chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe allergic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Severe allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Severe allergic reaction). At the time of the report, ALLERGY TO VACCINE (Severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Reporter did not allow further contact
patient c/o sore throat, feeling tired and muscle aches after vaccination. Has been taking tylenol and feeling better.
Chills, fever, chest congestion, general malaise fatigue. Dr prescribed amoxicillin. Did no good, so prescribed cefuroxime; seemed to help, but a rash on my chest developed, so discontinued.
Fever, chills, hot/cold sweats, extreme fatigue, chest pain, shortness of breath, every part of my body feels pain and aches, didn't feel alert much on day one but i did drink a lot of water, day two i am a little more alert but could hardly stay sitting up, extreme fatigue both days so far, dizziness, shortness of breath, had chest pain on day one throughout the day.  Tomorrow will be day 3.
vaccinated on 2/20/03.  Rash started on 3/14/03, resolved after 7 days.   Rash returned late in June, again lasting approximately a week.  Rash consists of target lesions on arms trunk and upper legs....about 12 total.  Patient has no other PMH, was on no other medications.  No allergies.    She went to  a dermatologist, was seen by his PA, who told her she had eczema, and put her on allegra and "a cream".    In the opinion of the health department physician, "I KNOW it wasn't eczema".
Information has been received from a certified medical assistant concerning an adult female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of Pneumovax 23 (Lot# 651404/0352F).  It was reported that the patient had been vaccinated with yellow fever virus vaccine two weeks prior to the Pneumovax 23.  On an unspecified date, the patient developed an injection site reaction that included local heat, pain and redness at the injection site.  The patient sought unspecified medical attention.  At the time of this report, the patient had fully recovered from the events (date unknown).  Additional information has been requested.
Moderna COVID-19 Vaccine EUA  By 4:45 p.m., my arm was sore from right above my wrist up into my collarbone.  I developed a headache by 5:45 p.m. I woke up the next morning around 7:00 a.m. with a temperature of 100, nausea, a migraine, extreme soreness throughout my arm, and chills/shakes. It is 4:18 p.m. now. The temperature is now 99.1, with the aide of Tylenol and ibuprofen alternating, the headache still exists, as does the soreness. There is a hard knot at the injection site with about a half inch wide diameter of a red circle around the injection site.
This spontaneous report as received from a female patient of unknown age refers to herself with no pertinent medical history and no drug reactions/allergies. On 03-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# was not reported). There was no concomitant therapy. On 03-MAY-2013, the patient experienced headache, irritation at the injection site and intermittent nausea. It was not reported if the patient seek medical attention. No treatment was given for the adverse event. No lab diagnostics studies was performed. The outcome of the adverse events was unknown. Additional information is not expected.
Information has been received from a physician assistant referring to a 4 months old male patient. Pertinent medical history and drug reactions/allergies were not reported. On 02-SEP-2015 the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse effect was reported. Additional information has been requested.
Patient received his pfizer covid vaccine on 06/09/21 at 11am and waited 15 mins post vaccination. Patient returned to the pharmacy about an hour later presenting facial redness and hives. Pt took 25 mg Benadryl and we observed him for a few more minutes. He felt okay and left the pharmacy after 10 minutes. Patient was not able to finish his work shift
Hi fever, excruciating headache, shivering, vomiting, nausea, pain and red big mark on side of injection looks like a spider bite and still very sore tireless. Still red and sore the arm and today is day three and I still have a headache.
Approximately 3.5 hours after flu shot I began to experience extreme fluid build-up in my chest.  began coughing, then fluid is pouring out my nose and mouth.  began to have rapid heartbeat, claminess, difficulty swallowing, confusion.  In 20 minutes it went from gad to worse.  I grabbed a cold cup of coffee while I was on the phone with the nurse.  within a few minutes of drinking the coffee I was able to breath without difficulty.  went to clinic.  diagnosed as severe reaction.  blood pressure was low and temperature was 101.  Information received from medical records includes neausea, runny nose.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:56 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that the patient was administered the vaccine that underwent temperature excursion.The vaccine was stored in an ultra cold freezer at minus 82 degrees Fahrenheit.The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion and minimum reached temperatures was negative 82 degrees Fahrenheit.The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19 Nov 2021, when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator.The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator.No vaccine state changes were noticed. The vaccine was never refrozen.None of the vials were punctured. No previous temperature excursions were reported. No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Patient received tetanus vaccine and hepatitis B vaccine at hospital. complained of itching, lips and tongue swollen and throat tightening patient received epi, Solumedrol and Vistaril. Discharge instructions patient to take Benadryl PO.
Herpes outbreak on left butt cheek.  3 days after 1st dose. and 2nd Herpes outbreak in similar location 13 days after 2nd dose; Herpes outbreak on left butt cheek.  3 days after 1st dose. and 2nd Herpes outbreak in similar location 13 days after 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0150), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 22:00 (at the age of 52-years-old) as dose 2, single for covid-19 immunisation. Medical history included none and had no known allergies. Concomitant medication included progesterone; estradiol (ESTROGEN); testosterone and multivitamins. Historical Vaccine included BNT162B2 (Batch/Lot Number: ER2613) on 23Apr2021 at 02:00 (at the age of 52-years-old) pm for covid-19 immunisation and experienced Herpes outbreak on left butt cheek. 3 days after 1st dose. On 26Apr2021 at 09:00, the patient experienced herpes outbreak on left butt cheek.  3 days after 1st dose. and 2nd herpes outbreak in similar location 13 days after 2nd dose. Treatment was provided with Valtrex medication & Abreva topical ointment. The patient received no other vaccine in four weeks. The patient was not COVID prior vaccination and did not test for COVID post vaccination.Outcome of the events were recovering.   No follow-up attempts are possible. No further information is expected.
Patient states that she has blisters on tongue 1 day after vaccination. Also feels very weak.
Information has been received from a registered nurse concerning a 4 year old male with no known allergies or pertinent medical history who on 09-MAY-2007 was inadvertently vaccinated SC with a dose of Zostavax (lot # 656606/0033U) instead of MMR. Concomitant vaccination included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine (manufacturer unknown) and PREVNAR. Unspecified medical attention was sought. The patient had no symptoms or adverse effects. There was no lab tests performed. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source. Additional information has been received from the registered nurse who stated that the error occurred because the bottles of the vaccines were kept in the same place and they looked similair. It was reported that now they store vaccines separately to prevent the product confusion. The patient did not experience any adverse event. No further information is expected. This is one of several reports from the same source.
Pt presented to the hospital with nausea and vomiting and cough.  Workup was notable for COVID-19 positive and a mild pancreatitis with a lipase of 800. The remainder of her workup was unremarkable.  She was admitted, given monoclonal antibodies by the admitting team, and IV fluids.
She got her vaccine, had no reaction, put ice on her arm and tried to stay moving it and was thirsty and drank a lot of water.  She took her shower and went to bed as usual.  The next morning early she felt so bad when she tried to stand up and she could not.  She felt so bad and shaking that she was having seizures.  Her whole body aches, her arm hurt, her head felt like she had gotten shot in the head.  She went to bed for 4 hours, went to the bathroom and had severe tremors/violently shaking.  She used the bathroom and slept for another 10 hours.  By about 6:00 PM that night she could sip some water but not a lot as was afraid of throwing up.  The 2nd day was bad as well, not as bad.  She started drinking around 12:00 and tried to hold that down and by about 5:00 PM she was bale to eat.  She had a temp of 101.7 and 101.9.  She did take Ibuprofen and when she tried to eat, she felt sick again like she was back to the first day and her temp came immediately back.  It's been a week and she still feels like crap, and was trying to go to the grocery store and had to leave as she had no energy.   She does have a rash on her right arm around the injection site.  She has improved some, able to eat 1/2 of what she used to, still feels sick after she eats, her temp is low grade and exhausts out quickly and does not feel well and not back to herself.   She did drive today but was afraid to do so due to the feeling she is still having.
general rash-eyes swollen closed difficulty breathing 1 day p/vax-ER 1 day p/did not appear to be related to MMR stated looked like an allergy to something pt ate or was exposed to
Hives approx 2 days post vaccination. Gave ZYRTEC and Allergist referral.
8/19/21 @ 1654 in the afternoon, call received from parent that child was at the emergency department of Hospital. Had a reaction to vaccine or medication prior to arrival. Reported patient had a bad seizure. Pt advised to discontinue guanfacine, see primary care provider, and neurology follow up. Discharged home.
Angioedema,   team; recommended 60 minute evaluation . No further intervention  Diagnosed with acute allergic reaction without anaphylaxis. 1120 135/85 24 RR 69 HR 100% O2 Sat.  1130 98% O2 Sat, 20 RR, 71 HR.  1140 98% 68 HR 20 RR.  Discharged at 1140. Patient stable.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
I have sudden symptoms of Urinary Tract Infection; extremely fatigued; develop upper respiratory congestion/discomfort; cough; This is a spontaneous report from a contactable consumer (patient herself). A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8731, expiry date: unknown) via unspecified route of administration, in left arm on 08Apr2021 16:45 (age at vaccination: 35-years) as dose 1, single for Covid-19 immunisation. Facility type vaccine was public health clinic/veterans administration facility. Patient was not pregnant at the time of vaccination. Patients medical history included obese from an unspecified date and unknown if ongoing. Patient had no known allergies. Concomitant medications were not reported. No other vaccine in four weeks was administered. Other medications taken in two weeks was topical nail fungal treatment. Patient stated to date, she had received first dose of the Pfizer Covid vaccination. Within 1-2 days, on 10Apr2021, she was extremely fatigued. This did not resolve within a day or so as she anticipated. She then began to develop upper respiratory congestion/discomfort 4-5 days post vaccine. She was presently still congested, fatigued, and have a cough as of 21Apr2021, with little improvement. On 10Apr2021, she had sudden symptoms of urinary tract Infection. She did do an e-visit for antibiotics to address the UTI. She had not been seen for the upper respiratory symptoms yet, but may go in if they persist into next week. AE resulted in doctor or other healthcare professional office/clinic visit. Nitro FU Rantoin macro crystal monohydrate 100 MG cap was given as treatment for the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. Patient underwent nasal swab (SARS-CoV-2 test) with negative results on 16Apr2021. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
thyroiditis subacute; This is a spontaneous report from a non-contactable consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced thyroiditis subacute. Time to onset was 0 days - occurring on the same evening. The reporter classified the seriousness criteria of life threatening, disabling/Incapacitating, intervention/medically important, congenital anomaly/birth defect, death, hospitalization required, hospitalization prolonged, other was reported as no. Treatment medication included corticosteroids for 2 months (tapered). On an unspecified date, the patient underwent lab tests and procedures which included endocrinological, thyroid function test, thyroid echography, all were resulted as unknown results. The outcome of the event was recovered.
Within 4 hours I had pain radiating up my arm to my neck and in my lower jaw. The next day 3/4/2021 I had a migraine, nausea, weak, off balance, diaphoretic, chills, dizzy, my neck was sore and I could barely move it and my lower jaw hurt. Medicine did not alleviate my symptoms. 3/5/2021 I had a bad headache, nausea, weak, dizzy, off balance and a slight sore neck. 3/6/2021 I had a headache, weak slight nausea. 3/7/2021 I had a headache and was tired.
light headed; fever; Very tired; sore arm; redness on arm; Puffy arm; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number P57AA, expiry date 31st July 2019) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix. On 19th March 2019, less than a day after receiving Shingrix, the patient experienced light headedness, fever, tiredness, pain in arm, erythema of extremities and swelling arm. On 22nd March 2019, the outcome of the light headedness, fever and tiredness were recovered/resolved. On 26th March 2019, the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the light headedness, fever, tiredness, pain in arm, erythema of extremities and swelling arm to be related to Shingrix.  Additional information received were as follows: In the evening of day of vaccination, the patient experienced light headed and very tired. The patient also had a fever. The patient's arm was sore, red and puffy. The light headedness, fatigue and fever resolved after 3 days. The patient's arm was sore, red and puffy for about 1 week. The reporter did not consent to follow-up.
Extreme hair loss, diagnosed as late-onset Alopecia Areata.   First noticed 5/11 by hairdresser.   As of 8/9, 70% of hair has been lost in large patches or extreme thinning in all other areas.  I have never had a hair loss event prior to this and there was no emotional stress trigger.     Also, very lethargic and body aches for day after vaccine.
Pt given first dose Pfizer on 8/3/21 and second dose on 8/27/21.  Pt was given booster on 12/7/21 when it should have been given on or after 2/27/22.  Pt reported no s/sx of adverse reaction after 15mins observation.  Pt stable and released from the vaccination site.
Case number PHEH2015US020013, is an initial spontaneous report from a health care professional received on 07 Oct 2015. This report refers to a 58 years old female patient. Concomitant medications were not reported. The patient with allergy to egg yolk was vaccinated with FLUVIRIN (batch number: 1514901) intramuscularly on 07 Oct 2015. No adverse event was reported.
Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 9899), via an unspecified route of administration in right arm, on 21Dec2020 at 19:00, at a single dose, for COVID-19 immunization. The patient's medical history included attention deficit disorder (ADD), gastroesophageal reflux disease (GERD), migraines, allergies to latex and cinnamon (severe), gluten intolerance, and lactose intolerant. The patient's concomitant medications included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), candesartan, galcanezumab GNLM (EMGALITY), glucosamine, magnesium, melatonin, iron, escitalopram oxalate (LEXAPRO), omeprazole, ursodiol, colecalciferol (VIT D3), and buspirone hydrochloride (BUSPAR). The patient previously took acetylsalicylic acid (ASPIRIN), fentanyl, and codeine and experienced allergies to the medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 22Dec2020 at 9 AM, the patient's arm was very sore and had some muscle aches and scratchy throat. These lasted a little over 48 hours (2 days). The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Dec2020.
FELT FINE WHEN GOING TO BED 1/31/2022.  6AM 2/1/2022 WOKE UP WITH  SEVERE HEADACHE, FEVER, CHILLS, DIZZY, WEAK, NO APPETITE, NASAL CONGESTION ALL DAY  7:30PM 02/1/2022 STILL FEELING:  SEVERE HEADACHE, FEVER, CHILLS, DIZZY, WEAK, NO APPETITE, NASAL CONGESTION CEASED
Left arm injection site swelling, severe pain, warmth, fever 99.9F, chills, nausea.
The most disturbing thing is the tinnitus. It began with an intense and unusual headache the morning after I received the vaccine. I have frequent migraines but this was even more intense and  on the other side, the side where I received the shot, with a focal point. I heard the loud pumping of blood, I assumed, and a whistling sound. Today the headache has lessened but the ringing remains quite loud plus the pumping sound is still there and distinctly was not there before waking up with that headache.  I have also had gastrointestinal symptoms.
My blood pressure started to go up and registering at higher levels several times a week.  It makes me very fatigued and "wossey" in the head. The doctor thought it was a temporary side effect of the vaccine.  The symptom still has not gone away.