chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FELT LIKE BRUISED ON INJECTION SITE; FEVER; 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. 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 03-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On 04-AUG-2021, the subject experienced felt like bruised on injection site. On 04-AUG-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and felt like bruised on injection site. This report was non-serious.
Chief Complaint:    Comfort care    History of Present Illness: Patient is a 69 Y male, history of metastatic cancer:, Inguinal hernia, hypertension, failure to thrive.  Presented with severe testicular swelling for several days now with necrotic black discoloration, severe pain which not improving with oxycodone.  Patient has history of incarcerated left inguinal hernia in the colon cancer seen multiple times by surgery team who recommend   palliative care , as patient is nonsurgical  in the ED found to have sign of severe sepsis with lactic acidosis very elevated white cell count, lactic acid.  Patient was seen by surgery after discussion with the family not surgical candidate plan for comfort care.  Discussed with the family wife at the bedside who understand and agree to initiate comfort care. ,  Understanding possible eminent death with severe sepsis lactic acidosis
Information has been received from a physician concerning a female who in August 2007 was vaccinated with a dose of Zostavax (Oka/Merck).  The physician reported that on 27-AUG-2007, the patient developed a varicella rash on both feet.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  No further information is available.
Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hours I began to notice itching. My back, neck, legs, arms. Begins once my zyrtec wears off around 7:30 pm I always take and antihistamine to keep my nose clear for better sleep. All nighttime meds are take at 8- 8:30 pm. Must take ativan to control anxiety and help get to sleep
Arrived at facility to receive vaccine. Was wearing a 3/4 sleeve shirt and expected to remove arm from sleeve, but was told was unnecessary and only lowered neckline.  Remember thinking "wow, that is really high and really far back" when received the shot. Minor arm/shoulder ache and weakness immediately after injection. Persisted and worsened as time went on. Sought a doctor visit after pain, weakness, and numbness in fingers became disruptive to sleep, workplace concentration, and minor tasks.  Had trouble figuring out what event caused the injury and inquired about whether it could have been vaccine related, considering the timing of onset of symptoms. Medical provider said it was possible, but treatment (anti-inflammatory, muscle relaxant, and physical therapy) would not change, and said adverse reactions should be reported here.
The pt started drooling; not walking firmly; stopped talking and participating in activity. These were the first signs seen shortly after immunized. Dx'd with developmental Delay and  Motor Apraxia. He went through a lot of therapy. Pt improved somewhat. Authorization forms included for neede immunizations information.
headache,nausea. presents to the ED for HA, nausea, myalgias after 2nd COVID vaccine yesterday, today pt noted midsternal chest discomfort and pain below her left scalpula.  65 yo f c/o multiple sx's approx 24hrs s/p administration of 2nd covid19 vaccine yesterday at approx 1000 (02MAR); Pt specifies ongoing chills sensation w/ongoing ha w/nausea w/o vomiting/visual changes starting last night, additional intermittent hypogastric abd pain sensation w/o radiation and cp centered on L side w/o radiation, last episode approx 5hrs pta w/spontaneous resolution; Pt denies any sob, dyspnea, rashes, urinary sx's, vaginal bleeding/discharge
She had redness at the injection site, which progressed into a rash area the next day. The injection site had a large red welt at the injection site that was firm, hard and warm to the touch and she complained of itching along with pain. Her primary care physician recommended BENADRYL and TYLENOL to treat the symptoms she was experiencing. It is resolving, but has not fully resolved as of 4 days from the onset of the adverse event.
This spontaneous report was received from an other health professional (who was also an administrator), via a company representative, and refers to a 12 year old male patient. Information regarding medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, lot number and expiration date were not provided), intramuscular. Concomitant medications were not reported. On an unknown date the patient developed hives on his arm and torso, as well as redness, tenderness and swelling at the injection site. The patient received BENADRYL as treatment for the adverse events. There were not laboratory studies performed. At the time of reporting, the patient had recovered from all the events (date unspecified). It was reported that the patient did not seek medical attention. No product quality complaint was reported. Additional information is not expected, as there was no consent to contact the physician.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number M041768 with an expiration date of 25-JUN-2018 and lot number N004946 with an expiration date of 05-OCT-2018 orally for prophylaxis (dose was not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1709USA011980: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
STORAGE IN REFRIGERATOR (2°C -8°C ) UP TO 30 DAYS. ( VACCINE USED AFTER 10-16-2021)
No adverse event; 5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  Pharmacist stated that perhaps 5 doses of the bivalent vaccine which was expired on 06-Jun-2023 were administered.  Vial size was reported as 2.5ML.  Date the vial was initially stored in the refrigerator was 06/07/2023.  Dates of administration of vaccine was reported as 1 dose on 06/07/2023 and 4 doses on 06/08/2023.   The vial had not undergone any temperature excursions.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729018, US-MODERNATX, INC.-MOD-2023-729029, US-MODERNATX, INC.-MOD-2023-729022, US-MODERNATX, INC.-MOD-2023-729027 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2023: Follow up received is significant. Report type is getting upgraded from invalid to spontaneous. Dose start date was updated, Event start date was updated and Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729018:dose 2 of 5 US-MODERNATX, INC.-MOD-2023-729029:dose 5 of 5 US-MODERNATX, INC.-MOD-2023-729022:dose 3 of 5 US-MODERNATX, INC.-MOD-2023-729027:dose 4 of 5
Information has been received from a physician concerning a female who on 01-FEB-2007 was vaccinated with an oral dose of Rotateq. On 15-FEB-2007 the patient experienced vomiting. The vomiting lasted for four days. It was not specified if the patient had recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
aneurysm; vomiting; greater than 35 days between doses of Moderna Covid-19 vaccine.; headache; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (aneurysm) and VOMITING (vomiting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0258218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 13-Mar-2021, the patient experienced VOMITING (vomiting) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced ANEURYSM (aneurysm) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and PRODUCT DOSE OMISSION ISSUE (greater than 35 days between doses of Moderna Covid-19 vaccine.). The patient was hospitalized for 14 days due to ANEURYSM and VOMITING. The patient was treated with Surgery for Aneurysm. At the time of the report, ANEURYSM (aneurysm), VOMITING (vomiting), PRODUCT DOSE OMISSION ISSUE (greater than 35 days between doses of Moderna Covid-19 vaccine.) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  Patient received his first Moderna Covid-19 vaccine on 03 MAR 2021, the patient reports having a headache. On 13 MAR 2021, the patient experienced vomiting and went to the hospital. The patient was found to have an aneurysm and was admitted to the hospital for surgery. The patient was discharged from the hospital 2 weeks later.  This case concerns a 65 year old male who was hospitalized due to Aneurysm with unknown days after receiving 1st dose of the vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: This case concerns a 65 year old male who was hospitalized due to Aneurysm with unknown days after receiving 1st dose of the vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested.
Felt a little unwell the next day following the booster; like hives; broken out like a rash all over the body, face, hands, legs; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt a little unwell the next day following the booster), URTICARIA (like hives) and RASH (broken out like a rash all over the body, face, hands, legs) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt a little unwell the next day following the booster), URTICARIA (like hives) and RASH (broken out like a rash all over the body, face, hands, legs). At the time of the report, VACCINATION COMPLICATION (Felt a little unwell the next day following the booster) outcome was unknown and URTICARIA (like hives) and RASH (broken out like a rash all over the body, face, hands, legs) had not resolved.            No concomitant medication were reported. Treatment reports were Benadryl and steroids Reporter states that patient Ended up on ER on Sunday night because it was moving to the throat.
Left side of her face was red and swollen.; She woke up in the morning and found little swelling on left side of body.; Left side of her face was red and swollen.; About 2 minutes later, her lips got tingling; her lips got tingling and they were swollen for about an hour.; 10 hours later, she had 2 big sneezes; She couldn't breathe through her nose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose) and SWELLING FACE (Left side of her face was red and swollen.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose) and ERYTHEMA (Left side of her face was red and swollen.). On an unknown date, the patient experienced SWELLING FACE (Left side of her face was red and swollen.) and SWELLING (She woke up in the morning and found little swelling on left side of body.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (About 2 minutes later, her lips got tingling), LIP SWELLING (her lips got tingling and they were swollen for about an hour.), SNEEZING (10 hours later, she had 2 big sneezes), DYSPNOEA (She couldn't breathe through her nose), SWELLING FACE (Left side of her face was red and swollen.), ERYTHEMA (Left side of her face was red and swollen.) and SWELLING (She woke up in the morning and found little swelling on left side of body.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19  immunization. No medical history reported. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient administered expired product (doses administered past the published expiry date). On Oct 26, 2021, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. It was stated the vial was removed from freezer at 8 am, Oct 26, 2021. This case linked to MOD-2021-364617 (patient link).
The undiluted pediatric vaccine vial was used to draw 0.3 ml.  No adverse event for the patient.
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 16Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 31Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obstructive sleep apnea" (unspecified if ongoing); "MALT lymphoma", start date: 2009 (unspecified if ongoing), notes: MALT lymphoma; "known allergies Sulfa" (unspecified if ongoing), notes: known allergies Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The contributory role of the suspect product, BNT162B2 vaccine to the reported vaccination failure, Covid-19 cannot be excluded as the efficacy of a vaccine varies individually and may be affected by various patient-related and vaccine-related factors.
I developed shingles on my lower back and right leg; had pain in my right leg from my hip to my ankle. It lasted a few weeks. I was prescribed and took an antiviral which stopped the symptoms from getting worse.
Headache for the entire day; Malaise; Fatigue; Body aches; Vivid dreams (fever); Vivid dreams (fever); This is a spontaneous report from a contactable nurse. This 41-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Ej1685), via unspecified route at left arm on 17Dec2020 07:30 PM at single dose for COVID-19 immunization. Medical history included Insomnia and obesity. No known allergies. No other vaccine in four weeks. Concomitant medications included zolpidem tartrate (AMBIEN), acetaminophen, acetylsalicylic acid (ASPIRIN) and diphenhydramine. On 08Jan2021, patient experienced headache for the entire day, malaise and fatigue, body aches and vivid dreams (fever), all with outcome of recovered in Jan2021. No treatment was received. No COVID prior vaccination. No COVID tested post vaccination.
This spontaneous report was received from a pharmacist concerning a 73 year old male patient with high blood pressure and no drug reactions or allergies. On 08-NOV-2013, the patient was vaccinated with a dose of ZOSTAV AX (Lot # J007301; expiration date 20-SEP-2014) (dose and route not reported). The pharmacist reported that a patient who received ZOSTAVAX developed a weeping rash. On 16-NOV-2013, the patient started taking "Valcyclovir" as treatment. The outcome of the patient was unknown. Additional information has been requested.
Heart palpitations started about 10 am, I wear a fitness watch and recorded by bpm at 184 would go down to 180 back up to 184 down to 127 to 135. I didn?t call 911 as I was afraid they would admit me in hospital. I got my flu shot today and the physician said to report this adverse reaction to you. I go back to doctor on Dec 3rd and will give her the printout of my heart rate.
Patient received her first pfizer vaccine on 3/4. She reports being itchy after first shot while in observation. When she went home she developed hive to her back. She called her PCP and he suggested she take some benadryl. The hives resolved but she has continued to have mild generalized itching since then. She reports she was cleared by PCP to receive second shot. She reports itching worsened after second vaccine. She was seen in 1st aid bay and was given Benadryl 25 mg PO. Her symptoms improved slightly. She refused transport to ED for eval with EMS. Husband picked her up. She will take more benadryl at home.
Started with a slight red rash on her forehead.  Noticed small "heat rash" like red marks on her back and chest.  It continually got VERY bad until her entire body had small raised red dots everywhere.  They were not itchy.
VERY painful arm - pain started 5 hours after shot, increased for 24 hours, then decreased over 24 more hours.  Bad for 48 hours total.  Felt like somebody hit it with an iron bar. Could not move it, it would not support weight. Mildly sore for 24 more hours.  No redness or swelling or hardness.  Swollen glands - 48 hours Slightly dizzy at intervals for 48 hours + brain fog for 3 more days Achiness in joints, especially legs
Pt became light headed, shaking, felt funny, heart beating harder, flushed, skin cool, face warm. Assisted back to exam room from lobby, did not want to lie down, sat in chair. Encouraged to relax no signs of difficulty breathing, no complaints of nausea or vomiting, headache, or other adverse reactions. Blood pressures taken, questioned patient about symptoms and past medical history. Pt stated has not had and problems and past medical history. Pt stated has not had any problems with vaccinations in the past but does have positional othostatic hypertension Repeated Blood Pressure 123/87 P 110, standing 16:50. No further complaints voiced repeated blood pressure 137/86, P 96 - no further signs or complaints voiced, flushing decreased, color pink, skin cool & dry. Pt was allowed to leave facility following resolution of symptoms. Prior to injection being given the screening questionair was completed by patient with no adverse reactions reported by patient previously. Pt questioned again by nurse prior to nasal inhalation being administered. Pt was given nasal H1N1 LAIV without ill effects, was prompted on any history of previous illness to medications or foods & didn't answer until prompted after incident occurred. Pt has hx SZ; physician made Diagnosis & then stated to nurses that she did have limited reaction before but didn't know if it was due to any medication but her doctor is new. This RN walked client to ICU and reported episode to brother included VYVANCE 30 mg once daily.