chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Series 1 : Enlarged lymph notes bulging from Left side of neck  Series 2: severe abdominal pain, severe vomiting, nausea, H/A, chills. Swollen lymph nodes in neck are tender and painful to touch.
I was unknowingly pregnant when I received both doses of the Pfizer COVID19 vaccination, estimated date of delivery was June 13, 2022.  I later learned that I experienced a spontaneous abortion at 9 weeks 1 day, as there was no heart beat at 10 weeks 3 days.
Case number PHEH2016US030608, is an initial spontaneous report received from a pharmacist on 16 Nov 2016. This report refers to a 65-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUZONE (batch number not reported) at an unspecified dose on 24 Oct 2016. The patient was vaccinated with a single dose of FLUAD (batch number: 165801, expiry date Apr 2017) at a dose of 0.5 ml intramuscularly on 16 Nov 2016. On the same day it was discovered that that in the same season the patient was already vaccinated with FLUZONE (on 24 Oct 2016). No adverse event was reported following this administration error. The case was assessed as non serious by the pharmacist.
Temporarily disabling but not life threatening side effects from COVID vaccine (Moderna), including: profound fatigue/lethargy; severe diarrhea, leading to dehydration; severe heart palpitations; moderate injection site pain (severe if touched); moderate neck pain; moderate chills; mild nausea; mild headache; mild fever. Symptoms began approximately 24 hours after receiving the second vaccine, and gradually subsided over the following 24 hours, with only moderate diarrhea, heart palpitations, and fatigue remaining. It was by far the worst reaction I've ever had to a vaccine The only side effects after the first vaccine were moderate fatigue the evening of the vaccine and moderate arm pain.
Severe headache, body/joint aches, slight fever 100.2F, slight nausea, extreme fatigue, local pain and swelling at injection site.  Symptoms started day after receiving vaccine, still present 4 days later to lesser degree on headache, body aches and fever, but still no energy and quite fatigued with no decrease of pain and swelling locally; right deltoid.  I am an RN that received this vaccine prophylatically at work.  I work at the clinic as listed above.  No treatment except tylenol and rest to date, with ice/heat to arm. The symptoms have been dibilitating in the sense that I have had extreme fatigue and lack of energy; not sleeping well as a result of discomfort to arm as well.
Patient reports no immediate reaction after vaccination on friday the 10th. Said monday morning afterward her left eye was swollen, and throughout the day the rest of her face including her right eye got more swollen, and her arms/rest of body were red and itchy. Patient said she consulted a nursing friend, took benadryl, and the symptoms were relieved in the next 24-48 hours.
sick; Initial information was received on 01-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involves a patient of an unknown demography who got sick (Illness), after the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer batch number and expiration date not reported via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  It was reported that patient could get sick from it.  No relevant laboratory data was reported.    It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Vomiting temp of 102-very fussy unable to keep anything down; To MD on 28FEB91 put on Pedialyte; MD feels it was flu since other household number had flu-like sx last wk;
Site of injection red, swollen entire top of arm, hard knot where injection was administered, warm to the touch. He is complaining that it itches and hurts.
Swollen legs; Tight legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen legs) and MUSCLE TIGHTNESS (Tight legs) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen legs) and MUSCLE TIGHTNESS (Tight legs). At the time of the report, PERIPHERAL SWELLING (Swollen legs) and MUSCLE TIGHTNESS (Tight legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.
lethargic; Very tired; tightness while stretching; her body and chest feeling like underwater; blood pressure high; a hard painful bump; painful bump; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high) and INDURATION (a hard painful bump) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical History information was provided by the reporter.  Concomitant products included IBUPROFEN, VITAMIN D NOS, ESTRADIOL (ESTROGEN), HYDROCHLOROTHIAZIDE and SERTRALINE for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced LETHARGY (lethargic) and FATIGUE (Very tired). In August 2021, the patient experienced MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high), INDURATION (a hard painful bump) and NODULE (painful bump). At the time of the report, LETHARGY (lethargic), MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high), INDURATION (a hard painful bump), NODULE (painful bump) and FATIGUE (Very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2022 as dose number unknown, single (Lot number: GH9694) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was used for treatment of COVID-19 from 20Oct2022 to 25Oct2022. The patient had reoccurrence of all symptoms (headache, congestion, body aches, fatigue) 3 days after stopping Paxlovid and isolating for 9 days.  No follow-up attempts are possible. No further information is expected.
Information has been received from a legal firm regarding a case in litigation concerning a female who on 4/29/99 was vaccinated, at the age of 9 months, with a dose of hepatitis B vaccine recombinant (yeast) (batch #not reported) that reportedly contained 12.5 micrograms of toxic mercury in the preservative thimerosal. Other immunizations reported include the first and second doses of hepatitis B vaccine, recombinant (ENGERIX B) (no lot number reported) received on 7/29/98, and 10/1/98 that each contained 12.5 micrograms of toxic mercury; the first, second, third and fourth doses of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA) (no lot number reported) received on 10/1/98, 12/3/98, 1/22/99, and 2/10/00 that each contained 25 micrograms of toxic mercury; and first, second, third, and fourth doses of haemophilus B conjugate vaccine (ACTHIB) (batch # not reported) received on 10/1/98, 12/3/98, 1/22/99, and 7/29/99 that each contained 25 micrograms of toxic mercury. Subsequently, the patient experienced mercury poisoning allegedly as a result of having received vaccines containing toxic mercury that were administered to the patient between 7/29/98 and 2/10/00. To date, the patient had received the neurological, social and developmental milestones anticipated for a child of her age. The patient's mercury poisoning persisted. Upon internal review, mercury poisoning was considered an other important medical event (OMIC). No further information is available.
Patient was given 1st Moderna vaccine and he was under 18 (17 yr and 9 mo) Patient and step-father deny and adverse reactions
Pressure in right ear developed 5 daysafter vaccination; Pain in right ear developed 5 days after vaccination; Tinnitus developed in both ears 36 hours after vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE 8730) via an unspecified route of administration in the right arm on 31Mar2021 at 12:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa and dairy. Concomitant medication taken within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 05:00, 36 hours after vaccination, the patient experienced tinnitus developing in both ears. On 05Apr2021, 5 days after vaccination, patient developed pain and pressure in right ear. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus, pain in ear and pressure in ear. The patient saw an ENT/Audiologist, 19 days after vaccination and received a week-long series of steroids (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE). Pain in my right ear decreased during the steroid series, but has returned since completing the steroid prescription. No change in tinnitus severity with the steroid and Flonase. The tinnitus is continuous and increases in severity with increased sodium intake or lack of sleep. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus developed in both ears, pressure in right ear and pain in right ear was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
11 days after MMR and VZV vaccines and on day 10 of Amoxicillin rash consistent with erythema multiforme minor vs. serum sickness like reaction.
Bright red, swollen right leg sore to touch, 5.5" length covered whole front leg spreading to back. Referred to hospital.
Complication after LE thrombosis left femoral and popliteal vein . Pain, compartment syndrome
Weight gain of 50 pounds since January, lactation without cause, extreme fatigue, lump in neck
Sick 10-24-2021. Admitted to health center 10-25-2021 with Chills, Diarrhea and rectal bleeding. Discharged 10-30-2021.
Post vaccine pt experienced multiple sneezes and became lightheaded. Pt assisted to floor by staff. Transported to med obs at 1300 via stretcher. Vitals obtained and monitored. While in med obs pt became nauseated and had several episodes of emesis. Water and saltine crackers given. All symptoms resolved. Pt released to home by self at 1405. After pt  was released, med obs staff was informed by vaccinator that pt appeared to have seizure like activity after vaccine was given. Pt was then in and out of consciousness and was assisted to the floor at that time. Vitals as followed: 1303 LYING BP 115/64 HR 61 RR 12 SPO2 94% 1310 LYING BP 123/59 HR 63 RR 12 SPO2 96% 1314 LYING BP 102/45 HR 86 RR 14 SPO2 95% 1322 LYING BP 113/59 HR 65 RR 14 SPO2 95% 1337 SITTING BP 93/66 HR 67 RR 14 SPO2 97% 1339 SITTING BP 115/67 HR 74 RR 14 SPO2 96% 1343 STANDING BP 108/66 HR 69 RR 14 SPO2 96% 1354 STANDING BP 132/65 HR 64 RR 14 SPO2 97%
This spontaneous report has been received from a medical assistant referring to a 46 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 23-JAN-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (strength, dose, route and lot number were not provided) for prophylaxis. No adverse effects were reported.
patient states he felt unable to swallow- anxious Narrative:  Patient received solu-medrol, famotidine, epi, benadryl, and fluids
On April 9, 2015, dad saw Dr, a pulmonary specialist for a routine visit. He said dad was doing fine and suggested he get the new pneumonia shot, PREVNAR 13. He received that vaccine the same day at the pharmacy. He started coughing that evening. By Friday, April 10th, he was unusually weak and tired, irritable, had loss of appetite and still had a terrible cough. By Saturday, April 11th, he continued to have the above mentioned symptoms which had worsen and hadn't ate anything that whole day, plus he was now experiencing wheezing, had a fever and had developed shortness of breath. He was so weak that he could hardly walk or get undressed for bed. We took him to the ER that evening and he was admitted to the hospital at once. We were told he had developed pneumonia. He was in the hospital and rehab for almost three weeks. He's now home, but is still receiving therapy to get his strength back.
Tested positive for Covid upon return home from Cruise. Did a home test. 10 people in the group of 13 all tested positive. We all had negative tests prior to the cruise. I assumed I had a sinus issue as I had post nasal drip, sore throat, drippy nose. Occasional cough. I tend to get these symptoms when traveling. No temp elevation that I am aware of.
patient was administered Menactra accidentally mixed with Varivax instead of diluent, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 11 years old male patient who received 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6522aa via intramuscular route in the right arm on 25-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), HPV VACCINE (HPV VACCINE), INFLUENZA VACCINE (INFLUENZA VACCINE) and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Immunisation.  It was a case of actual medication error due to product preparation error.  It was reported that a patient was administered Menactra accidentally mixed with Varivax instead of diluent. The medical assistant mistakenly thought the Menactra was the diluent for the Varicella and mixed them together and administered it to the patient.  At the time of reporting, no adverse reactions were 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 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.
L thigh redness, edema, red streaks minimal (per Mom). No fever, weakness. Local rxn only.
Rash appeared approximately seven days after injection.  I first noticed it because it was itchy.  Area around injection site is red, swollen, and warm to the touch.  The rash is roughly 7.5 cm in diameter.  It was just a little itchy the day it appeared (early hours of 3/12), but it isn't bothering me at all now (almost 24 hours later).  No pain, but a little more red and defined today.  I haven't needed to take any sort of OTC medication.  I alerted my doctor today after doing some research and determining that this was a known, uncommon, but ultimately harmless side effect of the Moderna vaccine.  I let him know I was going to go ahead and file a report.
Vaccine administered at 10:18am; after 10:20, pt began to feel a little dizzy and took a seat on a chair to see if she could recover, she was pale and sweaty looking and we placed an ice pack on the back of her neck and called a "Code White" (internal code for medical emergency) and called 911 for medical assistance; patient was alert to age and location, but still seemed in poor condition; She leaned forward, appeared to have passed out, leaned back on the chair, with extended arms, then vomited. at 10:25, patient appeared to recover, so we offered paper towels to wash up and a cup of water to rinse her mouth out, but she was still somewhat out of it. at 10:32, first responder, police office arrived, at 10:34, subject complained of feeling warm again, so we placed ice pack on back of neck and wet paper towels on face and wrist areas. at 10:35, Ambulance service arrived, evaluated patient, advised they would like her examined at Emergency Department, urgent care, or her primary care provider. She elected to go to hospital emergency department via ground ambulance;
Fever began at 1:45 am on 2/18/21 - 102.0 for almost 2 days, then down to 101.1, no fever on 2/21/21 Severe vomiting began 2/18 and was continuous for a little over 24 hours, then nauseous beyond that until Sat night 2/20/21 Could not drink fluids or eat for almost 24 hours, then took 1 tablespoon of water every 30 minutes for 5 hours Muscle soreness at site of injection, swollen
SUDDEN ONSET RHEUMATOID ARTHRITIS 46 DAY AFTER 4TH INJECTION.
Information has been received from a physician concerning a 7 day old patient who was vaccinated with a dose of RECOMBIVAX HB. There was no concomitant medication. The patient had a positive Hepatitis B surface antigen after RECOMBIVAX HB was given. The physician stated the patient's mother was negative. It was unknown if the patient sought medical attention. At the time of report, the patient had not recovered. Additional information has been requested.
Patient recieve both pneumo and flu vaccine in same arm.  Next day patient had red, hot, swollen back of arm, but no redness at injection site.  Patient went to instacare and was prescribed doxycycline and zyrtec and recieved an unknown shot and was feeling better in two days.
Patient reports sudden onset sore throat/ itching a few hours after receiving vaccine. She took an allergy medicine (name not given) and symptoms went away in a few mins-hour. Husband also had similar symptoms around the same time and he had received same vaccine as well.
I keep getting chills; I get hot; I have a headache; My arms I cant move its really sore and pain goes to my breast; My arms I cant move its really sore and pain goes to my breast; I was experiencing tightening in my breast; I felt terrible today; Earlier this morning I had trouble breathing and but it hasn't came back again I am not sure about 20 minutes; This is a spontaneous report from a contactable consumer reporting for herself. This report was not related to a study or programme. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0182; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 30-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history, investigation assessment included none. Concomitant medications included ibuprofen (IBUPROFEN); elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) taken for an unspecified indication, start and stop date were not reported. Patient stated she was taking both medications. The patient previously took first dose of BNT162B2 on 26Apr2021 for covid-19 immunisation in left arm. Patient stated that lot number for first one was EW0170, and she think it was 00 and not sure. Patient stated that there was no expiration date on there. The patient experienced keep getting chills, get hot, had a headache, arms cant move its really sore and pain goes to breast, was experiencing tightening in breast on unspecified date; earlier this morning had trouble breathing and but it hasn't came back again, not sure about 20 minutes, felt terrible today on 18May2021. Patient reported that she had second shot the day before this report and just getting, wanted to know the side effects that are possible because she felt terrible on the day of this report and wanted to think it was necessary for her to go to the hospital because she heard that you could get a side effect like lost it off because it was her second day as whatever as she did not know if it was true. Patient asked they usually what we put the shot you get a side effect that will last a day and patient asked if that was true. Patient reported that she keeps getting chills, get hot. Had a headache. Her arms cannot move it was really sore and pain goes to her breast. earlier on the morning of this report, she had trouble breathing and, but it hadn't come back again it was just for about 20 minutes. Patient thought it went away that morning her side effects came back again. Patient was just curious on when she should go to the hospital, or should she wait on it. Patient stated that she was experiencing tightening in her breast. Consumer was informed about Pfizer Medical Information Department. It was reported that due to poor internet connectivity issue voice did not get through and hence patient disconnected the call. Clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Headache, body ache, fatigue, pain, redness, hard knot at injection site.  Fever 102 degrees.  Flu like symptoms for two days so far.
This spontaneous report as received from a registered nurse refers to a 3 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
0835 Injection, 0930 Blurry Vision driving home / 150-200 feet before I could read road signs. 1000 hours chicken noodle vegetable soup. Lie down / chills them "hot" off and on PM / rest of the day / no discernible fever by forehead touch / mild headache. 0700 4-11-2021 no headache, but brain "felt sore"; best I can describe it. 1030 hours 1000mg Tylenol, repeat at 1900 hours / repeat at 0400 hours 4-12-2021. 0800 hours 4-12-2021 "brain soreness" mostly gone. Many bowls of chicken noodle vegetable soup 4-10 / 11- 2021. Muscle / joint pain 4-10 / 11 / 2021 but I expected that. Some joints surprised me. Blurry Vision / brain soreness was a total surprise.