chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt/mom indicated no known allergy. Was given chickenpox vaccine. Pt was nervous before the vaccination. Immediately after vaccination she complained it was itching at the site of injection. Patient standing by. Patient looked like she was about to fall on floor and I was able to hold her with help from her mom. She gained consciousness. Activated 911. Pt taken to emergency room.
The patient's mother asked for help. Patient was sweating and said saw black dots. Patient was wet to touch and pale.  Pharmacist talked with patient and there breathing was normal. Possibly anxiety. Had patient stay for addition 15 minutes and was fine when left.
Pt developed lesions on her shoulder, abdomen, and scalp, lesions will vesicular w/clear fluid, some being crusted over. Lesions were itchy per pt. Dx mild case of varicella.
Headache, Arthralgia, Fever, restless legs,L arm pain, severe fatigue Narrative:
After the expiration date/ All doses were administered by intramuscular injection and expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date/ All doses were administered by intramuscular injection and expired doses) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date/ All doses were administered by intramuscular injection and expired doses). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date/ All doses were administered by intramuscular injection and expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  None of the patients experienced any reported symptoms.   This case was linked to MOD-2021-413535, MOD-2021-413554, MOD-2021-413598 (Patient Link).
Symptom:  A very small raised, rough, white plaque appeared on my lower lip approximately 2-3 weeks after I had received my second covid shot.  The lesion persisted for about a month before I went to the dermatologist.  Since the lesion was so small, I was advised to return in a few weeks the problem persisted. I returned to the dermatologist on 10/11/2021.  A shave biopsy indicated lichen planus.  I have no previous history of Iichen planus, but I have had occassional flare-ups of lichen sclerosis in the past.
Developed pain and weakness at right shoulder after injection. Had a rotator cuff tear which was repaired in May 2018. Still has chronic pain and weakness after this injection.
patient did not have an adverse reaction.  he was received a vaccine that he was not due for. he had been vaccinated in feb of 2022
.01 mL JYNNEOS Intradermal was given via the wrong route: IM, right deltoid. Patient tolerated the IM injection well with no untoward response.  Administering nurse realized her error and called immunization Nurse Consultant, Nurse also informed  the patient of the error, as well as her colleague of the route error. Immunization Nurse Consultant conferred with another authority at the State level, who recommended that the dose be immediately given again in the intended site.  The recommended re-administration was explained to the patient, who consented to the re-administration of the dose intradermally. The patient tolerated the .01 mL intradermal injection in his RFA well, and stayed for 15 minutes after the injection for observation. He was also informed of all possible untoward responses that can occur with the vaccine.
Information has been received from a registered nurse (RN) concerning a 14 month old child who on 09 Mar 2006 was vaccinated with a dose of Variavax. The RN reported that in March 2006, the patient developed a maculo-papular rash. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information is not expected.
CHILLS; FEELS COLD AND CAN NOT SEEM TO SHAKE IT; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the subject experienced chills. On 21-JUL-2021, the subject experienced feels cold and can not seem to shake it. On 21-JUL-2021, the subject experienced fatigue. On 21-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and the outcome of headache, fatigue and feels cold and can not seem to shake it was not reported. This report was non-serious.
He got really irritable, cried a lot, complained about pain in his legs, was acting out, screaming, swollen at injection site, had a fever for 2 days, headache, his eczema got worse.
Light headed and nauseous; Light headed and nauseous; Fever 100.9 degrees and 99.5 degrees; This is a spontaneous report from a contactable other health professional reported for herself. A 34-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: El3247), via an unspecified route of administration at left arm on 29Jan2021 13:00 at single dose for covid-19 immunisation on workplace clinic. Medical history included gluten sensitivity, depression, anxiety, asthma, allergy: tetanus. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included sertraline hack 50mg tablet 1.5 tabs once daily within 2 weeks of vaccination. Once the patient got home, she was feeling light headed and nauseous. She checked her temperature and it read 100.9 degrees. She called her work immediately and reported (as the pop up clinic was through her employer). She retook temperature two hours later and was at 99.5 degrees. Event onset time was on 29Jan2021, 1:30 PM. No treatment received. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included, SARS-CoV-2 test(nasal, swab): negative.  Outcome was recovering. The case is reported as non serious.
Patient's left arm stiff in air. Patient staring not responding right away. Patient starting responding 1-2 minutes later. Was able to answer questions correctly and could tell us where he was. B/P 110/60 pulse 68. Juice was given and a sucker.
Pt was admitted to local nursing home facility, on 04/16/2021 from Hospital with Hospice Care. Pt previously admitted to Health Care, prior to admission to hospital on 04/10/2021. facility obtained consent via POA for 1st Moderna vaccine. Explained vaccine reactions and side effects. No prior vaccine or Hx of COVID.  Hx was verified prior to administering vaccine.  After administering vaccine and returning to facility to enter record in KYIR, it was discovered that Pt had Janssen vaccine at Health care 04/07/2021. current facility was notified. stated it was not noted in his medical record or transferred on admission. They were not aware of previous vaccination. Pt has been monitored by nursing home facility, no side effects, vital signs are normal. No adverse reactions at this time.
8/5/03 11:15am  After immunization VZV & Hep B given to child, approximately 10 min. later, face started flushing, child started wheezing with cough, c/o feeling hot and then started itching.  Alert & oriented x3.  Per emergency protocol, Epinephrine given x2 0.1ml SQ every 5 minutes, 911 called, EMS responded as the 2nd dose of Epinephrine given.  Tranxsported to Healthmark Hospital ER, DeFuniak Springs, FL.  Parent followed EMS.  Follow-up with ER, child treated and released to parent to go home.
At 48 hours moderate erythema and induration. At 72nd itchy with central vesiculo and peripheral ? almost erythema multiforme ?, fever to 102. At day 6, 17x10 peripheral erythema/?.
W/i 1hr of getting flu shot (got at pediatrician's), got Tm 103, chills, body aches, sore throat; next am woke up with temp and fainted; after episode of intense abd pain, vision went out, then was dreaming and woke up; not sure if how long episode lasted; taking Advil; feeling h/a and slight LH.
No side effects with 1st dosage.  within 8 hours of 2nd dose side effects included: rapid heart rate, insomnia, body pain, joint pain, lower back pain, severe chills, upset stomach, nausea, headache. Within 36 hours, most of the side effects were gone, except headache. 3 days later - still have headache, and flush feeling all over body with mild sore throat (as of 2/26/21 @ 11:27 a.m.)
Patient received a Moderna bivalent booster dose incorrectly as a primary series dose. This was the first covid vaccine patient had received. Patient did not report any adverse events at the time of event, but noticed incorrect vaccination upon returning to doctor's office and being informed that patient should have received primary doses before receiving bivalent booster dose.
pt stated she had a headache the day of the vax but the day after she woke up with pain in the armpit.  She said the lymph nodes are tender to touch and swollen under her right arm pit.  She contacted her PCP and she was told to watch it for a couple of days and if wasnt better to give him a CB.
sudden extreme pain in right shoulder radiating in arm pit and to clavicle area. Unable to extend or lift right arm and no strength to lift object. Felt swelling in nymph node area under arm and in neck. Totally immobile arm on day 8; improvement and dissipation on day 9. Today, day 10 no after effects; back to normal. Treated the pain and discomfort with Tylenol extra strength.
Migraine, fever, sore throat, dizziness, exhaustion, nausea/ vomiting. It has been 14 days since I got my vaccine and all of these symptoms have continued to come and go in waves.
6 out of 10 got COVID; 6 out of 10 got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). This is the sixth out of 6 cases.  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 (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical information: After receiving booster- sat at Christmas dinner and 6 out 10 & 5 children got Covid.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Spotted Rash developed over whole body when receiving booster dose of Moderna. Lot: 066F21A; Exp: 02/03/2022  Administered 11/30 at 1200; 10-12 hours later: fever, chills, loss appetite, loss taste; 36 hours later: fever persists, loss appetite, spotted rash across chest/legs now present. At home COVID test taking 12/1 and is negative. 1st DOSE Moderna: 12/31/20; 2nd DOSE Moderna: 1/28/21.
Felt all I have eaten was coming out of my ears; Temperature was 104.7 F; Shoulder really sore; A spontaneous report was received from a consumer concerning a 78-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder really sore(shoulder soreness), running at temperature(fever) and felt eaten was coming out of ears (feeling abnormal).  The patient's medical history was not provided. Concomitant medications included Metoprolol and Losartan.   On 30 Dec 2020, the patient received their dose of mRNA-1273 (Batch Number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced shoulder really sore and temperature was 100.7 F. On 31 Dec 2020, next morning patient administered Tylenol and temperature went down to 99.7 F followed by felt eaten was coming out of ears (feeling abnormal). On the same day 31 Dec 2020, patient's temperature was at 104.7 F. The patient was running at temperature.  Treatment details for temperature(fever) included paracetamol. No treatment information was provided for shoulder soreness and feeling abnormal.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, shoulder really sore was not reported. The outcome of the event, temperature 104.7 F was not resolved.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded
Tongue Enlargement, tingles around mouth, itchy ears and axillae, shortness of breath - Benadryl 25mg PO given
Shaking, headache, body/joint aches, stiff neck, heavy breathing, high heart rate, dilated pupils
I had a rash develop I might lower extremities from just below the knees to mid thigh. It happened around 4 p.m. I did not know if it was something that I had come in contact with outside so I took a shower and applied cortisone cream to the rash. Around 6 p.m. I developed a rash on the left side of my chest the rash continue to grow across my chest and my abdomen to both sides and my arms.   Again applied cortisone cream. Around 9 p.m. I took antihistamines and went to bed in the morning the rash is gone. I'm only reporting this because I've only read where the rash is on the arm or the injection site where this one was on my lower extremities and my upper extremities chest an abdomen.
Started with headache that caused nausea.  Then chills and fever: temperature ranging from 96.1 to 100.5.  Slept for almost 36 hrs.  Then headache left and I got nausea with minor vomiting and diarrhea.   Took almost 4 days to feel much better.
Headache, neck pain, injection site soreness, left arm soreness, fever (100.2°F), chills, sweats, joint aches, nausea, light headed, light sensitivity, decreased appetite
On 10/12/21 developed sore throat, sinus congestion, runny nose, headache, body aches, fatigue, weakness and chills.
Chest burning, shortness of breath, increased heart rate and respirations, couldn't get air exchange well for one hour.
Patient began getting dizzy, nausea, weak, and vomiting after first dose of Pfizer vaccination. Provided aid with ice pack and called 911. Paramedics arrived at 1:11pm, assessed the child. He was feeling better around 1:20pm and parents refused patient going to ER.
Systemic Pruritus and  Hives Treatment :  Claritin 10mg @ 10:30am                               Prednisone 5mg , 6tabs @ 1:45pm (taper dose  days)
"Pt w/ hx of lactose intolerance. Pt w/ medical hx for anxiety and depression. 12:20 - 15yo Female reported feeling nausea 10 min after vaccination.  Pt was taken to observation room.  Vitals BP 129/85, HR 86, RR 20.  Pt vomited for a few mins. 12:30 - pt reported relief after vomiting.  no signs of resp distress, dizziness, flushing was observed.  Pt is communicating w/ Physician and is stable.  Pt given water 8oz.   12:36pm - BP 101/70, HR 87, RR 16. 12:50pm - Pt stable and released from the vaccination site with mother."
I belive I had COVID just before Shot 2; Shortness of breath; no appetite; extreme fatigue; This case was initially received via the Regulatory Authority (Reference number: US-irms-MOD21-113330   ) on 20-Jun-2021. The most recent information was received on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I belive I had COVID just before Shot 2), DYSPNOEA (Shortness of breath), DECREASED APPETITE (no appetite) and FATIGUE (extreme fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 17-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), DECREASED APPETITE (no appetite) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced COVID-19 (I belive I had COVID just before Shot 2). At the time of the report, COVID-19 (I belive I had COVID just before Shot 2), DYSPNOEA (Shortness of breath), DECREASED APPETITE (no appetite) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive for COVID antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  It was reported the patient had Shortness of breath, extreme  fatigue and no appetite from 18-Feb-2021 to 20-Feb-2021 and again from 13-Mar-2021 to 15-Mar-2021.  No Treatment information was provided by the reporter.   This case was linked to MOD-2021-261939 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received contains Non significant information. On 26-Jul-2021: Follow-up information Received on 26-JUL-2021 contains No New Information. On 10-Aug-2021: Significant follow-up received included new event (COVID-19) and lab. Onset date for the events fatigue, decreased appetite and shortness of breath was added that was missed to capture in the previous version.
pt recv vax & approx 30min post vax pt exp a h/a;MD indicated that 8 other pt had similar exp (WAES97100694 & 97100697 through 97100703);
The day after the shot arm pain , redness, soreness and heat set into arm. It was followed by headache, muscle aches/pain in mid section.  Patient reports a knot developed on spine during the same time period. Patient has recovered from the fever,aches, and pains but still has a knot on her spine and has not seen a doctor for this at this time. It was recommended that she seek care to determine the cause of the knot on her spine.
10 min after injections there was a localized reaction of redness noted on both arms, more on right side. Pt denied SOB, chest tightness, throat swelling. 50mg benadryl and 125mg Solu-Medrol given. Patient began feeling better and was discharged home with instructions if further difficulty.
Patient has rash on left arm. The rash is small clusters of blisters. The patient stated he immediately had itching and fever after receiving vaccine. Patient did not come in until Wednesday, went to ER. Given VALTREX.
Patient comes to clinic c/o chills, body aches, and nonproductive cough starting this morning. States she believes it is because of flu shot she received yesterday. Temp 100.9 Pulse 120 Respirations 24 O2Sat 98% Given Tylenol and cough medicine, encouraged to monitor temperature and treat symptoms as needed.
12:58 Head Down, Dizziness , Nausea, Systolic 170 HR 80. Patient stated history of Hypertension, Gave juice and snacks 1:36 Systolic 138 2:00 Color is pink stood up stated she was not dizzy. She stated she felt better. Walked out of clinic in good condition.
Narrative:  Pt is a 88y.o. male who died on 04/01/2021 w/ h/o AFib, BHP, malignant tumor of colon, HTN, GERD, aortic&mitral valve disorders. Pt received Moderna Covid-19 Vaccination 2/2 on 02/22/2021. Pt presented to ED on 03/31/2021 after being found unconscious at home. Examinations found pt had a catastrophic subdermal hematoma and was intubated. Pt's family decided to extubate, and pt died shortly after. Unlikely Moderna Covid-19 Vaccine caused/contributed to pt death.
I tried using the website to upload the PDF but the form kept failing. Please see the attachment for report of loss of pregnancy due to Covid 19 vaccine.
Pt vaccinated with DTP experienced persistent irritability (crying) more than 6 hrs post injection.
Left arm local swelling, redness and tenderness 3x4cm by 48 hours at IM site left.
This spontaneous report was received from a pharmacist and refers to a patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 29-JAN-2019, the patient was vaccinated with a dose of M-M-R II subcutaneous injection, via intramuscular route (lot # R022423, expiry date: 06-AUG-2020) for prophylaxis which was reconstituted with Merck sterile diluent (lot # N003192, expiry date: 05-JUL-2019). No adverse effects were reported. Product quality complaint was not involved.
Patient presents to ED with hives and lip swelling.  Treated with IV diphenhydramine, methylprednisolone, famotidine, and oral cetirizine.  Symptoms improved.
On 12/13/2022, I had an episode of dizziness in the morning. That went away and I was pretty much fine all day. Around 08:00PM, I began to experience lack of words and couldn't put my thoughts together. It was not continuous but episodic. My daughter took me to the emergency room where they diagnosed me with a stroke in progress and gave me TPA. They admitted me to the ICU for three days. They did a lot of testing, and I had no further issues from the event. They did discover a clot in my carotid artery. Two weeks later, on 12/27/2022 I had a carotid endarterectomy to remove the clot. I am now home recovering.
Within minutes post administration of vaccines patient broke out in rash on face, abdomen and b/l thighs. No difficulty breathing or facial swelling.
Patient presented to ED with altered mental status and leg weakness at home causing fall. Ammonia 89, being treated with lactulose for hepatic encephalopathy. Patient currently admitted.
Had 2 seizures, requiring Life Flight to ER 1 wk after 12 m vaccines. Fever associated with second. Unknown with first.  12/06/2007 MR received for DOS 10/7-9/2007 with D/C DX: Seizure.  Pt presented after transfer from local facility following several episodes of generalized tonic-clonic seizure with cyanosis, as well as multiple staring episodes followed by a post-ictal state.  Temp 101 in ER.  Pt had been having congestion and cough x weeks.  Parents thought first episode was a choking episode and gave back blows.  PE (+) for swollen nasal turbinates and congestion.  Bruising on back from back blows. Circular rash on abdomen (x1 week). No further episodes and d/c home
This spontaneous case was initially received on 09-Oct 2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 08-Oct-2015, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015. Action taken: Discontinued. Event treatment: not provided. For relevant test results see appropriate report section. Reporter's assessment/comment: The reporter reported the term 'medication error' and assessed the case as non-serious.
Chills, then hot, body aches, severe headache, dizzy, nauseous.
Hives all over body, extremely itchy. Appear like welts. Started about 9 days after moderna booster
lt arm given DTP-came in office 11JUL 5x5 circle red, raised, blistering, hot to touch, very painful @ site of inj;