chrisvoncsefalvay/vaers-outcomes huggingface dataset:
09/09/03- Pt received 2nd MMR, 5th DTaP and 4th IPV. 09/18/03- Complained of increased temperature (today 101.5 F) which continued for about 2 days. 09/19/03- Complained of fever, headache, sore throat and swollen glands. 09/20/03- Dev a rash which spread cephalocaudally. 09/22/03- Presents for evaluation. Per mother rash is improving on face and pt is no longer complaining of fever, sore throat or headache.
Began having pain in right leg by 12/22/2021. On 01/21/2022 began having severe shortness of breath when walking. On 1/22, taken to Emergency Room at Hospital and admitted for blood clot in lung. Also, many blood clots found in right leg. Doctors could find no reason for the blood clots. After thinking about it, realized that the pain in the leg had begun shortly after receiving the third COVID Vaccine.  Currently still in Hospital receiving Heparin and Oxygen.
After the 1st dosage of the moderna vaccine,  I started to notice my left eye twitching randomly throughout the day. It has happened more than 10-15 times a day, everyday since my first dosage.  No pain, no treatment, no irritation, no redness, no swelling, no itching.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 17Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 28May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 09Aug2023 to 14Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300292179 same patient, different event/ drug;
Second dose of Pfizer vaccine was administered too early, at day 15.  Individual is reporting muscle pain, fever, and headache
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 27-DEC-2013 the patient was vaccinated with ZOSTAVAX, injection (strength, route, lot number and expiration date not provided). Other suspect therapies included PNEUMOVAX 23 injection (strength, route, lot number and expiration date not provided). The reporter mentioned that the patient was suppose to receive PNEUMOVAX 23 and a TDAP vaccine (manufacturer unknown) on this day, but it seemed that the ZOSTAVAX was administered instead of TDAP. No adverse symptoms were reported. Additional information has been requested.
Expired vaccines administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The vaccines  was expired on 27-Mar-2022. Treatment information was not provided.   This case was linked to MOD-2022-533553 (Patient Link).
Per staff at PCP office: cellulitis in the arm, fever, headache. Developed pneumonia.
rash;allerg rxn to vax;maculopapular rash over abd, back, arms +induration @ inj site 1 1/2cm on rt leg-HIB;allergic dermatitis poss combination drug reaction;
The patient complained of a itchy rash and swelling on  left bicep on arm where vaccine was given.  The vaccine was given in the left Deltoid IM.  She was told to monitor it  and ice it as necessary ,take a pain reliever and put a anti itch cream like Benadryl  cream on if necessary for up to a couple of days. If it continues or gets worse she should check with her doctor.
Reports dizziness, lightheaded, and weak post vaccination Vitals assessed / wnl; BP 120/70  P77; Rest, crackers and po hydration Monitored x 30 minutes, "feeling better" Released to home from facility
Had COVID-19 in 21 November 2020, brain fog and can't concentrate and confusion. After 2nd dose, slight soreness and nausea and lethargic for 3 days. In August 2021 felt many COVID-19 symptoms, coughing, fatigue and muscles aches, tested negative twice. In October, had shortness of breath and chest pains at 8AM and went straight to ER. Could possibly be recent fires but I had the symptoms before that.
Chills for @5 hours; Low-grade fever (99.1) @12 hours
BLOATING; BACTERIAL INFECTION; SWELLING FACE; BLOOD PRESSURE HIGH; SINUS INFECTION; PSORIATIC ARTHRITIS AGGRAVATED/PSORIATIC ARTHRITIS  OUTBREAK FOR TWO FINGERS AND TOES; UNSPECIFIED DISORDER OF INTESTINE/EXPLOSIVE INTESTINAL PROBLEM; GAS; This spontaneous report received from a patient via other manufacturer concerned an 88 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: Humira/adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from 10-AUG-2022 for psoriatic arthritis.  No concomitant medications were reported.  On AUG-2022, the patient experienced gas.  On 12-AUG-2022, the patient experienced psoriatic arthritis aggravated/psoriatic arthritis outbreak for two fingers and toes. On 12-AUG-2022, the patient experienced unspecified disorder of intestine/explosive intestinal problem.  On 20-AUG-2022, the patient experienced sinus infection.  On 26-AUG-2022, the patient experienced blood pressure high, bacterial infection, and swelling face. Laboratory data included: Blood pressure Over 200/100.  On an unspecified date, the patient experienced bloating.  Treatment medications (dates unspecified) included: Augmentin (amoxicillin trihydrate/clavulanate potassium). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from blood pressure high, and swelling face on 26-AUG-2022, unspecified disorder of intestine/explosive intestinal problem on 16-AUG-2022, and gas on 2022, was recovering from sinus infection, and the outcome of psoriatic arthritis aggravated/psoriatic arthritis outbreak for two fingers and toes, bloating and bacterial infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220916512-covid-19 vaccine ad26.cov2.s-Psoriatic Arthritis Aggravated/Psoriatic Arthritis  Outbreak For Two Fingers And Toe. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related. 20220916512-covid-19 vaccine ad26.cov2.s -Blood pressure high. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Severe itchy and painful rash. Had extreme fatigue with both vaccines but the rash only with the second dose
Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients.; product use in unapproved population; This non-serious spontaneous safety report, with Sanofi reference number 2023SA281679, was received by a partner on 14-SEP-2023 and forwarded to agency on 15-SEP-2023, from a HCP.   The reporter did not assess the causal relationship between Vaxelis and the events of "Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients" and "product use in unapproved population".  Due to the nature of the event, the causality between the events "Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients" and "product use in unapproved population" and Vaxelis was not applicable.   This case is considered an off-label use, due to product use in unapproved population and Incorrect schedule of product administration.  Further information is expected.
Patient was not evaluated until march 2022.  at that time, he had COVID and reported dyspnea on exertion and chest pain.  He stated he had similar symptoms after both the first and especially the 2nd Pfizer vaccine.  the first dose was on 3/31/2022 at the same location - it was a mass vax event.  He reported the symptoms resolved by May 2021 and he was able to enter new opportunity June 2021 and compelte training without problems.  He left new opportunity due to an unrelated issue when he cleared isolation so no labs were done acutely.  He was seen by a cardiologist in May 2022.  He had normal vitals, EKG showed incomplete right bundle branch block.  echo was normal.  exercise treadmill test was normal.  his symptoms again eventually resolved.  He was evaluated by cardiology back at new opportunity who deemed  it possible that he did have myocarditis post vaccine and maybe post-covid.  he did have biomarkers checked in Sept which were essentially normal.
Patient experience facial muscular failure the day after receiving vaccine from the pharmacy. She saw her primary care provider and was diagnosed with Bell's Palsy. The patient was told by her provider that the symptoms should subside in several days.
she has been experiencing "internal vibrations", "weird sensations", as her whole body is pulsing.; she has been experiencing "internal vibrations", "weird sensations", as her whole body is pulsing.; she has been experiencing "internal vibrations", "weird sensations", as her whole body is pulsing.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DYSKINESIA (non-serious), VIBRATION SYNDROME (non-serious), SENSORY DISTURBANCE (non-serious), outcome "unknown" and all described as "she has been experiencing "internal vibrations", "weird sensations", as her whole body is pulsing.". Additional information: She explained that she received the third dose of this vaccine in Nov2021. Since then, she has been experiencing internal vibrations, weird sensations, as her whole body is pulsing. She wanted to know if similar cases have been reported before.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt became pale and dizzy after shots. Vitals taken No wheezing on ausc. Pt left after 15-20 min and felt WNL & vitals stable.
No adverse event; Administration error: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 14-Sep-2022, ACCIDENTAL UNDERDOSE (Administration error: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL) outcome was unknown. At the time of the report, 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 ACCIDENTAL UNDERDOSE (Administration error: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No concomitant medication was provided by reporter.  Patient stated he administered doses of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent to 6 patients on 14Sep2022. Patients did not report any AEs after the vaccine was administered.  No treatment medication was provided by reporter.
Throbbing on left arm at the injection site, tingling in hands and fingers of the left hand, lightheadedness, hives, severe itching, headache.
Patient received Moderna Bivalent Booster dose but should have received their Second dose of the Primary Series.
Patient thinks she contracted Covid during a trip prior to the onset of symptoms. She developed symptoms on 08/19/2021 and they lasted about 3 weeks. She isolated with her husband (also positive) and resumed normal activities after about 4 weeks. She was admitted to the hospital 2x due to shortness of breath and 1x due to low blood sugar.
I was notified by IRIS that the individual was 17 years of age and not the 18 years of age per vaccine guidelines. She did come in with a company. I did talk with client and notified her and parent. Client said she has a little fever and that is all today. Feelling well she reports.
Cold x one week: yellow nasal d/c, cough, eye drainage, temp up to 103 deg (tympanic) x 24 hrs, rred bumps on RA. Red bumps on trunk and neck.
Fever 103.0, hives, nausea, swelling Rt-upper arm to fingers.
Cold symptoms on Sunday 1/31/21 (runny nose, headache), on 2/1 & 2/2/21 1 episode of "diarrhea" each day.  On 2/3/21 sore throat and chills, seen by PCP and diagnosed as "Pharyngitis" and treated with Ampicillin for 7 days.
PNEUMOVAX 23 and FLUZONE HIGH DOSE were administered on 9/19/2018 on the same arm at 2 different injection sites separated about 1 inch apart. Patient came back on 9/20/2018 and her whole arm was red and swollen.
Red bump appeared and where itching at injection beginning 3/6/21 At 7am And ending 3/8/21 around 430pm. I took benadryl to relieve temporarily until it went away on its own.
At approximately 4:07 PM Pt. complained of lightheadedness,  clammy skin, diaphoresis, and HR: 30's. O2 was given and Emergency services were contacted. After two drops in HR the Pt was transferred to facility. The Pt. stated that while in the ER he received an IV infusion, EKG, bloodwork, and chest X-ray. Pt. states that nothing serious was found. Pt. was released on 10/28/2021 at 8:00 Pm. Pt. described having symptoms of fatigue, muscle aches, fever, chills until Sunday 10/31/2021.
Throwing up, diarrhea went on without stopping for 3 hours. Called doctor and she called in a prescription to stop the throwing up and told me to take an Imodium. Following that soreness, chills, sweating, headache. Next day 09/04/2013 still was unable to eat anything except bland food---headache, soreness in muscles. By the third day still felt fatique but other symptoms cleared to the point I could eat normally. I have been taking the flu shot for years and never a problem. This was the 1 MI Fluzone HD 2013-2014.
Pt stating they had a bump the size of a grapefruit located where the vaccine was administered, but it went away a day later.
postherpetic neuralgia; shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 29-DEC-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) in a pharmacy by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequently to zoster vaccine live (ZOSTAVAX) inoculation, the experienced shingles and post herpetic neuralgia and was treated by a physician for the events. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.
This case was reported by a consumer via patient support programs and described the occurrence of rosacea in a 72-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included rosacea. Concomitant products included ibuprofen (Advil) and vitamins nos (Vitamin). On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 28 days after receiving SHINGRIX, the patient experienced rosacea, eyelid disorder and eye movement disorder. On an unknown date, the outcome of the rosacea was recovering/resolving and the outcome of the eyelid disorder and eye movement disorder were unknown. The reporter considered the rosacea to be possibly related to SHINGRIX. It was unknown if the reporter considered the eyelid disorder and eye movement disorder to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received first dose of SHINGRIX vaccine on right deltoid and developed Rosacea two weeks after administration. The Rosacea lasted for two months. The patient's condition was improved, 95 percentage of Rosacea was cleared at the time of reporting. The event did not cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. The reporting health care professional did not consider the events to be life threatening and to result in persistent or significant disability or incapacity. The patient did not die. The event did not require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The event did not result in a congenital anomaly or birth defect. The patient received no prescription medications as concomitant medications. The lot number was not available, reporter stated to contact pharmacy. He stated that around the end of May or the beginning of June 2018 he had a rosacea outbreak which was more severe than he had ever had in the past. He said that his rosacea blew up and that he had zits from hell and that his eyelids looked like hamburger meat and that it was not pleasant to move his eyes. He said he did not go to the hospital and he did not take any serious drugs to treat this but his physician did prescribe some creams. It would get better for 3 to 4 days but then it would get worse again and so the physician would try a different cream. This went on for a couple months. Finally in the past 3 to 4 weeks the rosacea was finally getting better and was almost clear. He stated that his physician did not think it was related to SHINGRIX but that she did not know what it was. The patient had denied permission to contact their physician.
Mom fed baby breastmilk and burped baby. During administration baby projectile vomited and broke out in hives.
10:05-10:15 patient received booster of COVID 19.  Patient within 5 minutes had a large vomiting.  Of note was told by staff that patient was pretty anxious getting vaccine.  Was able to have patient walk back into room and started vitals.  Patient looked pale but was talking, breathing comfortably and able to walk on own to room.  HR 76 and other first set  Of vitals were stable.  Was told patient had recent bagel for lunch.  Due to concern this could have been anxiety driven decided to monitor.  Juice and crackers offered.  Dads report no reaction to any previous vaccines.  No past medical history.  Denies any known allergies or medication she takes on regular basis.   ~10:25 patient said left arm was hurting and report some tightening in throat.  HR was now variable.  Within minute patient reported trouble breathing (reporting throat tightness without being asked) and dizziness.  Cyanosis was noted around mouth and HR dipped to 57 beats/min. At 10:27 epi was given.  HR increase.  Ambulance was called.  Please see repeat vital signs.  Beside sore left leg where epi pen was given patient seemed to improve and vitals were more stable   ~10:40 Ambulance arrived.  Sign out was given.  Patient was transferred to ER for further observation and work up.
Patient was given vaccines on 2/13/2009. Patient came into office on 2/17/09 c/o nausea, diarrhea, wt loss, fever, chills, stomach bloating and stomach cramps x 3 days.
The day after my vaccination after I got home from work, I started to develop a cough, followed by chest heaviness. I then noticed that I couldn't get warm and started taking my temperature every half hour. The highest it got was 101.6 at 11:30pm that night. I couldn't sleep, so after eating some soup and talking one Tylenol PM, I did finally get to sleep. The next morning, my temperature was 98.6 and I felt perfectly fine. Summary of symptoms -cough -heaviness in the chest -body chills (was still cold in a really hot shower) -fever of 101.6  -fatigue -duration: only lasted for one evening from about 6pm until I woke up the next morning feeling just fine