chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Considerable tenderness, swelling, reddening, and heat in 3-4  inch diameter circle around injection site.   72 hours post-injection, the symptoms remain, although the area of swelling has reduced and is no longer generating heat.  Otherwise, fatigue at 24 to 36 hours post-injection.
Fever, Shakiness, Hight Blood Pressure, up to 166/85, Weakness overall.
Swollen arm, stiffness, lump 16 days in area of injection. Throbbing pain radiating down arm.
Joints aching and sweats Third day  back ache  and swelling of hands  04-14-2021. Swelling of hands back aches still.
This spontaneous report as received from another healthcare professional refers to a patient of unknown age. On 21-AUG-2014 the patient was vaccinated with VARIVAX, lot number and other details unspecified, 0.5 ml, subcutaneously. On an unknown date the patient experienced the nurse reports that PROQUAD and VARIVAX that underwent a temperature excursion were administered and no adverse effect. The outcome of the nurse reports that PROQUAD and VARIVAX that underwent temperature excursion were administered and no adverse effects to be not related to VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
C/o dizziness. Noted pt color was normal. Nurse had pt lie down, and applied a cool compress to posterior neck and gave him water. Nurse notified MD. VS were taken and stable. Pt reported dizziness was gone. MD saw pt and gave him permission to leave.
t103.6, labored breathing-rate 80-100 per minute in ER;wheezing, cough;pneumonia placed on biaxin;
Woke up next morning with both eyes swollen. Happened again, only left eye, with second dose I received yesterday. Lot# 1805018
my arm was heavy and painful to lift; my arm was heavy and painful to lift; 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 female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "my arm was heavy and painful to lift".  Additional information: Caller stated On Wednesday, 09Feb2022, I got the booster dose and the next day my armpit was swollen and painful. I got it on the left-hand side, the injection site is tender but my under my armpit is painful. After I got the first and second dose and I did not have this, but my arm was heavy and painful to lift, which I know others experience that too, my husband had it too after the first and second dose. Is what I'm experiencing now (after booster) normal and how long does it last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue; checked the temperature again and this time it was 100.7; checked temperature again which was around 104.4; muscle soreness in the thigh; bad headache; chills; 1 hour afterward had a low grade fever with 99.6; Around 8 or 9 pm, fever rose up to 102; soreness in the arm; shaking; This spontaneous case was reported by a physician and describes the occurrence of LIMB DISCOMFORT (soreness in the arm), TREMOR (shaking), FATIGUE (Fatigue), PYREXIA (Around 8 or 9 pm, fever rose up to 102) and PYREXIA (checked the temperature again and this time it was 100.7) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus nephritis (.). Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D3 and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 19-Feb-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 19-Feb-2021, the patient experienced LIMB DISCOMFORT (soreness in the arm), TREMOR (shaking), PYREXIA (Around 8 or 9 pm, fever rose up to 102), CHILLS (chills) and PYREXIA (1 hour afterward had a low grade fever with 99.6). On 20-Feb-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (checked the temperature again and this time it was 100.7), PYREXIA (checked temperature again which was around 104.4), ARTHRALGIA (muscle soreness in the thigh) and HEADACHE (bad headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 20-Feb-2021, ARTHRALGIA (muscle soreness in the thigh) had resolved. On 21-Feb-2021, LIMB DISCOMFORT (soreness in the arm), TREMOR (shaking), FATIGUE (Fatigue), PYREXIA (Around 8 or 9 pm, fever rose up to 102), PYREXIA (checked the temperature again and this time it was 100.7), PYREXIA (checked temperature again which was around 104.4), CHILLS (chills), PYREXIA (1 hour afterward had a low grade fever with 99.6) and HEADACHE (bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020621 (Patient Link).
Pt received regular FLUZONE 0.5 ml IM to (L) deltoid at 7:35 pm 5 mins after vaccine administered pt. states "I have a sore throat" no SOB no wheezing no swelling of lips. Pt referred EPIPEN/BENADRYL signed AMA forms.
Patient described right leg pain and swelling following injection, right side body pain and tingling. Headaches, and pain at the injection site.(right deltoid injection site)
one week from the date of the first shot I have a swollen left arm at the site of the shot. It's a large red circle with bright red color, hot to the touch, itches, and hurts a little. I took a Tylenol for the pain and 2 Benadryl for the itching.
From the second day of had been administered the area turned red swollen and the days went by and the rash is bigger and it has been 12 days and it still the same
Nausea, headache, aches and pains, fever, diarrhea.
Loss of Hearing  in Left Ear - No Treatment as of now, Not sure what to do?
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 19-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Pt recvd MMR vax 4JUN92 & 6JUN92 pt devel fever; 19JUN92 also exp nausea, anorexia, vomiting, diarrhea, & acute tenosynovitis & edema of ankles & feet; t100-104 w/erythema & dehydration; 22JUN92 pt hospitalized; poss SLE/septic shock;
Burning pain right deltoid with radiation into arm, shoulder and neck.  Body aches. Chills. Swelling right deltoid.
Hives broke out around entire abdomen + upper thighs. No trouble breathing but Patient did state they "Felt slight wheeze" earlier. Took Benadryl 50 mg + is better
Pt had a high fever 10-12 hrs later, delirious unaware of her surroundings and thought she had ticks all over her body.
Patient developed jaundice 10/31 with abdominal pain and stool changes. Improved slightly 11/1, worsening again 11/2
Headache; stomach cramps; pain in legs and weakness; pain in legs and weakness; not hungry; arm pain; This is a spontaneous report from a contactable consumer.   An 82-Year-old female patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 05Feb2021 at 12:30  at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included hypertension. Concomitant medication included  lisinopril. On 05Feb2021 at 21:00 patient started experiencing headache, stomach cramps, pain in legs and weakness, not hungry, arm pain. The patient did not received treatment for the events. At the time of the reporting the patient had not yet recovered from the events.    Follow-up attempts are completed. No further information is expected.
NO ADVERSE AFFECTS REPORTED BY PATIENT. HE IS DOING FINE. VACCINE WAS GIVEN THREE WEEKS TOO EARLY
My son has had a sinus infection since the day he got the vaccine. It's not natural and I'm getting more mad every day. At first I thought it was not that bad. Now I want it on record that this vaccine can do this. I don't know what manufacturer made this vaccination. It was dTap. I will call the doctor on Monday morning.
Patient presented to ER from facility with reported SOB, fever and recent diagnosis of COVID19. Evaluation noting tachypnea, tachycardia and fever. Work up noting leukocytosis, elevated PCT. CXR completed noting interstitial markings in bilateral lower lung fields with basilar atelectasis. Later became hypotensive requiring IVF therefore admitted for further evaluation and management.    Patient developed diarrhea and tested positive for c diff. ID consulted and patient initiated on oral vancomycin. Additionally, IV remdesevir added for COVID19 infection.     Patient remains stable without hypoxia, received IV remdesevir x 5 days
11/06/21- 11/08/21: Fatigued, headache.  11/08/21- 11/10/21: Body aches, fever, joint pain, muscle pain, migraine, hot flashes.  11/10/21: a rash appeared on my hands, fingers appeared swollen. Chest was turning red.  11/11/21: a very pronounced rash with raised bumps on the hands and chest. I went to the ER around 7:45 AM knowing it was an allergic reaction. I was given steroids, Pepcid, and advised to take 25 mg of Benadryl once I was discharged home.  11/12/21: My joint pain, muscle aches, and headache improved greatly. My rash is not as visible. I am taking prednisone once a day. Benadryl twice a day and Pepcid.  I am to follow up with my primary care doctor on 11/17/21
Initial report received from the healthcare professional on 16-Dec-2013. A female patient age unknown, medical history and concomitant medications were not reported, had received MENACTRA (batch number U4686AA, expiry date unknown) and FLUZONE (batch number UH900AA, expiry date unknown) intramuscular on 11 November 2013. The patient was pregnant while receiving the both of the vaccine. The patient did not have any  other adverse event while receiving vaccine. List of documents held by sender: none.  Follow-up information received from healthcare professional on 15 January 2014. Father's health status was reported as unknown. The patient did not have any family history of congenital abnormality. The patient's last menstrual period was reported as 04 November 2014. The patient did not receive any treatment for infertility with no previous pregnancies. The patient received MENACTRA in left forearm. The patient received Methyl Phenidate 20 mg from 11 November 2013 to 12 December 2013 for ADD. The patient did not experience any non-serious adverse event. The patient carried only urine pregnancy test in office and will be going to an OB/GYN for prenatal care without any complications in pregnancy.
8/10 pain at the injection cite. Started 12 hours following the vaccine administration and resolved around 24 hours following administration of the vaccine.
Pt rec'd 1st dose of vax 24OCT87; following 2nd dose 27NOV87 pt reported she experienced an unspecified rxn;
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 17-JUL-2013, lot # H011350, expiration date: 21-FEB-2015). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored M-M-R II. Strength, dose, route and lot number were not provided. M-M-R II was exposed to a temperature between 46.5F and highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215 and 1405USA004216). Additional information has been requested.
Pt received the vaccine around 1400 on Friday the 5th, and began to feel perioral numbness, and mild tongue swelling for the next 24-36 hours. It was not severe enough for him to seek medical care over the weekend. He did denies taking any medications to counter the effects.
Initial report received from a healthcare professional on 07-Oct-2013: On 04-Oct-2013, the patient had received FLUZONE QIV vaccine. On 04-Oct-2013, 2 patients experienced high fever of 101 to 102F, and have flu like symptoms which include body aches. Patients are still having symptoms 72 hours after vaccination. List of documents held by sender: none.
Two hours after booster, Participant felt like she a cold with a scratchy throat, runny nose. A few days later took home test and tested positive for Covid. Did not go to the doctor.
Increase from baseline heartrate of 60 to 110, feeling of mild chest tightness with no abnormal lung sounds,  all other vital signs remained within normal limits. Stated throat felt slightly itchy, resolved without treatment after 2 hours. Patient kept under observation.
Patient had received a Flu vaccine from prefilled syringe. On completion, nurse was engaging the safety device and the syringe broke in half. There was no harm to the patient.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
Rash onset 2 days after vaccination.  Fever 6 days after vaccination.  Exposure to playmate who had fever same week patient had MMR and Varivax.  Examined by doctor 08/15/2005 and 08/22/2005, possible viral syndrome, maculopapular rash left thigh.
Prior to 08/17/202 relative in the house had COVID exposer to COVID went in on 08/17/202 to have a test and it confirmed the positive COVID results. Quarantining  til 08/31/2021. 08/17/2021 Urology removal of stent, UTI and Vaginal Infections.
Child presented 3 D post IZ's given. Mom states that he had swelling, redness and pain of his L arm on day of IZ's than day presented. Hot to touch.
Developed fever hours after vaccine...within 5 days he also had cough, runny nose and earache.  Was diagnosed 7 days after vaccine with ear infections. Otitis Media. (8-27-13).
01/08/23 presents to ED for "SOB". PMHx of "hypertension, diabetes, CAD"
Information has been received on 19-OCT-2016 from a female consumer (mother of patient) referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient received vaccination with a dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported). The mother of the patient reported that the patient developed a hard lump after receiving GARDASIL 9. Treatment and outcome of the adverse event was not reported. No further adverse event information was provided as the reporter declined to participate in answering questions within this adverse event report. No consent to contact reporter or physician. No contact details provided. No additional information is expected.
inc temp of 103 (p/APAP was given) for 48 hrs; inconsolable ? for > 3hrs;
About 5 mins after receiving  the shot, my hand started to sweat. The next day I would get a feeling in my eyes and I would immediately fall asleep for about an hour. Sometimes it would happen twice a day. This has happened everyday since I have had the second vaccine. I want to mention that I have retained gadolinium in my system since 2018. I seen a doctor and she didn't know what the problem was. I will see a neurologist this week. The area where I received the shot has been hurting for about 3 months.
None adverse reaction occured. Client given vaccine that is licensed four years and up, client is three years old.
This is a spontaneous report from a contactable consumer (reporting for his mother-in-law) and from his wife. A 90-year-old female patient received PREVNAR 13(lot N16515, expiry date Oct2017) on 14Oct2016 at 16:00 at 0.5 ml single in left arm for immunisation. Medical history included ongoing hypertension diagnosed 7 or 8 years before the report, ongoing blood cholesterol increased ongoing for years and swelling. The patient previously took influenza vaccine on an unspecified date in right arm for immunisation.  The patient was taking unspecified concomitant drugs for blood pressure and cholesterol. The patient experienced pain on 14Oct2016 with outcome of not recovered, swelling was worse since 19Oct2016 with outcome of not recovered, rash on 19Oct2016 with outcome of not recovered, could not lift arm on 14Oct2016 with outcome of unknown, was not feeling well on 14Oct2016 with outcome of not recovered, infection on an unspecified date in Oct2016 with outcome of unknown. The patient arm was blown up like a balloon and she had a rash going from her arm where it was put in maybe 8 to 12 inches and then 4 inches wide, moving around to the back. Rash resulted worsened at the time of report. The patient had already a little swelling before the shot, but she noticed on 19Oct2016 in the morning the swelling was worse. The patient was treated in the emergency room for swelling and rash, she was not admitted to the hospital. They gave her an antibiotic and prednisone lotion to put on the rash. The doctor just looked at the reaction and measured it. The doctor drew a box around it to make sure it did not get larger. The patient underwent blood pressure and body temperature measurement on an unknown date in Oct2016.
patient feeling lethargic after injection, progressing to fever the next night.  He presented to urgent care with lethargy,  fever, tachypnea and stridor.  transferred to ER
DONOR REPORTS THAT A COUPLE OF MINUTES AFTER RECEIVING THE SHOT SHE BECAME DIZZY AND LIGHTHEADED FOR APPROX 2 MINUTES. TEMP 98.9, DONOR STATES THAT SHE RECOVERED QUICKLY. DENIES NEED FOR EMS.
Itchiness in arm, 1-2 inches around injection site, no visible signs on skin, just itchy. Used no medication. Rubbed arm to promote circulation numerous times.  Lasted about 3 days.
12 days p/vax pt presented w/thrombocytopenia (platelet ct=6,000); tx w/ IV gamma globulin;
Injection site swollen, (5 cm) red, painful despite ibuprofen.  Peak at 4 days after, redness and swelling gone by 8th day, remains tender yet today.
Patient given vaccine at approximately 1130AM. Patient reported dizziness immediately following injection and was assisted to supine position. Patient then had witnessed seizure at approximately 1138 AM lasting approximately 30sec; No complaint of hypoxia during event. Patient recovered and was sent by ambulance to ER.
16 month old received BOOSTRIX; received BOOSTRIX instead of INFANRIX; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   On 5th October 2021, the patient received Boostrix. On 5th October 2021, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration and underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and underdose were unknown.  Additional details were reported as follows: The patient received Boostrix instead of Infanrix vaccine, which led to inappropriate age at vaccine administration and underdose. No further details were provided at the time of the call and no adverse reactions were reported. The reporter consented to follow-up
Lymph nodes swollen in her arm; 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 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jun2021 13:00 (Lot number: FW0181) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Verbatim: high blood pressure. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension (ongoing). The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Lymph nodes swollen in her arm". Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Patient had side effect after the first dose of the vaccine.  A 69 year old female patient who received her first dose of the Pfizer COVID-19 vaccine on 30Jun2021 and had lymphadenopathy in her arms. She was scheduled to receive her second dose of the vaccine today 21Jul2021. Caller wants to know if this side effect has been reported and what does it indicate. She had it probably 21 days ago, Her lymph nodes are swollen up in her arm. She was wondering if she should get it again and wants to know what does it indicate Started about 2 days after the shot and occurred probably in the evening. States that it went down. Took some garlic as treatment. States she was not taking any other Concomitant medications, just herbs and Hydrochlorothiazide. History of all previous immunization with the Pfizer vaccine considered as suspect were none, No Prior Vaccinations (within 4 weeks) or Additional Vaccines Administered on Same Date of the Pfizer Suspect, AE(s) following prior vaccinations: None, that she is aware of.  No follow-up attempts are possible. No further information is expected.
minor reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (minor reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (minor reaction). At the time of the report, ADVERSE REACTION (minor reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: positive Positive. In November 2020, SARS-CoV-2 antibody test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information not provided   Reporter did not allow further contact