chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient assessed by provider - redness noted to left thigh 1'x2', warm to touch - BENADRYL 2.5mL ordered by mouth and tolerated well. Patient observed for 40 minutes after, redness noted, but reduced in size. Allowed to be dismissed. Follow up tomorrow.
PT "PASSED OUT".  WAS ABLE TO WAKE UP WITH COAXING FROM WIFE. PT WAS ABLE TO LIE DOWN FOR 10 MIN OR SO. AND THEN WAS ABLE TO SIT UPRIGHT FOR 15 MORE MINUTES. PT VITALS. BLOOD PRESSURE, HR AND BREATHING ALL NORMAL AT TIME OF EXIT.
Profuse sweating, severe diarrhea, some nausea, shaking hands, arms and legs.
Case number PHEH2014US021088, is an initial spontaneous report from a pharmacist received on 17 Oct 2014. This report refers to a 47-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly on 06 Oct 2014. On the same day after vaccination, she experienced tingling of her entire arm including fingers. Also, she has severe soreness in the arm causing limited range of motion of the affected arm. Thi final outcome of the events was unknown. Seriousness and causality was not reported.
Sick / seriously ill; I couldnt walk; Leg wouldnt move; upset Stomach; Diarrhoea; Muscle pain; Fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick / seriously ill), GAIT DISTURBANCE (I couldnt walk), MOBILITY DECREASED (Leg wouldnt move), ABDOMINAL DISCOMFORT (upset Stomach) and DIARRHOEA (Diarrhoea) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick / seriously ill), GAIT DISTURBANCE (I couldnt walk), MOBILITY DECREASED (Leg wouldnt move), ABDOMINAL DISCOMFORT (upset Stomach), DIARRHOEA (Diarrhoea), MYALGIA (Muscle pain) and PYREXIA (Fever). At the time of the report, ILLNESS (Sick / seriously ill), GAIT DISTURBANCE (I couldnt walk), MOBILITY DECREASED (Leg wouldnt move), ABDOMINAL DISCOMFORT (upset Stomach), DIARRHOEA (Diarrhoea), MYALGIA (Muscle pain) and PYREXIA (Fever) had resolved.            No concomitant medication were provided.  It was reported that patient took all vaccines and boosters and felt sick after each dose of vaccine for atleast 3 to 4 hours. The last booster made patient seriously ill. Further it was reported that patient was told not to take any more boosters and should try another vaccine.    No treatment details were provided   This case was linked to MOD-2022-646099 (Patient Link).
A 6 month old male received his 1st dose of Prevnar, as well as, Acel-Imune, Hib-Titer and IPV (Aventis Pasteur SA) on 6/15/00 and within "minutes of Prevnar administration", developed an erythematous, macular rash on his chest and cheeks. Two doses of Benadryl were administered. The rash resolved within a few hours.
Diagnosed with acute promyelocytic leukemia within 48 hours of vaccine administration. Developed fevers immediately after vaccine, thought to be appendicitis, but diagnosed with leukemia. Currently undergoing induction chemotherapy.
diarrhoea; cough; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea), COUGH (cough), CHILLS (chills) and PYREXIA (fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIARRHOEA (diarrhoea), COUGH (cough), CHILLS (chills) and PYREXIA (fever). On 01-Feb-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, DIARRHOEA (diarrhoea) and COUGH (cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history and relevant concomitant medications weren't reported Treatment information was not provided
The evening that I received my shot, I started to feel heat under my feet and hands, heat all over my body, joint pain/swelling. sensitivity to heat/cold, tingling on my tongue, weakness, headaches and nausea. It's been 3 weeks since my first vaccine, and I'm still having the same symptoms.
Injection site occasionally has dull pulsating pain. Will go away but returns every few days for about a couple minutes.
erythema & swelling of arm to wrist started less than 8hr p/vax;
TEMPERATURE RANGING BETWEEN 95-95.5; CHILLS; FATIGUE; A LITTLE BIT OF A HEADACHE; ARM SORENESS; This spontaneous report received from a consumer concerned a female of unspecified age. 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: 204821A, expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUL-2021, the subject experienced arm soreness. On 10-JUL-2021, the subject experienced fatigue. On 10-JUL-2021, the subject experienced a little bit of a headache. On 11-JUL-2021, the subject experienced temperature ranging between 95-95.5. On 11-JUL-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) ranging between 95-95.5. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, chills, temperature ranging between 95-95.5, and a little bit of a headache, and the outcome of arm soreness was not reported. This report was non-serious.
This case was reported by a other health professional via sales rep and described the occurrence of redness in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patients experienced redness and induration. On an unknown date, the outcome of the redness and induration were unknown. It was unknown if the reporter considered the redness and induration to be related to BEXSERO. Additional details were provided as follows: This case was reported by a office manager. The office manager reported that an unknown number of patients experienced redness and induration with unknown number of BEXSERO vaccinations. The details of vaccinations and patients was not available. A message was left with the office manager to call back GlaxoSmithKline with event details.
Needle stick and full dose was not administered to patient; Needle stick and full dose was not administered to patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Needle stick and full dose was not administered to patient) and DEVICE CONNECTION ISSUE (Needle stick and full dose was not administered to patient) 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.    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 UNDERDOSE (Needle stick and full dose was not administered to patient) and DEVICE CONNECTION ISSUE (Needle stick and full dose was not administered to patient). At the time of the report, UNDERDOSE (Needle stick and full dose was not administered to patient) and DEVICE CONNECTION ISSUE (Needle stick and full dose was not administered to patient) had resolved.        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.   Concomitant medications were not reported.  No treatment information was specified.
pt began high pitched crying that mom described as screaming approx 1 hr p/ vax, crying cont for approx 10 hrs.T 101, rt leg red & swollen past knee cap. To ER-MD told mom rxn to vaccine
Myalgia, Fever, ErythemaMultiform, NauseaVomiting, chills,chest tightness, SOA, kidney pain, hand pain/tingling Narrative:  Queasy, leg cramps, fever, chills, myalgia, chest tightness, SOA, kidney pain, nausea, left arm puffy - axilla and thorax hurting, cough for 2 days. Bilatera hand pain/tingling. Feeling better. Did not seek medical care.
Hives; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced URTICARIA (Hives) and RASH (Rash). At the time of the report, URTICARIA (Hives) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  Treatment information was not provided
(R) shoulder pain started immediately after vaccine given, has continued intermittently x 18 days. Decreased passive ROM. Am starting physical therapy x2-4 wks. No swelling, erythema or fevers.
My right arm is in intense pain at my shoulder. I can hardly lift it. I've tried using heat and ice and taking ADVIL, which doesn't help. This started one hour after getting the flu shot. I messaged my dr today to report this.
pt recv vax 10FEB97;w/in 1 wk exp muscle aches & scratchy throat;the outcome is reported as unk;
Got vax 10/22-After 20 minutes developed episode of anaphylaxis, hoarseness, sweating, headache, and stomach cramps. Patient took Benadryl
I had the initial body ache that?s been associated with the second vaccine injection, it disappeared after 36 hours, followed by excruciating pain in my right jaw, the lymph node behind my right ear shooting into my right temple. Within a day my right eye was involved. After 2 misdiagnoses, and increased pain and emerging blisters, it was determined that I had shingles (4/18/2021)
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional  This case involves a patient (unknown demographics) who received an expired dose of suspect IPV (VERO) [IPOL] (batch number and expiry date not reported, about a month ago) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   Office manager reported that an expired IPOL was administered to a patient. She asked what to expect after that, and if there are any side effects or not.  This was a case of actual medication error due to extra dose administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  There will be no information available on the batch number for this case.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Tachycardia-Mild
Narrative: COVID infection after COVID vaccine 06/03 COVID vaccine dose #1 (of 1) 12/18/ pt c/o chills, fever, loss of taste or smell, COVID positive no further information documented.
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 14-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccination adverse reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-370411, MOD-2021-370398 (Patient Link).
Patient developed a Zoster rash in 2 dermatomes- L4 and L5 on his r. lower leg.  Had a 99.5 fever as well, following sl diarrhea illness.
This medically confirmed spontaneous report (initial receipt 18-Nov-2011) concerns a 52-year-old female patient, who had no pre-existing allergies, birth defects, medical conditions or illness at time of vaccination. In the morning of 28-Sep-2011 the patient received AFLURIA (batch number 04649221A) intramuscularly in deltoid on back side of arm. On 30-Sep-2011 the patient developed 'red, raised' and was hot to touch. The event outcome was recovered. The reporter considered events to be non serious. No further information was available. Case correction (02-Mar-2012): After internal review, Preferred Term and listedness assessment for the event 'Raised' were updated. Follow-up 1 (11-Jun-2012) : event outcome, no further information available.
Large, red itchy rash (about 3" in diameter) on the upper left arm close to the injection site. Another generalized (not as pronounced) itchy rash appeared about 9 hours later on the inner part of both lower arms. Benedryl was taken around 10 pm which helped alleviate the rashes on the lower arms. The large rash on the left upper arm is still present and still itching.
Patient reports feeling warm, lightheaded, dizzy, nauseous, anxious and not feeling good. Pt reports she did not take her BP meds and diabetic meds, she did not eat breakfast this morning.  BP: 213/125, 199/123,  200/100-(manual reading by EMS), pulse: 98-114,  Spo2 99%
Starting in the late spring of 1997, the patient began to experience lower back pain, intermittent swollen fingers, knee pain, stiffness in the joints, fatigue and adult asthma. These symptoms are still present. The patient is being treated for asthma. The dates of vaccination are 04/10/1997, 05/06/1997 and 04/13/1998.
Headache that started close to 12 hours after booster shot. Pain in my left arm started during the night Saturday and is a little tender this Monday morning.  Woke up Sunday morning with the headache worse, feeling exhausted (lasted all day) and horrible body aches. It lasted until over night Sunday night and I seem to be feeling better today.(12/12/21 @ 8:45am)
Employees were to receive Fluzone, but received high-dose vaccine in error from occupational health nurse.  Occupational health nurse received incorrect product from inpatient pharmacy.
Several days p/receiving a dose of Td, pt devel severe pain in the arm radiating to the neck & back; f/u info received 18DEC90, reporter did not recall the incident;
DIZZINESS; MALAISE; This spontaneous report received from a parent concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known history of drug abuse or illicit drug use. The patient had no known history of alcohol use. The patient had no known history of smoking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609) dose was not reported, once a total administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dizziness. On 17-MAR-2021, the subject experienced malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and malaise. This report was non-serious.
Employee returned to Employee Health office at 12:00 p.m. stating she started noticing swelling of the left arm, redness and itching of skin on both arms, chest, abdomen around 11:15-11:30 a.m. Denied any shortness of breath or throat constriction. Employee stated she took BENADRYL 50 mg at approximately 11:40 a.m. Employee was instructed to go to occupational medicine office for evaluation. Was seen there at 1:30 p.m. Diagnosed as reaction to the MMR vaccine and symptoms were nearly resolved when seen.
Dx Cough ? Nasal Congestion ? Sore Throat ? Headache Reason for Visit
Onset of fever, myalgias, headache, fatigue 1-2 days after 2nd dose of COVID vaccine then with onset of erythematous rash on bilateral legs 3 days after vaccine. Of note patient also taking Keflex which he started on the same day as the vaccine. Symptoms resolved by 4 days post vaccine.
Arm pain on the first and second day Acute waist on the second to the third day and other spontaneous body aches, weakness.  Allergic reaction in feet and legs on the fifth day as if they were insect bites.
pt recv in 1994 & pt exp dizziness & slowed heart rate & felt faint;when the pt was revaccinated pt exp the same sx;
Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out.  Pt clampy and sweating.  HR 47, Osat 97%.  Pt had difficulty breathing with conversation.   @1354 Lowered to the floor to lay flat.  1355 BP 101/62, HR 78, O2Sat 98%.  @ 1403 BP 100/68, O2Sat 96%, HR 79, pt sitting.  @ 1405 pt states "feels ok now"  Sitting on the floor 1410 HR 85, O2Sat 94%, Pt remained talkative, alert & oriented sitting on the floor until 14:32.  Pt standing 1433 "feels fine" alert and oriented x 3.  Pt discharged 14:42.  HR 82, Osat 98%
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 102. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant live follow-up: Additional reporter added.
Patent had Menactra at ages 11 and 14, less than 4 years between injections; Based on information previously received with Agency: 22-AUG-2018, the following information have been amended.   Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old patient who vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (MENACTRA) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's concomitant medications, medical history was not reported.  It was a case of actual medication error due to inappropriate schedule of drug administration.  It is not known whether the patient had any untoward experiences after administration.  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 Directive and Module VI of the 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.  Additional information was received from pharmacist on 02-Oct-2018.  No new information received.  Addendum: Based on information previously received with Agency: 22-AUG-2018, the following information have been amended.
Dizziness, Myalgia, CBG 136 which is elevated for pt Narrative:
Ihave high blood pressure. I became light headed after 10 minutes of receiving vaccine. Doctor told me it lowers blood pressure. My blood pressure was low all day. The next day my blood pressure was still not right and I was cold and could not warm up and it was 75 degrees in the house.I had mild spasms and twitches.
I had a lot of pain at the time of injection. The job wasn't noticeable but the infusion of the vaccine was very painful.  That stopped in a few minutes and there were no side effects as I waited the 15 minutes. A few hours later, my right arm hurt, not with the dull muscle pain I've had with other vaccines but with a sharp pain in the shoulder joint that was made worse by any motion. It was impossible for me to sleep that night. By the morning, the pain diminished if I didn't move but continued with any motion and my range of motion was substantially reduced. Over several days, the severity of the pain diminished somewhat and now occurs only on full extension of the arm/shoulder in any direction, particularly in reaching back as in attaching a seat belt. After a few nights, I was able to sleep again.
Covid19 breakthrough.  Vaccinated on 09/01/2021.  27 y/o PMH HIV, Rectal strictures presents to ED with c/o abdominal discomfort and constipation x5 days.  Had attempted use of enemas and stool softners to no effect.  Denies c/o fever, chills, SOB, cough, CP, NVD, HA or back pain.  Pre procedure covid test +.