chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PASSED AWAY; This spontaneous report received from a consumer via social media concerned a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number and expiry were unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date (a couple of days after vaccination), the patient passed away. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210508328.; Sender's Comments: V0: 20210506934 -COVID-19 VACCINE AD26.COV2.S - Passed Away. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Rash on right arm from injection site down about 6 inches on arm, slightly swollen, red, itchy and sore. This started on Monday, 2 August. When I woke up on Tuesday, 3 August, the right side of my tongue feels swollen as does the area beneath the right side of my tongue and down the right side of my neck. That whole area feels like I've been given a Novacaine injection. Not really any difficulty swallowing, my mouth and neck area just feel weird.
Started 10-8-18 with large redness, warmth, and swelling. Continued to get larger the next day. Lasted 3 weeks.
patient was admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine.; patient was admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine.; covid-19 pneumonia; This is a spontaneous report from a non-contactable other HCP.  An 87-year-old male patient received on an unknown date the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot unknown) and on 11Feb2021 the second dose (30mcg/0.3mL, lot unknown), both via an unspecified route of administration for COVID-19 immunization (age at vaccination 87-year-old). Medical history included: Chronic lymphocytic leukaemia (CLL) and hypogammaglobulinemia. Concomitant medication was not reported. The patient was recently admitted for covid-19, CTA positive for covid-19 pneumonia and covid-19 PCR positive, after 2 completed doses of Pfizer vaccine. On 23Feb2021 (post vaccination), the patient's COVID test nasal swab was positive. Patient did not have COVID prior vaccination. Outcome of events was unknown.  No follow-up attempts are possible; information about Lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19 , COVID 19 pneumonia and vaccination failure due to temporal relationship.
Hives on neck, arms, and hands. Lips swollen through the inside and out.
Patient was hospitalized on 12/31/2021 for 6 days.  Reporting System has no symptoms or pre-existing health conditions listed to report.
Pt received the 2nd dose too early. Reached out to the CDC and was informed pt needs to repeat 2nd dose at 3/26/22.
0930 Pt was given Hep A vaccine. 1420 Pt experienced sudden onset of shivers, sweating, nausea, weakness.
Pt brought to ER on 28NOV91 c/o rash on neck/abdomen, inc temp; ER temp 98.9 R; no tx given; pt advised that "this is normal reaction 10 days p/MMR;
Information has been received from a physician concerning a female (age not reported) who on 20-FEB-2007 was vaccinated with a 0.5 mL first dose of HPV. The patient was concomitantly vaccinated with a dose of Boostrix. On 21-FEB-2007 the patient experienced nausea and a headache. The patient sought unspecified medical attention. On 22-FEB-2007, the headache was clearing and the nausea was gone. Additional information has been requested.
Complete left side face and arm numbness along with a now three day migraine! Extremely unhappy this is what comes along with being forced to have something forced on me in order to work!
Progress Notes; Nurse Practitioner Cosign Needed Expand All Collapse All    COVID VACCINE CLINIC 12/22/2020                                                                  Date:  12/22/2020                                                                                            Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience Headache over the front of the head.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis.   Finger stick BS 101 12:15 pm granola bar and water given   Review of Systems  Neurological: Positive for headaches.  All other systems reviewed and are negative.        Objective    Vitals Vitals:   12/22/20 1203 12/22/20 1226 BP: (!) 158/81 (!) 153/75 BP Location: Left arm Left arm Patient Position: Sitting Sitting Pulse: 76 72 SpO2: 98% 98%       Physical Exam Vitals signs and nursing note reviewed.  HENT:     Head: Normocephalic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.  Eyes:     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.         Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.   Pt reports headache went away after she ate.  No new symptoms manifested.  Pt released at 12:30 pm       Electronically Signed 12/22/2020 12:29 PM
Started getting hives on my arms and legs every few days/It has got worse after the second dose; It does not itch too much and goes away in 2-3 hours/It has got worse after the second dose; Could not figure out what I was allergic to; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Started getting hives on my arms and legs every few days/It has got worse after the second dose), PRURITUS (It does not itch too much and goes away in 2-3 hours/It has got worse after the second dose) and ALLERGY TO VACCINE (Could not figure out what I was allergic to) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Started getting hives on my arms and legs every few days/It has got worse after the second dose), PRURITUS (It does not itch too much and goes away in 2-3 hours/It has got worse after the second dose) and ALLERGY TO VACCINE (Could not figure out what I was allergic to). At the time of the report, URTICARIA (Started getting hives on my arms and legs every few days/It has got worse after the second dose), PRURITUS (It does not itch too much and goes away in 2-3 hours/It has got worse after the second dose) and ALLERGY TO VACCINE (Could not figure out what I was allergic to) outcome was unknown.            No concomitant products were reported. No treatment information was reported by the reporter. Patient stated that events got worse after second dose.   This case was linked to MOD-2022-462023 (Patient Link).   Reporter did not allow further contact
5 mins p/vax pt devel vascular flush in both legs & a series of small welts or hives in both legs;  temp, pulse & resp remained nl, chest clear & no resp distress; in 15 mins the reaction subsided;
Pain, swelling of elbow - pt could not raise arm without pain. Severe cellulitis per MD in elbow.
Information regarding Prevnar was received from a healthcare professional regarding a 19 year old patient who was inadvertently given Prevnar instead of PPV23 and developed a reaction, the nature of which is unknown. The patient received a dose on 31 Aug 2006. Medical history-The patient has past history of splenectomy. Indication for Prevnar was immunization. Product was administered on 31 Aug 2006. Dose regimen was 1 dose 1 time per day. Patient was not taking concomitant therapy. Event Details: A physician reported that on 31 Aug 2006, the patient was inadvertently given Prevnar instead of PPV23 (wrong drug administered). The patient experienced a reaction, the description of which is unknown (unevaluable event). The outcome is unknown. No additional information was available at the time of this report.
Progressive bilateral lower extremity weakness and numbness/tingling in his hands that began 6 hours post-COVID-19 vaccination. He had 3 visits to the emergency room on 5/31, 6/2, and 6/4. On 6/4 he was hospitalized for suspected Guillain-barre syndrome and treated with IVIG with reported improvement.   5/31: ED visit for generalized weakness, urinary frequency, itching, joint soreness, fever. Normal CXR, CTPA, ekg. Elevated CPK and d-dimer. Treated with decadron 8mg IVP and po x 5 days and zpack. 6/2: ED visit for weakness/numbess in BLE.  No sig findings on CXR, CT Head, EKG. Prednisone 60mg po, naproxen 500mg po, Kcl 25mg po. Discharged with Medrol 4mg dose pack and naproxen.  6/4: ED visit for same complaint and back pain. No acute findings on CT L-spine. Transferred to a different hospital for neuro eval for suspected GBS Alternative Hospital course: Neuro A/P ? Acute to subacute onset of progressive and ascending LE weakness with areflexia. Main differential includes acute demyelinating polyneuropathy vs viral neuropathy including West Nile. LP and start IVIG. 6/7: Neuro progress note ? Pt with suspected acute demyelinating polyneuropathy. BLE weakness and ambulation improving. Unable to tolerate MRI.  CSF results: traumatic tap, normal OP/glucose. Elevated WBC and protein. West Nile IgG+, IgM negative.  Discharged to inpatient rehab on 6/10 and discharged home 6/24.
pt. got more hives Mon 9/27 pm and by Wed AM 9/29 had hives over entire body except face.  Hive were worse on the lower extremities.  Watery eyes.  No respiratory distress.
eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown.   Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.
Pt came back to the pharmacy a short while after receiveing the vaccine with symptoms of dry mouth and swollen lips. Pt said she just didn't feel like herself.
Fell, head injury and vertebrae fractured.   Probable stroke.  Dizziness.
Swelling of face, throat, around eyes, hives ,rash on face and neck and some on right arm and itching.  Swelling has subsided but redness and some hives and itching continues 7 days post first shot.
Large boil about 3 inches from my left armpit on the inside of my arm against my body
Within a 5 minutes after receiving the first dose of Hepatitis A, Tdap (Boostrix), and Polio Injectable vaccines, I felt very disoriented, dizzy, and sweating. I immediately asked the nurse if it was normal to feel dizzy and they had me put my head in between my legs and put ice on my neck. This lasted for around 5 minutes and I remained seated for another 10 minutes before I felt okay to leave the clinic. I am not sure now if I will return to get the second Hepatitis A vaccine after my vacation.
Patient complained of soreness in muscles morning after receiving the shot.  She went about her day had a smoothie, spoke to people and also went for a walk came home and went into her jacuzzi tub and consequently passed away while in the tub. She was found by her husband at around 545pm, time of death is unknown and cause of death is  currently pending.
1 week after vaccine, developed 11x9 cm area of erythema, warmth, and swelling. Pt reported it was itchy but not painful.
Patient received J&J vaccine on 7/19/21. He tested positive for COVID on 1/18/22. Presented to ER on 2/2/22. Recently diagnosed with COVID, has  been weak at home.  Also, he woke up this morning with night sweats, fatigue,  has had vomiting.  He was found to have leukocytosis, white blood cell count  of 26.  Workup is currently pending with imaging and a urinalysis.  He was  clinically dehydrated, has been started on IV fluids.  The patient looks much  older than his stated age.  He is being held off on chemotherapy at this time  due to decline in function.  Previous imaging does show worsening metastatic  disease in his liver.  He is agreeable to hospitalization at this time. Treated with ceftriaxone and was on room air his whole stay. Discharged on 2/11/22
NAUSEA; VOMITING; ARM SORENESS; FEVER; CHILLS; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event.   On 16th February 2022, the patient received the 2nd dose of Shingrix. On 16th February 2022, 4 hrs after receiving Shingrix, the patient experienced pain in arm, fever and chills. On 17th February 2022, the patient experienced nausea and vomiting. On an unknown date, the outcome of the pain in arm, fever, chills, nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fever, chills, nausea and vomiting to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The reporter declined to give her address and date of birth. The patient stated that she did not experience anything after first dose of shingrix. The patient received a dose of Shingrix and 4 hours later experienced arm soreness, fever, chills and the next day experienced nausea and vomiting. All events were ongoing. Consent obtained to contact consumer and health care professional. The reporter did not have any health care professional contact information or the name of the health care professional. The reporter disconnected the call and agent was unable to transfer call to after call survey.
Oozing, inflamed rash, drs. said it was fixed localized drug eruption on forehead, face, neck, and chest; bright red pustules filled with fluid, swollen eyes, and rash itself created swelling of skin - treated with cortisone pills and creams - rash present for 6-7 weeks.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.
felt very sleepy; very tired; Headache; elevated temperature; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient herself) reported that a 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, UPC/NDC number and expiration date were unknown), via an unspecified route of administration in the left deltoid (also reported as left shoulder) on 16Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included hypertension, for which she was taking medication for it and had a torn redness on her rotator cuff; from an unknown date and unknown if ongoing. Concomitant medications included cortisone injection as she had a torn redness on her rotator cuff, as she guessed and she was taking an unspecified medication for hypertension. The patient just wanted to report that after taking the vaccine (Covid-19 Vaccine) on the 16Jan2021, she felt very sleepy and then very tired, slightly headache and she had elevated temperature. The patient further stated that she had elevated temperature and lastly, after she had the injection, she got really, really sleepy. The patient stated that before she had the injection, she had a cortisone injection, so she didn't know.  The events did not require any visit to the physician office or to the emergency room. Therapeutic measures were taken as a result of felt very sleepy, very tired, headache, and elevated temperature, which included paracetamol (TYLENOL). The outcome of all the events was unknown.
Arm was itching; Arm is now red; white spot in middle of the redness that is halfway down her arm (between shoulder and elbow.); Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm was itching), ERYTHEMA (Arm is now red), RASH MACULAR (white spot in middle of the redness that is halfway down her arm (between shoulder and elbow.)) and VACCINATION SITE PAIN (Pain at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included VITAMINS NOS for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 26-Jan-2021, the patient experienced PRURITUS (Arm was itching), ERYTHEMA (Arm is now red) and RASH MACULAR (white spot in middle of the redness that is halfway down her arm (between shoulder and elbow.)). At the time of the report, PRURITUS (Arm was itching), ERYTHEMA (Arm is now red), RASH MACULAR (white spot in middle of the redness that is halfway down her arm (between shoulder and elbow.)) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was concerned as white spot in middle of the redness that was halfway down her arm (shoulder and elbow) was few inches away from the injection site.
Hi,  I recently received an EKG and they identified a Right Bundle Branch block in my heart.  I received an EKG for work 10 years ago and they didn?t identify any issues as far as I?m aware.  I never had myocarditis  and had no heart issues.  My PCP did the EKG because I turned 40 as a routine exam.  Ihad 3 shots of Moderna and caught COVID after my third shot.  No one knows if my Right Bundle Branch block is linked to COVID or the vaccine but I thought I would report it as I know there have been cases of MYocarfitis in males after vaccination.
Patient described a rash/hives appearing below the injection site about 30 minutes afterwards. Patient stated it resolved the next day.
Ran low grade fever reaching only 100.7, muscle aches, bad headache, nausea all after second dose, started around 12?14 hours after injection, lasted for 16 hours before fever broke
2nd Injection received approx. 11:05 AM on Wednesday 1/6/2021. First symptoms of reaction seen between 8-10pm on Saturday, 1/9/2021 which included hives around neck and covering chest torso and arms. Treated with topical Benadryl.  Rash/hives continued to persist spread to entire body, head, neck, face, torso, arms, legs, feet.  On early Monday, 1/11/2021 - Contact with Employee Health Nurse and PCP Dr. and advised to take Benadryl as the only symptom was the rash/hives - no facial swelling or shortness of breath.  Tuesday, 1/12/2021 after taking advice of Employee Health Nurse and PCP symptoms are nearly fully resolved.