chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 48 hours, around 9a on 11/08/2018, patient developed a fever.  She became extremely fatigued. She refused to play or get off the couch for the entire day. By 6pm her fever had increased to 104 degrees. It was around this time when she woke up from a small nap and started to vomit. Her body went completely limp. Her eyes rolled in the back of her head. I, her mother, picked her up off of the couch and laid her on the floor as she continued to vomit with her eyes rolled back. Emergency services were called. She was taken to the Hospital around 7pm and diagnosed with a febrile seizure.  The medical team continued to monitor her for several hours to ensure she did not have any recurring symptoms. We were sent home around midnight that same night.
patient had a vasovagal reaction just after the covid vaccine was injected.   Flu was administered just a moment before.  Mom reports he has had this same response before with a needle stick (finger pricks for blood as well as vaccines) due to his fear of needles.  He had decreased/tunnel vision, some belching, paleness, sweating.   We helped him to lay on the floor, elevated his feet, fanned him off, applied cool water to his neck and he improved quickly.   Kept for further observation for 20-30 min longer (had already been with him for that same amount of time) and he continued to feel good/ normal.
patient Had the high- dose flu vaccine for people 65 & older, Still got influenza A; Initial information received on 20-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who had the high- dose flu vaccine (INFLUENZA VACCINE (QUADRIVALENT)) for people 65 & older, still got influenza A.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect QUADRIVALENT INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for flu (Influenza).  On an unknown date, the patient developed a non-serious event of patient had the high- dose flu vaccine for people 65 & older, still got influenza a (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient Had the high- dose flu vaccine for people 65 & older, Still got influenza A).  At time of reporting, the outcome was Unknown.
- moderna dose 1 = 29 April 2021, 3:37 pm  RN, no gloves, no shield, after despite having requested in advance and on the spot to have vaccinated staff person, told me not vaccinated and no plans to do so - unusual bleeding when injected; surprising because very small gauge - some point 29 April ongoing could not raise left arm, upper arm = swollen, hot painful; not a problem [expected some] - had on long sleeves from evening 29 April to morning 1 May around 2 AM; when say left upper arm significant amount of bruising and skin changes - called Moderna, on call stated that bruising was not a symptom in the
PATIENT DESCRIBED A LARGE RED/ITCHY /DISCOLORED AREA AROUND INJECTION AREA BEGINNING ABOUT 4 DAYS AFTER VACCINATION AND STILL PRESENT.   THE AREA INCLUDED SOME SLIGHT SWELLING ON DAY 5 AND 6 AFTER VACCINATION BUT IS NO LONGER PRESENT.  PATIENT TRIED BENADRYL TO HELP CONTROL THE ITCHING AND SWELLING, WHICH HELPED SLIGHTLY.  PATIENT STATES ARM IS STILL PRESENT DISCOLORED AND SLIGHTLY ITCHY.
Ringing in my ears; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN2613) via an unspecified route of administration in the left arm on 25Mar2021 at 18:00 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. Vaccination facility type was reported as Pharmacy/Drug store. Patient medical history was not reported. The patient had no known allergies to medications, food or other products. The concomitant medications included rosuvastatin calcium (CRESTOR) taking 5mg every other day, with a daily dosage of 2.5 mg/alternate day, Cyanocobalamin (VITAMIN B12) (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3) (MANUFACTURER UNKNOWN) for unknown indications, from unknown start dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 19:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021 the patient experienced ringing in ears. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of ringing in ears and included treatment with ear wax removal from an unknown start date to an unknown stop date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears was not recovered at the time of report.   No follow-up attempts are needed; No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information which included Lot number updated from unknown to EN6199 in Historical vaccine notes, Vaccine Facility Information added, 5mg every other day added in narrative for Crestor, Narrative Dose 1 and dose 2 order updated.  No follow-up attempts are needed, No further information is expected.
A non-serious spontaneous report of chest pressure, dizzy, tiredness, sore throat, tickle in throat and headache has been received from a 33-year-old female patient, subsequent to H1N1, Intranasal. The patients medical history included anemia. The patient denies history of headache. No concomitant medications were reported. On 27-Oct-2009, the patient received H1N1, Intranasal for an unspecified indication. On 29-Oct-2009, the patient experienced chest pressure, sore throat, tickle in her throat and tiredness. On 03-Nov-2009, patient experienced a headache on the right side of her head that persists. As stated by reporter most of the other symptoms had resolved but she was still tired. At the time of report she was feeling dizzy when she gets up. The patient recovered from the events of chest pressure, sore throat, tickle in her throat and headache. The events of dizzy and tiredness were not resolved.
About 6 hours after receiving vaccine, the usual arm soreness became more prominent then chills, headache and nausea. Also, a terrible metallic taste in my mouth started making me produce increase saliva. My tongue felt numb and have become swollen. (This took 5-6 hours to subside, the tongue swelling was about 2x size but never increased beyond that size.) Also, during the time the systems started, I had waves of prickly or fizzy feelings that were different from the chills. These lasted at least 24 hours.
fever 104.2; inconsolable crying > 3 hrs< 24 hrs p/vax;
On day 9 after receiving the injection, I noticed itching at the injection site.  Itching persisted at a low level with a small red patch of skin on day 10 and 11. These events were mild and did not interfere with my daily activities. It is now day 11 and the itching and redness are continuing, so I will click "unknown" for recovery below.
I woke up in the middle of the night to go urinate on the night I got vaccinated with the booster dose of Pfizer for COVID. I felt very weak with muscle aches which I know to be normal symptoms. However, I began to feel dizzy while peeing and I fainted and fell. Later that morning at about 9am on 10/09/2021 I tried to get out of my bed but began feeling faint again within being up for 2 minutes. Some of the symptoms include dizziness, visual darkening, a cold sweat, and syncope with standing. I did a whole blood donation recently   on 10/02/2021 without any complications but I suspect these two things are related.
I received an injection in the left arm on 4/5/2021. Since that time my arm has been sore. I have moderate (4/10) pain, in the deltoid area when lifting the arm laterally to shoulder level and when reaching across my body to the right. The pain limits my activities but is not debilitating. It has not gotten better over three months. ..concerning.
Lot 015B22A, expiration per Manufacturer 2/12/23, administered on 2/22/23.
Patient received SPV (3), AVA (1), Hep A (2), Flu (TIV) and typhoid vaccines on 31 Oct. Patient received SPV in his L) upper arm. He reports receiving 2 previous SPV during childhood. Reports taking precautions to prevent autoinoculation and contact transmission. Has been changing SPV site dressing after showering and reports normal site progression. Patient denies any fever, chills, myalgias, arthralgias, or headaches during the first week post-vaccination. Also, denies any flushing, dyspnea, wheezing, facial swelling, itching or swelling of tongue, mouth or throat, or GI-related symptoms following vaccine receipt. Patient first noted itchy rash on his neck 2 days ago (7 days post-vaccination, 7 Nov) which spread to his chest and then "all over". Denies any lesions in his mouth or on his palms or soles. Describes as red bumps. No drainage from lesions. No scaling or peeling. Denies history of any similar rashes in the past. Denies any chronic skin conditions such as eczema, psoriasis, acne, etc. Denies allergies to medications, foods, latex or stings/bites. Only complaint today is itching. No chest pain, shortness of breath, or palpitations. Exam: Alert. In no acute distress. Not ill-appearing. Oral cavity: no lesions seen in mouth. Lungs CTA. No adventitious sounds were present. Heart Rate and Rhythm: Normal. Heart Sounds: Normal. Murmurs: No murmurs were heard. Skin: More than 15 skin lesions primarily maculopapular lesions on face, neck, trunk, chest, arms, thighs (reported, not examined), very few lesions below knees. No lesions on hands or feet. Normal except as noted. Assessment of Injection Site: showed no abnormalities Smallpox vaccination site on L) upper arm examined - scabbing with minimal drainage; minimal erythema surrounding area; no satellite lesions. No edema. At follow up visit on 14 Nov rash on face and neck markedly improved; new lesions on lower extremities (some appearing ecchymotic). No systemic symptoms. Photos and clinical notes from 9 and 14 Nov will be sent with VAERS report.
shortness of breath, fatigue, headache, nausea, vomiting, rapid heart beat,  3 days and continuing
first day of period was on February 9 and then second menstrual cycle came at March 18 which is almost 9 days late.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262) via an unspecified route of administration on 20Jan2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266) via an unspecified route of administration on 22Feb2021 (both at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any concomitant medication within two weeks of vaccination. 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 18Mar2021, the patient experienced delayed menstruation. Menstrual cycle has always been regular but ever since the patient got the COVID-19 Pfizer vaccine it has changed dramatically. The patient usually gets period every month regularly may be 2-3 days late but last first day of menstrual cycle was on 18Mar2021 and it was 03May2021 and still did not get menstrual cycle. The patient was not pregnant and did not have sex or engage in sexual activities. The month before that, first day of period was on 09Feb2021 and this was first period after first COVID-19 vaccine and then second menstrual cycle came on 18Mar2021 which is almost 9 days late. Since 18Mar2021, still have not gotten period (16 days late). This all began after getting the COVID-19 vaccine shots. The clinical outcome of the event delayed menstruation was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2012US003033, is an initial spontaneous report received from a nurse on 01 Feb 2012: This case refers to a female patient of unknown age. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: unknown) intramuscularly without reconstituting with Men A component on 30 Jan 2012. No adverse reaction had occurred following this administration error.
Got the vaccine and did not notice anything until he looked in the mirror on 2/17/21, became pink, patch round 2-3" in diameter, warm to touch.   Still has the area, it has not grown and a few degrees warmer than the rest of the skin in the area.
extremely fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix. On 19th February 2020, 1 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per vaccine indication. The patient received vaccine on day before reporting and on day of reporting experienced extreme fatigue. The patient enquired how long the fatigue would last. The permission to follow up was denied.
Plancier fasciitis acted up followed 3 days later by cellulitis, saw put on antibiotics cellulitis appears to be taken care of working on PT to alleviate plancier fasciitis
Follow injection there was no immediate reaction but, client did have a allergy to seafood. Only a rash and Benadryl usually cleared up any reaction in the past per client. Client was in taken into observation room for 30 minutes due to history. But, 15 minutes after arriving client c/o feeling itchy. I assessed airway immediately and it was clear. I took vitals B/P 142/94, temp 98.3, pulse 90, and o2 sat was 98%. After assessing I administered Benadryl per protocol IM. I maintained safety at all times and client remained in my office for 20 minutes and did express that she felt better. I then took a second set of vital which was within normal range ( temp 98.1, B/P 136/92, p 84, o2 sat99%). Following observation client stated she felt much better and did not have any one to come pick her up. So she was released and self ambulated out of the building ( no staggering or difficulty presented), and drove self home. Called and followed-up: she stated she was okay and had no existing side effect of the adverse event.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an 83-year-old 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.    In 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. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    Concomitant medications were not reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. No AEs were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:
1/29/21 1st dose - sore arm.  2 days after second dose, breathing became more labored, increasing more difficult by the day.  Gasping for breath; no relief from emergency inhalers.  Taken by ambulance with "acute respiratory failure" to hospital on 3/8/21.  Remained there until 3/11/21.  Received at-home therapy for 4-6 weeks after hospital discharge.
Nausea, chills, BP 141/90 (pulse 79). Water given.
12NOV97 pt recv vax & approx 1 1/2hr later devel a single hives on rt cheek w/a fine pruritic papular rash over cheeks;no resp distress or evidence angioneurotic edema;
Around dinner time on 11/26/22, it started feeling as if something in my body was pushing into airway so I could not breath and I could not swallow it away. I woke up on 11/27/22 with insane laryngitis, it felt like I had been a drill sergeant. By 4PM that evening, I had a fever, chills, body aches and tired. By Monday I was feeling just as bad, I took a home COVID-19 test that night that came back positive. Tuesday, I woke up with extreme sinus issues, I went to urgent care they did a rapid COVID-19 test that came positive. I was prescribed the PAXLOVID for the five days. My fever was gone by Tuesday, the sinus issues were gone by Wednesday, my glands were swollen, still had laryngitis, some fatigue. Thursday some fatigue, no sinus, no runny nose, no fever, no body. but a little bit of a cough started. By Friday I was feeling better a bit of a cough here and there, laryngitis was basically gone. By December 7, I was feeling much better.
22 patients received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Patient received first booster in the left arm. Date(s) of administration of vaccine, 2 doses on 05 Apr 2022, 13 doses on 06 Apr 2022, 2 doses on 07 Apr 2022, 4 doses on 08 Apr 2022. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  Treatment information was not provided.
The pt developed a fever of 101.5F and fine, red, bumpy rash over body, no pruritus and no fussiness. Went to FMD; no treatment given other than Tylenol or Motrin for fever.
Stiff neck both sides in back. Neck pain both sides in back. Headache front and back of head. Tingly and itchy face. Day 1: Tingle/itch of face began 20 minutes after injection and lasted about 2 hours. Headache and neck pain began after 2 hours and lasted rest of day (about 8 hours). Day 2-3: Continued headache and neck pain but much milder.
Awakened the next morning not feeling well. Took Advil and later took an Allegra. At 11 AM she still was not feeling well so she took some Tylenol. Temp at that time 101 and later on that evening her Temp rose to 103. She did not work the next day on Friday 10/7 as not feeling well in genera. She was lethargic and rested throughout the day with Temp of 101 and didn't feel like she could really use her left arm (site of vaccinations). On Saturday 10/8, progressively getting better, and was afebrile, Left arm continued sore and was a little swollen. Sunday evening was not feeling well and had left ear pain. she had taken an Allegra and about a half hour later she began having sensation of throat feeling tight. She was not sure if due to anxiety or progression of reaction, so client went to the ER where Dr observed, but did not give any additional meds due to having taken the Allegra. Contacted HD Thurs 10/13 to report the Adverse Event. States today is feeling better and can use left arm pretty well although it continues to be sore.
VESICULAR - NON PRURITIC ERUPTIONS ON BILATERAL LOWER EXTREMITIES, UPPER RIGHT EXTREMITY AND FACE. CHILD FEBRILE. NO OTHER ADVERSE REACTIONS.
Information has been received from a medical assistant concerning a 16 month old female who on 28-APR-2009 was vaccinated subcutaneously with a 0.5mL dose of VARIVAX (Merck) (LOT# 662577/0047Y).  On an unspecified date after vaccination the patient experienced injection site redness and swelling.  It also reported that unspecified medical attention was sought and the patient was recovered.  A lot check has been initiated.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  (Complaint ID # 154673).  This is one of several reports received from the same source.  No further information is available.
Extreme fatigue, generalized muscle pain and joint pain. Difficulty balancing and walking. Headache, difficulty sleeping, pain on left arm radiating to elbow.
Day of vaccine (9/21) tiredness / lack of apatite.  Day 2 (9/22) fatigue / weakness.  Day 3 (9/23) increased fatigue and nausea - called off work.  Day 4 (9/24) continued fatigue - called off work.  Day 7 (9/27) numbness in right leg.  Day 8 (9/28) weakness.  Day 9 (9/29) Stroke symptoms, no feeling entire right side, unable to speak words, collapsed.   Taken to  Medical Center via ambulance.
Dizziness, extremely high blood pressure,  heart palpitations  EKG 12 LEAD-POC