chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Face felt hot.  Area lateral to injection site was pink.  No rash or urticaria. Nausea and a "funny feeling" through anterior neck region.  Described symptoms as similar to those she expeienced when she had a reaction that caused her to be flown to a larger hospital. Initial S/S began about 3pm.  Patient had low grade fever then.  Took tylenol and benadryl 25mg, then another 25mg about a 1/2 hour later.  At approximatley 4:15, patient stated that she felt no better and felt like she did when she ws flown out for an allergic reaction.  Arrangements were made for patient to be seen in attached clinic.  Patient was evaluated by physician and sent to the ER in the attached hospital.  Presnted to the ER at 4:45pm and treated with IV SoluMedrol 125mg and Zantac 300mg.  She was admitted as an Extended ER and treated with singulari 10mg po, benadryl 50mg po every 6 hours and Prednisone 40mg at 8pm. Monitored overnight.  No further complications and a resolution of S/S.  Discharged to home at 9:25am on 10/15/2009.  Patient is to take Prednisone 50mg Daily for 4 days and Benadryl 50mg three times a day for 4 days.  She is to see her PCP in one week.
Information has been received from a consumer concerning her approximately 14 year old grandaughter with no pertinent medical history of drug reactions/allergies, who "about two years ago" in approximately 2006 received the three doses of GARDASIL 0.5 mL.  There was no concomitant medication.  The reporter stated that the patient either a month after receiving her first or third dose, experienced mononucleosis as well as an enlarged spleen.  Caller knew that patient received all three doses of the series, however it was unknown after which one the symptoms occurred.  Patient also experienced fatigue.  Last blood test was "about 6 months ago" in approximately March 2008.  The patient sought unspecified medical attention.  At time of report, the patient had not recovered.  Additional information is not expected.
Fever over 102, body aches, headache, redness and swelling and knotting 10-15 cm in diameter at injection site.
24 hours after influenza and HAVRIX were given in the left thigh, patient developed a warm, red, firm, tender area surrounding this site. It was measured at 7x3 inches max. No fever. Was treated with SEPTRA x 10 days and symptoms resolved in 9-10 days. No fevers.
feeling very ill; in an induced coma; in a complete disorientation; passed away; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (passed away), MALAISE (feeling very ill), COMA (in an induced coma) and DISORIENTATION (in a complete disorientation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling very ill) (seriousness criterion hospitalization), COMA (in an induced coma) (seriousness criterion medically significant) and DISORIENTATION (in a complete disorientation) (seriousness criterion medically significant). The patient died on 27-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MALAISE (feeling very ill), COMA (in an induced coma) and DISORIENTATION (in a complete disorientation) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  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.; Sender's Comments: 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.; Reported Cause(s) of Death: Unknown cause of death
Pt completed his COVID-19 vaccine series, receiving the second vaccine 4 weeks after the first vaccine. Each time the patient received the vaccine, he presented to the emergency department the following day with the following signs and symptoms: AMS, tachycardia, fever (Tmax 104.5), lactic acid 3.8, CRP 1.65, CPK 298, Troponin T 0.107, WBC WNL.
pt was in the store today to pick up her medication and she indicated that when she had her shingrix shot her arm hurt at site of injection and she had chills and didnt feel well for 24 hours. she has no issues presently
The patient stated that on the evening of the day when she received the vaccine she developed a generalized macular, non-pruritic rash. She had no fever or chills. The next day she started experiencing headaches and exertional dyspnea, desaturating into the 80s with minimal exertion. She presented to the ED on December 3 where she was found to have tachycardia and oxygen desaturation with exertion such as standing up (heart rate 140-150, O2 SATS in the 70s).  Patient was admitted for observation. The day following admission her symptoms were markedly improved and she was discharge.
Felt like indigestion and acid reflux but then severe chest pains began across upper chest rib area under breast and down to stomach. Could not lay down so propped up on sofa-movement made it worse-finally read online at 3:00 AM I might have costochondritis associated with flu shots and chest pain. Recommended taking Advil or Aleve anti-inflammatory so took 2 Aleve and severe pains left but still have some tightness in chest, stomach upset, gas and headache. I have allergies to some drugs, latex, rubber, soy, and plants.
Within five minutes of receiving the shot I had tingling in my left hand that spread throughout my entire body. I then had increased heart rate and blood pressure. The reaction lasted approximately 30 minutes and began to subside. Within the next few days the tingling began coming back periodically in different parts of my body. By day for the tingling was consistent throughout both arms and legs. By day seven the tingling had spread to my head and face. Today is two weeks from receiving the shot and the tingling can still be felt although it seems to be less intense.
I will be fully vaccinated in a week and I have never been so sick before in my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I will be fully vaccinated in a week and I have never been so sick before in my life".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vacccine was left at room temperature 24 hours,and was outside of the 12 hrs limit for puncturing; vacccine was left at room temperature 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vacccine was left at room temperature 24 hours,and was outside of the 12 hrs limit for puncturing) and PRODUCT STORAGE ERROR (vacccine was left at room temperature 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2022 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vacccine was left at room temperature 24 hours,and was outside of the 12 hrs limit for puncturing) and PRODUCT STORAGE ERROR (vacccine was left at room temperature 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vacccine was left at room temperature 24 hours,and was outside of the 12 hrs limit for puncturing) and PRODUCT STORAGE ERROR (vacccine was left at room temperature 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was first punctured on 12-FEB-2022 at 11:45 am and was left at room temperature for 24 hours on 13-Feb-2022. The vial was used outside of the 12 hour limit for puncturing. The patient experienced no adverse events from the immunization.  No treatment medications were reported.
Patient passed out shortly after given vaccine.  Immediately regained conscious but felt nauseous and sweaty.  Monitored the patient for thirty minutes and gave a cool compress.  After the 30 minutes he felt well enough to leave the pharmacy.  After two hour patient had eaten and felt completely fine.
feels very bad; feels like the head was going to explode; feels very warm; fever; chills; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels very bad), HEAD DISCOMFORT (feels like the head was going to explode), FEELING HOT (feels very warm), PYREXIA (fever) and CHILLS (chills) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced FEELING ABNORMAL (feels very bad), HEAD DISCOMFORT (feels like the head was going to explode), FEELING HOT (feels very warm), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain in the left arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (feels very bad), HEAD DISCOMFORT (feels like the head was going to explode), FEELING HOT (feels very warm), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain in the left arm) had not resolved.            No concomitant medications were reported.
This was  my second booster. It caused an off-target inflammation that triggered my Menieres Disease. My Menieres has been under control with my current medications for almost 2 years.  A couple of days  after the booster I started getting very load tinnitus in my left ear (my Menieres ear). This was followed by weekly Menieres attacks so serious that I had to stay home and just dose both Ativan and Promethazine to stabilize. I'm starting to stabilize now and the tinnitus is better, although still not completely gone.
Right thigh is edematous and hard 2 1/2" X 2" reaction with red streaks running down leg. Treated with cool compresses and Augmentin.
After about 48 hours my Tinitus has a significant increased in intensity and moved to a higher pitch.  My Tinitus is in the left ear and the ear feels hollow along with the increase in sound.
No additional adverse effect reported; MMR-II that underwent temperature excursions was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.      On 03-SEP-2021 the patient was vaccinated with a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-RVAXPRO) however reporter was unsure about which lot number administered to patient (Lot T000890 with expiration date reported 08-JAN-2022 and Lot T010650 with expiration date reported 26-MAR-2022 (dose, strength, frequency, route of administration and anatomical location were not provided) for prophylaxis, which was improperly stored (product storage error).  The temperature of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RVAXPRO) was stored had been above was 46F (49.6F) for 2 hours 21 minutes for lot T000890 and was 46F (56.1F) for 3 hours 33 minutes for Lot T010650. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000049: US-009507513-2112USA000050: US-009507513-2112USA000051:
ran fever for 4 days of 103 to 105; It was reported to MD; MD did not see pt on 3JUN94 MD ordered no more DTP;
At 10:45 5 minutes after receiving vaccine patient complained of itching at the left upper arm rash and redness noted.
Nausea and weakness days before menstrual cycle begins since first dose on 5/14/08. Seizure on 07/07/09. Has never had a seizure before. Is not on any prescribed or over-the-counter medications. Has never had any health problems, surgeries or head trauma.  8/4/09 Medical records received DOS 7/8/09 to 7/15/09 Assessment: Grand Mal Seizure. Seen at community hospital previous night post described seizure. Parent reports child made 'gurggle noises' then folded arms and was jerking. Stiff and not responsive. Patient presents with residual headache.  Neuro consult 7/15/09 in f/u to seizure event.  Pt had reported some shakiness to legs prior to event, possible partial seizures. No memory of event.  DX:  Grand Mal seizure.  8/12/09 ER Records recieved DOS 7/7/09. Assessment: Seizure disorder, first onset seizure. After visit to dentist patient was observed to have a sudden onset of seizure-like activity. Making an abnormal noise and 'twitching movements", unresponsive. Transient respiratory distress. Postictal stage in which patient was confused. No incontinence. No recent injury or head trauma. Feels sleepy. Altered mentation. Chest pain.  8/4/09 Medical records received DOS 7/8/09 to 7/15/09 Assessment: Grand Mal Seizure. Seen at community hospital previous night post described seizure. Parent reports child made 'gurggle noises' then folded arms and was jerking. Stiff and not responsive. Patient presents with residual headache. Neuro consult 7/15/09 in f/u to seizure event.  Pt had reported some shakiness to legs prior to event, possible partial seizures. No memory of event.  DX:  Grand Mal seizure. LABS and DIAGNOSTICS: EEG Pending. CT Head and unspecified labs performed at community hospital. PMH: none noted./pc  8/12/09 ER Records recieved DOS 7/7/09. Assessment: Seizure disorder, first onset seizure. After visit to dentist patient was observed to have a sudden onset of seizure-like activity. Making an abnormal noise and 'twitching movements", unresponsive. Transient respiratory distress. Postictal stage in which patient was confused. No incontinence. No recent injury or head trauma. Feels sleepy. Altered mentation. Chest pain.  8/24/09 Neurological consult records received DOS 8/17/09. Patient has no spells, eating, moody, not dizzy, alert. Strenght and gait OK. If no seizures, will wean from meds.
TACHYCARDIA, CHEST PAIN, WHEEZING, BOTH EYES SWOLLEN SHUT, UNCONTROLLABLE SHAKING, TONGUE ITCHING, LIPS SWOLLEN
Shot given on Thursday, itch Friday morning, Saturday redness, inner arm and extend 3 inches past elbow feels like "smirked", lousy shoulder/neck aching, lethargic.
rash Rt temple to neck, facial swelling.  continues to have above sx @ 11/09/09 12:00 PM
Information has been received from a female consumer who was vaccinated with a dose of Varivax. Subsequently, the patient experienced inferility. The patient sought unspecified medical attention. FOLLOW-UP information received from the registered nurse reported that the patient did not have an adverse experience. No further information is expected.
Patient states she has chills, fever on and off for 1 week since the injection. Patient also has upset stomach, nausea and loss of appetite.
Bloody stool after vaccine. Patient started going to bathroom 12 times, now patient is down to three times a day.
Rashes on different parts of my body (neck, wrist, waist, side of knee, buttock, etc.) with accompanying itching. The rash and itch on the neck attracted my attention a day or two after I received the vaccine. Then about 6 days later I noticed itching and rash on other body sites.
I had a migraine 2 days later; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The medical history included diabetes, allergies (unspecified), reflux and high blood pressure. Concomitant medications included ibuprofen (ADVIL), acetylsalicylic acid (BABY ASPIRIN), losartan potassium (LOSARTA), multivitamin (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not 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 7Mar2021, 2 days later at 13:00, the patient experienced migraine. The patient had not received any treatment for migraine. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the migraine was resolved on an unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1st shot:  soreness at the injection site 2nd shot: soreness at the injection site, whole body aches, fatigue, headache, fever, chills, sweating, nausea (all symptoms only lasted one day after shot)
Tachycardia; elevated pulse; High Blood Pressure; Hot flash; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), via an unspecified route of administration, administered in right arm on 25Jan2021 13:45 (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, asthma and hypertension. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination (not reported details of medications). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jan2021 14:30, the patient experienced hot flash in the face within 45 minutes of the shot. On 26Jan2021 02:45, the patient had tachycardia and high blood pressure which started at approximately 13 hours after the shot. High Blood pressure remained for about the next six days, but the elevated pulse has continued. The adverse event resulted patient to doctor or other healthcare professional office/clinic visit. The patient received treatment - increase in blood pressure medication.   Outcome of the event elevated pulse was not recovered and the outcome for other events was recovered with sequel.  Follow-up attempts are completed. No further information was expected.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # J000494 and expiration date 14-APR-2014), 0.65 ml, subcutaneous in the left arm. There was no concomitant medication. The pharmacist reported that the patient experienced an adverse event after receiving ZOSTAVAX. The pharmacist reported the patient's wife also experienced an adverse event (MARRS 1305USA002193). At the time of the report the patient's outcome was unknown. This is one of two reports from the same source. Additional information has been requested.
Developed four red spots on forehead and one on cheek- not raised, noted after giving vaccines. NO distress, exam normal, except for noted above, Baby was given Benadryl. Rash resolved within a few minutes. Observed for 30 minutes awake and no distress or rash before discharged.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories and concomitant therapies were not reported. On unknown dates, the patients received two doses of improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017) (dose and route of administration were not provided). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Severe swelling of face, eyes, arms. ER visit x 2 - given BENADRYL and steroid shot. Reaction was on from Sat - Monday and not much change today - Wed. MD - says not poison ivy or oak - but does not pinpoint reaction to FLUMIST.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 54-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID ACELLULAR + TETANUS TOXOID (TDAP VACCINE) for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), cetirizine hydrochloride (Zyrtec) and hydrochlorothiazide + valsartan (Valsartan-Hctz). On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and TDAP VACCINE. On 25th May 2018, 1 days after receiving SHINGRIX, the patient experienced headache and fatigue. On 29th May 2018, the patient experienced pruritus and rash. On an unknown date, the patient experienced crust. On an unknown date, the outcome of the headache and fatigue were recovered/resolved and the outcome of the pruritus and rash were unchanged and the outcome of the crust was unknown. It was unknown if the reporter considered the headache, fatigue, pruritus, rash and crust to be related to SHINGRIX. Additional information was reported as follows: The patient received Odactra as a concomitant medication. The patient called to inquire if SHINGRIX could cause chicken pox. The patient received two vaccines on the same day, the SHINGRIX vaccine on the right arm (vaccination time 15:00) and the Tdap vaccine on the left arm. The patient experienced headache and fatigue which lasted for about total of three days. She stated that on the fifth day post vaccination on May 29th she broke out in a rash accompanied with itching on her chest, neck, and to the edges of her face. The rash seemed to be crusting over and it was still spreading a little bit. The patient gave permission to contact the healthcare provider and provided contact details for the same.
09/17/2021- Tiredness, fever, nausea, shortness of breath, chest pains 09/22/2021 - Tiredness, fever, nausea, shortness of breath, chest pains
Pain to L arm/shoulder since receiving flu vaccine on 10.23.18. Per pt, she was told by PCP she may have nerve damage.