chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe chills with shaking; severe chills with shaking; 103 fever/ approx 20hrs after injection, fever of 100 or greater for 24hrs with minimal relief with Tylenol; body aches; pains in left flank; the first dose on 20Dec2020/second dose on 12Jan2021; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 32-year-old female patient (not pregnant) received the second dose of bnt162b2 via an unspecified route of administration on 12Jan2021 10:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included cardiogenic syncope, no COVID prior vaccination. Concomitant medications included birth control drugs, no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 on 20Dec2020 03:00PM on Left arm for COVID-19 immunization, topiramate (TOPAMAX) and experienced drug allergy, morphine and experienced drug allergy (hives). The patient experienced arm swelling with itchiness and warm to touch at site of injection, severe chills with shaking, 103 fever, approx. 20 hours after injection, fever of 100 or greater for 24 hours with minimal relief with Tylenol, body aches and pains in left flank. The adverse events started from 12Jan2021, 06:00 PM. Therapeutic measures taken for fever included Tylenol, no treatment was received for other events. The outcome of the events was recovering. The patient didn't test COVID post vaccination.  Information on the lot/batch number has been requested.
24 hours  after the vaccine patient developed rash with small red bumps all over body,  large whelps on thighs and buttocks, and severe itching. Spoke to pharmacist who instructed her to take antihistamine. Patien Took certirzine and Tylenol and a melatonin, and a small Xanax and the itching resolved.  By the next morning the rash was gone and completely recovered and she felt perfectly normal.
I got the shot and then I walked out and sat to wait for 10-15 min and within 5 minutes I could feel my throat closing, I texted my husband because my airway was going and I couldn't breathe, they gave me and EPI and I started bleeding everywhere. They called the ambulance and the ambulance came. I went to the hospital and I was monitored for three hours. I contacted my dr. I had to EPI 2-3 more times within the next 3 days to get it under control.
COVID vaccine was administered on 10/22/21 during the Initial medical exam and was administered again on 10/28/21.
First 3 days: soreness in arm when lifting arm or to the touch After 7-8 days: a large red splotch appeared around injection site. No pain, swelling or itchiness in first 36 hours after noticing the mark. Just discoloration.
patient received an expired dose of daptacel with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient to who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine 13v (pneumococcal vaccine 13v) and measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine) (MMRV) for Immunisation.  On 04-Oct-2022, the patient received an expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Strength: standard (formulation, dose, frequency: unknown) (lot number: C5774AA and expiry date: 18-Sep-2022) via intramuscular route in the right thigh with no reported adverse event (expired product administered; latency same day) for Immunization.  It was reported, Caller would like to know what they should do. This situation is reported as a medication error due to an expired dose being administered to a patient. An expired dose of DAPTACEL was inadvertently administered to a patient  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  At time of reporting, the outcome was Unknown  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 recv vax 2MAR98 & 2hr p/vax pt was observed having a tonic/clonic sz;
I got fairly standard injection site reaction  (soreness,  a little deltoid swelling ,  and a 1.5" harder,  red area) the first 3 days, which I didn't report as I expected it.  After 3 days it went away and I was surprised the tenderness went away so quickly as it can last longer with a flu shot. It stayed this way (injection site normal) for 4 days. One week after the shot I started to get an injection site reaction again and this time it is worse; red area is expanding, and is hotter and swollen,  I took some morning and night pictures over the last 1.5 days.
Information has been received from a 26 year old female consumer with allergic reaction to erythromycin and prednisone and a history of papilloma viral infection prior to receiving GARDASIL (specific strains unspecified), for GARDASIL, a Pregnancy Registry product, concerning that on 20-DEC-2009 she was vaccinated with a third dose of GARDASIL. Suspect therapy included AFLURIA (unspecified manufacturer) at the same time. On approximately 29-DEC-2009 "two weeks ago" the patient started experiencing nausea until today (11-JAN-2010). On 08-JAN-2010, the patient conducted a urine home pregnancy test and it came back positive. The patient's last menstrual period was 07-DEC-2009, and estimated delivery date was 13-SEP-2010. The patient contacted physician for medical attention. At the time of the report, the patient had recovered from nausea. Additional information has been requested.
Got vaccination 10-27-2008. 10-29-08 arm started aching. 10-30-08, arm swollen clear down into hand and up thru shoulder into neck.
parents watched rash which proceeded  to get worse;moved to thighs, elbows, forearms, hand;has macular papular, erythematous, discreet, 5mm-10m, lesions on knees, elbows, thigh, forearm & hands;rash itchy;T98.1;cough;dx hives;
His arm was very sore, more sore than the flu, and less sore than a tetanus shot; felt a little crumby; 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 60 year-old male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinus issues" (unspecified if ongoing), notes: Verbatim: sinus issues. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "His arm was very sore, more sore than the flu, and less sore than a tetanus shot"; MALAISE (non-serious), outcome "unknown", described as "felt a little crumby".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nerves in pt's head being affected paralysis of 6th optic nerve tingling in left side arm & foot started 4 days after vaccination.
After receiving the ProQuad vaccine 0.5 ml on right thigh, patient started scratching palm of hands and saying that the bottom of feet were itching bad.  Started coughing and trouble swallowing.  Rash appeared all over body. Abscess started appearing on right leg and right side of neck and ear. Was given 5ml tsp of Benadryl then 0.15 ml of Epinephrine injection was administered on right arm by Dr.  Patient was given water and vitals were taken.  He was kept in the clinic for 3 hours until he was stable.
patient complained of tightness in chest; vitals - bp 132/83, hr82, rr20, o2 sat 98%; patient denies any past medical history; complained of dizziness and feeling like he was gonna pass out. 911 was called; transported patient to hospital er.
back aches for a few hours; little bit of fewer; vaccinated on December-2020, and January-2021, then Jun-2021 and JUL-2021; vaccinated on December-2020, and January-2021, then Jun-2021 and; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and), EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and JUL-2021), BACK PAIN (back aches for a few hours) and PYREXIA (little bit of fewer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and). In July 2021, the patient experienced EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and JUL-2021). On an unknown date, the patient experienced BACK PAIN (back aches for a few hours) and PYREXIA (little bit of fewer). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In June 2021, EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and) had resolved. In July 2021, EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and JUL-2021) had resolved. At the time of the report, BACK PAIN (back aches for a few hours) and PYREXIA (little bit of fewer) had resolved.            No concomitant medication was reported. Action taken with mRNA-1273 in response to the events were not applicable.
Patient was having difficulty breathing and heart was racing. Gave her between 7.5 to 10ml of diphenhydramine liquid. Called emergency services
Woke in night with fever, chills, sweat, aches in muscles and joints, shaking. As if a severe flu. Resolved after three hours.  Second dose of Shingrix.
Tested positive for Covid on the 19th of January, 2022. My symptoms started about four hours after injection. The worst being on 1/17/22.
Patient's caregiver brought patient into the pharmacy on Wednesday 11/9/2022 to get a flu shot administered. A dose of Flulaval Quad(Lot 9722R, IM Left Deltoid) was administered to patient per the caregiver's request in the pharmacy. Staff member who administered the shot in the pharmacy was not informed by patient's caregiver that patient already received a dose of Afluria (Lot P100473764, IM Left Deltoid) when our mobile team visited the carehome on 10/26/2022. The caregiver apparently though the COVID booster was administered to patient on 10/26/2022 and not the flu shot.  We followed up with caregiver and caregiver reported patient experienced no adverse reaction after receiving the second flu shot.   We encouraged caregiver to inform patient's primary care physician of the incident.
lethargic; high fever/ temperature of 104 Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic) and PYREXIA (high fever/ temperature of 104 Fahrenheit) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-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 LETHARGY (lethargic) and PYREXIA (high fever/ temperature of 104 Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic) and PYREXIA (high fever/ temperature of 104 Fahrenheit) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Body temperature: 104 fahrenheit (High) 104 Fahrenheit. No concomitant medications were reported.
Minor body aches noted on 1/8/21, more severe back pain on 1/9/21, also swelling & redness under left knee. On 1/12/21 PCP diagnosed shingles on back & skin infection on left leg. Treated with Valtrex 1 Gm PO TID x 10 days, Bactrim , one tab PO BID
Patient received Flucelvax Quad on 2/27/2020 at approximately 8 PM.  She returned to the pharmacy on 2/29/20 around 10:30am to report an injection site reaction and possible skin infection from the vaccine.  She stated the area was warm to the touch and painful.  She also showed me the area which appeared red and swollen around her mid arm area.  She stated that a red ball appeared immediately after receiving the vaccine and that some vaccine leaked out. I advised her to see a physician to be certain if there is or is not an infection.
Extreme stiffness and soreness, dizzy, nauseous, migraine, then by the evening of my last shot I was having seizures
Thyroductal cyst - had this my whole life, inflamed approx 8 years ago and settled down/disappeared.  A few days after vaccine, woke up with cyst very inflamed and painful/difficult to swallow.   Took advil (2 pills) 4 x.  Cyst settled back down but going to ENT to have checked out.   Concerned getting the 2nd dose if adverse affects become greater.
Chills for over two hours followed by fever for two hours. Could not sleep. Kept waking up every half hour. Some chills during the following day. Slept very well the next night.
Patient developed fever and chills to 101 at 0200 on 1/14/21.  Headache and neckache.
lethargy, vomiting, irritability onset 24hrs of inj returned to ofc; 14 & 15AUG supportive measures only improved 16AUG;
Injection site was very sore at the beginning.  On January 10th I noticed that the swelling and redness was spreading down my arm.  I went to my PA on the 11th and was given a steroid pack.  After taking this it cleared up quickly.
The first 4 were associated with a left axillary enlarged lymph node that developed within a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201) at the age of 71 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "The first 4 were associated with a left axillary enlarged lymph node that developed within a few days".  Additional information: The first 4 were associated with a left axillary enlarged lymph node that developed within a few days and caused no problems and which resolved within several weeks.
The patient returned to the pharmacy several days after injection was given because her arm was red and slightly warm to touch. With a small hard knot. She said it didn't hurt or itch. I advised her to use an ice pack and use BENADRYL or TYLENOL as needed. She came back the next day and the site of vaccine was improved. Only slightly red and no longer warm. No further advise given.
Received a mumps vaccine on 1-26-06 at 9:00am. On 2-11-06 around noon I got a 101 degree fever that did respond to Advil, but then rose to 102 degrees on 2-12-06 (current). The form I was given said report a "severe" fever, but it does not define what "severe" is. Will go to a doctor if it continues to go up. (Box 13, not sure what Priorix or Viravac is)
I got up out of bed at approximately 2am and almost fainted. While standing my legs especially and whole body started feeling very heave and my vision became black. I was able to find a chair a few steps away and sit down. My heart raced for a couple minutes and I started profusely sweating where my arm was very wet to the touch. After I few minutes of sitting with my head in my hands I felt better and was able to make it back to bed. Research of these symptoms make me think it was a near episode of vasovagal syncope. Prior to this I also had chill starting around 9:30pm and then was very hot for 8-12 hours starting at approximately midnight.
VOMITING; DIZZINESS; BODY ACHES; DIARRHEA; NAUSEA; TIREDNESS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced diarrhea.  On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, body aches, diarrhea, nausea, fever, and headache on 09-APR-2021, and the outcome of dizziness and tiredness was not reported. This report was non-serious.
temperature of 99.8 F; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (temperature of 99.8 F) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-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 PYREXIA (temperature of 99.8 F). At the time of the report, PYREXIA (temperature of 99.8 F) 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.   No relevant concomitant medications were reported. No treatment information was provided.
CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned an adult male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received seasonal influenza vaccine on APR-2020, and streptococcus pneumonia (pneumococcal) vaccine on 17-NOV-2020 for prophylactic vaccination. The patient had not received BCG (Bacille Calmette Guerin) vaccination. On 18-NOV-2020, the patient was screened for tuberculosis and was negative.  On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drug included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported. On an unspecified date, the patient received booster dose of non company vaccine mrna 1273 (dose number in series: 2) (form of admin unknown, intramuscular, batch number was not reported), dose, start therapy date were not reported for prophylactic vaccination.  On an unspecified date, three to four weeks after the booster dose, the patient experienced chest pain, and shortness of breath (dose number in series: 2). The patient stated that he went to hospital when he could not breathe and was having bad chest pain. The patient was hospitalized (dates and duration unspecified). The patient continued with shortness of breath since the cardiac event and was seeing a cardiologist to determine possible heart attack verses blood clot. The action taken with covid-19 vaccine ad26.cov2.s, and mrna 1273 was not applicable; and action taken with adalimumab was not reported. The patient was recovering from chest pain, and had not recovered from shortness of breath. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220117359-covid-19 vaccine ad26.cov2.s-Chest pain and shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
The patient experienced severe pain at the injection site. She experienced overall body pain, aches, and stiffness.
Patient presented 12/12/2021 with 2 days of chest pain, found to have elevated troponin level and cardiac MRI with enhancement pattern consistent with myopericarditis.  Patient discharged on 12/13 in good condition but with ongoing mild pain.
About 20 minutes after receiving the vaccine both hands turned flame red from the wrists to fingertips.  No itching or burning.  Resolved after about an hour.
pt recvd vax & babysitter called home to report pt having rash on bottom of feet & seemed to spread to arms/legs & body; stated noticed a fine rash on feet SAT AM; 25JUN93 sl elevated temp; 29JUN94 rash was fading;
Fever,feeling nauseous,chills,muscle sore,high heart rate and redness and swelling of the shot area.
This spontaneous report as received from a nurse practitioner refers to a patient (gender unknown) either 6 months or 9 months of age. On an unknown date the patient was vaccinated with a dose of ROTATEQ (dose and lot # not reported). On an unknown date the patient developed intussusception and was hospitalized. The outcome of intussusception was unknown. Additional information has been requested.
5 min after administration pt fainted. head was down and hangs were in a catatonic state. Pt was not responsive and clammy, but within 5 minutes pt was talking and had recovered.
Patient during his observation period @1010 reported symptoms of HA, lightheaded, joint pain, and shortness of breath following Pfizer vaccine administration. Patient was provided 25mg Benadryl @1018 and legs elevated for possible allergic and syncopal symptoms respectively. After no immediate clinical improvement,  patient was transferred to ED via EMS . Patient did not require any interventions in ED and was diagnosed with Anxious reaction to vaccine. Patient released to home.