chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthritis in fingers in both hands, and in right toes. Stiffness. Lower Back Pain (very painful). It has been about three days of arthritis symptoms, it has gotten worse, not any better yet.
all over body numbness, legs, back, hands face, forehead that started 3 weeks and 5 days from the booster , symptoms a week later improving, no weakness
Patient was in clinic for 2nd dose of Moderna.  She did not have her vaccine card with her.  Nurse administered Moderna Bivalent instead of Moderna Monovalent.
Red blotches on thighs with itching. Itching on spine and shoulder blades
Initially total body myalgia, diffuse headache, joint pain beginning 9 hours after injection. Continued the following day and noticed L neck swelling (ipsilateral side). No fever or pain noted. Second night had night sweats. Finally felt better the next morning but noticed the left neck supraclavicular lymph node swollen. Still no fever or pain at the neck site, just pain when lifting left arm.
Patient first noted small patch of hives on wrist and then went to sleep. Awoke this morning with diffuse urticaria. No mucosal involvement or respiratory symptoms.
Respiratory distress; sleeps a lot; out of breath/ difficulty breathing; memory (short) problem; blister mouth; high blood pressure; oxygen 83-85; Temperature-100.3/100.8 Fahreinheit; Grunting; Dry cough; This is a spontaneous report from a contactable other healthcare professional. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 09Sep2021 23:00 (Lot Number: FC3182) (at the age of 79-years-old) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from Jun2020 and in 30Jun2020 for 10 days in hospital with Covid. The patient's concomitant medications were not reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 vaccine prior event being reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Aug2021 10:44 (Lot Number: EW0176) (at the age of 79-years-old) as dose 1, single for covid-19 immunisation and experienced short term memory, brain fog, sleeping a lot, out of breath. After 2nd injection on unspecified date in 2021, patient had 100.3/100.8 Fahrenheit degrees, high blood pressure, O2 (oxygen saturation) 83-85 for 5 days and out of breath. The signs and symptoms included sleeps a lot, out of breath, memory (short) problem, blister mouth in 2021. The time course of the reaction was between approximately 5 days and now. The patient did not require medical intervention for the events. The patient was not seen in the emergency department. The patient was not admitted to an intensive care unit. The Multiorgan involvement included Respiratory (out of breath) with respiratory distress, grunting (during night the most), dry cough, difficulty breathing. There was no hoarse voice, and it was unknown if patient had recession and cyanosis. The patient provided information to the reporter regarding the reported adverse event with the use of the product and the reporter considered the Pfizer product had a causal effect to the adverse. The outcome of blood pressure high, oxygen saturation decreased, body temperature increased was recovered in 2021 and outcome of all other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported event Respiratory distress. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Narrative:  Pt is a 87y.o. male who died on 02/12/2021 w/ h/o CKD4, Lung cancer, HTN, BPH, HLD. Pt received Moderna Covid-19 Vaccination 1/2 on 01/15/2021. Pt presented to ED on 02/11/2021 with low BS and AMS. Palliative Care consult 02/12/2021 with pt transitioned to comfort care. Pt died while inpatient on 02/12/2021 with physician reporting "Death was caused by: Severe sepsis with shock from urinary tract infection". Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
Patient presented at ER on 6/28/12 due to possible right leg infection after being immunized on 6/26/12. C/O redness, pain and swelling of right thigh. Patient was prescribed BACTRIM for cellulitis and released.
Information was received on 23-MAR-2018 from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 05-MAR-2015, the patient was inoculated at a hospital with ZOSTAVAX (lot number, dosage, and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 05-JAN-2017, the patient was diagnosed with shingles and neuropathic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Tested Positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested Positive for Covid-19) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced COVID-19 (Tested Positive for Covid-19). At the time of the report, COVID-19 (Tested Positive for Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she is taking concomitant medications but no specific medications provided. No treatment taken.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809), in right arm, on 26Feb2021 as dose 2, single (Lot number: EN6203), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 301308BA) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Jun2022 at 16:00 as dose 4 (booster), single (Lot number: 059M21), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: days after I completed my Paxlovid treatment; Positive, notes: 5 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Other medication in 2weeks was no. The patient received Anti-viral COVID 19 treatment from 19Jul2022 to 23Jul2022. The patient had no known allergies.
Left TMJ pain, persistent since 48 hours after vaccine.  Continues daily.   Intermittent frontal headaches 3 times a week
p/vax pt became fussy, crying for long period of time; crying episodes continued through 8/7/99; seemed lethargic; skin cold, clammy to touch; tylenol given;
Initial flushing in face and slight metallic taste in mouth lasting less than 5 min; Initial flushing in face and slight metallic taste in mouth lasting <5 min; tiredness; mild nausea; Next 1-2 days bruising more than my normal at site of injection; This is a spontaneous report from a contactable Other healthcare professional(patient). A 39-year-old female patient received first dose BNT162B2 via Intramuscular at Arm Left on 20Dec2020 11:00 at the 39-year-old at single dose for COVID-19 immunization. The medical history included Sulfonamide allergy, Varicose veins, 1/2 thyroid removed no meds, chronic sinuses take nasacort for and COVID-19. The concomitant medication was Vitamins. The patient previous took levaquin, chloraprep and both Allergies to them. On 20Dec2020 11:15 the patient Initial flushing in face and slight metallic taste in mouth lasting less than 5 min. Then tiredness for 12-24 hours as well as mild nausea and in well feeling. Next 1-2 days bruising more than my normal at site of injection. After that fine. Over all fairly mild symptoms. There was no treatment received for the adverse events. The outcome of the events Initial flushing in face and slight metallic taste in mouth was recovered on 20Dec2020 11:20, the other events was recovered in Dec2020.    Information on the lot/batch number has been requested.
Pain in upper arm and limited range of motion; currently performing self-prescribed exercises but still experiencing pain.
Information has been received from a RN concerning a 62 year old Caucasian female with a medical history of hypertension, asthma and "acid reflux" who on 11/05/03 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N)(P1: 10 years prior). There was no illness at the time of vaccination and no adverse events following prior vaccination. Subsequently, on approximately 11/05/03, the pt developed a rash, severe cough, local swelling, redness and heat also reported as red and inflamed at the injection site. Unspecified medical attention was sought, but the pt was not hospitalized. A product quality complaint was not involved. No further information is requested.
Felt tired and stayed home from school on 12/13/16. On that day they noticed a knot in his arm where the vaccine was given. Followed up in my office 1/10/17 for the knot that was still there. Told them to massage the area and move the arm around more. No redness at the injection site.
lost vision in one eye after 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of BLINDNESS (lost vision in one eye after 1st dose) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (lost vision in one eye after 1st dose) (seriousness criterion medically significant). At the time of the report, BLINDNESS (lost vision in one eye after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided.  No treatment information was provided.  Very limited information regarding the event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Pt. reports about 20 min after recieving her 2nd Hep B shout developed a headache involving the top of her head.  No visual disturbances.  On pain scale of 1-10 with 1=lowest & 10=highest, rate of H/A a 7.  Was pale B/P 130/90.  She consulted by phone with Hopsital, thought R/T Hep B shot.  No more Hep B shots.  2 hrs after took tylonal, H/A gon.  Felt fine.  C/O Nausea after H/A subsided.
Patient received 1st dose of Pfizer vaccine (Lot # EW0196), left deltoid at 0831, at 0840 patient started to complain off itching throat 7/10.  Vitals signs taken at 0845 and normal, Diphenhydramine 50mg (Lot # 6124006) given IM at 0900  in right deltoid by RN ., vitals signs taken again at 0909 and normal.  Patient stated itching decreased to 3/10 after diphenhydramine given.  Had NP  evaluate patient and airway is swollen.  Sending patient to ED via ambulance.
See attached The patient is a 27 y.o. female. She has not fully recovered from recent events. She states she got her pfizer covid vaccine on 9/5/21. She started having spasms diffusely the second day after her shot. It initially started in her feet then progressed upward. The spasms are not painful but it makes her jerk. The spasms occur randomly throughout her body throughout the day and last for a few seconds at a time. She is on magnesium to help her anxiety but this is not helping the spasms.  Then, she and her family then got sick with covid around 9/15/21.  She had palpitations and chest discomfort and went to the ER on 10/6/21. Her D-dimer and chest x-ray were normal. She still feels tired and has intermittent dry cough which comes and goes. She denies any shortness of breath. No fevers or chills. She continues to have the muscle spasms. She also had recent a bloody nose and had a large blood clots. Labs discussed with the patient.  PMH, FH, medications and allergies reviewed  Physical Exam: BP 128/72 | Pulse 76 | Temp 36.2 °C (97.2 °F) (Temporal) | Resp 17 | Ht 1.575 m (5' 2") | Wt 94.1 kg (207 lb 6.04 oz) | SpO2 97% | BMI 37.93 kg/m² General: no acute distress Head: normocephalic, atraumatic ENT: anicteric, EOMI, TM's clear, oral mucosa moist, no pharyngeal edema or exudates.  Neck: supple, no cervical lymphadenopathy, no thyroid tenderness or enlargement Chest: normal expansion. No use of accessory muscles of respiration Heart: regular rate and rhythm, S1 and S2 with no murmurs. Lungs: clear to auscultation, no wheeze, ronchi, rales, or crackles. Abdomen: bowel tones present, soft, nontender, nondistended, no guarding, rebound or rigidity Extremities: no edema, normal range of motion Neuro: alert and oriented, no focal motor deficits. Mood is appropriate  Assessment/Plan: 1. Myoclonus 2. Adverse effect of vaccine, subsequent encounter symptoms started after covid vaccine She declines medication treatment at this time  3. COVID-19 virus infection She has ongoing cough Will continue to monitor  4. Anxiety She is only taking amitriptyline prn  5. Fatty liver Liver tests in good range at this time  6. Iron deficiency anemia, unspecified iron deficiency anemia type Improved with changes in diet and supplements  7. Irritable bowel Has dicyclomine and hyoscyamine prn  follow up as needed.
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 54 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U032852 with expiration date 20-OCT-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 54 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U032852, expiration date 20-OCT-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Patient reports dizziness and sweating approximately 20 minutes after receiving vaccine. Temp 98.0, B/P 140/98, O2 Sat. 98%, HR 62.  Juice was offered.  Patient stayed one and a half hours before calling for a ride home.
Narrative: He notes having developed 5x episodes of vomiting a/w nausea after the initial vaccination. He did not seek or try any treatment and both resolved with rest/sleeping. He denied other common adverse effects or s/sx of immediate allergic reaction, angioedema, or anaphylaxis.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 27-MAR-2013, the patient was vaccinated with a dose of improperly stored PROQUAD (Lot number was H020140, expiry date was 07-MAY-2014, route and dose were not reported) at around 10-11 am. No adverse effect was reported. This is one of the three reports received from the same reporter. Follow up information has been received from the medical assistant refers to a 4 years old male patient. The patient was vaccinated with PROQUAD (lot # H020140, subcutaneously) on 27-MAR-2013. Additional information is not expected.
I had a stomachache and strange sensation on the back of my neck 15 minutes after getting the shots, then when I got home about 10 minutes later the stomachache went away but I started shaking a lot and felt really cold. Then I got a really bad headache and started throwing up a lot. I had a severe headache for probably 30 minutes, but I took ibuprofen so it lessened to a mild headache that I had for a few hours. I felt weak and tired all evening.
Case number PHEH2015US026883, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 31-year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 07 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse event was reported following this medication errors. Follow up report received from nurse on 26 Jan 2016: Updated reporters comments.
Received shot at 2:03pm. Around 2:30 started feeling flush and my face and neck, then my whole body eventually felt warm. My tongue was also tingly. Mild chest pain, but didn't know if that was me getting nervous. Felt like heart was racing a bit too. I also felt dizzy. Told pharmacist, and asked if I could take Benadryl. I took 25mg Benadryl around 3pm and waited an extra hour in the waiting area. Continued with dizziness, tongue tingling and warmth until about 3:45pm when I left the facility. Took Tylenol once I got home around 4pm. Symptoms resolved by 5pm.
Patient experienced severe muscle cramping and spasms around her chest and back.  Intensity severe and affected the depths of breaths she could take.  Received vaccination around 11:00 AM and went to ER around 3:00 PM.   Blood work and EKG were normal.  Received methocarbamol and Prilosec.  Symptoms resolved in 48 hrs.  Not believed to be an allergic reaction.
Felt very week,; following day, I got fever,; headache,; bodyache; joint pain,; nauseas.; after 3 hrs receiving vaccine got extremly tired.; Very sleepy, slept into the following day.; This is a spontaneous report received from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:ER8732), via an unspecified route of administration in the left arm on 26Mar2021 at 13:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were reported as none. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 17:00, the patient experienced extremely tired, very sleepy, slept into the following day. On27Mar2021 patient experienced fever, headache, body ache, joint pain, nauseas, and on an unknown date felt very week and slept most of the day. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient took TYLENOL as treatment for the reported events. The clinical outcome of the events extreme fatigue, very sleepy, fever, headache, body ache, joint pain, nauseas and very weak was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Information has been received from Merck Pregnancy Registry for GARDASIL from a physician concerning a 21 year old female patient with a history of back surgery for scoliosis and one previous pregnancy with live birth (no complications or birth defects) who on 30-APR-2009 was vaccinated with a first dose of GARDASIL (lot # 661044/0548X). There was no concomitant medication. On 15-MAR-2009 the patient had last menstrual period. When she received first dose of vaccine she was pregnant. On 20-APR-2009 was estimated conception date. 08-JUN-2009 she began to take prenatal vitamins 1 tablet once a day for supplement. On 09-JUN-2009 ultrasound was performed for estimated delivery date. Estimated delivery date is on 11-JAN-2010. Follow up information received from a physician indicated that the patient was a female. Sonograms performed on 01-SEP-2009 and 07-SEP-2009 showed no anomalies. On 14-JAN-2010 at 40 weeks from her last menstrual period the patient gave birth to a normal male with no congenital anomalies. The baby's weight was 3718 g, length 19.5 inches, apgar score were 9/9. The baby's head circumference was 34.5 cm. A On an unspecified date the patient developed gestational diabetes. The patient's gestational diabetes was unknown. No further information is available.