chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left foot swelling; Felt a little bit of discomfort; Severe pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180), as dose 2, single via an unspecified route of administration in left arm on 08Jun2021 at 11.00 for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0185), as dose 1, single via an unspecified route, administered in left arm on 18May2021 for covid-19 immunization, past drugs include second dose of shingles vaccine in Mar2021 and ongoing vitamins, started about 7 years ago. On an unknown date, the patient experienced left foot swelling around the ankle area. The patient stated that, left foot swelling is ongoing and right now has not worsened and was not worse and he saw his doctor yesterday and is waiting for test results which is x-rays and blood work. The patient was in perfect health and this is throwing him all off and his foot started swelling. He had a physical last year in Sep2020 and it came out clear and he takes no medications. The patient was not treated for the events, as he thought it would go away the first two weeks and he does a lot of walking for his job and did not have severe pain until this Monday and felt a little bit of discomfort and did go to his doctor yesterday. The patient underwent lab tests and procedures which included blood work and x-rays, result unknown. The outcome of the event of left foot swelling was not recovered. The outcome of the event of discomfort and severe pain was unknown.  Follow-Up (02Aug2021): Follow-up attempts are completed. No further information is expected.
3 hours after FLUVAX: developed dyspnea, cough, conjunctivitis, rhinitis, ST so came to doctor's office. When in office, became hypotensive. Dx:anaphylaxis and treated with IM BENADRYL and Epinephrine. Ambulance pt to hospital and given IV TAGAMET and recovered.  11/7/08 Reviewed ER medical records of 10/22/2008. FINAL DX: acute allergic reaction; conjunctivitis Records reveal patient experienced eye discomfort & swelling, heat, chest tightness, cough & jaw discomfort approx 2 hours s/p vaccination.  RTC & tx w/epi, IM benadryl.  BP at that time 80/50 & transported to ER.  Improving by the time arrived in ER.  Exam in ER revealed dramatic swelling & crusting of eyes, scleral injection, tongue cramping.  Pulse ox initially was 91% & BP supine 130/76, standing 106 systolic.  No reaction to previous flu shots.
This is a spontaneous report by a contactable physician. This female physician reported on behalf of a female patient, unspecified age and ethnicity, received PREVNAR 13 unknown dose unknown frequency by unknown route unknown dosage form at 10:50am on right thigh and hepatitis A vaccine on left thigh on 16Apr2013. Relevant medical history was none. Relevant concomitant medications were none. Vaccines taken within the last four weeks were none. On 17Apr2013 in the morning while PREVNAR 13 unknown dose unknown frequency she experienced fever. On 19Apr2013 in the morning, she experienced facial swelling, body swelling and difficulty in breathing. In Apr2013, she was hospitalised in Intensive Care Unit and was kept in an incubator in response to facial swelling, body swelling and difficulty breathing. The physician was not sure if there was a causal relationship between the vaccine and the events. Sibling information was unknown. Relevant lab data was none. At the time of the report, she had not recovered from all the above mentioned events.
Sudden death while sleeping at night. Post mortem pending.  7/3/07 Received autopsy report which reveals COD as Sudden unexplained death of infancy while co-sleeping w/adult & manner of death as undetermined.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 10-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N030174 and expiration date 13-JUN-2019) orally for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Left arm soreness following the injection lasting a week. 4 hours after injection, Pt experienced fever, chills, and sweats lasting most of that first night. 100.4 degree F temperature for several hours during that night.  Day 1 - Pt had severe whole body muscle aches, neck soreness and ringing in left ear. Pt experienced severe balance issues, including a fall from standing height without injury. The balance issues lasted 4 days, and the ringing in ears lasted for 1 day. Day 10 - Pt described having hot flashes that lasted from a few seconds to several seconds in duration this continues today, this has been happening since Day 6. In addition, Pt feels mildly fatigued, with episodes of "spacyness" that continue today.
Patient received a vaccination on 01/29/2018, on 02/01/2018 patient called the pharmacy complaining of hearing loss in the right ear, pressure on the left side of his head, hot flashes, chills, vomiting, and diarrhea. Patient stated the symptoms started the day after he received the flu shot on 01/30/2018.
I received Moderna vaccine on March 11th and my life has not been the same since; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I received Moderna vaccine on March 11th and my life has not been the same since) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced IMMUNISATION REACTION (I received Moderna vaccine on March 11th and my life has not been the same since). At the time of the report, IMMUNISATION REACTION (I received Moderna vaccine on March 11th and my life has not been the same since) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Since received Moderna vaccine, patient's life was not been same. Treatment details were not reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Tingling in left hand, forearm and left foot almost immediately after being administered shot. Symptoms continue to persist a few hours after shot.
Extreme fatigue, severe nausea, fever (100.7), ear ache, headache, body aches, oxygen level dropped to 95% (usually 100%), heart rate increased to 99 (normally low 60's), felt overall horrible for 24 hrs. Then, all symptoms went away except the fatigue which was pretty bad for 2 more days and then has lingered at a more mild level since the vaccine.
Allergic reaction; Allergic reaction (rash); This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction and rash. On an unknown date, the outcome of the allergic reaction and rash were unknown.   It was unknown if the reporter considered the allergic reaction and rash to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had an allergic reaction rash after receiving a Flu vaccine manufacturer unknown 15 years ago prior to the reporting date. Conservatively captured the event.
Pt 30 yo m Physician w/ no prior allergy history who was administered a COVID Vaccine 2hrs prior to his pruritic rash b/l hand, neck and lower mid back itching otherwise not in any acute distress, with normal vitals and negative difficulty breathing, swelling of face and throat or tachycardia.  Physical Exam was normal other than reported symptoms.  Plan to treat w/ H1 Antihistamine. Pt will follow up ER if breathing or throat becomes an issue.  For now will treat w/ H1 antihistamine.  No H2 antihistamine at the pharmacy.  I'll be submitting VARES.
woke up with shakes turning into convulsions lasting 30 min. followed by uncontrolled vomiting 4 hrs fever, headache, dizziness.  4 days sore muscles from vomiting and convulsions
pt playing in floor had been running some mild fever; pt started seizuring; mom grabbed pt up-states pt temp sky-high by feel-went to ER-t103.5 when taken; pt CXR & tests to r/o infect;
11 mins into having the 2nd shot my daughter Was saying her stomach hurt she couldn?t breathe her heart was pounding she turned white as a ghost she was sliding out of her chair, then wasn?t able to really speak much, be came hot in touch sweaty. Call the pharmacist over he offered us an ice pack then put it on her head it was rotating it to her side of her neck and back  then her color started coming back.
Localized reaction, 3.5x2.5cm of induration, erythema - slightly warm and slightly tender.
Cardiac arrest! Stopped breathing, collapsed! CPR w/in 5 mins, AED w/in 10 mins Paramedics. ER - implanted w/ ICD. 11/12/08-records received for ED visit 10/21/08-presented after a witnessed collapse while in basketball practice. AED was connected and a single shock given. At ED awake confused and agitated. Transferred to another facility.12/1108-records received for DOS DC 10/21-10/26/08-DX ventricular fibrillation status post implantation of cardiac defibrillator.
Patient states injection site was painful immediately after injection and has remained that way since (has been about 1.5 months). Directed patient to reach out to her PCP to rule out other possible causes of her prolong pain at the injection site.
needle separated from syringe during attempted injection; half of the dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle separated from syringe during attempted injection) and ACCIDENTAL UNDERDOSE (half of the dose administered to patient) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021 at 1:01 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021 at 1:03 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (half of the dose administered to patient). On 31-Mar-2021 at 1:01 PM, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle separated from syringe during attempted injection). On 31-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle separated from syringe during attempted injection) and ACCIDENTAL UNDERDOSE (half of the dose administered to patient) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle separated from syringe during attempted injection) and ACCIDENTAL UNDERDOSE (half of the dose administered to patient) to be not related.    It was reported that appoximately half way through the injection the needle separated from the syringe at the hub resulting in 1/2 dose being administered. The staff was instructed to administer a second inject of 1/2 dose. This resulted in 2 injections but a full dose was administered.  The reporter stated that the patient stayed for observation (15 minutes) without any adverse effects. Also noted that a follow up call was made several days later and the patient reported no adverse effects. No concomitant medications were reported. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Patient demographics, product information and event details updated
Sunday evening around 9pm, I suddenly got a severe headache, and while I always take only 1 Ibuprofen, I knew that this was a 2 tablet headache. The headache increased in strength through the night, and my whole body felt half paralyzed... I found it difficult to move my arms or legs or anything. Headache pain continued to increase Mon. morning, although I was able to sleep Sun night. Partial 'paralysis' continued through Mon, but was gone Tues. morning. I tried to eat a cup of chicken broth on Mon, but it, and even water later, came back up. Could not eat and keep down anything until Wed morning (1 egg), and I contacted Medical Nurse. She suggested Saltines, and plenty of water, which I had been trying to drink. Am finally out of bed today, Thurs, but exhausted just from dressing!
Hello Dr.,   Yesterday after we got home around 3:30 and patient had a moderate allergic reaction with symptoms of anaphylaxis. It looked exactly like his past food related reactions and when we were pretty sure his symptoms indicated breathing trouble we gave him the epipen.  He complained of sore throat, trouble/pain swallowing, tummy pain, and he was very sneezy and runny nose/trouble talking, lots of gas, swelling in his face. The Epipen definitely helped but he still had some sore throat and discomfort. I just wanted to run this all by you since he also had the Covid shot yesterday. We called the 24/7 advice people and the Doctor we spoke to said there was no history of this type of reaction from the vaccine and said we could stay home and monitor. Patient ate some novel packaged snacks that could have potentially been the cause but it?s really not clear so we plan to discuss with allergist. He?s still sleeping but We?ll monitor him today. We?ll see you tomorrow for his well check.
PT REPORTED THAT THE NORMAL REDNESS AND IRRATATION ASSOCIATED WITH VACCINES HAS BECOME WARM TO THE TOUCH AND IS SPREADING OUTWARD.
easy bruising up and down the arm/the patients platelet count was "7,000" and dropped to "2,000"; This spontaneous report was received from a physician via company representative and refers to a 17-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) subcutaneous injection, dose 1, lot # R030806 and expiration date 24-OCT-2020 (formulation, exact dose, route of administration were not reported, site of administration was not confirmed, reported as left or right arm) for prophylaxis.  On 07-JUL-2019, the patient experienced easy bruising up and down the arm (not confirmed if the bruising was on the same arm the injection was administered into). On 07-JUL-2019, she was admitted to the hospital and her platelet count was 7.000 and dropped to 2.000 (units not provided). As treatment she was administered a dose of IVIG (Intravenous Immune Globulin), and a second dose 24 hours later. On 10-JUL-2019, it was noted that patient's platelet count stabilized at 20.000 (units not provided) and she was discharged from the hospital. The outcome of platelet count decreased was reported as recovered/resolved on 10-JUL-2019. No causality assessment was provided by the reporter.
Patient had a localized reaction, redness and swelling knot at site. Patient is to apply cool compress and can take motrin if he is having pain. Typically go away in 5-7days. This is not the first time this have happened with our patients who receive the Menveo (meningococcal) vaccine.
LETHARGIC; VOMITING; SHAKING; FEVER; DIARRHEA; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included sulfa allergy, gluten allergy, dairy allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2020, Laboratory data included: Glycosylated hemoglobin abnormal (NR: not provided) UNKNOWN. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced lethargic. On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced vomiting. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced shaking. On 06-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, vomiting, chills, shaking, and diarrhea on 06-MAR-2021, and had not recovered from fever, headache, and lethargic. This report was non-serious.
Patient presented with abdominal pain two days following administration of vaccines, later to be diagnosed with mesenteric panniculitis.
330AM on 7DEC98 by 950P pt devel severe dizziness & nausea;treated @ hosp ER w/IV fluids x 3hr & released;exhausted all day 8DEC98;
HAD SHORTNESS OF BREATH AND FELT LIKE LUNGS WERE FILLING UP HAD COUGH ALL NIGHT THAT RESOLVED IN AM AND HAD MYALGIAS FOR THREE MORE DAYS FEVER FOR 24 HOURS COUGHED UP "MOUTH FULLS" ALL NIGHT PRESSURE BEHIND EYES HAD
Received Moderna Booster 2/23 at 11am  around 8pm extreme exhaustion hit at 8pm. Went to bed never really fell asleep awful headache developed, shills, arm soreness, chills then the sweats and body ache over the night remained awake no meds helps headache. The headache continues and left flank pain developed and nausea arm pain better but large tender axilla discomfort on side of injection.. The flank pain developed in a very sharp constant pain near my scapular. Headache resolved Friday evening and sweats continues 1 more night by Saturday at 5pm scapular pain better and headache remained gone. Axilla still tender very slight flank pain all other symptoms resolved at the time of this report.
Body aches, especially left arm. Swollen arm. Big red patch on arm. Lymph nodes in right armpit swollen and tender to the touch. Lymph nodes were swollen for 4 days
Every flu shot I have ever taken has made me sick; Initial information received on 08-Dec-2020 regarding an unsolicited non-valid non-serious case received from a consumer (Patient) via social media.   This case involves a patient of unknown demography who developed every flu shot  had ever taken made sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination, family history and concomitant medication was not reported.   On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site.   On an unknown date (unknown latency), the patient got INFLUENZA VACCINE and reported every flu shot  had ever taken made sick (illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Pt presented to Hospital pediatric clinic 24 hours after receiving 2nd varicella vaccine with abrupt onset of edema, erythema, pain, tenderness, and itching over site of injection.  Erythema measured approx 5x6 cm.  Treatment initiated with Atarax and amoxicillin (for possible cellulitis).
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)0.5 ml in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
PATIENT HAD SEVERE BODY ACHES THROUGH THE NIGHT, THE NIGHT OF THE VACCINATION. LASTED APPROXIMATELY 12 HOURS. NO MEDICATIONS WERE TAKEN FOR THIS. PATIENT SAID THIS SUBSIDED IN THE MORNING
Patient reported to pharmacy on 4/2/18 she saw her physician on 3/31/18 for shingles-like symptoms. She reported a burning/tingling sensation accompanied by a rash on her right leg. Physician prescribed an anti-viral. Vaccines were administered on 3/24/18.
Lesion almost like a bulls eye 1 1/2" x 1 1/2" 7 days post injection of Varivax vaccine. Treatment suggested was cool compresses
Baby had MMR on 4/28/10 developed rash 9 days later over entire body was seen in office on 5/8/10-dx MMR Reaction (Erythema Multiforme).