chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started with Severe pain felt like a charlie horse in my left calf and foot that would not go away for more than 24 hours. My Blood pressure spiked and i got a migraine from the pain , My left leg and food felt like stone.. The next day  I called the nurse from my insurance company and she advised I go in to the hospital. Went to ER got a Ultrasound, blood tests and the ultrasound came back positive for a DVT clot. Treatment is Xarelto and follow up with my primary. Lab Results came back normal.
LOWERING OF WHITE BLOOD CELL COUNT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 19-MAR-2021, the subject experienced lowering of white blood cell count. Laboratory data included: White blood cell count (NR: not provided) Lower. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lowering of white blood cell count was not reported. This report was non-serious.
Nausea, Vomiting, Headache, severe chills, severe muscle aches, injection site pain, fatigue. Onset was 12 hours post injection and have lasted for 36 hours since symptom onset. Symptoms are improving slightly as of submission of this report.
Patient received the Moderna vaccine, and he is only 17.  He experienced no adverse effects, but this vaccine has not been approved for his age.
No symptoms or reactions reported. Patient was accidently given another flu shot this year. (2 total)
COVID 19 Treatment; COVID 19 Treatment; Name of Drug as Reported: Moderna, Dose number: 04; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6206), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 46 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Sep2022 at 05:00 as dose 4 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "perimenopause" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "migraine" (unspecified if ongoing); "non specific joint/connective tissue disorder with similarities to, but lacking diagnostic criteria for, EDS, Marfan's" (unspecified if ongoing), notes: non specific joint/connective tissue disorder with similarities to,; "known allergies:Sulfa" (unspecified if ongoing), notes: known allergies:Sulfa; "known allergies:penicillin" (unspecified if ongoing), notes: known allergies:penicillin; "known allergies:latex" (unspecified if ongoing), notes: known allergies:latex. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022, outcome "unknown", described as "Name of Drug as Reported: Moderna, Dose number: 04"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2022) Negative, notes: Tested negative for COVID (after taking Paxlovid) on antigen test Friday, Saturday, Sunday; (15Oct2022) Negative, notes: Tested negative for COVID (after taking Paxlovid) on antigen test Friday, Saturday, Sunday; (16Oct2022) Negative, notes: Tested negative for COVID (after taking Paxlovid) on antigen test Friday, Saturday, Sunday; (17Oct2022) Positive, notes: Monday - tested positive for COVID again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: It was reported that other medications in two weeks reported as yes. Patient started treatment for COVID 19 with Paxlovid on 09Oct2022 and stopped on 13Oct2022.
I had a delayed reaction to Dose 3 Moderna on 12/03/202, 045321, on 04/07/2022, in which I had an increased heart rate and blood pressure to point that have to leave work and miss a couple of days work. I sought advise from my primary care physician and we are working on test and treatment plan. The following test are being administered, Echocardiogram, Stress test via exercise, and VA-us-carotid-duplex bilateral, and blood work. Still under care treatment plan with physician. Blood pressure is still irregular.
This spontaneous report as received from a health professional refers to a 14 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of Gardasil. It was reported that the dose the patient received was unspecified. On an unspecified date, the patient developed genital wart after receiving the vaccine. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a nurse practitioner concerning a 22 year old female patient with no medical history or allergies who on 22-FEB-2007 at 13:00, was vaccinated IM into the left deltoid with a first dose of GARDASIL (Lot# 653938/0954F). There was no concomitant medication. On 16-APR-2007, the patient developed diffuse genital warts with no exposure to a new sexual partner. The patient was treated with ALDARA with good resolution. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Received second dose more than 36 days after the first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after the first) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after the first). On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after the first) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-424298 (Patient Link).
Chills (4 h after vaccination, might last for 6 h) Nausea (just after vaccination, last about 1h) High fever (10 h after vaccination, might last for 3 h, about 102F) headache (12 h after vaccination, last for a day, I took ibuprofen after the fever to relief the headache) fatigue (the second day, last for 3 days) rash (the second day, last for 1 day) canker sore ( the second day, last for a week) short of breath (the third day, last for 2 days)
IMMEDIATELY AFTER GIVING THE VACCINE, THE PATIENT SAID HE WAS GETTING NAUSEOUS THEN PASSED OUT IN THE CHAIR, THEN HAD A SEIZURE WHICH LASTED APPROXIMATELY 15-30 SECONDS (SMALL JERKY MOVEMENTS AND MADE SNORING SOUNDS). 911 WAS CALLED. PT SPONTANEOUSLY REVIVED WITHOUT RECOLECTION OF THE INCIDENT.  HE WAS PALE AND CLAMY, AND VOMITED A SMALL AMOUNT. HE DID RECALL THAT BEFORE LOSING CONSIOUSNESS,  HE FELT NAUSEOUS AND HAD TUNNEL VISION.  EMT CAME, AND PATIENT REFUSED CARE.   AFTER WAITING 30 MINUTES, PT THEN LEFT.
Restlessness, insomnia, generalized itching, runny nose, headache.
4 mo physical on 6/23/03. Mother stated post 2 mo shots both legs swollen and tender. Infant extremely fussy. Applied warm compresses 6/24/03 after DT and IPV. Stated L leg site round, red, puffy, dime size-Tylenol compresses.
3 days after my  1st vaccination, I was laying down and I had tremendous sharp pain in my left upper shoulder,  just going across my chest  and shortness of breath. I had a hard time laying down and getting comfortable. The next 3 nights I laid  in a chair, because I couldn't lay down to sleep. I walk like 6 miles a day, I went to bend over to get a newspaper, I could hardly get up because of the pain , if it weren't for my walking stick, I don't know if I could of gotten back up. About the 4th night, I couldn't breathe, so I went to he ER. After about 7 hours they diagnosed  that I had fluid in the heart. And they prescribed Prednisone. The whole time I was in the ER room, I just saw nurses, never saw a doctor. That really upset.  My neighbor who is a doctor, reminded me these symptoms started after my vaccine.   A week later I  thought I was literally going to die because I couldn't breathe, the pain was so intense. I went to a different hospital. I had a sonogram that showed I had fluid in my heart. And they gave me a very high dose of Prednisone. I was admitted in the hospital for 2 days. I was under a lot of observation and they administered the prescribed medication.  Unknown, If I am recovered from the AEs because I am still under the care of Dr. until December because I am still on Prednisone and he is trying to wean me off.  I never had heart problems prior to the vaccination. There are no heart problems in my family.
Right arm sore, red, hard. Around 1:00 a.m. I became very nauseous. Chills began and lasted through night. Upon awaking light headed, arm worse but nausea had stopped. My taste was funny like when I had Covid. No appetite. Chills came back during morning. Fever 101. Fatigued went to bed. Slept all afternoon. Still no appetite. Cough returned as when had Covid. Fever no higher. Went to bed woke up fine. Lasted 36 hours.
Recurrence of tinnitus after 8 years of not experiencing with loud noises or just around me. Subjectively, background tinnitus is about 2X what it was before and tinnitus with loud noises is 10X-20X more intense to the point of making me try to avoid the noise triggering it.
Determined to have Miller-Fisher Syn. 10-5-15 at hosp. Received plasmapheresis 5 days.
On the left side of her throat feels like something is in there.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), 0.3 ml single (Lot number: FM0698, Expiration Date: 31May2022) at the age of 61 years, in left hand for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Manufacturer: Pfizer, NDC: Unknown, Lot: EW0151   , Expiration: 31Jul2021, Time given: She said time is not listed but she received during the day., Anatomical location: Left hand side, Dosage: 0.3 ml), administration date: 08Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Caller said just the sore arm and that was it."; BNT162b2 (Dose 2, Manufacturer: Pfizer, NDC: Unknown, Lot: EW0167, Expiration: 31Aug2021, Time given: During the day , Anatomical location: Left hand side, Dosage: 0.3 ml), administration date: 30Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Caller said just the sore arm and that was it."; BNT162b2 (Dose 3 (First Booster), Manufacturer: Pfizer, NDC: Unknown, Lot: FH8020, Expiration: 31Jan2022, Time given: During the day, Anatomical location: Left hand side, Dosage: 0.3 ml), administration date: 03Nov2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "Caller said just the sore arm and that was it.". The following information was reported: OROPHARYNGEAL DISCOMFORT (non-serious) with onset 27Apr2022, outcome "not recovered", described as "On the left side of her throat feels like something is in there.". The event "on the left side of her throat feels like something is in there." required physician office visit.  Additional information : Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine was reported as none.  No follow-up attempts are possible. No further information is expected.
Noted on Thursday night 6:30 pm during bath. Redness, Swelling-tight, hot. Shoulder to 1 inch above on outer aspect  of left arm. Taken to quick Care. See pmd in a,. State they saw doctor this morning. Swelling down. Tylenol and ice packs. Low Grade Temp.
6/9/10 PA note: Veteran presents with chief complaint of L arm numbness/tingling. He was given a PNEUMOVAX 23 in L arm earlier this morning by nurse and thinks he may be having reaction. Hypertension, uncontrolled. Muscle weakness left side, rule out TIA or embolic event. From nursing note: Veteran ambulatory to clinic with complaint of pain and discomfort in Rt deltoid. PNEUMOVAX 23 was given to him this AM in that arm. No redness noticed, but movement was difficult and painful. From urgent care note: This 57 y/o male presents with: to uc per w/c sent for eval of increased BP. Reported from nurse that pt presented to clinic c/o left arm weakness, states he received a PNEUMOVAX 23 vaccine in that arm this am. Upon eval found to have BP of 201/125 rechecked in 5 min 158/108. On admit to UC pt is a/o, calm and cooperative. Denies any chest pains, dizziness, or headache. Speech is clear. States left arm is weak and feels like he cannot move it, pt was able to lift it and exercise it upon request. BP 203/129 p 100 on admit. BP recheck in 2 minutes 189/93 p 99. From June 10 PA note: Left upper arm hot, red and swollen in the area of the injection site. Elevated tempskin mildly indurated and tender to touch. Cellulitis. KEFLEX 500mg po BID x 14 days Prednisone 10mg po q day x 2. Ice pak x 20min. QID PRN pain. From June 11 PA note: Pt is here with chief complaint of chronic pain issues, reports the cellulitis is much improved. Symptoms: numbness tingling, hot skin, cellulitis at site.
Passed out at work; abnormal EKG; PVCs; This is a spontaneous report from a contactable other healthcare professional (patient).  A 52-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 12Jan2021 10:30 (Batch/Lot Number: UNKNOWN) as SINGLE DOSE for COVID-19 immunisation. Patient received first dose on unspecified date. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The  patient is not pregnant at the time of vaccination. Concomitant medications included losartan; nadolol; levothyroxine sodium, all were taken for an unspecified indication, start and stop date were not reported. On 27Jan2021 16:30, the patient passed out at work, has abnormal EKG, now PVCs. The event required Emergency Room visit. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
Information has been received from a nurse practitioner concerning a 16 year old female not pregnant who was vaccinated with a 0.5 mL dose of Gardasil.  On approximately 21-JAN-2008 (reported as last week) the patient was diagnosed with cervical dysphasia.  The patient's cervical dysphasia persisted.  The nurse practitioner reported that she did not know if the patient finished all three doses of Gardasil.  On approximately 21-JAN-2008 (reported as last week) a "PAP test" was performed.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/8/2008; 2/15/2008; 2/27/2008. In follow-up it was reported by the nurse practitioner that the patient a 16 year old female received GARDASIL vaccine from another provider. It was reported that the patient came to the nurse practitioner later for PAP which came back as high risk human papilloma virus on liguid prep. Typing was not done. Additional follow up form the NP indicated that she "wasn't the one seeing this patient when GARDASIL vaccine was started - she may have been infected prior." No further details were provided. Additional information is not expected.
postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation and referring to an adult patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On or about 16-NOV-2016, the patient was administered with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date were not reported) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by health providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): herpes zoster and postherpetic neuralgia. The outcome of the events was unknown.
Redness and hives around neck area - front and back and upper chest, also itching.  Also had cold-like symptoms.  Lasted from Wednesday, June 19 til June 23.
I've developed a large rash covering my stomach and chest as well as down into my crotch area.
Pt returned to health clinic 45 minutes after immunization reporting dizziness and blurry vision
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/10/2021. Death 8/20/2021. From Vital Records COD = SEVERE HYPERKALEMIA, ACUTE RENAL FAILURE, ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 PNEUMONIA. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT, HOSPITAL; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN.
50 doses administered after temperature excursion; 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 PRODUCT TEMPERATURE EXCURSION ISSUE (50 doses administered after temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (50 doses administered after temperature excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (50 doses administered after temperature excursion) 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.   No concomitant medications were provided. No treatment information provided.
This spontaneous report was received from a consumer, refers to a 45 year old male patient with hypertension, blood cholesterol increased and asthma. There were not drug reactions or allergies. On 20-FEB-2015 the patient was vaccinated with PNEUMOVAX 23 injection, subcutaneous, (strength, dosage, lot # and expiration date were not reported). Concomitant therapies included losartan, SIMVASTATIN TABLETS, USP, ZYRTEC and VENTOLIN (ALBUTEROL). On 21-FEB-2015, the patient experienced dizziness, injection site erythema, nausea and pyrexia, subsequently the patient called to his physician and was prescribed ZOFRAN, for his nausea, other therapies given as treatment for the adverse events were TYLENOL, and MOTRIN. There were not laboratories diagnostics performed. The outcome of dizziness, nausea and pyrexia was reported as recovered on 02-MAR-2015. At the time of this report, the outcome of injection site erythema was not recovered. Additional information has been requested.
Patient was given vaccine on 7/8/22 which had a refrigeration expiration date of 7/2/2022. This was second booster dose.
First menstrual cycle after second dose lasted 4 days longer than normal and I experienced far worse cramps than normal. Additionally I have experienced spotting and bleeding between that menstrual cycle (16 Sept-22 september)  2021) and now. (13 october 2021) My next menstrual cycle is due to start in 3 days. My period is managed by nuva ring and I have never experienced these symptoms while on this form of birth control which I have been taking for approximately 1 year.
shot given at 6:04pm, passed out at 6:04pm. Patient fell and hit his head on the bottom of the pharmacy shelves. He was snoring, sweating, urinated on himself and came to at 6:06pm. He drank water, sat up and felt better at 6:15pm. The ambulance arrived at 6:20pm and patient declined medical help.
no sense of taste and smell; no sense of taste and smell; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 19Dec2020 8:15 pm intramuscularly to left deltoid at single dose for COVID-19 immunization. Patient medical history included diabetes diagnosed 02Nov2020. Family medical history was none. Concomitant medications included Metformin. The patient previously took PPD many years ago and had a rash. She received the COVID 19 vaccine on 19Dec2020. On Sunday (20Dec2020) 07:00, she had no sense of taste or smell and still has that as of today. She has not seen anything that says that is a normal side effect. There was no prescriber. She received it at the hospital where she works. She stated she just takes Metformin but did not believe it was relevant to this report. NO ER or physician's office required. No test. Vaccination facility type was Hospital. Not a military facility Vaccination. No previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). None Additional Vaccines Administered on Same Date of the Pfizer Suspect. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Localized redness at injection site. Varicella illness with lesions to head, neck, and extremities. Treated with Valcyclovir 1gm three times daily for seven days.
After the injection I had a red rash at the site of the injection and swelling but it went away within few days. On Day 8 I started experiencing itching, redness, and swelling at injection site. I took antihistamines throughout the day because my arm felt like it was on fire. Today is day 11 and I still have a rash, swelling and soreness on my arm. The rash fades a little at times throughout the day. It is not feeling as itchy today.