chrisvoncsefalvay/vaers-outcomes huggingface dataset:
102 fever, chills, convulsions, headache, fatigue, rapid heart rate, nausea
I was extremely sleepy.  I went to sleep Saturday night, got up at 8 am.  At 9:30 am I was so sleepy I could hardly walk.  I went to bed and slept  for 7 hours without waking up.  When I got up I felt better.
Narrative: Patient passed away due to COVID-19. He had received a COVID-19 vaccine.
Didn't feel well for a day after the booster; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Didn't feel well for a day after the booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse effect with Pfizer and Pfizer. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Didn't feel well for a day after the booster). At the time of the report, IMMUNISATION REACTION (Didn't feel well for a day after the booster) outcome was unknown. No concomitant medications were reported. 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 we missed to be booked-in.
I stopped having my period since I got the Pfizer shot on 9/20/2021 until now.  I didn't have my period since September 2021 until this week; this week (2/28/2022) I am bleeding for over 7 days straight and I feel very dizzy.  My usual period lasted 3-5 days when heavy bleeding was only for 1-2 days.
No adverse event; however, faulty BD Integra syringe/needle combo. Vaccine was pulled up appropriately. Upon injection, an unknown amount of vaccine was injected into patient's arm. Most of vaccine fell directly out of syringe and onto the top of patient's arm.   Vaccine was redrawn from a new vial and re-administered to the patient per CDC guidelines.   Faulty syringe information: Lot - 0002373; Exp - 12/31/24
2nd Shingrix shot.  21 hours after receiving shot, feeling fatigued and chilled, I experienced sudden onset of vertigo and some nausea.  Vertigo lasted approximately 20 minutes and gradually faded.  Had my first shot around June 6 from same pharmacy and experienced identical symptoms.  Fatigue, chills and sudden onset of vertigo which last roughly 20 minutes and subsided.    Note I have Meniere's which makes me prone to vertigo, but I have not had an episode outside of the Shingrix experience in over 3 years.
Inappropriate schedule of vaccine administered/another child who received GARDASIL on similar, if not the same, dosage dates.; No adverse effect reported.; This spontaneous report was received from a consumer referring to her child of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.  The patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot # and expiration date were not provided) for prophylaxis. Another patient on the following schedule: "18-AUG-2011, 11-JAN-2012 and 13-FEB-2012". And the patient who received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) on similar, if not the same, dosage dates (inappropriate schedule of product administration). No adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA013789:
Shoulder pain at the joint. MRI given and MD determined related to vaccine. Anti-inflammatories prescribed and physical therapy initiated.
fever.  PT presents with frontal HA and fever x 1700 reports received JJ vaccine this morning. took 1 tablet unknown dose tylenol x1 hr PTA.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a infant patient who received Hib (Hiberix) (batch number 25Z52) for prophylaxis.   On 26-JAN-2023, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
AFTER A DAY,  I DEVELOPED A  HEADACHE AND PAIN IN MY LEFT ARM AND SHOULDER, THEN IT BEGAN TO MOVE DOWN INTO MY LEFT SIDE. WITHIN A WEEK MY ENTIRE LEFT SIDE WAS IN PAIN. I WENT INTO A CRPS FLARE UP OF MY ENTIRE LEFT LOWER EXTREMITY.  I WAS BEING TREATED FOR THIS BY PHYSICIAN BECAUSE SHE IS AWARE OF THAT DISORDER AND KNOWS HOW TO TREAT THIS.  SHE AGREED IT COULD HAVE BEEN BROUGHT ON BY THE VACCINE.  I DID REPORT THIS TO THE CDC ON MY PHONE AND I HAVE BEEN IN CONTACT SINCE THEN.  I DEVELOPED A AVN ACUTE VASCULAR NECROSIS IN THREE MONTHS IN WHICH I HAD TO HAVE MY LEFT HIP REPLACED 8/30.  I ALSO HAVE AVN IN MY RIGHT HIP.  THE SURGEON HAS NO IDEA HOW THIS HAPPENED. I HAVE NO ARTHRITIS AND THIS HAPPENED LITERALLY IN THREE MONTHS POST COVID VACCINE.  I HAD AN MRI IN JUNE WHICH CONFIRMED THIS DIAGNOSIS.  I HAD PERFECTLY PERFECT HIPS THAT WERE CLEAN WITH NO ARTHRITIS AT ALL PRIOR TO VACCINE.  I AM A NURSE AND I AM EXTREMELY UPSET BECAUSE I AM AWARE THAT PTS WITH NEUROLOGICAL DISORDERS WERE NOT FIELD TESTED BEFORE THE VACCINES WERE DISTRIBUTED TO THR PUBLIC.  WAS IT BECAUSE IT WOULD CAUSE A RED FLAG, OR DISRUPT THE RESULTS TO GET THIS APPROVE BY THE EMERGENCY ACT.  THIS WAS NOT EVEN GIVEN APPROVAL BY THE FDA AND THE PHARMA COMPANIES ARE EXEMPT FROM ANY LAW SUITS.   I  HAVE LOST ALL RESPECT FOR THE CDC AND THE PHARMA COMPANIES AND ANYONE ELSE WHO DECIDED THIS WAS ACCEPTABLE.  THANK GOD I AM RETIRED BECAUSE I AM NOW FACING ANOTHER HIP REPLACEMENT .   I WAS TOTALLY FINE BEFORE THIS VACCINE..TOTALLY FINE.
Rash started 2/7/06 in afternoon. At bedtime client was having trouble breathing. Mother directed her to take a shower and take Tylenol. Then she fell asleep. On 2/8/06 client glands swollen and trouble swallowing continued taking Tylenol. Dr examined client. Client advised to seek medical care if client has increase trouble breathing (911). Client alert and oriented. Talking with difficulties. Advised not to get another MMR. Cline no "acute distress."
Swelling of lips, hives on breast and within 36 hours, generalized hives. On 9/21/00, pt came in with above symptoms. Treated with Solu-Medrol and Benadryl.
Information has been received from a physician concerning a 13 year old female, who, on  an unspecified date, was vaccinated IM with a dose of GARDASIL. Subsequently, the patient passed out. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
17 days post vax the pts eyelashes had fallen out and her eye brows had started to fall out. She was not losing any hair as of 05/23/2000. The most recent information received reports the outcome of the event is resolved.
About 1 week after vaccination got a widespread cellulitis of left arm at and around injection site. Contacted employee health to report and advised to see PCP. PCP placed me on antibiotics for cellulitis.
Second dose administered from a punctured vial that was put back in fridge for a month; A spontaneous report was received from a nurse for a 48-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a dose administered from a vial punctured a month ago (expired vaccine used).  The patient's medical history was not provided. No concomitant product use was reported.  On 19 Jan 2021, a punctured vial with extra doses left within the vial was placed back in the refrigerator after 6 hours.  On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. This dose was administered from the punctured vial that was put back in refrigerator a month ago on 19 Jan 2021.  Treatment information was not applicable.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event was considered resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # unknown)  with no associated AEs reported.; Sender's Comments:  MOD-2021-027810:same reporter,same event, different patient MOD-2021-027749:same reporter,same event, different patient
Fevers of 103.  panycytopenia neutropenia dry cough body aches lowback pain thigh pain.
Cellulitis - arm with 10 cm of surrounding erythema/central area 2.0 cm x 2.0 cm - increased induration.
itching; Got a bad rash all over my body; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9264, expiration date was not reported) via intramuscular route, in left arm, on 04Feb2021 15:00 (at the age of 74-years-old), at dose 1, single for covid-19 immunization. Medical history included epilepsy from 1950 and ongoing (age 4- 1950), ongoing blood pressure increased (onset age: 45-50), ongoing increased cholesterol (onset Age: 60-65), ongoing hypothyroidism (onset age:70), Epileptic Seizures from an unknown date to 18Feb2020; had a lot of seizures but haven't had any since 18Feb2020, last year 2020, subdural hematoma. Concomitant medications included atorvastatin taken for cholesterol from 2007 and ongoing; clonidine taken for blood pressure from 2004 and ongoing; gabapentin taken for Epileptic Seizures from 13Mar2019 and ongoing; levetiracetam taken for Epileptic Seizures from 13Mar2019 and ongoing; levothyroxine taken for hypothyroidism from 2007 and ongoing; metoprolol tartrate taken for blood pressure from 2004 and ongoing; primidone taken for Epileptic Seizures from 20May1964 and ongoing. The patient experienced got a bad rash all over the body on 11Feb2021, itching on an unspecified date. The event rash all over the body resulted in physician office visit on 12Feb2021. The patient underwent lab tests and procedures which included blood electrolytes: ok; at age 73; could not take calcium because it causes constipation (as reported).  , chest x-ray: ok on age 46; chest hitting steering wheel, CAT (computerized tomogram): ok on Age 46; subdural hematoma due to severe seizure, EEG (electroencephalogram): unknown results on age 4 ;unknown results on age 10; unknown results on age 18, full blood count: ok on cholesterol increased, onset date a age 73 , blood calcium: decreased on age 73.  All tests on an unspecified date. Therapeutic measures were taken included steroid shot and placed on Ciprofloxacin for 5 days for rash and for itching: Clindamycin, Ciprofloxacin, antibiotics but neither this has done any good, also with 2 tubes of Hydrocortisone. The patient had his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202) on 25Feb2021 at 13:30-14:00 and had arm sore. The outcome of the events was not recovered.  Follow-up (13May2021): New information received from same contactable consumer which includes: concomitant drug details added (Primidone, Clonidin, Metoprolol Tart, Atorvastatin, Levothyroxine, therapy details for Levetiracetam and gabapentin), RMH details, lab data, event details (physician office visit details), treatment details.  Follow-up attempts are completed. No further information is expected.
TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2689) was received from a pharmacist on 29-Oct-2019. It described a male consumer who "took an unrefrigerated dose of Vivotif" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: It was reported that the consumer took a dose of unrefrigerated Vivotif after it had been left out for multiple days.  Action taken with Vivotif with respect to event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.
Patient is 41 years old, male. Alert, oriented X3, clear speech, able to answer to the questions. Underlying medical conditions include Down Syndrome, high cholesterol, and asthma. History of allergic reaction to bethanechol ? swelling, no anaphylactic shock. Denied having allergies to food, other vaccines, or components of COVID-19 vaccine. Patient was tested positive for COVID- 19 in December 2020, was hospitalized for 11 days but was not admitted to ICU or intubated. At 11:50 am, patient received first dose of Pfizer, lot number EW0150, expired on 07/2021 on right deltoid, given by RN. At 12:08, while waiting in observation area, patient reported of tingling and swelling in right hand. EMTs and RN responded. Vial signs were taken every 5 minutes. At 12:08, BP 121/82, Sp02 at 95% room air, HR 110bpm; skin was warm to touch, normal skin color on face and lower extremities. At 12:13 pm, BP 123/82 sitting, HR 107 bpm, 2+, RR 22 res/minute, unlabored, patient was moved to anti-gravity chair. Per sister, patient hasn?t eaten anything this morning. Water and cookies were offered, patient ingested 250 ml and 100% of cookies, patient stated ?I?m feeling a lot better, no more tingling?. Upon assessment, noted significant decreased swelling on right hand, normal skin color, capillary refill <3s bilaterally. At 12:24 pm, BP 121/80, SpO2 92%, RR 20 res/min, unlabored, no acute distress noted. At 12: 28, BP 121/79, HR 104, strong, RR 20 res/min, unlabored, SpO2 95%. At 12:34 pm, BP 121/78, SpO2 95%, HR 102 bpm, RR 20 res/min, unlabored, patient ingested 250 ml of water, denied any discomfort. Patient?s education was provided to patient and his sister, they verbalized understanding. At 12:45 pm, patient left facility, he was accompanied by family members and EMT to their car. Patient was able to walk without assistance, gait was balance.
Pt stated his heart started to race, pt was diaphoretic, took vitals, pt met requirements for  epi and benadryl. 911 called. Pt moved to a room with a bed. EMS arrived and transported pt to ER
elevated fever 18APR;maculopapular rash w/fine rash w/confluence;
Pt was pale and dizzy.  Fell over in chair.  Never lost pulse or resp.  This occurred about 12 min Post-inj.
In the left thigh baby got a hard lump and bruising that was still noticeable two months later at next well baby appointment. Mom eventually took baby to the ER where the doctor drained an abscess at the injection site.
Patient stated she woke up on 10/31/18 (3 days after injection) with severe arm pain right beside injection site. The pain was severe enough that she couldn't move her arm. She stated she had mild pain previously that she took ibuprofen which seemed to help; however, the pain seemed to increase. Injected was given 10/28/18. Recommended patient call PCP and follow-up with us if needed.
Patient had a severe reaction after receiving this vaccine. A nurse from Dr.'s office gave her the shot.  Later that afternoon, patient returned to classes at College. Later that night, she had chills, nausea and fever and her arm was swollen and the skin was very hot.  The next day her arm was swollen even more and she felt worse.  She also had a ring and a rash around the site. She went to the Hospital.  The E.R. physician diagnosed CELLULITIS.  He gave her Keflex. The rash and ring on her arm got bigger and she felt worse. We had to take our son to another Hospital for a previously scheduled procedure on Friday, March 28 so my husband dropped me off with my son then drove to pick up patient and bring her home to see Dr., who she had treated her in January 2008 at another Hospital and he diagnosed double pnemonia. She spent a week in the hospital. When my husband and I called Dr.'s office to tell her about patient's arm and cellulitis diagnosis, the nurse in the office told us Dr. was out and the other doctor would not speak to us.  When we persisted in talking to the doctor at this office about patient's worsening condition, we were again told that the doctor refused to talk to us even though patient had signed a release allowing us to discuss her medical information. The reason patient received this vaccine was because she had a check-up with Dr. on 3/25 and was told she had to get this vaccine that day. Patient's father picked her up on 3/28 and took her to see Dr. and he prescribed Levaquin. She also saw Dr. again on 3/29. To date, Dr. still has not called patient or me or my husband to discuss her reaction, her symptoms, or her health.  Her nurse has called patient but the doctor has not. Patient is currently still recovering.
Left eye does not want to open all the way; patient showing extreme fatigue, pain in limbs, difficulty understanding speech. Loss of appetite and 101 degrees fever.
I had fever, extreme body and headaches, tiredness, my arm hurts. I had flu-like symptoms.
In November of 2020 I was diagnosed with COVID 19 and subsequently recovered.  This was my first Moderna shot.  I took the shot in the right arm and completed my work day with no side effects.  I went to the gym that night - as usual - and wanted to "work that arm" a little.  I had a good workout, no issues.  Went home, ate and went to bed.  About 1 or 2 am I woke up with the hottest raging inferno flu-like fever I can recall having as an adult.  I did not want to alert my wife, so I simply stayed in bed and did not measure my fever level.  My guess is it was >102.  Fever continued until a.m. and deep body pain hit me.  At dawn my fever measured 101.  I took acetaminophen and took a cold shower.  Fever subsided for a short while.  Then it came  back.  I felt weak and flu-pain so I stayed home from work and simply slept it off.  Symptoms slowly subsided by 7pm day 2.  Day 3 I was not 100% but I went to work and was fine.  No other symptoms since.
At 5:15 pm, same day as shot, a migraine occurred. A bad migraine, unable to stand because it caused so much pain in my head. at 8:00PM I went to bed due to the pain. at 1:15 AM, my body was in pain. My right rib cage hurt so bad that I couldn't sleep on my right side. My legs, back, and pelvic bones were in so much pain as well. I felt as if my bones were going to break or I had severely bruised my bones. Breathing, coughing, sneezing hurt because of my rib cage hurting. My migraine had not gone away, and my lymph nodes were really swollen. Couldn't put my arms down, my neck was swollen and walking hurt because my legs were swollen. This occurred for 24 hours. Next day, migraine is gone and left a headache. Swelling is still prominent and bones still hurt.
Pt called stating that the injection site was sore than a few hrs or so after she was in so much pain she couldn't move her arm.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. On 19-NOV-2013 the patient was vaccinated with a dose of MMR II (lot # 1648AA, expiration date 21-OCT-2013) (0.5 ml, subcutaneous). No other suspect therapies or concomitant medications were reported. The nurse reported that the patient received a dose that has expired on 21-OCT-2013. No adverse effect reported. Additional information has been requested.
VACCINES GIVEN OUTSIDE THE 6 HOUR TIME FRAME (PUNCTURED AT 13:00 ON 28-JUL-2021 AND ADMINISTERED NEXT DAY BETWEEN 10:00 TO 13:00); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced vaccines given outside the 6 hour time frame (punctured at 13:00 on 28-jul-2021 and administered next day between 10:00 to 13:00). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccines given outside the 6 hour time frame (punctured at 13:00 on 28-jul-2021 and administered next day between 10:00 to 13:00) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802801 and 20210802909.
Woke up day after shot, with swelling and redness left arm from shoulder down to elbow. The area was warm to touch. Denies other symptoms. Was unable to contact doctor. I gave her BENADRYL and referred to PCP. I spoke w/ their office and pt had an appt to see nurse today.
Child received Td shot 6/14/2004 and mother states she developed rash all over body 3 days later
receive 2 doses on 2020 and then 2 more doses on 2022; receive 2 doses on 2020 and then 2 more doses on 2022; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose on 24th June 2020) and Shingrix (patient received 2nd dose on 3rd September 2020).   On 15th June 2022, the patient received the 4th dose of Shingrix. On 16th March 2022, the patient received the 3rd dose of Shingrix. On 16th March 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 15th June 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.    Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: The reporter wanted to receive guidance.  The reporter stated that a patient received 2 more additional doses of Shingrix in 2022. The reporter gave consent to follow up by mail. Additional Supportive Information: The patient received 2 additional doses of Shingrix, which led to extra dose administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018110009:Same reporter
pain on the left back part the body; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (reported as patient's age: 40; unit: unspecified) received BNT162B2 (COMIRNATY, Solution for injection), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "tumor on left kidney" (ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain on the left back part the body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.