chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; A patient received doses of Gardasil 9 on 18-FEB-2021, 04-MAY-2021 and 29-JUN-2021; This spontaneous report was received from an officer manager, referring to a 41-year-old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 18-FEB-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot# T008151, expiration date 21-JUN-2022, for prophylaxis (strength, route and frequency were not reported).  On 04-MAY-2021, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot# 1659422 has been verified to be a valid lot number (expiration date not reported, but upon internal validation established as 04-SEP-2022), for prophylaxis (strength, route and frequency were not reported).  On 29-JUN-2021, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot# T027789, expiration date 27-FEB-2023, for prophylaxis (strength, route and frequency were not reported) (inappropriate schedule of product administration). No additional adverse events reported.
High fever, muscle aches and stiffness, nausea, headache l, blurred vision.
pt recv vax 28FEB96 & 01MAR96 pt exp a red rash @ the inj site, which was hot & painful;no further details were provided
Information has been received from a nurse practitioner (NP) concerning a 90-year-old immunocompromized patient with heart failure that resides in a nursing home who was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included an unspecified antibiotic.  It was reported that the patient developed shortness of breath and pulmonary problems following vaccination and required oxygen.  It was unspecified if medical attention was sought.  No further information was available at the time of this report.  No product quality complaint was involved.  Additional information has been received on 15-OCT-2007 from the director of nursing at a nursing home.  She reported that she had "no concerns with the administration of the Zostavax (Oka/Merck) at all particularly because the patient had extensive history and problems prior to receiving the vaccine".  Additional information has been requested.
Initial report received from a consumer, who was the patient, via another manufacturer on 22 April 2011. A 71-year-old female patient with medical history of allergy to pain medicine, received in 1990's an injection (route and site not reported) of TETANUS TOXOID, manufacturer and lot number not reported. The patient reported that "my throat swelled to the point where I could not swallow". The outcome was reported as recovered. No further information was provided. The subjects had another SAE captured in case 2011-02453. Documents held by sender: None.
Seizure while in store, fell backward & gashed head on shelving; transported by ambulance to Medical Center since he was on warfarin for the positive HIT dx & was actively bleeding from his head wound...he was also nonresponsive to questioning by EMT personnel.  Has some sort of red rash all over his face going down toward top of his shoulders, but dr had no idea what caused it (perhaps allergy to bindings they used to tie him down to gurney in ambulance (trying to protect his neck & keep him still as he was very combative in ambulance we were told).
The pt developed red with mild swelling approx 10 cm in diameter on right deltoid injection site area. Advised to give Tylenol or Motrin and apply warm compresses. Child voices no complaint of pain or discomfort, good range of motion.
My entire body turned bright red within a minute of receiving the vaccine. My throat started to close, I immediately started sweating profusely. Store immediately administered 2 doses of Benadryl, followed by another 2, followed by another 4. Epinephrine was given to me to take home. I was put on prednisone and hydroxyzine.
Almost a month later I got a headache, fever, muscle pains, sore throat, and coughing. I had a positive covid test so I quarantined myself at home. I stayed in the room. 1/9/2022 I got another covid test to confirm if I have covid, but I won't be able to get those results back until 1/11/2022. I am still coughing and feel tired.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 14-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Upon internal review, varicella pneumonia was determined to be medically significant. Additional information has been requested.
Admission Date: 8/26/2021   Pending issues/labs/tests: CBC, BMP and INR in 2 days.   Admission Diagnoses: Anemia [D64.9] Anemia of chronic disease [D63.8] Renal dysfunction [N28.9]   Discharge Diagnoses/Hospital course: Patient is a 72-year-old male who was hospitalized for anemia the anemia is progressive decline I will continue to follo On 8/26/2021  4:53 PM.  The patient hemoglobin did trend down on 2 days prior to discharge however the patient's hemoglobin has remained stable on the day of discharge compared to yesterday.  The patient is very anxious to be discharged home.   Patient will have to quarantine 11 days from 8/26-  (September 7 is the day that quarantine ends.)  ASSESSMENT/PLAN: Acute issues: Acute on chronic anemia most likely anemia of chronic disease/end-stage renal disease POA -status post 1 packed red blood cell unit.  Hemoglobin is trending down today did discuss possibility of being discharged tomorrow.   Chronic kidney disease stage V POA -nephrology consulted I do not see any urgent need for dialysis at this time but appreciate assistance.   Asymptomatic Covid positive -patient is not on oxygen he was satting 100% on 2 L and was subsequently weaned off.   DVT prophylaxis - none      Other medical issues: Chronic systolic heart failure, permanent atrial fibrillation, hypertension, COPD, hyperlipidemia and protein calorie malnutrition
Case number PHEH2014US002356 is an initial spontaneous report from the nurse received on 31 JAN 2014. This report refers to a 16-year-old male patient. He was accidentally vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: M12011) intramuscularly without reconstitution with Men A lyophilized component. No adverse event reported following this medication error.
Pt with hx of anaphylactic reaction to several medications. After 30 minutes, pt feels tingling and itchy skin on entire torso.  No hives noted.  No other symptoms.     Actions Taken: Vitals taken at 1722 as follows: 135/82, HR 86, Respirations 14.  O2 sats on RA 95%.  No c/o shortness of breath, throat closing, itchy throat, SOB or stridor.   After 15 minutes, Pt feels the same and no changes for the worse.  Vitals at 1738 as follows 119/68, HR 85. O2 sat 96% on RA.  Pt requests to head home and will take Benadryl upon arrival.     Disposition: PT d/c to home per pt request @ 1820
Mom states a few hours, post vax, child began breaking out with a weepy rash (hives), erythematous with edema. Rash and edema of lips. Was given Benadryl with relief. No difficulty breathing, wheeze, paleness or dizziness. Instructions given to mom. Mom also stated child had eaten grapes.
Fine until 1/22/21. Noticed a pinkish red circle  at the site. of injection .No raised bump or any other markings. A bit warm but not hot to the touch.
Patient "collapsed" in grocery store; CPR initiated, ambulance called & was intubated. MD available - noted pt. to be apneic & bradycardic but responded to epinephrine. Transported to hospital & discharged home next day.
felt horrible; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reported for him/herself. The patient received Shingles vaccine after his/her sister had them. After receiving Shingles vaccine, the patient felt horrible and stated that, it was better than getting shingles. This case had been linked with case US2021AMR241370, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241370:same patient - 2nd dose
Breakthrough case observation admission after three doses Moderna 3/4/21 Lot# 03021A Moderna 4/1/21 Lot# 025b21A Moderna 11/20/21 Lot# 067F21A
Shortly after I had the vaccination, I got dizzy that night. The next morning I was okay, but then  I got really dizzy as the day went on. I went to the doctor to get checked out. I also felt a drum-like beat in my right ear. They gave me Meclizine to help with the dizziness then sent me home. the dizziness went away but I lost 75 percent hearing in my right ear.
extreme fatigue, migraines, muscle aches, shortness of breath all began approximately 16 hours post 1st vaccine.  Shortness of breath and muscle aches continued for approximately 1 month.  Extreme fatigue and migraines persist.
Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands. Treated with Diphenhydramine 12.5 mg IV, Pepcid 20 mg IV, SoluMedrol 125 mg IV, Normal Saline IV solution x 1000 ml
swollen; red; itchy; COVID arm; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen, red, itchy, covid arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event(s) swollen, red, itchy, covid arm.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 11 Feb 2021 the outcome of event(s), swollen, itchy, covid arm was resolved. The outcome of event(s), red was unknown.
Employee reported that approximately one week after she recieved the vaccine that she noticed a red area around the injection site that "itched".  She also noticed a few areas on both arms that she decribed as bumps that looked like insect bites, they too "itched".  She reported no fever and no rash noted on the trunk of her body.
there was a body fluid coming under her arm, on the left side of her chest, it was flapping around; Chills; body aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DISCHARGE (there was a body fluid coming under her arm, on the left side of her chest, it was flapping around), CHILLS (Chills), MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCHARGE (there was a body fluid coming under her arm, on the left side of her chest, it was flapping around), CHILLS (Chills), MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DISCHARGE (there was a body fluid coming under her arm, on the left side of her chest, it was flapping around), CHILLS (Chills), MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            NO Concomitant medication was reported NO treatment medication was reported   This case was linked to MOD-2021-385672 (Patient Link).
right face was swelling up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (right face was swelling up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (right face was swelling up). At the time of the report, SWELLING FACE (right face was swelling up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Wheal developed immediately upon injection. Bleeding from both site and internally as well.  Pressure was held to stop the bleeding. Ice applied to site to help with the swelling  Area marked for size determination.  Checked arm every 15 minutes during the evening.  As of today, still have wheals in two spots and hematoma under the skin as well as tenderness.
This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-JUL-2021, the patient experienced flu-like symptoms, problems with circulation in both legs, difficulty walking, and numbness in both legs. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, problems with circulation in both legs, numbness in both legs, and difficulty walking. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Patient's mother reported that the patient received Acel-Imune, MMR (Merck), and IPV (Aventis Pasteur SA) vaccines on 8/31/99. Subsequently the patient began crying and screaming that lasted for hours. Later that evening, the patient developed a low-grade fever and stiffening of both legs. The stiffening of her legs caused her to awaken that night screaming. The low-grade fever and leg stiffness resolved within 5 days. On 9/5/99, the patient developed head pain. Copies of this report have been forwarded to Merck and Aventis Pasteur, manufacturers of the concomitantly administered vaccines.
8:45 am had this weird taste in mouth 3:00 Pm pain on site of injection
p/ pt recv vax approx 15 days later pt devel maculopapular rash w/40-45 lesions fr waist down & fever of 101f. addl info requested
This spontaneous report was received from a medical assistant and refers to a 12 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, in the left deltoid (LD), lot # M031557, expiration date 07-APR-2019 (exact dose was not reported). She failed to receive second dose according to the schedule. On 16-JUL-2018, almost 18 months after the first dose, she was vaccinated with the second dose of GARDASIL 9 intramuscularly, in the right deltoid (RD), lot # N019104, expiration date 02-MAR-2020 (exact dose was not reported). No adverse effects were reported. No prescription drug treatment was required for the experience. The patient did not receive any other vaccinations within 4 weeks prior the reported vaccines.
pt was given the PEDIATRIC pfizer dose of 0.2ml of the PEDIATRIC Pfizer vaccine. However, pt was 12 years old and should have rec'd the 12+ Pfizer vaccine
patient received Moderna booster at 1422. No issues with first two Moderna vaccines, NKA. Approximately 14:25 patient reported feeling like she was going to pass out. While walking to stretcher, patient felt dizzy and was assisted to the ground.  patient cold, pale, clammy, diaphoretic, reported nausea, no vomiting. patient remained responsive, answered questions appropriately, no loss of consciousness.  Denied chest pain, headache, shortness of breath. Lungs clear with auscultation, respiratory rate 28.  ***   BP 126/81, HR, 54, O2Sat 100% Room air.  ***   Approximately 14:28 Supervising provider arrived. BP 129/109, HR 55, O2Sat 100% RA, RR 22. patient assisted to stretcher, Apple juice given.  ***   14:32  BP 112/70, HR 62, O2Sat 100% RA, RR 24.  ***   14:41  BP 104/69, HR 67, O2Sat 100% RA. Blood glucose 103. patient stated she felt better, provider instructed to have patient remain in clinic until symptoms resolved.  ***   15:03  BP 106/69, HR 60, O2Sat 100% RA, RR 18.  patient stated symptoms completely resolved, returned to baseline. Reviewed S/S to seek urgent medical attention, patient verbalized understanding, left clinic.  ***
About 30 minutes after vaccine she felt like her tongue and throat were itchy and swollen. BENADRYL 25 mg po x 2. EPI 0.3 mg IM x 1.
Pt is currently 28w4d gestation with an EDC: 8/5/2018, pt received TDAP inj in office, pt states that about a couple hours later her arm felt heavy and sore, then as the night went on she noticed a bump at the inj. site, over the next 4 days the injection site had a red wheel around it and increased up to about 4" in diameter, yesterday (Day 3) pt was very fatigued and nauseated, pt called today when she noticed her s/x getting worse a, pt states that the wheel is very hot to the touch, pt was advised to use topical OTC Benadryl cream and ice for relief, if she has trouble breathing pt to go to ER, if her rash cont. to spread pt to see her PCP or Walk-In Urgent care
This spontaneous report was received from a physician regarding a patient of unknown age and unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient developed chickenpox via possible secondary transmission of the varicella virus after a household member was recently administered VARIVAX (Merck) lot/batch, dose, route unknown. Concomitant medications were not reported. On an unknown date, Polymerase chain reaction (PCR) analysis revealed that the specimen contained the wild type varicella zoster virus. The outcome of chicken pox and possible secondary transmission was unknown. Causality assessment was not provided. No product quality complaint (PQC) was reported. Additional information has been requested.
pt recv vax 19JUN97 & 26JUN97 pt devel a mild rash & a sl fever;pt sx were considered poss r/t varicella vax;
Blisters on arms, legs, chest, hands after receiving Shingles Immunization.  Also diarrhea, and upper respiratory congestion.  Blisters continue to surface over past two weeks.  Worried if I can get reoccurring shingles now since this caused an outbreak on my body? I have never had shingles before. Since this is a realatively new immunization, I felt it important to report this negative affect.
irritation on bottom of stomach; felt sick; couldn't eat; couldn't hold anything down; joint pain, pain in shoulder, pain in elbow; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt sick), EATING DISORDER (couldn't eat), VOMITING (couldn't hold anything down), ARTHRALGIA (joint pain, pain in shoulder, pain in elbow) and ABDOMINAL DISCOMFORT (irritation on bottom of stomach) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ILLNESS (felt sick), EATING DISORDER (couldn't eat), VOMITING (couldn't hold anything down) and ARTHRALGIA (joint pain, pain in shoulder, pain in elbow). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (irritation on bottom of stomach). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) ongoing since an unknown date at a dose of 1 dosage form and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ILLNESS (felt sick), EATING DISORDER (couldn't eat), VOMITING (couldn't hold anything down), ARTHRALGIA (joint pain, pain in shoulder, pain in elbow) and ABDOMINAL DISCOMFORT (irritation on bottom of stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal.         No allergies, current illness was reported by patient.  No concomitant medication was reported by patient. Treatment- Water, Percocet, Pedialyte.  Patient reported that he received first vaccine on 1-Apr-2021 and had no symptoms after first dose. patient received second dose on 29-4-2021, he was sick for 3 days after vaccine and symptoms lightened up on 3-May-2021. Patient had a previous injury on his arm, patient visited HCP he was suggested CT scan that came normal. Patient also reported small irritation found on bottom of stomach, HCP confirmed that is common irritation and was not related to vaccine.  Clarification requested from Safety regarding date of the following sentence 3-Apr-2021 symptoms lightened up. Agent spoke to original agent and he clarified that he meant 3-May-2021.   This case was linked to MOD-2021-231643 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23-June-2021 and it contains No new information.