chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 80 year old female patient with allergy to sulfa drugs and penicillin (unspecified). On 10-JUL-2016, the patient was inadvertently vaccinated with ZOSTAVAX (lot # L046897, expiration date 20-FEB-2017, dose was not reported0 via the intramuscular route rather than the recommended subcutaneous route. Concomitant therapies included lovastatin (manufacturer unknown), spironolactone, valsartan and VESICARE). On an unspecified date in  July 2016, the patient had an area about 1-1.5 inches that was red, hard, swollen, burised and itchy at the injection site. The patient sought medical attention so visited the pharmacy and reported the events. The patient received unspecified treatment for the events. None labs were performed. There was no product quality complaint. The outcome of the events was reported as not recovered, at the time of the report. the relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Covid-arm - reaction 9 days after shot. Red rash around shot area. Itchy and sore.
Patient initially had a positive COVID-19 NAA test on 12/25/2022. He is a resident of a long-term care facility. On 12/30/2022, patient presented to the emergency department after a fall/found lying on floor at the LTC facility, and with COVID-19 symptoms - shortness of breath, cough and generalized weakness. Patient had significant rhonchi and some bronchospasm; pulse oximetry stable in the low 90s; no signs of respiratory failure; chest x-ray showed no pneumonia. Patient was diagnosed Weakness, Fall, Unable to ambulate, COVID-19, Shortness of breath, Hypoxia, Acute bronchospasm, Urinary tract infection without hematuria, and site unspecified Severe sepsis. He was treated with DuoNeb nebulizer, ceftriaxone, dexamethasone, and normal saline bolus in the emergency department. Patient was then admitted to the hospital for additional care and treatment.    Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital
Evening of September 6, 2021, patient began experiencing trigeminy PVC heart rhythm which lasted approximately 18 hours and returned occasionally over the next few days. On September 8th, patient began experiencing bigeminy PVC heart rhythm, which continued nearly non-stop for approximately one week, and slowly receded after that. Stopped metoprolol and started Coreg 3.125mg 2x Daily. After Zio patch results showing high PVC frequency, doubled Coreg to 6.25mg 2x Daily. PVC frequency significantly diminished, trigeminy and bigeminy patterns appear to have dissipated.
This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX injection, lot # N012131, expiration date 17-APR-2019 (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK) used for reconstitution of the dose of VARIVAX was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source.; Sender's Comments: US-009507513-1712USA014470: US-009507513-1712USA014471: US-009507513-1712USA014472: US-009507513-1712USA014468: US-009507513-1712USA013124.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Shingrix for prophylaxis. On 2nd August 2018, the patient received the 1st dose of Shingrix. On 2nd August 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle pain, shivering, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, muscle pain, shivering, injection site erythema, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, shivering, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. Limited information was provided. The patient want to remain anonymous. The patient did not wanted to answer any further question and disconnected the call. The patient had also denied permission to contact their physician.
Patient given Moderna booster dose 0.25mL instead of 0.3mL Pfizer dose. No adverse events reported yet. The outcome not yet reached.
As requirement for my employment, they stated my blood test showed no immunity to mumps, even though had been working there for 16 years, so they said in order to keep working there I was required a booster. I received the booster in Nov 2011 3 weeks later I had flu like symptoms and joint pains that persisted. I Went to my Family Dr. about 3 or 4 months later with this chronic complaint. I didn't mention that I had a vaccine 3 or 4 months before.
Shivering, headache, myalgia and general fatigue, Relieved by NSAID. Shivering lasted about 24 hours, myalgia, general fatigue about 48 hours.
arm was sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (arm was sore). At the time of the report, MYALGIA (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
think they might have been exposed to COVID-19 after receiving the vaccine; slight headache; a little bit of fever; little of bit of cold; chills; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient and her husband were near to a person who was diagnosed with COVID-19; but they haven't been tested for COVID-19, they think they might have been exposed to COVID-19 after receiving the vaccine. She asked if they would test positive for COVID-19 after the exposure and if that was the case, would their doctor defer or re-schedule their second dose which was currently scheduled for 15Feb2021. On an unspecified date after getting first dose of the COVID-19 vaccine, the patient experienced a slight headache and a little bit of fever, little of bit of cold and chills. The outcome of the event "think they might have been exposed to COVID-19 after receiving the vaccine" was unknown while the outcome of all other events was recovered on an unspecified date.  Information on the batch/lot number has been requested.
cold shooting through extremities, torso going to jelly, heat on back of neck.  Would come in waves every 5-10 mins.  Started about 30 mins after injection.  Hospital treated with benedryl, and high dose anti-inflammatory.   Observed for 3 hours.  Symptoms quit.
1shot on 12/29/2020: 1/9/2021 started to brake out  herpes simples on my lips 2nd shot 1/15/2021: 1/16/2021 body and join aches, can barely walk, huge headache, not able to function. The worst lasted 24 hours. 1/17/2021 I felt better : manageable headache, body/join  aches almost gone 2/5/2021 very  bad headache,  vertigo, slept most of the day. 2/6/2021-2/8/21 headache and high blood pressure. 2/8/2021 urgently seeing my PCP
Urinary tract infection; Arm bothered her with first shot, it was just very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 21Jan2021 at single dose as the patient didn't want to get Corona and die. Medical history included compromised immune system, asthma which was diagnosed in the late 80's or early 90's, fibromyalgia from 2000 and ongoing, and being sensitive to Bandaids. Concomitant medication was reported as none. The patient received the first shot 3 weeks ago on 21Jan2021. She mentioned that she was fine and the only thing that bothered her was her arm, but it was fine, like she knew she had a shot. Her arm bothered her with the first shot, it was just very sore on 21Jan2021 and lasted about maybe 24 hours. The patient also experienced urinary tract infection last week (Feb2021) and took CIPRO for 10 days which she was still on. She told her doctor she would get the second shot and said that it was not a problem. The outcome of the event pain in arm was recovered on 22Jan2021 and unknown for urinary tract infection.
This spontaneous report as received from a certified medical assistant refers to a male patient of unknown age. On 03-APR-2014 the patient was vaccinated with PNEUMOVAX23 (lot # J011714, expiration date 20-FEB-2015), 0.5 ml, intramuscular. On an unknown date the patient experienced headaches and pain at the injection site. The patient called the office and was suggested to use ice compresses and ibuprofen. No lab tests were performed. The outcome of headaches and pain at the injection site was reported as recovering/resolving. The medical assistant was requesting a lot check. This is one of several reports received from the same source. Additional information has been requested.
Rash/hives on face, neck, itching on back, following administration of 2nd Hepatitis B vaccine - accelerated.
Arm swelling, pain, night sweats, chills, nausea; lasted 3 days.
Patient received vaccine 4/25/21. Patient stated he had no symptoms or issues until evening of 5/2/21 with pain in the injection area. He stated when he woke up today, the area was large, red and swollen the "size of approximately a golf ball." Patient was directed to his doctor for further evaluation and to make sure that the area is not infected.
Liver and Kidney "failure" - "temporary" because liver and kidney started functioning again. Don't really think this was a reaction to the vaccination. I didn't have much of reaction after the two shots, and this was way after the shots. Doctors didn't even ask/care if I got the vaccine. The V-safe app. text asked if I had any problems since the last time "you" asked. After I started to answer, I thought if you thought it was way too long after the vaccination, you wouldn't be asking. I also thought, no one "knows" the long term effects of the vaccine. I respond online to a follow up a phone message inquiry to my V-safe text comment, because this would be totally misunderstood verbally. I also follow up "JUST IN CASE" others may have similar "ailments" that maybe "overlooked" as associated with the vaccine. You would have the data from "all" to see the "big picture". Hope it's not. Again, just in case. The world's lives are in your hands. Body aches, small chill, nausea, weakness, generally felt really shitty. Yellow eyes and skin. Negative covid test, so went to urgent care. Blood tests - sent to ER.
Had the PPV shot along wityh the influenza shot and with in 6 hours started running a high fever of 101 It lasted for at least 48 hours....the arm where the ppv was injected became extremly painful I could not move the arm at all and it was swollen and inflamed and a BIG red mark around the injection sight...It iwas so painful I couldnt move oreven touch my arm,...the aches and fever were unbarable as of today October 26th the arm is still swollen hot and tender to the touch and a big red mark where the shot was adminisered
Left side of face is swollen and has hives/Left arm has small hives scattered and left leg has hives scattered; Left side of face is swollen; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 10Aug2021 at 13:00 (lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included tachycardia and bipolar disorder both from an unknown date. There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 10Aug2021 at 18:15, the patient's left side of face is swollen and has hives. The patient's left arm has small hives scattered and left leg has hives scattered. The patient received allergy medication as treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient felt anxious after vaccine administration about 5 minutes after dose given. Tremors in hands. No difficulty breathing or swelling. Patient states she gets anxious every now and then. Patient monitored for about 30 minutes. She felt "better" and was able to get up and leave when she felt comfortable.
Lower down bad ache; Muscle cramp one on my leg; Weakness; Arm ache not at the shot but right the down lower/both of my arm aches real bad; Muscle cramp one on my leg and one on my stomach; I do have a 'dental sleep' issue; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient)   A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 02Jun2021 1:30 pm (at the age of 67-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history includes migraine and anxiety. Patient family history reported as nothing or weakness. Concomitant medications include sumatriptan succinate (IMITREX) for migraine headache, clonazepam (KLONOPIN) for anxiety, calcium, colecalciferol (CALCIUM + D3) for normal things. Patient historical vaccine includes flu short for influenza immunization on an unspecified date, shingles shot and pneumonia shot for immunization on unspecified dates. Patient did not received other vaccine 4 weeks prior to Covid-19 vaccination. On an unspecified date in Jun2021 after the vaccination, the patient experienced lower down bad ache, muscle cramp one leg and stomach, weakness for two and half weeks, arm ache not at the shot but right the down lower and dental sleep. It was stated patient did not do any exercise but lower down her ache was very bad and 3 days later she had a muscle cramp one on my leg and one on her stomach, she had weakness and she was going on two and a half weeks now, there was a muscles cramp in her stomach area and in her leg and I had arm ache not at the shot but right the down lower at her arms and she had general weakness right now and she had this for two and a half weeks getting ready for my second shot on 26Jun2021." She had a 'dental sleep' issue. Treatment options patient took include aspirin or NSAID just diclofenac sodium topical get lidocaine (2%) and "bupivacaine" (further not clarified) (1%), the lotion I had for muscle pain. Consumer stated, she had weakness, lying on bed and trying to get best immune system that would really help better, she doesn't have any shortness of breath, just curious if someone experienced weakness or any felt like in the arm. The events assessed as non-serious. The outcome of the events pain, muscle spasm, abdominal pain and sleep disorder was unknown. The outcome of event asthenia was not recovered, pain in extremity was recovered on Jun2021 and unknown for all other events.  No follow-up attempts possible. No further information expected.
Breakthrough case admission after 2 vaccines Pfizer 3/12/21 lot# EN6207;  Pfizer 4/7/21 lot# ER2613
Pain that went down my leg to my foot, feeling it going down my thighs and knees; Pain started with one side of the hip then both; Tired; Sleepy; I have lack of appetite; lost 17 pounds; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain started with one side of the hip then both), FATIGUE (Tired), SOMNOLENCE (Sleepy) and DECREASED APPETITE (I have lack of appetite) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain started with one side of the hip then both), FATIGUE (Tired), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite) and WEIGHT DECREASED (lost 17 pounds). At the time of the report, PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), ARTHRALGIA (Pain started with one side of the hip then both), FATIGUE (Tired), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite) and WEIGHT DECREASED (lost 17 pounds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Biopsy by colonoscopy was positive for Lymphocytic Colitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE ), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE ), for COVID-19 immunization. The following information was reported: COLITIS MICROSCOPIC (medically significant), outcome "unknown", described as "Biopsy by colonoscopy was positive for Lymphocytic Colitis". The patient underwent the following laboratory tests and procedures: Colonoscopy: positive, notes: Biopsy by coloscopy was positive for Lymphocytic Colitis.  Clinical course: Patient started to develop symptoms 4 months after third Pfizer COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event colitis microscopic  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
HPI: 24yo F with no known significant neurologic history with new onset seizures with initial status epilepticus. She had a potential rabies exposure on Wednesday 3 May and, having had prior rabies vaccinations x 2, underwent post exposure prophylaxis for rabies exposure with 2 dose series of rabies vaccine. Within 5 minutes of the second dose of the vaccine on day 3 after exposure she felt unwell, then became unconscious, and had seizure-like activity with rapid eye movements and rhythmic shaking of the left arm at about 1330. She remained unconscious with GCS 3 for the next 3 hours with frequent episodes every 2-20 minutes of recurrent seizure activity lasting 15 seconds to 3+ minutes. She was treated initially with midazolam in recurrent boluses of 2mg up to 12mg in total. She was loaded with levetiracetam 4500mg IV and given an additional 10mg IM diazepam. She underwent CT head with and w/o IV contrast which was negative. She had a total of over 23 seizure-like events over about 3 hours. Over the next week she had progressive improvement in mental status. She had no further large events after about 24hrs and had only 1 very brief event.
Employee (patient) reports expected soreness at site within 24 hours of vaccination. However at about 3 weeks, discomfort progressed to muscle tightness affecting ROM - which progressed to arthralgia in shoulders, hips and knees. Sought assistance from primary care provider who felt this was most likely due to an inflammatory response to the pertussis component of the vaccine as the patient had never experienced a like reaction with Td alone.  He treated her with a Medrol (prednisone) dose pack.  Employee (patient) reports a complete resolution of symptoms.
She received Moderna COVID-19 vaccine 2/17/21 and developed symptoms of left ear discomfort followed by left sided facial and eye droop on 2/27/21. She was seen by MD on 2/27/21 and was confirmed to have Bell's Palsy. She was given prednisone with taper and valacyclovir for 7 days.  Also advised to wear an eye patch.
Breakthrough case admission after three vaccines: Moderna 2/18/21 Lot# 037K20A; Moderna 10/24/21 Lot# 024C21A;  Moderna 5/5/22 Lot# 004M21A.
Information has been received from a healthcare professional concerning a patient (age and gender unknown) who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (651401/0619F). Subsequently, on an unspecified date, the patient developed redness all over the injection site down to the elbow. At the time of this report, the patient had recovered. No product quality complaint involved. A lot check was requested by the reporter. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the agency and was released. Additional information has been requested.