chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after her 2nd booster dose she couldn't stand up or walk; The day after her 2nd booster dose she couldn't stand up or walk; felt dizzy all day long/stayed in bed most of the day; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (The day after her 2nd booster dose she couldn't stand up or walk), DYSSTASIA (The day after her 2nd booster dose she couldn't stand up or walk) and DIZZINESS (felt dizzy all day long/stayed in bed most of the day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048E21A, 034F21A, 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced GAIT DISTURBANCE (The day after her 2nd booster dose she couldn't stand up or walk), DYSSTASIA (The day after her 2nd booster dose she couldn't stand up or walk) and DIZZINESS (felt dizzy all day long/stayed in bed most of the day). At the time of the report, GAIT DISTURBANCE (The day after her 2nd booster dose she couldn't stand up or walk), DYSSTASIA (The day after her 2nd booster dose she couldn't stand up or walk) and DIZZINESS (felt dizzy all day long/stayed in bed most of the day) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  Patient drank fluids. It was reported that the patient was better at the time of this report however patient was not back to 100 percent.  No Treatment information was provided.   This case was linked to MOD-2022-537825, MOD-2022-537773 (Patient Link).
Chills; full body aches; fatigue; loss of apatite; light fever; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0182) via an unspecified route of administration in the left arm on 25May2021(at the age of 26 years) at 19:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had known allergies to shellfish, lithium, and lactose all since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26May2021 at 04:00 the patient experienced chills, full body aches, fatigue, loss of appetite, light fever, and sore throat. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, full body aches, fatigue, loss of appetite, light fever, and sore throat were recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Day one no reaction, days 2-6 mild itching, Hives began on day 7. Photo of arm on day 7 available.
GOT SUPER SICK AND COULD NOT WORK. THROWING UP, DIARRHEA, SUPER NAUSEOUS, CHILLS, FEVER, HEADACHES, BODY ACHES, SUPER TIGHT CHEST, TROUBLE BREATHING. FELT LIKE I WAS GOING TO DIE AND THERE WAS NOTHING I COULD DO BUT LAY THERE. IT LASTED FOR 2 DAYS, THE SECOND DAY WAS BETTER THAN THE FIRST DAY.
I had a sore throat, cough, fever, and stuffy head congestion for some days. I went and got tested on 03/28/2022 during a telehealth visit and found out I was positive for COVID-19 the next day. I had a dry cough and fever the next couple of days. My worst symptoms only lasted for about 3-4 days. I took Tylenol and Albuterol as prescribed by my doctor to help Benzonatate to help with my cough and help recover faster. Quercetin and some supplements like Vitamin C helped speed up my recovery as well.
States shortly after injection felt achy for 2 days, freezing cold, possible fever, left arm soreness shoulder to elbow that radiated to left breast. Injection site was left deltoid. Area red, swollen and itchy area 6 inches by 6 inches visible on 11/21/2011. Pt states High dose flu shot given at pharmacy on 11/17/2011. Pt called pharmacy who told her not to have the injection again. Pt did not consult with primary MD. Denies heart and lung issues, chest pain or SOB.
pt recvd vax;exp soreness, redness & swelling at inject site more than usual; apap & warm compress used;
Vaccine administered 2/15/08. Symptoms began 2/23 with lateral neck pain (no swelling noted): throbbing, and sore throat, with difficulty swallowing. Reported 2/26/08 and states it is beginning to resolve. No treatment.
Vaccine given to patient on 2/20/17 and Patient came into the pharmacy on 2/28/17 stating that she has difficulty breathing and it is getting worse. Pt claimed/suspected it is due to vaccine. So we are reporting it.
PATIENT WAS SCHEDULED FOR A SECOND DOSE OF MODERNA VACCINE WHEN HE RECEIVED A DOSE OF JANSSEN VACCINE .FIRST
administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) 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 EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    No concomitant medications were reported.  It was reported Patient identifiers for patient number 12 are documented in this case.  No treatment medications were reported.
pt recv vax 1NOV96 & pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv flu vax;this is one of 25 cases reported by pharmacist;
Information has been received from a licensed practical nurse concerning a 4-month-old male who on 17-APR-2007 was vaccinated with a dose of MMR II. Concomitant vaccines administered on 07-DEC-2007 included a dose of VARIVAX and on 17-APR-2007 therapy included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and Hib conj vaccine (unspecified carrier). On 29-NOV-2007, the patient had a chest x-ray for possible ingestion of necklace beads. The chest x-ray revealed that the patient had an "element of cardiomegaly." Cardiomegaly was also reported as being diagnosed when the patient was 4-months-old. The patient sought medical attention via an office visit. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Patient had initial Shingrix administered at her pharmacy 11/05/19. She relays onset of oral ulcers with associated headaches and myalgias on 11/08/19. Exam with 1 aphthous ulcer and 2 small superficial tongue ulcerations.  Oral lesions not listed as potential side effect/complication - unclear if correlation, but VAERS report being sent in case.
fatigue, muscle aches, chills for about 30 hours  and sore arm where the injection occurred
Blood pressure elevated to stage 2 and hypertensive crisis levels with highest systolic at 202 and highest diastolic at 123. Acebutolol dosage of 200mg daily keeps levels at normal to elevated levels most of the time occasionally with the need for a second daily dose to maintain control in the normal levels. I needed to boost the level of acebutolol to 400mg twice daily to maintain stage two. I was about ready to head to a clinic when the pressure started downward. Monitoring was at about every two hours while awake. The reduction of blood pressure was achieved on day four after receiving the vaccination.
I continue to have readness 4x4 inch in armpit; swelling in armpit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (i continue to have readness 4x4 inch in armpit) and SWELLING (swelling in armpit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced ERYTHEMA (i continue to have readness 4x4 inch in armpit) and SWELLING (swelling in armpit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (i continue to have readness 4x4 inch in armpit) and SWELLING (swelling in armpit) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported.
The morning after I broke out in an itchy rash, upper chest, neck, face, swollen eyes which has lasted 2 weeks to date. I am wondering if this has ever been reported before.  First 2 vaccines were Pfizer; booster Modena even though I had been promised Pfizer
Within days after the vaccine I started noticing a cool tingling feeling around my left eye.I went to a ENT doctor that prescribed antibiotics and told me to try Selsum Blue around my eye but that did not resolve the issue. I informed my general care provider that this existed - but no guidance was provided. I was informed that a neurologist would be the next step.  To this day, I still experience the tingling around my eye. It was worse for the few months following the vaccine but now I mainly notice it in the mornings upon waking up.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
nausea; vomiting; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 14Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, No events reported), for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious) with onset Oct2021, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset Oct2021, outcome "not recovered", described as "vomiting"; DIARRHOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "diarrhea".  Additional information: He took the second Pfizer Covid shot on Thursday and he's had some side effects and even has them still today. had nausea, vomiting, diarrhea (running to the bathroom more than normal). He does not need to go to the hospital or anything. He is at work right now and trying to find out the best option will be best or if there was anything recommended. Asks are any of these kind of side effects normal or heard of, or is it abnormal.   Follow-up attempts completed. No further information is expected.
mistakenly gave a 21 year old female a high dose flu shot; mistakenly gave a 21 year old female a high dose flu shot; Initial information received on 29-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via Agency (under the reference 00878105).  This case involves a 21 years old female patient whom mistakenly gave a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Inappropriate age at vaccine administration and overdose (same day latency).  It was reported "I mistakenly gave a 21 year old female a high dose flu shot. Are there any contraindications to this or any complications that need to watched for?"  No adverse event reported.  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.  There would be no information on the batch number for this case.
Mom reports that the evening after the immunizations,then patient complained of a lot of pain on Friday he had redness and swelling to elbow and could hardly move arm on Saturday she took patient to emergency room who said arm was infected and gave him CEPHALEXIN.  Mom says problem is improving.
CHF, Resp failure, intubated, on Levophed, suspected septic and cardiogenic shock.
lt leg swelled twice size of rt; mom states DTP leg screamed for 4-5 hrs; temp not taken had several seizures (4-5) APAP given;
had t103 w/APAP started 4-5 hrs p/vax; very fussy-refused cereal did take some formula; leg really sore & red; lasted 48 hrs-3rd day back to nl; no problemss since;
3/2/2023 That afternoon I thought I had allergies and did not feel too bad. I did not have any other symptoms. 3/4/2023 I tested negative for COVID with a home test. My husband also tested and his was positive. I tested again and was positive with a home test. My allergy symptoms became worse. Then I lost my sense of taste and smell. I was also very tired. I have not recovered and have not retested again yet.
Erythema, edema, Approx 4" X 4"- Left arm, Pt received shot at 05:00.
a patient got a booster dose of the Moderna Covid-19 Vaccine more that 12 hours after the 1st puncture; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient got a booster dose of the Moderna Covid-19 Vaccine more that 12 hours after the 1st puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer vaccine (First dose, Lot number ER2613) on 17-Mar-2021, Pfizer vaccine (Second dose and Lot number EW0158) on 07-Apr-2021.Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient got a booster dose of the Moderna Covid-19 Vaccine more that 12 hours after the 1st puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (a patient got a booster dose of the Moderna Covid-19 Vaccine more that 12 hours after the 1st puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Symptoms: It was reported that the patient had received booster dose of Moderna vaccine 12 hours after first punctured, it was first punctured on 28-Nov-2021 at 03:22 pm and kept back into the refrigerator, then took out from refrigerator on 29-Nov-2021 at 09:15 am, kept at room temperature and was administered to patient at 11:49 am. Number of doses: 1dose/1vial, was initially stored in the refrigerator on 27-Nov-2021, and the vial did not undergo any temperature excursion,amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 2 hours 30 min No concomitant medications were reported. No treatment medications were reported.
Headache, Myalgia, Pain Discomfort/Fatigue or tiredness Narrative:
When injected after about 60 seconds semi severe achy-burning feeling  in my arm that subsided in a few minutes. After 15 minutes slight tingling/numbness on the tip of my tongue and slight tingling in the upper lips of my mouth. I was not worried. I took 1 Benadryl and 2 Ibuprofen (400 ml) at that time for symptoms. I took additional 1 Benadryl and 4  Ibuprofen about 6 hours later as a precaution.  Day 2 after about 36 hours I had slight soreness, and some sweating as I slept the 2nd night. Treated with 4 ibuprofen. Also I woke up with a feeling of uneasiness in the middle of the night on the 2nd night.  Day three, just a general feeling of tiredness. Day 4 and 5 still slight ache in the injection sight if pressure is applied. Other than that I feel normal as of day 5.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 30-SEP-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (strength, dose, frequency and route were unknown; lot number L046900 with expiration date 23-FEB-2017). Temperature for vaccine was 22 F with duration of 8 hours. Tike frame was 8 hours. The call was not because of a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of the two reports that received from the same source. Additional information has been requested.
sore arm; Migraine type pain; Neck Pain; Shooting pain into her head and down her back; body aches; Shooting pain into her head and down her back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back) and MYALGIA (body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091021A, 040A21A and 02FB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concurrent medical conditions included Diabetes.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back), MYALGIA (body aches) and HEADACHE (Shooting pain into her head and down her back). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD [ACETYLSALICYLIC ACID;CHLORPHENAMINE MALEATE;PHENYLEPHRINE BITARTRATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back) and HEADACHE (Shooting pain into her head and down her back) had not resolved and MYALGIA (body aches) was resolving.            Concomitant medications were not reported.   This case was linked to MOD-2021-355604 (Patient Link).
Started to be a little achy about 4 hours after receiving second vaccine (~9 pm) so went to bed.   I woke at 5:30 a.m. with a pounding headache and aching joints.  My joints all hurt.  My legs and arms feel like they are on fire. I am very tired which is a blessing because I have slept for most of the day.  I have had chills and sweating off and on, going from cold to hot.  I am somewhat nauseated.    I have taken four Ibuprofen so far.   I continue to drink clear liquids, mostly water.  I am eating very lightly and sleeping.  I have cancelled all activities.
Red skin, hot, hard, swollen area around injection site. Swelling increased  for 24 hours. Applied ice to affected area. At the time of this form the site is less swollen, no longer hot, and less red.
Vaccine administered was stored greater than thirty days in refrigerated temperatures. A case opened with the vaccine manufacturer demonstrated that the vaccines were still safe and effective but requested that we report to VAERS
pt recv vax & that evening devel fatigue, chills, & sweats;pt then exp itching @ the inj site which spread from shoulder to elbow & a 2-inch area of swelling & erythema @ the inj site;pt recovered p/48-72hr;
Patient reported feeling itchy and had red rash on back of neck. Pt immediately given 50mg of oral liquid diphenhydramine. Pt then reported to us her rash was now showing on the left side of her abdomen. Epipen given and patient felt better for and itching subsided.  Pt began to itch again, so second Epipen was given and called 911. Pt was transported to the hospital.
pt recvd vax 1DEC92 & w/in 6 to 8 hrs of inject pt devel hives; 24MAY93, lab eval was neg for anti-HBs;