chrisvoncsefalvay/vaers-outcomes huggingface dataset:
almost passed out 2X within a 20 minute period; didn't feel good; hot; clammy; nauseous; headache; A Spontaneous report was received from a Consumer concerning a female patient of 34 years who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced almost passed out twice,  feeling hot, feeling abnormal, nausea, cold sweat, headache, .  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 17 Mar 2021, the patient received her dose of mRNA-1273 (lot/batch: 038A21A) on her right arm for prophylaxis of COVID-19 infection.   On 18 Mar 2021, the patient reports, since morning she did not feel good, was hot, nauseous, clammy, had a headache. when she was at the store, she almost  passed out  twice within a 20 minute period.   Laboratory details were not provided.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  On date of this report, the outcome of the events of patient experiencing almost passed out, feeling abnormal, feeling hot, nausea, cold sweat, headache were not recovered/ not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt received MMR left upper arm SQ and varicella vaccine right upper arm. Vaccines administered at 11:10 AM. At 11:28 AM mother request PHN to look at left upper arm. Left upper arm red, warm to touch, swollen 4 cm diameter. Saw PMD 11/3/03. Prednisone 15mg/5ml, give 1 tsp by mouth qd for 2 days.
(07/15/2021) A cyst infection appeared while on vacation and was getting worse for 4 days and at Clinic the abscess was lanced and drained. Antibiotics prescribed. Follow up with Dr. for care and further treatment.
Subjective: left arm numbness, tingling, feels cold in hand. Neuro exam in office is normal. Vaccine given in mid deltoid.
Pt vaccinated with FLUOGEN developed rash over trunk w/intense itching 13 hrs after injection. Felt "very bad". Myalgia.
Initially, pain at injection site (which is still present but mildly improved). Then, muscle cramps/pain of legs > hands as well as tingling of feet and legs that began around midnight/12 am, 10/02/2018, about 5 hours after the vaccine.....did not attribute it to the vaccine initially? thought it was my imagination but it continued and hindered my sleep throughout the night and this AM it persists and then I thought about the fact that I did have the flu vaccine and began researching side effects (never had these symptoms with prior flu vaccines).
information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. follow up information has been received from pharmacist considering a 61 year old patient of unknown gender, who on 01-OCT-2012 was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-SEP-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA004579, 1212USA005680, 1212USA005681, 1212USA005682). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information is not expected.
Paperwork indicates child was given varicella and Proquad.  Two doses of varicella in the muscle instead of subcutaneously.
8/25/10, 8 PM, fever, chills, LUA redness/swelling/discomfort. 8/26/10, 8 AM, fever, nausea, HA, generalized joint discomfort. 8/26/10 Phone notification to Dr. 8/28/10, 10:20 AM seen by Dr.
At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Used medication for asthma. Flovent inhaler for 5 times. Used xyzal 5mgs via oral. These medications are used by doctor's orders.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 02-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
My arm where I got the vaccination was swollen after a couple of weeks was really bad I had to go to the urgent care and I was there for a while and it did not get any better at all. I went to a lot of doctors because the pain was unbearable. The doctors prescribed me Bactrim and that helped a bit.
felt really terrible; pain all over; nauseated; achy all over/achy arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really terrible), PAIN (pain all over), NAUSEA (nauseated) and MYALGIA (achy all over/achy arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced FEELING ABNORMAL (felt really terrible), PAIN (pain all over), NAUSEA (nauseated) and MYALGIA (achy all over/achy arm). At the time of the report, FEELING ABNORMAL (felt really terrible), PAIN (pain all over), NAUSEA (nauseated) and MYALGIA (achy all over/achy arm) outcome was unknown.      No Concomitant medications were provided.  No treatment medications were provided.
Prolonged crying for 4 hrs p/immun; resulted in an ER visit w/no treatment given; Was seen by MD the next day who decided p/hearing the sx that was probably DTP rxn & recommended peds DT in future; pt was treated for yeast infect;
almost fell asleep driving; Tiredness; dizziness; 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 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01May2021 (Lot number: EW0172) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Colon cancer" (ongoing); "chemo treatments" (unspecified if ongoing), notes: for treating possibly colon cancer. Concomitant medication(s) included: REMICADE. The following information was reported: FATIGUE (non-serious) with onset 02May2021, outcome "not recovered", described as "Tiredness"; DIZZINESS (non-serious) with onset 02May2021, outcome "not recovered", described as "dizziness"; SOMNOLENCE (non-serious), outcome "unknown", described as "almost fell asleep driving".  Additional information: Patient reported as dizziness and extreme tiredness was worsened. Patient stated that she was also on chemo treatments and does not know the name of the medication for treating possibly colon cancer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient started with his calf muscles hurting. Then it progressed to increase mucus production, whole body aches, headache, and throwing up by Thursday 3/30/17.
New onset of one episode of hematemesis and melena x 36 hours.  Symptoms then resolved.
05/05/2022 I noticed increased fatigue, headaches and body aches every day. TYLENOL and ibuprofen would not help the pain. The pain would wake me up at night, on nights that I could sleep. I would have trouble getting comfortable many nights. I found a tick bite two weeks later. My doctor tested for Lyme's Disease which was negative. I continue to be exhausted and need to lie down. I was so exhausted several times while I was driving and I felt like I needed to pull over, this is not normal for me. I am having mental focusing issues. The headaches are not as often. The doctor put me on a low dose of anxiety medication which helped with some of the pain, but I am still having some pain. A couple of times during this, I took several at home COVID tests which were all negative.
Initial report received from a Healthcare professional on 26 April 2012. MIS/VIS number: 12-0248. This case is linked with AER n# 2012-04721 case received under same MIS/VIS number by same reporter and similar adverse events occurred after administration of PENTACEL lot number C4163AA. A 04-months-old patient, whose medical history and concomitant therapy were not reported, had received 2nd dose of PENTACEL (lot number C4163AA, route and anatomical site of administration was not reported) on unspecified date. On an unspecified date the patient was developed leg swelling and redness. The lab details and corrective treatment details were not provided. The outcome of event was not reported. List of document held by sender: none.
Immediately upon completion of inject-local rxn occurred by MMR site-area of redness-warm to touch. Examined by MD-no other sx manifested-liq Benadryl given. Observed w/out further problems.
External shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (External shaking) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (External shaking). At the time of the report, TREMOR (External shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.
Soreness at injection site, and also swelling....both occurring on the second day after the injection.
Developed itching on right side of face  between temple and earlobe while driving home. Once home was noted to have 3 dime sized hives in that area which lasted approximately 2 hours and then resolved without intervention or further adverse event.
Patient was given COVID TRIS-SUC (PFR 5-11) (PFR COVID TRIS-SUCROSE (10 X 10 (0.2ML/DOSE) MDV) instead of COVID-19 MRNA (PFR) (PFIZER COVID-19 (195 X 6 (0.3ML/DOSE) MDV))
Complained of falling out of bed due to legs not moving even though she was trying to walk.  When she tried to lift herself off floor with her arms she report they gave out.  She was able to finally get up but felt like her movements were not fully working.  She slept most of the rest of the day and was better upon waking.
arm started hurting, aches pain, severe backache;temp elevated;flu sx;arm swollen;could not move arm;rash x 2 days;sx resolved x 3 days;
Patient started high pitched screaming off and on for 48 hours. She could not be amused for that time, normally she was a happy, giggling, smiling baby. She began twitching and shaking her arms back off and on for the 48 hours as well. I called the Dr office on the 17th and they said what I was describing was normal as long as it didn't persist. Baby began acting more normal after 6pm the 17th and so I did not call the Dr back.
This spontaneous report as received from a registered nurse regarding multiple, unspecified patients of unknown demographics. There was no information about concurrent condition. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L006386, expiration date- 25-FEB-2017, lot # L018002, expiration date- 19-MAY-2017 and lot # L021215, expiration date- 10-JUN-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
7/18/22 pt admitted from Hospital to a different hospital for AHRF and EKG changes; pt had tested positive for COVID and was started on BiPAP, Decadron, ABX; pt also had a low Hgb and received 2 transfusions; pt had initially refused intubation, but O2 needs increased and she allowed intubation before her transfer to hospital; pt's condition deteriorated and the family transitioned pt to comfort measures; she passed away in the hospital
Myalgia, swelling in arm, swollen lymph node, facial swelling  Narrative:
Wrong vaccine used - used Dtap instead of Tdap. No adverse event occurred - See attached notes.
Parent called on 8-23-18, 2 days after vaccine was given and states that patient has swelling redness on left arm that vaccines QUADRACEL and MMRV was given in. Parent states not hot to touch and patient does not complain with pain only itching. The majority of left upper arm was red, inflamed and looked like a moderate size whelp. I reported this reaction to Dr the patient's physician here and she instructed parent to give patient age appropriate OTC BENADRYL LIQUID dose every 4 hours as needed. Parent also instructed to do ice packs to area about 10 mins several times a day until better. Parent instructed to observe and contact PCP office if needed. Signs and symptoms of anaphylactic reaction discussed and parent instructed to take patient to local emergency department if suspected anaphylactic reaction occurs. Parent stated understanding of all instructions for patient care. This was on a Thursday and BC we had not heard from patient before then I contacted patient back on that following Monday to check on patient. Patients Mom states by Sunday the area was completely better and patient had no problems through weekend or since then. I instructed parent to contact us back with any concerns at any time.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, reported as "during his childhood" the patient was vaccinated with two doses of VARIVAX injection, subcutaneous (strength, dose, lot # and expiration date were not provided) to prevent chickenpox. On an unknown date in approximately 2017, (reported as over 5 weeks ago) the patient had a blood titer performed, which was negative for varicella antibodies. No treatment was given for the event. After that, on an unknown date in approximately 2017, the patient received a third dose of VARIVAX injection, subcutaneous (strength, dose, lot # and expiration date were not provided). The outcome of the event and the relatedness between the event and VARIVAX were not reported.
Heart beating rapidly; Headache; Lingering migraine so had to go to emergency room after first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Lingering migraine so had to go to emergency room after first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleep deprivation.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Lingering migraine so had to go to emergency room after first dose) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced HEART RATE INCREASED (Heart beating rapidly). On 01-Apr-2021, HEART RATE INCREASED (Heart beating rapidly) had resolved. On 02-Apr-2021, MIGRAINE (Lingering migraine so had to go to emergency room after first dose) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: (normal) normal. On 01-Apr-2021, Electrocardiogram: (normal) normal. On 01-Apr-2021, Heart rate: (High) Heart beating rapidly. On 01-Apr-2021, Liver function test: (normal) normal. On 01-Apr-2021, Pulmonary function test: (normal) normal. On 01-Apr-2021, Renal function test: (normal) normal. On 01-Apr-2021, SARS-CoV-2 test: (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient after receiving their first dose of vaccine experienced extreme reactions and ended up going to the emergency room where they gave the patient an injection cocktail for their headache. The patient said it helped but the headache came back the next day for a total of 3 days and also reported a migraine for 3 days and their heart was beating rapidly. The patient undergone several tests which included lung test, electrocardiogram (EKG), blood test, liver, and kidney levels. All the test results appeared to be normal. The patient was also tested for COVID-19 and the result was negative.   Treatment medication for the event headache included injection cocktail.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-100742 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This spontaneous report was received from a licensed vocational nurse refers to 3 unspecified patients of unknown age and gender. Medical history or concurrent conditions were not reported. On an unspecified date in June 2014, reported as last week, the patients were vaccinated with VARIVAX (Merck), dose 0.5 ml, subcutaneous (lot # reported as: J004204; Exp. Date: 12-APR-2015) and (lot # reported as: J008443; Exp. Date: J008443) (strength and dose number not provided). The VARIVAX (Merck) was exposed to 81F for 72 hours. The reporter did not have specified administration dates. It was unclear which patient received which lot. No adverse effects were reported. PQC (product quality complaint) not involved. Additional information has been requested.
Pt recvd vax 6DEC90, 6MAR91, 5JUN91 & 4FEB92 dx w/OM; drainage was cultured H. influenzae type b; tx w/ATB; no permanent hearing loss or damage occurred; pt recovered;
Developed Rhabdomyolysis after working out out on 1/15/21. Was hospitalized on 1/19/20 due to Rhabdomyolysis.
Blood clots in both lungs upper and lower chambers New stage 2 HBP Chest pain and tightness Shortness of  breath Fever, headache, joint pain severe, chills, nausea
Information has been received from a nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with VAQTA (route, dose, Lot# and expiration date not reported), which were improperly stored. No adverse effect had been reported.  This is one of several reports received from the same reporter. Additional information has been requested.
Pt complained of pain on left arm and shoulder joints, 2 days post vax. Pt stated she had taken Motrin for pain in shoulder and joints. Pt states she had tendonitis problem in left shoulder before. Stated this pain got intense after the flu shot. Slightly relieved after taking ibuprofen, as per pt statement.
Information has been received from a physician concerning an 8 week old female, with no medial history and no allergies, who was vaccinated with a first 0.5 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live by injection.  Concomitant vaccines administered on the same day included a dose of poliovirus vaccine, a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and a dose of hepatitis B vaccine, recombivax (manufacturer unknown).  It was reported that the patient had recovered. It was noted that the physician would complete other doses.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
seen 10OCT97 w/diffuse papular rash 200 lesions scattered all over the body;itchy;no vesicles;no fever-no cough;dx atypical varicella;exposed to varicella 25-27SEP;
Child was seen on 9/12/18 for well child visit. Received immunizations but was also screened for possible UTI. Was given Rx for BACTRIM. Mom took child to ER on evening of after child developed fever of 101 axillary at home. Child vomited x 2 at home. Per ER documentation child arrived with temp of 100.5 axillary, with complaints of body pains, chills, irritability, and mild redness at upper left arm. Mom told ER that she had not given child BACTRIM due to vomiting. Child was evaluated and discharged to home with diagnosis of fever.
Myalgia, Arthralgia,  "bone pain and sore throat/swollen throat" referred to PCP/local setting
11/14/2005 9pm chills, sweating, T 99.2, weak, 11/15/2005 1am weak, frequent Bowel movements by x 5, Abdominal cramps, headache, felt like fainting, tachycardic ? rate, felt short of breath. 911 called in ER headache, stomach pain, med given. Headache remains now.
No known adverse outco me.  Child was given Tenivac at age 5.  Child is otherwise unimmunized.  He should have received an Infanrix.
Pt woke up at 2am violently "shaking" for 15-20mins
Injected FLUARIX into left deltoid. Patient returned within 5 minutes and said her throat was closing up. EPIPEN was given immediately and no second dose was needed. Called ambulance.
p/vax pt presented w/a chickenpox-like rash w/approx 20 to 25 pustules mostly on chest & abd, as well as the face, legs & arms;fever 101 & was irritable;
Information has been received from a liscensed practical nurse concerning an 18 year old female with an allergy to Penicillin and no medical history, who on 30-JUL-2007 was vaccinated with a 0.5mL first dose of Gardasil (Lot# 655324/0089U). Concomitant vaccination included meningococcal vaccine (unspecified) (manufacturer unknown). On 30-JUL-2007 the patient developed a sore throat. On 31-JUL-2007 the patient experienced 'shortness of breath and stomach tightness." The patient was treated with an albuterol nebulizer treatment and Benadryl 25mg. The shortness of breath resolved with treatment and the stomach tightness improved. No laboratory diagnostics were performed. At the time of the report, the patient was recovering from stomach tightness and sore throat. No product complaint was involved. Additional information has been requested.