chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided.  It was reported that in a treatment program, one of the other participants who had the Moderna Covid-19 Vaccine tested positive for COVID 19. Everyone in the program was sent to dorm quarantine.  Treatment information was not provided.  Company comment-This spontaneous case concerns a patient of unknown gender and age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. COVID -19 test was positive on an unknown date. No further details on clinical course, other lab test and treatment received were reported. Outcome of the event Covid 19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown gender and age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. COVID -19 test was positive on an unknown date. No further details on clinical course, other lab test and treatment received were reported. Outcome of the event Covid 19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Chills, fatigue, feverish, aches, nerve pain in hands and feet, vomiting
Patient describes bilateral ringing in his ears starting two weeks after his booster vaccine for Covid-19.  Ringing is constant however worsens with quiet
He got the first shot at (Pharmacy name) and got Covid just a few days after the first dose.; He got the first shot at (Pharmacy name) and got Covid just a few days after the first dose; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is 1st of two reports. A (Age: 45 Unit: unspecified) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot and batch number were not reported) via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient medical history, concomitant medications and past drug history were not reported. On an unknown date, He got the first shot at (Pharmacy name) and got Covid just a few days after the first dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Started with sore throat, frothing at mouth. Severe fatigue. Severe body aches, extreme headache. Similar to reaction to 2nd dose, only with the sweating, and a lot more pain.
5 1/2 months after vaccination on 4-15-2022, I started having a cough. The following day on 4-16, I had a fever of 100.0, body aches, a scratchy throat, runny nose and sinus pain. I went to go test and it was positive for COVID-19. Thru that night, I started having diarrhea. One week later, I started having gum pain so I went to my dentist and they stated I had COVID-19 sores in my mouth. I am reporting a breakthrough case of COVID-19 after being fully vaccinated.
Fever started 1 week after vaccine then 3 days later fever accompanied by a full body rash. Peds office did NOT give a VIS and declined initial request for urgent visit due to vaccine reaction. After messaging her provider I was able to bring her in and was told "I'm not sure what it is but its not from the vaccine. She can return to daycare but should stay away from un-vaccinated kids, pregnant people, and those on chemo. resulting in taking my daughter to another facility where the provider confirmed the symptoms as a reaction to the vaccine and we were informed to keep her home until rash and fever subsided which should only last about 1 wk  from when symptoms first started.
swelling in underarm area on right arm; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old non-Pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0168), via an unspecified route of administration on 23Aug2021 at 13:00(at the age of 57-years-old) administered in Arm Right as a single dose for COVID-19 immunisation at Public Health Clinic/Military Facility. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0168), via an unspecified route of administration on 28Jul2021 at 09:00 am administered in Arm Right as a single dose for COVID-19 immunisation at Public Health Clinic/Military Facility. The patient medical history was not reported. Concomitant medication(s) included estradiol taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. On 25Aug2021 at 05:00 AM, the patient experienced swelling in underarm area on right arm. No treatment was given for the event. The outcome of the event was not recovered.  Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
She also has some headache; Patient had fever at night after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (She also has some headache) and PYREXIA (Patient had fever at night after receiving 2nd dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced HEADACHE (She also has some headache) and PYREXIA (Patient had fever at night after receiving 2nd dose). At the time of the report, HEADACHE (She also has some headache) and PYREXIA (Patient had fever at night after receiving 2nd dose) outcome was unknown.            No treatment medication was provided.
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: pt was  fainting and failing right after he received pfizer.  he hit very hard on the registor counter.  He look so very pale and fainted. He had low blood pressure, 106/60.  He had the same symptoms on the first short. He was given water.  Paramedic came and checked him up.  Mon refuse to take him to hospital. Paramedic leave it up to mon to get check out with his PCP.  She states that he does not have PCP.
patient has received dose of SHINGRIX outside of vaccination schedule.; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of inappropriate schedule of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: patient has received dose of SHINGRIX outside of vaccination schedule).  The outcome of the inappropriate schedule of vaccine administered was unknown.   Additional Information: GSK receipt date: 18-Aug-2023 The case was reported the pharmacist. No additional information was provided. No adverse event or product quality complaint was reported. The patient received a dose of Shingrix outside the vaccination schedule, which led to inappropriate schedule of vaccine administered.
The vaccinator at our health clinic accidentally administered a pfizer (orange cap / 5-11yr) dose to a 12 year old. The patient was fine and did not experience any symptoms post vaccination. The CDC guidelines recommend to NOT REPEAT DOSES for this patient based on her age. I explained what happened to the mother and we all apologized for this event occurring. We recommended he to stay for 30 minutes just to ensure we can assist if the patient experienced any side effects.
This literature marketed report was received from the authors. RATIONALE: Manifestations of immune dysregulation in common variable immunodeficiency (CVID) included granulomatous disease, autoimmunity, chronic lung disease, enteropathy, among others. Sweet's syndrome, or acute febrile neutrophilic dermatosis, was a hypersensitivity reaction characterized by fever, neutrophilia, and cutaneous eruptions. Few reports existed describing Sweet's syndrome in association with primary immunodeficiencies. METHODS: The authors herein presented a child with idiopathic, refractory Sweet's syndrome with extracutaneous manifestations and a subsequent diagnosis of CVID. RESULTS: A 9-year-old male developed fever, neutrophilia, mucocutaneous lesions, and tracheobronchial inflammation. Skin biopsy histopathology revealed a dense dermal neutrophilic infiltrate, and bronchoalveolar lavage fluid had a predominance of neutrophils. He was diagnosed with idiopathic Sweet's syndrome, ultimately well-controlled on tocilizumab and lenalidomide. His immune evaluation was unremarkable at diagnosis. Over 15 months, he had declining immunoglobulin levels and protective vaccine responses. Immunoglobulin G (IgG) declined from 536 to 290 mg/dL, IgM from 36 to <25 mg/dL, and IgA from 108 to 16 mg/dL. He received pneumococcal conjugate and polysaccharide vaccines (manufacturer unknown) (dose, lot # and expiration date not reported) and had unsustained responses. He had normal B-cell number and cellular immune evaluation. He clinically developed upper and lower respiratory tract infections. With these findings in mind, the patient was diagnosed with CVID and started on immunoglobulin replacement therapy. CONCLUSIONS: Immune dysregulation was common in CVID. Sweet's syndrome was an inflammatory skin condition generally associated with autoimmune disease and malignancies. This is one of few cases reporting Sweet's syndrome in the setting of CVID. This case should encourage providers to screen Sweet's syndrome patients for underlying primary and acquired immunodeficiencies. The outcome of the event was unknown. The causality between the event and pneumococcal conjugate and polysaccharide vaccines (manufacturer unknown) was related. Additional information has been requested.
PATIENT REFERS THAT APROXIMATELY 30 TO 45 MINUTES AFTER VACCINATION THE PATIENT BEGAN VOMITING (3 TIMES), STRONG HEADACHE AND BACK PAIN. WENT TO THE ER AND RECEIVED AN INJECTION TO STOP THE VOMITING.
Pt reported rash on left shoulder 3/11/2019, then was admitted to the hospital on 3/13/2019 with worsening rash extending to left face, and back, and lesions developed at other metastatic sites on body. Seen by ID and dermatology and rash diagnosed as disseminated Zoster.
This was a duplicate bivalent dose. Patient previously received bivalent booster dose on 10/10/22.
Intermittent pain and swelling in left upper arm since received vaccines.  Has a 1/2 cm palpable nodule at the injection site
One week after the vaccine I experienced lower back pain that has now lasted a week and has gotten worse.
Patient states her arm started hurting immediately after the pneumonia vaccine and stayed sore for approximately 2.5 months. Then this past April it started hurting in the exact same spot and she had difficulties lifting her arm and doing daily task such as clip her bra, etc. The right arm is the arm that has been giving her the problem all along. She decided to go to the doctor this week about it. She used ice and it intially helped her but from October but when it started bothering her in April ice didnt help and she resorted to SALONPAS patches to see if they would numb the area.
COVID-19 Treatment; COVID-19 Treatment; 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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose number unknown, single (Lot number: 30135BA) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "hashimoto thyroiditis(hypothyroid)" (unspecified if ongoing); "Allergy: Mushrooms" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: anti viral details  Paxlovid, treatment start date: 02Jun2022,treatment stop date: 04Jun2022, indication: Treatment of COVID-19
redness; itching; Hot to touch a little lower than the injection site and keeps going further around the arm; There is a Rash; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (redness), PRURITUS (itching), FEELING HOT (Hot to touch a little lower than the injection site and keeps going further around the arm) and RASH (There is a Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL for an unknown indication.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ERYTHEMA (redness), PRURITUS (itching), FEELING HOT (Hot to touch a little lower than the injection site and keeps going further around the arm) and RASH (There is a Rash). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 01-Feb-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (redness), PRURITUS (itching), FEELING HOT (Hot to touch a little lower than the injection site and keeps going further around the arm) and RASH (There is a Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: blood clot in left arm near elbow-Medium
incorrect age group, child is 5 years  old and given the 6months to 4 year dose.
got sick from the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got sick from the vaccine). The outcome of the sickness was not reported.   The reporter considered the sickness to be related to Shingles vaccine.     The company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2023. This case was reported by a patient via interactive digital media. The patient got sick from the vaccine but patient dad said that patient would felt much worse, the patient couldn't imagine, patient was glad that got the vaccine. The follow-up could not be possible as no contact details were available.
Received vaccine to left deltoid with immediate hematoma formation dime size. Went home applied heat 15-20 min. Then started having shooting pains in neck and throat felt like it was closing approximately 3:30pm took BENADRYL 25 mg 4pm started chilling and nauseated, vomited once lasted until 845pm took another BENADRYL 25 mg went to bed. 1145 pm started chilling again went back to bed. This morning aching severely all over, bones ache, arm really sore to touch. Throat feels sore today.
Lip and nose itching, progressed to L facial numbness and "felt like her throat was closing". Administered 1MG of Epi and 50MG of Benadryl intramuscularly. Called EMT. Pt reported some relief. 5 minutes after injections, pt reported SX returning. Vials were stable. EMT arrived and transported pt to hospital for observation.
administered every year; no adverse effect; Information has been received from a lawyer via referring to a currently 66-year-old female patient. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (strength, dose, route, lot # and expiration date not reported) for prophylaxis. It was reported that the patient received pneumococcal vaccine (manufacturer unknown) every year (inappropriate schedule of product administration). She did not experience any adverse reactions or side effects.   This is one report split from a case in litigation (regulatory authority# 2108USA004990).; Sender's Comments:  US-009507513-2108USA004990:
Very very sick with stomach ache, nausea,  diarrhea-- but most important nearly fainting at more than one moment-- having to choose between finishing going to the bathroom & lying down SO I WOULDN'T FAINT!!
I did not have a reaction to the vaccine. I was diagnosed with bronchitis in 02/2023. I had a cough that lasted three weeks and I was really tired. I contacted my doctor and got a prescription for an inhaler and an antibiotic. I never tested for COVID-19. As of today, I feel better with no lingering symptoms.
heavy numbness in right side of face, mouth and jaw, right arm and right side of torso. Pain on side of right thigh. Symptoms lasted around 15-20 minutes and subsided. Symptom of numbness in right side of face, mouth and jaw resurfaced on March 12th which prompted me to visit my primary doctor.
Chest discomfort, aches pains, chills fever, Swelling of arm and armpit and faitgue
Information has been received from a physician concerning an 82 year old female with osteoporosis, hypertension and gastrooesophageal reflux disease who on 09-APR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included alendronate sodium, Benicar, Celebrex and Ambien. On 13-APR-2007 the patient experienced itching of the skin and hives over the body. No previous allergic reactions were known. She returned to the physician's office and the physician immediately treated her with steroids IM and oral steroids for one week. No further information was provided. Additional information has been requested.
Psychiatric/daily medications stopped working. Panic attacks, paranoid same day as vaccination.  Panic attacks, severe mood impairment, night terrors, rapid heart rate, low blood pressure, the next 2 days after vaccination. By day 4, medications started to slowly work again. By day 5, medications seems to working normally again.
Dizziness, difficulty breathing, body aches and pains, fluctuating heartbeat ,anxiety, loss of taste and appetite, confusion, Symptoms have been lasting almost a month,
Fever 103, swelling, 1 in raised area noted to injection site, itchy halo.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine past it's beyond use date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine past it's beyond use date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Two patients received vaccine past it's beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This vaccine was removed from freezer on 8/31/21 and stored in a monitored refrigerator.  By manufacturer guidelines, refrigerator thawed vaccine has a storage life of 30 days (9/29/21).  Concomitant medications was not reported. Treatment medications was not reported.   This case was linked to MOD-2021-374545 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Significant follow up received Patient demographics, Past history and suspect expiry date updated.
About 4 hours after administration arm pain began. 8 hours later started with mild nausea and diarrhea and increasing arm pain on abduction laterally. 12 hours after began with lower back pain. By 13 hours had full body aches, especially joints, continued nausea and diarrhea, chills/sweats, fever up to 100.9, lymph node swelling in neck, general malaise
Hives starting evening of vaccination and progressing until time of visit 3/15. Has not yet been treated. Recommended today to start treatment with benadryl.
Moderna COVID-19 Vaccine  Dizziness about 5 minutes after receiving shot that lasted for 10-15 minutes Sore/itchy throat that started 5 minutes after shot and lasted for about 24h Headache (intermittent) in the 48 hours following, not severe enough to hinder work or activity Moderate-severe injection site pain, worst between 24-48h post injection, radiating down to elbow and up neck on same side as injection
I felt shortness and restriction of breath, fever 101, body aches and headache. I have had issues with micro clotting, heart rate is even more irregular, and I was diagnosed as having a TMI. I rode in the ambulance on Mother's day was hospitalized
103.9 fever,Muscle pain,Dizzy, No appetite, Lethargic  Took Advil. Did not help. Fever down to 99.6 by 9pm. Finally gone by 11am.
Acute kidney failure, unspecified Hypocalcemia Hyperkalemia Syncope ARF (acute renal failure)  Abnormal EKG Elevated troponin Elevated LFTs