chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PEDVAXHIB (injection) that went through an unsupported temperature excursion from 29-OCT-2013 to 06-NOV-2013 (dose, route and lot number were not provided). No concomitant medications were reported. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1311USA004586, MARRS# 1311USA004587 and MARRS# 1311USA004588). Additional information has been requested.
AE:  Patient stated felling light headed 5 minutes post vaccine administration. Treatment : Patient was given water to drink and monitored . Symptoms improved after drinking water. Outcome:  Patient was discharged to POV/Home.
Patient reports that her tendonitis has returned. It woke her up the following morning in pain.
Patient had itching the day after shot (2/7/16).  Patient had swelling, redness, warmth near injection site after receiving Zostavax.  He said these reactions started on about 2/9/16 and seemd to get worse by 2/11/16.  Patient had no fever at any point during this reaction.  The affected area of skin was getting further down the arm, away from the injection site.  Inject site was on upper left arm, and the reaction had moved down the upper arm, but not reached the lower arm. He said that the affected area of his arm felt kind of hard to the touch.  He was written a prescription for Cephalexin for possible cellulitis.
A week after shot arm reswelled at and around the injection sitewith a huge red welt that was hard to the touch. The welt was sore and appeared to have a fever in itself along with  itching.
Information has been received from a 43 year old male pharmacist with no known allergies or past medical history who on 07/16/2001 at 8:30am was vaccinated with the first dose of hep b vaccine recombinant IM in the left arm. There were no concomitant therapies. On 07/18/2001, the pt developed malaise, exhaustion, night sweat, fever of 102 F., cough, sore throat and general flu like symptoms. On 07/19/2001, the pt tested positive and diagnosed with mononucleosis. The symptoms were attributed to the Epstein-Barr virus. On 09/15/2001, the pt recovered from the mononucleosis. Additional info is not expected.
Covid19 breakthrough.  1st Vaccine received on 07/09/2021.  65y/o male with PMH of ETOH abuse, HTN, MI, CVA, GERD, COPD, Anemia and admits to huffing 20 aerosol cans/day.  Pt arrived to ED after being Baker Acted by police for Suicidal Ideation.  While in ED, pt's oxygen needs increased, O2 sat on 6L NC 90%.  CXR-PNA.  Covid test +.  Pt deteriorated on 1/10/2022 requiring emergent intubation.  Treated with IV ABX/IV steroids and Remdesivir.
I want to register in the pregnancy registry; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I want to register in the pregnancy registry) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. The patient's last menstrual period was on 12-Oct-2020 and the estimated date of delivery was 19-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (I want to register in the pregnancy registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (I want to register in the pregnancy registry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Approximately 15 minutes after vaccines administered, developed multiple red, raised, whelps on face, neck, arms.  No s/s of distress, no crying, itching or difficulty breathing.  Advised to report to ER now.
+ PCR Covid test on 7/11/21 after completion of Pfizer vaccine series > 2 weeks ago.
Pt had arm swell up to an extensive degree. He came back immediately to the clinic that same day within 2 hours later with swollen arm. Pt was told to return home and use antihistamines. (Zyrtec and Benadryl) Pt went to school the next day. Arm swollen down to the elbow and up through shoulder. School nurse called mother around 9am to return pain and swelling. Pt went on with his day. He then had a syncopal episode where he lost consciousness while putting things into his locker.  This happened around 1045 am. He was then brought to the ER by ambulance. He was alert and oriented upon arrival to the ED.  He was given IM steroid per weight and sent home on a tapering dosing of oral steroids. Pt's arm remains swollen on assessment.
Narrative:  Presented to the ED at Hospital on 4/14/21 with shortness of breath, was hypoxic on presentation. Saturation in the 80's on 4 L oxygen by NC. CXR with small area of focal infiltrate in the right lung. CT chest showed extensive bilateral PE with potential right heart strain. Patient was admitted to ICU and has right pulmonary artery thrombectomy and a large amount of clot was removed and right lung was reperfused. He was started on Apixaban and sent to acute rehabilitation at Healthcare center from where he was discharged yesterday.. Patient has advanced parkinsonsian features including impaired gait, slow muffled speech and mask like facies. Of note, this episode of PE was 2 weeks out from the 2nd shot of Pfizer COVID vaccine that the patient received on 03/29.
Pt called today stating that it feels like someone is sitting on his chest. I told him to go to the emergency room. He agreed.
Extreme pain at injection site moving down that same arm. Nausea. Sleepiness. General malaise.
throwing up non stop/throwing up all fluids now; feeling really woozy; Nauseous; Diarrhea; Sluggish; she broke out in a sweat; all her energy went away; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20May2021 at 11:15 (Lot Number: EW0168) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she just got her first dose of Pfizer COVID vaccine at 11:15 am on 20May2021. At around 12:30 or 1pm, she started feeling really woozy and nauseous. Since 2:3 or 3:00pm, she has been throwing up non-stop. She stated that all her energy went away, felt sluggish was nauseous and she broke out in a sweat. She even had diarrhea a few times and that threw her off. She was throwing up all fluids now and she was scared to drink anything. The patient did not receive treatment for the events. the events did not require a visit to emergency room or physician office. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
The following day I felt a little sluggish the next day. 4-5 days later my throat began bothering. It was extremely red and constantly painful. I also had a few blister looking spots on the sides of my tongue.
After the fourth dose, I had a pounding headache, a fever, body aches, extreme fatigue with some lymph nodes swelling on the left, I slept a lot. It lasted about a week. On 8/5/22 I was exposed. I woke that morning with a sore throat. By noon that day, I had a fever, headaches, body aches and I could not breath as I has a stuffy nose. I had no energy and appetite and I tested positive. I was coughing really bad. It was all so quick. I did telehealth on 8/8/22. I was told to go the hospital if I have trouble breathing. She said my symptoms were "mild". I am still symptomatic. I was positive for about a month. I was sick for 5 days. The stuffiness lasted 7 to 9 days. Headaches, and body aches lasted for over a month. The fever lasted about 3 weeks of low grade fever and the highest 101.6 temperature for fever. I still feel out of breath. I forget things constantly which never happened prior to testing positive COVID-19. I am still coughing and clearly my throat a lot.
Started noticing chest pain a few days after injection. At first the pain was controlled by taking Aleve, but eventually that stopped helping. The chest pain started getting more consistent about 7-10 days after injection and around that time I also started to have episodes of shortness of breath and the feeling of my heart pounding. The pain gets worse when laying down. On 9/9/21 my doctor put me on diclofenac.
Pt experienced rash on both arms, itchy started on 4/5/19. Saw dr 4/11 and dr started pt on prednisone for 5 days. Will check in on patient in a few days.
Tinnitus increased to 4 sounds; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 18Aug2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were reported as not applicable (N/A). On 24Aug2021 at 06:30, the patient experienced tinnitus increased to 4 sounds. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent COVID-19 test via nasal swab and the result was unknown. The clinical outcome of the event tinnitus increased to 4 sounds was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 36 month old male who on 26Jan2001 was vaccinated with a first dose of varicella virus vaccine live. On 15Oct2003 the pt developed a breakthrough case of varicella. It was reported as a mild case of chickenpox. No treatment was necessary. No further information was given. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that the pt developed chickenpox 3 years after vaccination. No other details of vaccination are known. The pt was reported as recovered. No further information is expected.
Pt son, reports patient passed away on 2/1/21 in the early hours. Pt wife, told Pt's son that patient started feeling "bad" with common cold like symptoms on 1/31/21, had a temp of 99.0. Pt's wife went to take a shower, when she got out patient was unresponsive. She called EMS, they pronounced patient deceased upon arrival.    Pt's son also reports patient and Pt's wife both had their 1st COVID-19 vaccine 13 days prior. He was told by EMT on sight to notify the facility where they received their vaccines. He did contact them and was told to notify PCP.
Received moderna vaccine on 3/26/21 and 4/23/21. COVID positive on 2/15/22. Presented to ER on 2/15/22. who was admitted for COVID-19 pneumonia with acute hypoxic respiratory failure on 02/15/22. He was requiring 100% FiO2 on Optiflow and BIPAP and was in the intensive care unit. He was started on antibiotics , Remdesivir and decadron , and was followed by Pulmonology/Critical Care and Infectious disease services. Unfortunately early hours of 2/18/22, he developed cardiac arrest and required multiple resuscitative efforts coded twice each for a prolonged amount of time resulting in irreversible shock.  He expired on 02/18/2022 at 0532 AM
The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022; patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 031A21A and 039A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the patient did not reported any adverse events after first and second dose and after second booster no other adverse reactions are known of.   On 21-Jul-2022, the vial was initially stored in the refrigerator.  Number of doses or vials includes 4 doses.  The vial did not undergo any temperature excursions.  No treatment medication was reported.
41 y/o male, PMH of bipolar 1 disorder, DM, HTN, schizophrenia, seizure, spina bifida, Tourette's disease, and arthropathy, admitted for hyperglycemia, N/V, and DKA on 8/19/21. Pt came to the ER on 8/17/21 for DKA and was diagnosed with Covid19 and was released on 8/18/21. DKA was treated with aggressive IV hydration, insulin, bicarb, etc. Covid was treated with Regeneron. Pt was discharged home on 8/22/21.
Itching, swollen lymph nodes, fever, pain & swelling at injection site. - Sx. Patient received IV fluids, ZOFRAN & PEPCID as well as oral erythromycin and BENADRYL in ER. Today, we gave no new medications.
Before leaving the doctors office, the pt told the clerk that her chest felt tight and the clerk notified the RN. The pt stated that the tightening occurred suddenly. They loosened clothing and had the pt lie down. The tightness continued and her throat began to feel numb. Her color remained pink. 911 was called. Treated with epinephrine and transported to the hospital.
I developed a rash on L and R outer upper thigh. 1 week after injection.   I am unsure if they are related but wanted to report it.
A few hours after receiving vaccine I developed high fever (not certain about the temperature) chills, shakes, sweating, headache, extremely sore arm.  It felt like I had a severe case of the flu. About 24 hours later, with the assistance of Acetaminophen, the symptoms seemed to have lessened. I am afraid the same thing will happen tonight again. Upon your follow up, I will advise.
Swelling on right side of trunk on side of injection site. Redness on right side, headache. On Keflex.
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 an unknown date in 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-AUG-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. Additional information has been requested.
Leg & foot Pain & needles level went from a 2 to a  6 after vaccine.  Now on Gabapentin daily to with stand the pain.  Also now have chronic head aches when not taking the medication.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No concomitant medications reported.  Concurrent medical conditions included Hypertension.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant or treatment  medications were reported. Patient would like to know if someone received their 1st injection and had Covid, how would that affect the vaccine in him. He received his first dose yesterday. He woke up with sinus area headache which has faded since. He received his 1st dose (037A21B) in the right arm. He did not take anything for symptom. He has hypertension
Cellulitis of left arm, edema, erythema, swelling, red streaks, hot to touch.
booster; Had to remain bedridden for the day due to extreme fatigue; ran a fever of 100.9 which lasted about 36 hrs; had an excruciating headache accompanied by body aches and pains; had an excruciating headache accompanied by body aches and pains; Lymph nodes in neck and underarm pits were swollen the next morning and remain swollen 72 hrs after; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FATIGUE (non-serious), outcome "unknown", described as "Had to remain bedridden for the day due to extreme fatigue"; PYREXIA (non-serious), outcome "unknown", described as "ran a fever of 100.9 which lasted about 36 hrs"; HEADACHE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "had an excruciating headache accompanied by body aches and pains"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph nodes in neck and underarm pits were swollen the next morning and remain swollen 72 hrs after". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (09Dec2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
On 9/11/01, child awoke with giant hives over entire body but no mucous membrane involvement.
PAIN IN SHOULDER MUSCLE AFTER VACCINATION AND AGAIN 10 MONTHS AFTER VACCINATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced pain in shoulder muscle after vaccination and again 10 months after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in shoulder muscle after vaccination and again 10 months after vaccination. This report was non-serious.
HAVRIX given at about 12:30pm. By 7PM, arm ached - pain in (L) elbow- Daily pain increase in all joints and pain has continued even now.
SORE THROAT; FEVER; MUSCLES ACHES; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non smoker, and other pre-existing medical conditions included patient have no known allergies, no drug abuse or illicit drug usage, no medical history, no etoh.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 642A2119 expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 08-JUN-2021, the subject experienced sore throat. On 08-JUN-2021, the subject experienced fever. On 08-JUN-2021, the subject experienced muscles aches. Laboratory data included: Body temperature (NR: not provided) 100.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, sore throat, and muscles aches. This report was non-serious.