chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLISTERS THAT COMES AND GO; INSIDE OF MOUTH, NOSE AND CHEEK WAS RED; MOUTH IRRITATION; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blisters that comes and go, inside of mouth, nose and cheek was red, and mouth irritation. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) Nothing came up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blisters that comes and go, inside of mouth, nose and cheek was red and mouth irritation was not reported. This report was non-serious.
I started with severe chills and fever of 101.4, and nausea during the night about 15 hours after the vaccination. Within a few hours I was so weak I couldn't get out of bed by myself.  When my husband helped me up, I started to black out.  He got me to the bathroom and I couldn't sit up on the toilet by myself and became so nauseated I got the dry heaves. My husband was holding me up and trying to keep me from going completely unconscious.  He gave me a wet washcloth to put on my face, but I was to weak to hold it myself.  I became drenched in sweat.  Once my husband got me back to bed, I fell asleep and dry heaves stopped.  I took Tylenol for the fever and that reduced my fever.  I slept through that day and night and the next day I felt fatigued and nauseated, but not so weak and the fever was reduced significantly.
10-22-14 Flu shot administered. 10-24-14 Currently left shoulder/arm pain. 12-16-14- PCP left shoulder/pain-made referral. 12-31-14- Orthopedist rotator cuff/bursitis tendonitis. 03-31-15 Steroid shot, referral for physical therapy present physical therapy 04/28/15 left shoulder cortisone injection.
This spontaneous report was received from a physician refers to a 12 month old male patient with routine vaccine. The patient did not have any pertinent medical history, drug allergies. The patient had fever one week prior to receiving M-M-R II. On 13-FEB-2014, the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous. On 17-FEB-2014 (reported as 4 days later), the patient had an rash which was diagnosed as measles, when physician tested IgG and IgM which were found to be positive. The patient contacted physician. No treatment was provided for the event. The outcome of measles was unknown. Additional information has been requested.
eczema that has not gone away for almost 1 yr. Started 6-7 wks after last Pfizer dose. Never used medications took no supplements regularly, none new. While I understand under emergency release no culpability is assigned however if ever another mass vaccine is reqst, I would definitely pass & stand w the never vacciners. Adverse effects must be identified b4 releasing on gen. population. Many I  know in immediate community across country have skin problems after the vaccine while the official rpts say the skin issues go away in 2 wks, that is not true for many of  us and you all need to fess up bc there will not be a willing public w/o full admission I've lost trust in the whole sys, bc instead of protecting ppl, it set up top protect hospital sys. That says the sys is NOT to bust enough. Allergy testing: both food and environment (definitely not food) Continuous dermatology (which I NEVER had ANY problems!) Quality of life issue! In addition to the many reporting skin problems to the vaccine, given general environmental allergy, I took the time to find where to report (not well advertised) and I'm send many more have to and should but have not reported or know where to report.
Chills, hot flashes, sweating, random ?tickles? on various body parts, pain at injection site(6-7/10), brain fog.  Symptoms diminished by more than half 24 hours after first expression.
Possible administration of booster dose to a 12 year old patient; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Possible administration of booster dose to a 12 year old patient) and NO ADVERSE EVENT (No Adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Possible administration of booster dose to a 12 year old patient) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Possible administration of booster dose to a 12 year old patient) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Possible administration of booster dose to a 12 year old patient).    No concomitant medications were reported.   Pharmacist reported that, a mother was asking hypothetically what would happen if a 12-year-old receives a booster dose of the Moderna COVID-19 vaccine. Upon further probing, HCP states that the mother had not said anything else and was just asking a hypothetical question.  No treatment details were reported.   Reporter did not allow further contact
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 30-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
devel fever, irritability, poor feeding shortly p/vax to be seen on 4JAN96-pt had temp of 102 R, a full fontanel, & irritable;vomited once in office;full sepsis work/up done;
RIGHT ARM SWELLED UP THAT WAS INJECTED AND IT GOT WORSE; SORE RIGHT ARM; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: environmental allergies, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage and allergy to drug but not sure about the nature of allergy to both medications. The patient experienced drug allergy when treated with amoxicillin, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced right arm swelled up that was injected and it got worse, and sore right arm. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative for blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right arm swelled up that was injected and it got worse, and sore right arm on 26-APR-2021. This report was non-serious.
thought she would pass out and it went downhill from there; flu symptoms; she got hot; This is a spontaneous report from a contactable consumer reporting for herself. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E18982), via an unspecified route of administration on 21Jan2021 13:00 by injection once to left arm at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included apixaban (ELIQUIS) as blood thinner. Patient was calling about COVID 19 vaccine. She had the first shot 21Jan2021, and had had flu symptoms ever since on 21Jan2021 and when they gave the shot they didn't ask for her allergies or anything, and she read on a letter given after, she was taking blood thinners, she was not sure what they do to the vaccine, that wasn't asked of her either, before she decided whether to take second or not, she needed some answers, she hadn't had the flu for 40 years. Her shot was at 1PM, and about 6 or 7PM that night, she got hot and thought she would pass out and it went downhill from there. Patient did not have some medical problems that she checked off when she registered, none of that came through either. Patient was thinking about not taking the second shot if she didn't get some medical information. The outcome of event flu symptoms was resolving, outcome of other events were unknown.
sx began monday pt reports pain & itching;area 3inch in diameter today is erythematous, swollen, & hard;pt also reports nausea & fatigue;14JUL98 pt reports sx resolved 1wk p/onset & has had no further problems;
felt like there was something that was surrounding her breath and on her skin; She has rashes on her arms and at the back; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that:  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 as dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 11Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medication was not reported. On an unspecified date, she had rashes on her arms and at the back. She felt like there was something that was surrounding her breath and on her skin she mentioned that she was going to get an examination and see what it was. Patient said she had these experiences after she took the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with single doses of ROTATEQ injection, route of administration not reported, defaulted to oral (strength, dose, lot# and expiry date unspecified) post both supported and not supported temperature excursions. No concomitant medications were reported. No patient had reported experiencing an adverse effect due to receipt of vaccination post temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Shortly after vaccine administration, approximately 15-25 minutes child had syncopal episode that was prolonged with noticeable pallor, and fluctuant heart rate = 80 bpm with 100% saturation. No rashes, no wheezing noticed. Patient then fell asleep with heart rate remaining in  80's. After about 20-30 minutes Pt. awakened in no distress - heart rate returned back to 110-115 bpm and no distress noticed, presumed vasovagal response (prolonged) - EKG ordered to r/o cardiac arrhythmia
1/27 , 13 hours after vaccination (dose #2),  2:30am- strong rigors.  Temp 102 1/27-1/28 SEVERE pain on the top and back of head, neck pain, and back pain. Pain untouched by consistent 1000mg  tylenol and 600mg iburpofen. Also, generalized joint and muscle pain + weakness. I was unable to sit up these days.  1/27-1/29 Fevers for 3 days straight. Unable to get temperature below 99.8 even with Tylenol.  Alternated 600mg Ibuprofen and 1000mg Tylenol.  1/28-1/29 Diarrhea - 5-6 bowel movements
1st 24 hours nausea, couldn't eat or drink, muscle aches; swelling of right bicep, rash, itchy, hot spread all the way to elbow lasted about 8 days
I felt no side effects after dose #1 of Pfizer apart from arm soreness. About 5-6 days after dose #2 my left eyelid started twitching intermittently throughout the day. I monitored this because it was unusual for me. I have only every experienced normal eyelid twitching from caffeine or lack of sleep but this was persistent and different. It is Aug 1 as I write this and my left eyelid twitching continues.
On Day of vaccine I felt fine. The next day my arm itches a little where vaccine was given. By the following week I went ahead and had my covid vaccine on Monday evening and developed a fever on Tuesday and by Wednesday where my yellow fever vaccine was given my arm had a bright red , very itchy and bubbly rash. I became nervous and took precautions by using cortizone10 otc cream and taking Benadryl. It itched worse and looked worse by Thursday.
had immun @ 330 one afternoon & woke up the next AM w/feeling of throat swelling; no interference w/air exchange; gagging feeling w/phlegm per pt;
Localized warmth, redness and moderate induration at the injection site (L)eft deltoid.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# N009802, expiration date 19-DEC-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 54 minutes. There was no previous temperature excursion. Digital data logger was involved. The outcome of the event was not reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA004753: US-009507513-1709USA008504: US-009507513-1709USA008503:
Localized rash, indurated red w/ papules. No vesicles. Mother reported, no further problem, local reaction resolved after 1 week by report.
they (mom patient) had fever, body aches and fatigue; they (mom patient) had fever, body aches and fatigue; they (mom patient) had fever, body aches and fatigue; two doses of the vaccine was drawn into syringes last Thursday, 31Dec2021 and stored in the refrigerator but the doses were only administered today, 04Jan2022.; two doses of the vaccine was drawn into syringes last Thursday, 31Dec2021 and stored in the refrigerator but the doses were only administered today, 04Jan2022.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 41 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 04Jan2022 09:37 (Lot number: FJ1620) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01, Lot number: FJ1620, Route of administration: IM, Anatomical site of injection; left arm), administration date: 11Dec2021, for COVID-19 immunization. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 04Jan2022, outcome "unknown" and all described as "two doses of the vaccine was drawn into syringes last Thursday, 31Dec2021 and stored in the refrigerator but the doses were only administered today, 04Jan2022."; PYREXIA (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 01Feb2022, outcome "recovered" (2022) and all described as "they (mom patient) had fever, body aches and fatigue".  Additional information: Reporter called to ask about the Pfizer COVID 19 vaccine purple cap. She stated that two doses of the vaccine was drawn into syringes last Thursday, 31Dec2021 and stored in the refrigerator but the doses were only administered on 04Jan2022. She stated that 41 year old female received the doses. She wanted to know if the dose was still valid. Patient had a routine appointment for her check up on 01Feb2022 and reported to the physician that had fever, body aches and fatigue. It might have been from the expired vaccine or normal reaction. Patient had recovered.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200009167 same reporter/product, different patient/event
patient arrived to hospital 11/4/2021 with stroke like symptoms. admitted for 2 days (11/4 -11/6/2021). discharged home with confirmed diagnosis Left posterior limb internal capsule acute ischemic stroke
5 minutes p/inject devel pruritus; progressed to urticarial react; treated @ ER w/DPH;
Unsure if reported by provider. Found in hospital reporting system. Per event report "Patient came to the office for her second covid-19 vaccination. When I entered work at 8 am, there were Covid vaccines laying on my desk with a sticky note stating that they could be used at 8:20 am. I assumed that the vaccines had been removed this morning and were ready to use. I gave the patient one of the vaccines that was laying on my desk. Afterwards, I was made aware that the vaccines were from yesterday. They were not thrown away after the expiration time yesterday. I was not at work for the last two days, so I was not aware that they were not from this morning. I spoke to Dr., who called infection control. He was told that the patient may need to receive a booster earlier than 8 months, but infection control is looking into this further and will let us know a definite answer. Dr. spoke to the patient about the incident and she was understanding of the situation."
Vasovagal reaction 28 hours following Hep B vaccine. Vomited at home & then 5-10 min later became limp, pale & lethargic. Pulse 160 RR 24.
Client fully vaccinated. Tested positive via PCR for COVID 19 on 11/28/21 and is currently hospitalized with severe symptoms at Hospital.  Experiencing SOB, chest pain, dizziness, and extreme weakness.
Patient stated he received the vaccine and did not have any signs/symptoms of a reaction until about 6 hours later. Donor then had itchy hives on the left forearm that resolved within 2 days. Donor took BENADRYL until resolved.
pt recv vax 22FEB95 & 17MAR95 pt devel a rash on the extremities (arms & legs);pt treated self w/DPH;to dermatologist for eval;dermatologist felt that the rash was unrelated to vax dx as folliculitis
Red rash and itch at injection site.  Within 3-1/2 hours rash and itch gone.  First morning after injection rash and itch at injection site had returned and expanded to area approximately 4" X 1-1/2".  2nd morning after injection rash and itch still present, no chage in area size.  At this time, just waiting for change.
Following the REcombivax pt devel sl fever, nausea & 1 episode of vomiting; also devel an unusual severe h/a which lasted for 12 hrs; some relief noted w/APAP; also had metal-taste in mouth for 12 hrs period;
PATIENT CAME IN 9/17/21 MORNING TO ASK ABOUT IMMUNIZER WHO GAVE HER PFIZER VACCINE ON 8/23/2021 AND TO REPORT THE ADEVERSE REACTION THAT SHE HAD AFTER GETTING VACCINE. PATIENT REPORTED SHE WAS HEALTHY AND NEVER HAD HEART ISSUES UNTIL THE SEOCND DOSE OF VACCINE. SHE HAD BEEN DIAGNOSED WITH HEART PROBLEM AND NOW SHE HAS HEART RATE MONITOR AFTER VACCINE EVENT AND SHE IS NOT BACK TO NORMAL CANNOT GO BACK TO WORK SHE IS STILL LOW ENERGY.  PATIENT MENTONED WITH 1 ST DOSE  ON 7/28/21 SHE HAD BAD HEADACHE AND SHE TOOK 2 TYLENOL WHICH TOOK CARE AND SHE WAS FINE. ON 8/13/21 SHE HAD SECOND DOSE SHE HAD BAD HEADACHE AND SHE LEFT PHARMACY AFTER 20 MINUTES AND WHEN SHE WENT HOME 10 MINUTES AFTER SHE WAS ABOUT TO TAKE TYLENOL IN KITCHEN AND SHE HAD PASSED OUT. HER HUSBAND CALL 911 AND SHE WOKE UP IN EMERGENCY ROOM WITH HEART RATE MONITOR. AS PEPER FROM ER SHE HAD ABNORMAL ECG. DIAGNOSIS ON PAPER MENTIONED PATIENT HAD SYNCOPE, BRADY CARDIA WITH HEART RATE 30 AND SINUS RHYTUM BIGEMINY. PT NOW SEES CARDILOGIST  AND HE IS MONITORING HER. PT WAS NOT HAPPY SINCE HER LIFE IS NOT NORMAL ANYMORE. SHE WANTS SOMEONE FROM CDC TO CALL HER. I INFORMED PATIENT THAT WE WILL BE REPORTING THIS ADR TO CDC , VAERS WEBSITE AS PER PHARMACY INTERNAL SYSTEM.
Patient presented to ED for SOB, Afib with RVR on arrival, rate improved with metoprolol.  Solu-Medrol given, and tolerated home oxygen level, 3 LNC.  RVP positive for Covid-19.  ProBNP elevated, COPD and mild CHF exacerbation secondary to viral infection, UTI on urinalysis, Rocephin given.  Recommended to patient admission to hospital, patient chose to go home.  Patient was discharged home on steroids and antibiotics.  Patient expired on 03/17/2022.
When pt. got home after vaccine was given, the Left arm began to swell in the area the vaccine was given and became sore/painful. In 2 - 3 days, the area below axilla to elbow was discolored with black bruising. Quarter size bruise (yellow) noted 2" below shoulder. On 11/2/23 swelling , pain, and bruising noted. 11/7/23 no swelling, minimal pain, and decreased bruising noted.
This spontaneous report as received from a physician refers to a female patient with no pertinent medical history. The patient was vaccinated with a dose of live (Merck) VARIVAX at age 12 months and a second dose as an adult. No other co-suspects were reported. No concomitant medications were reported. The physician reported that a recent varicella titer was negative. Medical assistant then came to the phone to provide the patient's name. The patient was seen in the office for medical attention. At the time of the report, the patient had not recovered from negative varicella titer. The patient experienced negative hepatitis B titer while on therapy with RECOMBIVAX HB (MARRS # 1301USA002522). Additional information has been requested.
Got shots this AM, cried all day, will not drink. PC w/mother; since 45 minutes after the vaccines, the infant has been crying. Mother did give infant acetaminophen (correct dose for infant's wt per mother). The infant slept for about 20 minutes was crying inconsolably again. She has refused her formula until took about an ounce a little while ago. Will calm down for couple minutes if bounced on mother's knee and back rubbed. Injection sites and areas surrounding sites look usual per mother. Plan: recommended the mother to take infant to ER. Follow up call made. Mom states she did not go to ER. That patient was much better, she had a lg bm. Mom stated that she had given patient a full jar of bananas the night before and believes this was the cause of babies fussiness. Injection sites clear. No redness/swelling. Reported to DPH.
The next day after the shot, I felt awful.   Muscle soreness, I was tired, cold, headache.  About 10 or 11 that night I felt better but still have muscle soreness and it is currently PM of the next day, 01/09/22.  Not yet 100%.  My mom got the Moderna booster and felt bed for a couple of days.   And my friend got a booster,  don't know which one, and he felt bad for a couple days.   So I expect by tomorrow, the 3rd day, that I'll be back to normal.