chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy rash on arm; Rash is from the injection site down, 4-5 inches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on arm) and VACCINATION SITE RASH (Rash is from the injection site down, 4-5 inches) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced RASH PRURITIC (Itchy rash on arm) and VACCINATION SITE RASH (Rash is from the injection site down, 4-5 inches). At the time of the report, RASH PRURITIC (Itchy rash on arm) and VACCINATION SITE RASH (Rash is from the injection site down, 4-5 inches) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Missed miscarriage, required D&C the following week. Embryo measured 6w2d with no heartbeat.
One day after patient received PNEUMOVAX 23 a rash was developed 3 inches below the injection site. Patient was advised to have BENADRYL 25 mg orally to relieve the symptom, and apply hydrocortisone 1% to rash area.
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 11 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 19-APR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.32 degree Celsius. The time frame was 0.77 hours on 02-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
7 days after the injection, the site of injection began to swell, redden, and itch. It feels like a sting, in terms of the stiffness and soreness due to the swelling. The area around the injection has swollen approx 2 inches vertically and 3 inches horizontally. At 8 days post, the swelling appears to be at its peak, the reddening has gotten worse than yesterday, almost like a bruise. I am able to use my arm like normal, just feels sore and like it's twice as wide as normal (even though the raised welt is less than an inch) and I'm massaging the area to help break up the swelling. It hasn't gone away yet, so I am watching it still, just in case.
Presented to hospital on 5/3/21 with nausea, vomiting, diaphoresis, left shoulder pain, and left lower quadrant pain; discharged home 5/4/2021.
rupture in blood vessels; one eye is black; blood shot; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (rupture in blood vessels) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced EYE HAEMORRHAGE (rupture in blood vessels) (seriousness criterion medically significant), EYE CONTUSION (one eye is black) and OCULAR HYPERAEMIA (blood shot). At the time of the report, EYE HAEMORRHAGE (rupture in blood vessels), EYE CONTUSION (one eye is black) and OCULAR HYPERAEMIA (blood shot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.  No concomitant medication was provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Felt Dizzy , cold/hot sweats ,  blurry vision/Hearing ,  nausea at first.   BP low  (per paramedics)
something sitting on my chest; I had a headache but it got worse and worse; blood pressure was 160/80; This is a spontaneous report from a non-contactable consumer (patient) via information team. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. About 24 hours after the vaccination, the patient had a headache but it got worse and worse and 28 hours after that the patient's blood pressure was160/80. Over the course, the blood pressure had run high 132/72, 152/75, 135/70. On, 05May2021, the blood pressure came down to 110/62 which is the closest to her consistent 90/60. The patient also reported 'something sitting on chest'. The outcome of the event headache and chest discomfort was unknown. The outcome of the event high blood pressure was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash began at ankles and wrists. No blisters or clusters. Intense itching. Moved up both legs. Did not appear on torso, neck or face. My primary care physician recommended OTC antihistamine and topical anti itch cream   Reporting 1 week after it started and it is improving.
Patient stopped eating all together and started having episodes of her body shaking. She had to be tube fed.
Developed left ear pain morning of 11/17. No fever or URI symptoms. In clinic, had erythema and small purulent effusion behind left tympanic membrane, no signs of rhinorrhea, nasal congestion, cough, or fever. Pain responsive to ibuprofen, so mother and I opted to watch and wait, with option to start Amoxicillin if symptoms worsened.
24AUG92 pt recvd 2 doses of Engerix-B  25JUN92 & 30JUL92 & p/2nd dose w/in 24 hrs pt mouth, face & hands blew up (became swollen); also exp a red, itching rash over entire body; also devel coughing & hives;
Patient developed a rash that spread across her torso, neck, and face. She also developed swelling in the face and around her eyes. He reports a fever that would go up and down and also having a headache. She has been taking Benadryl every four hours and also some Tylenol as well. As of 3:00 PM on 10/10/2013 her rash and swelling have not resolved, but she reports that they are not getting worse.
Headache, swelling at injection site, shooting pain across shoulders, numbness/tingling of extremity. Temp 97.4, 2 in x1 in hematoma noted in deltoid at 90 degrees abduction from body.
Patient was given undiluted pfizer pediatric dose yesterday morning. mom reports no side effects today but will continue to monitor. Pediatrician notified.
A few hours after vaccination pt began to have severe pain in entire left arm.  States that bandaid was literally up on the shoulder so thinks that the pharmacist may have administered too high and that is why she was in so much pain.  By the next morning she states that she was barely able to lift her arm.  She said it took about 3 days but here arm is back to normal now.
Left axillary pain and left sided arm and knee/ankle ache for 3 days, 10 days after immunization.
6 hours, post vax, pt had an onset of profuse frequent diarrhea, continuing for 5 days, at time of visit on 11/21/01.
Patient notes dizziness, chest pain, and right arm numbness/pain after vaccination. Monitored with provider for 15 minutes without resolution and addition of nausea. Transferred to ED.
Right side Bell's Palsy. 2 weeks later, bilateral facial paralysis. Diagnosed as Bilateral Bell's Palsy pending further medical testing. Took one course of Famvir antiviral beginning 11/3/09, prednisone 11/20/09-11/25/09. 12/03/09 PCP records received for DOS 10/26/09,  12/10/09 Opthalmology records received for DOS 11/10-11/24/09. Pt. presents with flashing lights in both eyes. DX: myopic changes, both eyes; no  signs of tears or detachments; photopsia, both eyes; bilateral sequential 7th nerve palsies 12/14/09 Neurology records received for DOS 11/20/09, 11/24/09, 12/07/09. Pt reports slight improvement in the left side of  face; has not noticed any improvement in the sense of smell. Reports loss of sense of taste.  DX: Bilateral Bell palsy/multiple cranial neuropathies
After receiving the shot I was fine for the first few hours. Then my arm started to get really stiff and felt almost swollen. I had my mom check it and it wasn?t swollen but the day after I woke up and felt like something wasn?t quite right. I felt where my lymph nodes are near my clavicle and there were very swollen almost the size of a golf ball, my lymph node under my armpit was also quite swollen. I had a headache on the left side of my head and around my eye. My lymph node near my clavicle is still quite swollen but I?m feeling alittle better. I kept using a cold compress on my arm and lymph nodes as well as taking Tylenol. I did also have a slight fever of about 100 one night but it went away by the next day.
Patient was admitted with symptoms of weakness and fatigue of severity such that a visiting caregiver found patient unable to perform self-care or activities of daily living. Patient had been given a first dose of COVID-19 vaccine the preceding day (day 10 following onset of symptoms) during discharge from hospital after a 6-day stay for symptomatic COVID-19 infection complicated by acute hypoxemic respiratory insufficiency, shock liver, rhabdomyolysis, heart failure (ejection fraction 36%) and stress cardiomyopathy. Supplemental oxygen was provided, stage 5 chronic kidney disease was managed with intermittent hemodialysis, type 2 diabetes was controlled with insulin adjusted by the glucose management team, and extended thromboprophylaxis was provided due to markedly elevated D-dimer. Due to contraindications, patient did not receive antivirals or corticosteroids. Patient?s discharge plans included home health care visitations, arranged transportation services for established dialysis appointments, and follow-up medical care with internal medicine, cardiology, and nephrology.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 1:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 1:58 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 72.82 years.  No concomitant product use was reported.   It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 2, on 17-Feb-2021, Excursion duration at 8 am 20, at 9 am 22, at 10 am 37, at 11 am 41, at 12 am 42, at 1 pm 39, at 2 pm 40, at 3 pm 42, at 4 pm 41.  On 29-Apr-2021, excursion time at 9 am temperature was 22, total doses given for the day was 62, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vial was moved to clinic. Vaccine BUD date was 13-Mar-2021.  Vials only punctured right before administration.  No treatment information was provided.
pt recv vax 10FEB95 & 16FEB95 devel mumps; No further details were provided;
Patient described red, warm, tender swollen area at injection site with numbness in fingers.  Went to urgent care and area without redness or warmth with minimal tenderness and intermittent numbness in finger.  Swelling mild.
Mother called to report child had redness and swelling of arm with a temp of 100.8. Took child to ER. Area was "drained" and child given antibiotics (cephalexin 500mg TID and bactrim 800 mg BID).
Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 14 year old female patient who on 23-FEB-2007 was vaccinated IM with 0.5 mL of Gardasil. On 23-FEB-2007 the patient fell to floor in a seizure like state. After 30 seconds she became conscious. Patient never had a seizure like episode before this incident. Unspecified medical attention was sought by the patient. The patient recovered the same day. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
It started with a headache the next day and pain in my jaw  Then overtime this progressed to numbness in the right side of my face and tinnitus, Which then progressed to Jaw locking, pain and pressure in my face, and feeling like the nerves in my face are on fire Over a month later I still have the symptoms and the jaw walking has only gotten worse
Red, itchy rash at injection site 10 days after vaccine. Initial redness and swelling at injection site for about 4 days after injection, went away, and then new redness and itchiness days later. Still monitoring to see if it worsens or goes away.
Low grade fever (99.5); redness at injection site in circular shape; tender to touch.
testedCOVID-19 positive today; fever; flu; testedCOVID-19 positive today; This is a spontaneous report from a contactable consumer for her mother from a Pfizer-sponsored program. A female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced testedcovid-19 positive today on 02Feb2021, fever and flu on an unspecified date. Reported as "HCP in-behalf of her mother who received our vaccine shot 2-weeks ago. Her mother suffered from fever and flu after receiving the 1st shot. Her mother did a rapid test, and tested COVID-19 positive today. The caller is worried and doesn't know how to deal with this. her mother is scheduled for the 2nd shot next week." The patient underwent lab tests and procedures which included COVID-19: positive on 02Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 13-MAR-2015 the patient was vaccinated with an expired dose of PROQUAD (Lot Number: J006569-Expiration date: 30-NOV-2014) with route of administration and dose unspecified, and no adverse events were reported. Additional information has been requested.
A few minutes after vaccine was given patient notes numbness in L thumb then L arm felt heavy and slightly numb; This resolved completely within 30 min
Between 10-15 minutes after receiving her first dose of the Moderna vaccine the patient became unresponsive and shaky. She began to drool slightly started shaky breaths and became clammy. Emergency services was called immediately. After a minute or two the patient started breathing normally again. She asked to be laid down because she was feeling very dizzy and shaky. She began to calm down and only complained of being slightly dizzy when the paramedics arrived.
Complains of being lightheaded because "was talking on cell phone." Did not eat breakfast this morning. VSS. Offered water and Powerade. Felt better. Left clinic at 1:05 pm.
pt experienced a severe skin reaction about ~48 hours after receiving vaccination. area affected from his knee caps, neck, upper body. went to the ER to get treated. currently on a steroid regimen. will go in to see a dermatologist on 10/27 to discuss further treatment.
Swollen lip within minutes of 2nd Covid 19 vaccination.  Blood pressure elevated at 206/110, heart rate 97, pulse 97.8.  Gave patient 50mg of oral diphenhydramine and monitored vitals and symptoms post dose for approximately 1 hour and 45 minutes. 1/2 hour post vaccination dose BP=180/100.  At 1 hour post injection BP was returning to patients normal BP 164.98, pulse 81, Lip swelling is reducing. Also took patients blood sugar to check 1 hour post vaccination , it was 120.
Tired; Small rash on leg, arms, back, legs, thighs, wrists and butt; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 14Apr2021 at 09:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and post-traumatic stress disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications included paracetamol (ACETAMINOPHEN) from an unknown date, for unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 25Mar2021 at 10:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 14Apr2021 at 14:45 the patient experienced, as she got home she went to bed, cause the vaccine made her tired. She woke up at approximately 14:47  and had a small rash on her leg. The next day her rash was worse. It was on her arms, back, legs, thighs, wrists and her butt. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events tired and small rash on leg, arms, back, legs, thighs, wrists and butt was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case is linked to case number 2013-07089 (same reporter, same vaccine). Initial misuse report received from a healthcare professional on 07 June 2013. It was reported that a nurse mixed ACTHIB powder from PENTACEL with Merck sterile water and administered to a child. The nurse never gave the DTaP/IPV. No adverse event was reported. Documents held by sender: none.
This spontaneous report was received from a health professional refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD (lot# L011080, expiration date 01-OCT-2016, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female in her early 20s who in August 2007, was vaccinated in her arm with the first dose of GARDASIL (route and lot # not reported). In August 2007, the patient experienced swelling of her lower extremities. It was reported that the patient sought unspecified medical attention. Patient outcome was not reported. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NIKKI, start date: 14Apr2022; AZELASTINE HYDROCHLORIDE, start date: 14Apr2022, stop date: 16Apr2022; FLUTICASONE, start date: 14Apr2022, stop date: 16Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19. Clinical course: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
right clavicle was swollen; right clavicle pain; soreness of her right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3247) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BONE SWELLING (non-serious), outcome "unknown", described as "right clavicle was swollen"; BONE PAIN (non-serious), outcome "unknown", described as "right clavicle pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of her right arm".  No follow-up attempts are possible. No further information is expected.
Extreme pain on left side of abdomen. Went to family doctor and the ailment was diagnosed with diverticulitis. (On Monday, 11/22/2021). Prescribed two antibiotics (Cipro and flagyl). Pain continued and on Thanksgiving Day 2021 went to the ER.  Admitted for IV antibiotics for diverticulitis.