chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 hrs after I developed severe reaction and could not stop vomiting for following 48 hrs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (5 hrs after I developed severe reaction and could not stop vomiting for following 48 hrs) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and G41C21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder pain (Worsening due to neck and back injuries from vehicle accident.) on 15-Jun-2016, Back pain (Worsening due to neck and back injuries from vehicle accident.) on 15-Jun-2016, Neck pain (Vehicle accident.) on 15-Jul-2019, Back pain (Vehicle accident.) on 15-Jul-2019 and Illness from 02-May-2021 to 04-May-2021. Concurrent medical conditions included Migraine (Worsening due to neck and back injuries from vehicle accident .) since 01-Jan-1977. Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (DAYQUIL COLD & FLU) from 01-May-2021 to an unknown date for Allergy, CLONAZEPAM from 20-Feb-2020 to an unknown date for Anxiety, QUETIAPINE from 10-Oct-2020 to an unknown date for Bipolar depression, OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) from 18-Jun-2020 to an unknown date and CYCLOBENZAPRINE HCL from 20-Oct-2020 to an unknown date for Chronic pain.   On 02-May-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021 at 5:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VOMITING (5 hrs after I developed severe reaction and could not stop vomiting for following 48 hrs) and NAUSEA (Nausea). The patient was treated with DIMENHYDRINATE (DRAMAMINE) on 04-May-2021 at a dose of UNK dosage form. On 04-May-2021, VOMITING (5 hrs after I developed severe reaction and could not stop vomiting for following 48 hrs) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Urine analysis: postive (Positive) Positive for fentanyl use.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had taken pesto and OTC sleeping meds along with pain medicines to try to sleep.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15 Jul 2021 contains significant information-Updated patient information, New events:  Nausea. And updated event outcome: Recovered.
Tired shortly after my shot. Had chills and sweats overnight. Woke up to shower and passed out in the shower, had blurry vision, passed out again after getting out of the shower. Rapid heart rate and chills with migraine. No appetite, did not leave my bed for 24 hours, very lightheaded and nauseous. I have been having serious headaches for a week now after the shot
On 4/16/15, pt came into to report that she had severe nausea, dizziness and weakness starting 4/9/15. Vaccine given 4/8/15. On 4/10/15, pt went to ER. Pt returned to care on 4/16/15.
Patient given PFIZER formulation for 6m-4yo, patient current age 5.
Prolonged arm pain > 4 weeks after injection. Patient did not "move arm for 2-3 weeks". Subsequently developed signs of impingement syndrome with arm. We treated times one - Aleve.
Large about 2 inches in diameter red raised hot area that appeared about 1 week post vaccine and continued to expand.  Never was itchy. It was located at the vaccination site.
COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma, Crohn's and Arthritis. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA) for Crohn's and Arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient developed signed and symptoms that lead to a positive COVID test on 16Aug 2022. They were trying to get more clarity if there were further information to support how far after infection a patient who may have these immune variables should wait until getting the bivalent booster (ie the standard recommended at least 3 month wait or possibly sooner if these variables had any evidence of lesser/shorter immune response). Patient had extreme anxiety about how to proceed and what the best way to proceed would be.  Treatment medications were not reported.
4 to 5 patients received shot past 30-day use by date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. Expiration date was 1/20/22. Number of doses/vials was 15-dose vial. Date the vial was initially stored in the refrigerator was 08 Sep 2021. Patient had no side effects.   This case was linked to MOD-2021-351064, MOD-2021-363707, MOD-2021-363708, MOD-2021-363703, MOD-2021-363708, MOD-2021-351064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up information contains NNI.
described first experience in getting the vaccine as "bad" and "dramatic".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  An adult female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "described first experience in getting the vaccine as "bad" and "dramatic".".  Additional information: The case was reported as non-serious. The patient plans to get booster this month. They described first experience in getting the vaccine as "bad" and "dramatic". They are a Pfizer employee, so likely if it was the Pfizer shot they submitted an AE with the occurrence already.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
All started about 3pm-330pm or later  Fever hovering up to 102 deg F and on day after, temps hovering 99-100 deg F Tachycardia confirmed by BP home cuff and pulse ox going upwards of 120's and day after hovering 100-105 or lower so far  Sweat/Chills day 1  Respiratory Rate: upwards of 18-22 on day 1, regular on day 2  SPO2 ~ 94 on day 1, day 2 ~ 95-96
NOTICED BLISTER ON FACE AFTER 1 WK OF RECEIVING SMALLPOX VACCINATION.
Red itchy irritation at injection site, no treatment needed.  It went away after two days.
Headache, NauseaVomiting, Bradycardia,  fatigue Narrative:
body ache and pain (chest, back and arms); joint  and hip ache; back and side of neck ache; nausea a;  chills; lethargy and tiredness; mild forehead fever.
4/11/21 - extreme vertigo with nausea; Epley maneuver helped but  took all day before I could walk. Continued to do Epley daily for both sides and only started to dissipate on late on 4/18/21.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 25-FEB-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
This spontaneous report was received from a certified medical assistant and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of improperly stored M-M-R II injection, lot # L026553, expiration date 16-JUL-2017 (albumin status, dose, route and site of administration were not reported). No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion at 47.1 degrees Fahrenheit for 11 minutes. Data logger was involved. There were no previous temperature excursions. Product quality complaint was not involved. No additional information was available. Additional information has been requested.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Medium, Additional Details: patient is experient under arm lymph node swelling and painful.  Patient is under to resume normal activities after 3 days.  He will follow up with MD after one more day of taken advil or motrin.
Patient was administered a full dose of the Moderna vaccine in error instead of the intended booster (half dose). Patient is not experiencing any side effects as a result of this over administration.
5  hours after injection fever started, chills, sweats, body aches allover, headache all of this ebb and flowed over  7 days.  Max temp 104.  Called nurse hotline was advised to go to emergency room.  Fever broke that afternoon. Following three weeks I simply could not muster much energy.  Sleeping 9 to 12 hours per day and quite exhausted.  Reported this to the doctor who took a blood test and found my cortisol level was dangerously low.  Went to a specialist ASAP. Doctor and she ran several test eventually telling me I had adrenal dysfunction but could not ID the cause.  Eventually 1 month later I felt better.
One week after vaccine developed fever, rash starting on face & moving down to trunk and arms. Fever of up to 101.6 (R) lasted 6 days & rash started to fade on 6th day. Had stomach upset, diarrhea, rhinitis & sore throat also.
9/03 injection given in afternoon woke up @ 03:30 (AM) after rolling over in bed - deltoid swollen very sore noticed redness. By following afternoon (9-4-09) redness over entire deltoid with increased swelling - redness almost to mid arm in onto inner aspect (L). T 99.4 achy & fatigue x 3 days.
COVID 19 Treatment; COVID 19 Treatment; Dose #1, #2, #3: Moderna/Dose #4: Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 037K20A), in left arm, on 05Feb2021 as dose 2, single (Lot number: 012M20A), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 076C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Oct2022, outcome "recovered", described as "Dose #1, #2, #3: Moderna/Dose #4: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 25Aug2023 to 29Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300292559 same patient, different drug/event;
Rash around eyes and forehand. Erythematous papular rash to thighs bilaterally. (2/5/02 AM)
Feeling terrible; Body was shaking from chills aggressively; Fever; Joint pain; Fatigue; Headache; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling terrible), TREMOR (Body was shaking from chills aggressively), PYREXIA (Fever), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) in a 78-year-old female patient 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 14-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling terrible) and TREMOR (Body was shaking from chills aggressively). At the time of the report, FEELING ABNORMAL (Feeling terrible), TREMOR (Body was shaking from chills aggressively), PYREXIA (Fever), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment drug administered included acetaminophen, ondansetron and icy hot.; Sender's Comments: 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.
During the afternoon feeding, the infant had an episode in which he paused in his breathing, had his eyes rolled back in his head, became somewhat pallid and limp.  Mother rubbed the patients stomach and responded within 1 minute to normalcy.  While waiting for EMS to arrive the patient had another episode lasting two minutes.
Case number PHEH2013US016334 is an initial spontaneous report received from a medical assistant on 30 Jul 2013 and a follow up report from the medical assistant received on 20 Aug 2013. This report refers to an 11-year-old male child. He was vaccinated with MENVEO, (batch number: unknown) at a dose of 0.5 ml intramuscularly in the arm on 17 Jul 2013 (at 9:15 am). On the same date, after vaccination he experienced localized red reaction at injection site, which later became as red swollen arm. On 20 Jul 2013, he recovered from the event. The event was reported as non serious. The causality assessment of the event was not reported. Follow up report from the medical assistant received on 20 Aug 2013: The vaccination site and date, event (red swollen arm), start date and outcome of the event and seriousness of the event were updated.
pt recv vax & exp severe local rxn associated w/fever, nausea & abd cramps; approx 5MAY94, sx had completely resolved; No further details were provided;
Pt observed swelling of (R) upper arm - elbow to shoulder day following vaccination, remained swollen x 2 wks mid Feb developed severe URI symptom: fever, cough, nasal cong. Treated 2/24/13 with AUGMENTIN. 3/1 significant (L) sided mid back pain wrapping to (L) chest seen 3/4 urgent care & treated for shingles. Visible light rash, no vesicles (L) lower thoracic.
PATIENT PASSED OUT  5-7 MINUTES AFTER GETTING VACCINES.  SHE WAS ASKED TO SIT ON CHAIR WITH LEGS RAISED AND OFFERED WATER TO SIP. SHE STARTED FEELING BETTER IN ABOUT 5 MINUTES. PATIENT WAS FEELING FINE UPON CHECKING UP ON HER IN COUPLE HOURS.
Chills, shivering when I laid down to go to bed. About 20 minutes.  Woke in the middle of the night feeling extremely dehydrated - despite drinking about 32 oz. before bed and about 48 oz over the course of the day post shot.  Fever in the morning. 100.5 upon waking.
Patient died abruptly May 2, 2022. She was 54 years old. Her mother lived to be 83. Mother survived Covid in 2021.   I don't know what vaccine patient had. I think it was Pfizer. Double vaxxed and boosted.
This case was reported by a pharmacist on behalf of a physician and described the occurrence of autism in a subject of unspecified age and gender who was vaccinated with Pediarix (GlaxoSmithKline).  On unspecified dates in 2006, the subject received unspecified number of doses of Pediarix vaccine.  At an unspecified time recently, the subject was diagnosed with autism.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the event was unspecified.
Cannot lift right arm- weakness in right upper arm- very painful and limited abduction of right upper arm Felt like she was Wandering last night after the vaccine   Motor: No weakness elsewhere except right upper arm.. Normal tone, power except for right upper arm unable to abduct, no shoulder deformity- tenderness present around injection site over the deltoid - no hematoma or swelling at injection site, can cross right arm across chest; cannot perform internal rotation of the right arm - using left arm to help abduct right upper arm.        Gait: Gait normal.
Information has been received from a physician concerning a 22 year old female who in October 2006, was vaccinated with the first dose of Gardasil. There was no concomitant medication. In December 2006, the patient was vaccinated with the second dose of Gardasil. The patient experienced injection site pain. Five days later, she experienced flu like symptoms and unsteadiness. Subsequently, the patient recovered from injection site pain. The flu like symptoms resolved after 7 days. The patient's unsteadiness lasted for 14 days. No lab testing was performed. Additional information has been requested.
10 x 10cm round, warm, red area (L) arm. 2 x 2cm round, warm, red area (R) arm.
Pt. and parents confirmed eating breakfast before visit. Granola bar and bag of cookies and juice given to pt. prior to vaccine admin. Patient is waiting room for monitoring after immunizations. 920AM mom informed front desk that pt was not feeling well. In exam room pt stated felt nauseous, 'saw different colors' and per mom pt looked "green" and pale. Pt had stated felt better. Juice box was already given. Examined by MD no loss of consciousness cleared for discharge 925AM.
patient was sicker; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional (Patient).  This case involves patient (unknown demography) who was sicker (illness), while the patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sicker (illness) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Red itchy the size of an egg on injection sight.  Feels warm. No fever.  Started shortly after getting injection.  Still is red and itchy.
8:45 AM Gave MMR. 8:50 AM Complained of shortness of breath, has rash, whelps on arms, throat and chest. 8:55 AM Called Dr. Order given Benadryl 50 mg IM now, called ambulance (911) complained of difficulty swallowing. 9 AM Benadryl 50 mg IM given right deltoid. 9:05 AM Rash disappearing, states "throat better, not as tight, can now breathe, better. 9:09 AM Ambulance arrived. Dr arrived, ordered Solu-Medrol 125 mg IM. 9:10 AM left with paramedics, they are to administer Solu-Medrol 150 mg.
Introduction: Good's syndrome was a rare association with thymoma and acquired immunodeficiency. Selective IgM deficiency was very rare and usually accompanies malignancies or auto immune conditions. Lichen planus was a chronic inflammatory mucocutaneous disease with autoimmunity as a possible underlying mechanism. We report a case of Good's syndrome characterized by thymoma, lichen planus and a selective IgM deficiency. Case Report: A 49 year old male presented with a lichen planus on his tongue. A few months later, he presented again complaining of a dry cough and vague chest discomfort that had worsened over the previous 3 weeks. His chest x-ray revealed a large mediastinal mass. A chest CT confirmed the finding with a high degree of suspicion for a thymus malignancy. The patient underwent a sternotomy with complete thymectomy. Biopsy was consistent with a B1 thymoma. Shortly after his thymectomy and over the following two years, the patient suffered from recurrent otitis media, sinusitis, pneumonias and onychomycosis. Lab work showed markedly decreased IgM level at <4 mg/dL and CD 19 cell count at 2/uL. However, his IgG, IgA, CD4, and CDS were within normal limits. His IgG level was retained at normal level despite low level of IgM. His post PNEUMOVAX 23 were not in the protective range. Antibodies to candida and tetanus were undetectable but protective for diphtheria. His HIV test was negative. The patient was then started on IVIG. He was reassessed 6 months later and reported that he was doing very well with no recurrence of any infections. He also noted a slight improvement of his oral lichen planus. Conclusion: The incidence of immunodeficiency of thymoma patients ranges between 6-11%. It was recommended for all patient's with a thymoma to check immunoglobulin levels and B and T cell subsets at the time of diagnosis and every other year thereafter. Despite a successful thymectomy, most Good's syndrome patients would retain their immunodeficiency status and require life-long treatment and monitoring. Additional information has been requested.