chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates the patients received unspecified number of doses of improperly stored GARDASIL. The nurse reported that the doses may have been given from the following lots: Lot # K011325 (expiry date: 08-APR-2017) and lot# K011562 (expiry date: 08-APR-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Tested positive for Covid 19; Tested positive for Covid 19; Bad chills, and all this stuff; Got a lot sicker than she did; This is a spontaneous report from a contactable consumer. A contactable consumer reported different event for 2 patients. This is 2 of 2 reports. This contactable consumer reported for a male patient (reporter's friend) of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE and received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced tested positive for covid 19, bad chills, and all this stuff got a lot sicker than she did. The patient underwent lab tests which included sars-cov-2 test: positive on 2021. The outcome for all events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient is a 70 y.o. male who presented with frequent falls from his mobile home. PMHx of end-stage renal disease on hemodialysis TThS, hypertension, coronary artery disease, hypoxic brain injury during CABG, cognitive impairment. The patient presented with generalized weakness and increased falls at home.    The patient was admitted with right lower extremity cellulitis and placed on cefazolin. The patient has known severe PAD likely contributing to ulcerations but has declined revascularization in the past. An US of bilateral lower extremities was performed which showed a right lover extremity thrombus within a right intramuscular vein in the mid calf. Anticoagulation for this alone is not warranted. Over the course of the hospitalization the patient showed improvement in erythema and completed total 7 day course of antibiotics.    The patient was also incidentally found to have COVID-19 infection. He is vaccinated and was initially asymptomatic. He later developed SOB and wheezing at which time CXR showed bilateral infiltrates and he was started on Decadron 6mg daily and albuterol. Patient remained on RA and completed course of Decadron.    Overall, the patient has a documented history of medical noncompliance. He is a poor candidate for anticoagulation due to frequent falls. Anticoagulation was discontinued. He was placed on Plavix due to his severe PAD.    Nephrology followed along while inpatient to continue patients outpatient dialysis schedule.    On morning of discharge, patient was found to be slightly hypothermic but asymptomatic. He was briefly placed on Bair-Paws and temperature improved and remained stable off warming devices. He did have a mild leukocytosis which was felt to be reactive from steroids. He had no complaints on day of discharge and felt great. He was discharged to SAR in stable condition.
Patient was given a Pfizer COVID-19 vaccination. They are under the recommended age of 12. No adverse effects noted.
9pm 4/30 fatigue and aches set in. Mild symptoms.  Took a sleep aid and ibuprofen for bed. Fell asleep shortly after 10pm.   1am woke with intense chills, body aches and fever of 100.6.  Added heating pad, took Tylenol, added blankets and clothes but couldn?t get warm. Was so uncomfortable from the body aches I tossed and turned. I was extremely fatigued and weak.  Was still awake with extreme aches and chills at 4am, so I took a bath from 4-5am to warm up.  Symptoms persisted post-bath, but dozed off at 5:30am from exhaustion. Fever of 100.6 remained.  Rose at 8am feeling exhausted, heavy, brain fog, weak, chilled and body aches. Pins and needles over body from 1-9am.  Took 3 ibuprofen (600mg) and went back to bed. Fever reduced to 99, which was enough to break the chills/aches and allow rest. Slept until 10:30.  Chills and aches gone, but extreme fatigue and brain fog continued through day. Too weak to tend to kids, read books, or stand.  Appetite was fine. At dinner and snacks. Drank fluids and rotated ibuprofen and Tylenol as long as symptoms persisted.  Evening of 5/1 headache set in. Mostly dull ache.  Took OTC and went to bed.  Slept through the night, waking at 8am 5/2 with a smashing headache. It felt like someone hit me over the head with a bag of bricks, then put my head in a vice.  Drank water and took ibuprofen (400mg).  Still felt weak, but better.  As the day went on, symptoms improved and headache reduced. Went away completely in afternoon and back at bedtime.   Longest lasting symptoms of anyone I know. No health risks or complications. Generally healthy.
This spontaneous report was received from a Nurse Practitioner refers to a 22 year old female patient. None pertinent medical history, drug reactions/allergies and concomitant medication. On 25-MAY-2016, the patient was vaccinated with GARDASIL 9 in the arm (lot number and dosage not reported). On 26-MAY-2016, the patient felt "woozy, my bones ache, heavy feelings in arms. The patient also was not able to lift anything over 10 pounds and had the feeling of being hot and cold". The patient sought medical attention, called the nurse. The patient received unspecified treatment for the event. None lab diagnostics studies performed. On 27-MAY-2016, patient "felt better" from the events. The reporter did not provide any causality assessment between events and GARDASIL 9. Additional information has been requested.
Pt presented came in to our clinic and for an infection and mentioned that she had an adverse reaction to her shot from may 1, 2018. She said it was fine for 2 days, then woke up and injection site was swollen and sore and warm to touch. Symptoms have not improved and arm is stiff.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 17-SEP-2013 the patient was vaccinated with a first dose of RECOMBIVAX HB (dose, route and lot # not reported). On 01-NOV-2013 the patient was at the pharmacy to receive the second dose of RECOMBIVAX HB (dose, route and lot # not reported). No adverse symptoms were reported. Additional information has been requested.
seizure; very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Medical history was reported).   On 10-Apr-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 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (very tired). On 12-Apr-2021 at 3:00 AM, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) and FATIGUE (very tired) outcome was unknown.    No Treatment related information was reported. Patient went to bed like normal that night. Patient called a nearby family member, who took patient to her neurologist later the next day.; Sender's Comments: This case concerns a 63-year-old female with a serious unexpected event of seizure, and nonserious expected fatigue. Event onset 1 day after first dose mRNA-1273, with seizure occurring 2 days after vaccination. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Chills, Fever, Headaches, Body aches, Night sweats, Cough , hard to take a deep breath, extreme fatigue, and Vomiting -all started on April 19.  I was admitted to the ER after several hours of vomiting. I had a fever of 102.2 and oxygen levels in the 70%. After 3 hours my O2 level went up to 90 and I was sent home. For the next week I continued to suffer from all the above symptoms with the exception of vomiting and my O2 level was consistently in the mid 80's. I returned home and slowly the O2 level went up and after another week the symptoms subsided one by one. After 2 weeks I am now slowly regaining
The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
patient developed what she described as a heat rash first up her neck then on her arms and abdomen that was itchy at first, then turned into what she described as bumps that looked like bug bites and then it would blister.  She thought it was posion ivy at first, but it would return in cycles. She saw her doctor on July 29th and the doctor's office after researching concluded that she had developed chicken pox and prescribed Valtrex.  She picked up the Valtrex on 8/4, spoke to patient today on 8/6 and she says her symptoms have pretty much resolved now and she did not start the Valtrex, but picked it up in case the symptoms return
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "Multiple Sclerosis". Clinical course: The neurologist said he had another patient with multiple sclerosis after the COVID booster shot. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200500520 Same product/event, different patient.
Pt called our office on 5/14/10 complaining of arm pain, swelling, redness, tenderness, shortness of breath and wheezing. She used her albuterol inhaler to alleviate respiratory sxs. Dr. recommended she take 600-800mg ibuprofen and ice the area and continue to monitor. Pt went to walk in clinic on Friday night d/t development of swollen/painful lymph nodes and worsening redness at injection site. Saturday pt went to the hospital as she developed 102 fever and worsening sxs. She was admitted.
Migraine; Headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ew0150) via intramuscularly in left arm on 04Apr2021 at 12:15 as dose 1 single (at the age of 44-year-old) for COVID-19 immunization.  Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. There were no prior vaccination within 4 weeks. The patient stated that, twelve hours after the first dose, on 05Apr2021 at 00:15, patient developed a migraine, headache, which lasted (on and off) for a day. Patient also received second dose of BNT162b2 (ew0172) via intramuscularly in left arm on 25Apr2021. There were no relevant tests done. Therapeutic measures were taken as a result of the events (unspecified). The outcome of the events was recovered on 06Apr2021.
10/25/03 got stomach pains and eating problems, went to ER on 10/26/03. Admitted for couple days, d/c went back to work; 1-2 nights later was out getting food and got confused and almost unable to get home, called dad, dad arrived at pt home next day. Contact Dr, MRI done a couple weeks later; unable to work or be alone. Disabled diagnosed with ADEM-Acute disseminated encephomyopathy by Dr who said may recover in 6-9 months. Dr referred pt to neurologist, neurologist referred also to another doctor and an endocronologist. Also seeing a psychiatrist. Dr referred pt to a gastroenterologist. Dad said he is preparing to move soon with him. I saw pt-he sat in passenger's side of vehicle. I told pt "sign here" and pointed to signature area and pt said "who me"-he did this same thing two times-while signing and releases. Meds now are Prozac for depression, clonopine for depression, Protonex for stomach/ gas. In the past was on Rimeron and Zoloft-was on for 1 year and stopped about 6 mo before 10/9/03.This is a 36 year old male who presents to the ER saying that he has had nausea and vomiting 5-8 days with a stomach ache in mid abdomen. He reports that he hasn't eaten in the last two days any food. Pt tells the ER physician that he duobled on his Cortef the last two days but did not take that morning upon arrival to the ER. Pt reports this is similar to when he has had asthma crisis but it is also similar to when he has been really depressed. Noted in the ER record, pt says he has a new job at work. He saying that his nausea and vomiting always gets better when he has Valium because that puts him to sleep and multiple bizarre comments as noted in the ER record. Pt actually was seen in my office for the first time on Monday, October 20, at which time he was seen because he called the office he couldn't hold together anymore is what he told the office. He didn't have a pt appointment until the middle of November but per request of my staff, I saw him earlier to make sure he wasn't suicidal. At that time, I re-started his Prozac which he had ran out of. Pt was requesting Valium at that time in leu of his Klonopin which I explained I would not do until I got medical records and further assessed him .pt then called my office back on Friday requesting Valium because he needed ti to get him through this spell. He said the Prozac wasn't working. At that time, he did not tell anybody in the office that he had some nausea or vomiting. He actually was at work when he called. He spoke to two of my nurses who assessed that he did not report any illness what so ever. Information from Annual Follow-up report states last I heard, pt died - due to Addison complications and not a Rx to flu vaccine.
Mom states "He was very irritable had a fever of 104, Tylenol did not reduce fever. Ibuprofen did help with the fever he had swollen glands in the back of his neck, he broke out in a rash on 5/04/2013.
c/o dizziness Patient disoriented to name and year for about 3min when medical and EMS arrived. Mental status back to normal after 3min. Reports anxiety, denies chest pain, SOB, palpitation, dizziness, headache. BP: 117/65 ( sitting), 147/71 ( standing) HR: 94 Sp02: 98% No acute distress, seen and cleared by EMS
A 16 month boy came in for a well child visit and received his flu vaccine for the year. I then went to document the flu vaccine in his Xcir and couldn't find the lot number. Later I found out that the flu vaccine was from last year and it had expired 6-30-11. I called the health department and I was notified to inform parent, to have child have flu repeated and to report to this site. All has been done. Thank you!
sore arm but it wasn't bad; fever during a few hours; body aches; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm but it wasn't bad), PYREXIA (fever during a few hours), MYALGIA (body aches) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 048A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism (20 years ago), Acid reflux (esophageal) and Dust allergy. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS], AMLODIPINE and PARACETAMOL (TYLENOL) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm but it wasn't bad), PYREXIA (fever during a few hours), MYALGIA (body aches) and HEADACHE (headache). On 10-Feb-2021, PYREXIA (fever during a few hours) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (sore arm but it wasn't bad), MYALGIA (body aches) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood thyroid stimulating hormone: increased.   The patient never had COVID + test or diagnosis. The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  With first 3 doses of Moderna COVID-19 vaccine, the patient had body aches, sore arm and headache during 2 days approximately. On 12-Mar-2021, the patient experienced second episode of PAIN IN EXTREMITY (sore arm but it wasn't bad), second episode of PYREXIA (fever during a few hours), second episode of MYALGIA (body aches) and second episode of HEADACHE (headache). On 12-Mar-2021, second episode of PYREXIA (fever during a few hours) had resolved. On 14-Mar-2021, second episode of PAIN IN EXTREMITY (sore arm but it wasn't bad), second episode of MYALGIA (body aches) and second episode of HEADACHE (headache) had resolved. On 26-NOV-2021, the patient received the 1st booster dose of Moderna COVID-19 vaccine. On 26-Nov-2021, the patient experienced third episode of PAIN IN EXTREMITY (sore arm but it wasn't bad), third episode of PYREXIA (fever during a few hours), third episode of MYALGIA (body aches) and third episode of HEADACHE (headache). On 26-Nov-2021, third episode of PYREXIA (fever during a few hours) had resolved. On 28-Nov-2021, third episode of PAIN IN EXTREMITY (sore arm but it wasn't bad), third episode of MYALGIA (body aches) and third episode of HEADACHE (headache) had resolved.  No treatment medications were reported.   This case was linked to MOD-2022-657015 (Patient Link).
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Antiviral COVID 19 Treatment include Paxlovid, treatment start date was 08Jun2022 and treatment stop date was 11Jun2022. Adverse event was rebound covid after seven days. Patient had no allergies. No other medication in 2 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia,  H/A, chills, mild body aches, Narrative:   Other Relevant History:
Had the vaccination and still got it/suspected vaccination failure; shingles; feel miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The patient self-reported the case. The patient received Shingles vaccine and still got the shingles. The patient stated that, he/she was miserable but a little better and this was week 4 till the time of reporting. Additional Supportive Information: This case was reported via  interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
pt recv vax & 10min p/vax had rash on face, under eyes remained @ hlth dept recv DPH;rash faded stayed 1hr;24NOV97phone # no good unable to contact;
I got one vaccine do I need more; This case was reported by a consumer via and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, got one vaccine did need more.
h/a 14AUG, 15 & 16 worse day; malaise-Fri began 13AUG; nausea 14 & 15 & 16AUG;
Pt received 2nd H1N1 vaccine dose @ 9:00 am. She came to school clinic @ 9:40 c/o tongue "burning and stinging" B.P. 102/64 HR 80 O2 96% No other symptoms. When mom notified she wanted to call 911. Pt transported to local hospital.
body aches / fever of 101.5 for 48 hours / tired / headache / unable to move from bed without help / chills / nausea / loss of appetite  received the vaccine on a Tuesday (9-7-21) - went to bed the evening after the vaccine at 6:00 pm - missed school the two next days -  stayed in bed until Friday morning and was able to go to school but didn't feel fully recovered until Saturday.  Gave Tylenol and Advil alternating every 4-8 hours to help with symptoms -