chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning an unknown age female patient who on 16-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# 665524/1374Y). On 18-JUN-2010, 48 hour after received the ZOSTAVAX (Merck), the patient reported a reaction described as a silver dollar in size, which included redness, swelling and inflammation. It was noted that the patient's relevant history, concomitant medications and past drug history were unknown. It was unspecified if lab tests were performed. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Fatigue, headache, muscle pain, joint pain, chills and fever for 24 hours.
Was supposed to receive COVID-19 Pfizer Bivalent, but was given a primary dose with the monovalent formula.
No adverse event; Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used).    No concomitant medication information was provided. The vial was initially stored in refrigerator on 7-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses. No treatment medication information was provided.
dry throat; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.    A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date 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 experienced dry throat 2-3 hours after the shot and thought it was just talking to his student too much. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: Agree with the reporting consumer, the reported dry throat reported as " just talking to his student too much" is considered unrelated to the administration of BNT162B2 for COVID-19 immunization,Linked Report(s) : US-PFIZER INC-2020510790 same reporter, suspect drug, event, different patient
Patient went to Emergency Room as advised by LPN after complaints of itching and redness. Emergency Room MD treated with PO 1 dose Prednisone 40 mg and 25mg IV BENADRYL for 1 dose.
Whole arm bruising; pain in back; red bruising on buttocks; hospitalization on 6/10/21 with CT scans and multiple blood tests/scans; diagnosed with Acquired Factor VIII Inhibitor; Prednisone (June - August 2021); Retuxan (2 doses - October 2021); Death (November 2021); multiple hospitalizations and blood transfusions, including two procedures for bleeding in stomach (August 2021).
Acne, significant increase in visual, auditory aversions that interfere with eating to an eating disorder, and decreased abilities to life function w/o extreme reaction of behavior.
sleeping a lot/slept 12 hours; tired/wiped out/dragging around; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping a lot/slept 12 hours) and FATIGUE (tired/wiped out/dragging around) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HYPERSOMNIA (sleeping a lot/slept 12 hours) and FATIGUE (tired/wiped out/dragging around). At the time of the report, HYPERSOMNIA (sleeping a lot/slept 12 hours) and FATIGUE (tired/wiped out/dragging around) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatments were reported.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/02/2021. PATIENT FULLY VACCINATED ON 04/11/2021.
Pt recvd Engerix-B vax & p/3rd dose 24JAN92 non-response (neg); pt lost 40-50 lbs last year poss while series was being given;
1237pm- injection of covid vaccine into left deltoid 1240p-hives noted on left arm Benadryl 50 mg given po liquid 1241p-hives spreading rapidly on body physician notified, rapid response called epipen 0.3 mg IM given 1242p tingling of left arm noted 1245- transferred to observation unit on floor with RN/ physician present 1Pm-3pm, itchiness noted, some shakiness due to epipen, hives resolving 145pm 25 ng Benadryl po given one hour post epiepn given itchiness increasing on body, saying throat is itchy 245pm increasing itchiness, discomfort with swallowing solids, taking liquids, says he feels funny, sl lightheaded, did walk to bathroom to void Famotidine given 40 mg PO per Dr  330- remains very itchy, with dysphagia, some hoarsness, breathing comfortably, ambulance called and take to hospital.
Approximately 10 minutes after receiving the vaccine (9:30am), patient stated she was dizzy and hot. Patient was taken from waiting area to an exam room. Patient's vitals were BP 138/100--sitting, Pulse 80, Respirations 20. Patient was alert and oriented. Patient stated she felt she needed to use her epinephrine pen. 0.3 mg of epinephrine was administered via patient's personal epinephrine pen. Patient continued to experience chest tightness and used her personal Ventolin inhaler, 2 puffs.  O2 at 15 L via Adult Non-Rebreather mask was started, and ambulance was called.  Approximately 20 minutes after vaccine was administered (9:40am) vitals were BP 142/102--supine position, Pulse 90, Respirations, 21. Patient continued to be alert and oriented, and continued to state she was having difficulty breathing. Ambulance crew arrived at 9:46 am and transported patient to Hospital.
SEVERE REACTION; This spontaneous report received from a patient via a company representative 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious.
My child received 2 doses of H1N1 vaccine. First dose on December 8, 2009 Manufacturer: Novartis Lot# 102137P1 and a second dose on January 7, 2010, Novartis Lot# 102141P1.  She had an upper respiratory infection which developed into pneumonia requiring an emergency room visit.
for 9 days after above vaccines were given this baby appeared lethargic to mom; symptoms resolved thereafter
This is a spontaneous report from a contactable consumer via a sales representative. An elderly female patient received PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on 24Aug2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced widespread pain in her body and general feeling of discomfort on25Aug2018. The outcome of the events was unknown. Information on the batch number has been requested.
Chills; High Fever; Bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Bad headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal) since 1997. Concomitant products included FAMOTIDINE (PEPCID AC) for Acid reflux (esophageal).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Bad headache). On 16-Feb-2021, CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Bad headache) had resolved.            Treatment information included acetaminophen twice on February 15th and the symptoms went away February 16.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.   This case was linked to MOD-2021-018199 (Patient Link).
Six hours after receiving a second Moderna shot, while slicing food in the kitchen, my right hand (between the thumb and middle index finger) began to burn and itch. The skin blackened over the right hand area. I immediately took a low dose aspirin for fear of a blood clot. One day later, the blackened area is still present.
Ears are clogged and congestion; Ears are clogged and congestion; Chills; Fever; Aches, pains; Fatigue; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: GN 6200; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 10:30 (at the age of 58-years-old) as DOSE 2, SINGLE for covid-19 immunisation at clinic/facility. Patient was not pregnant at the time of vaccination. Medical history included back pain from an unknown date and unknown if ongoing. Concomitant medications included gatifloxacin, loteprednol etabonate (LOTREL G) taken for HBP, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Pfizer EL9263) via unspecified route in left arm on 29Jan2021 10:00 as dose 1, single for covid-19 immunisation. Other vaccine on the same date, other vaccine in four weeks, covid prior vaccination, covid tested post vaccination, known allergies included none. The patient experienced ears are clogged and congestion, chills, fever, aches, pains, fatigue on 20Feb2021 06:00. Reported events occurred after second dose. AE resulted in none of the above (unspecified). No treatment was received. Clinical outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
On May 25, 2022, I had a Spontaneous Coronary Artery Dissection (SCAD), leading to a heart attack. Prior to this event I did not have any risk factors for a heart attack.
pt awake 28MAR94 & t101.6 under weather all day-spotty rash developed later that day on face, neck, arms, back, & legs-pt was not sick enough to see MD;
Swollen lymph nodes; joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) and ARTHRALGIA (joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) and ARTHRALGIA (joint pain). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
epilepsy: several seizures over several months; lethargy; joint pain; serious autoimmune, autonomic, and neurological dysfunctions, chronic fatigue, syncope/neurocardiogeniogenic syncope (dizziness); serious autoimmune, autonomic, and neurological dysfunctions,; serious autoimmune, autonomic, and neurological dysfunctions,; as well as a constellation of adverse symptoms, complications, injuries, and other adverse events; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning female patient (age not specified). Patient's current conditions, medical history and concomitant therapy was not reported. On 05-FEB-2019 (at 14 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, following her vaccination, pt suffered lethargy, joint pain, dizziness, syncope, pt also had several seizures over several months that required multiple emergency room visits. She was prescribed eslicarbazepine acetate (APTIOME) for her seizures, she also received a tilt table test and tested positive for neurocardiogeniogenic syncope. As a result of her symptoms, pt had been unable to engage in activities that a normal young person would enjoy. Based upon her chronic and severe post quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to epilepsy, chronic fatigue, neurocardiogeniogenic syncope. Pt contends that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection caused her to develop serious and debilitating autoimmune, autonomic nervous system imbalance, and neurological, injuries, including but not limited to epilepsy, chronic fatigue, and neurocardiogeniogenic syncope, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) induced autoimmune disorder. At the time of reporting, plaintiff had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All the events were considered as disabling by reporter.  Upon internal review, the event of epilepsy, and autoimmune disorder were determined to be medically significant.
Patient started experiencing chest tightness and dizziness a few minutes after her Pfizer COVID19 vaccine was administered. An ambulance arrived to treat her and her lungs were clear to auscultation bilaterally and no obstruction to airway was found. The EMTs concluded that she was having an anxiety/panic attack and the patient refused to be transported to a hospital for further evaluation.
became very sick; diffuse/transient joint pain; Fever of 101 degrees Fahrenheit; inability to sleep/insomnia; GI symptoms; More than 42 days from first dose; swelling of entire left arm; This spontaneous case was reported by a physician and describes the occurrence of INSOMNIA (inability to sleep/insomnia), PERIPHERAL SWELLING (swelling of entire left arm), ABDOMINAL DISCOMFORT (GI symptoms), PRODUCT DOSE OMISSION ISSUE (More than 42 days from first dose) and ILLNESS (became very sick) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0411.20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hormone replacement therapy. Concurrent medical conditions included Autoimmune disorder (Autoimmune/hyperimmune disorder), Lyme disease (Chronic) and Thyroid disorder NOS. Concomitant products included ESTRADIOL (ESTROGEN) for Hormone replacement therapy, LEVOTHYROXINE for Thyroid disorder NOS, ATENOLOL for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (swelling of entire left arm). On 02-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days from first dose). On 03-Mar-2021, the patient experienced INSOMNIA (inability to sleep/insomnia), ABDOMINAL DISCOMFORT (GI symptoms) and PYREXIA (Fever of 101 degrees Fahrenheit). On 09-Mar-2021, the patient experienced ARTHRALGIA (diffuse/transient joint pain). On an unknown date, the patient experienced ILLNESS (became very sick). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 02-Mar-2021, PRODUCT DOSE OMISSION ISSUE (More than 42 days from first dose) had resolved. On 04-Mar-2021, PYREXIA (Fever of 101 degrees Fahrenheit) had resolved. On 07-Mar-2021, PERIPHERAL SWELLING (swelling of entire left arm) had resolved. On 17-Mar-2021, ABDOMINAL DISCOMFORT (GI symptoms) had resolved. On 10-Jun-2021, INSOMNIA (inability to sleep/insomnia) had resolved. At the time of the report, ILLNESS (became very sick) and ARTHRALGIA (diffuse/transient joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (abnormal) 101 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non significant follow up received. Patient is querying mailing address to print out the form and mail it as she doesn't have a scan or fax available. On 21-Jul-2021: Follow up received. It provides no new information.
L arm swollen at injection site, headache, fever of 102, vertigo, erythematous 4.5 x 4cm, arm pain.
Patient received Pneumovax 23 on 3/18/15, she has had swelling, redness, fever & chills since then.  Today she has developed a rash.  She is here to r/o cellulitis.
Myalgias x24h Nausea x 18h Chills x36h Fever (Tmax 103.8F) x28h Headache >48h
Pt did not develop "protective titers" p/3 injects of Engerix-B; "plan to revax pt; Reporter states the non-protective titers can possibly be disabling and/or life threatening "if a person contracts Hepatitis";
Headache, nausea within 3 hours of receiving vaccine. Nausea with vomiting and headache one day after receiving vaccine.
Day 1: Pain at injection site  (moderna 2nd shot) Day 2: Flu symptoms; muscle pain; low fever; mild headache; queasy stomach;  lasting approx 12 hrs until it started to abate.  Symptoms gone by morning of day 3. Day 3: Rash started; heaviest on ankles and up calves and thighs;  lesser on forearms but very noticeable red minimally raised blotches.  Not painful or itchy. Mostly gone by Day 6; telltale signs of rash still present on ankles (smallish red cluster of spotting  slowly disappearing.
Intense Muscle pain-Full body Fatigue-Not Able to walk - Did not urinate - Fever of 99.5 - was incoherent- This took a toll on my body & Mind-I am scared to take the Booster shot, but Also Afraid Not to take it. Please AdviseME.
The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; This spontaneous report was received from a nurse, referring to a child patient between 1 and 2-year-old of an unknown gender. The patient's pertinent medical history, previous drug reactions, allergies, or concomitant medications were unknown by the reporter.  On an unspecified date, the child was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dose administered subcutaneously, as "routine vaccination" (lot number S027459 which has been verified to be valid, expiration date reported and validated as 02-MAR-2021) (vaccination scheme and anatomical site of injection were not reported).  On an unspecified date (also reported as "within 1-10 days of administration"), the patient experienced fever (pyrexia) and rash. According to the nurse, it could be chickenpox (varicella). The patient sought medical attention, however, no treatment was given for the events and the patient did not have any laboratory diagnostics or studies performed.   The outcome of the events pyrexia, rash and varicella was reported as recovered. The causal relationship between the abovementioned events and therapy with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) was not reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001872: US-009507513-2006USA008951: US-009507513-2007USA001873: