chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Petechia; Severe migraine; Numbness in the right leg; the site where the shot was done was red and tender; the site where the shot was done was red and tender; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 07:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included heartburn. Concomitant medications included unspecified birth control medication, multivitamin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) and influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Apr2021 at 08:00 (reported as of today), the site where the shot was done was red and tender. She had a severe migraine on Friday and also had numbness in the right leg. She had petechia and those spots had increased. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events the site where the shot was done is red and tender, severe migraine, numbness in the right leg and petechia. The clinical outcome of the events the site where the shot was done is red and tender, severe migraine, numbness in the right leg and petechia were resolving at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The Patient Complained of a red raised bump on her arm that hurt and that her arm was swollen and sore for the last 3 days.  She took an anti inflammatory for the pain and was going to call her Dr for an appointment.
This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 63 years old female patient. Weight: not provided. Height: not provided. The patient received Influenza (Seasonal) (no brand name). No additional drugs suspected. On an unknown date, after starting treatment with Influenza (Seasonal) (no brand name) the patient experienced Eyes blurry / Vision blurred, [Weak areas intensified / Weak], dizzy / Dizziness, Nervous extremely / Nervousness, More floaters / Vitreous floaters, Weak areas intensified / Weak [, dizzy] / Asthenia, Ears hurt / Ear pain, Legs hurt / Pain in extremity, Teeth hurt-need crowns / Toothache.
pt recv vax & noticed redness & swelling w/warmth to touch;area has enlarged @ this reporting;advised to apply moist heat;called MD should sx persist or worsen;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "cancer" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient had no known allergies. Patient received COVID 19 Treatment Paxlovid from 17Aug2022 to 22Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Injection site sore; the right arm which is numb.; fever; Chills; muscle aches; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included hepatitis B shot with an associated reaction of illness (received 3 or 4 shot series, many yeras ago from the date of reporting and the patient's body did not build up the titers. For the tolerance of doses, refer linked case US2021AMR116449) and Shingles vaccine (1st dose received on an unknown date at age 55 years; 2nd dose received on an unknown date at age 60 years).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site numbness, fever, chills, muscle pain and pain. On an unknown date, the outcome of the injection site pain, fever, chills, muscle pain and pain were recovered/resolved and the outcome of the injection site numbness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site numbness, fever, chills, muscle pain and pain to be related to Shingrix.  Additional details were provided as follow: This case was reported by patient herself. In mid-November 2020, the patient received 1st dose of Shingrix in left arm and had a mild reaction included fever, chills, muscle aches, pains, and her left arm was sore (at the injection site).  The reported events were resolved except numbness. The patient had a little numb spot at the site of the injection which had not resolved, the patient felt it was still there, and it felt weird and was numb. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR116458. This is 1 of 3 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116458:Same patient: Shingrix 2nd dose US-GLAXOSMITHKLINE-US2021AMR116458:Same patient, 2nd dose
bilat axillae w/macerated, sl edematous, erythematous, peeling, patches of confluence tapering out to isolated vesicles on base;no exudate;
Patient developed redness and hot to touch area 5 1/2 inch by 3 inch area on L deltoid 2 weeks after moderna  COVID vaccine. No other complaints voiced.
Pt experienced 103F fever on 2/2/01 which quickly returned to normal. Blanchable, maculo-papular, measly looking rash which started on stomach on 2/4/01 and then proceeded to spread to arms, legs, back of neck and face on 2/6/01. Rash most pronounced on trunk, bilateral upper and lower extremities. These small circular lesions on palms and in diaper area. Also, soles of feet spared, currently. No strept exposure; lungs clear; nose clear discharge; minimal erythema in throat. Due to time course, it is questionable if related to MMR vaccine given on 1/24/01. Given Zyrtec for itching and rash. Otherwise, pt's activity and appetite are normal.
very achy, sore left arm at injection site; mild headache and nausea; overall achiness.
pt recvd vax;granma reported between groin & knee at site became red w/ bumps,warm to touch;however no fever/resp difficulty;x3 loose stools,f/u,no d,legs cont to have isolated bumps;encouraged to monitor,contact MD if stable status changes
agitated & febrile, tachycardic somewhat disoriented, pain to back, rapid resp, skin flushed, contractions to fingers;
Very bad ringing in my ears. Started in left now in both and progressively getting louder.  Extreme dizziness when I get up or even roll over in bed.
-ARM  AT PLACE OF INJECTION WAS ITCHY AND LARGE RED ROUND (BASEBALL SIZED RING) SURROUNDED THE AREA. NOW SWOLLEN, JUST LARGE RED CIRCLE. -LEFT LYMPH SWELLING/IRRITATED AT LEFT CLAVICLE. WAS VERY UNCOMFORTABLE. -MULTIPLE BRUISES ON SEVERAL PLACES ON LEFT ARM/WRIST
Received injection on 3/8/17. Sore, painful red lump appeared morning of 3/9/17. Difficult to move arm from pain all day. Night of 3/9/17 101 degree fever. 3/10/17 Redness got larger. Took ibuprofen for fever and pain in arm/Per Dr. use cold compresses and BENADRYL and IBU.
The morning of 1/25/03 Pt noticed small red spots along the upper portion of chest. The quantity of red spots multiplied by the following morning reaching down to the bottom of the sternum. This morning (1/28/03) Pt noticed even more of the spots reaching to the top of his abdomen. Now the spots are forming in more of a cluster formation in some sites. At this time the "rash" does not itch cause discomfort.
This spontaneous case reported by a consumer, describes the occurrence of cough in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cough. At the time of the report, cough outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Onset w/in 2 hrs of fever 103, macular red rash, swelling of lt knee & ankle; persisted for next 2 wks until present w/sx  JRA (ESR 138, CRP 19, HCT 26);
cannot sleep on my right arm; losing range of motion in my right arm/ having trouble raising my right arm / have trouble stretching my right arm/ I cannot sleep on my right arm/ I cannot move my right arm straight out; pain in her right arm / right arm remains painful sometimes hurts down to my finger tips; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (cannot sleep on my right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (losing range of motion in my right arm/ having trouble raising my right arm / have trouble stretching my right arm/ I cannot sleep on my right arm/ I cannot move my right arm straight out) and PAIN IN EXTREMITY (pain in her right arm / right arm remains painful sometimes hurts down to my finger tips) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (cannot sleep on my right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (losing range of motion in my right arm/ having trouble raising my right arm / have trouble stretching my right arm/ I cannot sleep on my right arm/ I cannot move my right arm straight out) and PAIN IN EXTREMITY (pain in her right arm / right arm remains painful sometimes hurts down to my finger tips). At the time of the report, INSOMNIA (cannot sleep on my right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (losing range of motion in my right arm/ having trouble raising my right arm / have trouble stretching my right arm/ I cannot sleep on my right arm/ I cannot move my right arm straight out) and PAIN IN EXTREMITY (pain in her right arm / right arm remains painful sometimes hurts down to my finger tips) had not resolved.            No concomitant medication was reported.  No treatment medication was reported.
the Acthib she received last year was expired/no AE; Initial information received on 03-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 years old female patient who was administered expired HIB (PRP/T) VACCINE [ActHIB] last year (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; HIB VACCINE CONJ (TET TOX) (HIBERIX) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 19-Feb-2019, the patient received a fourth 0.5mL dose of suspect HIB (PRP/T) VACCINE lot UI895AAB via intramuscular route in the left thigh for prophylactic vaccination.  This is a case of actual medication error due to expired product administered.  At the time of this report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 69-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 9th November 2018, for tolerance refer case: US2019GSK013766). On 17th January 2019, the patient received the 2nd dose of SHINGRIX. On 17th January 2019, 12 hrs after receiving SHINGRIX, the patient experienced injection site tenderness, chills, feeling hot, pain and headache. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site tenderness, chills, feeling hot, pain and headache were recovered/resolved. It was unknown if the reporter considered the injection site tenderness, chills, feeling hot, pain and headache to be related to SHINGRIX. Additional details were provided as follows: At 10:30 AM, the patient received SHINGRIX. After 12 hours of vaccination (at around midnight) the patient experienced headache, chilled, felt hot, and tenderness at the injection site. The patient stated that, his nurse had seen more side effects with 2nd dose of SHINGRIX compared to 1st dose of SHINGRIX. The patient did not consent to follow-up.
ringing in the ears started on 9/1 told primary MD and there was no reaction or investigation as to what is going on  been to three audiologists all share decrease hearing in Left ear
Lab data Jan2022 - COVID Positive.; Lab data Jan2022 - COVID Positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Jan2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single, administration date Jan2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single, and administration date Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single, for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Aug2021, stop date: Aug2021, notes: Covid + in Aug2021- Received Monoclonal antibodies infusion; "heart disease" (unspecified if ongoing); "COPD" (unspecified if ongoing); "polio" (unspecified if ongoing). The patient took concomitant medications (unspecified statin medication). Past drug history included: Monoclonal antibodies infusion. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Lab data Jan2022 - COVID Positive.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) positive; (Jan2022) positive. Therapeutic measures were taken as a result of covid-19 and included the patient was prescribed Paxlovid, 3 tabs- twice a day from 06Jan2022 to 12Jan2022. Clinical course: The patient was fully Vaccinated with Pfizer In Jan2021- Pfizer Booster received Sep2021 and the patient was Covid positive in Aug2021 for which the patient received Monoclonal antibodies infusion, the patient was Covid positive again Jan2022 and was prescribed the Paxlovid.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200051641 same patient, drug, event, different dose;US-PFIZER INC-202200187584 same patient, different drug and event
Temperature 101.3.  Advised to use Tylenol.  Call if symptoms change.
Swollen and sore throat. Difficulty swallowing  Congestion, pain in ears, and mild cough
Headache, nausea (no vomiting) 7-8 hrs after Hep B 1st shot. Resolved within 24 hrs. (Felt hot/cold at the time and throat felt tight after onset of symptoms.)
Pfizer vaccine was administered outside of Facility- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------- J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/23/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE
pt acted fine until 8 or 9 day p/vax; pt began drinking & urinating excessively & acted fussy; suspected diabetes & tested blood sugar to confirm suspicions;
Pt collapsed approximately 5 mins after HPV4#3 and Hep A#2 injections and started to seize for about 30 seconds. BP, P and O2 were taken immediately after she became responsive, 6 mins and 10 mins after. Pt was taken to hospital via EMS for further evaluation.
Got the 1st dose of COVID-19 Pfizer vaccine and after 24hours, kid got rash on the stomach and left shoulder and it became worse day by day. Have seen the pediatric and after examination, she mentioned that it could be Pityriasis Rosea  and advised to see a dermatologist and also report this event.  I am reporting this as advised by the pediatrician.  Not sure if this is the side effect of vaccine but believe it could be because this started after 24hrs of receiving vaccine.
Swelling, redness, warm and painful to the touch. Left upper arm with area of induration and edema measuring 15X12 cm, with scattered overlying erythema.
Fever at onset. Unmeasured. Erythema at site of injection. Generalised mild edema of upper arm. No excessive warmth or induration.
Feeling numbness on left arm, since 2:00PM (Night) and Saturday.  Whole left side - Feet to head has numbness. Called VARES to report but open only Mon- Fri. I will checking with local health today.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EN7533), in left arm and on 22Apr2021 as dose 2, single (Lot number: ER8736) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS; FLONASE [FLUTICASONE PROPIONATE]; FLOVENT. Past drug history included: Known allergies: cephalexin, reaction(s): "Drug Allergy", notes: known allergies: Cephalexin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) positive, notes: I tested positive for Covid-19 on 02Jul2022; (10Jul2022) negative, notes: I finished the 5 day course, and tested negative 10Jul2022; (13Jul2022) positive, notes: I began to feel minor symptoms 13Jul2022, and again tested positive on that date. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 02Jul2022 to 07Jul2022.  Clinical Course: Reported as, patient tested positive for Covid-19 on 02Jul2022. patient began treatment with Paxlovid on that date. She finished the 5 day course, and tested negative 10Jul2022. She began to feel minor symptoms 13Jul2022, and again tested positive on that date. It was her belief that it was Covid rebound.
right after vaccine, eyes started itching and watery and drainage. They went to clean daughter's house, the more they cleaned, the worse he felt. After that, chills, achy, dizziness. sounded congested.  Had vomiting and diarrhea  later that night, arm was red and blotchy. Next day, urine had an awful smell and brown, chills, and dry heaves. Friday, finally was able to eat. Saturday and Sunday felt better. Today he's feeling good.
some problems with her eyes; Eyes were  itchy; Eyes were red; pink eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (some problems with her eyes), EYE PRURITUS (Eyes were  itchy), OCULAR HYPERAEMIA (Eyes were red) and CONJUNCTIVITIS (pink eye) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced OCULAR DISCOMFORT (some problems with her eyes), EYE PRURITUS (Eyes were  itchy), OCULAR HYPERAEMIA (Eyes were red) and CONJUNCTIVITIS (pink eye). At the time of the report, OCULAR DISCOMFORT (some problems with her eyes), EYE PRURITUS (Eyes were  itchy), OCULAR HYPERAEMIA (Eyes were red) and CONJUNCTIVITIS (pink eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
pt recv flu vax & the following day devel redness, swelling, & warmth @ the inj site; pt was treated w/DPH q 4 hr as needed & ice compresses 4 times daily to inj site;
Patient called the office the morning of 01/15/2020 stating at 8:30 pm her right arm started swelling and becoming painful from the top of the arm to her hand. States she could not lift her arm. States she felt like she had a fever but didn't  have a way to take it. She came to the office on 01/15/2020 at 4pm to have Dr. and myself look at the arm. The upper right arm was only slightly swollen but did have pain to touch. The right hand was red, slightly swollen and cool to touch. She was only able to lift her right arm a few inches. Dr. instructed her to take Benadryl for the swelling, Advil for pain, warm compress to the hand and to keep the hand elevated. Called pt. this am at 11am. States she took Benadryl 25 mg every 4 hours after she went home. The swelling is getting less, the pain is better-she was able to sleep during the night and she is able to lift her arm a little farther this am. States she has not taken any Advil for pain . She was given a note to stay off work until Monday. She will call the office in the am for another update on her condition.
Pulmonary embolism with symptoms developing within several days of vaccination with third dose/booster of MRNA vaccine, unclear whether moderna or pfizer