chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad muscle pain in right shoulder that has not gone away. Pain is bad enough I can?t move my neck or rotate my body without very bad pain. Pain has not gone away. I have not gone to the doctor yet but likely will if this does not clear up.
2JUN97 area measuring 3x3 swollen & hard & red;6JUn first day that pt didn't need APAP to use arm;9JUN area measuring 1x1, swollen & hard;1AUG area finally back to nl (muscle still tires easily) lethargy & nausea 1JUN-4JUN;
Patient said had a history of fainting or blacking out when receiving vaccines. After immunization was administered we asked that he stayed for observation for 20 minutes. he said he was fine and that he was going to do some shopping in the store. When at the front register he blacked out and hit his head on the counter on his way down. he immediately came to and said he was ok. more embarrassed than anything else. We contacted EMS  and had him sit in a chair and gave his some gauze for a gash on his nose. He refused care from EMS but had a friend with him to drive home
Medication administration error of 1.8 cc given. And no adverse events at this time.
Hot to the touch; Swelling; Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (for tolerance of 1st dose refer case US2019072370).   On 19th April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, feeling of warmth and swelling. On an unknown date, the outcome of the injection site erythema, feeling of warmth and swelling were unknown.   It was unknown if the reporter considered the injection site erythema, feeling of warmth and swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient notes her arm is swollen, red and hot to the touch after 2nd dose of Shingrix series.   The health care professional described swollen as a red circle about the size of a grapefruit. Exact start dates for events were not provided. No outcomes and outcome dates of events were provided.
total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid non-serious case received  via other health professional.  This case involves a 1 years old and unknown gender patient who was administered vaccine with reported total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine with lot UJ578AAA and expiry date: 10-Sep-2022 (dose, route and administration site: unknown) for Immunization.  On 17-Oct-2021, It was reported that temperature excursion of Pentacel vaccine occurred with total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c, on 19-Oct-2021,  temperature excursion occurred with 30 minutes with a minimum of 12.3c and maximum of 15.6c, 1 hour with a minimum of negative 1.8c and maximum of 1.8c with no reported adverse event (product temperature excursion issue).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event out of range for 2 days with a minimum of 9.2c and maximum of 28.3c with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I started having persistent head pain in my left temple area for roughly a week. I then lost control of the muscles on that side and went to the ER, fearing it was a stroke. The doctor on call diagnosed me with Bell's Palsy.  I have NEVER had a headache this long before, nor have any history whatsoever of nerve issues. Yet roughly a month after receiving the COVID vaccine I develop this relatively serious condition.   I feel strongly this is a side effect of the vaccine people should know about. I am upset this is happening to me.
Sore after administration but by Saturday it was really red, swollen all the way to elbow. Called pharmacy and doctor on call who advised ice and BENADRYL. Also felt sick and did not have much appetite. Treatment doctor advised helped; the swelling decreased. There still is redness but hoping it will go away in a couple of days.
On 10/2 patient received flu shot at pharmacy. After patient reports heavy pain and no being able to move her arm upwards past her hips. Since some mobility has improved but the pain is debillitationg to patient. She can barely hold items heavier than a few pounds.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Soreness at sight of injection and surrounding area within 2 hours. 24 hours after added symptoms experienced were headache, chills and dizziness.
Patient had vaccination- shortly after the site became red  and inflamed. The size increased following day and became warm to touch. Size approx 4"x3". Patient was advised to come in. Patient treated with BENADRYL, patient's inflammation was resolved after one dose.
Pt reacted w/macular/papular circumscribed lesion w/out pattern on lower extremities, evident on posterior surface of legs;
Anaphylactic reaction; fainted on the floor; Throat and face swell until cannot breathe; Throat and face swell until cannot breathe; Throat and face swell until cannot breathe; This is a spontaneous report from a non-contactable consumer (patient).   A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced anaphylactic reaction, throat and face swell until cannot breathe fainted on the floor. Patient stated that "need see allergist do blood test then they said I also allergic to some other stuffs I am not aware of. Been prescribed with 2 Epipens after that". The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Redness at injection site that gradually moved down the arm. Itchy at times. Took 4-5 days to clear.
administered with an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Two days after second shot pain in bones and fatigue began and I started taking ibuprofen but it did not improve pain. I have never had pain in bones before. Symptoms continued to increase. Nov. 8, 2021, for next 2 weeks spent most time in bed with pain and extreme fatigue. Whole body felt heavy. Nov. 10, 2021, office visit blood pressure 180/100 (my pressure is normally low). Stopped taking ibuprofen, prescribed Prednisone and Amlodipine. Eight days later pain in bones diminished, fatigue lessened. As of today 12/12/2021, pain in bones less, fatigue less, blood pressure lower but still not normal range.
ER diagnosis of cellulitis on 06/08/13. Prescribed BACTRIM x 10 days.
Site code 11109; Moderna 002C21A; or OU2C2IA or 1A I am confused if i should get another shot, or it was actually food poisoning. No one else got sick.
pharmacyst administer vaccine to 9 patients. It looks like the lots are expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired) 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 EXPIRED PRODUCT ADMINISTERED (pharmacyst administer vaccine to 9 patients. It looks like the lots are expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were provided. It was reported that there were no specific dates when administration occurred, but they had the lot number, and it was before 13-Jul-2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.  Dosage text for suspect product was reported as unknown. No treatment medication was provided.  This case contains information about patient 3rd out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
At time of the 2nd shot my body weight was 166 lbs. Over the next 7 months this has reduced to 155 lbs. On 20Sep21 at 4:30 AM.  I awoke to a high heart rate (120 bpm), heart palpitations and arrhythmia (as noted on oximeter display).  After blood tests I have been diagnosed with Grave's disease.  On 26Sep21 I began a course of Methimazole,  and metoprolol as needed.  Given Vera-Lastra(2021 Thyroid 31.9 p.1436) paper, there is a finite probability that the vaccine may have played a role.  BEFORE I get a booster, I would like to make sure the appropriate tests are done before/after so it can help the community understand if there is a correlation.  I am a researcher and I understand the importance of collecting the correct information before/after a potential rare event to fully understand any correlations.  Whatever I can do to help, let me know
sudden onset of fever, musculoskeletal pain, malaise, fatigue, chills weakness, stomach cramps, bloating, headache
Pt. recieved smallpox vaccine on 4/15/03. On 4/21/02 developed fever of 99.9, malaise, tired, swollen tender lymph nodes & went home for 4 hours. Fever etc. improved but seen on 4/24 with enlarged lymph nodes and recieved dx of lymphangitis which resolved without incedent by 4/26/03
Medical Assistant, inadvertently administered Menveo liquid portion alone without mixing with the powder to an 18 year old female patient; Medical Assistant, inadvertently administered Menveo liquid portion alone without mixing with the powder to an 18 year old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA932A, expiry date 30-JUN-2024) for prophylaxis.   On 25-AUG-2023, the patient received Menveo. On 25-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Medical Assistant, inadvertently administered Menveo liquid portion alone without mixing with the powder to an 18 year old female patient) and inappropriate dose of vaccine administered (Verbatim: Medical Assistant, inadvertently administered Menveo liquid portion alone without mixing with the powder to an 18 year old female patient).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter stated her medical assistant colleagues inadvertently administered Menveo liquid portion alone without mixing with the powder which led Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The reporter consented to follow up.
Information has been received from a physician assistant concerning a 16 year old female on 20-MAR-2009 was vaccinated with the first dose of GARDASIL (lot number, dose not reported). Concomitant therapy included YAZ as birth control pill. On 21-MAR-2009, the next day the patient experienced rash on her abdomen, arm and shoulders and the patient's eyes were itchy. On unspecified date, the patient sought unspecified medical attention. Additional information has been requested.
atrial fibrillation from taking the COVID shots; This is a spontaneous report from a contactable consumer. This consumer reported similar events for himself and two other patients. This is the third of three cases.    A patient of an unspecified age and gender received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. It was reported that the patient has been diagnosed with atrial fibrillation on an unspecified date after taking both COVID shots. The outcome of the event was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021274387 same reporter and drug, similar event, different patient;US-PFIZER INC-2021269817 same reporter and drug, similar event, different patient
Patient reported allergic reaction such as red itchy bumps on her neck, shoulders, arms, chest and under the breast area. She also had fever, dizziness and nausea. The red inflamed bumps are still visible after more than 10 days but are improving gradually. She is concerned about the second dose and will be contacting  her Doctor to confirm. She has already also reported her adverse effects to Moderna.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: I administered two vaccines (pfizer covid then fluzone quad), upon receipt of the 2nd vaccine, the patient lost conciosness/fainted and fell off the chair she was sitting on.  The patient came to within 5 seconds, and she was confussed as why she was on the floor.  she said she felt fine, but we had called 911.  The EMT arrived and took her out to vehicle to check her out.  The patient returned 20-30 minutes later and she said she had cleared the EMT visit.
developed migraine the evening of vaccination.  Migraine has persisted since.  She has taken Excedrin and Zofran for the nausea associated with the headache.  Arm is sore but complains mostly of the headache
rash on stomach and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on stomach and back) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Lung disorder NOS (lung problems). Concomitant products included TAMSULOSIN, CLOPIDOGREL, LOSARTAN, SENNA, BUDESONIDE and MORPHINE for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on stomach and back). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash on stomach and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitantly, patient was taking perosomad and aderid.
Tested positive for Covid 19 on 11/5 despite having 3 shots. Also had covid back in December of 2020.
Herpes.  Valacyclovir Hcl 1 Gram Tablett (2 tablets by mouth every 12 hours for 1 day.
swollen lymph nodes and headache after the first dose; swollen lymph nodes and headache after the first dose; This is a spontaneous report from a contactable other health professional (patient) from a Pfizer Sponsored Program Pfizer First Connect.  A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced swollen lymph nodes and headache on Dec2020. The patient outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Eye pain; Eyes dry; Painful joints; Peripheral neuropathy aggravated; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy aggravated) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.  Concurrent medical conditions included Rheumatoid arthritis.  On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy aggravated) (seriousness criterion medically significant), DRY EYE (Eyes dry), EYE PAIN (Eye pain) and ARTHRALGIA (Painful joints). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy aggravated), DRY EYE (Eyes dry), EYE PAIN (Eye pain) and ARTHRALGIA (Painful joints) was resolving.     No concomitant medications were reported.  It was reported that, the patient had dryer eyes, neuropathy was worse, pain in joints and eye got hurt.  it was unknown if patient was enrolled in a covid 19 vaccine trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an elderly female patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral (reported as Peripheral neuropathy aggravated), unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Sender's Comments: This spontaneous case concerns an elderly female patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral (reported as Peripheral neuropathy aggravated), unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.