chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  4/6- J&J vaccine x1 dose 7/27- cough, congestion; patient reports recent exposure to person to COVID 19 (daughter and son-in-law) 7/29- reports to ED for COVID 19; productive cough, congestion with occasional wheeze , SOB with exertion; sent home with pulse ox and instructions for monitoring 7/21- sx still mild, reports cough, fatigue, runny nose, headache; sent home with meds and lower spo2 threshold for returning to ED (<93%) 8/6- meets CDC criteria for resolution of COVID 19 infection 8/2- O2 at 96%, still reports headache, congestion, body aches 8/4- reports to ED for increased SOB and body aches,
Vaccinated 1/11/21 1/12/21: while at work patient became symptomatic and was sent to the ED - reports "heart was racing, I felt dizzy and nauseous". Patient recently had 2nd dose of COVID vaccine yesterday morning and recently found she is pregnant. Patient states her heart rate went to 188 and her hands and feet were numb & tingling She took deep breaths, but remained tachycardic In ED SVT resolved with vagal maneuvers Repeat EKG shows sinus tachycardia
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant and refers to a 4-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 27-APR-2022, the patient was vaccinated with improperly stored second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (exact dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis, after the vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours; -10 degrees C up to 8 degrees C for 1 h, 30 min on 23-MAR-2022 (product storage error). No previous temperature excursion was reported. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2205USA007852: US-009507513-2205USA003614: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007739: US-009507513-2205USA007809: US-009507513-2205USA007957: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008000: US-009507513-2205USA008002: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008064: US-009507513-2205USA008066: US-009507513-2205USA008100: US-009507513-2205USA008105: US-009507513-2205USA008189: US-009507513-2205USA008795: US-009507513-2205USA008800: US-009507513-2205USA008830:
Extreme tiredness; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 08Oct2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide/telmisartan (TELMISARTAN HCTZ) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 15Jan2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 05Feb2021 at 11:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Oct2021 at 21:00, the patient experienced extreme tiredness. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme tiredness was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Swollen lymphnode in left arm pit, muscle spasms in left arm, left leg (calf) top of left buttock
Information has been received from a physician concerning a patient who was vaccinated with GARDASIL (route, site and lot number not reported). Subsequently the patient experienced contact dermatitis from the GARDASIL band-aids. The skin affected was the shape of the band-aids. The patient came in the day after the band-aid was applied to report the reaction. There was no additional information at that time. Further information was received from the office manager. It was reported that "several girls" mentioned that the band aids "should not be used." The patient information was not recorded at the time, and therefore, the office had no way of knowing "who made the comments."
mom states 32 hrs p/receiving immun pt screamed; 4 hrs straight in a high pitched cry;
I had a miscarriage. My hormone levels were progressing normally until I received the vaccine at which time they began to drop leading to a miscarriage on 11/26/09. 12/3/2009 OB records, pregnant patient with EDC 7/15/2010, hx of infertility, c/o's vaginal bleeding, sudden decrease of HCG levels and rt sided pelvic pain, had spontaneous AB 11/26/2009.
Unscheduled menstrual changes including cramping, abdominal pain and bleeding beginning on 8/6/2021 until present.
a-fib; irregular heart beat; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (a-fib) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardioversion in May 2021 and Cardiac ablation on 18-Aug-2021. Concurrent medical conditions included Heart disorder and Blood pressure abnormal. Concomitant products included CLONIDINE, LOSARTAN and AMLODIPINE for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ATRIAL FIBRILLATION (a-fib) (seriousness criterion medically significant) and HEART RATE IRREGULAR (irregular heart beat). The patient was treated with Surgery for Atrial fibrillation. At the time of the report, ATRIAL FIBRILLATION (a-fib) and HEART RATE IRREGULAR (irregular heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Heart rate: irregular (abnormal) irregular. On 09-Apr-2021, Electrocardiogram: atrial fibrillation (abnormal) atrial fibrillation. On an unknown date, Heart rate: very slow (abnormal) very slow heart rate.         Concomitant medications included blood pressure medicine. It was reported that patient developed atrial fibrillation exactly two week after his second dose of Moderna COVID19 Vaccine.  He stayed in normal rhythm for about a day and a half. He was preparing to go back to the hospital to start a new atrial fibrillation medication because he had a very slow heart rate.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant product use was not provided by the reporter.No treatment information provided.
Patient was fine the night of the vaccine then awoke in severe pain. She presented to the hospital and was in an acute sickle cell crisis. The crisis continued to develop for 2 days and has now been in the hospital for a week receiving fluids and pain medications.
On 23JAN91 @ 11AM child displayed large hive-like macular eruptions approx 2x3 in-irregular border. Eruptions around scalp, down spine & on lower back. By 24th welts on arms, thighs & abdomen. Itchy blistered solid, not fluid filled.
Information has been received from a consumer concerning her 16 month old son with no pertinent medical history and no drug reactions/allergies who on 19-MAR-2008 was vaccinated in the left leg with a dose of MMR II (lot number: 655380/1326F). Suspect therapy that same day in the left leg also, included VARIVAX (lot number: 658932/1343U) There was no concomitant medication. On 26-MAR-2008 the patient developed an infection at the injection site. The patient has been ordered on KEFLEX. He did not have a fever. No further information was available. There were no laboratory diagnostic studies performed. Unspecified medical attention was sought, the patient was seen in the office on 27-MAR-2008. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
11/9/2005:  Patient states about 6 hours after receiving injection she began hurting under her arm and having nausea.  Took Darvocet for pain.  Was unable to sleep.  Still complained of soreness and nausea today.  Denies arm being red or hot to the touch.
Employee got COVID vaccine to right arm 12/21/2020. He noticed a rash to his right arm on the night of 12/27/2020. The rash was red and raised, he didn't think anything of it at the time. The rash persisted and was growing in a linear fashion and seemed to have an unusual appearance. He scheduled a telehealth visit with a Hospital Urgent Care on 12/31/2020. At this time he was diagnosed with Shingles and started on an antiviral. Multiple providers on the telehealth visit think that Shingles is a reaction to the Covid vaccine, as he is otherwise healthy and young and had recently gotten the vaccine. His symptoms are improving and he will be on antivirals for a week total. He denies other symptoms or concerns at this time.
Patient received immunizations 11/27/06. Patient reaction started 11/29/06 per moc patient had a cyst form @ site of DTAP when she was little also. 11/30/06 patient came in because of DTAP reaction. Put on Keflex, ice pads, Tylenol/Motrin PRN.
Small red dots all over arm that received vaccination. Patient denied any swelling, pain, tenderness or soreness.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (unknown strength, route and dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Pt exp a large area of erythema & warmth (approx 8cm) @ inject site p/receiving flu vax; This persisted for 3 days w/complete resolution of sx occuring 1 wk p/vax;
Case number PHEH2013US005840, is an initial spontaneous report received from a consumer via Taro pharmaceuticals Inc. on 12 Mar 2013. This report refers to an adult female patient. Her medical history included hysterectomy in the past. Concomitant medications included estradiol 2 mg, Taro phenytoin sodium extended capsules USP 300 mg qd in Nov 2012 for seizures and started KEPPRA in Dec 2012 by her neurologist, but this did not affect the frequency of her seizures. KEPPRA dose was increased to 1000 mg twice daily but this did not affect the frequency of her seizures. She was vaccinated with seasonal influenza vaccine (batch number and manufacturer: unknown) on 20 Feb 2013 at around 11:00 am. At around 1 pm, she developed itchy, red eyes and an elevated heart rate. She started vomiting at about 2 or 3 pm. She went to the emergency room at about 4 pm. She had a heart rate of 150, was shaking, vomiting, had trouble breathing and had chest pain due to the difficulty breathing. Her blood pressure was 162/100, her "lips were white"; she was flushed and had vertigo. EPIPEN, BENADRYL IV, ZOFRAN 4 mg, DILAUDID 1 or 2 mg and ATIVAN 1 mg were administered. She had received other medications also, but does not have her medical records now. While in hospital she had two seizures. Her "DILANTIN level" was tested. It was 0, not just close to zero such as zero point something, it was actually 0. She was administered a bag of CEREBYX IV. Blood work and EEG were performed but the results were not reported. She also had an MRI previously on an unspecified date. The only abnormality on the MRI was a small cyst in the "back of her head" which the doctor stated was not likely causing her seizures. The patient was not hospitalized for the events. The symptoms she developed after flu shot were resolved. She was discharged at about 10 pm on 20 Feb 2013. Causality of the events was not reported.
Presents for hypoxia x1 day. Dx w/pneumonia by PCP. RA o2 sat 62%. Admit for pneumonia due to COVID & hypoxia. Tx: O2 via NC, abx, steroids, vit c, zinc, singulair, remdesivir. DC to home on O2.
Pt called at on  4/22/2021 regarding large boil after covid vaccination yesterday. Pt denies emergency s/sx. Pt states she got large boil(diameter less than 1 cm) and fever 100.4F yesterday after covid vaccine(Moderna). Noted pt had thyroid cancer 2016 then done thyroidectomy 2016 without chemotherapy, pt is clear from thyroid cancer per pt. Pt said she visited NP yesterday regarding of boil occurrence and was told that the boil seems not big concerns by NP. Pt declined the offering to make appt with provider for evaluation. Pt said she will visit Sutter for further evaluation within 24 hours. Pt is educated for covid vaccine side effect. Pt agreed and verbalized understanding. All questions answered.
Sore throat, nausea, chills, joint pain, muscle pain, sweating bouts off and on, abdominal pain that comes and goes, increase in mucous production resulting in deeper voice and postnasal drip with clogging and pressure in space between the nose and the throat, heavy lung feeling and breathing feeling, fever off and on up to 102.5 but happens in bouts and then restabilizes to around 97 or 98, extreme fatigue, trouble staying awake at times, toe cramping, mucous thickening to look and appear glue like and is clear and white in color, small bouts of diarrhea but not severe, dizziness, lack of appetite, continued since vaccination, but not sure if it's due to my immune system being distracted and instead allowing something else in or if it's truly the vaccine.  However the adverse effects are similar to my past doses just a little more intense this time.  But not unmanageable, with the exception of preventing me from doing my normal daily activities and such.
Sore arm; fever; chills; flu-like symptoms; This is a spontaneous report received from contactable consumer. A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration in left arm on 31Mar2021 at 18:00 (at the age of 39-year-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration in left arm on 08Mar2021 (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 10:30, the patient experienced sore arm and had fever, chills, flu-like symptoms. The patient did not receive any treatment for the events. The outcome of the events was reported as resolved on an unknown date.  No follow-up attempts needed. No further information expected.
She had redness and rash and itching at the site of injection ~30 minutes after injection. BENADRYL 1mg/kg PO was given in office with plan to continue BENADRYL 0.5mg/kg q6 hours for 24 hours. No wheezing, true hives, or other signs of anaphylaxis were noted.
First dose was 5/22/21; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose was 5/22/21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose was 5/22/21). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose was 5/22/21) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication was reported.   Reporter did not allow further contact
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a five-year-old female. Neither the patient's medical history nor concomitant medications were reported. The product expired on 12-Feb-2012. On 22-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Received TD #1, Hep B #1, chicken pox #1, Hep A #1 on 3/26/03 without immediate side effects. On 3/28/03 left arm chicken pox site erythema area 5cm x 5cm warm to the touch, raised, child complained of a headache, Tylenol tab PO given this AM per mom. Temp 97.8. Referred to CMC 3/28/03.
Feel weak; Severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feel weak) and VACCINATION COMPLICATION (Severe reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feel weak) and VACCINATION COMPLICATION (Severe reaction). At the time of the report, ASTHENIA (Feel weak) and VACCINATION COMPLICATION (Severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation received on 19 Oct 2021 contains translation  of social media post
rash is approximately 10 inches; Warmth; redness and erythema; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number F29KK, expiry date 22nd October 2022) for prophylaxis.   On 6th October 2021, the patient received Shingrix. On 6th October 2021, less than a day after receiving Shingrix, the patient experienced injection site rash, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The pharmacist reported that the patient received Shingrix and experienced warmth, redness and erythema on left arm and rash approximately 10 inches by 4 and half, were she received the vaccine. The reporter consented to follow up.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 21-AUG-2015, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (strength, dose and frequency were not reported) lot # K023623, expiration date 20-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tinnitus in left ear. Started day after received booster dose of moderna vaccine. Tinnitus remains unchanged nearly two weeks later. Say my primary doctor today- physical exam normal. Received initial moderna covid vaccines 12/30/2020 and 1/25/2021.
Noted burning sensation at site of Tdap approx 12 hrs. after injection. Redness noted later, warm to touch and firm deltoid. Pt stated she had "paralyzed" feeling with increased burning sensation starting to feel better when seen at clinic, appears firm much of deltoid, no redness, very slightly warmer than rest of arm. Pt. does not know if she had fever, but did have headache.
One week after shot was given, large, red, itchy spot appeared on right arm by injection site.  By the evening, the itchiness had continued and skin felt hot.  Right hand also felt almost "swollen".  I took an antihistamine that evening and it felt better.  3 days later, the patch is lighter in color. less itchy.
after injection (about 3 minutes ) "little bit of blurry vision but it went away - not severe" "I do not like shots and  I had a mask on that could have been blowing into my eyes."