chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 16-JUL-2013, lot # reported as 1459AA expiration date: 22-AUG-2014. No adverse event was reported. This is one of the reports from the same source. Lot # 1459AA is an invalid lot # for GARDASIL. Additional information is not expected.
Developed nasal stuffiness in one week, followed by development of nasal hemangioma requiring removal as an outpatient
My last booster shot on 9/15/22 caused me to get a shooting pain on the outside of my lower left leg that came and went. It was very painful and on the same side I got my booster shot, left side. It seemed to happen randomly  and started the same night I got the booster but then started to happen more frequently the next day. At one point I was having them every 2-3 minutes. It was terrible. I took pain killers for about 24 hours and it finally went away.
Severe Nystagmus, dizziness, loss of vision, Increased blood pressure (symptoms started at 9:30) Taken by Ambulance to hospital for stroke evaluation which was clear. Symptoms started resolving while in ED Department. Work up given including Neurology consult. Discharged approximately 8 hours later.  Still currently having issues with imbalance and general just not feeling well.
Vaccine administered at 1550. At 1608, team lead was called into observation area by school nurse. Patient looked flushed, was shaking, and stated that her tongue felt swollen. Patient was able to speak in full sentences and no shortness of breath. Vitals were taken at 1610: BP 170/100, HR 120, RR 22, SPO2 100% on rom air. Patient had her own epi-pen which she administered in left leg without recommendation by the clinicians on site.  EMS was contacted and patient was transported to nearest hospital.
heart started to flutter/tossing and turning in bed; fast heart beat/135 beats per minute; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER and HEART RATE INCREASED in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced CARDIAC FLUTTER and HEART RATE INCREASED. On 16-Apr-2021, CARDIAC FLUTTER and HEART RATE INCREASED had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 15-Apr-2021, Electrocardiogram: results not reported results not reported. On 15-Apr-2021, Heart rate: 135 (High) beats per minutes.         No concomitant medications were reported.  No treatment medications were reported.  Reported that he had no symptoms with receiving the first dose of the vaccine. Within 30-40 minutes after receiving the second dose of the vaccine he felt like he had drunk a lot of cups of coffee. That evening patient's heart had started to flutter, he was lying down, tossing and turning in bed. He looked up his symptoms online and went to the emergency room. While in the ER his heart was monitored and he received an EKG. His heart rate got up to 135 beats per minutes. They discharged him home. His rapid heart rate returned to normal approximately 24 hours after receiving the vaccine.  This spontaneous case concerns a 44-year-old male patient, with no medical history provided, who experienced the non-serious AESI of CARDIAC FLUTTER. The event occurred on the same day after receiving the second dose of mRNA-1273 and has recovered by the time of this report. The rechallenge is not applicable since no information about further dosing has been provided. Patient states that on vaccination day, his heart started to flutter so he went to the Emergency Room were an electrocardiogram was performed, but no results have been provided at this time. He also experienced increased heartbeat. No further information was provided. The benefit-risk relationship of mRNa-1273 is not affected by this report.    He believes he had covid-19 in February or March 2020 where he quarantined himself in a room for 40 days. He slept 18 hours a day, had a fever of 101, his chest was inflamed and burning, he was coughing up blood, and in and out of sickness. He was tested for RSV, flu, covid, and other illness but there was never an official covid-19 diagnosis. He has never been previously diagnosed with myocarditis or pericarditis in the past.
Severe fatigue, one episode of dizziness, edema of the right deltoid and fever.
18MAY93 nausea, severe leg cramps radiating into groin 18MAY & 19MAY felt strange from waist down; 21MAY93 rash, facial & body edema 26MAY93 recovered;
Follow-up was requested on this cluster and information was received for one of the vaccine recipients (unclear if additional patients were involved) on 22 February 2008 from the original reporter who is a health care professional. This case will be the case of reference for that patient who is a 44-year-old female patient, who had no concurrent illnesses, or pre-existing medical history, and who had received an intramuscular dose of FLUZONE 2007-2008 (lot number U2529AA) on 14 November 2007. The time of vaccination was unknown, and the site of administration of the Fluzone vaccine was not reported. That night following vaccination, the patient woke up "felt warmness in her face" and self medicated with Tylenol. The following morning, the patient's face was swollen and red, and she self medicated with two Benadryl. The symptoms did not resolve and she presented to the emergency room with itching in her arms and a rash on her face. She was treated with Zyrtec and Prednisone. Final diagnosis was not provided. At the time of this report, the patient had recovered. After medical review of this case, the case was upgraded to serious.
None stated. 11/30/09 Death Certificate Received. DOD 10/03/2009. Final Cause of Death: Acute Methadone Toxicity. Additional Information - Underlying conditions: Constrictive Atherosclerotic Artery Disease.
This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 22-JUL-2013 pediatric patient was vaccinated with primary dose of VAQTA dose 0.5 ml, route intramuscular. The nurse reported that a pediatric patient required a booster dose of VAQTA 5 months after the primary dose of VAQTA on 17-DEC-2013. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Hard for him to sleep; Chills at night; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills at night and hard for him to sleep/poor quality sleep.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 20 Mar 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced chills at night and it was hard for him to sleep. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events chills at night and hard for him to sleep was not reported.
PER PATINET, AWOKE OVERNIGHT WITH HEART PALPITATIONS/MILD CHEST PAIN THAT HAS CONTINUED TO PRESENT TIME
4/16/2022 PM-Present to ED via EMS from group home, c/o SOB, congestion and chest pain. Hypoxic on RA 87% that improved to 95% on 4L NC weaned to 2L. No oxygen use baseline. R Covid + test.  D-Dimer 714. CXR:patchy linear opacities within both lung bases atelectasis. Admit acute hypoxic respiratory failure Covid. Zosyn and dose given. Start Decadron and azithromycin, .  4/17/2022-Chest CT : moderate size pericardial effusion. Start Doxy , remdesivir and ceftriaxone. Increase need for 02 to 6L NC o2 sat 88-92%.  4/18/2022- O2 sat low to mid 80's on 6L. Bubble bottle applied, o2 increased to 8L no improvement in sat. Placed on NRB at 15 LPM o2 sat increase to 97% Chest PT ordered . On bipap at night 12/6 50% sats mai 4/18/2022- sats maintained at 80-90's.  4/19/2022-D-Dimer 714. Cont. remdesivir and decadron. Start Rocephin and doxy . Having periods on 30L high flow. 4/21/2022- D Dimer 365 4/24/2022- O2 titrated down to 7L nc, VSS.  4/28/2022- Alternating between 10-12L o2 NC. Cont resp distress, non productive cough.Currently on Rocephin, Doxy, Flagyl, Dulera and duoneb, CXR-scateered atelectasis at the bases, right side appears mildly improved.  5/2/2022-Bipap at HS, titrate down from 10 L to 4 L NC. 5/3/2022-wbc 9.9 5/10/2022- Weaned to 2L nc, unable to titrate off. Completed antibiotics. labs improved, D/C home.
fainted; rash; died 2 weeks ago after receiving the covid vaccine/ passed away;This is a spontaneous report received from a non-contactable consumer reporting on behalf of the patient via a Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first and second dose, both via unspecified route of administration on unspecified dates (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter mentioned that she had a friend that died 2 weeks ago after receiving the COVID vaccine. They are going to search for the cause of death (autopsy) because after the vaccine she had a rash, fainted, and went to the hospital, and she recovered (unspecified dates). But after a month or so, she passed away. The reporter mentioned that the patient was born very unhealthy person.  Outcome of rash and fainted was recovered on unspecified dates. The patient died in Apr2021.  It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died 2 weeks ago after receiving the covid vaccine/ passed away
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over) and PRURITUS (his entire body was itching) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported.). Concurrent medical conditions included Cholesterol and Heart disease, unspecified. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Itching all over). On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (his entire body was itching). At the time of the report, PRURITUS (Itching all over) outcome was unknown and PRURITUS (his entire body was itching) had not resolved.            Treatment information included Lotion,Rubbing alcohol. Concomitant med also include: Blood thinners and heart medicine   This case was linked to MOD-2021-018398 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
I had vaccination on 01/18/2023. On 05/13/2023 I started to experience severe vertigo. I went to the emergency room and I had a Angiogram CT Scan and blood panel. I have an MRI scheduled for 05/23/2023. I am still presently suffering from the vertigo on 05/18/2023. I was prescribed Meclizine and antibiotics with Zofran.
I woke up Sunday morning and had a sore throat. I started having chills and achy bones. Later that day, I had a fever and I started with the runny nose. A cough developed after. I started taking Tylenol and the next day, I still had a fever, cough, runny nose, sore throat, and the achy bones had ceased. I took some cough medicine for the cough as well as Tylenol and fluids. I was then prescribed Paxlovid from my PCP. Monday night I started taking that medication and took it yesterday and today. I still have 3 days left. I took some Vitamin C and Zinc as well, and Mucinex. I took the DM Max and the PM Mucinex. I still have a slight cough and runny nose. Other than that, I don't have any more symptoms.
Breast soreness for three weeks; Menstrual cycle began on 5/18/21. I have not had a cycle since 2019.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: EW0161) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2019 (unspecified if ongoing); "high cholesterol", start date: 2019 (unspecified if ongoing); "Sulfanamide allergy", start date: 2019 (unspecified if ongoing). Concomitant medication(s) included: TRIAMTEREEN; ROSUVASTATIN; AMLODIPINE BESILATE; TRIAMCINOLON COMPO. Past drug history included: Daypro, reaction(s): "Drug allergy"; Gluten, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (dose_number=1,, vaccine_location=Left arm, lot_number=EN6203,), administration date: 23Mar2021, for Covid-19 immunization. The following information was reported: BREAST PAIN (non-serious) with onset 18May2021, outcome "recovering", described as "Breast soreness for three weeks"; MENSTRUAL DISORDER (non-serious) with onset 18May2021, outcome "recovering", described as "Menstrual cycle began on 5/18/21. I have not had a cycle since 2019.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast pain, menstrual disorder.  Additional information: It was reported that, patient had breast soreness for three weeks. Menstrual cycle began on 18May2021. She have not had a cycle since 2019. Patient did not receive any other vaccines within 4 weeks prior and received other specified medications 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted within one minute of receiving vaccine. He was monitored and asked to lay down flat on floor with feet elevated on chair. He immediately regained consciousness and was okay after some observation and fluids.
Myalgia Narrative:  Per nursing report: "received second dose 2/11/2021-reports body aches [2/12]"  Other Relevant History:
I'm having flu like symptoms; headache; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A male patient of an unspecified age (reported as 43, no unit) received the first dose of BNT 162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient is having flu like symptoms and had a headache. The patient was asking if he can take Dayquil or ibuprofen, and will it affect the vaccine at all? The outcome of the events was unknown.   Information on the lot/batch number has been requested.
The first AE was simple and was the next day--headache/malaise with a possible facial droop (and right side of my face felt funny) that resolved in 24 hours with 600mg of ibuprofen. I did Zoom with a neurologist who checked up on me later and by then I felt better.  What I want to report is that I got a GIANT HIVE exactly one week later at the injection site--raised, white, itchy, indurated, with satellite hives and surrounding erythema. I am a doctor and called an allergist colleague and did FT who concurred it looked like a histamine reaction..  I took 20mg Zyrtec and 400mg ibuprofen.  It looked much better the next day.  Now it is just red and flat--about 8.5 x 5.5 cm.  I have great pictures.  Very strange that the injection site was fine and then I got this reaction there.
Patient reported head pressure shortly after vaccine admin, observed for 30 mins, resolved at time of discharge from clinic.
Erythema at the injection site; Tenderness/Pain at the injection site; Weakness; Internal fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE ERYTHEMA (Erythema at the injection site), INJECTION SITE PAIN (Tenderness/Pain at the injection site), ASTHENIA (Weakness), PYREXIA (Internal fever) and CHILLS (Chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D11J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Seafood allergy and Drug intolerance.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Erythema at the injection site), INJECTION SITE PAIN (Tenderness/Pain at the injection site), ASTHENIA (Weakness), PYREXIA (Internal fever) and CHILLS (Chills). At the time of the report, INJECTION SITE ERYTHEMA (Erythema at the injection site), INJECTION SITE PAIN (Tenderness/Pain at the injection site), ASTHENIA (Weakness), PYREXIA (Internal fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol.; 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.
received an expired dose of FLUZONE; headache; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case involves a 29 years old female patient who experienced headache and received an expired dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (Menactra) for Prophylactic vaccination.  On 24-Oct-2023, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved [fluzone] suspension for injection (lot- U8096AA and expiration date- 30-Jun-2023) via intramuscular route in the left arm (dose, strength: not provided) for Immunisation (expired product administered) (latency- same day)  On an unknown date in Oct- 2023 the patient developed headache (unknown latency) following the administration of   Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events (headache).  At time of reporting, the outcome was Recovered / Resolved in 2023 for the event headache and was Unknown for the event received an expired dose of fluzone.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
neuropathy / following administration of Shingrix; Radiating Nerve Pain arm on injection arm; This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hyperparathyroidism. Concurrent medical conditions included osteoporosis.   On 1st February 2021, the patient received Shingrix. On 1st February 2021, less than a day after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and nerve pain. On an unknown date, the outcome of the neuropathy and nerve pain were unknown.   It was unknown if the reporter considered the neuropathy to be related to Shingrix. The reporter considered the nerve pain to be unrelated to Shingrix.  Additional details were provided as follows: The patient was healthy. The reporter reported neuropathy or nerve pain following administration of Shingrix vaccine. The patient experienced nerve pain that radiated down her arm following Shingrix vaccine. The reporter stated that she did not think that the nerve pain was from the Shingrix vaccine but called to see if there was any additional data about this adverse event. The reporter consented to follow up. Discrepancy: The reaction end date of nerve pain was provided as 26th April 2021 (which was also report date), however reaction outcome was marked as unknown, hence the outcome was captured as unknown.
Patient received second dose of Pfizer vaccine 9/14. On 9/15, patient began to notice dark urine. On 9/25 patient reported feeling "off", hungrier than normal, sleep disturbances with frequent need for naps. On 9/30 patient began feeling dizzy. By 10/2 patient had continued feeling low energy, nauseas, poor appetite. 10/3 patient noticed her stool looked pale.  Patient presented to hospital on 10/4 and found to have AST/ALT in the 1000s, elevated INR to 1.6, T bilirubin up to 8. Negative hepatitis panels and unremarkable US and CT.  Since 10/4 patient has continued to have sleep disturbance, intermittent abdominal pain, fatigue, dark urine and pale stools. Patient currently still hospitalized and being treated with N-acetylcysteine for drug-induced liver injury.
1. Every night since the vaccine was given, I have woken up soaked in sweat. ( no fever) 6 nights now. 2. Left armpit started hurting 2 days after the vaccine was given on the left arm. 4 days now
(NERVE) PAIN, MUSCLE WEAKNESS IN LEFT ARM WITHIN MINUTES OF INJECTION AND PERSISTING UNTIL PRESENT DATE 1/11/2022
Patient tested positive for Covid19 after being vaccinated with Janseen vaccine EUA 05-23-2021
1wk post inj started w/diffuse red rash plus 3-4 small pox;17 days post inj inc to several fluid containing pox over trunk & extremities;fever & swollen glands;
Information has been received from a pharmacist concerning a 61 year old female with no pertinent medical history, drug reactions or allergies who on 27-JAN-2008 was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX (Lot # 659325/1823U).  There was no concomitant medication.  On 29-JAN-2008, approximately 48 hours post vaccination, the patient developed redness and swelling at the injection site, about 2.5 inches in diameter.  At the time of reporting the patient had not yet recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested.
Patient developed some dizziness after receiving the COVID Vaccine. CAT called to evaluate patient. Dizziness subsided after several minutes. Patient declined to go to ED for Follow-up. Instructed to return to ED if dizziness returns or develops other symptoms.