chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/08 began having flushness in face and began having chills. Was not running fever. 01/09 Woke up in the middle of the night with a lot of congestion, pressure in my ears, swelling in my neck, and sore throat. In the morning when I woke up I took a COVID-19 test and it was positive. Called PCP and was prescribed PAXLOVID. Symptoms have maintained and I have also had extreme fatigue. Developed metallic taste in my mouth after beginning PAXLOVID. 01/11/2023 Symptoms have been improving but still very fatigued.
Nausea, dizziness (Patient received a dose of GARDASIL 1st dose on 3/22/09, 2nd dose on 7/31/09 similar symptoms after each of these doses).
Since previous report, next shot series taken in December 1999. Shoulder pain (right) as prior report but less severe, but becoming more chronic. Still recurring in cycles.
approx 2yrs p/ vax pt broke out in a mild case of chickenpox w/no fever.
headache, left body stiffness and pain, left sided weakness (sensation of body drooping). Strong flu-like symptoms
Sore arm, occasional burning sensation in arm, fever (102.5 °F), stiff joints, teeth sensitivity - 9th and 10th April
This spontaneous report as received from a physician refers to a patient of unknown age and gender with no pertinent medical history. On 11-AUG-2011, the patient was vaccinated with dose 1 VAQTA (dose, route and lot # not provided). On 27-DEC-2011, the patient was vaccinated with dose 2 VAQTA (dose, route and lot # not provided). No concomitant medications were reported. The Medical Assistant reported that patient received two doses of VAQTA only about 4 months apart. No adverse effects reported. Additional information has been requested.
Spread to the entire front of neck and chest and was slightly itchy.; red splotchy rash appeared on left side of neck/chest; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 03Apr2021 at 09:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis. Patient had no allergies to medications, food, or other products. Concomitant medications included hyoscine (SCOPOLAMINE) from, calcium (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and estrogens conjugated (PREMARIN), all for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6199), via an unspecified route of administration in the left arm on 11Mar2021 at 14:15 (at the age of 50-year-old) as a single dose 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 04Apr2021 at 13:00, the patient experienced red rash. On 05Apr2021, the patient experienced itchy rash. Its reported that approx. 28 hours post second dose, a flat, red splotchy rash appeared on left side of neck/chest. 2 days post second dose, the rash had spread to the entire front of neck and chest and was no longer splotchy. It was all red and slightly itchy. The patient did not receive any treatment for the reported  events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of  red rash and itchy rash  were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
2 days later after the first dose of Pfizer I started feeling tingling in my head. The tingling would move around and not stay in one spot. Sometimes it is severe, it would sometimes be accompanied with a headache. I have been taking Tylenol every 6 hours and resting.
Narrative:  COVID infections following completion of COVID vaccine series 04/09/21 COVID vaccine dose #1 05/13/21 COVID vaccine dose #2 05/19/21 Pre-op COVID test NEGATIVE 07/17/21 Pre-op COVID test NEGATIVE 07/26/21 Pt presents to screening and reports prolonged contact with COVID positive caregiver but no symptoms; COVID POSITIVE 07/27/21 Pt reports cough with some mucus that started 2 days ago; rx given for guaifenesin, zinc 07/28/21 Pt reports fatigue, muscle pain 07/29/21 Pt reports productive cough, and continued fatigue and muscle pain but is stable 07/30/21 Pt reports fever (temp 100.0) and ongoing cough 08/01/21 Pt reports afebrile and no symptoms 08/02/21 Pt reports mild cough and nausea/vomiting; rx given for benzonatate 08/12/21 Pt presented to non-facility ED and admitted to ICU; reported near-fainting, lightheadedness, weakness, cough, shortness of breath, no appetite, N/V/D; admitting diagnosis was COVID pneumonia, sepsis, hypokalemia
swollen; warm; itchy; arm was tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm was tender), PERIPHERAL SWELLING (swollen), FEELING HOT (warm) and PRURITUS (itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced TENDERNESS (arm was tender). On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen), FEELING HOT (warm) and PRURITUS (itchy). At the time of the report, TENDERNESS (arm was tender) had not resolved and PERIPHERAL SWELLING (swollen), FEELING HOT (warm) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.
I waited 15 minutes before leaving the facility.  I got out to the car  and my cheeks and chin started tingling and were red, I started to have a slight reaction.  On the drive home, I started to get a metallic taste and was starting to have difficulty swallowing.  I advised my husband of this.  The difficulty swallowing and metallic taste subsided after 2 days.  It never got to the point where I needed to go to the ER.  NOTE:  After the first dose, the only side effect I had was tiredness for 1 day and a headache for 2-3 days.
Patient received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse 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)) 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 EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date).    This case included information of patient 186 out of 190 reported patients.  No concomitant product reported by reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 190 patient received a vaccine past the beyond use date from 9 different lot number vials.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
atrial fibrillation; a little achiness the evening of her 1st dose and soreness the next day; took little warm and my arm was little ache; took little warm and my arm was little ache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27Aug2021 09:30 (also reported as about 9:15-9:30am) (lot number: FD8448; expiry date: unknown) at the age of 74-years-old, as dose 1, single for Covid-19 immunisation. Medical history included kidney stones, tuberculosis (TB) from 1950 to 1952 young child before age 5, pancreatic cancer from Nov2006 to Dec2006 about 15 years ago and had surgery and chemo (whipple resection), pancreatic cancer-had surgery, chemo, atrioventricular nodal reentrant tachycardia, ongoing hypothyroid, and ongoing depression. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroid from 1994 and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for depression from 2002 and ongoing; cyanocobalamin (VITAMIN B 12) taken for an unspecified indication, start and stop date were not reported, and cyanocobalamin, pyridoxine, thiamine (NEUROBION) taken for an unspecified indication, start and stop date were not reported. The vaccine was administered in a pharmacy.  Patient stated that she waited a long time and researched because she has had an adverse reaction to every vaccine she has ever had, and she doesn't do the flu, shingle or pneumonia shot as she has always had very bad adverse events. Because of the newer technology with MrNA she suspected she would be fine, and she waited a long time and did a lot of research and decided Pfizer was the best one for her. She was concerned about myocarditis and pericarditis and those can happen with Moderna and Guillen Barre with the Johnson & Johnson so she picked Pfizer as it had fewer side effects she was concerned about. She hasn't had a vaccine since she was in her late 20's, she had a few injections before she went to Europe but no vaccine since her late 20's. With rubella she had 3 weeks of joint pain and fever. These were certainly not life threatening but she always reports side effects from when she changes medication if it's serious. On 27Aug2021, the patient experienced little achiness in the evening of her 1st dose and soreness the next day. Patient took Tylenol as treatment for these events, then she was a little warm on unspecified date in 2021. She also had a little ache on her arm. On unspecified date, the patient experienced atrial fibrillation. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
administered Tenivac instead of Boostrix with no reported adverse event; Initial information received  on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who was administered Tenivac instead of Boostrix with no reported adverse event , (suspect vaccine: DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]) .   Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Prophylactic vaccination; HPV VACCINE (HPV VACCINE) for Prophylactic vaccination; HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for Prophylactic vaccination; and POLIO VACCINE (POLIO) for Prophylactic vaccination.  On 13-Jun-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, once, ( lot: U71E9AA ; Expiry date: 30-Sep-2023)  via intramuscular route in the left deltoid for immunization.  The reported stated that they administered Tenivac instead of Boostrix to the patient  with no reported adverse event (wrong product administered) (onset and  latency: unknown)   Action taken : not applicable.  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01145424:
Fever of 101, chills, severe soreness and stiffness, more chills, headache, nightmares. The fever dropped down to 100 around 11 AM. Chills went away around then, but the other symptoms remain.
Information has been received from a nurse practitioner through the pregnancy registry concerning a 19 year old female with asthma and genital warts and a history of migraines, miscarriage at 4 months of pregnancy and high blood pressure who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (lot # 654741/0013U). Concomitant therapy included ADVAIR and trichloroacetic acid. On 25-JAN-2007 the patient was noted to be pregnant (last menstrual period was on 03-JAN-2007). On 03-FEB-2007 the patient was treated with 500 mg of CIPRO for gonorrhea. At the time of this report, the outcome of the events was unknown. No further details were provided. Additional information has been requested.
Patient presented with swollen, hardened, fevered red rash around where the vaccination was given.  Patient was advised to apply warm, moist heat at 20 minute intervals to the injection site. patient was also given some amoxicillin clavulante 875 bid for 10 days. Patient was just seen today (03-01-2018) so we are unsure of outcome to treatment.
vaccine underdose; syringe connection issues; A spontaneous report received from a Healthcare Professional (pharmacist) concerning, patient of unspecified age and gender who received dose of the Moderna COVID-19 vaccine and developed syringe unscrewed itself twice and HCP do not know how much the patient received.   The patient's medical history was not included. Patient's concomitant was not included.  On unknown date, the patient received their dose of the two planned doses of mRNA-1273 in unknown arm (Batch number not provided) for prophylaxis of COVID-19 infection.   Healthcare Professional stated that the patient was given Moderna COVID-19 Vaccine. Healthcare Professional stated that the syringe unscrewed itself twice and he did not know how much vaccine the patient received.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event syringe unscrewed itself twice and HCP do not know how much the patient received was unknown.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273.  There were no reported adverse events associated with this case.
Symptoms include breathing rapidly, slight paleness, dizziness, fever. Pt advised Ibuprofen & to go to ER.
see blood in urine few hours of vaccination of the 1st dose of Pfizer covid 19 vaccine at clinic.  Continiue to see blood till now (Saturday afternoon).   Had kidney stones in the past and last time I saw blood in urine is 3 /4 yrs back.
This is a spontaneous report from a contactable pharmacist via a Pfizer-Sponsored Program "IBCC (inbound Call Center for HCPs)". A 65-year-old male patient received PREVNAR 13, in left arm, in Jan2016. No other vaccines were administered the same day. Relevant medical history included knee arthroplasty approximately 1.5 months before vaccination (unknown which knee was replaced). Concomitant medications included AFLURIA, intramuscular; ZOSTAVAX, subcutaneous and NORCO, for pain after surgery. The patient experienced cellulitis at the incision of knee replacement on an unspecified date. The reporter assessed the event as unrelated to PREVNAR 13. Outcome of the event was unknown.
Pt mother gave the wrong age of the patient.  An 11 year old was given a Pfizer vaccine
Per dermatologist, erythematous eczematous patches started right arm, then appeared on left arm and both legs and feet over the course of 3-4 days. The patches were itchy. Primary care physician prescribed Doxycycline 100 mg. 2 times daily for 10 days and prednisone 50 mg. daily for 5 days; however, a nose bleed developed after the 1st dose of prednisone and it was tapered off.  Coincidentally, an appointment was made with a dermatologist for an irritated seborrheic keratosis, and Betamethasone augmented 0.05% topical cream was prescribed. As of this date (4/24/2021), there are no new patches, the original patch on the arm is still present but much improved and the patches on the legs and feet are also improving.
Severe swelling and pain, redness, dizziness,  warm/hot at injection site
Within 3-4 minutes of receiving my 2nd COVID vaccine I had sudden onset of pounding in my chest. I was immediately hooked up to a monitor and found to be tachycardic to 160's. hypertensive to 160's/90's. My hands were clamped down and white. About 10 minutes later I was overcome with chills. I drank water and tea and gradually returned to baseline. I was monitored at the vaccine site for 1 hour.
Patient came in on 11/5/23 and reports they had an adverse reaction to possibly the arexvy vaccine recieved on 10/18/23. Patient reports they experienced some local injection site reactions on the same evening of 10/18/23. On 10/19/23, patient reports it was red, hot to the touch and raised slightly and it was slightly bigger than previously. On 10/20/23, patient reports that the reaction was from the deltoid muscle to the elbow and had wrapped around three-quarters around. Patient the was given bactrim DS for 7 days for cellulitis starting on 10/20/23. On 10/22/23, patient reports relief and reduction in size of reaction. Patient reported no fever nor any systemic symptoms for the duration.
This case involves patient (unknown demography) who was sick for awk (illness), after receiving INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. In 1959, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. In 1959, the patient developed a non-serious sick for awk (illness), approximately in the same year following the administration of INFLUENZA VACCINE. Also reported that: patient was now 79 years old and haven't had a flu shot, nor the flu. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was not reported for the event illness. There will be no information on the batch number for this case.
Approximately 8 hours after receiving the vaccine, I had body aches and general fatigue.  My arm ached but that was expected.  I went to bed about 9:30 pm and woke at 10:00 with muscle tremors of my whole body.  I got up from bed and felt severe nausea with my stomach having a burning sensation.  I was running a low grade fever of about 100 f.  The tremors were so intense, it made speaking difficult.  I attempted to vomit hoping it would make me feel better, but I could not.  I read the side effects brochure and surmised it was a vaccine reaction so I waited before calling the ER.  The tremors lasted about 2 hours and after that I was able to go to sleep.  The nausea persisted for about 4 hours.  The next day I had an annoying headache which I took Tylenol and unusual fatigue.  I think it is important that people know about this reaction as it was scary to go through.
Post operative wound infection right hip, Hospital admission. This visit was within 6 weeks of receiving COVID vaccine.
patient states directly after shot her tongue was swelling and she had  a very itchy throat. It started within 3 - 5 minutes. She continued to have very itchy skin for 24 - 48 hours after this vaccine.
Rash throughout entire body with swelling around both eyes, approx. 1 hour after vaccination - mother gave Benadryl at home, no sob, no respiratory issues, Benadryl worked and rash and swelling went away by end of day.  Prior HPV vaccine, patient had rash throughout body - unsure what vaccine as patient was also given Menveo first time.
Hearing loss; vertigo; Dizziness; Tinnitus; This is a literature report for the following literature source(s):(Privacy).  A 51 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Meniere's" (ongoing), notes: 5 years. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; VERTIGO (non-serious), outcome "unknown", described as "vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus". The events "hearing loss", "vertigo", "dizziness" and "tinnitus" were evaluated at the physician office visit.
Information has been received from a registered nurse concerning a 31 year old Caucasian female patient with no known allergies and a history of pituitary tumor (1993), liposuction (1998) and breast enlargement (1998) who on 04/12/2002 at 3:00PM was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot # 636654/1158K) in the left upper arm.  Concomitant therapy included cabergoline (DOSTINEX).  It was reported that on 04/19/2002 the patient developed nausea and diarrhea.  On 04/21/2002 at 3:00PM, the patient developed flu-like symptoms, a horse/sore throat, and muscle weakness.   And on 04/22/2002 the patient developed "swollen upper body lymph nodes," a fever (102 degrees F); and a general body rash.  It was noted that the swollen lymph nodes were more prominent on the left side, described as "worse on side of the vaccination site."  The patient sought unspecified medical attention.  It was reported that the patient recovered.  It was noted that the patient did not experience any adverse events following prior vaccinations.  No further information is expected.
Patient received her vaccines on the morning of 5/23/22.  She was in her usual state of health.  The following morning as she was breastfeeding mom noted that seemed congested.  This was about 6 am.  She fell back to sleep after eating.  At about 6:30 am she heard her gagging and when she checked on her, her left arm was shaking and the right side of her face was twitching.  Her fists were clenched and she was gazing upwards.  After she fell asleep and seemed tired.  The entire episode lasted approximately 2 minutes.  She was taken to the ER for evaluation.  After she arrived home she had a low grade temperature of 99.  2 days later she had a temperature of 100.2 .  Clinically she seemed well.  An upper respiratory panel was positive for human rhinovirus. However,  5 days later she had another episode of seizure and was admitted for further evaluation.  She was started on Keppra.  She had labwork done including an EEG and MRI of her brain.
hives-around site of inject in PM p/inject given in AM; 20AUG94 rash generalized on total body; t99 given DPH;