chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was recently hospitalized for a septic shock secondary to UTI with Klebsiella and myroides bacteremia likely cat scratch and discharged home on ciprofloxacin.  Patient return to the ER on 01/17 for altered mental status and found to be hypoxic.  CT head revealed small area of ischemia and internal capsule could be artifactual.  COVID test was positive. Patient admitted and continued to be obtunded and hypotensive and was intubated and started on with active support.  Patient was admitted to ICU and started on bicarb infusion and broad-spectrum antimicrobials.  On 01/19 patient self extubated and tolerated it well.  Patient was transferred out of ICU on 01/20/2022 and continued to have behavioral issues,  psych was consulted with no intervention,  likely it acute metabolic encephalopathy due to medical conditions.  Patient also developed RVR with AFib and cardiology was consulted and started patient on amio drip and warfarin  and was rate controlled.   Patient had acute drop of hemoglobin and given 1 unit PRBC, due to episodes of black stools GI consulted and warfarin was held.   Patient underwent EGD on 01/23/2022, which did not show any active bleed. Pt discharged on Levaquin for two more days to complete 5 days course. Pt also discharged with seven day course of dexamethasone 1mg and amiodarone 400po bid X7 days followed by 200mg po daily along with warfarin. Psych was on consult, d/ced Zyprexa and Cymbalta, agitation much improved but somnolent. Pt discharged home with HHC in stable condition.
Starting about 72 hours after vaccine, severe pain in the right hip for about 60 minutes. Treatment included rest. Additional symptoms manifested soon after but were typical (fever, exhaustion). Patient also had a flu vaccine on 11/05/2021, one day prior to Covid 19 Pfizer vaccine.
pt recv vax & by afternoon devel inc temp up to 104 orally;had a weird rash, very lethargic;By Wednesday was croupy;saw MD put on ATB;had whooping cough;temp down to 102;finally well by Saturday when temp finally back to nl;
Following morning I woke up with a head ache.   (Scale 1-10)  about 2. ...  Was feeling nauseated (Scale 1-10) 2-3..   also was feeling exhausted as in no energy...  ( Scale 1-10) 3-4
About 5 minutes after administration, the pt passed out, eyes rolled back, and he began shaking briefly.  He revived almost immediately and said that his tongue felt numb and his legs felt weird. He admitted that he was very nervous to get the shot.  EMS was called and he was checked out.  Blood pressure and vitals were normal, he was not admitted or taken to the hospital.
Patient received Pfizer COVID Primary Dose instead of Bivalent booster. Patient will return in 2 months for correct vaccine.
female patient age 54 was given FLUZONE HIGH DOSE with no reported adverse event; female patient inadvertently was administered Fluzone High-Dose Quadrivalent vaccine rather than Fluzone Quadrivalent vaccine with no reported adverse event; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case from other health professional and physician via Agency(under reference 00810932).  This case involves a 54 years old female patient who inadvertently was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age and wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no concomitant vaccines.   On 28-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ690AB and expiration date: 30-Jun-2022) via unknown route in the arm for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (same day latency).  It was reported "Caller states on 28SEP2021, a female patient age 54 was given FLUZONE HIGH DOSE; caller would like to report the incident and obtain information regarding re-vaccination and adverse effects to look out for; caller asked for any efficacy and safety information on Fluzone High-Dose administered to patients younger than 65 years of age, and any comparison information on the Fluzone High-Dose and Fluzone vaccines. Reporter was unsure whether it was administered in the left arm or right arm."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd fluogen vax & became dizzy 2 days p/vax; Pt's BP was not checked; pt has a h/o hypertension;
pt recv vax;devel high pitched cry intermittently;episode of staring which lasted few sec;
This spontaneous report as received from a consumer refers to a 69 years old female patient. The patient's medical history included back pain, 4 back surgeries and pulmonary issues. The patient was vaccinated with ZOSTAVAX on 08-APR-2005. Other suspect therapies included PNEUMOVAX23 at the same time as the ZOSTAVAX. Concomitant medications included NEURONTIN, NASACORT, pravastatin sodium, PULMICORT, albuterol and "Polasec 40 mlgms". On 2010 the patient experienced shingles on her head. In total she experienced four times shingles on her head and in October 2012 she experienced shingles on her left eye. She was treated with VALTREX. The outcome of shingles on her left eye and shingles on her head was unknown. The relatedness for shingles on her left eye and shingles on her head was not provided for PNEUMOVAX23 and ZOSTAVAX. Additional information has been requested.
Sore arm started shortly after injection was  given. Woke up at 4a.m. on the 13th will chills and shivering.  When I got up around 8 a.m. I was nauseous,  had a temperature of 99.7, achy all over and had a headache.  Arm was sore at injection site and could not raise it above 90 degrees without pain.  Felt tired all day.  Checked temperature in the afternoon and it was 99.2.  Slept late on the 14th and felt tired again most of the day.  Slight headache when I woke up but it eventually resolved.  Arm is still sore but can raise my arm.  Took Acetomenaphine in a.m. and p.m. on the 13th.
Fever (102); Nausea; Vomiting; Diarrhea; Fatigue; Loss of appetite; Headache; Localized pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 21Apr2021 at 13:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, COVID-19 and known allergy to cephalosporins. Concomitant medications included paracetamol (TYLENOL), ibuprofen (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and etodolac (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 21:00, the patient experienced fever (102), localized pain at injection site, nausea, vomiting, diarrhea, fatigue, loss of appetite and headache. On 21Apr2021, the body temperature was reported as 102 (unit unspecified). The clinical outcome of the events fever (102), localized pain at injection site, nausea, vomiting, diarrhea, fatigue, loss of appetite and headache was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a female who in approximately 2007 was vaccinated with the second dose of GARDASIL. She was pregnant at the time the vaccination was administered. Her last menstrual period was in approximately March 2007. The patient did have her child who is approximately 17 months old currently. Following the birth, the patient received the third dose of GARDASIL. The patient sought medical attention. Follow-up information was received from the nurse. She reported that the patient's baby was healthy and normal. Follow up information has been received from the registered nurse concerning this 25 year old female who was vaccinated with the 1st, 2nd and 3rd doses of GARDASIL (1st lot #653735/0688F, 2nd lot #655165/1425F and 3rd lot #659441/1446U) on 13-NOV-2006, 19-JAN-2007 and 04-JAN-2008 respectively. Subsequently, the patient was pregnant at the time of vaccination. The patient's last menstrual period (LMP) was 02-JAN-2007. Her estimated date of delivery was 09-OCT-2007. It was noted that the patient had one elective termination, one previous pregnancy and one full term delivery. There were no birth defects and no infant complications in her previous pregnancy. On 08-FEB-2007, a urine beta-human chorionic gonadotropin test was performed because the patient missed her period. The test result was positive. It was reported that the patient took IMITREX 100 mg as needed for the treatment of migraines during her first trimester. On 10-OCT-2007, 40 weeks from her LMP, the patient delivered a normal, healthy, female baby. There were no complications or congenital anomalies. The baby weighed 7 pounds, 1 ounce, her length was 10 1/2 inches and her head circumference was 14 inches. There were no complications during pregnancy or labor and delivery. Additional information is not expected.
no adverse event; Caller is a nurse calling on behalf of a physician to report that a dose of PROQUAD was inadvertently administered to the patient on 28JUN2022.; This spontaneous report was received from a nurse referring to an unknown age and gender patient. Pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 04-SEP-2018, the patient was vaccinated with the first dose of varicella vaccine (manufacturer unknown) and measles (+) mumps (+) rubella vaccine (MMR) (manufacturer unknown). On 29-NOV-2021, the patient received the second dose of varicella vaccine (manufacturer unknown) and measles (+) mumps (+) rubella vaccine (manufacturer unknown). On 28-JUN-2022, the patient was vaccinated with a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection 0.5 mL (lot# U022728, expire date 16-JAN-2023) inadvertently (strength, route of administered \were not reported) for prophylaxis (accidental exposure to product). No additional adverse event was reported (no adverse event).
Pain radiating up and down my right arm, severe headache, diarrhea, joint pain.
Red spot at injection sight, swelling of arm muscle, arm turned red and hot over night, arm very sore to move. Used hot wet compress on sight, took aspirin. Lasted about 4 days.
Developed generalized itching throughout entire body. Administered benedryl 50 mg PO x1 once patient complained of itching (approx 15 min after vaccine administration) with no improvement/worsening of itching. Patient was walked over to ER at hospital for further evaluation and monitoring. Denied all other symptoms. No respiratory distress or symptoms.
Pt stiffened w/dialated pupils last short time according to mom, then became alert & cried; Tken to MD later same day;
Chilkd developed erythematous base with vesicles around the vaccine site. 2 days later 11/2, developed macular rash to trunk. Child was fussy, crying, not sleeping well
Information has been received from a medical assistant concerning a 67 years old female patient. The patient had a history of unspecified reactions to penicillin, codeine, hydrocodone, ceftriaxone and moxifloxacin. The patient had no pertinent medical history. Information about concurrent condition was not reported. On 18-SEP-2018, the patient was in the office and was administered a dose of PNEUMOVAX 23 (lot # N024717, expiration date 06-APR-2019 and intramuscular; strength, dose and frequency were not reported) and a dose of influenza vaccine concomitantly in the left arm for prophylaxis. On the same day, within a few hours of the vaccine administration, the patient experienced swelling, erythema and tenderness at the injection site. On 20-SEP-2018, the patient returned to the office for treatment. Physician treated the patient with cold compresses, unspecified anti-inflammatories, and unspecified antihistamines. No lab diagnostics or studies were performed. The outcome of the events was reported as not recovered. The causality for the event was not reported.
Low grade fever today and has broken out with 30+ chicken pox lesions on trunk and legs mostly.
Vaccination site redness, warmth, pain to arm and axilla. Low grade fever at home.
Lightheaded x 1 week, Fevers 101-101 x 1 week, lack of appetite x 3 days, fatigue x 10days, severe headache, diarrhea
Face flushed, head felt full.  Other than that nothing until we started home.  Upper lip began to itch a little.  A little itching around eyes.  About an hour after, felt tightness in my throat and neck, glands felt swollen.   Became slightly hoarse, had to clear my throat often.  Felt a little like asthma attack.  Have had similar reaction when eating seafood
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 21-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000180:
Patient developed papule at PROQUAD injection site on 12/10/17. Stated same day redness at site and fever both went away next day.
Pt was given vaccine that had exceeded the 45 days allowed in the refrigerator. Pt did not report any symptoms and was notified of the vaccine error
Vasovagal Response. Nausea and brief loss of consciousness. pt recovered after approx. 15 seconds
When signing up to schedule for a vaccine appointment, they have to attest that the person receiving the vaccine is 16 years of age or older.   When the patient arrived to vaccine clinic, the date of birth was overlooked not realizing the patient was only 15 years old; therefore, the patient recieved the 1st dose of the pfizer vaccine.
This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX. On 5th September 2018, less than a day after receiving SHINGRIX, the patient experienced chills, sweating, fever and headache. On an unknown date, the outcome of the chills, sweating, fever and headache were unknown. It was unknown if the reporter considered the chills, sweating, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX the day before reporting day and the night before reporting he had chills and woke up sweating with a fever and headache. The patient was inquiring about how long the events would last.
Headache, Diarrhea, NauseaVomiting, fatigue, sore at injection site Narrative:
Patient had swelling and redness at both injection site. the right leg had 6" by 8.5" reaction with some induration. the left leg had a red and swollen area that was slightly bigger than a half dollar. They were both hot to touch. She was placed on antibiotics.
Severe Rheumatoid Arthritis Flare with only 1st dose.  Reaction on day 3.  joint pain and electricity type shocks felt at joints. (this has never been felt before even before RA was treated.)
Patient reports of "passing out 5 minutes after getting the vaccination; felt tingly; Felt fuzzy; Blotchy skin; Itching all over; A spontaneous report was received from a consumer and concerning a 46-year-old female patient who received Moderna's COVID-19 vaccine and experienced Passing out 5 minutes after getting the vaccination while waiting in the monitor room, felt tingly and fuzzy, itching all over and blotchy skin.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Mar 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.   On 22 Mar 2021, after first dose of vaccine, the patient experienced Passing out 5 minutes after getting the vaccination while waiting in the monitor room, felt tingly and fuzzy was hospitalized for 3-4 fours. The event passed out was medically significant. Treatment for the events itching all over, blotchy skin included Claritin or Benadryl. No lab details were provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, Passing out 5 minutes after getting the vaccination while waiting in the monitor room, felt tingly and fuzzy, itching all over and blotchy skin were unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded
Had vaccine administered at about 0630 on 10/15/15. At around 1230 began to feel dizzy, with chills. Left work and took 600 mg Ibuprofen at home for temp 99.4. At 1500 noted temp to be 102.1. By 1700 temp down to 100.2. On 10/16 saw PCP who prescribed oral prednisone to decrease the immune response which now included body/joint aches and continued low grade fever. Improving but not completely well.
11/8: affected arm had: sore tricep/bicep, limited movement range, swelling, redness from elbow to armpit of affected tricep, tiredness, 1 hour of chills that night.  11/9: swelling, itching, redness like one large hive over bicep and tricep area, painful muscles, limited movement without pain, tiredness.  11/11 swelling, itching, redness slightly reduced, sore muscles improving but now extending into elbow and upper forearm, less tired.  11/12 pain, redness, itching reduced. 11/13 symptoms 95% gone.
PATIENT HAD VACCINE ON 3/1/19. ON THE FOLLOWING WEDNESDAY PX NOTICED SEVERE VISION LOSS (VISION WAS 20/50). BY THE FOLLOWING MONDAY (3/11/19) PX VISION HAD DIMINISHED TO 20/350 AT EYE EXAMINATION.
Felt  light headed; Within seconds of vaccine, felt very hot.; dry heaved a little; Then throat got tight; lips tingled; Started shaking; couldn't catch breath; Heart was racing; Things were foggy; didn't feel right for rest of night; This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient of an unspecified age received bnt162b2 (Lot Number: EP7533), dose 1 via intramuscular, administered in left arm on 31Mar2021 07:00 AM as single dose for covid-19 immunization. Medical history included Covid-19 in Dec2020 and known allergies included shellfish, contrast dye, multiple antibiotics. The patient's concomitant medications within 2 weeks of vaccination were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Within seconds of vaccine (31Mar2021), the patient felt very hot. Then dry heaved a little. Then throat got tight and lips tingled. Then pharmacist gave 50 mg of diphenhydramine hydrochloride (BENADRYL). Started shaking and couldn't catch breath. Heart was racing. Felt light headed. Were ready to give epipen, didn't. Things were foggy. Symptoms started to get better after half hour but heart was still racing. Stayed over and hour. Went home, didn't feel right for rest of night- took more diphenhydramine hydrochloride. Woke up next day and felt OK. Treatment received for the adverse events included diphenhydramine hydrochloride. The outcome of events was recovered.
Left arm , leg, armpit pain. Headache nauseated.  dec 16 feel most of joints pain, mild chill headache and nauseated, Fever 102.5. Tylenol 1000 mg rapids relief. Cold pack one hour go down to 101.x. Couple hours later go to 100.1  Dec 17. Temp 99.5 this morning. Still headache.
fast heartbeat (over 100) on iwatch since the shot and fever (101.7 F), short of breath, Diziness and weakness
PT FAINTED WITHIN 1 MINUTE OF SHOT. WOKE UP 10 SECONDS LATER AND COULDN'T REMEMBER FAINTING. LIPS WHITE, FELT CHILLED AND STARTED SHIVERING, WEAK. BP WAS 86/56, PULSE IN 60S. FELT BETTER AFTER A FEW MINUTES SO SAT UP, LIPS MORE PINK. QUICKLY FELT NAUSEATED, SO LAID BACK DOWN. LIPS TURNED WHITE AGAIN. INTENSE SHIVERING. GOT UP AND LEFT AFTER ABOUT 40 MINUTES AFTER CHECKED OUT BY EMS.
Pt came in on the 13th, 2 days after shot had arm swollen and red. Pain was 2.5" of diameter. Physician gave pt Mortin with food, if got worse to come back in. Pt has not come in after that visit.
massive explosion of eczema on my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAND DERMATITIS (non-serious), outcome "unknown", described as "massive explosion of eczema on my hand".  Additional information: The patient got massive explosion of eczema on hand from the Pfizer vaccine (Covid 19 vaccine) and Pfizer has admitted that this is the side effect of the vaccine and hands are just exploding.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is not having any adverse events to the dose.  However, patient received a "booster" of pfizer when Moderna was the patient's primary series.
Got vaccine october 2018 in left bicep,  next day left hand swelled up and felt broken, 2 days later swelling and pain subsided,  January 2019 started symptoms of muscle twitching in left bicep,  may 2019 final diagnosis of familia ALS,  genetic test confirmed C9ORF72 gene that has to be activated by something to start progression of ALS, causes listed to activate that gene , though listed rare, a vaccine can trigger it
Client came into the health dept 9/9/13 stating that her Rt arm was swollen from Td received on 9/6/13. No redness at site where Td was administered. Approx 1.5 inch below injection site was a red, swollen area approx 1.5 rectangle shape. Mild tenderness to touch. Stated doesn't recall any bites by insects. Advised to seek medical care if worsen. Instructed to use cool compress for 20 min, 4xc daily for 24 hrs.
Right arm soreness, about 12 patches of red raised blotchy slt itchy, slt tender rash on Right arm and R thumb, numbness in all fingers of right hand, now only thumb and index. Also headache, bandlike.