chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave birth; 2nd dose was administered more than 35 days after 1st dose; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of DELIVERY (gave birth), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 35 days after 1st dose) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 35 days after 1st dose). On 30-Sep-2021, the patient experienced DELIVERY (gave birth). The delivery occurred, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, DELIVERY (gave birth) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 35 days after 1st dose) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. No concomitant medications were reported.  This case concerns a 30 year old pregnant female with no relevant history who experienced the non-serious, unlisted events of Maternal exposure during pregnancy and Inappropriate schedule of vaccine administration of the second dose 37 days after the first dose of mRNA-1273. Re-challenge is not applicable as this was the second dose. Benefit -risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-110128 (Patient Link).; Sender's Comments: This case concerns a 30 year old pregnant female with no relevant history who experienced the non-serious, unlisted events of Maternal exposure during pregnancy and Inappropriate schedule of vaccine administration of the second dose 37 days after the first dose of mRNA-1273. Re-challenge is not applicable as this was the second dose. Benefit -risk relationship of mRNA-1273 is not affected by this report.
FEVER; This spontaneous report received from a patient 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 was not reported, administered on 02-SEP-2021 for prophylactic vaccination. 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 03-SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Rash, itching, pain in heart. I did not seek treatment. Itching stopped after a few days. Rash is almost gone. One spot still on Oct. 8, 2010.
MOTHER REPORTS CALLED DR. ON HOLIDAY WEEKEND TO REPORT ADVERSE REACTION OF AGITATION, INABILTITY TO SLEEP AND FUSSY
Information has been received from a certified medical assistant concerning an adult pt who on 6/30/04w as vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. IN Oct 2005, the pt was inadvertently vaccianted IM with an 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. In Oct 2005, the pt developed injection site reaction to include redness, swelling, pain and warmth. Unspecified medical attention was sought. The pts outcome was unknown. Additional information has been requested.
Information has been received from a licensed visiting nurse (LVN) concerning a 3 yr old Caucasian male who on 27Feb02 was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot 639490/0574L). The LVN reported that on 20Oct04, the pt developed breakthrough varicella with 8 to 10 fluid filled lesions on scalp that were not itchy. The pt did not have a fever. Unspecified medical attention was sought but no treatment was prescribed. It was reported that the pt recovered from the varicella. A product quality complaint was not involved. Additional information is not expected.
DRUG INEFFECTIVE; pneumonia; COVID; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 3-month-old patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE/ PNEUMONIA (hospitalization, medically significant), outcome "unknown"; COVID-19 (hospitalization), outcome "unknown", described as "COVID". The patient was hospitalized for pneumonia, covid-19 (hospitalization duration: 5 day(s)). Clinical course: The patient ended up being hospitalized with pneumonia 1 month after receiving their first dose of Prevnar 13. The patient also contracted Covid. The patient was in the hospital for 5 days and was discharged. The patient still has a cough. They did not know what caused the pneumonia.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  COVID infection represents a conincidental viral infection during the pandemic unrelated to the vaccine use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Diffuse redness around injection site. Burning sensation and itching accompanying the redness. Redness spreads from axillary area to elbow area. Denies scratching at wound. States her son had a previous allergic reaction to an unknown vaccine with a little swollen area on his leg. Not as severe as her reaction, per pt.
Patient started to feel sweaty around 15 minutes after the vaccine was given, no other complaints of discomfort expressed by patient.  Patient was observed and Vital were taken, first set was hr 72, bp 190/100, resp 18, and 98% saturation.  Water and a cookie was given and consumed, Patient states that he's diabetic and has a history of hypertension and did not take his morning medication.  Patient stated was feeling fine and skin warm and dry.  Second set of vital taken hr 79, bp 160/100, resp 20 and saturation is 97%.  Nurse educated patient on adverse reaction symptoms and when to seek medical assistance, patient gave understanding.
In December 1996, I had just found out I was pregnant and was in for the first ultrasound at clinic. It was confirmed and the fetus had a heart beat. The fetus was normal and thriving for 8 weeks of development.   The doctor gave me the flu vaccine.  2 weeks later, I was at clinic, for a routine pregnancy check. They found no heart beat and said that the fetus was age 8 weeks and no longer living, even though we were at 10 weeks pregnancy (it was January 1997).   They transferred me to the hospital and had to remove the baby. They asked if I wanted to have the fetus studied to see potential cause.  I did. The fetus was chromosomally normal, age 8 weeks from conception, a girl, and had been dead for 2 weeks. I didn't figure it out then, but now I suspect that the flu vaccine killed my fetus, and since that is an unnatural way to die, that is why I didn't have a miscarriage but had to have the fetus removed. Have you studied babies that die in utero and that the mother carries around for weeks to see how many correlate with instant death after a vaccine? If you haven't you should.
I got extremely ill felt like I was having a stroke but diagnostic test didn't support that was admitted for three days discharged n readmitted the following day for a week still presenting like a stroke but test did not show that.
MEDICATION ADMINISTRATION ERROR/DOSE WERE WITHDRAWN FROM AN EXPIRED VIAL; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-AUG-2021, the patient experienced medication administration error/dose were withdrawn from an expired vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication administration error/dose were withdrawn from an expired vial was not reported. This report was non-serious.
INCREASED HEART RATE; NAUSEA; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. 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 10-APR-2021, the subject experienced increased heart rate. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased heart rate, and nausea. This report was non-serious.
It was determined that it was an acute sinus infection and treated with antibiotics.  I am fine now.
headache that seems to be dull that started around two weeks ago and causesIt feels like there is pressure on his head and he felt is more in his ears.; vision issues; pressure on my head; headache that seems to be dull that started around two weeks ago and; right shoulder, where I got the injection, feels like there is a torn rotator cuff; both shoulders hurt; legs were starting to hurt; it started moving up to his upper body: neck, hands, ache in fingers, lower back, but mostly; hasnt felt right since the second shot; body has been achy, not terrible, but when he exerts to certain amounts; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (hasnt felt right since the second shot), PAIN (body has been achy, not terrible, but when he exerts to certain amounts), HEADACHE ( headache that seems to be dull that started around two weeks ago and causesIt feels like there is pressure on his head and he felt is more in his ears.), VISION BLURRED (vision issues) and HEAD DISCOMFORT (pressure on my head) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L0A and 02LM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rotator cuff injury.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced MALAISE (hasnt felt right since the second shot) and PAIN (body has been achy, not terrible, but when he exerts to certain amounts). On an unknown date, the patient experienced HEADACHE ( headache that seems to be dull that started around two weeks ago and causesIt feels like there is pressure on his head and he felt is more in his ears.), VISION BLURRED (vision issues), HEAD DISCOMFORT (pressure on my head), TINNITUS (headache that seems to be dull that started around two weeks ago and), VACCINATION SITE PAIN (right shoulder, where I got the injection, feels like there is a torn rotator cuff), ARTHRALGIA (both shoulders hurt), PAIN IN EXTREMITY (legs were starting to hurt) and PAIN (it started moving up to his upper body: neck, hands, ache in fingers, lower back, but mostly). At the time of the report, MALAISE (hasnt felt right since the second shot), PAIN (body has been achy, not terrible, but when he exerts to certain amounts), HEADACHE ( headache that seems to be dull that started around two weeks ago and causesIt feels like there is pressure on his head and he felt is more in his ears.), VISION BLURRED (vision issues), HEAD DISCOMFORT (pressure on my head), TINNITUS (headache that seems to be dull that started around two weeks ago and), VACCINATION SITE PAIN (right shoulder, where I got the injection, feels like there is a torn rotator cuff), ARTHRALGIA (both shoulders hurt), PAIN IN EXTREMITY (legs were starting to hurt) and PAIN (it started moving up to his upper body: neck, hands, ache in fingers, lower back, but mostly) outcome was unknown.
Patient reported flushing, sweating, and dizziness about 5 minutes after vaccine administration.  Symptoms subsided within 10 minutes of onset.
On 10/10 received vaccine, shortly after received developed HA, achiness, chills & hot alternating. Nausea next day, with aching & tired.
Information was received from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed this plaintiff suffered personal injuries and damages as a direct and proximate result of being inoculated with ZOSTAVAX.  The plaintiff was inoculated with ZOSTAVAX on or about 03-NOV-2014 (dosage, route and site of administration unspecified) as recommended for routine adult health maintenance for the prevention of shingles.  It was claimed that the vaccine did not prevent shingles as intended, but rather caused the plaintiff to contract a persistent and chronic strain of herpes zoster.  On or about 07-JUN-2015, the plaintiff was treated by a physician for blistering vesicular lesions accompanied by weakened immune symptoms and severe discomfort and distress which was diagnosed as severe herpes zoster on the face.  The plaintiff has been prescribed hydrocodone and gabapentin for management of her painful and persistent symptoms.  As a direct and proximate result of these malfunctions, the Plaintiff suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Eye surgery/Did not know that she was going to have the eye surgery/She is in such a "big ole" mess here; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (Eye surgery/Did not know that she was going to have the eye surgery/She is in such a "big ole" mess here) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011120A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 EYE DISORDER (Eye surgery/Did not know that she was going to have the eye surgery/She is in such a "big ole" mess here). At the time of the report, EYE DISORDER (Eye surgery/Did not know that she was going to have the eye surgery/She is in such a "big ole" mess here) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and medication information provided. The patient also stated that in July, she had an eye surgery which was after she received the first dose of the moderna vaccine and stated that she did not know that she was going to have the eye surgery the time she took the first dose of the moderna vaccine. While searching for the vaccination card, the patient said she is in such a "big ole" mess here. On 13-Feb-2021, the patient received second dose of moderna vaccine in left arm, intramuscular injection, lot: 028L20A. No treatment information provided.   This case was linked to MOD-2021-380931 (Patient Link).
Received Hepatitis B #2 and TdaP.  Developed rash on neck, right and left upper arm.  Denied rash prior to injections.  Denied itching, SOB, edema.  VS remained stable.  Benadryl 50 mg given IM.  Symtoms improved and patients sister arrived to take her home. Referral form was given for patient to take to PCP.
Sheets of blisters on mid back extremely itchy, sores formed, early on 3/1 by 3/8, spread to arms, legs, buttock, as of today I still have numerous pox type sores on arms legs and back 4/7/2019.
Pt received Covid vaccine and immediately felt light headed. Was immediately rigid in chair.  Pt was lowered to the ground by staff. Pt was breathing regularly by this time.  Pt transferred to wheelchair and wheeled to EMS room. Pt stiffened and had a second seizure-like episode. Pt was transferred to bed in EMS room and placed in recovery position on left side. Pt was able to verbalize and was alert and oriented x3. EMT arrived and took blood sugar 109. Vitals continued to be stable. Report given to EMS and pt transferred to Hospital via EMS
Customer reported fever of 101 degrees F 24 hours after receiving the vaccines. She also has reported that both her jaws are hurting along with body aches.
Information has been received from a physician concerning a 15 month old male with no illness at the time of being vaccinated and no pre-existing illness who on 03-DEC-2007, at approximately 11 AM, was vaccinated with a first dose of PEDVAXHIB (lot # 656522/0437U)  IM in the left thigh.  On 03-DEC-2007, within 24 hours of being vaccinated, the patient developed watery stools that lasted for 2 weeks.  Medical attention was sought.  The patient did not have a fever or vomiting.  No one else was with illness.  No diagnostic tests were performed.  The diarrhea lasted 2 and 1/2 weeks that prompted a repeat visit.  On an unspecified date, the patient recovered.  The physician reported that the lot number was one of the recalled lots.  No additional information is expected.
Patient was given bexero on 9/4/19 and on 9/6/19 mother called in patient broke out in rash on 9/5/19 small bumps on face, arms and legs , sore at injection site.
8 hours after receiving 1st H1N1 vaccine, patient had grand mal tonic clonic seizure, lasting several minutes.  He was brought to ED where metabolic and infectious evaluation was normal.  He was not found to have fever.  He has been neurologically normal before and since.
PATIENT DEVELOPED CELLULITIS ON THE LEFT FOOT (SAME SIDE AS INJECTION) WITHIN 24 HOURS OF RECEIVING THE VACCINE.  PATIENT SAID AREA WAS RED AND HOT TO THE TOUCH. PATIENT REPORTED NO PREVIOUS INJURY OR OTHER MEDICAL ISSUES RELATED. PATIENT REPORTED NO LOCAL INJECTION SITE REACTION OR OTHER ADVERSE EVENTS.
At the time of injection pt experienced pain and soreness in deltoid area, radiating late to entire body after two weeks. Pt had difficulty rising from bed, legs felt like leaden weights. Pt also experienced difficulty in raising arms to shave. Pain would ease at times, but pain remained from neck to fingers to back to toes. Pulse rate was also affected. Pt saw an MD and a prescription for Vioxx was given. The annual follow-up states arthretic pain in both wrists, hands and fingers. tingling sensations in instep of left foot recall that vaccine was injected in , left arm and immediately caused great pain in left arm probably hit a nerve. Fatigue continues and calves of both legs are crampted and feel unusually heavy.
Swollen lymph nodes and throat infection for one week. Extreme pain in ear and throat on left side only. Visited a Physician Assistant at Ear Nose Throat clinic and was prescribed antibiotic Cefdinir. I am halfway through the antibiotics and seeing great improvement so far.
patient reported pain ( > 10 on scale of 1-10) at time of injection and that the pain subsided over the next few days, similar to past flu shots; called back today said that still was having some pain when moving the arm ( 5 on scale of 1-10); patient asked what he should do, pharmacist that spoke to patient recommended that patient call PCP for evaluation.
posed to give the consumers a flu shot, which is the Fluzone Quadrivalent (influenza vaccine) 0.25 mL, no AE; receiving Adacel, which is an adult tetanus vaccine, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA272535 and 2019SA272536.  This case involves a 15 months old male patient who was vaccinated wit a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6378AA, expiry date: 04-Jul-2021 via unknown route in unknown administration site on 28-Sep-2019and was supposed to give the consumers a flu shot vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong vaccine administered and Inappropriate age at vaccine administration.  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 holder's 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.  List of documents held by sender: none.
arm hurts after the second dose; 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 PAIN IN EXTREMITY (arm hurts after the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PAIN IN EXTREMITY (arm hurts after the second dose). At the time of the report, PAIN IN EXTREMITY (arm hurts after the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.