chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tongue and throat swelled to the point that she couldn't swallow her own saliva; Tongue and throat swelled to the point that she couldn't swallow her own saliva; Heart rate went pretty high up; Blood pressure went pretty high up; Shaking; Tickle in my throat; Couldn't stop coughing as throat was so irritated; Couldn't stop coughing as throat was so irritated; A spontaneous report (United States) was received from a consumer concerning a 36-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue and throat swelled to the point that she couldn't swallow her own saliva, heart rate went pretty high up, blood pressure went pretty high up, shaking, tickle in my throat, couldn't stop coughing as throat was so irritated.  The patient's medical history was not provided. The patient was allergic to shellfish, all nuts besides pistachios and cashews, a lot of raw fruits and vegetables, sulfa drugs, latex, Macrobid, and MRI contrast. No relevant concomitant medications were reported.  On 13 Jan 2021 at 08:00 PM, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, 3-4minutes after vaccination, the patient's tongue and throat swelled to the point that she couldn't swallow her own saliva, her heart rate and blood pressure went pretty high up, she was also shaking. Patient was at hospital during this time hence she was wheeled to the ER. She adds that she had a tickle in her throat, so she couldn't stop coughing because her throat was so irritated. Patient didn't get any medication for event even as they were busy hence they patient didn't get her epinephrine. Patient also confirmed that she had never had a severe reaction to any type of immunization. Treatment for the event included diphenhydramine before she got to the emergency room. She was supposed to take more of treatment medication and loratadine on 14 Jan 2021 by 11AM as her tongue started swelled up again.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events tongue and throat swelled to the point that she couldn't swallow her own saliva, heart rate went pretty high up, blood pressure went pretty high up, shaking, tickle in my throat, couldn't stop coughing as throat was so irritated were not reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product (LOT 041L20A) and the start date of the events within 3-4 minutes after vaccination, a causal relationship cannot be excluded. Patient's has known hx to allergy to shellfish, all nuts besides pistachios and cashews, a lot of raw fruits and vegetables, sulfa drugs, latex, Macrobid, and MRI contrast. Further information has been requested
Headache, Myalgia, Fever, joint pain, chills, fatigue Narrative: Employee states: Approx 16 hours after receiving first injection she began to experience muscle aches all over, joint pain, chills, headache, fatigue and low grade fever. The symptoms lasted approx 24 hours after onset. She missed one shift of work but was back to work the next evening.
Subjective fever within 3 hours of vaccine. Also had fever this morning. Also had body aches and headache. Also noticed jitteriness. No rash.
experiencing symptoms which feel very reminiscent of when I had the viral arthritis; This case was reported by a consumer and described the occurrence of viral arthritis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral arthritis (lasted about 2 months).   On 25th November 2020, the patient received Shingrix. On 14th December 2020, 19 days after receiving Shingrix, the patient experienced viral arthritis. On an unknown date, the outcome of the viral arthritis was not recovered/not resolved.   It was unknown if the reporter considered the viral arthritis to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had a viral arthritis when he/she was younger, it lasted about 2 months. The patient had no side effects and have felt no arthritis since recovering. The patient felt that he/she might be a good candidate for a case study on the vaccine's effects on someone with this condition. The patient received Shingrix vaccine and since past 3 days from the time of reporting the patient experienced symptoms which felt very reminiscent of when the patient had the viral arthritis in 1983 or 1984.
Started on Sunday, Jan 21 with small red dot at injection site on left thigh. Redness spread. Seen on 1/23/07 with 4.5cm x 2cm oblong red area with 3 linear nodules palpable beneath skin surface. No fever. Advised Pts mother to use warm compresses. Call if no improvement.
Patient had no side effects from the vaccine.  He did have a mini stroke five days later.   Patient experienced numbness in his arm and hand as well as his leg.
79 year old male with known atrial fibrillation (on AC and amiodarone), HTN came here with three weeks history of cough and two days of weakness with recent fall due to this weakness, no head trauma.    In the ED he was found to be profoundly weak and became hypoxemic with minimal exertion. Work-ups were significant for mild leukocytosis, chest x-ray unremarkable and patient tested positive for COVID-19.  Patient was admitted under hospitalist service.  Patient stayed in hospital for approximately 3 days.  Patient started on Decadron 6 mg daily.  Patient has been weaned off oxygen and 1st 24 hours of stay.  He was monitored and continued to be stable.  His CRP were monitored as well and down trended.  PTOT evaluation initially recommended subacute rehab but with the reassessment and patient much improved recommendations had changed to home health and patient discharged home stable.
diaphoretic; dizzy; This is a spontaneous report from a contactable nurse. A 51-year-old female patient (not pregnant) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ek5730) at single dose on 21Dec2020 11:00 AM intramuscular on left arm for Covid-19 immunization. Medical history included known allergies with codeine. Patient reported similar reaction of diaphoretic and dizzy to giving blood. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. Concomitant drug was not provided. Patient became diaphoretic and dizzy approximately 11:15 AM on 21Dec2020 (also reported as 8 min after injection). The adverse event result in doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment reported as patient was laid down with feet up, cool compress applied, drank some juice. The events were reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events diaphoresis and dizziness cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
This spontaneous report has been received from a healthcare worker refers to a patient of unknown age and gender. On 05-FEB-2015 the patient was vaccinated with PROQUAD (Merck) (lot # K009894, exp date 11-JAN-2016), 0.5 ml, subcutaneous. The PROQUAD was exposed to a maximum of 23 degree centigrade for 15 days. No adverse effects were reported. The outcome and causality were not provided. No PQC (Production Quality Control) was involved. This is one of several reports from the same source. Additional information has been requested.
Itchy throat; left side of face burning; left side of face burning/tingling sensation; burning/tingling sensation left side of lip; burning/tingling sensation and left side of lip; This is a spontaneous report from a contactable other healthcare professional. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL3302) on 21Jan2021 17:00 at single dose on right arm for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: E11284, on 29Dec2020 13:30 on right arm. Medical history included asthma and seasonal allergies. The patient did not test for COVID post vaccination. The patient is not pregnant. The patient experienced itchy throat, left side of face burning/tingling sensation and left side of lip on 21Jan2021 17:45. The patient took Benadryl as treatment for the events. The outcome of the events was recovering.
pt recv vax 1APR96 & on 30JUL96 pt devel shingles consisting of a rash w/radial nerve distribution on the same side as the vax inj;rash was painful & all over the pt forearm & dorsum of the hand;
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ (lot # L023866 with expiration date 24-MAR-2017; dose not reported) orally. The vaccines were exposed to 1 degree Celsius (C) for 60 hours and 90 minutes. A data logger was used to log temperatures, and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
ADVERSE EVENT NOS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter is linked to 20210416449.
Patient presents to office with painful, cellulitic appearing lesion (L) arm. Afebrile, no N/V, no SOB. Postiive lymphadenopathy.
NAUSEA, VOMITING, DIARRHEA, FEVER, JOINT PAIN, WEAKNESS.
Patient was given Tdap intradermally instead of PPD intradermal; developed reddened hard bump or knot at site of Tdap injection.
Tear through swelling, pain, wamth at site of previous hialuronic acid injection 4 months prior
Woke up with splotches and redness.  Itching and increased heart rate/anxiety.  Went to ER. Was given diphenhydramine and steroids and sent home.  Seemed to improve, then late Saturday afternoon more spots and diarrhea.  Rash radiated from trunk to extremities. At 10am 10/14 still had rash on legs but improved.  Patient had received HD flu shot in the past.
body aches; joint pain; fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age (Age: 32; unit: Unknown) and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on 28Mar2021 15:00, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever on 30Mar2021, body aches, joint pain on an unspecified date. Patient was asking if paracetamol (TYLENOL) can be taken for cold-like symptoms. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Joint pain, fever, rash through body( not itchy but red).exhaustion, headache, body ache , difficulty concentrating
Sore shoulder, body aches, chills, lethargy, indifference (mild), loosely flu-like symptoms
Within hours of receiving my booster, I felt tired, flu like  symptoms, headache, body aches, extremely tired. I went ahead and went to bed for the night. Possibly took Tylenol for headache and body aches but not certain. For next 3 days, slept a lot.
LOCAL REACTION (URTICARIA) AFFECTING LEFT ARM DAY 2 FOLLOWING 1ST DOSE - PRESCRIBED BENADRYL.  SYMPTOMS PROGRESSED DAY 3 (21 FEB 2021) DESPITE REPORTED COMPLIANCE WITH BENADRYL TO INCLUDE:  URTICARIA AFFECTING TRUNK (CHEST/BACK) AND BILATERAL ARMS/LEGS.  NO AIRWAY SYMPTOMS, OROPHARYNX AND MUCOSE MEMBRANES SPARED. VITAL SIGNS STABLE.  PRESCRIBED PREDNISONE TAPER; WILL DEFER 2ND DOSE.
MISSED TO TAKE THE DOSE ON DUE DATE; This spontaneous case report (PVX2019-1927) was received from a pharmacist on 25-Jul-2019. It described a female consumer who "missed to take the dose on due date" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif on 22-Jul-2019 and missed to take the scheduled dose on 24-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed to take the dose on due date" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "missed to take the dose on due date" was considered as not applicable.
Pt's Daughter states that after receiving the 3rd dose of Phizer 11/29/2021, started experiencing symptoms 11/30/2021 of shortness of breath and heaviness in the chest. 24hrs after Vaccination was experiencing confusing, losing color, and struggling to breath. Emergency Services called for transport (Home Defibrillation), admitted to ICU while admitting Pt. died. 11/30/2021 Hospital : Location
Severe gastrointestinal illness; severe diarrhea, stomach cramps, sweating, nausea.   I lose four pounds of fluids overnight.
HARD TIME BREATHING; SPOT WHERE SHOT GIVEN IS RAISED AND BUMPY; CONSTANTLY NAUSEOUS; PAIN FROM ARM AND CAN'T MOVE IT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On MAR-2021, the subject experienced hard time breathing. On MAR-2021, the subject experienced spot where shot given is raised and bumpy. On MAR-2021, the subject experienced constantly nauseous. On MAR-2021, the subject experienced pain from arm and can't move it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard time breathing, constantly nauseous, pain from arm and can't move it and spot where shot given is raised and bumpy was not reported. This report was non-serious.
A day after the shot was given, my husband began to feel very sleepy.  He will get up or 1/2 an hour and then go back to sleep. It seems to have gotten worse.  Yesterday, he slept most of the day and then slept for 11 1/2 hours.  Today he got up about 7 am and stayed up for about 1/2 an hour. Then went back to bed. He wolkeup about 12:30 pm and I gave him some lunch. He has gone back to sleep for the rest of the afternoon. I don't know what is going on.
Tightness in the chest, feeling of having a heart attack, uncontrollable shaking of the body.
Shortness of breath, shaking, teeth chattering, soreness, weakness, 102 fever.
No adverse event; VARIVAX may have accidentally pushed out some of the vaccine prior to administration thus administering less than the full 0.5 mL dose to patient; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 03-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (ml), lot #U024220, expiration date: 04-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided); which had been diluted with sterile diluent, lot #T032311, expiration date: 05-MAY-2023. It was reported that the medical assistant who administered varicella virus vaccine live (oka/merck) (VARIVAX) to the patient might had accidentally pushed out some of the vaccine prior to administration thus administering less than 0.5 ml dose to the patient. The reported stated that the patient might had received 0.3 ml or 0.4 ml (accidental underdose). No adverse event was reported.
Since 4/2 I have had 102+ temperature, body aches, chills, and headache off and on through today 4/6.
Information has been received from a licensed practical nurse concerning a healthy 15 month old white female with amoxicillin trihydrate (+) clavulanate potassium (AUGMENTIN) allergy and cefprozil (CEFZIL) allergy and a history of urticaria (reported as AUGMENTIN and CEFZIL = hives) who on 3/25/02 at 10:30 was vaccinated IM in the right outer aspect thigh with the third dose (lot # 641323/1389L) of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). Concomitant therapy on 3/25/02 included a dose IM in the left thigh of diphtheria toxoid/pertussis vaccine/teta (manufacturer not reported). Additional concomitant therapy included a dose of Streptococcus pneumoniae vaccine (PREVNAR). The patient was afebrile and had no complaints at the time of injection. During the evening of 3/27/02, the patient developed a rash. She presented to the physicians office the next morning (3/28/02).  The patient's mother reported no new foods or detergents. At the office, the patient was noted to have red, raised hives at the site of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) injection (also reported as right anterior thigh). The area involved was 4cmx9cm, which started at the site of injection and headed toward the inner part of the thigh. It was reported that the injection site was towards the top of the area. The patient was afebrile at the visit. Subsequently, on a unspecified date, the patient recovered. No further information is available.
Diagnosed with nummular excess on arms and lower legs that has gotten progressively worse. Noticed this about 2-3 weeks after booster shot. No other incidents at the time. Saw my physician and was tild that it could be stressed or from something bumping my immune system
Pt came in for blood work on 04/01 stating that left arm (upper) swollen and red. Iced area day before. Adverse reaction to pneumovax. To use cold compress x 48 hours, then warm.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 56-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Vaccine was expired on 07-APR-2022.  The vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
Body aches and chills started 24 hours after vaccine.  I ran a high fever for 102 -104 for 8-10 hours.  The fever dropped to 99.5 by 10 p.m. the day after the shot. The next morning I had a mild temp just below 100.  I had a headache for several days.  Two days after the vaccine and I am still tired and achy. My injection sight is tender to the touch.
pt receied moderna booster on 10/30/21.  Called hospital call ceneter on 11/4/21 following c/o intermittent weakness and dizziness for the last 2-3 days, since taking vaccine.  Has similar symptoms when he takes his oral DM medications.  PT was unable to check SMBGs. Advised to go to ER for evaluation.
Patient received both Prevnar 20 and Twinrx at approximately 3:15 today 3/20 about 5:00 the patient call and said about 1 hour after she left the store that she experienced a black spiderweb over her eye and when she looks down it goes down and visa versa. I told her that  that was not a common side effect from either of the vaccines and I also looked further into side effects in facts and comparison and searched the web. I also told her that it was possible that she had a detached retina ( that this was how most people describes it when it happens) . I asked her if she had an eye doctor and she said she did and had called them but they were closed. I told her it was very important that she call them back first thing in the morning and to let me know  the outcome after they saw her . I told her that I did not believe that it was a side effect of either of the vaccines but that we could definitely not rule it out, although not documented in resources.
Armpit tenderness; lump to injection site with redness, swelling, and warmth.
p/vax pt exp a mild rash w/less than fifty lesions on the neck & torso;pt was afeb;
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with dose 2 and 3 of GARDASIL in 209 and on 02-JUL-2012 respectively (lot number, dose and route not reported). No adverse effects reported. Additional information has been requested.
Pt was noted to have a febrile seizure approx 18 hrs p/immun administered; fever 104, w/brief <30 sec event described as stiff body, shaking extremities, eyes rolled back, w/sleepy post ictal state;
I had my first Moderna vaccine on 12/23/20 and my second Moderna vaccine on 1/19/21.  On 5/10/21 I found out I had a miscarriage when the fetus was approximately 9 weeks gestation- no heart beat was detectable at 10.5 weeks during my ultrasound.  It should be noted that I have had two other healthy pregnancies and no miscarriages prior.  It took my body 4 weeks to remove all tissues naturally; however, bleeding continued so my physician scraped the inside of my uterus to remove more tissues.  My cycle is still not regular.   Also since June 2021, I have had pitting edema of my bilateral lower extremities with my left lower extremity being worse than my right lower extremity.  This is not normal for me.  I do get pitting edema when further along in pregnancies which is currently not the case due to the above stated miscarriage.  There has also been some incidences of abnormal resting, high heart rate.
Patient complaining of shooting , neuropathic type pain from top of head radiating down.  Patient complaining of increased saliva production, difficulty swallowing.