chrisvoncsefalvay/vaers-outcomes huggingface dataset:
There was no visably  apparent reaction within the first 30 minutes.  At the 45 minute time frame, I began to feel extemely tired and upon arrival at home I layed down in my recliner and that is the last thing that I remember for over 24 hours.  During the next 24 hours, I felt varying changes in the level of my consciousness as well as extreme levels of pain throughout my entire body, especially muscular, joint, and bone pain.  There was extreme itching all over, and the sensation of pins and needles.  I could feel the swelling in my nose and mouth.  And, there was pain at the site of the injection.  During this time, I was unable to move and did not talk.  I was given my medications and was on CPAP and 2 L/Min of Oxygen Therapy.  I did not go to the bathroom, and did not eat or drink, other than the small amount of water that I took with my Medications.  I have no memories of this.  During the last 24 hours of the acute phase.  I have more memories and was able to get up to the bathroom;  I experienced massive episodes of diarrhea and urination.  My Immunologist, Dr.  told me that I had experienced a Cytokine Storm, and a type of coma during those 72 hours.
Fatigue; quite sore; Left arm 5 inch circumference rash that went down underneath my arm; violent case of chills; vomiting; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (quite sore), VACCINATION SITE RASH (Left arm 5 inch circumference rash that went down underneath my arm), CHILLS (violent case of chills) and VOMITING (vomiting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 019F21A, 002A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (quite sore), VACCINATION SITE RASH (Left arm 5 inch circumference rash that went down underneath my arm), CHILLS (violent case of chills) and VOMITING (vomiting). On 20-May-2022, CHILLS (violent case of chills) and VOMITING (vomiting) had resolved. At the time of the report, FATIGUE (Fatigue) had not resolved, VACCINATION SITE PAIN (quite sore) outcome was unknown and VACCINATION SITE RASH (Left arm 5 inch circumference rash that went down underneath my arm) was resolving.     No concomitant medications was provided by the reporter. Reporter stated 6 hours after vaccine, experienced violent case of chills, vomiting. Wrapped up in a bunch of blankets, drank hot water. Left arm 5-inch circumference rash that went down underneath my arm, no knot at the site. Rash, it's all going away. Chills lasted for about 1 hour. Vomiting's lasted for about an hour; vomiting started half hour after chills started. Chills started to go away when vomiting was increasing. No treatment medications was provided by the reporter.
FF2593 Labeled expiration 11/2021, pharmacy notified lot was expired 11/24/21. Vaccine administered 11/29/21
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The nurse reported that, "yesterday", on 27-OCT-2014 the patient was vaccinated with an expired dose of GARDASIL (dose, route not reported, lot # J005661, expiration date 26-SEP-2014). Concomitant medications were not provided. No adverse effect was reported. Additional information is not expected as the reporter did not want to be contacted.
A female reported that she received an injection of Tetanus Toxoid Adsorbed, and subsequently developed a fever, sore throat, and swollen lymph nodes. The patient considered this to be a serum sickness like reaction. The reporter declined to provide additional information and declined to grant permission for the follow up investigation.
My left knee that I had a total joint replacement on swelled up the next day and was swollen for about two days. I also had trouble gripping with my hands and joint pain. I started getting hot flashes and headaches. The headaches lasted about 8 weeks. More recently, I've experienced hair loss that my doctors don't know the reason behind.
TINNITUS WAS 50 FOLD SINCE GOT THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: tinnitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced tinnitus was 50 fold since got the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus was 50 fold since got the vaccine. This report was non-serious.
After 10 days of the first dose, I start to have tinnitus which is stronger in my left ear. The tinnitus is still there till now.
Pt. reports left arm pain/heaviness after receiving 2nd dose of vaccine. Pt. was given 2nd dose in the right arm. Pt. described the feeling in his left arm as aches and mild heaviness. He reports pain in his left arm after the first dose that went away after a few hours. He denied chest pain and chest tightness, swelling, itching, and syncope. Pt. appeared stable after vaccine. He improved after further observation. Pt. given directions to go to ER if symptoms worsen.
This spontaneous report was received from a registered nurse via medical assistant and refers to a 13-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 18-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666;  US-009507513-1710USA014650: Original Case: 1710USA014649;  US-009507513-1710USA014651: Original Case: 1710USA014649;  US-009507513-1710USA014649: Original Case: 1710USA014649.
pt recv vax 23OCT96 & 7APR97 pt devel a case of breakthrough chickenpox & presented to MD:
Pt came for a flu vaccine but was given 0.25ml Moderna vaccine instead.  The pt had previously received Pfizer Covid vaccine doses 1 and 2 on 09/10/2021 and 10/01/2021 respectively. At the time of this report no adverse symptoms had been reported by the pt.
MALToma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 94-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. No prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization; Bnt162b2 (DOSE: 3), for COVID-19 immunization. The following information was reported: EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (hospitalization) with onset Dec2021, outcome "recovered" (Feb2022), described as "MALToma". The event "maltoma" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Positron emission tomogram: clear PET scan, notes: Caller states her mother in law had the lymphoma removed and has a clear PET scan now. Therapeutic measures were taken as a result of extranodal marginal zone b-cell lymphoma (malt type). She states one went for an operation to get the lymphoma removed and the other one is undergoing chemotherapy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was informed and given information regarding Pneumovax.  By patient report she had never previously had a Pneumovax vaccination. Area was prepared and she was given pneumovax 0.50cc subcutaneous Right are upper outer aspect. patient left with no adverse effects.  patient called 9/6/07 to report the discomfort and swelling of her arm at the injection site. Patient was unable to come in to this clinic to be seen, after calling to report swelling and tenderness. Patient report (she is a RN) is as follows: "Pneumovax injection given posterior/laterally of Right upper arm in Chest clinic 9/4/2007 with noted increasing redness, induration and tenderness around the injection site ofver the next 48 hours. Clinic was called.  Ms Mowbray was unable to come in and was advised that no Allergy physicians would be on hand the next day (Friday, 9/7/7).  Ms Mowbray contacted a physician the following day(72 hours), by which time the redness had spread to and area apporximately 7"x9", with increasing induration and discomfort.  Keflex was ordered and redness began to recede with in 18 hours.  Five days into 10 day course of Keflex, erythamatous area was significantly reduced."
Local reaction on left leg - red, warm, firm 9x7cm. Fatigue.
This spontaneous report as received from a physician refers to a patient of unknown age. It was reported that "three years ago', in 2009 the patient was administered "the first two doses in the GARDASIL (lot # not reported) vaccination schedule". This physician noted the patient would be administered intramuscularly the third dose in the GARDASIL (lot # not reported) vaccination schedule on 26-OCT-2012. No adverse effect reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Injection administered high in left deltoid.  I IMMEDIATELY felt medication being injected into arm with radiation of med up into anterior shoulder. This caused immediate pain. Swelling in deltoid that has continued for 6 days at time of completing this form  Treatment has been OTC pain relief, tylenol, ice to area and rest with little to no improvements in symptoms  Will f/u with primary Md when office reopens monday 2/15
I made a mistake and accidentally administered a dose from a vial that had expired. Pt has reported no adverse reactions or any problems. The vial was opened on  11-09-2021. Aseptic technique was used. The vaccine had been kept in a vaccine-specific medical-grade vaccine refrigerator with DDL, within the required temperature range. The vaccine liquid was clear and was not cloudy at the time of vaccine administration.
December 27, 2022, I had mild COVID-19 symptoms.  I had been battling a sinus infection.  I had fever for a day.
Pt. given HPV and meningococcal vaccine (MENACTRA). Within a minute, (+) syncopal episode, fell of exam table, within 2 min awake and oriented x3, vitals stable, no distress.
Red, itchy, swollen area at injection site 9 days after injection.  No initial reaction to shot.
As of disease investigation date of 8/3/21 case reported onset of symptoms on 7/30/21 which included Fever, subjective fever, chills, muscle aches, runny nose, sore throat, fatigue, cough and nausea
Information has been received from a physician concerning a 3 year old male who in October 2007, was vaccinated IM with a 0.5 ml dose of VAQTA (no lot number provided). Suspect vaccination at that time included a dose of influenza virus vaccine (unspecified) ("Flu shot"). Subsequently the patient developed injection site swelling and redness. The patient sought unspecified medical attention and was noted to be "improved." There was no product quality complaint. Additional information has been requested.
Within 2 hours, high fever, brown spot size of nickel at injection site, ache all over, stopped eating and drinking. 3 Advil for 3 hours for unrelieved pain. 2 weeks - abdominal pain and nausea. One week - chest pain and right shoulder pain.
This spontaneous report was received from a health professional refers to unspecified number of patient of unknown demographics. The health professional reported that all these unspecified patients were administered 13 improperly stored doses of GARDASIL (Lot # K005881, expiry date: 14-JAN-2017) on the following dates: 1 dose on 17-FEB-2015, 1 dose on 18-FEB-2015, 1 dose on 24-FEB-2015, 4 doses on 25-FEB-2015, 1 dose on 26-FEB-2015, 2 doses on 02-MAR-2015, 1 dose on 03-MAR-2015, 1 dose on 04-MAR-2015 and 1 dose on 11-MAR-2015. No adverse effects were reported. Outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. This is one of several reports from the same reporter (MARRS # 1503USA011669). Additional information has been requested.
Injection site red, tender, swollen arthralgia left arm. F/U visit 01/11/2006 pt C/O tenderness, slight redness.
Fever; chills; body aches; Date of start of drug: 11Jan2021/ 12Dec2020; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, expiration date unknown), intramuscular on the left arm 11Jan2021 at 08:00 at a single dose and the first dose (lot number: Eh9899) via intramuscular on the left arm on 12Dec2020 at 08:00 at a single dose for COVID-19 immunization. Medical history included Known allergies to Latex and 1000 island dressing. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 12Dec2020 for COVID-19 immunization and with which the patient experienced fever, chills and body aches. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient has no COVID prior vaccination and no COVID testing post vaccination. The patient experienced fever, chills, and body aches on 11Jan2021 at 20:00, 12 hours post vaccine. The events were resolving.
Same day of vaccination, pt describes feeling lightheaded and falling to the floor several hours after returning home. Did not lose consciousness. Pt rose and made it to the bed where he was diaphoretic and nauseous. Pt began vomiting and proceeded to vomit repeatedly. 911 was called and pt was transported to local ED where he was given fluids and promethazine and sent home same day.
14 hrs following vax, pt awakened crying, febrile t102.5, recurrent tonic episodes x 9 occurring w/in 10-15mins period; no color change; remained alert; dec activity & appetite following day;
very itchy; rashes broke out in his torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (very itchy) and RASH (rashes broke out in his torso) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M120A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 PRURITIC (very itchy) and RASH (rashes broke out in his torso). At the time of the report, RASH PRURITIC (very itchy) and RASH (rashes broke out in his torso) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No relevant concomitant medications were provided. Treatment activities for event was done with  antihistamine shot, cream to help with itching.
Injection site redness; Cellulitis at the injection site; A spontaneous report was received from a pharmacist, concerning a 70-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced cellulitis at the injection site and injection site redness.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced redness at the injection site.  On 05 Jan 2021, twelve days after vaccination, the patient experienced cellulitis at the injection site and had to consult at an urgent care. Treatment for the event included amoxicillin/clavulanante.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, cellulitis at the injection site and injection site redness, was unknown.; Reporter's Comments: This case concerns a 70 year-old, female patient, who experienced events of cellulitis at the injection site and injection site redness. The event of cellulitis occurred 14 days after the first and last dose of mRNA-1273 vaccine administration. The event of injection site redness occurred after the first dose of vaccine on an unknown date. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (dose unknown, lot # L013192, expiration date 19-JAN-2017, lot # M004508, expiration date 29-JUN-2017) orally. The vaccines had been exposed under temperature 1.05 degree centigrade for 49 hours, but did not undergo previous excursion. Data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 4 year old male patient with no drug reaction/allergies and no other pertinent medical history. On 29-JUL-2013 the patient was vaccinated with a dose of M-M-R II lot # H015829, expiring 24-AUG-2014, 0.5 ml, subcutaneous. Other suspect therapies administered on the same sate included VARIVAX (Merck) lot # H016911, expiring 10-SEP-2014 (dose and route not provided). Concomitant therapies administered on the same date included KINRIX. On 02-AUG-2013, the patient developed hives noted as red splotches all over his body some that looked like half moons. The patient's mother called physician's office on 05-AUG-2013 for medical attention. The physician instructed the patient's mother to give the patient BENADRYL as needed. No lab diagnostic tests were performed. The outcome of the event was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of dyspnea (labored breathing) and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dyspnea (labored breathing) and nausea. At the time of the report, dyspnea (labored breathing) and nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported. Reporter did not allow further contact.
Patient given vaccine, mother nursed after administration about 5 minutes after admin. mom notice rash on leg. Mom came out of exam room and got nurse. Nurse removed bandaids of both legs. Provider made aware. BENADRYL dose given. Pt stayed in office for observation for 45 minutes single urticarial lesion measuring 2x4cm.
Barely can lift arm up, shoulder swollen.  Taking Aleve, using cold/warm packs.
12-11-09 evening fussy & sleepy, not eating. 12-12-09 tired, fever 102-103-104 with TYLENOL. 12-13-09 crying, irritated, fever 105-took to emergency room, then admitted.
was painful for a week; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments:  This case was received from patient cousin via interactive digital media. The patient received 1st vaccine which was painful for a week. The follow-up would not possible as no contact details were available.
The parent related a high temperature (never taken) headache, chilling and then sweating. Treatment of bath and Tylenol. This was reported by Dad.
Itchy rash on trunk, underarms, groin and at and around injection site. Symptoms began 8 days after first vaccine dose.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 65-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced fatigue and injection site pain. On an unknown date, the outcome of the fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fatigue and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient had soreness at the injection site less than a year after receiving SHINGRIX vaccine. The fatigue peaked about 3 days after the vaccination. The both events were for several days. This case was linked with case US2018182833, reported by same reporter and having same patient.