chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 15-OCT-2012, the patient was vaccinated with GARDASIL dose 1 and on 09-NOV-2013, was vaccinated with the dose 2 (inappropriate schedule of drug administration). Patient present status was reported as no adverse effects. No product quality complaint was involved. The outcome of the event was unknown. Additional information has been requested.
Immediately after the vaccination, she felt cold.  She's continued to have low energy, body aches, arms hurt,  sweating, difficulty stretching fingers and fingers hurts. She was not supposed to receive Menactra, she was supposed to receive MMR. She ended up receiving MMR on 2/16/22 after these vaccines.
she is not feeling "so well."; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she is not feeling "so well."".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Person experienced syncope after 1st Pfizer vaccine.  Person was experiencing diaphoretic, nauseous and was pale.  Shortly after receiving first Pfizer vaccine the person lost consciousness for about 2 minutes.
did not receive the second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a few years ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The nurse reported that, till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.  The patient´s details were unknown and vaccine's details (lot number and expiration date) was unknown. The reporter did not consent to follow-up.   Upon review following correction was made with GSK receipt date as 30th November 2021: The country of occurence was updated and the case was processed accordingly. The consent to follow up was granted.
This spontaneous report was received from a registered nurse referring to a male patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 11-JUN-2018, the patient was vaccinated with RECOMBIVAX HB lot # M010671, expiration date 02-JUN-2018, for prophylaxis (rout of administration and dosage information were not informed). No adverse effects reported.
RIGHT ARM NEAR INJECTION SITE HAD RED RAISED RASH THE SIZE OF A GOLF BALL, NO PAIN OR ANY OTHER SYMPTOMS.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
fever of 103 axillary 24JUL98 w/vomiting, reduced appetite;APAP given & temp remained @ 102 orally for 24hr;
Sore arm started the day of shot and ended 5 days later.  Mild headache, tiredness, fever 101.8 started 24 hours after the shit and lasted for 3 days. Took 400mg Ibuprofen every 4 hour with no effect. Switched to 1000mg Tylenol every 4 hours and fever was maintained at 99 until resolved.
Did not receive the second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the second dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the second dose) outcome was unknown.        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.   No concomitant medications were reported. The treatment information was not provided.
5 minutes post injection patient became pale and unresponsive. lowered to floor, sternal chest rub,  legs raised ice pack applied to neck. vitals signs done, patient aroused  within 1 minute, assisted to sitting position. denied lightheadedness  apple juice given continuously monitored, 15 minutes patient became diaphoretic and unconscious, lowered to floor again, sternal chest rub, patient regained consciousness, EMT notified ambulance on scene @0938, EMS resumed care, vitals signs, blood sugar done.  Patient  returned to baseline, refused transport to ED for further evaluation.  Patient reported history of fainting after discussing medical history.  Blood sugar 141  orthostatic vital signs done by EMS  full assessment completed by EMS  patient returned to baseline and allowed to discharge to home.
Received the vaccine on May 15th and on May 24th at 5am I woke up and my vision was completely blurred.  My vision is normally perfect. I could not see 2feet from my face.  This lasted for four days straight. I could not drive or go to work.
Anaphylactic reaction: tongue swelling, throat slightly closed off. On April 6th Urgent care gave steroid shot, prescribed Zyrtec & Pepcid for next 2 weeks. April 7th returned to Urgent card with chest tightness/burning.  EKG & x-ray all negative.  Was given Maalox for heartburn.
Fever 100.9, chills, all over body aches, throbbing headache, arm stiffness, extreme thirst, fatigue lymph nodes sore under right arm. Started about 4:30am Saturday for 24 hours. Fever normal and symptoms reduced gradually by Sunday  Well on Monday. Lymph nodes still a little sore.
Information has been received from a physician concerning a 5 year old male who in approximately 2004 at the age of 18 months was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a mild case of chicken pox. Unspecified medical attention was sought. At the time of this report the patient's status was not reported. There were no lab studies performed. No further information was provided. There was no product complaint involved. No further information is expected.
Information has been received from a certified medical assistant (CMA) concerning a 48 year old female with allergies to penicillin, latex, adhesives, nickel sulfate, neomycin sulfate, Balsam of Peru, dichloride, Nubian and ADVAIR, a history of lung cancer and no concomitant medication usage. The patient was recovering from cancer at the time of vaccination. On 13-DEC-2007, the patient was vaccinated (site and route not reported) with the 1st dose pneumococcal 23v polysaccharide vaccine (lot#657626/1084U) intramuscularly in the left arm in the pm. On 14-DEC-2007, post vaccination, the patient experienced injection site reaction that was red and swollen with white bumps. The injection site was also very sore. The patient was treated with ice and diphenhydramine hydrochloride (BENADRYL). No diagnostic lab test were performed. Subsequently, the patient recovered on a unspecified date. No additional information is expected.
On June 30th, 3 days after the vaccine (dose 3), I had nauseous and vomited.  I also had diarrhea and have had diarrhea since then.  I did not have a fever but have felt "gross".  I have had a bit of fatigue since then but the diarrhea has been intense.  I had a tele visit with Dr.  on July 11th.  She added a supplement, GI Detox and Pepto Bismal.  She ordered a stool test but do not have results yet.
DIED 2 WEEKS AFTER GETTING SECOND SHOT; This spontaneous report received from a consumer via Social media via a company representative concerned a male of unspecified age, race and ethnicity.   The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer)(suspension for injection, route of admin, batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died 2 weeks after getting second shot from unspecified cause. It was reported that "My husbands friend died 2 weeks after getting his second shot." (Dose number in series 2). It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211230043.; Sender's Comments: V0:20211229704-COVID-19 VACCINE AD26.COV2.S-Died 2 weeks after getting second shot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DIED 2 WEEKS AFTER GETTING SECOND SHOT
Neurological issues; Shaking hands; major brain fog. Can't remember what I just said or if I just spoke; Can't remember what I just said or if I just spoke; Shortness of breath; This is a spontaneous report from a contactable other-HCP (patient herself). A 31-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in right arm on 03Aug2021 18:30 as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Facility type Vaccine was reported as Public Health Clinic/Veterans Administration facility. Patient did not receive any other vaccine in four weeks. Patient had COVID-19 prior to vaccination. Patient was not tested for COVID-19, post vaccination. Patient medical history included migraine, COVID-19 and dyspnoea (as bad as she had during covid). The concomitant medications were reported as none. The patient did not take other vaccine in four weeks and other medications in two weeks. The patient did not covid tested post vaccination and not had allergies. On 04Aug2021 20:00 the patient experienced neurological issues, shaking hands, major brain fog, could not remember what she just said or if she just spoke and shortness of breath. It was reported that shortness of breath was as bad as she had during covid. It was unknown if treatment received for events. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Information about lot/batch number cannot be obtained. No further information expected.
Rash with raised bumps on left half of scalp. Not itchy but sore to touch.
Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a female who in the first week of April 2008, was vaccinated with VARIVAX (Merck). Subsequently she became pregnant. Prior to the VARIVAX (Merck) vaccination, a urine pregnancy test was taken and was negative. Physician stated patient, who is also her friend, called her stating she took  a home pregnancy test and it was positive. Physician stated that patient did not know if she will continue the pregnancy. Follow-up information was received from a  nurse who stated that the patient had a miscarriage in May 2008 (about 4 weeks after vaccination of VARIVAX (Merck). The cause of miscarriage was unknown. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 7 year old female patient who was diagnosed with molluscum a couple years ago. The patient was vaccinated with the first dose of VARIVAX (Merck) at 12 months of age and the second dose of VARIVAX (Merck) (lot# 658936/1350U) at 5 years old. There was no concomitant medication. Subsequently the patient presented with chickenpox at the age 7. The patient sought unspecified medical attention. At the time of the report, the patient's chickenpox persisted. Follow up information received from a nurse practitioner concerning a 7 year old female patient with no illness at time of vaccination, no preexisting allergies, birth defects and medical conditions, and no adverse event following prior vaccinations, who was vaccinated with the first dose of VARIVAX (Merck) (lot # 656577/0447U) in the left leg on 13-JUL-2007, and the second dose of VARIVAX (Merck) (lot # 660061/0090X, previously reported as 658936/1350U) on 07-JUN-2008. On 25-JUN-2010 the patient had case of varicella despite having received 2 doses of VARIVAX (Merck). There were no labs or diagnostic tests performed. The patient recovered at time of the reporting. Additional information is not expected.
Severe myalgia, muscle pain of injection site at right shoulder.  No rash, no swelling, simply muscle soreness at injection site where Tdap given.
WOKE UP WITH SEVERE BODY ACHES, WITHIN AN HOUR DEVELOPED CHILLS, ROUGHLY 0500 IN THE AM BECAME NAUSEATED VOMITING ONCE. TOOK TEMP AT 0600 WITH MILD FEVER 100 DEGREE (F). WENT TO DOCTOR 0800 OF SAME DAY TREATED FOR WHAT WAS ASSUMED TO BE SIDE EFFECTS OF ANTHRAX VACCINE WITH 1000mg ACETAMINOPHEN.  BODY ACHES AND FEVER SUBSIDED, WITH RECURRING ONSET AT 1400 THAT AFTERNOON.  RE-ADMINISTERED ACETAMINOPHEN 800 MG AT 1600. NAUSEA SUBSIDED AROUND THE SAME TIME. THROUGH THE EVENING CONTINUED TO JUST HAVE BODY ACHES AND LOW FEVER AROUND 100 DEGREE (F).  NEXT MORNING WOKE FEELING SIGNIFICANTLY BETTER, WITH SYMPTOMS IMPROVING AND SUBSIDING COMPLETELY BY THAT EVENING.
patient experienced nausea, fatigue, body aches and abdominal discomfort lasting at least 4 days after 1st dose
Soreness of the arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (husband) who had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reported two AE for her and her husband. Reporter mentioned that her husband experienced soreness of the arm. The outcome of the event was unknown.  This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts had been completed and no further information was expected.
Began having sever pain in shoulders, lower back, hips, moderate pain in elbows, knees about 2hrs after vaccines. On 12/04 began having muscle pain in legs and arms. Have had difficulty walking and lifting.  Have taken prednisone along with aspirin and Tylenol to help. Have a dr. appt on 12/06
Patient was scheduled for our COVID clinic for 5-11 yr old's, but had turned 12 yrs old by the appointment date.  This was not caught and patient received the pediatric dose of Pfizer instead of the adult dose.  We called the local HD for guidance and was given the link for the CDC that states to not repeat the dose, but to give him the adult dose in 21 days.
STIFF JOINTS; ACHINESS/SORENESS; LETHARGY; FEVER; NAUSEA; TIRED; FELT MESSED UP/BONES GOING TO GET MESSED UP; WORRIED; This spontaneous report received from a consumer concerned a 51 year old female. The patient's weight was 150 pounds, and height was 65 inches. 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: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced felt messed up/bones going to get messed up. On NOV-2021, the patient experienced worried. On 09-NOV-2021, the patient experienced stiff joints. On 09-NOV-2021, the patient experienced achiness/soreness. On 09-NOV-2021, the patient experienced lethargy. On 09-NOV-2021, the patient experienced fever. On 09-NOV-2021, the patient experienced nausea. On 09-NOV-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, achiness/soreness, stiff joints, tired, lethargy, felt messed up/bones going to get messed up and worried was not reported. This report was non-serious. This case, from the same reporter is linked to 20211125901.
About 5 minutes after the vaccine developed chest tightness, increased work of breathing, palpitations and severe dizzyness.  Transferred to the ED where i received oxygen, IV benadryl, IV fluids and monitoring.  Released after about 4 hours and continue to take benadryl 50 mg PO q 4 hours.  Also developed red facial rash (unknown time) Pain at injection site began the morning after the injection.
Itching near injection site; Rash near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching near injection site) and VACCINATION SITE RASH (Rash near injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included LISINOPRIL, ZINC, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching near injection site) and VACCINATION SITE RASH (Rash near injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching near injection site) had resolved and VACCINATION SITE RASH (Rash near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within 5 minutes after vaccine administration, patient reported weakness in the left arm (same arm as the vaccination) from the shoulder to her hand. She also reported stiffness in the left side of her neck. Symptoms did start to improve after 30 minutes.
Muscle pain in upper left arm.  I can hardly lift it. It?s getting worse with time.
Brachial neuritis: deep aching in left shoulder joint, muscle spasms in left upper arm, shoulder and neck for two days. Loss of hearing in left ear for a day. Slow improvement and still in physical therapy.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (MI) (Reference number- 00567142) and transmitted to Sanofi on 19-Apr-2021.  This case involves a four-year-old female patient who received an expired 0.5 mL of 4th dose of vaccine IPV (VERO) [IPOL] (lot R1B25 and expiry date: 13-Mar-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 15-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and chickenpox for prophylactic vaccination.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
A red, dry rash was noted 2 inches in diameter and 3.5 to 4 inches below the injection site two days after the injection. A scraping of the rash was taken by a dermatologist and diagnosed as shingles. He was diagnosed with shingles in 1993 and this is his second flare up.
Patient received flu vaccine in left arm on 10/20/11. She returned on 10/22/11 to show me her arm. Reaction started about 1 inch below injection site. It has progressed to a very large bruised area on arm. Patient is on COUMADIN and aspirin. The affected area is swollen and patient has not yet contacted her doctor because office was closed. Pharmacist suggested patient should contact her doctor & see what he suggests.