to help much. Most of the day saturday I had a headache that was manageable and 100.2 degree fever. Saturday evening I was fever free and had a dull headache. Sunday, I was exhausted.
ON 1/11/21, DEVELOPED SHINGLES LIKE REACTION. RAISED, RED, PUSTULES ON LEFT UPPER BACK. BEING TREATED WITH VALACYCLOVIR BY PCP.
Ten days after receiving my first shot of Moderna I woke with a sharp pain in my arm.  That morning I noticed a red, itchy spot. The following day the area had doubled in size, was hot to the touch, raised and painful.  I went to Urgent Care on Tuesday, was prescribed the antibiotic listed above, topical benadryl and oral benadryl as needed. The doctor drew a circle around the inflamed area and said to let him know if it spread past the line.  Today I woke and found it had blown past the border to encircle my whole arm and was rising toward my shoulder.  The doctor prescribed the steroid, which I am taking in conjunction with the antibiotic and benadryl.
This spontaneous report was received from a medical assistant concerning a 4 year old female patient. Information on the patient's pertinent medical history was not reported. The patient had no known allergies. Concomitant therapies included PROQUAD. On 17-SEP-2018, the patient was inadvertently vaccinated with both VAQTA and HAVRIX for prophylaxis (dosing details, route, lot # and expiry date unknown). The patient sought medical attention at physician's office. No adverse event was reported. No product quality complaint was involved.
dizzy; sensation of brief increased heart rate; Flu sx; nausea; This is a spontaneous report from a contactable nurse (patient herself). A 44-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, Expiry Date: unknown) via intramuscular in the left arm on 25Jan2021 at 13:15 (at the age of 44-year-old) as a single dose for COVID-19 immunization. The patient medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medication (within 2 weeks) included ascorbic acid (VIT C), ergocalciferol (VIT D), biotin, loratadine, calcium, silybum marianum (MILK THISTLE), paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past drug included Claritin (patient was premeditated 1 hour before the shot). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284, Expiry Date: unknown) via intramuscular in the left arm on 04Jan2021 at 13:30 as a single dose for Covid-19 immunization. After receiving her second dose of BNT162B2 on 25Jan2021 at 13:15, within five minutes the patient experienced dizzy with sensation of brief increased heart rate, MD on site was notified. The patient was provided with water and snacks and went home after 30 minutes observation as the symptoms resolved and on an unspecified date in Jan2021 (day2-3), the patient had Flu sx (flu symptoms), Dizzy spell on and off existed till day 5 and nausea was still ongoing. Patient did not received treatment for the events. The outcome for the events sensation of brief increased heart rate was recovered, Flu sx (flu symptoms) and dizzy was recovered with sequel (reported as recovered with lasting effects) on an unspecified date in Jan2021 and nausea was not recovered.  Follow-up attempts are completed. No further information is expected.
Administered the vaccine and patient proceeded to waiting area. After a few minutes, the patient's mother recognized that she was becoming very pale. Patient had difficulty communicating, her eyes were moving, and she stated that she could not hear. I picked the patient up to lay her on the ground and she lost control of her body. Her mother and I laid her on the ground and held her legs up. After 15-20 seconds, she regained consciousness. I gave the patient a bottle of water. She waited for about 15 minutes before leaving and stated that she was feeling fine and would return for her second dose.
Extreme aching pain at injection site. Pain 7 out of 10.  Pain lasted for 2-3 days.