chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate heat, redness and itching over back-  "back was on fire",  This was followed several hours later with similar symptoms on face which lasted days.. Several days after vaccine, noted loss of sense of taste and smell which lasted less than 25 hours
Noted to have area of erythema, 3 cm x 3cm, on right leg while in for follow-up of MMR reaction of left leg. Area is not tender to touch an no warmth noted. Erythema area noted to be sites of DTaP/IPV administration on 4/14/04. Parent applying cream to area as well.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Medical history was not provided, concomitant medications were not reported. In November 2012 the patient was vaccinated with the first dose of GARDASIL (dose and lot number were not provided). IN April 2013 the second dose of GARDASIL was administered. Immediately following both of these administrations the patient experienced macular dermatitis. The outcome of macular dermatitis is unknown. The relatedness of macular dermatitis is unknown and GARDASIL was not reported. Additional information ahs been requested.
5/25/2021 Feeling of pins and needles in upper middle back and shoulder blades right and left of spine. 06/25 little bumps but thinks it was just scabies. 4/26/2021 Heart palpitation (seems to have a history of it happening once every 2 yrs.).
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Sender's Comments: US-009507513-1708USA013488: US-009507513-1708USA013518: US-009507513-1708USA013516: US-009507513-1708USA013517.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (16Jul2022) Unknown results, notes: Covid rebound diagnosed on 16Jul,days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severely painful vulvar ulcer; These are very painful - shooting and stabbing pain to the point; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VULVAL ULCERATION and VULVOVAGINAL PAIN 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VULVAL ULCERATION and VULVOVAGINAL PAIN. The patient was treated with CLOBETASOL for Adverse event, at an unspecified dose and frequency. At the time of the report, VULVAL ULCERATION and VULVOVAGINAL PAIN had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The reporter stated she has seen 3 cases of severely painful vulvar ulcer in patients who were administered with the COVID-19 vaccine. She was sure that 2 of them received Moderna COVID-19 vaccine. The reporter was observed a few days after the administration of the vaccine. MD states that this was different from the herpetic lesions that she sees these were very painful - shooting and stabbing pain to the point that the patients want to take narcotics. She states that they may not be infectious in origin but may be autoimmune. She prescribed Clobetasol and they resolved.
Information has been received from a health professional for GARDASIL, a Pregnancy Registry product, concerning a female who became pregnant during the series of vaccinations. The patient was being seen at a different clinic for the series. The patient received her first dose "a few months ago" (date unspecified). The patient's LMP was 10-Jan-2008. The patient returned to the clinic two weeks ago for a pregnancy test and was inadvertently administered a second dose of GARDASIL. On approximately 20-MAR-2008, the patient was vaccinated with her second dose of GARDASIL (lot number unspecified). Concomitant therapy included PEDIARIX and a third vaccine (name not known at the time of report). The patient has had a urine pregnancy test that was positive and blood work completed. She also had an ultrasound performed on 26-Mar-2008 and the results are pending. The patient has not reported any difficulties thus far. Follow up information was received from a Licensed Practical Nurse who reported that the patient had not returned to her clinic, the patient received her prenatal care at another clinic. The L.P.N had gotten in contact with the patient's mother. It was reported that the pregnancy ended in spontaneous abortion at five months (approximately on 10-JUN-2008). The patient was RH negative and had not received any Rhogam in preparation for the pregnancy. The patient's doctor stated that this was the reason for the miscarriage and that it was not related to the vaccination with GARDASIL. The L.P.N indicated that the patient is pregnant again and "everything was going well with the pregnancy". No further information is available.
Headache, nausea then profound weakness in legs and inability to move lower extremities. At the time she got to the table, she was having slight trouble breathing and cramping in her lower extremities. She was transported to the nurses office after brief exam. EMSA and mother were notified. B/P 124/72, Respirations 18/min unlabored, hand grips were equal and strong, no nystagmus, PERLA at 3mm. Had feeling in lower extremities but couldn't move her legs or wiggle her toes. EMSA arrived and place patient on O2 and checked her FSBS=80mg/dl. Transported to Hospital.
This spontaneous consumer report (initial receipt 09-Dec-2015) concerns a 50 year old female patient. The patient had no medical history except that she had two children. She also confirmed that she was not pregnant or breastfeeding while on AFLURIA. This was the first time she had received the flu shot. On 04-Dec-2015, the patient received AFLURIA (batch number not reported) in the left arm. On 02-Dec-2015, she had also received hepatitis A vaccine (manufacturer and batch number not reported) and typhoid vaccine injection (manufacturer and batch number not reported). Each shot was given in different arm. After receiving AFLURIA, later that night, she go a 'little case of flu' in which she felt tired and achy. Her arm was painful and bruised. This lasted for 1.5 days. The patient could not sleep during that time and took acetaminophen which helped her sleep. She stated that by 5 pm, the next day, she felt 100% fine. The soreness at the injection site went away. The next couple of days, she felt achy on the left. She felt pain on the back side of her arm and also felt neck pain. She could not provide and exact date but stated that she was achy all the time. The patient further stated it to be getting worse. to self treat her left arm, the patient was moving it around to keep it mobile. She stated it was difficult to move though. The outcome was reported as resolved as of 11-Dec-2015. It went away on its own without any type of treatment.
severe localized react @ site of inject of DTAP, erythema; fever 100; MD visit 11NOV-dx as allergic react DTAP;
15 minutes after Hepatitis B administered, developed "internal itching" at site of injection. No swelling, allergies, shortness of breath, dyspnea , rash.
pt recvd 3rd dose of vax 8FEB93 w/in 2 wks noted recurrence of palpitations, lighheadedness, & fatigue; TSH 1.8, T4 7.0; had persistant nausea; mild upper abod pain-referred to cyn; CAT scan, gallbladder eval;  pain & abdo spasm;
tested positive for COVID-19/still has "cold symptoms"; tested positive for COVID-19/still has "cold symptoms"; This is a spontaneous report from a Pfizer-sponsored program, Support from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on an unspecified date. The patient was due to receive her second dose on 05May2021. However, in between these doses, she has tested positive for COVID-19. The patient has since been re-tested, which came back negative, and reports that she still has "cold symptoms" that she was told could go on for awhile. Caller would like to know if she is okay to get the second dose of the vaccine because of this. She states her doctor told her she should be fine because she quarantined for 14 days. Outcome of the events was unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
About 5 hours after the vaccination symptoms: eyes puffy, muscle aches,  fever, malaise.  Took Tylenol and Benedryl.   did not seel Medical attention. symptoms resolved in 36 hours.
Mother states child cried, ran fever of 101-102.0 did not like to move legs, cried when touched for 4 days.
Pt devel inject site rxn with soreness at inject site, she is 1 of 8 employees at this facility to devel inject site rxn with lot #4978139
Swollen, red, painful (L) arm. Went to ER twice -> given IV ABX (unknown); now on a 7 day course of clindamycin 300mg QID. Pt. reports diagnosis of cellulitis.
Sore arm (expected) but sore, stiff, painful lower back muscle spasms (started 4/2 but by 4/4 & 4/5 I could not stand upright-NOT EXPECTED). Coldness of body & extremities with no fever (NOT EXPECTED), rash on anticubital area on right arm & rash on face & neck (started on 4/4 by 4/5 on neck & face-NOT EXPECTED). I missed work on 4/5 due to reactions
WHOLE ARM HURT FOR DAYS; This spontaneous report received from a consumer via a social media via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose not reported,1 total, start therapy date were not reported for prophylactic vaccination. The patient was ok after primary vaccination and no adverse events reported (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose not reported,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced whole arm hurt for days (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of whole arm hurt for days was not reported. This report was non-serious.
Painful, swollen, fever, achy, fatigue. Patient has been out of work for 2 weeks.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hbp" (unspecified if ongoing), notes: Other medical history: Hbp. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: No other medication in 2weeks. Anti viral details: Product: COVID 19 Treatment with Brand: Paxlovid. Treatment start date: 01Jul2022. Treatment stop date: 06Jul2022. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immunization given at 2 pm 5/1/08.  "Fever" that night, lethargic, next day wouldn't walk.  On 5/4 at 1 am "fever" was worse and had seizure.  Taken to ER where temperature was 102 and O2 sats were 82.  Developed cough and asthma, bronchitis for 10 days.  Finally improving this week. 5/27/08-records received for DOS 5/4-5/5/08, DC DX: Child with recent pneumonia with some persistent infiltrates on x-ray which could be resolving from prior infection versus new from current febrile respiratory illness. First time febrile seizure.  Four days prior to admission had decreased eating, decreased activity and not acting his usual self, 2-3 days ago fever and somewhat sluggish. Three days prior received vaccines. Coughing day prior and vomiting. Began shaky or jerking movements, stiff.
AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/24/2020.pfizer Lot#EK9231 2nd dose:01/14/21.pfizerLot#EL3247 Diagnosed covid positive: 03/18/21 Exposure:Unknown Symptoms:Fatigue, headache, chills,mild cough.
chills; moderate headache; fatigue; This is a spontaneous report from a contactable nurse, the patient. A 66-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the left arm on 08Feb2021 at 15:45 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included gluten allergies and celiac. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were none. The patient did not have any other vaccines within 4 weeks of the vaccination. On 11Feb2021 at 23:30, the patient experienced chills, moderate headache and fatigue. The events started to resolve on 13Feb2021, but the patient continued to have a very mild intermittent headache. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of chills and fatigue resolved on Feb2021, while moderate headache resolved with sequel on Feb2021.   Information on the lot/batch number has been requested
Patient received monovalent Pfizer COVID vaccine on 1/15/22 (lot # FJ1614), 2/11/22 (lot # FJ1614), 8/22/22 (lot # FW1331), and bivalent Pfizer COVID vaccine on 11/9/22 (lot # GJ3277). On 11/21/22, patient was intubated in the field and admitted to our CCU with acute respiratory failure with hypoxia in the setting of COVID-19 pneumonia and bilateral bacterial pneumonia superinfection or aspiration, septic shock, UTI, and thrombocytopenia. As of today (11/28/22), patient is still in CCU intubated.
I began having chest pain, tightness and pressure which did not go away over night. I called the nurse line and was advised to go to the emergency room. I was given an EKG, Chest X -ray, and blood work and a heart condition was ruled out. The condition is ongoing and sometimes spreads from the left to right. I have attempted to take OTC antacids but it has not made any difference in the pain or discomfort. I am attempting to schedule a follow up with doctor. The chest pain does not seem to be exacerbated by exercise/my daily routine.
chest pain, shortness of breath, sense of throat closing.  onset 10 min after vaccine, resolved after one hour.
arm pain from the injection site up to her shoulder; "penny-sized lump" above her collarbone (on the same side she was vaccinated on) which is painful to the touch and "feels like it is full of fluid"; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first Pfizer covid vaccine on 31Dec2020; and 7 days later (07Jan2021), the patient experienced arm pain from the injection site up to her shoulder and also reported "penny-sized lump" above her collarbone (on the same side she was vaccinated on) which was painful to the touch and "feels like it is full of fluid". The patient asked if these effects were normal and if she should receive the second dose of the vaccine. The outcome of the events was unknown.  Information of lot/batch number has been requested.
Cold and Flu symptoms about 10 days after shot. Bronchitis symptom about 1 week later. Bronchitis presents to 12-12-16 -  nearly 2 months!
Began with dizzy spell on Wednesday, April 7, 2021.  On April 19, had a more severe dizzy spell.  Called my primary care physician who ordered blood tests, CAT scan, and stress test.  In June I have had two episodes of dizziness, strong headaches and vomiting.
Fever of 101-102 - currently on day 5 (not yet resolved); loss of appetite; shaking chills; headache; very sore throat with white spots; mouth sores causing inability to eat or drink; tired/fatigue
Vaccine error: patient was listed in system twice, so when staff pulled the immunization history this vaccine was not listed on the profile, but it was listed on the other immunization profile. This vaccine was given twice, a month apart, in error.
He received varicella vaccine 1-19-16 during his 15 month well check. He developed bumps all over his body on Monday.
Mom brought pt to the HD, for nurse to see rash. Pt. received HPV & DEPO PROVERA on 11-19-10. Mom said pt broke out in a rash Sunday night 11-21-10. Pt had fine rash all over body & c/o itching. Inst Mom to give pt. BENADRYL AD on bottle & to see MD if it doesn't get better.
Received a Moderna Pediatric Covid Vaccine, dosage 0.5 ml/IM instead of Moderna Bi-Valent Booster. No adverse events occurred. Advised to reschedule Moderna Bi-Valent Booster in 4 weeks.  Patient agreed to this plan.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.
2/23/23 I felt like I was getting a cold. I had a little tickle in my throat, a mild cough and a little congested. Over the next week, it became worse. My cough and congestion were worse. I had 101.5 to 102 fever. I did four at home COVID tests that were all negative.  On 3/4/23 I went to Urgent Care because of my fever.  I was tested for RSV, Flu and COVID and all were negative.  I got a prescription for an antibiotic because they felt like I had pneumonia in one lung.  A side effect for this antibiotic was ruptured tendons. After two or three doses, I woke up early in the morning with a pain in the back of my ankle. I stopped taking the medication. I went back to the Urgent Care and told them I would not take the antibiotic anymore. My lungs sounded clear, the fever was gone, but I still had some cold symptoms that were improving. By March 11,2023, I felt well.
This spontaneous report as received from a pharmacist refers to an unspecified number of patient of unkonwn age and gender with no pertinent medical history and drug reactions reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose, route, lot number and expiration date were not reported) that were improperly stored. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Information has been received from a physician and L.P.N. concerning a 70 year old female homemaker who on 12-DEC-2006 at 14:39 was inadvertently vaccinated IM in the left deltoid with a 0.5 ml first dose of Varivax (lot # 654813/1088F) instead of Zostavax. Unspecified medical attention was sought. This was reported to be staff error and not product confusion. The administering L.P.N. stated that the office stopped carrying Varivax on an earlier date and she did not realize that they started carrying it again. The L.P.N. said that she grabbed the vaccine out of the freezer, saw varicella on the bottle and thought it was Zostavax. After administering the vaccine the L.P.N. saw the brand name of the vaccine on the bottle. The patient has not had any adverse experiences. There was no product quality complaint involved. No additional information was provided. Additional information received indicated that the patient was vaccinated with a first dose of Zostavax (lot # 652966/1211F) on 14-DEC-2006 at 14:31. There was no illness at the time of vaccination. There were no lab tests performed. Additional information is not expected.