chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt light headedness right away. The night that I got the injection, I felt kind of drunk. I felt like I had too much alcohol. I am very sensitive to things. I felt silly - loose - tired.  In the night, I had aches and chills - no fever. The next day I felt achy and really really tired. I had a pain at the injection site. That evolved into a left side migraine (the achiness and fatigue and pain from shot) It created tension up my arm and up my neck - and I did get nausea with the headache - on Saturday. Sunday, I felt a little bit better but energy was still low - unusual tiredness; couldn't exercise as I felt a heavy fatigue. On Sunday, I went to a dance class but it was difficult as I was tired. On Monday, I felt a tiny bit better but still fatigued and did another dance class which went a little better. On Monday evening, I felt like I did the night of the injection - a little loopy and "drunk like." Monday night, I woke up with a Fiery, achy, itchy, burning rash on both of my arms and the tops of my legs. If I would itch it, it would exaggerate it. When I woke up the next day - the rash went everywhere in my body - it would come and go in different places - neck, face, down and up my legs and feet and on my butt. Pretty much every spot had the rash at one time or another. It was really bad on Tuesday morning, I called the doctor. Was treated with Benadryl and cortisone cream which helped with the symptoms. Tuesday night, it was excruciating - it was all up and down my legs, arms, neck and face and stomach and rear end and feet. It was very achy, burning and itchy - very intense. It would hurt if I scratched it. Accompanied with really intense fatigue. Wednesday, after taking Benadryl, I woke up and it was a tiny bit better. It was still on my legs, neck and face. Sometimes my arms would flare up and sometimes they wouldn't. Any kind of exertion - like my dance class - would trigger the rash - so I took a break from exercising that week.  It started getting incrementally better - very slowly. Still there on Thursday - still fatigued and I was still taking Benadryl. Friday, also. Saturday, it was pretty much gone but it would threaten to come back and I felt itchiness in my legs when I went for a walk. It still feels a little lingering - my legs are itchy. I'm still building back my energy. Incrementally my energy is increasing. Still not 100% there but it's getting better day by day.  Note: My history with my skin: I do get flare ups when I get bug bites and when I get poison ivy - I have very sensitive skin.
sore arm; stomach ache; itchy rash on body; Dizzy all day; muscle aches; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day) and MYALGIA (muscle aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dizziness and Rash. Concurrent medical conditions included Drug allergy (Cipro allergy and Vicodin) and Contrast media allergy (Iodine based contrast dye). Concomitant products included BUDESONIDE (PULMICORT FLEXHALER) for Asthma, LIFITEGRAST (XIIDRA) for Dry eye, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, OXYGEN supplementation (OXYGEN), MULTIVITAMIN [VITAMINS NOS], MAGNESIUM CITRATE, VITAMIN D3, VITAMIN B2 [RIBOFLAVIN], PROBIOTICS NOS, FISH OIL, DOCOSAHEXAENOIC ACID (DHA) and CURCUMIN for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day), MYALGIA (muscle aches), HEADACHE (headache) and FATIGUE (Fatigue). an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day), MYALGIA (muscle aches), HEADACHE (headache) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   This case was linked to MOD-2021-021976 (Patient Link).
Almost passed out while driving. Extremely dizzy with any movement or anything visual moving. Had to be picked up. Dizzy for 3 days. Low grade fever and chills for 1 night.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date the patients were vaccinated with doses of improperly stored PEDVAXHIB (dose, route and dose number were unspecified), lot# was reported as J001082/exp 08-MAY-2016, lot# was reported as J006415/exp 24-FEB-2016, lot# K026533/exp 07-AUG-2017, lot# K025002/exp 20-JUL-2017, lot# K011078/exp 31-MAR-2017. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
pt reported swelling, reddness, tenderness of area of inject; reddness 1 1/2" diameter area;
Macular papular erhthemic rash over creases in skin, started evening after pt got the flu shot. Pt given medrol dose pack.
We administered dose 1 of  Pfizer COVID 19 vaccine to the patient without incident at administration.  She was asked to wait for 15 minutes in our waiting area and about 10 minutes after her vaccine, I noticed her slumping in her chair and ran over to her.  We called an ambulance, helped her to the floor, and checked her pulse. We were able to feel her pulse, but she did seem to faint for a few seconds. She then remained responsive, answered our questions, and squeezed our hands when we asked.  We did not administer any rescue medications. The ambulance arrived and they did transport her to the ER.
Donor had shot and during followup, which happened 20 minutes later, donor stated she felt nothing and everything was fine. Donor then stated that when she went home, several hours later, she had diarrhea, a major headache that went went away after a day but that for several days after she felt disorientation and tiredness. When center contacted donor to come in to take the second shot in series donor then informed center about reaction to shot on 01/15/2021 when the call was made 01/25/201.
Pt seen in office today and states she had her first Moderna vaccine last Wednesday. Last night felt the tip of her tongue was numb and lost her sense of taste. This morning woke up with left side of face drooping, left eye tearing. Denies any dizziness, weakness, lesions or skin changes. Denies fever, chills, nor recent infection
The child was administered the vaccine at about 11:15 a.m on 2/7/2021. She woke up about 14 hours later with vaccine side effects the family was prepared for, including headache, chills, nausea, vomiting and fatigue. This all resolved within 48 hours. Approximately  one week later, the child woke up again in the night with severe chills in the middle of the night. It was a sudden onset following a week of feeling well. She had to sit in a warm/hot shower for an hour to get warm. She described it as "freezing to death." She has never experienced anything like this before.
Varicella rash, exposed to mom with chickenpox about one wk ago.  Started with rash in last couple days on face, neck, back, chest & spreading.
painful, erythema, swelling, knot on left arm. Dyspnea, chest tightness, wheezing, feeling of swelling in throat, struggling to breath on the 6th and went to ED.  Fever 104. CT scan, ultrasound of arm, Oxygen and nebulizer treatments beta agonists, +diphenhydramine. Prednisone+azithromycin+benzonatate+prn rescue inhaler (albuterol). As of 2/22 still using treatments and still having symptoms as an  outpatient. Assessment for emboli.
Patient complains of reported symptoms of itchy red palms and soles of feet & facial flushing occurring 3 times since vaccination. Episodes lasts 45 min to 1 hour. First noticed 11/27 or 12/4/11. Also complains of severe hives to thigh, abdomen, groin, & buttocks once lasting a couple of hours after exercising 1 week ago sneezing (12/9/11).
My arm is still sore at the injection site 3.5 weeks after the shot was administered.
Approximately 5 months after my 2nd dose vaccination I contracted COVID-19 and had the following symptoms: Runny nose, Slight Fever, Fatigue, Headache, Body Aches, Loss of Smell and Taste. I took Vitamin C and Ibuprofen for treatment and it did help to improve my overall symptoms. I called my doctor for consultation and was not really prescribed with specific medications and just advised me to isolate for 14 days until I test positive.
This spontaneous report as received from a nurse refers to a currently 39 year old non pregnant female patient. In 1975 the patient was vaccinated with a dose of M-M-R II (dose, route, lot # and expiration date were not provided). The reporter was unsure if it was "(M-M-R) or (M-M-R II)". In 2007 titers were drawn and was noted that the patient did not have immunity to the measles. The patient did not seek medical attention and no treatment was given for the event. At the time of the report the outcome of the event was unknown. Additional information has been requested.
No adverse symptoms reported; improperly stored PROQUAD was administered to patient; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions, or allergies were not reported.   On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: digital data logger), subcutaneously, with lot number S003176 which was verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) with expiration date reported and established as 30-JUL-2020; no strength, dose, frequency, or anatomical location was reported. The vaccine was administered as prophylaxis.  Temperature excursion (product storage error) was reported as follows: temperature -9 degrees Celsius to 8 degrees Celsius (3.4 degrees Celsius), the timeframe was 98 hours and 45 minutes. No previous temperature excursions were reported. The product storage error was identified via a data logger. No adverse symptoms reported. No product quality complaint was reported.
Patient  56 y.o. year old   Date of incident: 03/24/21 Time of incident:  1013 am       Location of incident:  vaccine hub triage area  Pertinent patient history:  History of severe anaphylactic reaction to gabapentin in 2018. Patient had discussed with PCP and allergist who agreed that patient should receive her COVID-19 vaccine.  Description of incident: Patient was brought back to the triage area for vaccinator to administer the vaccine near emergency equipment and patient had her own epi pen with her (this was not used). Patient agreed and consented to receive the COVID-19 vaccine. Patient received the COVID-19 vaccine at 1013. At 1023 patient started feeling "off" BP was 177/105, pulse 96 and oxygen 97% Dr. was notified and was present in the triage area and 1st dose of epinephrine was administered in patients right thigh. Patient was coughing and feeling like her throat was closing. Patients BP at 10:25 was 197/109 and 10:26 pulse ox 95% and pulse 64. Patient continued to cough and experience shakiness and unable to catch her breath oxygen was applied at 6 L/minute per VORB from Dr. Patient received 2nd dose of epinephrine at 1026 per VORB from Dr. Patient received 125 mg of IM solumedrol in left deltoid VORB from Dr. at 1032. No benadryl was given due to allergies. EMS arrived at 1035 and administered a 3rd dose of epinephrine. IV started by EMS. EMS transported patient to ED. Patients wife was present during event and drove to meet patient at ED.      Orders initiated per RN protocol: EpiPen administered per protocol Additional verbal order for 6 L oxygen by nasal cannula, 2nd dose of epinephrine & 125 mg of solumedrol given by Dr. - read back by RN   Patient outcome:  Transported via EMS to ED     Patient left vaccine clinic via Patient Transport: Ambulance: EMS Called at 1023 arrived at approximately 1033.    Other notes:  Other RN's involved in this event were RN, RN, RN, Dr., and Dr.    RN ....................  3/24/2021   11:04 AM
Fever x 1 day, cough x 2 days, sinusitis, decreased appetite,
p/ recv vax in 7/96 in 4/98 pt presented w/8 vesicular lesions. pt sought MD attention
Hives on left and right arms and thighs, and right cheek and neck. Vaccination was given at approximately 11:15 am, I saw the reaction at approximately 12:30. (He had a sweater and pants on so it could've started sooner.)
Pain in left neck from shoulder to ear for 48 hours; Diarrhea; Swollen & Numb lips; Swollen & Numb lips; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3182) via an unspecified route of administration in the left arm on 30Aug2021 at 18:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient's medical history reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were reported as N/A. On 30Aug2021 at 20:00, the patient experienced pain in left neck from shoulder to ear for 48 hours, diarrhea for 24 hours and swollen and numb lips for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was resolved on 31Aug2021, after the duration of 24 hours; while that of the events pain in left neck from shoulder to ear and swollen and numb lips were resolved on 01Sep2021, after the duration of 48 hours.
Less than 5 minutes after vaccine, Patient was warm and sweaty then dizzy and light headed with blurred vision, then patient passed out and continued in and out of consciousness through out the 20-25 minutes he was here.
Hives on abd, legs, arms - began on 8/3/08. Saw NP - Rx with Prednisone with prompt improvement.
Sore; My body got so tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "My diaphragm is paralized in the up position" (unspecified if ongoing), notes: My diaphragm is paralized in the up position; "phrenic ner is damaged from an icd implanted in 2013" (unspecified if ongoing), notes: phrenic ner is damaged from an icd implanted in 2013; "icd implanted", start date: 2013 (unspecified if ongoing), notes: phrenic ner is damaged from an icd implanted in 2013. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, The first one as in Jan), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Sore"; FATIGUE (non-serious), outcome "unknown", described as "My body got so tired".  Clinical course: Back in Jan-Feb when she/he got her/his first and second Pfizer vaccines. Was not a good sight for her/him. The first one as in Jan and #2 was 6 weeks later. The first was no issues. The second one made her/him so sore. Her/his body got so tired she/he had to force herself /himself out of bed after a weeks time. No more vaccines. Her/his diaphragm was paralyzed in the up position and her/his phrenic ner was damaged from an icd implanted in 2013. Some people the work, some don't. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approx. 1 pm on 12/1/99, pt. started high-pitched crying.Pt. would not take a bottle and temp. went to 104.5.Legs were red and swollen at injection sites.
Patient began having seizures. Presented to ER was given IO ATIVAN. Admitted to the Hospital.
Pt reports itchy mouth. 25mg diphenhydramine PO admin per MD order. Vitals WDL, patient provided MD consult and discharge.
CLIENT RECEIVED ADULT HEP A VACCINE TO LEFT DELTOID IN THE MORNING ON 6/7/2010.  SHE REPORTED HAVING ITCHING AND HEADACHE BY EVENING.  SAW PHYSICIAN LATER IN THE WEEK WITH REDNESS AND SWELLING.  REC'D PREDNISONE FROM PHYSICIAN.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 15th of 24 patients described by the reporter.  Patient age was between 6 months to 5 years.  Concomitant Medication use information was not provided by reporter.  Clinic received incorrect guidance from the DOH, who instructed to order and give the pink top. This resulted in patient being under vaccinated. Patient was contacted and revaccinated with the correct dose. RCA being performed and DOH notified of their mistake.  They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
While seated after receiving the vaccine, the patient's husband alerted us that she was not responding normally. She seemed pale and lethargic, eyes closed. I applied a cool compress to her forehead and temples. She became alert within moments. Paramedics arrived in response to our 911 call. After they left, the patient said that she was leaving for her doctor's office for an evaluation.
Act-Hib vaccine that expired on Friday and it was accidently given today with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and gender patient to whom,  accidentally HIB (PRP/T) vaccine [ACT-HIB] was given today which was expired on Friday with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of an expired HIB (PRP/T) vaccine, powder and solvent for solution for injection (With unknown strength, route, lot number, expiration and at unknown administration site) for prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency: same day).  It was also reported that She would like to know if Act-Hib is a live or non-live vaccine.  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
fever 102 17DEC92; fever 105 19DEC92; vomiting, limpness, seen in ER put on ATB; blood test done for kidney infect was not urinating; stated ATB interferred w/blood test; kidney inf unk;
Allergic to Moderna and everything in it; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic to Moderna and everything in it) in a 74-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Autoimmune disorder.    In November 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic to Moderna and everything in it). At the time of the report, ALLERGY TO VACCINE (Allergic to Moderna and everything in it) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  Patient had the bivalent 1 year ago last November. Stated had a rare auto immune disease, stated they need to adjust medication before takes the shot. Patient stated cannot take the Moderna at all and was allergic to everything in it, and Pfizer has been wonderful as it was the only safe brand patient can take.  No treatment medications were provided.   Reporter did not allow further contact
pink, swollen, hardened area (2 1/2wide & 2" long) on lt deltoid;c/o pain in arm;temp next was 101.4;mom gave 2 APAP doses;instructed to give APAP this AM;still tender;
6 days after receiving the vaccination, my upper left arm muscles became quite painful.  Pain increased each day to the point of limiting arm range of motion, especially abduction and internal rotation.  Today is 4/25, I am still unable to internally rotate my arm, or reach behind myself due to the severity of the pain in the muscles.  Pain also prevents me from sleeping on my left side which is my natural sleep position.  I have tried OTC meds, stretching, hot/cold compresses and self massage none of which has worked to loosen up and reduce pain in my arm.   Although the level of pain is no longer increasing each day, it is not decreasing at all.
Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Mild