chrisvoncsefalvay/vaers-outcomes huggingface dataset:
portion of the vaccine came out of her arm; No Adverse Event; This spontaneous report was received from a nurse refers herself a 32-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with the three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.   On unknown date (reported as: reporter did not know the exact date of the event sometime 2 years), reporter referred that when she received her 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) during the time of injection 2 years ago, portion of the vaccine came out of her arm. It was stated by nurse, that she always wondered if she was fully vaccinated (incorrect dose administered). She has completed all her 3 doses of vaccination. No additional adverse event reported (no adverse event).
Soreness of entire left shoulder - skin very tender - stiffness into neck on left - started 3 days after vaccine.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursionq; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursionq) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 1:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursionq). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursionq) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.18   Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 9AM, 10AM temperature was 34, 37 total doses given for the day was 184 for 9AM, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021. On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM:34, 10 AM: 30, 11 AM: 41, 12 AM:45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This case was reported in a literature article and described the occurrence of injection site edema in a 4 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (manf unspecified) for prophylaxis. Previous and/or concurrent vaccination included combined measles, mumps and rubella vaccine, live attenuated (new strain) (manf unspecified) left thigh given on the same day than the DTPa vaccine. On an unspecified date the subject received booster dose of Dtpa (unk right thigh). The child had missed his previous DTaP booster vaccination at 12-18 months of age and was this receiving the fourth dose of Dtap. Twelve hrs after vaccination with Dtpa, the subject was admitted to the emergency ward with diffuse swelling and erythema of the right thigh. Erythema and swelling progressed to involve the entire right thigh with mild main noted around the Dtap injection site. No other systemic reactions such as fever, nausea, vomiting, diarrhea, abdominal pain or dyspnea were noted. Physical examination at the emergency ward revealed a well appearing child in no acute distress. Rectal temp was 97.2deg F, blood pressure 102/44 mmHg, pulse rate 106/min and resp rate 24/min. The right anterior thigh was markedly erythematous, warm to touch and mildly painful with movement. An erythematous papule surrounded by an area of pallor marked the injection site of the DTaP vaccine. The remainder of the physical examination was normal. Lab studies showed a white blood cell count of 8700/mm3, a platelet count of 118000/mm3 and a negative blood culture. Because of concern for infection, therapy with intravenous oxacillin sodium (oxacillin) was initiated. Over the course of several hours, the area became increasingly pruritic and diphenhydramine was administered. A contrasted computed tomography scan of both thighs revealed extensive oedema and soft tissue swelling of the right anterior thigh. The thickness of the soft tissues between the anterior surface of the thigh and the patella on the right was 1.10cm, and that on the left was 0.43cm. The thickness of the muscles in the right thigh was 6.92cm, and that on the left was 6.64cm. No evidence of deep venous thrombosis. During the hospitalization. The child remained afebrile and playful, with normal appetite and normal leg mobility. The subject was hospitalized for 2 days. The subject was treated with oxacillin sodium and diphenhydramine. By the end of the 2nd hospital day, the events were resolved. The author considered the events were related to vaccination with Dtpa.
Started with body aches, chills, fevers, high blood pressure, heart rate in 150's-160's around midnight of 1/5/21. Arm muscle soreness which I know is to be expected.
Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who on an unspecified date was vaccinated with the first dose of Gardasil, injection, 0.5ml. Concomitant medications was not reported. Subsequently on an unspecified date, the patient developed a rash on her chest and arm after receiving the first dose of Gardasil. The physician gave the patient an antihistamine (unspecified) and the rash on her chest and arm cleared in about 20 minutes. Subsequently the same day, the patient recovered from rash on her chest and arm. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 23 year old, female student with no pertinent medical history who on an unspecified date was vaccinated, intramuscularly, into the deltoid with the first dose of GARDASIL injection 0.5 ml. Concomitant medication was not reported. Subsequently on an unspecified date, the patient developed a rash on her chest and arm after receiving the first dose of GARDASIL. The physician gave the patient an antihistamine (unspecified) and the rash on her chest and arm cleared in about 20 minutes. Subsequently the same day, the patient recovered from the rash on her chest and arms. Additional information is not available.
Onset of tinnitus the morning after second dose beginning around 07:00. On a scale of 1-10, usually around a 3-5.
Rash developed morning of 4/26/21, saw PCP that afternoon who prescribed antihistamine hydroxyzine to take instead of Benadryl. Later that evening, sudden onset of tachycardia and extreme dizziness, so I went to the ER. ER doctor gave me 60mg prednisone followed by another three days at 40mg, and sent me home an hour later after it was clear the rash was responding to the prednisone. Beginning in the afternoon of 4/28/21, I suddenly felt like my body weighed a million pounds and like I had been drugged, like I was excessively relaxed and moving in slow motion, but my HR was high. I saw Dr. the following day, 4/29, when I was still feeling heavy, slow, and sedated. She was concerned about my HR and did an ECG which was normal. Later that night, I woke up in the middle of the night with the opposite sensation, like my body was in a full on fight or flight response for no apparent reason, my heart racing and my blood pumping so forcefully through my veins it was slightly painful. I got up and took my BP and it was 145/75. The next evening I developed chest pain in addition to continued tachycardia so I went back to the ER. The ECG they did was also normal but they did no further testing. The doctor explained what I was experiencing must be a side effect of the prednisone and should go away now that I was off of it. This whole time in addition to tachycardia I had been feeling generally ill, weak, shaky, developed a tremor, nauseous, lost a few pounds. I continued to experience tachycardia and unusual blood pressure fluctuations in the second weak following the vaccination but the nausea, weakness, and tremor subsided. In particular, I have developed orthostatic intolerance, with my HR jumping to 120s upon standing and into the 130s-140s when on my feet for more than a few minutes at a time. During this time I have been unable to work normally and unable to care for my two-year-old daughter. I noticed some improvement in my HR issues beginning 5/5/21 but since then I have still been having good and bad days. I had another episode when I went to see an allergist regarding my vaccine reaction on 5/11/21, and they took my vitals reclined (BP 95/59, HR 110), seated (BP 100/62, HR 126), and standing (BP 102/74, HR 136). The allergist said my reaction to the vaccine was a morbilliform rash and was not an allergic reaction, but likely an overactive immune response due to having had Covid in March 2020.
patient presented to ER with myalgias/arthralgias, flu like symptoms including fever, congestion, sore throat. Pt had COVID vax 6/9. In ER, noted to have leukocytosis of 36k with neutrophil predominance. Admitted and no infectious source identified. COVID negative on 6/22. Pt transferred to higher level of care due to concern for hematologic malignancy. All tests unremarkable so far. Ferritin was > 11k. Pt case reviewed by rheumatology who suggested adult onset Still's disease which could be vaccine related. Starting Anakinra asap in effort to see improvement
injection site pain; Information has been received from a pharmacist referring to a female patient of unknown age via company representative. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.      On an unspecified date in July 2019 (reported as within the last month), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         Immediately after the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), she experienced injection site pain. She went to see the pharmacist, sought for medical attention. The patient's present status was unknown.     The reporter did not provide causal relationship between the event and suspect vaccine.
"spaced ouy/like a mental thing"; no energy; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL FATIGUE ("spaced ouy/like a mental thing") and ASTHENIA (no energy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Liver cell carcinoma recurrent. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 10-Feb-2021 to an unknown date for Liver cell carcinoma recurrent.    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, the patient experienced MENTAL FATIGUE ("spaced ouy/like a mental thing") and ASTHENIA (no energy). At the time of the report, MENTAL FATIGUE ("spaced ouy/like a mental thing") and ASTHENIA (no energy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood bilirubin: way up (High) way up. one number was high and other was down..         No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021,contains No new Information.
No additional AEs were reported; Medical assistant reported that a patient received an expired MMR II vaccine on 01/05/2023.   No additional AEs were reported, no further information provided.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 05-JAN-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number t033814, expiration date 05-OCT-2022 (dose and route of administration not reported) for prophylaxis that was reconstituted with sterile diluent (expired product administered). No adverse event was reported.
Information has been received from a 71 year old female patient with history of shingles before vaccination and no known drug allergies/drug reactions who in "early January 2009" was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) subcutaneously. Concomitant therapy included KLOR-CON, levothyroxine, PREMARIN, lisinopril (manufacturer unknown) and lovastatin (manufacturer unknown). It was reported that in the "early part of February 2009" the patient experienced her first outbreak of shingles which "cleared up in about 3 days". It was reported that on 29-APR-2009 the patient experienced her second outbreak of shingles. The patient did not seek medical attention. There were no laboratory diagnostic tests performed. The outcome of the patient was unknown. Additional information has been requested.
Patient fainted after receiving 2nd dose of covid vaccine while being under 15 minute post vaccine observation. Patient fainted in arms of clinical observer. She did not fall or hit her head. She was aroused after her episode (about 30 seconds in duration). She then drank some juice. She continued to be diaphoretic, pale and felt as though she were going to faint again. Since her symptoms did not seem to be resolving we called an ambulance. EMS arrived within 5 minutes and took patient to the hospital.
Symptoms started mid morning after on 11/29/21 - fever, chills, severe hip pain - especially on the right ,  upper back pain, lower back pain that radiated into right knee,  pain in both knees, pain in both hands especially knuckles/ fingers,  severe pain at injection sight hard to move arm, very fatigued, no appetite, severe headache, bad vertigo.  Took ibuprofen for symptoms it hardly helped at all but kept chills to a minimum.  There was little improvement with anything I tried. This went on for about  20 hours.  The Fatigue continued for the rest of the week.  Arm pain lasted about 10 days.  Vertigo still going on but not as bad.
Diagnosed with erythema nodosum. Symptoms began appearing on 12/1 and got worse through 12/6
5 days after 1st injection, redness, increased temperature and swelling and pain occurred near injection site.  This area was  approx 7 in long and 5 in. wide.  This progressed so on day 8 after injection I went to walk in clinic, where a 5 day course of antibotics was subscribed..Cephalxin 500mg. 4 times daily.  Now 9 days after injection are is slightly better, with less redness.  Still showing warmth and pain...
small papular, not itchy papular on this anterior aspects of the thigh in a crib around site of approox 5 cm in diameter;
given on morning of 9/20/21 @ 0912 expired 9/19/21 LVN administered vaccine syringe was labeled Moderna lot # 025C21A exp 9/19 no adverse reaction to patient  RN manager aware pharmacist aware Dr. infectious disease made aware
Within 6 hours my left arm became unusable due to excruciating pain.  It excruciating painful  to move the fingers on my left hand.  This paralysis via pain lasted  for 3 days.  Now 4 days later I have only about 80 % functionality of my left arm and hand.
fever, body aches, fatigue, cold sweats, migraine, runny nose, sore throat, soreness around injection site, muscle aches around injection site.
Break down hives on my left wrist; I don't feel well; I am just disgusted at this point; This is a spontaneous report from a contactable consumer or other non-HCP.  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on Jun2021 as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization. Medical history included different allergies, allergy to plants, dust allergy, allergy to animal, food allergy as the patient was given contaminated food and water on purpose, helminthic infection as the patient have been sick for years for years with them, illness as the patient sick for years. The patient's concomitant medications were not reported.  on an unspecified date of 2021, the patient experienced break down hives on left wrist, don't feel well and was just disgusted at this point. The outcome of event break down hives on left was not recovered while outcome of rest all events was unknown.  Follow-up (04Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Feb 28, Sunday: went sleep around 12:45am, woke up 7:15 am, fever 100.6 F, dizziness, complete hearing loss in right ear, fatigue, stayed in bed for a few hours, fever continued through the day, 100.2 to 102.1 F Mar 1, Monday: went sleep 12:00 am, fever 100.4F. Woke up 8am, sudden hearing loss (SHL) in right ear continued, no change, and 99.6F in morning, dizziness, fever was gone by afternoon. SHL continued.  Mar 2, Tuesday: SHL continued, dizziness, temperature 96.7F, body ache and soreness were less. Went to Otolaryngology for checkup and treatment at 11:40 am. Diagnose results: complete hearing loss in right ear. Received treatment: injection into right ear and prescription of Prednisone 10mg, injectio
had the 1st shot then got covid the following week; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (had the 1st shot then got covid the following week) 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 COVID-19 (had the 1st shot then got covid the following week). At the time of the report, COVID-19 (had the 1st shot then got covid the following week) 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 were reported.  Patient wanted to confirm if the second dose could be taken as the patient had event over 9 months ago.  Treatment medications were not provided by the reporter. COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old patient with no clinical history who experienced the unexpected event of COVID-19 (AESI) The event occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old patient with no clinical history who experienced the unexpected event of COVID-19 (AESI) The event occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No adverse event; Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine).    No concomitant medications were reported. HCP reported to accidentally administered less than the authorized dose of the Moderna Covid 19 bivalent vaccine and would like to know advice for same. Patient had no known allergies and no concomitant medication. No treatment information was reported.
Minor but noticeably sore for 2 weeks with a large lump accompanied by redness that appeared at the injection sight about a week after injection.  2.5 weeks in and the redness has gone and the lump has shrunk to about pea sized