chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever and diarrhea, dehydration. 8/5/08-records received-presented to ED on 7/31/08- with C/O vomiting and diarrhea which began day before. Low grade fever. Decreased oral intake. Impression:immunization reaction. 8/1/08-presented to ED with C/O fever times three days, vomitting diarrhea. Impression: Fever. 8/2/08-presented to ED with C/O fever, vomiting and diarrhea, decreased urine output and oral intake. Crying. Impression: Acute fever. Admitted.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.  Reporter reported that the vaccines were stored in freezer and they take out one to two vials and place in fridge each day as needed.
Woke up  with body feeling stiff on 10/13/21 with pain in left hip and back.  Legs feel weak and stiff, especially at night. Gradually felt better but never fully recovered.
Patient reported she had fever and chills all night after the vaccine. She took some TYLENOL. She did not record the fever, but the TYLENOL helped.
I got vaccine back in February 19 2021. I took OTC Tylenol the following day at around 7pm due to the pain I was having. I found out I was pregnant in March 2021. I had a miscarriage on 04-16-2021. I currently am pregnant again and I found out on Father's Day 06-20-2021. I am currently 14 weeks pregnant as of today. My EDD is 02-22-2022.
Her arm is sore and swollen and a little hot; Her arm is sore and swollen and a little hot; Her arm is sore and swollen and a little hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Her arm is sore and swollen and a little hot), VACCINATION SITE PAIN (Her arm is sore and swollen and a little hot) and VACCINATION SITE SWELLING (Her arm is sore and swollen and a little hot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Her arm is sore and swollen and a little hot), VACCINATION SITE PAIN (Her arm is sore and swollen and a little hot) and VACCINATION SITE SWELLING (Her arm is sore and swollen and a little hot). At the time of the report, VACCINATION SITE WARMTH (Her arm is sore and swollen and a little hot), VACCINATION SITE PAIN (Her arm is sore and swollen and a little hot) and VACCINATION SITE SWELLING (Her arm is sore and swollen and a little hot) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  Treatment medication was not provided by the reporter.
This spontaneous report as received from a pharmacist refers to a 68 year old female patient. This patient had no allergies. On 25-JAN-2013 the patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot # h020000, expiry date 02-FEB-2014). Whether the patient had any concomitant medications was unspecified. She returned to the pharmacist on 28-JAN-2013 concerning a reddened area around the injection site, about the size of a palm which was hot and raised. This patient had been using a topical hydrocortisone cream, with no relief. The patient had not yet seen her doctor. The outcome was unknown. Pharmacist requested a lot check of ZOSTAVAX (lot # h020000, expiry date 02-FEB-2014). The pharmacist also reported another patient who received ZOSTAVAX and develop similar injection site reactions. Additional information is not expected.
Within 10 hours had achy joints, diarrhea & foggyness.  Within 15hrs shot area had a rash and I had a fever of 101°.   Fever continued for 2 days and itchy rash persisted.  3rd day I got cancer sores in my mouth and my throat. Rash still itched but fever was gone.  Called Doctor on morning of Day 2 and was told to take Benadryl,  Tylenol and Pepsid. 3rd day began taking Zyrtec instead of Benadryl.  Called Doctor on day 3 & was told it was OK to began taking Acyclovir for the beginning of a fever blister.  4th day still home from work. Sores in mouth throat is red and generally still feel ill.
Information has been received from a health professional concerning a 4 year old black female pt with no pre-existing medical conditions, who on 03/21/2001 was vaccinated SQ in the RA with 1st dose of varicella virus vaccine, live. On 06/11/2004, the pt developed  a case of chickenpox. It was not reported if medical attention was sought. There were no lab or diagnostic tests performed. The pt recovered. No additonal information is expected.
The next morning I woke up with an expected sore left arm and feeling under the weather. What I didn't expect was a noticeable lump under my left armpit, swelling that carried down my left side, stopping at the lower bra line and my left breast became red and twice the size of my right breast. It was very uncomfortable.
Went to beach the weekend after and noticed that I was more sensitive to sun. Right foot actually had 1st ever sunburn (I'm meticulous about sunscreen).
Pfizer 8/23 and 9/15. Positive on 1/2/22.
Throat swelled, became hard to swallow within 15 min of injection. Was home when event started and took 50 mg of Benadryl and continued for 36 hours. I contacted friend nurse that advised me to take Benadryl.
Headache, Fever, Diarrhea, FATIGUE, LIGHTHEADEDNESS Narrative:
red blotchy rash; itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red blotchy rash) and PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 ERYTHEMATOUS (red blotchy rash) and PRURITUS (itching). At the time of the report, RASH ERYTHEMATOUS (red blotchy rash) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Ten days after the vaccine, I was in my yard working, I started feeling my heart beating irregularly. I am a nurse, I listened to my heart with a stethoscope and I could hear it. I waited to Monday to see my PCP. By then it was back to normal. This lasted about 3 days. I went to a cardiologist and wore a heart monitor, stress test, echocardiogram. It came back with atrial tachycardia.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Pharmacist).  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27Jun2022 to 01Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Information has been received from a physician concerning a 24 year old female who on 19-MAR-2010 was vaccinated intramuscularly into the right arm with a first 0.5 ml dose of GARDASIL (lot # not reported). There was no concomitant medication, it was reported that the patient received her first dose of GARDASIL on her right arm and was fine until on 15-JUL-2010 she reported that now her left leg was tingly and had some soreness in her left arm. The patient sought unspecified medical attention. No lab test performed. As of 15-JUL-2010 the patient had not recovered, the patient decided not to receive other doses. Additional information has been requested.
Injection 2:  day one:  slight fever, chills,  extreme muscle pain in both arms, legs and feet, headache, chest pain. First day.  Injection 1:  day one thru day three.  Same as injection one.  Headache was severe all three days.
Blurred vision; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurred vision). At the time of the report, VISION BLURRED (Blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.   Reporter did not allow further contact
Patient came in and was administered half of the Moderna dose and a full dose of the Fluad vaccine.
A report was received from a health professional on 07Nov01, concerning a 32 year old female pt, who was administered the Fluvirin vaccine on 06Nov01 whilst 7 weeks pregnant. The pt experienced nausea and dizziness in the evening on 06Nov01. The pt had a pregnancy test 2 weeks previously which tested positive. Per the pt, her obstetrician said she was 7 weeks pregnant. The pt experienced nausea and dizziness in the evening of 06Nov01. At the time of the report the pt had recovered. There was insufficient information to determine the reporter's causality assessment.
Patient give first dose of Pfizer COVID 19 vaccine 12/21/21 @ 1020. Around 1025, patient started having a seizure lasting 15 seconds. Ten minutes later patient appeared to have an additional seizure, lasting approximately one minute.  Patient was back to his baseline within 5 minutes. Patient admitted for AMS, encephalopathy and focal seizures. Patient has been given anticonvulsants since admission. Seizures were similar to the ones he was experiencing during this admission. Neurologist notified and increased dose of Keppra and ordered extra 500mg dose x1. No further adverse reactions noted.
16 Weeks Pregnant Given Heplisav-B; Initial Report Received on 08-Dec-2021   A licensed practical nurse reported that a 30 year-old female patient (race, and ethnicity unknown) who was 16-weeks pregnant received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No medical history was reported. The patient had allergies to amoxicillin (mild rash).   No concomitant medications were reported.   On 07-Dec-2021, the patient received the one dose of HEPLISAV-B (Lot # 935848, expiration date 02 Dec-2022, and NDC # 43528-003-01) in the right deltoid.  No adverse events associated with this event were reported. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
The evening of 11AUG97 pt started w/cough which worsened;@ ER pt found to be wheezing given albuterol nebulizer x3 & prelone;sent home on amox, albuterol;CXR nl;f/u 14AUG w/persistent wheezing, no tachypnea , no evidence of infect;
Joint pain in arms and back,  increased pulse, (120-135) slight fever 100.4 - my temperature is usually around 97, the next morning temperature was 94.4.  cough.  These symptoms lasted, off and on for about a week.  I had fever once.   Feeling limp as a rag.  No energy.
No additional AE reported; An expired MMR II was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided.  On 25-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot # T013727, expiration date: 21-APR-2022; strength and route were not reported) 0.5 mL for prophylaxis (expired product administered). The vaccine did not have a temperature excursion. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Information has been received concerning  a pt who on 04/28/00 was vaccinated with his first dose of varicella vaccine. It was noted that the pt's mother felt that the pt moved and did not receive the full amount of varicella vaccine. the pt sought unspecified medical attention and on 06/16/00 a titer was done resulting in negative immunity.
Nasal Swab; (17Dec2022) Positive; covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EL0140), on 19Jan2021 as dose 2, single (Lot number: EL3247) and on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. ThThe following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "unknown" and all described as "covid test result=Positive"; DISEASE RECURRENCE (medically significant) with onset 17Dec2022, outcome "unknown", described as "Nasal Swab; (17Dec2022) Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Nasal Swab; (17Dec2022) Positive, notes: Nasal Swab. Additional information: Facility type vaccine: Hospital. No other vaccine in four weeks. None medications in two weeks. No covid prior vaccination. No Known allergies. No Other medical history.; Sender's Comments: The reported COVID-19 positive twice after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202300047540 same patient, different vaccine dose/event;
Information has been received from a physician concerning a 66 year old male with glaucoma, hypertension and dyslipidaemia who on 31-OCT-2007 was vaccinated with 0.65 ml of zoster vaccine live (Oka/Merck) (Lot# 658602/1080U). Concomitant vaccine therapy that same day included influenza virus vaccine (unspecified)(manufacturer unknown). The physician reports that the patient had no prior history of shingles, and on 06-NOV-2007 the patient developed zoster. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Follow up information was received from a physician through the Merck VZV identification program M-15786098391, who reported that on 31-OCT-2007 the patient was vaccinated with 0.5 ml (previously reported 0.65ml) of zoster vaccine live (Oka/Merck) (Lot# 658602/1080U) into the right arm, also reported as "Zoster right hip". On 10 NOV 2007 (previously reported as 06 NOV 2007) the patient developed a rash with 8-10 lesions distributed on the right upper extremities, which was diagnosed as herpes zoster. The patient had no recent exposure to chickenpox or shingles. Concomitant medication included HCTZ, and FAMVIR 500 mg TID "2 weeks". At the time of reporting it was unknown if the patient recovered. Additional information is not expected.
Quoting pediatrician: "blowout diarrhea starting right after the shot, stool was green and malodorous." Caused a rash on buttocks.  Temperature of 102 degrees in the evening after receiving the vaccines low grade fever ever since."
I began feeling feverish about 12 hours after the vaccination.  Fever went above 101 deg, at times for about 24 hours.  I took one 650 mg Acetaminophen at 0330 the following morning to reduce the fever and continued taking this at 6 hour intervals until 1/22 (today).  Also I had a headache, sore muscles and symptoms similar to the flu during this entire period.  During the first night just before taking the Acetaminophen my pulse was up to 104 bpm.  It went down during the following day to about 84 and is now at 72 bpm (9am/Jan22); my normal pulse is usually between 58 and 64 bpm.
p/vax pt devel skin lesions, a fever of 101.5 & was lethargic;majority of lesions were directly under the rt arm about the size of a dollar approx 24 lesions;also lesions on rt chest, back & neck approx 30 lesions total;
Pt c/o rhinorrhea, cold, fever, chills, fatigue, ha with photophobia, dizziness, within 24 hours after FLUMIST on 10/17/2009. He described dizziness as a spinning sensation inside his head. He took NYQUIL and slept. On 10/21/2009 he c/o fever, ha, cough, malaise, fatigue, weakness, weight loss x 4 days with n/v and vertigo. He collapsed boarding ship "shaking all over" with "tonic-clonic" movement x 5 min unresponsive to sternal rub or verbal commands. No bowel or bladder incontinence or tongue biting. EMS documents 2 more episodes lasting total 1 min enroute to hospital. During his hospital admission x 5 days, his temperature ranged 99.3-102.5 F, pulse 62 RRR, 139/81, resp 16, SpO2 100% room air. Orthostatic vitals normal pulse (80's) and blood pressures with complaint of dizziness (130/80 supine, 142/85 sitting). His diagnoses included syncope with seizure-like activity, flu-like illness and vertigo. He continued to experience persistent dizziness over next 1-2 weeks being followed by neurology, cardiology and his PCP. Antivert was stopped 11/9/2009. His next syncopal like episode was mid Aug 2010 with ships inspection while standing and de-rigging an A-ladder. He c/o lightheadedness, vertigo and vision changes x 4 min with loc and "convulsing" w/o loss bowel/bladder. LP was negative and d/c with headache and dizziness on Antivert. Follow up evaluations by neurology, cardiology and primary healthcare provider document normal EEG (9/14/2010), EKG (9/14/2010 NSR rate 66 bpm), and echo (9/10/2010). Neurology evaluations (9/1/2010) suggested diagnosis as probable vaso-vagal, convulsive syncope. Cardiology commented pre-syncope with above events were not characteristic for cardiac etiology based on test findings; but was more suggestive of a vasovagal event. It was recommended he increase his fluid and salt intake.
Patient received the flu vaccine and his arm wasn't sore, a few days later it became sore and his upper arm is now still sore in the muscle.  He still has complete range of motion and the pain is reduced if he takes Tylenol.
Area around DTP 6cm X 7cm rash w/ hyperthermia elevated fever 101 27AUG90, by 28AUG90 warm soaks, upper arm erythema - cold compress gone by 29AUG90; Cough with clear nasal drainage fever 103.5by 28AUG90. 29AUG90 a febrile cough decreased.
Patient was given ADACEL first without incident pt was then given GARDASIL vaccine and immediately lost consciousness for 2-3 minutes, followed by a 15-20 min duration of pallor, nausea, light headedness. Had pt rest, cool compress to head, given juice and crackers.
She also had a rash with the previous dose she receive which was the bivalent.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "She also had a rash with the previous dose she receive which was the bivalent.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old male patient 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 an unspecified date as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient had no known allergies to food, medications and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue and headache was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a Licensed Practical Nurse via a company representative refers to a female patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, expiry not reported), intramuscularly. No concomitant medications were reported. On an unknown date, the patient experienced syncope and her eyes rolled back into her head when GARDASIL was administered. The outcome of the events were reported as recovered. Additional information has been requested.
Severe hives to back of neck, between breast, inside the bend of arms, middle of lower back