chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started out talking very hoarse which then progressed to mild shortness of breath with any major activity. Within a few days, I noticed I was having much greater difficulty breathing and more severe shortness of breath with minimal exertion. I could also feel my heart pounding. On 01/09/2010 I went to the ER with shortness of breath and tachycardia, as well as HTN of 180/119. Within a few days, my body launched a full auto immune flare up worse than I have ever experienced in the past. I still have difficulty with breathing upon any exertion of more than basic walking, my heart rate continue to stay at 120 or above with basic walking both of which are new for me. I also have developed a blurry left eye that came on suddenly after having an eye appt only a few weeks ago. My nails beds have continued to be pale white for several days now which in not the normal. Usually the nails bed go white in the cold and then return to normal color as they warm up. I also have chest pain, painful swollen joints, extremely dry eyes and mouth, headaches in major severity almost everyday, the list goes on and on. I usually have a flare years apart from each other in stressful times. The last one was on Oct 2009. I had fully recovered and was back to work feeling my best. That is the reason I opted for the H1N1 vaccine as I didn't want to take any chances of becoming sick. The flare prior to that was Oct of 2007 in a particularly difficult semester of college. Prior to that was 2003 during a divorce. I do not feel it was coincidence that I would end up with another flare up immediately following one. A person knows their body. During the first of December 2009 everyone at work was asking how I was feeling and I told them I was back to my old self and would not have a flare again for at least a couple years. Now here I am again in a worse condition than ever. I firmly believe that the H1N1 vaccine launched a full auto immune attack on my body far more severe than I have ever experienced.
Swollen at injection site 10 days after injection along with rash. Sore and itchy and warm to touch. Benadryl and Tylenol helped and getting somewhat better today after 3 days but still have symptoms.
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 29-JUN-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA002267: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Rash requiring an immediate injection (steroid) and 2 courses of steroids after.
Joints have been stiff.Pain in joints since the shots were given on 09132019.
injection site pain; chills; joint pain; She did not sleep well that night; This is a spontaneous report from a non-contactable consumer. An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date with no adverse event reported. After second dose on 07Jan2021, the patient experienced injection site pain eight hours after on 08Jan2021; and then an hour later (9 hours after second dose) on 08Jan2021, she had chills. Later on, that night, she had joint pain and she did not sleep well that night. The next day (09Jan2021), she was fine. The outcome of the events was recovered on 09Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt fainted about 5 minutes after administration of HPV. Pt did not fully lose consciousness went back to room and waited 30 min. before leaving. Drank apple juice and applied ice pack to back of neck. Pt left fully recovered.
PFIZER BIVALENT VACCINE WAS GIVEN AS PRIMARY DOSE IN PRIMARY SERIES, WHICH IS NOT INDICATED
soreness in arm; started feeling bad; couldn't get out bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), FEELING ABNORMAL (started feeling bad) and MOBILITY DECREASED (couldn't get out bed) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm), FEELING ABNORMAL (started feeling bad) and MOBILITY DECREASED (couldn't get out bed). The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (soreness in arm), FEELING ABNORMAL (started feeling bad) and MOBILITY DECREASED (couldn't get out bed) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No treatment medication were reported.   This case was linked to MOD-2021-044697 (Patient Link).
complete numbness of entire right side of my body; same side where I received the vaccine. after 4-6 hours after shot. lasted almost two days. scalp, cheek, eye socket numb and worried. cortisone and zovirax to prevent bell's palsey. reported to VAERS and no one seems to care. no swelling of lymph nodes yet after almost one week. diarrhea severe. cortisone helped but affects immune response and antibodies so stopped steroid. will not get second. Guillain-Barré syndrome and septic shock, cytokine storm, autoimmunity, run in the family. just want people to be aware and wish they'd tell people. I'm in the medical field and not an anti vaxer. chills, fatigue weakness but I expected that. statistics don't matter unless it affects you and your family members. I'm doing lymphatic drainage for lymphedema also, like for breast cancer patients.
tenivac was administered to patient which was exposed to room temperature (72F) for 4-5 days (96-120) due to fridge wasn't working, with no ae; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to case 2019SA311273.  This case involves an unknown age male patient who received unknown dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Lot no: U6265AA expiry date: 19-APR-2021) via unknown route on unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to the Product storage error. It was reported that tenivac was administered to patient which was exposed to room temperature (72F) for 4-5 days (96-120) due to fridge wasn't working, with no ae.  At the time of reporting, the patient had no 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 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.
A couple of hours after vaccination experienced chills and shaking. Covered up with blankets. A couple hours developed a temperature of 100.4. Blood pressure was elevated. Pulse 133. Called doctor. Nauseous. Went to ER and was given Tylenol. Fever subsided after releases from ER. Fever returned later that night. Still experiencing symptoms on today.
Rash Developed around injection site (right arm) and then spread to left arm. Resolved when patient took additional diphenhydramine but did reappear after 1st dose of diphenhydramine wore off (~4hours after vaccination).
This patient received a Flu vaccine on 12/04/00. The patient noticed hives on his back on 12/06/00. The hives continued to worsen, no respiratory distress involved. He was seen by the Doctor on 12/08/00. The patient couldn't verify if it was flu shot or not causing the hive episode.
BROKE OUT  IN SWEATS; VOMITING; CHILLS; SKIN SORE TO TOUCH; HOT/SWEATY; TENDER SKIN; MUSCLE ACHES; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 20/MAR/2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced broke out in sweats. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced skin sore to touch. On 20-MAR-2021, the subject experienced hot/sweaty. On 20-MAR-2021, the subject experienced tender skin. On 20-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 20-MAR-2021, and had not recovered from broke out in sweats, chills, skin sore to touch, hot/sweaty, tender skin, and muscle aches. This report was non-serious.
Redness to face, mild, puffiness to eyelids, uncontrollable crying, fever, documented 101 degrees (after Tylenol was given).
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from Other health professional (Medical assistant). This case involves a 9 months old patient (gender unknown) who received 0.5ml vaccine ADACEL lot 597AA, expiry date not provided via intramuscular route in unknown administration site on 21-Aug-2018. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that ADACEL was given to a 9 month old after a dog bite in the emergency room. The hospital stated it was their standard protocol to do so. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender- none.
No additional AE/PQC; HCP called to report the patient was given a dose of VAQTA after the dose was stored improperly; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 05-MAY-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #X003791, expiration date: 01-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 34 degree fahrenheit for 7 hours; no previous temperature excursions were reported.  No adverse symptoms were reported.
BlurredVision  aggravating myasthenia gravis and fatigue  Narrative:
This spontaneous report was received from a pharmacist regarding her 18 year old daughter. Patient did not have any pertinent medical history and drug allergies. Concomitant therapies included ORTH-NOVUM 1/35. On 14-MAR-2016, the patient was vaccinated with her third dose of GARDASIL 9, lot # L038917, expiry: 20-FEB-2018, intramuscularly. The reporter stated that there was a funny, squishing sound when the vaccine was administered. On 14-MAR-2016, reported as immediately after administration and for several hours later, the patient experienced burning pain. On next day, 15-MAR-2016, the patient developed a red, raised area, 3 inches in diameter and quarter inch high, that was firm in the middle and very painful at the injection site. Pharmacist also describes the area as having "irregular lobes, resembling the shape of a dinosaur". Treatment included ice and ibuprofen. The patient sought medical attention at physician's office on 15-MAR-2016. On 17-MAR-2016, the patient visited the office again and it was reported that the area was larger, diffusing and still firm in the area of the injection site, but the pain improving. No lab test were performed. The outcome of pain and injection site was reported as recovering. The outcome of injection site erythema and injection site mass was not recovered. The reporter did not assess the relatedness between the events with GARDASIL 9. Additional information has been requested.
Tingling all over, numbness, felt hot and legs shook uncontrollably on 7/26/06 in the late evening. Mom states patient had the exact same symptoms about 5 days after he received the hepatitis B vaccine at age 10. Patient is back to normal today.
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022; No Adverse event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-Aug-2022).    No concomitant medications were reported.   Patient administered COVID19 6MO-5YO Moderna Pediatric 25/0.25 blue. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-628787; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628787:
Pt had swelling redness and fever after TDAP injection 2 days ago. No fever today, swelling has gone down. Taking TYLENOL for discomfort. Arm still sore to raise.
Pt. had the above vaccine administered on 8/14/19.  The vaccine was given to early due to pt. having Hep B vaccine and MMR on 8/12/19. Pt. will be contacted by our office and monitored for reaction.
Jan 9, went to sleep at 2100hrs.  Woke at 2200 to urinate.  When I went back to bed, had tightness of chest, numbness/tingling in extremities.  Met ambulance while enroute to ER.  First responder advised that I had slurred speech, incoherent speech, jerky movements, and right pupil was larger than left.  At ER, they found potassium was slightly low.  Chest XRay, head CT, Head MRI, Stress test, and Echo were all normal.  Believe possible TIA.
Vitiligo (L thumb discoloration and shaft of penis progressed to L nipple and knees), eval and treatment by Dermatology on 6/18/2020. Continues to follow. Tracolimus 0.1 %. Triamcinolone 0.1%.
No actual adverse event. Vaccine was given IM in right buttock due to patients emaciated build with minimal muscle mass of deltoids in which IM to right buttock was given to ensure absorption.  No rash, no allergic reaction, no skin changes. No observed or subjective adverse reaction. Asked to report on VAERS due to atypical injection site.  Documented appropriately on both card,consent/screening form, and medical record at the skilled nursing facility.
Right after injections no issues at all 4 months later May 17th had right thalamus stroke etiology unknown was on vacation. No pre-symptoms normal blood pressure, no headaches, no cough, no fever. Got up in the morning. picked up shoes and had extreme dizziness and double vision, slight drift of left arm. No other symptoms
This spontaneous report was received from the patient's mother via a company representative and refers to a 13-year-old son. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of M-M-R II injection, intramuscularly (IM) (strength dose, frequency, anatomical location, lot number, and expiration date were not provided) for prophylaxis. On an unknown date reported as "one week after" the vaccination, the patient experienced ulcerative colitis. However,  it was reported that the patient continued the therapy. At the reporting time, it was unknown whether the patient recovered from the event of ulcerative colitis. The causal relationship between the therapy with M-M-R II and the event of ulcerative colitis was not provided. There was no product quality complaint involved. Upon internal review, the event of ulcerative colitis was considered to be medically significant. Additional information is not expected as there was no information to contact the physician.
41-year-old female RN was received a flu shot on 09/02/2021 during the mass vaccination. She reports that during the injection the injection felt as if it was given high up on the arm and she recall feeling intense pain after the injection. She reports that continues to have pain in the shoulder, she used Ibuprofen OTC briefly (2 tabs BID) but this did not really help. On presentation she reports that she had intermittent pain rated 0/10 sharp and made worse with forward reaching and reaching overhead. She denies other medical problems, possibility of being pregnant or prescription medication use. She Denies any previous issues with vaccinations. She denies any recent illness.  She is allergic to sulfa. She is tolerating full duty.
The next day I was so sleepy , chill's and severe headache I had to leave work.  Around 2:00 I was running a low grade fever of 101.  I went to sleep for until the next morning at 6:00am  When I woke up my arm was very red and swollen below where I was given my injection.  Today I'm still having headaches and feel very sleepy and very nausea.
Narrative: COVID infection following COVID vaccine series 12/31/2020 Pfizer, dose #1 01/21/2021, Pfizer, dose #2 08/16 pt cc: chills, cough, headache, exposure: unknown 08/16 -08/30 symptoms continue 08/16 SARS-COV-2 LLINEAGE B.1.617.2 08/16 SARS-COV-2 CLADE 21A DELTA 08/16 COVID swab, result: detected 08/25 COVID swab, result: detected 08/29 COVID swab, result: detected 08/30 clinically resolved 09/10 COVID swab, result: detected
Information has been received from a consumer concerning her 16 year old daughter who on 06-MAY-2010 was vaccinated with a dose of GARDASIL. On 06-MAY-2010 the patient developed hives on the opposite arm where blood was drawn after getting GARDASIL. The reporter believed that it was due to the latex. It was unknown if the patient sought medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Mild hives on arm, neck and face; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Mild hives on arm, neck and face) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Mild hives on arm, neck and face). At the time of the report, URTICARIA (Mild hives on arm, neck and face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
About 20 minutes after immunizations given, as parents were checking out, patient collapsed to the floor; her arms and legs stiffened; eyes were open but glossed over and patient was pale.  After a few seconds, patient became alert and oriented.  She was given orange juice to drink and cool compresses were applied to her forehead and neck.  As a result of her fall, patient had a dime size surface abrasion on her right lower jaw, a reddened area on her right flank area of her back, and a 2 inch by 2 inch surface abrasion on her anterior elbow area of her right arm.  No open areas.  Patient retained in the office for an additional 10 minutes and parents advised to call PCP for further instructions/recommendations regarding her abrasions from the fall.
Two weeks after getting the MMR. Patient came down with a sudden fever. Ranging 102-104 degree F.  Had a fever and was throwing up for 2 days straight. Then broke out in hives all over her entire body.  She?s been miserable and feeling awful since. Struggling to eat and nurse. Not sleeping well.