chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a pharmacist refers to a 52 year old female patient. The patient's medical history included brain tumor. No drug reactions/allergies. On 23-JAN-2015 the patient was vaccinated with ZOSTAVAX (lot# reported as K020801, exp 31-JAN-2016), 0.65 ml, once, subcutaneous in the right arm. Concomitant medication was other unspecified medications. On 24-JAN-2015, swelling, redness, and warmth at the injection site in her right arm after received ZOSTAVAX. No treatment and no lab given to the events. The patient had sought medical attention by contacted pharmacy. The outcome of the events was reported as recovered/resolved on an unknown date in 2015. No PQC involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Pt with history of pancreatic cancer with Mets to liver and recurrence and refractory to treatment.  After 4th shot developed more implants and more obstructed jaundice
12/27 vaccination woke up, I felt lethargic, nauseous, very sore arm (couldn't lift arm) Have felt this way with flu shot; 'semi - normal' to have this type of reaction  I felt better by 3PM the next day 3rd pregnancy;
about 1 week after receiving his first dose of the Moderna COVID-19 vaccine on 7/31/2021, upper abdomen and chest pain which he initially attributed to GERD and eating spicy food, but he did not get relief with over-the-counter medications.  He continued to get  short of breath and lightheaded with physical activity.
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 21-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA012930: US-009507513-1809USA013686: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA013683.
PREGNANCY; A nurse prospectively reported that a 16-year-old female subject was inadvertently vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) during the first trimester of pregnancy.  On 21 October 2005 the subject received a dose of Boostrix (lot AC52B001AB) during the 1st trimester of pregnancy.  The date of the last menstrual cycle was not reported.  The estimated due date is June 2006. Follow-up will not be available.  Upon internal review done on 13 Sep 2019, the pregnancy outcome was updated to lost to follow-up.
Arm swollen at injection site, red rash with itch, fever and diarrhea
After receiving the vaccine and after 5 days I had a little knot then yesterday 10 days later, I woke with a baseball size knot and I'm now on antibiotics for cellulitis.
Within 24 hours post vax, the pt experienced flu-like symptoms, soreness at the injection site and a fever. She did not seek medical attention. She recovered within 48 hours.
Painful injection. Nine days after, patient developed increase in tenderness and warmth at injection site. By 10/5, the area was still tender to touch with a slight fullness at the injection site.
Covid Arm. It began itching the evening of 8/24 and when I woke up the AM of the 25th, I had a medium sized rash surrounding my injection site. It is puffy, slightly itchy and red. I also have pain in my left elbow, which I believe is related to this.
redness, tenderness, and warm to touch at injection site  (apprx palm-size)
Redness and swelling at site of TRUMENBA 8-9 cm redness.
can't drive because feels weak/weakness; can't drive because she feels dizzy/dizziness; tossing and turning and cannot sleep on her left side; nausea; chills; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (can't drive because feels weak/weakness), DIZZINESS (can't drive because she feels dizzy/dizziness), INSOMNIA (tossing and turning and cannot sleep on her left side), NAUSEA (nausea) and CHILLS (chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 029L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease. Concomitant products included VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ASTHENIA (can't drive because feels weak/weakness), DIZZINESS (can't drive because she feels dizzy/dizziness), INSOMNIA (tossing and turning and cannot sleep on her left side), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue). At the time of the report, ASTHENIA (can't drive because feels weak/weakness), DIZZINESS (can't drive because she feels dizzy/dizziness), INSOMNIA (tossing and turning and cannot sleep on her left side), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) outcome was unknown.            Concomitant medication included thyroid pill every morning for Graves disease.  The patient did not take any treatment medication. The patient usually was very healthy and active.
Based on the additional information received on 13 April 2015, this case initially considered as non-serious was upgraded to serious due to important medical events: upper respiratory infection, cough, fever, scratchy in throat, sinus disorder, fatigue and mild emphysema. Initial unsolicited report received from a nurse on 26 February 2015. A 46-year-old female patient had received first dose of 0.1 ml of IPOL (batch number, expiry date was not reported) via intradermal route in right forearm on 24 February 2015. Patient had no illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical condition was unknown and concomitant medications were not reported. On 24 February 2015 same day after vaccination, the patient developed redness at the injection site. The patient required ER/doctor visit. Laboratory investigations and corrective treatments were not reported. On an unknown date the patient was recovered from the event (duration was reported as 15 minutes). Documents held by sender: none. Follow-up information received from health care professional on 13 April 2015. The patient was also administered with TUBERCULIN PPD (TB:PPD) (batch number: 720409, expiry date: 6 April 2015) via intradermal route in left forearm on 24 February 2015. The patient had a history of emphysema and hereditary history of asthma. On 24 February 2015, patient experienced hives. On 27 February 2015, the patient required doctor's visit in which patient was diagnosed with cough, sinus drainage, fever, fatigue, lungs hurt, feels scratchy in throat. The patient had not received any other vaccinations four weeks prior to this vaccination. Patient did not have any illness at the time of vaccination. The time at which vaccine administered and event occurred, patient details were updated. The state and country where vaccine administered was updated. The patient was prescribed with Azithromycin as corrective treatment. At the time of this report, on 25 February 2015, the patient was recovered from the hives. Outcome of the other events were unknown as patient did not present for the follow up however the nurse assumed that the patient was recovered. Document held by sender: None.
Moderna COVID- 19 Vaccine EUA Patient reported account of vaccination on 12/21/20: I received my 1st dose of the Pfizer Covid-19 vaccine yesterday afternoon and about 2 mins post injection I felt flushed, dizzy, and nauseous which disappeared quickly but then came back about 10 mins post injection and then never happened again. I felt completely normal after that and I feel fine today.
Headache, coughing, muscle aches, fatigue, runny nose, changes in breathing ability
PATIENT (MY DAUGHTER 13 YEARS OLD) GOT VAACINATION FIRST DOSE (PFIZER)ON MAY 16 FROM SCHOOL, RIGHT SAME NIGHT SHE GOT FEVER. FEVER DID NOT STOP AFTER 10 DAYS SHE CONTINIOUSLY HAD FEVER EVEN AFTER GIVING AETOMOPHIN EVERY DAY BUT WOULD REDUCE AFTER TAKING MEDICATION. WE REPORTED TO OUR PEDRATICIAN HE DID BLOOD WORK (COVID, STREP THROAT, IRON, THYROID, HEMGLOBIN ETC) WORK AND SUGGESTED TO COME BACK AFTER FOOLLWED BY AGAIN ACETAMOPHIN WITH NO CHANGE IN FEVRS WE WENT AGAIN TO PEDATRICIAN WHO SUGGESTED MORE BLOD WORK WE DID BLOOD WORK AGAIN AND FOOLWED BY AZETHROMYSIN DOSE FOR 6 DAYS FEVER USE TO GO DOING IN EARLY MORNINGS AND COME BAC AFETR NOON. SHEE COMPLETED ANTIBIOTICS DOSE BUT NO CHANGE IN FEVERS. JUNE 25 PATIENT FEVER WENT TO 105 AND WE ADMITTED HER TO HOSPITAL WHERE SHE STAYED 2 DAYS WITH MANY BLOODS WORK AND FOLLW UPS WITH RHEUMATOLOGY. SHE WAS RELEIVED FROM HOSPPITAL WITH FEVER FROM UNKNOWN SOURCES AND REQUESTED TO SEE RHEUMATOLOGY AS OFFSIE VISIT WE SAW HIM AND WAS TOLD TO DO CT OF CHEST, ABDOMEN AND PELVIC CT REPORT SHOWED INFLAMATION IN LIVER SHEEN, LYMPHNODES AROUND THE HEART AND WAS TOLD TO GET ADMISSION IN EMERGENCY AGAIN WE TOOK PATIENT TO HOSPITAL WHERE SHE IS ADMITTED FOR LAST 5 DAYS AND DOCTORS DID A BIOPSY FOR LYMPH NODES AND EXTRATED ONE FROM HER ARMPIT WITH 2 INCH INCESION. SHE HAS MET WITH INFECTOUS DISEASE, RHEUMATOLOGY, GI, DERMATOLOGY, ONCOLOGY AND PEDIATRICS WITH NUMEROUS BLOOD WORK. PATIENT WAS ALSO TESTED BY GI WITH ENDSCOPIC BIOPSY WITH NO FINDINGS. WE ARE STRUGGLING TO FIND THE CAUSE OF FEVERS. THIS IS HUGE PROBLE FOR US PRAENTS LOST WORK DAYS AND WENT THUGH LOT OF SUFFERING WITH NO DIAGNOSIS AND HUGE MEDICAL BILLS. I STRONGLY BELIEVE THE MEDICATION HAS SOME SIDE AFFECTS WHICH NEED TO BE ADDRESSED. PATIENT DID NOT HAD HER SECOND PFIZER DOSE DUE TO FEVER AND ALL ADULTS IN FAMILIY HAVE TAKEN BOTH WE ARE REALY REALLY CONCERNED ABOUT PATIENT. PLEASE CALL US AND HELP US.
An hour later, I developed a rash on the front of my neck.; itching in my toes/ My entire body felt itchy; deep redness in my finger and hands; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included photorefractive keratectomy performed two months prior, COVID-19. The patient had no known allergies. Concomitant medications included fluorometholone (EFFLUMIDEX) eye drops, lisdexamfetamine mesilate (VYVANSE) 30 mg, and acetylsalicylic acid (ASPIRIN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the arm right on 19Mar2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 15:20 the patient experienced deep redness in finger and hands, also developed itching in toes. On the same day at 16:00, the patient experienced a rash on the front of neck. On the same day at 15:30, experienced entire body felt itchy, especially fingers and toes. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events deep redness in finger and hands, also developed itching in toes. rash on the front of neck. entire body felt itchy, especially fingers and toes recovered on 09Apr2021 at 18:00.  No follow-up attempts are needed. No further information is expected.
Bell's Palsy; Shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-000003478 (Novavax).  A 29-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COLDS; DIZZINESS; UNEXPECTED THERAPEUTIC BENEFIT (RECOVERED FROM UPSET STOMACH/GASTRO SYMPTOMS); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: upset stomach, gastro symptoms, and covid, and concurrent conditions included: diabetes, and blood clots in body and brain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included rivaroxaban for blood clots. On 26-MAR-2021, the patient experienced colds, dizziness, and unexpected therapeutic benefit (recovered from upset stomach/gastro symptoms). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the colds, dizziness and unexpected therapeutic benefit (recovered from upset stomach/gastro symptoms) was not reported. The reporter and company causality between covid-19 vaccine ad26.cov2.s and colds considered as not related. This report was non-serious.
Immediately after the injection, site turned red, I got hot and began sweating profusely. This lasted about 10 minutes and resolved.
This initial spontaneous report was received from a female consumer of unknown age reporting on herself. There was no pertinent medical history, concurrent conditions, concomitant medication or drug allergies/drug reactions described. On an unknown date reported as "at age 15", the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# and expiration date were not provided). She was refused the second dose of GARDASIL from the doctor at the time as the doctor said it was due to the fact that she "had lost her virginity". On an unspecified date, the patient was diagnosed with HPV (papilloma viral infection). The patient stated that she will get tested for cervical cancer in the coming days. The GARDASIL was not reintroduced. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of papilloma viral infection was not recovered. The relatedness between the event to the suspect product was not reported. Additional information has been requested.
I have never had hives or an allergic reaction to a vaccine before. I rec. my flu vaccine leaving work like I do every season (nurse) went straight to bed, and this time I woke up in hives. I have had hives daily since. Mostly in heat (too bad I live and run around at my job) even just walking to the car I get hives, finger swelling, etc. I also had a traumatic experience with the actual injection. Not sure what the girl did but she tore up my arm. I bled all over (like, stained the ground & my whole upper arm was black and blue) I have been dealing with the hives consistently since I woke up in the middle of the night after my flu shot.
Fainted twice. 2 minutes apart. Approx 5.5 hours after vaccinated. No other adverse reactions. Cannot ever remember fainting previously in 48 years, for any reason. Not concerned at this time, after reading information from cdc. Just wanted to contribute,  and not go unheard.
11.4 weeks pregnant at the time of the vaccination. Around 8 pm on 09/09/2021, after getting out of the shower I noticed a red circle around the vaccination site, it was hot to touch and raise slightly. I proceeded to go to bed. Around 01:47 am, I woke up with the worst headache, chills, and night sweats. The following morning, I tried to get up to go to work and felt very dizzy to the point I almost fell down so I laid back down. I set a new alarm and tried to get out of bed about an hour later. At that time, I was unable to pick my body up. I dealt with night sweats, chills, headache, dizziness, generalized weakness and extreme fatigue until about 5:00 pm. The fatigue and weakness lasted until 09/11/2021 around 11:00 am. The spot on my arm continued to grow and become very irritated over the next several days. It got to the size of a softball and then turned until a bruise.
Urticarial rash developed 5min after administration all over body, no respiratory s/p noted. Rash took a few days to resolve on Benadryl/Orapred. Pt was given 1 dose of Benadryl/Orapred she started to get rash decrease in within 1 hr.
Nausea, 2 pm, continue thru evening   Diarrhea onset 3:30 pm, off and on thru 8 am at report time  Severe shoulder soreness, joint noticeably  swollen  Severe headache, onset around 4 pm day of vaccine  no relief from tylenol, headache continue thru to time of reporting   Feeling feverish, although no fever on thermometer  Extreme tiredness
Right arm pain, right axillary lymphadenopathy, arm swelling, body aches, chills, temp 99.
Soreness at injection site, extreme fatigue, light headed, cold sweats, muscle soreness pain, sore back/kidneys(?), headache, testicular tenderness
Nosebleeds, fluctuations in blood pressure, diarrhea, vomiting, red streaks on arm, headache.
Patient is a 75 y.o. female with paroxysmal atrial fibrillation on xarelto, orthostatic hypotension, chronic asthma/cough, hyperlipidemia and history of TIA who presents from home on 11/17/23 with palpitations. Pt states she received her RSV vaccine 11/16/23 then around midnight developed chills and palpitations so decided to present to ED for evaluation. Pt found to be in Afib with RVR, started on cardizem gtt. Pt states this happens occasionally, usually related to dehydration. Pt HR drastically improved and rhtyhm converted back into sinus with cardizem and gtt has been stopped.    Pt follows with Dr. of cardiology. Has had multiple admissions for afib RVR over the past year which generally resolves quickly with Cardizem or spontaneously. Most recently, Pt was admitted to Medical Center 10/30/2023-11/1/2023.
I've experienced full body shakes; Diarrhea; Tingling in both my hands; Extreme pain in the injection site; Sweating; Severe headaches; I started feeling nausea in the evening and started throwing up continuously later in the evening; I started feeling nausea in the evening and started throwing up continuously later in the evening; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old patient of an unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 08:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit disorder (add), obsessive compulsive disorder (ocd), post-traumatic stress disorder (ptsd), broad spectrum disorder, unspecified allergies, graves disease and insomnia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included clonidine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (TRI-SPRINTEC), paroxetine hydrochloride (PAXIL) and "pr"; all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 08:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 08:30, the patient experienced full body shakes, diarrhea, tingling in both hands, extreme pain in the injection site, sweating and severe headaches. On the same day, the patient started feeling nausea in the evening and started throwing up continuously later in the evening. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the patient started feeling nausea in the evening and started throwing up continuously later in the evening, the patient had experienced full body shakes, diarrhea, tingling in both hands, extreme pain in the injection site, sweating and severe headaches was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Fever, Swelling at injection site along with red, hot welt,  chills, tiredness.  Narrative:
After estimated 10 mins after vaccines administered pt. felt lightheaded. Pale, became weak, wet herself. Pt. was taken to exam room. Laid down, given cool towel, feet elevated, given water. Orange to eat. B/P 96/74 HR 118 upon lying down. Pt. left clinic walking out the door, "feeling normal". Pt says she felt lightheaded immediately after HPV shot however began walking out with mother and then had pre-syncopal episode. No loss of consciousness. Episode was witnessed. 40+ mins - pt felt normal to leaving.
Headache, muscle, aches, fever, shivering, fatigue, trouble sleeping.
Began experiencing allergy-like symptoms the afternoon of Sunday, July 10. Symptoms worsened Monday, July 11. After positive at-home test, antivirals begun evening of July 12. Symptoms lessening as of Wednesday, July 13.