chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a physician on 29 Dec 2009: The patient received S-OIV FLUVIRIN, 0.5 ml, intramuscularly on 21 Dec 2009. The patient was concomitantly administered with LEVAQUIN as a prophylaxis for infection. The patient experienced flushing on 22 Dec 2009. The patient also experienced coughing, chest discomfort, diaphoresis, arthralgia, myalgia in her lower extremities/bilateral myalgia in his calves on 25 Dec 2009. It was reported that, the symptoms dissipated and returned to work on 28 Dec 2009. The patient visited his physician and found that his lungs were clear and had nasal congestion on 29 Dec 2009. The patient was then treated with post nasal drip. The patient was advised to continued LEVAQUIN for another three more days (dates unspecified). The outcome the event was reported as condition unchanged.
Right complete facial paralysis, lagophthalmos, articulation difficulties, oral incompetence with liquids, with facial rash
Pt recvd vax & exp pain in shoulder & rib cage 5 days later; pt also devel a fever 7 days p/inject which lasted for 5 days;
18 months old pt received an adult dose of Havrix; 18 months old pt received an adult dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 18-month-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2022, the patient received Havrix 1 ml and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received an adult dose of Havrix at the age of 18 months by mistake which led to adult product administered to child and overdose. The reporter consented to follow up was granted.
Auto-immune encephalitis; It effects your memory; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS AUTOIMMUNE (Auto-immune encephalitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENCEPHALITIS AUTOIMMUNE (Auto-immune encephalitis) (seriousness criteria hospitalization and medically significant) and MEMORY IMPAIRMENT (It effects your memory). The patient was hospitalized on sometime in March 2021 due to ENCEPHALITIS AUTOIMMUNE. At the time of the report, ENCEPHALITIS AUTOIMMUNE (Auto-immune encephalitis) and MEMORY IMPAIRMENT (It effects your memory) outcome was unknown.            Additional concomitant medication included unspecified hypertension medication.  Patient had the Moderna vaccine in January and February and ended up with auto immune disease. Patient was admitted to hospital in March for three weeks and was diagnosed with autoimmune encephalitis. Patient stated it affects the memory. Patient was on medical leave from work at the time of this report. Patient's neurologist recommended her to get the third dose. Patient declined to provide further medications due to having memory issue. Treatment medication was not provided by the reporter.  Company comment: This case concerns a 61-year-old, female patient with previous relevant medical history of hypertension, who experienced the unexpected event of encephalitis autoimmune. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-337939 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, female patient with previous relevant medical history of hypertension, who experienced the unexpected event of encephalitis autoimmune. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient first dose was with Phizer and got 2nd dose of vaccine with MODERNA  on day 05/06/2021
Injection site was hot to touch; Itching around the injection site; Redness around the injection site; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Tenderness). The patient was treated with CORTISONE (topical) for Adverse event following immunisation, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE ERYTHEMA (Redness around the injection site), VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. In addition to cortisone cream patient reported using cold compresses to help with adverse events following vaccination.
Fever; Severe chills; Severe body aches; Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587), via an unspecified route of administration in the left arm on 18Sep2021 at 12:30 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183), via an unspecified route of administration in the left arm on 28Aug2021 at 10:15 (at the age of 15-years-old) as a single dose for COVID-19 immunisation.  On 18Sep2021 at 21:30, the patient experienced fever, severe chills, severe body aches and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL), heating pad, fluids and rest from unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, severe chills, severe body aches and severe headache was not resolved at the time of this report.
Tingling; Numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given the Janssen Covid 19 vaccine on 4/7/21 around 11:55am in her left deltoid. She was accompanied by her husband at the clinic. After the immunization she was seated in the waiting area to be observed for 30 minutes after her vaccine. Approx. 5 mins after the vaccine was given, the patient passed out in the chair and I (the pharmacist) was alerted. The patient came back to when I arrived at her seat and was able to talk and asked for water. Her husband stayed by her side while I went to obtain water and I heard her husband say she passed out again and then regained consciousness. He layed her on the floor while I called 911. An ambulance came and took the patient to the hospital.
1430 PATIENT  EXPERIENCED A VASOVAGAL SYNCOPE RESPONSE.   VS DONE INDICATED PATIENT HAD A HEART RATE IN THE 30'S.   AFTER A FEW MINUTES PATIENT RECOVERED.
she tested positive for covid after first dose; she tested positive for covid after first dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for Covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient tested positive for covid after first dose in Jan2021 with outcome of unknown. Second dose scheduled for Saturday. She was in quarantine for two weeks. She would like to know if she should get second dose or not. The patient underwent lab tests and procedures which included covid 19 test: positive in Jan2021. Serious: No.  Information about batch/lot number has been requested.
Pfizer vaccine was not removed from the freezer at the 14 day cutoff when it is supposed to be moved to warmer fridge temperature. THis vaccine was kept in the freezer and thawed at the 19 day mark. The vaccine does not have stability datat published after 17 days, but was not yet expired or out of freezer temperature at any time other than to thaw.
High heart rate. Went up to 158 bpm. Severe body aching and fatigue. Nausea.
After vaccine was administered it was discovered that the punctured vial was the day before vial. Contacted vaccine committee who directed me to reach out to Pfizer. Pfizer provided me with data to support inadvertent excursions to the labeled storage for vaccine in Punctured vials and or syringes. Within the supported 24 hours post puncture at 2 degrees Celsius and 30 degrees Celsius
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the influenza-like symptoms was recovering/resolving. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX on an unknown arm. The patient experienced sore arm, which lasted for a couple of days. The soreness reducing with each day. The patient states that most recently, her arm was tender to touch. The patient had flu symptoms, that are recovered 85 to 90 percent. The patient did not consent to follow up with physician. This is 1 of the 2 cases reported by the same reporter.
Started about 8 days after the vacination.  First looked like a rash on legs then arms.  It became like water blisters and weeped.  Left after days scabs, some there.  It burned a lot and itched.  It is more prevalent on skin that is exposed.
A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a registered nurse/health professional concerning a 33-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
had seizure 1 day following DTP 2 minutes tonic clonic; poss structural abnormality of the central nervous system; findings are compatible with, but not diagnostic, of an epileptic disorder, & suggest the presence of an asymmetry, abn brain
Dry cough -> nausea, vomiting & diarrhea, "clammy skin". Next morning -> headache & weakness.
One week after 1st dose of HIB vaccine, patient got ITP (Ideopathic purpura). She required an emergency dose of immunoglobulin as her blood count went down to 3,000 platelets.
This spontaneous report as received from a licensed practical nurse refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that on unknown dates, the patients were vaccinated with the improperly stored doses of PEDVAXHIB (lot # K011077 with expiration date 30-MAR-2017 and lot # reported as L042257 with expiration date 17-AUG-2018; dose, frequency and route of administration were not reported). The vaccine was stored in 32.9 F for 96 hours. No previous temperature was reported. No adverse effects were reported. Additional information has been requested.
Severe body aches, constant headache, nausea, sore throat, cough, fever, congestion, diarrhea, hives & swelling of Eurasia and lips
Patient is a 84 y.o. male past medical history of severe aortic stenosis, COPD who presented from home on 5/3/2023 with 1 day of fever, altered mental status and subsequently tested positive for COVID-19.  Patient noted to have delta positive troponins and hypoxia   Acute Hypoxic Respiratory Failure -Due to COVID-19 infection with suspected viral pneumonia -No evidence of PE on CTPA -Clinically does not appear volume overloaded on admission.  Viral pneumonia COVID-19 Infection - Presented with: lethargy, fever - Symptom onset: 5/3 - Positive COVID-19: 5/4/23 at facility - Vaccination status: yes - CXR on admission showed bibasilar infiltrates - Oxygen status: 2L NC  - PO Decadron for 10 days total - Seen by Pulmonology   - Treated with Remdesivir x3 days hererecommended by Pulm   Elevated troponin -Possibly demand ischemia from hypoxia, and infection.  No chest pain, syncope, dyspnea noted.   -Troponin 52-- >92  - CTPA show pneumonia - Seen by Cardiology (Dr) - TTE show EF45-50%, mod/severe AR, pulm htn - Recommend close outpatient f/u with Cardiology (follows with Dr)   Acute Metabolic Encephalopathy - Mild, waxing/waning - Likely multifactorial due to covid infection, hospital delerium - Nonfocal neuro exam - CT head non-acute - Resolved   COPD -Per history.  No wheezing appreciated during my exam though noted by EMS and while in the emergency department. -PFTs 4/2023: Moderate to severe obstructive disease, normal DLCO -Patient has been initiated on steroids for COVID-pneumonia as above which would also provide management for COPD -Continue home bronchodilator regimen -Follows with pulmonary, Dr.    Severe Aortic Stenosis Bicuspid AV Thoracic Aortic Aneurysm -Does not appear volume overloaded on admission -TTE 5/22: EF 56%, severe AS with AVA 0.7, mean gradient 39, mild to moderate MR, RVSP 59 -BNP 10,500 -TTE ordered -Resume home beta-blocker -Patient undergoing work-up for possible TAVR and is due for repeat echo. Follows with cardio, Dr    HTN -Continue home Lopressor, ACE inhibitor -No leukocytosis -CXR: Mild bilateral lower lung infiltrates vs. Edema, trace bilateral pleural effusions -CTPA with premedication for contrast allergy ordered -Decadron for COVID infection -Hypoxic on room air, currently with adequate oxygenation on 2 L nasal cannula   V
I  initially felt fine after the injection. Approximately 15 minutes after receiving the vaccine I felt pain in my left arm then felt nausea, light -headedness ,dizziness nearly syncope. I did not pass out. I recovered with in 10-15minutes. I had no respiratory symptoms and no rash or swelling. I was taken to the  ER and released shortly after. I had no other symptoms aside from a mildly sore arm for a day. I have had no subsequent symptoms.
Client received astrazeneca covid vaccine, no reaction. Previous vaccine unavailable, Janssen given as an alternative 9.15.2021.
On the morning of Sunday, June 6, 2021, I woke up with dull pain in the center of my chest (right where the sternum is). My mother took me to urgent care. A doctor there did an EKG with came back slightly abnormal, and she recommended I go to the emergency room. The doctors there ran a few tests. By about noon or so, my chest pain had subsided and has since not returned. My only abnormal test was troponin. After the first troponin test, I was transferred from the ER to an observation area. After the fourth troponin test, Dr. ordered an angiogram. The angiogram occurred on June 8, 2021, at around 5:00 pm or 6:00 pm. It revealed no signs of damage or inflammation. I was discharged from the hospital the morning of June 9, 2021. Since then, I had a follow-up with my primary care provider, on June 15, 2021, and with the Dr. on June 23, 2021. Neither of them detected anything wrong with my heart. To summarize, I went to the hospital with chest pain that subsided quickly and has not returned since, and I remained in the hospital with elevated troponin.
given half of adult dose to substitute for pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a 13-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th April 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the Havrix adult dose was halved and given to the pediatric patient, which led wrong technique in product usage process. The reporter asked if this dose was valid dose and how to proceed further. No other information was provided. The reporter consented to follow up. This case is linked with US2021090127, by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090127:Same reporter. Patient 1 of 2.
pt says the day after taking the vax she had diarhea and irregular heartbeats.  She continued to have irregular heartbeats daily.  Pt contacted her PCP and she was sent to hospital on 3/25/21 to get a Heart Monitor.   She was having irregular heartbeats every couple of minutes. She continued to have these symptoms.  She became dizzy and lightheaded and unlocked front door and laid down in case she needed to call 911.  A couple of days later her heart was racing, skipping beats, and pounding.  She thought she was having a heart attack.  She went to hospital on 5/13/21.  they did a 12 lead, CT, Covid test, lab work.  She was admitted was for 24 observation.
Narrative: 84yo elderly male patient with Hx of T2DM 35-40 +retinopathy +neuropathy, HTN >20 years, HLD, hypothyroidism, anemia and renal disease diagnosed on 9/30/2021. Pt died of unknown causes on 10/14/2021 outside of hospital. No information on cause or place of pt's death. Pt had received covid vaccines on 1/28/21 & 2/23/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Myalgia, NauseaVomiting, Fatigue Narrative:  Off work x 2 days
Breakthrough case admission after 4 vaccines  Moderna 2/28/21 Lot# 025A21A;  Moderna 3/27/21 Lot# 016B21A;  Moderna 10/2/21 Lot# 039D21A;  Moderna 4/26/22 Lot # 056A22A
pt recv vax & 30 days later became pregnant;AFP levels at gestation wk 17 were noted to be elevated;amniocentesis indicated down's synd;pregnancy was terminated @ 18wk;father had hodgkin's disease w/poss x-ray tx;
No additional AE/PQQQC reported.; HCP calling to report an AE regarding the PROQUAD vaccine. HCP reported that the PROQUAD vaccine was administered to a unknown adult patient. HCP provided limited demographic data. Permission was not provided to contact the HCP. Request case 02480129; This spontaneous report was received from Pharmacist and refers to an adult patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml/ 1st dose, lot #X007358, expiration date: 09-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, HCP called to report an AE regarding the PROQUAD vaccine. HCP reported that the PROQUAD vaccine was administered to a unknown adult patient. HCP provided limited demographic data. Permission was not provided to contact the HCP. Request case 02480129 filed. No additional AE/PQQQC reported.  Lot Number X007358 is valid.
Atrial fibrillation, onset of palpitations 13-14 hours after vaccination, managed with diltiazem with resolution.