chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hit with extreme fatigue four days after 2nd shot. Legs felt rubbery. And I am a walker doing about 5000 steps a  day. Then  four days after the fatigue, I was hit with dizziness, and still experiencing both but not to the degree I was at first.   Also have a red, scaly rash on the backs of both hands. Been rubbing Neutragena  gel on them which has helped.
Lip, chin, face swelling; Lip, chin, face swelling; Rash and hives all over entire body; Rash and hives all over entire body; This is a spontaneous report from a contactable consumer (patient). A 12-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 03Sep2021 (15:00) as dose 1, single, with route of administration unspecified, for COVID-19 immunization at the physician's office. Medical history included sulfa meds allergy. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took amoxicillin, and had drug allergy. The patient did not receive other vaccines in four weeks. On 06Sep2021 (20:00), the patient had lip, chin, and face swelling, rash, and hives all over entire body. The events were reported to be serious (medically significant); and had resulted into a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had received steroids, allergy medications and asthma medications as treatment for the events. The outcome of the events was not recovered. The patient did not have COVID-19 prior to vaccination, and has not been tested post-vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Headache immediately after vaccination, then body aches and other "flu-like symptoms". Day 2 with swollen cheeks and mouth, aches continued. Day 3-4 developed shortness of breath (SOB). To emergency department. Diagnosed with allergic reaction and sent home with Benadryl. Day 5 with slight SOB, continued aches and fatigue. Day 6-7 with decreasing symptoms.
At 0915 received TDAP vaccination - at 0935 turned pale & shaky - BP 110/50. Placed on cot. Feet elevated. 0942 BP 110/55 remains shaky, pale but states feeling better - given cracker & water. 0955 112/80 on standing - 1005 transport to hosp.
Type of dose gave after expiration date and date second dose 07Apr2022; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 41-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 07Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number: 01, Manufacturer: Pfizer), administration date: 10Mar2022, when the patient was 40-year-old, for Covid-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Type of dose gave after expiration date and date second dose 07Apr2022". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report was rec'd concerning a child vaccinated who experienced mycobacterium avium complex (MAC) osteomyelitis an unspecified length of time after receiving influenza vaccine (brand unspecified), DTaP with hepatitis B (brand unspecified), inactivated polio vaccine (brand unspecified), oral polio (brand unspecified), and varicella vaccine (brand unspecified) on an unknown date. No BCG was administered. On an unspecified date the pt presented with a 3 month history of L lower leg pain and a 3 wk history of fevers up to 38.9C. the leg pain was constant dull ache that had increased gradually. Her pain localized over the anterior L lower leg but there was no swelling or erythema. She had a noticeable limp and avoided walking. There was no improvement with non-steroidal anti-inflammatory drugs. The was no history of previous leg pain, trauma, lymph node swelling, rash, insect bite, viral infection or joint swelling. the pt's mother had a history of recurrent MAC osteomyelitis. The pt was not toxic on physical exam but was anxious and guarded her left leg. Her temp was 38.5C, pulse 120 beats/minute, respiratory rate 28 breaths/minute, and blood pressure 85/45. the exam was remarkable for  1X1cm non tender, soft, mobile, L submandibular lymph node. Her L tibia was tender to palpation without visible edema or erythema. There was no lymphadenopathy or organomegaly. Laboratory date initially revealed a leukocyte count of 17,500 cells/mm3 with 50% lymphocytes, 37 % neutrophils and 1% eosinophils. The haemoglogin was 7.3 g/dl and the platelet count was 583,000 cell/mm3. Erythrocyte sedimentation rate (ESR) and C-reactive protein were elevated at 105 mm/hr and 8.1 mg/dl, respectively. Plain X-rays demonstrated lytic lesions of the tibia and femur. In the opinion of the reporters, the dx was unlikely to have been growing pains as massage and acetaminophen did not help. In addition, growing pains are intermittent, and she had progressive unilateral lower leg pain. Cellulitis was ruled out as there was a lack of localized swelling AND ERYTHEMA OVER THE SYMPTOMATIC AREAS. The pt's newborn screen was negative for sickle cell disease and titers were no sickle cells on the peripheral blood smear thereby excluding sickle cell disease. The presence of the lutic lesions sad the absence of joint symptoms, make JRA unlikely. There was insufficient information to determine the reporters causality assessment.
PATIENT FORGOT TO GET HER SECOND DOSE; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the paient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient forgot to take 2nd dose of Shingrix.
Approx. 15 min. after administration of 2 vaccines, pt. became tachycardic & hypertensive. C/O feeling flushed & dizzy at times. Initial B/P 210/84 HR 140 O2 Sat (RA) 98%. Pt. was monitored continuously until she felt better. She left with spouse for home. Last B/P 170/80 HR 89 O2 97%.
Admitted with malaise, fatigue, hypoxia, genernalized weakness, fever  and COVID.  Acute respiratory failure with hypoxia requiring oxygen.  IV remdesivir, decadron, albuterol and Breo inhaler.  Toxic metabolic encephalopathy started on ativan and risperdal.  Discharged to home.
On 22OCT92 2 hrs p/DTP was given mom reports pt had difficulty breathing; pt was taken to ER just a/7PM on 22OCT92; t102 was adm to hosp & placed on apnea monitor; all lab test were nl;
Initial case received from a nurse on 17 November 2010. It involves a case of misuse, i.e. wrong vaccine administered. This case pertains to  1 of a cluster of 5 patients who experienced adverse events following intradermal administration of DECAVAC. A 26-year-old female patient received an intradermal right forearm injection of DECAVAC (lot number U3422DA) on 16 November 2010. Medical history included allergies to BACTRIM and Sulfa, and concomitant medications included PROVERA and VIVELLE-DOT. The day of vaccination, the patient experienced irritation at the injection site described as a 3 cm x 4 cm area that was red, raised, and painful. Additionally, the patient complained of pain "running up the arm, and the arm is painful to touch". Outcome was not reported. Information for the other patients is captured in case numbers 2010-06503, 2010-06506, and 2010-06508.
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). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Jun2022 to 16Jun2022. The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. After finishing Paxlovid course on day 6 of initial symptoms, new symptoms developed on day 8 and positive antigen result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 19 th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master
pt states that she did not know she pregnant when taking first dose of covid vax.  On 2/3/2021 pt stated she started having vaginal bleeding and was transported to the ER by ambulance.  She was given IV fluid and did US and blood work.  She was told she was pregnant and that the baby was fine but she had a small hemorrhage.  She has a repeat US on 2/12/2021 w/ OB/GYN doctor to get update on hemorrhage and to make sure baby is ok.  Pt states this is her second pregnancy and due date is September 29, 2021.
Swollen red, raised, hot, painful, lump at injection site., size of walnut to golf ball.  Started few hours after shot. Lasted about 4 days.
I was freezing cold with chills, body aches, totally no energy. The next day it went into my lungs.  I taste, smell, or appetite.  My chest was tight and coughs were not productive. I also had hair loss.
11/06/21 presents to EC ED for "cc of BL LE extremity weakness". PMHx "GERD, dyslipidemia, HTN"
pt admitted with AHRF secondary to COVID pneumonia, pt was already intubated; PMH:  CHF, CKD, COPD , CAD; refused remdesivir due to kidney disease; pt's condition worsened and he passed away in the hospital
SEVERE ATOPIC DERMATITIS RESULTED FROM THE VACCINES THE FOLLOWING DAYS AFTER THEY WERE GIVEN. THE CONDITION HAS LASTED EVER SINCE, FLARING UP AGAIN AND GETTING WORSE AFTER HIS 6 MONTH VACCINATIONS FROM THE SAME CARE FACILITY AND THE SAME VACCINES.
neuropathy; shingles; This initial spontaneous report was received from a lawyer, regarding a case in litigation and referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around October 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for it's intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles and neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of shingles and neuropathy was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter assessed both events to be disabling.  Upon internal review, the event of neuropathy was determined to be medically significant.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion and minimum reached temperatures was negative 82 degrees Fahrenheit.The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19 Nov 2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer or refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator.No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
TESICLES BLEW TO SIZE OF A BASEBALL; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, dose number in series was 1, administered 1 in total for prophylactic vaccination. It was unknown whether patient had any adverse events (Dose number in series was 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported (dose number in series was 2) 1 in total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s the patient experienced testicles blew to size of a baseball (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of testicles blew to size of a baseball was not reported. This report was non-serious.
Information has been received from a 69 year old nurse with Crohn's disease and hypertension concerning herself who in 2006 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included levothyroxine sodium, paroxetine, azathioprine, TRICOR, COREG and REMICADE. On 01-NOV-2009 the nurse experienced shingles. She was evaluated in an emergency room of a hospital, but not admitted. The nurse was treated with antivirals and was taking oxycodone and LYRICA for persistent pain at the reporting time. CT scan and Ultrasound of kidneys for diagnosis of pain performed on unspecified dates and results were not provided. At the time of the report, the nurse had not recovered. Shingles was considered to be disabling. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 27-JUL-2012, the patient was vaccinated with a first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date were not reported) intramuscularly. On 09-NOV-2012, the patient received second dose of GARDASIL (lot number and expiry date were not reported) and on 14-DEC-2012 received the third dose of GARDASIL (lot number and expiry date were not reported) intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Pt received 36 mo and up vaccine instead of under 36 mos. MOC informed per office protocol.
Mild difficulty swallowing, mild tongue swelling approximately 45 minutes to an hour after the vaccination was administered. Took 2 Benedryl and the issue cleared up within an hour.
Injection site was sore; It has become black and bluish; Site was red and bumpy; Bumpy; It started to itch; Big red mark 4-5 inches on my shoulder and arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It started to itch), VACCINATION SITE RASH (Big red mark 4-5 inches on my shoulder and arm), VACCINATION SITE PAIN (Injection site was sore), VACCINATION SITE ERYTHEMA (Site was red and bumpy) and VACCINATION SITE URTICARIA (Bumpy) in an 81-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.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Big red mark 4-5 inches on my shoulder and arm). On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (It started to itch), VACCINATION SITE ERYTHEMA (Site was red and bumpy) and VACCINATION SITE URTICARIA (Bumpy). On 08-Feb-2021, the patient experienced VACCINATION SITE BRUISING (It has become black and bluish). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site was sore). At the time of the report, VACCINATION SITE PRURITUS (It started to itch), VACCINATION SITE RASH (Big red mark 4-5 inches on my shoulder and arm), VACCINATION SITE PAIN (Injection site was sore), VACCINATION SITE ERYTHEMA (Site was red and bumpy), VACCINATION SITE URTICARIA (Bumpy) and VACCINATION SITE BRUISING (It has become black and bluish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.