chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received PROQUAD (Merck) (lot # K000710 and expiry date: 16-JUL-2015) which was exposed to temperatures outside of the proper storage range. No adverse effect reported. No product complaint was reported for PROQUAD (Merck). This case is linked to 1411USA001655, 1411USA004432, 1411SUA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
Patient was admitted on 12/09/21 due to headache and left-sided numbness.  She was found to have atrial fibrillation with rapid ventricular response.  This was treated with amiodarone drip.  CT scan of the brain was not able to complete right away due to agitation and hypoxia.  She required emergent intubation and admitted to intensive care unit.  Subsequent CT of the brain was negative for any acute process.  She required Haldol and Zyprexa due to agitation.  Patient was stabilized and extubated.  She have a significant deficit with physical activity and deconditioning to now she is transferred to Mary Free bed for comprehensive inpatient rehabilitation. on 12/21/21 Discharge was planned, screening test for COVID-19 was positive postpone the discharge because she has to stay in isolation the facility does not a for the patient with COVID-19.  She have a no symptoms from the COVID-19 in terms of a oxygenation or breathing problem.
Pfizer Dose 1 3/5/21 (EN6199); Pfizer Dose 2 3/31/21 (EN6207); Pfizer Dose 3 12/1/21 (FH8027); COVID Positive 3/10/22; 3/10/22: This is a 72-year-old female with history of type 2 diabetes mellitus, chronic kidney disease stage 4, hyperlipidemia, hypertension, sick sinus syndrome status post pacemaker placement in the past and monoclonal gammopathy who presented to the emergency department with shortness of breath and swelling in both legs. Patient states that her symptoms started about 2 weeks ago. She has been getting worsening dyspnea and she noted more edema in her legs than usual. She has no associated fever, chills, chest pain, nausea or vomiting. In the emergency department, patient was found to have a blood pressure of 168/92. Labs showed a creatinine of 6.4, BUN of 68, proBNP of 32636, troponin level of 0.79 with repeat of 0.74 hemoglobin of 9.1. Chest x-ray showed fluid overload. Patient received nebulizer treatment, p.o. aspirin, IV Lasix 80 mg. 3/16/22: Patient is a 72-year-old female who presented on 03/10/2022 with chief complaint of shortness of breath and bilateral lower extremity edema.  Symptoms had been progressing for 2 weeks.  Creatinine was 6.4 on arrival. Patient was noted to be in fluid volume overload. Echocardiogram showed EF of 60-65%.  There was also mention of severe aortic stenosis and moderate to severe mitral regurg.  On admission, it was thought that her symptoms were secondary to progression of her baseline stage IV CKD. She already had had a fistula placed in her right forearm prior to admission in anticipation that she would need dialysis in the near future.  Patient was started on HD. She tolerated this well.  Patient felt overall improved from time of admission.  An outpatient dialysis chair was arranged.  She was therefore discharged on 03/16/2022. Prior to her discharge, we did have a risks/benefits discussion about staying in the hospital for cardiology consultation and workup for possible TAVR.  Through shared decision making, it was felt reasonable to have the patient follow-up as an outpatient within the next week or so since she was overall doing better.
NONE: Given expired covid-19 vaccine: expired 10/25/2022: Given 1/12/2023
I experienced nausea, chills, and fatigue about 24 hours after the shot for roughly 24 hours thereafter. That cleared and I was back to normal. A few weeks later (I estimate 10/12 but do not recall that date for sure, but somewhere around there), I experienced bilateral armpit itching and discomfort. I also developed a rash on my stomach and discomfort (itch, sensitivity) a few days later that did not resolve with washing sheets, towel, etc. Both armpit pain and the rash have lingered for weeks, and I finally got worried I had developed shingles (I had chicken pox as a kid and was diagnosed with shingles at the surprising at of 21 in 2007) after reading that some people may experience it after vaccination as a result of the depressed/stressed immunity. So I sought treatment at an urgent care after being advised to do so if I actually suspected shingles (which I did, even though the bilateral symptoms didn't seem quite right). I was surprised the ARNP thought it was not shingles but rather a reaction to the shot, and an ER doctor friend agreed that's likely what it was. The armpit pain may be unrelated (lymph nodes were not swollen on examination), and the ARNP advised switching deodorants, which I am testing now. (I had used the same one for years, so that was not a recent change. Both sites (armpits and trunk) are slightly better, but the armpits are still causing discomfort. ARNP guessed rash should resolve within a week. The bumps are red and scattered below my breasts and above pubic area on just the front of my trunk. They look like little pimples. Not super angry-looking, but uncomfortable, and both the armpits and my stomach have impacted my sleep and my interest in certain activities.
Swelling & redness at Lt. deltoid injection site - measures 8 x 6 cm. C/O achy feeling, applied ice, advised to take Ibuprofen.
After MA administered HPV (gardasil-9) about 2 mins after patient reported feeling dizzy, blurry vision.  MA laid the patient down vitals taken. After patient was more aware gave juice, and observed patient in clinic for 30 minutes post vaccine. Patient was back to normal within 5 minutes after. Dizziness, pale lasted about 5 minutes.
Pt. mother brought child back to clinic a day after vaccination. Reaction on left thigh red raised and warm to touch covered from upper thigh to knee.
Mother states child had seizure that lasted 1 minute. Occurred about 30 minutes after leaving office after receiving immunizations. Child was taken to ER. Had a fever of 103.4 at ER.
little bit of tenderness; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TENDERNESS (non-serious), outcome "unknown", described as "little bit of tenderness"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".   Additional information: The patient received the 1st dose of the Pfizer vaccine on 07APR2021 and he was scheduled to get the 2nd dose on 28Apr2021. He's supposed to work on the 29th and he was hoping if he could take it a day early. He was asking if it will cause any difficulties with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came into the pharmacy on 10/15/2018 complaining of pain in arm of injection and that it was radiating across his shoulders.
8 x 9 area of erythema, induration at thigh at site of injection, nontender. Occurred 24 hours after Influenza vaccine (Fluzone) seen after 3 days.
PT REPORTS THAT SHE WHEN SHE WOKE UP FOR WORK ON THE MORNING OF FRIDAY 1/15/2021 AT 6:30 AM TO GET READY FOR WORK SHE HAD HIVES ON HER CHEST, FACE AND BACK. SHE WENT ON TO WORK AND SHE SHOWED THE SCHOOL NURSE. THE NURSE GAVE HER A BENADRYL AND SHE WENT HOME. SHE SAID AFTER SHE HAD GOTTEN HOME SHE TOOK A 2ND BENADRYL  AND LAID  DOWN. WHEN SHE HAD WOKEN UP THE HIVES WERE GONE. LATER THAT NIGHT SHE NOTICED THAT SHE HAD RED BUMPS ALL OVER HER FACE. SATURDAY MORNING WHEN SHE WOKE UP SHE REPORTS SHE HAD HUNDREDS OF BUMPS THAT HAD SPREAD TO HER SHOULDERS, BACK AND CHEST.
inflamed psoriatic arthritis,    Very sore muscles , chills, rash, fatigue, stomach upset          since march 10, 2021
little bit of itching on elbow; I am falling asleep; not able to function as normal; a little red; tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little bit of itching on elbow), SOMNOLENCE (I am falling asleep), FEELING ABNORMAL (not able to function as normal), ERYTHEMA (a little red) and FATIGUE (tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (little bit of itching on elbow), SOMNOLENCE (I am falling asleep), FEELING ABNORMAL (not able to function as normal), ERYTHEMA (a little red) and FATIGUE (tired). At the time of the report, PRURITUS (little bit of itching on elbow), SOMNOLENCE (I am falling asleep), FEELING ABNORMAL (not able to function as normal), ERYTHEMA (a little red) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received included no new information.
C/o nausea, dizziness, light headed. Last meal 9:00AM. Received injection ~ 8:15AM 12/8/09. Denies shortness of breath or chest pain no redness or swelling at injection site.
This spontaneous report was received from a vaccine administrator (non health care professional) referring to unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication information were not reported. On 03-OCT-2016, the patients were vaccinated with improperly stored doses (wistar ra 27-3) M-M-R II lot # M004899, expiration date: 27-JAN-2018 (route, strength, dose and route were not provided. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash extending from head extending to trunk. Fever of 102.5 which lasted for 3-5 days. Cough.
Cold; Swelling; Muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold), SWELLING (Swelling), MYALGIA (Muscle pain) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], HYDROCHLOROTHIAZIDE, ATORVASTATIN CALCIUM (LIPITOR), BRIMONIDINE TARTRATE (ALPHAGAN P) and LATANOPROST (XALATAN) for an unknown indication.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced SWELLING (Swelling), MYALGIA (Muscle pain) and CHILLS (Chills). On 04-Mar-2021 at 11:00 AM, the patient experienced FEELING COLD (Cold). At the time of the report, FEELING COLD (Cold), SWELLING (Swelling), MYALGIA (Muscle pain) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 152/82 (High) Her blood pressure was 152/82.         Treatment details included aspirin and heating pad. Action taken with mRNA-1273 in response to the events was not applicable.
pt recv vax 27JUN96 & 21MAY97 pt presented to MD office w/chickenpox;
Skull crushing headache that started about 12 hours after injection and lasted for about 18 hours. After 48 hours from injection, headache is 90% improved. Took Advil, but that did nothing for headache.  It was the worst headache that I can ever remember having.  Extreme muscle pain in various parts of the body started at same time as onset of headache. This, too, died out as the headache got better.  Slight nausea on day #2.  No fever. Was steady at 96.6 throughout these adverse reactions.
patient started having fatigue, headaches, body aches which come and go. Has been ongoing since with no worsening but also no improvement. Has only been able to work half days due to fatigue as well.
Adverse reactions occurred 16.5 hours after 2nd shot. High fever (temperature not taken), nausea, vomiting, diarrhea, 2 episodes of blacking out, extreme fatigue, muscle aches, headache, no appetite. High fever subsided within about an hour, then lower fever went away in about a day. Nausea, vomiting, and diarrhea limited to one episode each. No further black outs. Fatigue, muscle aches,  headache and loss of appetite continued through second day after shot. No pain medications were taken at any time after shot. The 3rd day after the shot, patient was back to normal.
Moderna Bivalent Booster 0.25mcg was given to patient and was to receive a full dose 0.5mcg. Wrong dose given.
devel nausea 8AUG94 devel chest tightness & emesis x 2 9AUG94, 10AUG94 recurrent chest tightness; pt felt hot, t not taken;
Around 02/15/2023, my eyes started bothering me. They were light sensitive and aching. It began with my right eye and a little bit into the left but it was mostly the right eye. It has kept on going today. The right eye is a little better but the left eye is getting me with the same symptoms. It's gotten worse in the left eye. I've been squinting and needing to wear sunglasses outside. I've been to the eye doctor twice, with yesterday being my 2nd appointment. The first appointment was on 02/16/2023. The doctor prescribed eye drops. Some for moisture and an antibiotic steroid mixture. I used that to the completion but it did not help much. I made the 2nd appointment and yesterday the doctor noted that my left eye looked like it was burned, rough, and bumpy. A little on the bottom of the right eye is some dots and splotches. He prescribed erythromycin eye drops that I picked up this morning and I will be using that for 3 days for both eyes. I have another new eye drop which is SYSTANE preservative free moisture drops. At night, I use a preservative free SYSTANE gel. I don't feel any different at this point today, but I haven't started the erythromycin yet. They do hurt and I was squinting, and in my profession, I need to be able to see. I do feel better in the dark and they don't hurt as bad. The eyeball itself kind of aches.
Mom reported fever of 104.7 and face swelling. Parent reported taking child to the ER. Stated ER dr dx with pharyngitis gave rx for antibiotic. Parent stated took child to family dr the same day. Dr. told her it was a reaction to the vaccine. Stated child also had rx to the antibiotic. Mother stated she alternated MOTRIN/TYLENOL per MD order to tx fever that day.
Some pain on Day 2. Later Itching, large area of red   I made up the dose # because I don?t know it.
Left deltoid is swollen, red and sl tender to touch, warm to touch, started on Sat am, got on Thursdat given by MA.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (lot # M004330, 26-JAN-2018), (lot # M009767, 23-FEB-2018). No symptoms were reported. There was no previous temperature excursion. It was administered. Temperature 5.5F for 15 minutes, 11.3F for 45mins, 5.1F for 15mins, 9.3F for 30mins, 5.1F for 15mins, 8.6 F for 15mins. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning a 10 year old patient (gender unknown) who on an unknown date was vaccinated with Varicella.  It was noted that on 20 JAN 2005 the patient developed breakthrough Varicella.  There was no product quality complaint reported.  No additional information was provided.  Unspecified medical attention was sought.  Additional information was requested
FATGIGUE AND CHILLS Narrative:  EMPLOYEE c/o symptoms day of receiving injection. also  reported having symptoms after receiving first dose. pt has pmhx: of DM, OSA w/CPAP, HTN, will f/u with PCP 2/1/21.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative who reported the same event for 2 patients. This is for the 1st of 2 reports. A patient of an unspecified age, race and gender received PREVNAR 13 via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed a lump underneath the injection spot since an unspecified date with unknown outcome. Sender's Comments: Linked Report(s): US-PFIZER INC-2017142905 same reporter/drug/event different patient.
Developed vertigo-like symptons 5 days after 2nd shot.  Still have them.  2nd Lot #FF2588
vomiting; nausea; chills; body aches; large swollen lymph node in arm pit; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; swelling and pain in neck and shoulder; fever; headache; extreme fatigue; dose_number=3; dose_number=3; This is a spontaneous report from a contactable Other HCP (patient). A 32-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via unspecified route, administered in Left Arm on 28Sep2021 (at the age of 32-year-old) at 16:45 as dose 3 (booster), single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history included allergy to arthropod sting (bees). The patient concomitant medication included oral contraceptive nos (ORAL CONTRACEPTIVE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took first and second dose of bnt162b2 via unspecified route, administered in Left Arm on an unspecified date (both at the age of 32-year-old) as dose 1, single and dose 2, single respectively both doses for covid-19 immunisation. The patient previously also took pertussis vaccine for pertussis and experienced drug hypersensitivity and cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient was allergic to cipro and pertussis vaccine, and bees. No covid prior vaccination. No covid tested post vaccination. On 29Sep2021 at 14:00 (24 hours post vaccination), the patient experienced vomiting, nausea, chills, body aches, large swollen lymph node in arm pit, swelling and pain in neck and shoulder, fever, headache, extreme fatigue. The patient did not receive any treatment for the reported event. Outcome of the events was recovered with sequelae.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Headache, Myalgia, fatigue Narrative:  missed work following second dose due to symptoms
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 19-JUL-2016 the patient was vaccinated with an improperly stored dose of PROQUAD with lot # M001152 Expiration date: 05-JUL-2017 (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature was -14 C for 4 days. No data logger and no previous excursions were involved. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of three reports received from the same source. Additional information has been requested.
High fever over 102, sleeplessness, headache, nausea, swollen at injection site, all over body pain.
red rash on my neck shortly after shaving; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 03Mar2021 at 16:45 (at the age of 67-years-old) as dose 1, single for COVID-19 immunisation. Medical history included chronic back pain and obesity from an unknown date. Concomitant medications included fentanyl (DURAGESIC); serotonin; atorvastatin and ezetimibe (EZET), all taken for an unspecified indication, start and stop dates were not reported. On 03Mar2021 at 21:30, the patient developed a red rash on his neck shortly after shaving. He does not normally have evidence of irritation after shaving. There was no treatment received for the event. The outcome of the event was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8.5cm x 8cm red, warm, swollen local reaction in left upper leg.  Non tender, slight itchy, no fever, nausea, vomiting, shortness of breath. Used childrens Benadryl and ice on the site.
Patient returned to clinic today with rash at varicella vaccine site. Left anterior thigh with patch of vesicles on red base.
Treatment of Covid-19; Treatment of Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seronegative arthritis" (unspecified if ongoing); "Beta thalassemia" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; GABAPENTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of Covid-19". Therapeutic measures were taken as a result of suspected covid-19 which included Paxlovid from 29Apr2022 to 05May2022.  Clinical course: Rebound Covid symptoms started a few days after finished medicine. Mild Covid symptoms so far.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
In Friday morning, after vaccination, some allergic reaction happened a few min (5-10 min). After 30 min of the vaccination, the doctor gave a dose of BENADRYL (12.5 mg/ml oral liquid). The patient was transferred to urgent care for observation for 4 hours.  At home, the patient was received 3 doses of BENADRYL (12.5 mg/ml oral liquid) every 6 hours for 3 days.  1) Red Rash with itchiness all over the body  2) low fever (less 101 degrees) 3) shivering with cold 4) Swelling in the face (eyes, mouth) and neck, hard to breathe  5) sleepiness and no energy / appetite
Was ill 2 days before influenza IZ - resolved with no more loose stool or vomiting (had only one vomiting). Received IZ after well approximately 10 hrs, went to sleep and awoke 9 hrs later with fever 102 degrees, vomiting many times for 2 days. No diarrhea, had normal formed stool x 1 today. Fever 101.5 in clinic with emesis.