chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little puny; heart racing like an adrenaline rush, heart racing; out of breath or become winded, Today she has felt more difficulty with breathing; dizzier; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (a little puny), PALPITATIONS (heart racing like an adrenaline rush, heart racing), DYSPNOEA (out of breath or become winded, Today she has felt more difficulty with breathing) and DIZZINESS (dizzier) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 12-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ASTHENIA (a little puny), PALPITATIONS (heart racing like an adrenaline rush, heart racing), DYSPNOEA (out of breath or become winded, Today she has felt more difficulty with breathing) and DIZZINESS (dizzier). At the time of the report, ASTHENIA (a little puny) and DIZZINESS (dizzier) outcome was unknown, PALPITATIONS (heart racing like an adrenaline rush, heart racing) had not resolved and DYSPNOEA (out of breath or become winded, Today she has felt more difficulty with breathing) was resolving.            No treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Reporter information- Occupation updated and Report Sent to Regulatory Authority by Reporter  from the initial case.Significant Follow-up received on 31-AUG-2021 contains: Updated  Patient demographics, Dose details, Concomitant medications and outcome of the event -'out of breath or become winded, Today she has felt more difficulty with breathing'.
Got the vaccine, no reaction to the site.  He was able to sleep okay, but then he starting on 3/20/21 his lower back and legs were very painful, really aching for the entire week.  The lower back and thighs were sore for the entire week, and didn't know if it was from the vaccine, but talked to some coworkers and they too had the same reaction and missed work.  These symptoms lasted until about 3/29/21, and had a miserable week all week lying on a heating pad/ice.  He could not sit for very long, couldn't be in the car for longer than 20 minutes.  He took Tylenol and Diclofenac for these symptoms.
Initial report received from a consumer's parent on 06 May 2010. A 3-year-old male patient, with a medical history of insulin dependent diabetes mellitus controlled with insulin pump and no known drug allergies, experienced fever, fatigue, sleepiness, a need to increase NOVOLOG regular insulin, bruising at the injection site of right deltoid and mildly raised erythema rash after he received a right deltoid injection of DAPTACEL, batch number C3322A on 03 May 2010. The patient had to increase the basal rate of NOVOLOG regular insulin and bolus doses of NOVOLOG insulin via insulin pump. He had a slight bruise at the injection site of the right deltoid and a rectangular area of mildly raised erythema rash which was 2 inches by 3 inches and located 1 1/4 inch from the injection site. The patient had a history of fever and a need to increase basal insulin rate via pump when he received doses 1 and 2 of DTaP at possible age 2 years. The outcome for the events was reported as unknown. Follow-up information was received 24 May 2010 from a health care professional. The patient received DAPTACEL as an intramuscular right deltoid injection. The reported events began on 03 May 2010 and did not require a doctor's visit. The patient received corrective treatment with ice at home. According to the reporter, the patient recovered. Follow-up information was received on 10 June 2010 from a healthcare professional. The first dose of DTaP the patient received was DAPTACEL (lot number C3083AA) given intramuscularly in the deltoid and the second dose of DTaP was DAPTACEL (lot number C2999AA) given intramuscularly in the thigh. Documents held by sender: None.
Swelling on her Face; Swelling on her Lips; Hives; This is a spontaneous report from a contactable consumer (patient's daughter). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 (Lot Number: EN6206) (at the age of 65-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported but reporter started patient had an underlying condition. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 13Feb2021 (Lot Number: EN6201) (at the age of 65-years-old) as dose 1, single for covid-19 immunisation and had no reaction to the first shot. Reporter stated that the side effect happened after the second shot. The patient had hives on 06Mar2021, but it only happened at night. They were worse the first week and a half and then they got a little better. Reporter asked the patient if they had completely gone away, and the reporter stated the patient has had none the last two days and then clarified that the hives were still a little present, they were not completely gone. The reporter stated the patient had swelling on her face and lips on 24Mar2021. The swelling was only at night for the first day and now the swelling was showing during the daytime too. It was gone and came back like the hives. The patient took Benadryl as treatment for the events. Reporter stated they called the doctor and he told them to call the place that administered the vaccine but that place they haven't been able to reach. Reporter stated that everything else had been normal for the patient and she didn't change anything. The outcome of hives was recovering, and outcome of swelling face and lip swelling was not recovered.  No follow-up attempts are possible. No further information is expected.
A nurse reports accidental exposure to the flu following administration of Flumist to a pt in a physician's office. She presented with symptoms of burning eyes, scratchy throat, fever with chills, feeling achy and still with occasional cough four days after administering Flumist. The reporter stated that she had administered her first and only dose of Flumist to a child on 22Oct04. The child immediately sneezed after receiving FluMist. On 26Oct04, four days after exposure from the child's sneeze, the reporter became very achy and stiff. She developed a 101.8 degree fever with chills, scratchy throat, burning eyes, as well as a complaint that her joints hurt worse on 27Oct04. She began treatment with ibuprofen and the events improved. On 28Oct04 the chills continued along with the aches, burning eyes, and occasional cough. As of 29Oct04 she was mildly achy and her eyes continued to burn but she stated that she felt better. Of note, the reporter received a flu vaccine three weeks prior to her exposure to FluMist. No further information is available.
Upon receiving vax, walked to elevator was having a sz; 2 RN's responded pt found lying on floor of elevator; eyes focusing; mom states pt had a sx; eyes rolled up, no extremity involvement; lasted 30 sec; Became diaphoretic & nauseated;
Patient previously completed Pfizer series.  Patient then requested Moderna but did not show his completed vaccine card with the previous Pfizer doses. Patient came in for his second dose of Moderna. Patient presented a vaccine card with the initial dose of Moderna. Again, he did not show his vaccine card with the completed Pfizer series.
Client vaccinated for Covid with Moderna vaccines in end of April and end of May, 2021 (not sure of exact dates but knows the months).  Tested + for Covid on 9/9/2021.  Asymptomatic.  Reported as a breakthrough Covid case in vaccinated person.
After event, Patient was found in alert to have already completed the series with Moderna. She did not report this at the time of the event.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 55.84   Concomitant products were not provided.  On 03-Nov-2021, Excursion time were at 10 AM was 35, total doses given for the day was 117 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials was moved to clinic. Vaccine BUD date was 05-Nov-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a  traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
pain at the injection site.redness and swelling at the injection site. moderate fever(102 F).  headache. stomach ache.
Enlarged area of swelling, redness, warmth measuring 5in by 4in size located right upper arm w/o discharge or streaking.
Approximately 10 days after the 2nd vaccine dose, red and itchy bumps/welts/blisters began to appear on the fingers and thumb of my right hand.  They are not nearly as painful and itchy as the reaction was after the 1st dose of the vaccine.  There are only 5 smaller spots on my right hand at this time, instead of all over my hands, feet, knees, elbows, hips and thighs like the 1st time.  I have had success in treating them with over-the-counter antihistamines that stop the itchy and make them less painful.  The blisters from the reaction after the 1st does are still drying out and peeling and are still visible.
An initial report was received from a health care professional on 18/Jul/2005.  An 11-year-old male patient complained of a headache, right arm swelling and a fever of 102 degrees Fahrenheit in the evening after receiving an intra-muscular injection of MENACTRA, lot number U165BAA in the right deltoid and DECAVAC, lot number U1215DA intra-muscular in the left deltoid.  His fever lasted three days.  He was not seen by a physician.  As per the patient's mother he recovered.  Follow-up information received on 08-August-2005.  The patient did not have any laboratory/diagnostic tests performed.  He did not have any other vaccinations within 4 weeks; he did not have any illness at the time of vaccination and was not on any medications.
About 32 hours after the vaccine, I experienced lethargy, felt like I did when I first got COVID in November 2020.  I had chills and felt very cold.  I ran a temperature of 99.7F .  I took 2 Ibuprofen.  The fever and aches went away around 9:30 pm on April 12. As of today, my arm is still sore and  a little warm where the injection was given.
Recovered from having COVID in July, 2021.  Sense of smell had not fully returned, but sense of taste had been fully restored prior to getting first covid injection.  Six days after receiving the first injection, started experiencing severe rancid meat smell AND taste.  Items like hand soap, laundry detergent, family pets, etc all smell like putrid, rancid meat.  Everything that touches my tongue, including breads, fruits, beverages and some sweets, taste the exact same as the rancid meat.  Not getting any better, only seems to be getting worse.
Product storage error; Administered moderna vaccine beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccine beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter. Moderna vaccines are kept frozen until they are ready for administration which means they would have been in the fridge about 1-3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and be ready for the patients when needed.
Received the first does of this vaccine on 04/16/2021.  I Started getting headaches more frequently than what I normally would have gotten per month.  It wasn't until after I got the second dose of the Pfizer Covid-19 vaccine and on December 16 (flew and up at altitude noticed I was getting a headache), when I went for a Ski trip, that my frequent headaches became constant.  Went to the clinic as I thought it was a case of altitude sickness, and they gave me oxygen for about 30 minutes and water.  They suggested I rent an in home oxygen tank, which I used for nearly a full 24hrs, with no effect of helping the headache.  Had to cut our trip short, and even by coming back to Chicago the lower elevation didn't help.  I've seen multiple doctors including two neurologist, and they have classified my headaches as daily persistent headaches.  The severity of this headache changes on a daily and sometimes hourly basis.  These headaches are a dull constant pain in the temples and forehead.
itchy rash between thighs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 62-year-old female patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (1 in 2 wk), subcutaneous. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: CITRACAL [CALCIUM CARBONATE;COLECALCIFEROL;VITAMIN K NOS], start date: May2020, stop date: 14Jul2022; MULTIVITAMINS + IRON unknown, start date: May2020, stop date: 14Jul2022; OMEPRAZOLE, start date: Jan2020, stop date: 14Jul2022; NATURE'S BOUNTY ADULT MULTIVITAMIN, start date: May2022, stop date: 14May2022; ACETAMINOPHEN, start date: 13Jul2022, stop date: 13Jul2022; EVUSHELD. Past drug history included: Ampicillin, reaction(s): "Allergy: Ampicillin"; Vicodin, reaction(s): "Allergy: vicodin". Vaccination history included: moderna covid-19 vaccine ((Elasomeran), Dose: 1, Route of Admin: Intramuscular), administration date: 30Mar2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (Dose: 2, Route of Admin: Intramuscular), administration date: 15Aug2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (Dose: 3 BOOSTER, Route of Admin: Intramuscular), administration date: 02Mar2022, when the patient was 62-year-old, for Covid-19 immunization; moderna coviD-19 vaccine ((Elasomeran), Dose: 4 BOOSTER, Route of Admin: Intramuscular), administration date: 27Apr2022, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Dose: 5 BOOSTER, Route of Admin: Intramuscular), administration date: 03Jul2022, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 16Jul2022, outcome "not recovered", described as "itchy rash between thighs". The action taken for adalimumab was unknown.  Causality: Humira(Adalimumab) 1) Itchy rash  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A   Causality: Pfizer Biontech Covid-19 Vaccine 1) Itchy rash  Action(s) taken with drug: Not Applicable Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: ~~~
RA swelling, erythema 8x6 cm, induration 3 1/2 x 4 cm.
Patient woke up at 5:00 AM with migraine with nausea, eye soreness, stomach cramps, blurry vision (possibly due to migraine per patient), nose congestion (went away after an hour), and body aches. Patient was able to fall back asleep after an hour, but then woke up around 8:30 AM with migraine and nausea persisting. Patient took TYLENOL and got some relief temporarily but lingering headache persisted and got exhausted around 3:30 PM and has had early stages of a migraine since then. Patient is also experiencing loss of appetite.
Chills, fever, muscle aches, nausea, abdominal pain , arm pain, redness. All symptoms lasted about 35 hours. Also,  my children and husband contracted covid 4 days after I received second dose. I have had 2 negative tests since my family fell ill. Still no symptoms.
pt recv vax & devel vasculitis,characterized by a rash on the upper & lower areas of both legs;pt also exp joint stiffness & swelling in knees & ankles;presented to ER on 15NOV95 & treated w/pred & DPH;
Swollen with a red rash, on injection arm ....itchy, painful to touch or sleep on.  Large visible lump.  It moved down arm to my left thigh.  Lasted a week or more.
Pt recvd measles  in JAN72 & on 3JUL90 pt vaxed w/MMR (WAES90120546); On 5OCT90 lab eval revealed neg titers for measles & mumps; no further details were provided;
Patient contacted Public Health by phone call on 04/12/2021 to report the following information. Patient states approximately 15-20 minutes after leaving vaccination clinic her "tongue felt swollen, dizzy and staggering around, felt out of it, nausea, face was pale, felt drained". Patient also stated she still feels "out of it, tongue feels weird, doesn't feel 100%, trouble sleeping".  Patient denies taking any medication such as an antihistamine and denies contacting her healthcare provider. Public Health advised patient to contact her healthcare provider now and seek emergency care if symptoms worsen, any shortness of breath, difficulty swallowing.
Developed tinnitus within hours of getting vaccine. Nurse practitioner examined and cleaned out built up suramin. Nurse practitioner advised that it's possible that the pressure build up from response to vaccine will diminish. Prescribed FLONASE. Ringing in right ear diminished slightly when ear cleaned out. Still remains in both ears.
Guillain Barre Syndrome; nerve pain; legs were numb; woke up thirsty with her heart racing; woke up thirsty with her heart racing; she fell and had a urinary incontinence.; she fell and had a urinary incontinence.; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection: Lot number: unknown), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient is a 29 year old female who received her 2nd dose of the Pfizer BioNTech COVID 19 Vaccine on 07May2021. It was reported that patient was admitted (hospitalized) on 08May2021 at around 5AM. As of 1:10AM today (12May2021), caller reported that the patient developed symptoms overnight. She reported nerve pain and that her legs were numb. She woke up thirsty with her heart racing and as she was getting water, she fell and had a urinary incontinence. Patient was diagnosed with Guillain Barre Syndrome, Vaccination Initial Encounter and was still hospitalized as of today. It was reported that the patient was uninsured and needs medical attention and physical therapy in order to return back home. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Chills, Fever, Chest Pains, Lungs Hurt to Breathe, Extreme Weakness, Joint Pains and Burning, Heart Racing, Headache, Neck Pain, Diarrhea, Slight Swollen Thyroid. Arm Soreness  With my first shot, all I had was a sore arm for 4+ days.  The second shot I  has diarrhea the day before going to be only to wake up in the middle of the night with all of the above symptoms at 4:00 AM,  By Noon that day, I was fatigued but able to go to work.  A week later, I had chills again  and lost my taste and smell which I had a majority back from having COVID-19 3 months earlier.
Systemic: Joint Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: muscle ache/pain, uncontrolled jaw movements
fever 103 not relieved by acetaminophen for over 8 hrs; pt was ill for 2 days
I felt very fatigued starting around 6pm. Severe chills began around 9pm, followed by a fever. The fever went from 100.1 to 102.2 over the course of about an hour (11:30pm-12:30pm), at which time I took 400mg of ibuprofen. The fever was 102.1 thirty minutes after taking the ibuprofen. Along with the fever I experienced tachycardia, body and muscle aches, and moderate to severe deltoid pain at the injection site. I believe the fever broke around 3:00am. The fatigue and body aches lasted about 24 hours since they began, but the majority  of the rest of my symptoms were gone after the fever. The arm pain at injection site was noticeable and painful for about 72 hours before subsiding.
The side effects started within twelve hours. They included muscle pain in the left arm where the shot was given and redness and swelling at the injection site and it was  extremely warm to the touch. I was having bad chills and I could not get warm starting twelve   hours after the shot and lasting for 24 hours. I had a fever a few times within that time period and I was very tired. Most of my symptoms were gone within 48 hours.
Shortly after receiving the flu shot, I had some itching.  fter arriving hom I was itching all over and started to have some red spots which itched.  after waking up I had hives, not a lot but some on my arms, head legs and stomach.