chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Mild fever after those; Pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Mild fever after those) and INJECTION SITE PAIN (Pain at the injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 010A21A and 039F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Cold sores, SERTRALINE and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), PYREXIA (Mild fever after those) and INJECTION SITE PAIN (Pain at the injection site). At the time of the report, FATIGUE (Fatigue) and PYREXIA (Mild fever after those) outcome was unknown and INJECTION SITE PAIN (Pain at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   He did not have any cutaneous reactions to this dose. No treatment details were reported for the particular dose events.   This case was linked to MOD-2021-403273, MOD-2021-402965, MOD-2021-402691 (Patient Link).
1150 started feeling anxious. b/p 126/82, hr-104, r-18, 02 sat 98%ra. Reporta anxious, slightly dizzy, tingling in whole body and shakey. Pt kept extra 15 minutes and issues resolved prior to going home.
Reaction started with red spot on left upper arm 2 hours post injection and progressed to a large red area on left upper arm lateral and distal to injection site. Swelling increased over the couse of 2 days. By 10/15/2020 left hand and left side of face has pitting edema and the patient complains of neck tightness, a mild cough, and regurgitation.
MA grabbed high dose flu and administered, not regular dose (Thurs). Monday - spoke w/pt. Friday and Sat had headache, nausea, vomited stomach acid; site tender, slightly swollen, sore, no redness. Feeling better today. Headache often. (CDC notified).
Patient requested a booster dose for the Covid Vaccine.  She originally receive Johnson and Johnson for her initial vaccination and requested Moderna for her booster. Dose was administered at the 0.5 mL dose as opposed to the correct 0.25 mL dose appropriate for a Moderna Booster. At the time of report, patient has not experienced any side effects from the vaccine.
She reports a temp of up to 100.7, body aches, malaise, extreme chills, and reports her legs gave out and couldn't walk Friday night. She reports she had to crawl from the bathroom. She reports she felt "Punky" all weekend and does not feel "100%" today.
Arm began to swell and turn red a week after dose was given. Pain also continued in arm (burning, soreness)
None--pt was given vaccine that had been stored in conventional freezer for more than 2 weeks.  Pt offered additional dose.
tested positive for Covid-19; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer (patient) reported for herself that the patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown and Expiry date: Unknown) through an unspecified route (age at vaccination:62-year-old) on 26Apr2021 as a single dose for COVID-19 immunization. Patient's medical history and concomitant medication was not reported. On 28Apr2021, Wednesday, the patient tested positive for Covid-19. The patient enquired what to do about the second dose of the vaccine and did they need to take it or wait. Caller mentioned that she didn't think she got COVID from the vaccine but wasn't sure. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient described rash , redness, and itching,  Whole body.   Patient indicated he had used hydrocortisone to some effect, and while the redness has lessened over the last 4 weeks, the itching remains and is problematic.  Patient will follow up with PCP but was instructed to try diphenhydramine (oral) by the pharmacy at this time.
Around two weeks after my 2nd vaccine in the morning I felt very dizzy and lightheaded and felt like I was going to faint. Then from there I had multiple symptoms that occurred in subsequent days. I had a funny feeling in head and chest, very hard feeling to pinpoint. I had very hard a fast heartbeat where I could actually feel it. I felt like when I notified my doctor it felt like I had vertigo, and had loss of hearing in my left ear almost total that lasted for a day or two and then it gradually came back. I have had migraines a great duration of my life but they went away after I retired. I also have had silent migraines before that I usually get 4 times a year or so, and after the vaccine it came back. I felt more brain foggy about recalling names and places, and this lasted for a couple of months on and off. Sometimes I felt a little nauseated from time to time; unsettled. I had diarrhea now and then as well. I had sensitivity to loud noises. All of these happened in the duration of a couple months on and off. The heart palpitations and vertigo, head dizziness, lasted for about 5 months. I went to the doctor and found out that my BP was higher than normal 188/88. I went to my PCP 03/19/2021, and put me on 40mg once daily, Valsartan to control my BP and they referred me to cardiologist. My PCP also scheduled an MRI for my head and the results came back good. I saw (cardiologist) on 05/05/2021 and my BP 175/91 then he increased the valsartan to 80mg once daily. After May visit I began to have several tests done.  On 6/24/2021 I had an echocardiogram, vasus renal artery duplex, and vasus carotid. I returned to Dr. on July 14, 2021 and my bp was 140/80 and then I returned to my PCP on 07/20/2021 and bp was very similar. Since then it has been in the 120's to 130's over 75 when I check it periodically. Around August, beginning of September, I finally began to feel normal again.
Child awoke about 7:00AM. Rash and itching noted about 8:00 AM. Pt had eaten an egg- has tolerated them before. Rash began on legs, progressed to trunk and arms. Mom states eye lids are swollen. One red spot on face- right cheek. No other wheals on face or neck. Wheals, erythema (patchy) on torso, extremeties. Temp 96.5 9:00AM. Referred to provider office immediately.
No symptoms first dose 2nd dose:  18 hours- headache 24 hours-joints ache, sore arm 52 hours- diarrhea, sore arm 74 hours- diarrhea
LEFT ARM RED, SWOLLEN, WARM TO TOUCH- USE COOL COMPRESSES AND BENADRYL AND HYDROCORTISONE CREAM.
vertigo, nausea ,muscle pain general malaise, elevated blood sugars without eating anything.
Post vax, the vaccinee experienced chills, fever, slight headache, general achiness, and malaise. The reaction lasted approximately 12 hours.
Patient experienced significant bruising and damage to area of the leg where both vaccines were given. No recommendations on a decrease dose of product when the patient is a micropremie.
Red rash with symptom beginning 10 days after injection. Warm to the touch, some times itchy, no pain.
About the 20th of June, I was visiting family, and in the morning at a hotel, I woke up with a terrible stiffness in primarily my left shoulder and left arm. I attributed it to maybe sleeping in a bad position because it was a weird bed. It didn't do go away. Gradually over the month of July, it faded. I noticed it was hard to wash my back with my left arm in the shower. It didn't bother me too much and I just ignored it. It continued to be an inconvenience and I attributed it to age. I got my 5th dose on 9/9/2022 and it was no big deal. I felt nothing out of the usual for the first 24 hours and everything seemed fine. Towards the end of September and beginning of October, my shoulder became much stiffer. I could not put on my suit jackets and shirts on well. I thought it was just age and just tried to work it out. I thought it would go away with time, but it didn't go away. I saw my primary care doctor, and she recommended I see PT or Orthopedic. At my regular check up, I told her that my shoulder was getting stiff and interfering with some activities so she recommended to see PT. A week later, I suddenly came down with a sinus infection and it was a weekend. I went to the local clinic and while getting checked out, he noticed when I was leaving that I was putting on my jacket on a weird way. He looked at me and said not to go to PT but to go to Orthopedic right away. 11/1/2022 was when I had an appointment with orthro and went through the range of motion, took images of my shoulder and x-rays. It was in that conversation that he told me that I have adhesive capsulitis of the left shoulder. He asked some questions and asked about the COVID-19 vaccines and I noted that they were all in my left arm and that's when he showed me some research that could be in relation to the vaccines. He said I'll have to go through physical therapy and it'll take probably a year to recover the motion. I'm more than a month into PT currently. I'm not sure if this is in relation the vaccine.
Soreness at injection site. Soreness became a painful burning sensation. Pain the injection  site. Then, progress to a radiating pain extending from shoulder to neck. Collarbone area sensitive to touch.  Lymph nodes swelled to ping-pong ball size.  Injection site swelled to softball size. Hives around injection site, warm at injection site and along neckline.  Increased heart rate, shortness of breath.
almost immediate onset of Nausea, light headedness; continuing into today with diarrhea and light headedness & "Just not feeling right"
17 year old received dose; A spontaneous report was received from a nurse concerning a 17-year-old patient of unspecified gender who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that vaccination site inadvertently administered COVID-19 vaccine to a 17 year old..  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, 17 year old received dose was considered as resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
B/P 124/70 P 63 4/30/13 230pm. 240pm syncope, fainting outside clinic. Fall/shaking to ground per mother. Carried into clinic pt room by other person. Pale, alert, laying down exam table. Noted (L) upper lip swelling, (L) elbow scrape. Seen by Dr. 247pm B/P 124/70 P 63. Observed, cleaned, sent home.
Information has been received from a certified medical assistant regarding unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of M-M-R II (route and dose were unknown). No adverse event was reported. The information of administered vaccine was below: Lot# L012482 with expiration date: 10-APR-2017 was administered on 21-JAN-2016, 27-JAN-2016, 01-FEB-2016, 08-FEB-2016, 11-FEB-2016, 13-APR-2016,  22-APR-2016. The information of temperature excursion and time frame was below: On 07-JAN-2016, it was stored in 49 degrees F for 24 hours. On 23-FEB-2016, it was stored in 34 degrees F for 24 hours. From 14-APR-2016 to 18-APR-2016, it was stored in 48 degrees F for 95 hours. On  22-APR-2016, it was stored in 47 degrees F for 24 hours. Lot# K024825 with expiration date: 02-DEC-2016 was administered on 12-JAN-2016 and the temperature excursion and time frame was 49 degrees F for 24 hours on 07-JAN-2016. Lot # L015280 with expiration date 30-APR-2017 was administered on 08-JAN-2016, 05-FEB-2016, 24-FEB-2016, 15-MAR-2016, 23-MAR-2106. The information of temperature excursion and time frame was 49 degrees F for 24 hours on 07-JAN-2016 and 34 degrees F for 24 hours on 23-FEB-2016. Lot# K026366 with expiration date: 15-DEC-2106 was administered on 26-JAN-20106, 05-FEB-2016, 12-FEB-2101, 18-FEB-2016, 07-MAR-2016, 21-MAR-2106. The information of temperature excursion and time frame was 49 degrees F for 24 hours on 07-JAN-2016 and 34 degrees F for 24 hours on 23-FEB-2016. Lot# L007217 with expiration date: 03-APR-2017 was administered on 07-MAR-2016. The information of temperature excursion and time frame was 49 degrees F for 24 hours on 07-JAN-2016 and 34 degrees F for 24 hours on 23-FEB-2016. Lot# L033589 with expiration date: 02-SEP-2017 was administered on 28-MAR-2016, 04-APR-2016, 08-APR-2016, 06-APR-2016, 13-APR-2016, 21-APR-2016, 22-APR-2016. The information of temperature excursion and time frame was below: On 23-FEB-2016, it was stored in 34 degrees F for 24 hours. From 14-APR-2016 to 18-APR-2016, it was stored in  48 degrees F for 95 hours. On 22-APR-2016, it was stored in 47 degrees F for 24 hours. From 13-MAY-2016 to 24-MAY-2016, it was stored in 33 degrees F for 264 hours. Lot# L039612 with expiration date: 07-OCT-2017 was administered on 25-APR-2016, 26-APR-2016, 27-APR-2016, 18-MAY-2016. The information of temperature excursion and time frame was below: From 14-APR-2016 to 18-APR-2016, it was stored in 48 degrees F for 95 hours. On 22-APR-2016, it was stored in 47 degrees F for 24 hours. From 13-MAY-2016 to 24-MAY-2016, it was stored in 33 degrees F for 264 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Gastrointestinal upset, flulike symptoms, frozen hands, long term fatigue and exercise intolerance
Large itching Red whelp approximately 2? diameter ,increasing in size 8 days after vaccination.
BAD FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bad fever, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad fever, nausea and headache was not reported. This report was non-serious.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 19 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and the patient was doing well and did not have any adverse event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944784.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 06-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient brought to the ED via EMS on 11/2 for weakness and a cough that began three days prior. Additionally, he was found by EMS to have O2 sats 88-90% on room air and a temperature of 101.3F. The day prior to ED arrival, patient reports he tested positive for COVID. He additionally was tested for COVID-19 by PCR in the ED and tested positive.  Patient admitted to the hospital 11/2 - 11/14 with acute respiratory failure with hypoxia secondary to COVID-19 pneumonia; this resolved during his admission. Additionally, he was diagnosed with acute bronchitis. Patient has received the primary COVID vaccine series and two boosters.
Blisters on back side of arm down to wrist and raise in blood pressure for about a week.
Case PHEH2016US028823 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to elder female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) at a of 0.5 ml intramuscular in left deltoid on 13 Sep 2016. It was reported that the patients have been vaccinated with FLUVIRIN that had experienced several temperature excursions (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius (C) for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The nurse states she did not have any patient information at this time. The nurse also stated that, the patient had been revaccinated on an unknown date. No adverse event was reported following this medication error. The seriousness of the event was reported as non serious.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: blisters two of them around injection site-Medium, Additional Details: has itching around the injection site and up the neck  and near scapula also with pain but can sleep at night
C/O LEFT ARM SHOOTING-TYPE PAIN INTO ELBOW, T: 98.2, PULSE 100, RESP:20, 134/64; EQUAL STRENGTHS OPPOSITION, RESISTENCE BILATERALLY; ABLE TO RAISE ARMS AND FULL ROM WITHOUT ANY DRIFT; INTACT AND EQUAL SENSATION BILATERALLY, EQUAL, BRISK CAP REFILL AND RADIAL/BRACHIAL PULSES; DIGITS WARM TO TOUCH; ADVISE TO ALTERNATE ICE AND HEAT THERAPY FOR 20 MINUTES EVERY 2 HOURS, IBUPROFEN OR TYLENOL EVERY 6 HOURS AS NEEDED FOR PAIN, HAD FOLLOW-UP WITH PRIMARY PHYSICIAN WHO AGREED WITH ABOVE PLAN AND PRESCRIBED DARVOCET FOR PAIN; PATIENT CONTACT AND REPORTED SHE WAS IMPROVING BUT HAD NOT INSTITUTED ABOVE MEASURES EXCEPT TO TAKE DARVOCET.  PATIENT REPORTED SHE HAD CALLED PRIMARY PHYSICIAN AGAIN BECAUSE DARVOCET MINIMALLY EFFECTIVE FOR PAIN; ADVISED BY PRIMARY PHYSICIAN TO SWITCH TO IBUPROFEN AND HEAT/COLD THERAPY.  PATIENT RECOVERED
This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender not reported). On 24-MAR-2014 the patient inadvertently administered with 1 single dose of ROTATEQ (lot # H015682), orally, that has expired on 18-MAR-2014. No adverse effects were reported. Additional information has been requested.
14 Sept 21: One day following initial vaccination: pleuritic chest pain, palpitations, body/joint aches 4 Oct 21:  Headaches, fatigue, shortness of breath, joint pain, rt eye weakness, tingling sensation on head/groin area, testicle/abdomen discomfort. 27 Dec 21: Chest pain/tightness 25 Feb 22: Continued chest pain, reduced endurance 16 Mar 22: Continued chest pain, reduced endurance
4 hours after administration 102 oral temp, then 14 hours later 104 degrees rectal temp. Nasal drainage and cough X 2 weeks (15 days).
Tired, achy & feverish; Achy & feverish; Feverish; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FATIGUE (Tired, achy & feverish), PAIN (Achy & feverish) and PYREXIA (Feverish) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 11-Sep-2020 and PFIZER BIONTECH COVID-19 VACCINE on 02-Oct-2020. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced FATIGUE (Tired, achy & feverish), PAIN (Achy & feverish) and PYREXIA (Feverish). At the time of the report, COVID-19 (COVID-19), FATIGUE (Tired, achy & feverish), PAIN (Achy & feverish) and PYREXIA (Feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. It was reported that patient had decided to withdraw from pfizerinc COVID clinical trial. It was reported that patient had stopped using inhale two weeks ago as the cough was finally gone with which patient was suffering. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Antiphospholipid syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 18Dec2022 to 22Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Myalgia fatigue and chills on second day, resolved spontaneously. Narrative: