chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscles were really bad; Sleeping a lot; Fever; Feeling really tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscles were really bad), HYPERSOMNIA (Sleeping a lot), PYREXIA (Fever) and FATIGUE (Feeling really tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Muscles were really bad), HYPERSOMNIA (Sleeping a lot), PYREXIA (Fever) and FATIGUE (Feeling really tired). On 18-Feb-2021, MUSCULAR WEAKNESS (Muscles were really bad), HYPERSOMNIA (Sleeping a lot), PYREXIA (Fever) and FATIGUE (Feeling really tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by reporter.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patient and her sister are fine.
Heplisav accidentally given to a 17 yo; Heplisav accidentally given for 3rd dose; Initial Report Received on 02-Oct-2019  A reporter reported that a 17-year-old (unknown gender and race) was accidentally administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization for their third dose.   Relevant medical history and concomitant medications were not provided.   On an unknown date, the patient accidentally received Heplisav-B (lot #, expiration date, and NDC # not reported) for their third dose. It was unknown if the vaccine was administered from a vial or prefilled syringe.   No further information was provided.   At the time of the report, the outcome of the event was not reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the events of product administered to patient of inappropriate age and extra dose administered as non-serious. The events of product administered to patient of inappropriate age and extra dose administered are unlisted per HEPLISAV-B.; Sender's Comments: : The company assessed the events of product administered to patient of inappropriate age and extra dose administered as non-serious. The events of product administered to patient of inappropriate age and extra dose administered are unlisted per HEPLISAV-B.
Received Flu vaccine 9/26/11 3:25pm, went to ER 9/27/11 approx 3:51 am. Per mother fever since 10pm 9/26/11 ranged from 104 - 105.7 F responded to TYLENOL, no other symptoms. T 101.7F rectal in ER treated with MOTRIN, fever resolved. Normal physical exam.
Colleague states that immediately after the injection she felt a little reaction as the needle was pulled out and it immediately started itching. Area was swollen next day like a "turtle shell" in the area. Colleague marked arm to observe for redness growth, but area did not get bigger. States she has received the flu vaccine annually since 2004 with no history of reaction.  Was seen in Emergency Room.  Took Benadryl and Pepcid for a few days and site reaction eventually resolved.
On Wednesday, February  17, 2021 around 7:00 pm I had a pounding headache that I never experienced before.  The next morning headache began again and started vomiting at 7:45 a.m. thru out the morning until 11:30 a.m.  I could not eat anything , tried eating a piece of toast & after one bite the vomiting began again.  I vomited again at 3:15 p.m.  Tried again to eat white rice and immediately began vomiting again.  On Thursday morning had a slight headache with no vomiting.  Friday I felt OK, just weak from all the vomiting.  Saturday morning I felt Okay, then suddenly I felt dizzy and though I was going to faint.  My daughter immediately told me that she was driving me to the ER because I was pretty dehydrated.  Was diagnosed with dehydration at the ER.
Head fullness,  sinuses dried, nose stuffy, weak, spacey, rapid pulse, Felt as if I would pass out, ashy/pale complexion.   Felt extremely weak in the evening.
fainting; Fatigue; dizziness/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); nausea/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); hot flashes/sleep disturbance (wake up with hot, dizzy, nauseous every few hours); chills; loss of appetite; unable to focus; sleep disturbance (wake up with hot, dizzy, nauseous every few hours); This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#EL9269), via an unspecified route of administration in left arm from 02Feb2021 14:00 at first single dose for Covid vaccine. Medical history included known allergies: Oak trees, kiwi. Concomitant medication in two weeks included hydroxyzine hydrochloride (ATARAX), sertraline hydrochloride (ZOLOFT). No other vaccine was received in four weeks. The patient experienced fatigue, dizziness, nausea, hot flashes, chills, fainting, loss of appetite, unable to focus, sleep disturbance (wake up with hot, dizzy, nauseous every few hours). Adverse event start date: 03Feb2021 02:00 AM. AEs resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received for the events. No covid prior vaccination. Covid was tested post vaccination: nasal swab on 05Feb2021: negative. Symptoms lasting 6 days and counting. Outcome of the events was not recovered.
following vax pt exp 3 min seizure pt stiffened & fell straight, feet & legs jerked, eyes rolled up. then went limp. dx febrile sz.
felt dizzy with a severe headache; felt dizzy with a severe headache; slumped to the floor; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 24-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Nov2021 10:15 (Lot number: FF2589) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; VYVANSE; BUSPAR; CLONAZEPAM; SERTRALINE; CLONIDINE; MELATONIN; BENADRYL. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207), administration date: 19Mar2021, when the patient was 23 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729), administration date: 12Apr2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 10:15, outcome "unknown", described as "Booster"; DIZZINESS (non-serious), HEADACHE (non-serious) all with onset 19Nov2021 10:30, outcome "recovered" (Nov2021) and all described as "felt dizzy with a severe headache"; FALL (non-serious) with onset 19Nov2021 10:30, outcome "recovered" (Nov2021), described as "slumped to the floor". The events "felt dizzy with a severe headache", "felt dizzy with a severe headache" and "slumped to the floor" were evaluated at the physician office visit. Therapeutic measures were taken as a result of immunisation, dizziness, headache, fall. Additional information: Facility where the most recent COVID-19 vaccine was administered was school or  health Clinic. Adverse event treatment She drank water and rested for approximately 45 minutes. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are needed. No further information is expected.
Excruciating upper back pain, sharp pain in both temples like  I was being hit with a sledgehammer, difficulty breathing due to pressure inside chest cavity that seemed to come fromy back, soreness in both shoulders
pt recvd vax & w/in 15 mins there was a fine red raised rash in circles where every inject was given;
The first COVID-19 shot put me into a sort of zombie like coma for some reason I was a little bit tired and slightly dizzy and my arm hurt the day of the shot but I thought nothing of it at the time then went to bed and passed out into the deepest sleep and got woken up by my concerned mother 18 hours later who was freaked out that she had gone to work and come back again and I was still sleeping so she forced me to stay awake for the next 3 hours during which all I wanted to do was go back to sleep again immediately and I was not terribly alert and remember nothing of those 3 hours other than begging her to let me go back to sleep again because i was just SO TIRED but according to her she apparently dragged me to IHOP for my grandmothers birthday dinner and I made very bare minimum mumbling small talk conversation only if you prompted me to respond two or three times  and kept nodding off leaning against the side of my booth seat partner and having to be shaken awake again she finally let me go back to bed again at 9 that night and I slept for another 15 hours and woke up more alert but with the feeling that I had a moderate but semi functional case of sleep deprivation like I had just pulled an all nighter working on a school project or something so thinking i was feeling better I went grocery shopping and by the time I got to the end of my list I was starting to feel more fatigued and I remember driving to the store but not driving back and only random bits and pieces of putting the groceries away and then thinking that i was unbearably hot and being concerned that I had a fever so i went to the bathroom and checked my temperature which was 98.6 then stood in front of the AC vent thinking I should take a cold shower and the very next second i am startling awake to a super loud song on my MP3 player that i don't remember turning on and curled up in the foidal position on the couch and the contence of my pockets are all over the living room floor for some unknown reason and i have lost nearly two hours worth of time but feel much better and only a normal amount of tired then went to bed that night at 10 and slept for 12 hours then woke up by myself totally normal fully rested fully functioning awake and alert and with no more memory or lost time or fatigue or sleep issues ever since that point  and when I went in to get my second stage of the COVID-19 shot today (about an hour ago from the time I am currently typing this report and FYI as of this moment so far I feel fine luckily) and told the pharmacist about my zombie coma experience and asking if that was going to happen again she told me that she didn't know and also that it was apparently an abnormal reaction to the shot to try to sleep it off like that and she told me that I should report it here on the website so here I am reporting it now...
Patient complainted of feeling dizzy and light-headed. Staff responded by offfering snacks. Soon after, Patient became pale and unresponsive for 60 seconds. Awoke spontaneously and offered juice.
This spontaneous report was received from a registered nurse, concerning to multiple unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies, or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (dose, frequency and route were not reported) lot # L050561 with expiration date of 14-DEC-2017 and lot # M019841 with expiration date of 20-APR-2018, for prophylaxis. The sterile diluents (manufacturer unknown) (lot # and expiration date were not reported) used to reconstitute the VARIVAX were properly stored. The temperature of the VARIVAX was between 6 °F and 14 °F for a time frame of 30 minutes. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010916:
R-Deltoid (Dtap) whole arm swollen noticed 6/16/09 received imm on 6/15/09 4pm gave Rx Dermatop - watch give tylenol Benadryl as needed.
vomiting; diarrhea; Initial information was received on 30-Nov-2020 regarding an unsolicited valid non-serious case from patient's child via social media .  The case was cross-referenced to 2020SA345863 (case for mother).  This case involves an adult female patient of unknown age who had vomiting and diarrhea (diarrhoea), after being vaccinated with INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date were not reported] at an unknown dose, via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient was in bed suffering from vomiting and diarrhea (diarrhoea) for 3 days (unknown latency), following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
02dec089 pt vax 2nd hepta B. pt devel polyarthralgia affecting knees and ankles, low grade fever, and flulike illness.  06feb90 pt to er and drained knees.  pt tx w/ prednisone. arthritis waxed and waned.
This is a spontaneous report from a contactable other healthcare professional (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 31Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included diabetes (reported as diabetis), high blood pressure, allergy to penicillin and sulfer; and COVID-19 (prior to vaccination). Concomitant medications included metformin, apixaban (ELIQUIS), valsartan, propafenone and amlodipine besilate (AMLODI). On 31Jan2021 10:30 AM, the patient experienced redness, warm and itchy around injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.
I received my 2nd Pfizer\BioNTech vaccination on 2/12/21 at approximately 4:00 p.m. Around 10:00 p.m. to 10:30 p.m. on 2/13/21 I began to experience severe chest pains and heart palpitations. When I attempted to lie down that night I also had difficulty breathing. **It should be noted that I had not previously experienced any chest pains/Shortness of breath prior to receiving my second dose of the aforementioned vaccine.
A few days (week maybe?) my arm got a rash that looks like hives near the injection point on my arm.  It's hot to the touch, but does not itch.  It is not sore at all, just very red.  No fever or anything either.  This was only my first vaccine shot.  It's been almost two weeks and it's still red and warm to the touch at injection point.
24 hours post vax, the pt developed a swollen, large, red area around the injection site on the left thigh, the size of a softball or larger. Site was red with fever and very firm. All symptoms were gone within 72 hours of the reaction.
1. A few hours after first injection of Moderna, I began to experience a loud ringing/hissing sound in left ear.  I later learned it was called tinnitus. It lasted through the night and disappeared the next day. 2. On the 8th day after the first shot a red, hot circular mark/rash appeared at site of first injection followed by chills and elevator fever and 3. About one week after the second injection of Moderna (four weeks after first injection) I began to feel sporadic dizziness. This turned into dizziness so severe I had to lie on the floor as things were spinning. About a week after that the tinnitus returned along with severe headaches. Now I feel dizziness and tinnitus and headaches sporadically all the time.
Syringe Connection Issue; Vaccine underdose; Accidental overdose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe Connection Issue), UNDERDOSE (Vaccine underdose) and ACCIDENTAL OVERDOSE (Accidental overdose) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Syringe Connection Issue), UNDERDOSE (Vaccine underdose) and ACCIDENTAL OVERDOSE (Accidental overdose). At the time of the report, DEVICE CONNECTION ISSUE (Syringe Connection Issue), UNDERDOSE (Vaccine underdose) and ACCIDENTAL OVERDOSE (Accidental overdose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Ulcerative Colitis flare up - severe stomach pain, diarrhea, urgency, fatigue, stomach cramps
Pfizer-BioNTech COVID-19 Vaccine EUA  Sore throat, chills, fever, body aches
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 38 patient's symptoms improved after Moderna vaccine; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) 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 third 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine).    Concomitant medications were not reported.  Reporter stated she had been administering the 65+ bivalent dose to her patients who have symptoms of "long-haul COVID" (non-indicated use of vaccine) and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reaction reported. Treatment medications were not reported.  This case contains information for patient 28 out of 42.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Patient 28 out of 42 patients
Nurse administered Kinrix Vaccine to a 2 month old baby  nurse charted that she gave 2 injections and she gave 1
Mother of pt notified on 6/18/03 that after shots in December pt had crying and fever for 3 days-fever up to 104 and possible 106. Did not notify MD or health dept. Parents gave Tylenol and Motrin.
Arm stiff and sore. Can't lift arm higher than shoulder. Can't bear weight on arm or lift anything with left arm.
Pt. states that after receiving the 3rd dose of Booster Moderna 09/30/2021, started experiencing symptoms 09/30/2021 of chills, fever, nausea, fatigue, loss of appetite, and dry cough. Still continuing to experience symptoms, Primary communications still waiting for recommendations.
5 pimple like spots around vaccination rite (RLT). No fever or illness reported.
Itchy rash everywhere, on her back, chest.; hives all over the body; hives all over the body that were painful; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash everywhere, on her back, chest.), URTICARIA (hives all over the body) and RASH (hives all over the body that were painful) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced RASH PRURITIC (Itchy rash everywhere, on her back, chest.), URTICARIA (hives all over the body) and RASH (hives all over the body that were painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (Itchy rash everywhere, on her back, chest.), URTICARIA (hives all over the body) and RASH (hives all over the body that were painful) outcome was unknown.            No concomitant medications provided.
Onset of watery diarrhea 2 days after injection of Covid and flu vaccines. Diarrhea has persisted 16 days with no improvement.   I also received Fluzone HD 65 t PF2022-2023 inj.  .7 ml at the same time.
After experiencing chills, fever, hot flashes and stomach aching, extreme swelling around the left eye occurred to the point that there was no vision possible. This swelling lasted for more than 2 full days. Began to subside several hours after taking prednisone to reduce swelling.