chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After administration of vaccine, client stated his arm hurt. Advised client to move arm around and client stated "I feel like I'm going to faint." Client assisted with transfer to cot and placed in lying position with knees bent. Client given juice to drink. Client's legs began shaking as if he was shivering. Client had color in cheeks and was not diaphoretic. Arms and body began shivering. Client stated "when I try to move I shake more. Client advised to relax on cot and take slow deep breathes. Pulse 84 beats per minute. Client understood. Client alert and oriented to person, place, and time. After ten minutes, client sat up on cot. Stated he was feeling better. Client was a stand-by assist to sit in chair, no longer shaking. After 5 more minutes of observation, client able to walk to car.
Friday Jan 15th - arm pain. Saturday Jan 16th - fever of 99.5, chills, no appetite, dehyrdration, swelling and redness around injection site, progressed throughout day. Sunday Jan 17th - further swelling and arm pain, lymphnods in underarm area painful and swollen, bruising  Monday Jan 18th - Swelling and redness size of palm, warm to touch, painful, itchy
kind of pain in chest; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0153) via an unspecified route of administration at left arm on 04May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0171) via an unspecified route of administration at left arm on 13Apr2021 as dose 1, single for COVID-19 immunisation. The patient had kind of pain in chest and reporter wanted to know these side effects were severe. Reporter confirmed that side effects were after taking the second dose. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Swelling tingling upper and lower lips with fever blisters and sever pain.  Oral ulcers. This has continued for over 5 weeks. I have been on two rounds of Valtrex at 2,000 mg. Per day at 7? day treatments. With no results and 2 weeks of Desonide.
Received vaccine on 3/21/16 - now has a lesion on right deltoid approx. 2 in diameter - redness/subcut firm swelling, very tender to touch instructed to take BENADRYL, ice arm TID - 20 min at a time move arm as much as possible.
head pressure; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head pressure) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (head pressure). At the time of the report, HEAD DISCOMFORT (head pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were not provided.
Sick/felt unwell since the booster COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Sick/felt unwell since the booster COVID-19 vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Psoriasis.    Concurrent medical conditions included Psoriasis.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On 10-Feb-2022, the patient experienced IMMUNISATION REACTION (Sick/felt unwell since the booster COVID-19 vaccine). At the time of the report, IMMUNISATION REACTION (Sick/felt unwell since the booster COVID-19 vaccine) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. She has been a little sick stated she had not felt well since the booster.  The reporter's causality for the event of immunisation reaction was not provided with SKYRIZI(RISANKIZUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient woke up the morning after vaccine with a severe headache and cough. 5 days later still feeling a lot of chest congestion. She did report that she had been on an airplane 7 days prior so it is possible she got sick from that and it was a coincidence.
My son had an acute ITP reaction after receiving negligent 2nd dose of MMR, varicella, and IPV vaccines. Due to his history of severe aplastic anemia, he now suffers with chronic ITP.
turned red and she was sore for 48 hours afterwards; she was sore for 48 hours afterwards; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 28-year-old female patient that:  A 28 year old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were not reported. On 12Jul2021, the patient experienced turned red and she was sore for 48 hours afterwards. It was ended two days after. Seriousness of event was reported as non-serious. The outcome of events were recovered on 14Jul2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I have experienced shortness of breath and I am still receiving treatment and going to the doctor for it.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 29-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Sedation, Myalgia, Arthralgia, Pain, redness, swelling, itching at the injection site Narrative:  Other Relevant History:
GI issues Severe Diarrhea for weeks, intolerance to dairy, decreased appetite, consistent fever 103, leg weakness would fall and stumble, scream in pain for hours, would not sleep for longer then 30min-1 hour at a time, irregular sleeping, constantly yells and screams, cries as if he is in pain, behavioral regression no longer able to talk does not even say mama or dada symptoms have been going on for at least 1-2 months now. He completely is not the same kid any more. His blood work that was done all came back abnormal.
Swelling (into a ball) in the location which the shot was injected in (Right Deltoid).
Patient complained about numbness and tingling on the arm flu shot was given 9 days later she couldnt lift her arm.
Nurse administering HPV vaccine noted that there was particulate matter in the syringe after drawing up the vaccine. The nurse discarded this syringe in the sharps container, but then used another vial from the same lot number. The new vial did not have any visual problems (no visible particulate matter), and the nurse injected this dose. Because particulate matter was noted in the first vial with the same lot number, the nurse should have used a different lot number.
Tremors (first episode), low grade fever (100-103), changed behavior-clinging, prolonged crying;
Headaches started within 10 hours of receiving second dose.  I have had continuous headaches since 1/24/2021
Diffuse Macular rash. shortness of breath.  Patient was treated with IV Solu-Medrol and Benadryl.  She has been placed on prednisone and Zyrtec outpatient without relief.
No adverse event noted. Person pre-registered with incorrect birthdate. Minor inadvertently recevoed first dose of Moderna vaccine on 4/2/2021.
4/6/21 Per, he felt two electrical pulses going to arm at the time he was vaccinated, noticed a change in dexterity of thumb, forearm feels heavy, a little pulsating in thumb, not numb, "dropped something", can use arm and hand, saw PCP on 4/6/21 who thinks is inflammation of nerve and will resolve.
I experienced general symptoms like fever, chills, aches (bad), neck lymph pain, fatigue, and nausea but the fever reached 102 degrees Fahrenheit which is slightly high.  A concerning side effect was that my resting HR was consistently above 105BPM from about 4:30AM-4PM the day after receiving the second dose. It reached as high as 125BPM without doing much movement at all to account for the high HR.
Myalgia, Fever, NauseaVomiting, chills,  Narrative:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and myalgia. On an unknown date, the outcome of the injection site reaction and myalgia were unknown. It was unknown if the reporter considered the injection site reaction and myalgia to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the healthcare professional (HCP) for himself. The age at vaccination was not reported. The patient reported that she experienced a severe injection site reaction and extreme myalgia. The patient did not want to provide any information regarding the adverse events. The patient would not provide an address or any other information.
At 6 am this morning I started having the chills. I have had them ever since and it is almost 2 pm my time. The second I received the injection I felt pain and soreness in my arm, it?s been sore ever since. Lingering head ache all day and muscle aches, worse in my back than anywhere else, though I feel achy all over. Extreme lethargy, very tired and want to sleep. Increased appetite since receiving the vaccine, increased thirst.
Moderna vaccine received on 8/28/2021 and caused a red spot the size of a quarter.  9/5/2021 the red spot started itching and turned into a raised hive with hot feel and then a couple days later arm turned red in a circle 2 1/2 inches wide.
PCP discussed vaccine error with mom. Told s/s to monitor for. Give TYLENOL for fever. Mom told to call if fever >101.
Patient became extremely pale, disoriented, and dizzy approx. 3-5 min after vaccination. He appeared to be recovering, then experienced same symptoms again a few minutes later. 911 was called. Patient recovered by the time they got there. EMT checked his B.P. -> it was normal.
Patient experienced blurred vision during observation period.  Onsite provider observed patient and there were no further symptoms.  Patient released from observation.
Full body rash started morning of  3/16/23 and has worsened in severity over the day.
2 day hx of vesicular rash on right flank began on back and spread in a dermatomal distribution along (R) side. Mother has history of shingles. Most recent outbreak one week ago. No exposure to children with chicken pox.
3 days after the booster, I had routine bloodwork for a routine doctor appointment.   There were 2 abnormal results that I never had before  NE% was  38.7  and   MO% was 15.2.     First physical symptoms were soreness in both shoulders  around 7/1/22.   Had low grade fever/chills in July 22. Eventually diagnosed with Polymyalgia Rheumatica.    Also developed Giant Cell Arteritis.
Developed swelling and mild redness of left upper arm from left shoulder to left elbow on 7/11/08 - examined at my office afternoon 7/11/08 and felt to be local reaction/limb swelling related to DTaP and not a cellulitis. Patient was afebrile, normal range of motion and normal neuro and peripheral vascular exam. treatment recommended - cool compresses, Benadryl prn itching, Tylenol prn pain.
Hallucinations and severe room spinning, eye rolling, Hallucinations were in middle of the night, the spinning, eye rolling, nausea were at 6:30 am till noon
Developed Shingles (herpes zoster) approximately 8 days after second COVID-19 dose. Initially noticed one sensitive bump on upper-mid right side of body which developed into a rash within the next two days. Went to doctor and received anti-viral medication approximately 5 days after symptoms appeared. I had chickenpox as a child
Infant developed chicken pox rash on 6/29/05. Infant had cold-like symptoms prior to rash.
signs and symptoms:  SOB, cough, myalgias,  hypoxic.  Pneumonia, acute respiratory failure,  treatment: IV steroids, breathing tx, oxygen, remdesivir
My wife and I received the 2nd Covid (Moderna) Vaccine. Wife did well with no adverse reactions. However, I experience Chills, body aches, mild headache, and night sweats.
Started reaction 1 week after shot. Arm is swollen, hot, and very sore to the touch. It progressively got bigger, until almost completely circling my arm, that was on the 21st. On the 24th, I went to Urgent Care and was diagnosed with cellulitis. I am now taking  sulfamethoxazole/trimethoprim. After taking 2 pills the inflamed area is still spreading. It had been circled with a surgical pen.
FEELING ACHY, TIRED THEN HEADACHE A 10/10 PAIN, NECK PAIN, OVER 4 HOURS OF CHILLS FROM 10:00PM TO 2:30 AM. COULD NOT MOVE ARM  A 10/10 PAIN OR ANYTHING I HURST SO BAD NAUSEA THREW UP AND FEVER OF 101 TO 102. ALL DAY TUESDAY I HAD EVERY THING BUT THE CHILLS. LOST A DAY OF WORK. STILL HAD A HEADACH FEVER ACHY AND TIRED AND FINALLY RESOLVED BY 6:00PM ON 05/25/2011. MY ARM STILL HURTS 3/10 PAIN.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent  medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unspecified dates between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# reported as M021407, expiration date: 30-APR-2018 (dose and site of injection were not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursion took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016"). On 13-DEC-2016 (also reported as "recent"), another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of GARDASIL 9 were administered following the recent temperature excursion. Digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007250: US-009507513-1612USA007251: US-009507513-1612USA007248: US-009507513-1612USA007249.
Tongue went numb on right side. My face then went numb on the right side and spread to my ear. It then progressed up to my right eye lid. I took a dose of Benadryl and Flonase. Numbness stopped spreading. It lasted about 35 hours. No facial drooping noted. I was able to close my eyelid then entire time.
My brain is not working; All I want to do is sleep, it just feel weird; It feels like I am coming out of an anesthesia and I can't get enough sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 10:00 (Lot number: EW0187) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus", start date: 08Aug2009 (ongoing); "High Blood Pressure", start date: 07Jul2000 (ongoing); "Fatty Liver Disease", start date: 10Oct2020 (ongoing); "Inflammation Disease", start date: 15Feb2021 (ongoing); "stroke" (unspecified if ongoing); "Dystonia", start date: 24Oct1988 (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Batch/Lot number: EW0171, Time: 9:30, Site and route of injection: Left arm), administration date: 22Apr2021, when the patient was 61 years old, for COVID-19 Immunization.  The following information was reported: SOMNOLENCE (hospitalization) with onset May2021, outcome "not recovered", described as "It feels like I am coming out of an anesthesia and I can't get enough sleep"; FEELING ABNORMAL (hospitalization) with onset May2021, outcome "not recovered", described as "All I want to do is sleep, it just feel weird"; CONFUSIONAL STATE (hospitalization) with onset May2021, outcome "not recovered", described as "My brain is not working". The patient was hospitalized for somnolence, feeling abnormal, confusional state (start date: 23May2021, discharge date: 24May2021, hospitalization duration: 1 day(s)). The events "it feels like i am coming out of an anesthesia and i can't get enough sleep", "all i want to do is sleep, it just feel weird" and "my brain is not working" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (23May2021) normal; computerised tomogram: (23May2021) normal; electrocardiogram: (23May2021) normal; urine analysis: (23May2021) normal. Therapeutic measures were taken as a result of somnolence, feeling abnormal, confusional state.  Clinical course: Patient stated that she was having an adverse effect to this vaccine, she didn't know what to do because it feels like she was coming out of an anesthesia and  couldn't get enough sleep. She was asking whether she should go to the hospital because of the events. Patient stated that she was taking like 8 concomitant medications(no further information provided). Also stated, patient had stroke and did lab work done probably in June or 12May that was last time. Vaccination facility type was Pharmacy drug store. No prior vaccinations received. AE outcome was mentioned as recovered and date of recovery was mentioned as still ongoing.  Follow-up attempts are completed. No further information is expected.
Pt was given dose of 0.5 mL instead of pediatric dose of 0.25mg of FLUZONE (Sanofi).
positive on 16Jan2023; positive on 16Jan2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 16 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jul2021 as dose 1, single (Lot number: EW0198), in left arm, on 06Aug2021 as dose 2, single (Lot number: EW0198), in left arm and on 03Mar2022 as dose 3 (booster), single (Lot number: FL3198), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Migraines", start date: Dec2021 (ongoing); "Crohn's", start date: Jan2021 (ongoing); "Pain relief", start date: Mar2022 (ongoing). Concomitant medication(s) included: GABAPENTIN oral taken for migraine, start date: Mar2022 (ongoing); INFLUENZA VACCINE intramuscular taken for influenza immunisation, on 21Oct2022 as dose number unknown, single; NAPROXEN oral taken for analgesic therapy, start date: Mar2022 (ongoing); PENTASA oral taken for crohn's disease, start date: Jul2021 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jan2023, outcome "unknown" and all described as "positive on 16Jan2023". The patient underwent the following laboratory tests and procedures: Colonoscopy: (29Mar2021) Crohn's; Electromyogram: (27Mar2023) Unknown results; Endoscopy: (Oct2021) Crohn's; Magnetic resonance imaging: (12Apr2021) Crohn's; (02Apr2022) Migranes; (13Feb2023) slight loosnes of humeral head; SARS-CoV-2 test: (16Jan2023) Positive; (23Dec2021) Positive; Ultrasound joint: (17Mar2023) Unknown results; X-ray: (04Jan2023) Unknown results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272460 same patient different dose.;
pt put to bed-mom heard pt moving around was having sz when checked. Had 4 more szs, was cyanotic-T 102 when checked @ ER. Mom gave APAP prior to vaxs & later in day
Moderna COVID-19 Vaccine EUA Approximately 7 hours after the injection pain at the site of the injection developed (left arm). Approximately 20 hours after the injection general side effects developed. Those included fever/elevated temperature (99.5 F) and fatigue. Pain at the injection site got substantially stronger. General side effects resolved after approximately 2 days. Pain at the injection site resolved after approximately 2.5 days.
A non-serious, spontaneous report of administered expired FLUMIST was received from a health professional concerning a eight-year-old male. Neither medical history nor concomitant medications were provided. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 14-Feb-2011: Reporter confirmed that there was no late occurrence of adverse events.