chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse, subject) and described the occurrence of sore arm (injection site) in a 61-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). The subject's medical history included gallbladder attack and gallbladder exeresis. Concurrent medications included Vitamin D, Calcium salt (Calcium) and Oestradiol (Estradiol patch). On 31 October 2013 the subject received 1st dose of FLULAVAL TETRA 2013-2014 (unknown details, left arm). The subject reported that she was required to receive the vaccination as part of her employment. She also reported that she "would have to use a face mask with her interactions with patients in the hospital." On 31 October 2013, within "a few hours" of vaccination with FLULAVAL TETRA 2013-2014, the subject experienced sore arm (injection site), injection site reaction (difficulty in moving arm). The subject reported that she could "barely life her arm." On 31 October 2013, within the same day as vaccination with FLULAVAL TETRA 2013-2014, the subject experienced chest tightness and headache. In 2013, within weeks of vaccination with FLULAVAL TETRA 2013-2014, the subject experienced runny nose, watering eyes and decreased in thinking of words to say. The subject reported that she had "some difficulty with saying words and speaking, due to her not being able to think about what she wants to say". At the time of reporting the events of sore arm (injection site), injection site reaction (difficulty in moving arm), and decreased in thinking of words to say were resolved on an unknown date. The reporter documented that the chest tightness had improved. The reporter stated that events of runny nose, watering eyes, and headache were not resolved at the time of reporting. The healthcare professional considered the events of sore arm (injection site), injection site reaction (difficulty in moving arm), and chest tightness were probably related to vaccination with FLULAVAL TETRA. The nurse did not document causality with the other events. Follow-up information was received on 09 December 2013 via healthcare professional (nurse), who is also the subject. The subject had not received FLULAVAL TETRA previously. The subject reported the events occurred on 31 October 2013 and are unresolved (different from initial report). The reporter did not consider the events to be serious. She did not attribute the events to medical history/concurrent illness, lack of efficacy or suspected transmission of infectious agent via medicinal product. Follow-up information received on 08 January 2014 via physician who reported the events started shortly after the subject received the flu shot and have since resolved. The physician did not attribute the events to medical history/concurrent illness. The physician reported the subject "came to see me one and half after the vaccine was given at her work. She doesn't want to receive flu shot again. Her symptoms had resolved by time she presented to me." At the time of the report no other information was provided.
Second dose of Pfizer Covid19 vaccine on 07June2021. Onset of pleuritic chest pain on 10June2021 with elevated troponin. Cardiac MRI with epicardial and sub-epicardial enhancement consistent with myocarditis. Also meeting diagnostic criteria for pericarditis.  Evaluation for other potential causes negative.   Currently undergoing treatment for myopericarditis.
This spontaneous report was received from a registered nurse, concerning an unspecified number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses VARIVAX (dose, frequency and route were not reported) lot # M027344 with expiration date of 01-JUN-2018. The temperature of the VARIVAX was between 6 °F and 14 °F for a time frame of 1 hour and 30 minutes; no previous temperature excursion was reported. No adverse effects were reported and no product quality complaint (PQC) was involved. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004588:
tested positive for Covid after receiving his 1st dose of Pfizer Covid19 maroon cap vaccine; tested positive for Covid after receiving his 1st dose of Pfizer Covid19 maroon cap vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 13-month-old male patient received BNT162b2 (COMIRNATY), as dose 1 (maroon cap), 3 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid after receiving his 1st dose of Pfizer Covid19 maroon cap vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course:Caller states that her son's doctor's office scheduled him to have his 2nd dose of Pfizer Covid19 maroon cap vaccine 6 weeks after receiving his 1st dose. Caller is asking, "is there a problem if his son receives his 2nd dose later than the recommended vaccine schedule.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Day 9: Itchy feet in evening Day 10: Woke up to rash over mostly around feet, ankles,  arms, and thighs.  Toes tender like after walking on hot asphalt. Day 11: Rash worsens to  full body and to itchy, inflamed hives.  Toes painful and difficult to walk with slight discoloring.  Different more bumpy rash develops on right arm about the size of a palm.  At this point I read up on side effects because of the correlation to injection site and seems like I have all three skin reactions: Covid toes, full body rash, and Moderna arm and begin Benadryl. Day 12 (today): Feet very tender to walk, rash has not worsened, but not improved.
Did not feel well for a few days; lost 95 pounds; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL9267), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pre-diabetic" (not ongoing), notes: no longer a diabetic or pre. No medicine.; "diarrhea" (unspecified if ongoing); "migraine" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bystolic for high blood pressure; Colestipol for diarrhea; Metformin for pre-diabetic . The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Did not feel well for a few days"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost 95 pounds". Relevant laboratory tests and procedures are available in the appropriate section.
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. The patient's medical history, current medical conditions, historical drugs, drug reactions and allergies information was not provided. The reporter stated that, on 22-MAR-2018 and on 03-APR-2018, the patient was vaccinated with the first and second dose, respectively, of GARDASIL 9 (inappropriate schedule of drug administration), intramuscularly, for prophylaxis (anatomical site of vaccination, lot number and expiration date were not reported). The reporter also stated that there were no known adverse effects. All the reported information was reconfirmed with the reporter, and no further information was provided.
Approximately 24 hours post vax, complaint of redness, pain left deltoid. MD noted no acute distress positive redness with slight induration left lateral arm, treatment dicloxacillin.
11/21/12 24 hrs after: itching, swelling, blistering of both arms, hands- worse on Rt side (inj on left) even up behind Rt ear. Itching was intolerable. Blisters started1/4", then stretched 4"-5" long, lasted 40 hours. Coughing & sore throat.
I had fatigue and fell. I could not get up and was there for 2 days until someone found me. I was taken the ER. They did blood work, showed my electrolytes were low. It also happened a second time were I fatigue and feel.
Lymph node swelling mainly in left arm but spreading to right arm with a few hours.  Started with redness and hives then spread out across underside of both arms. Day 2 included waking up with swollen hands and face.  Mainly effecting left eye.
w/in 48hr of vax broke out in rash-cold, clammy skin, inconsolable screaming;partial complex sz x 3-4 daily;
Received immunizations 082610. Was given TYLENOL prior to immun. During night (430 AM) client had 103 degrees temp; TYLENOL & MOTRIN, alternating given. Had temp 2 days. Got better; 3rd, 4th day. On 5th day had 101 to 101.8 temp. gave more TYLENOL; feeling better. Today she couldn't get out of bed because her legs hurt & she couldn't stand up. Had fever 101.6 degrees. Fever went down. Didn't stay at school.
Today, 2/18/21 I noticed a large red patch on my upper left arm. I believe it?s now referred to as  ?COVID arm?. The two evenings before,  the injection site was itchy which it hadn?t been before . But only turned red and slightly swollen and warm this morning. Not painful.
Itching about two hours after did not scratch took Benadryl woke in the morning to a red very swallon lump on arm . Got bigger through out day. At 3 pm put a circle around it and the morning of the 5th it went past circle called primary and he said it was bacterial infection , warm and itchy. Put me on cephalexin 500 mg three times a day for seven days.
Patient fainted about 5 minutes after shot in waiting area.  EMT/hospital attributes to low blood pressure and patient not having breakfast.
A male with PMH of ESRD ON PD, HTN, CHF and DM presented to the ED via EMS with complaints of generalized weakness and altered mental status. Pt is a poor historian and the history is taken mostly from review of chart and ED provider. Pt lives with his son who does the PD but he has COVID and is quarantined so pt's last dialysis was 8/20/21. Pt tested positive for COVID today and only got the vaccine earlier this month.  CXR shows patchy airspace disease in lungs.TMAX in ED 100.4, HR 112, RR 25. O2 sat on RA was 87%, 90% on 6L ans 98% on high flow NC. SBP has been i the 160s.
extreme bloody diarrhea lasting roughly five hours starting at 7:00 p.m.   on October 1.  After passing blood once again in the middle of the night, bleeding completely stopped the following day and normal stools appeared by the end of the day.  I also breifly suffered from extreme dehydration briefly until I replenished my fluids.
Booster; He stated the female patient died; Transverse myelitis; Unable to move her arms and legs; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose number unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (death), outcome "fatal", described as "Booster"; DEATH (death), outcome "fatal", described as "He stated the female patient died"; MYELITIS TRANSVERSE (medically significant) after vaccination three days, outcome "unknown", described as "Transverse myelitis"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "Unable to move her arms and legs". The event "unable to move her arms and legs" was evaluated at the emergency room visit. The patient date of death was unknown. The reported cause of death was "He stated the female patient died". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: He stated the female patient died
Pruritus; Like her skin is very sensitive to anything that is touching it; It worried her/has so much anxiety over this; Itchy mouth; Thrush in mouth; Her mouth gets really dry; A little bit of nausea; This is very depressing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Pruritus), SENSITIVE SKIN (Like her skin is very sensitive to anything that is touching it), ANXIETY (It worried her/has so much anxiety over this), ORAL PRURITUS (Itchy mouth) and ORAL CANDIDIASIS (Thrush in mouth) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hormone replacement therapy. Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO), FAMOTIDINE (PEPCID [FAMOTIDINE]) and LORAZEPAM for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (Pruritus), SENSITIVE SKIN (Like her skin is very sensitive to anything that is touching it), ANXIETY (It worried her/has so much anxiety over this), ORAL PRURITUS (Itchy mouth), ORAL CANDIDIASIS (Thrush in mouth), DRY MOUTH (Her mouth gets really dry), NAUSEA (A little bit of nausea) and DEPRESSION (This is very depressing). The patient was treated with SALICYLIC ACID (EUCERIN [SALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Pruritus), SENSITIVE SKIN (Like her skin is very sensitive to anything that is touching it), ANXIETY (It worried her/has so much anxiety over this), ORAL PRURITUS (Itchy mouth), ORAL CANDIDIASIS (Thrush in mouth), DRY MOUTH (Her mouth gets really dry), NAUSEA (A little bit of nausea) and DEPRESSION (This is very depressing) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported itching were in odd spots, behind her knee, back of neck, hands, bend of her hands, in really weird places and felt very horrible. Patient used an unspecified anti-itch cream for the treatment of the events.   According to the latest follow-up conditions still persisted but she felt slightly better.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Reporter information, medical history, event Information and treatment medicine updated. On 06-Apr-2021: Update on outcome of events. On 09-Apr-2021: Events outcome updated.
C/o right am numbness from injection site down back of arm.  Full ROM of R. arm.  Felt dizzy, slight redness below injection site. BP taken was elevated, sent to ED for additional monitoring
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 19-FEB-2016, the patient was vaccinated with a dose of GARDASIL (lot # L020015 and expiration date August 2017, unknown route) and with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route) which were exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
she fell body ache and muscle pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (she fell body ache and muscle pain) in a 32-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 16-Apr-2021, the patient experienced MYALGIA (she fell body ache and muscle pain). At the time of the report, MYALGIA (she fell body ache and muscle pain) outcome was unknown.            The concomitant medications were not provided. The Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a certified medical assistant referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored M-M-R II (batch/lot number #K012473, expiration date 26-AUG-2016, batch/lot number #L032182, expiration date 25-AUG-2017, batch/lot number #L041456, expiration date 22-OCT-2017, dose and route not provided). No adverse reactions were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Hospitalized.  2 doses of Moderna on 1/21/21 and 2/28/21.
This is a spontaneous report from a contactable occupational health nurse. A 50-year-old male patient of an unspecified ethnicity received PREVNAR (Lot Number: F8804; Expiration Date: 30Sep2013), intramuscular on 22Jan2013 at 10:00 hours at 0.5ml single dose on left (deltoid) upper arm. Medical history included an ongoing allergy to penicillin. Concomitant medications included FLUZONE (Lot Number: UN713AB; Expiration Date: 30Jan2013) on the left upper arm on 16Jan2013. The patient previously received the flu vaccine on 25Oct2011. The patient previously received MENACTRA on 03Nov2010 at the age of 48-years-old and experienced fever. It was also reported that the patient had body aches and fatigue after receiving an unspecified immunization on an unknown date in 2010. On an unknown date, the patient experienced flu like symptoms and fever, which lasted 2-3 days. On 22Jan2013, the patient had body aches, chills, and left arm soreness. The patient experienced fatigue on 23Jan2013. The patient was advised to be on bed rest. The clinical outcome of the events, flu like symptoms and fever, was recovered on an unknown date. The clinical outcome of the event, body aches, chills, and fatigue, was recovered on 25Jan2013. The clinical outcome of the event, left arm soreness, was recovered on 26Jan2013. The nurse assessed the events, flu-like symptoms and fever, as possibly related to the PREVNAR. The nurse assessed the events, body aches, chills, left arm soreness, and fatigue, as related to PREVNAR. Follow-up attempts completed. No further information expected. Follow-up (25Mar2013): New information received from the same contactable health nurse includes: suspect product data, past drug event, reaction data (added events: left arm soreness and chills), causality of events, body aches, chills, left arm soreness, and fatigue (related). Follow-up attempts completed. No further information expected.
Patient received vaccine 08232022 ...The following days no reaction. At about day 7 after vaccination Patient could not lift arm do to shoulder pain. Patient thought about visiting ER or PCP however did not. At day ten and on patients symptoms totally resolved on there own. Patient Never visited hospital or primary physcician
Within 5 min he developed a rash, had facial flushing and become lightheaded.
pATIENT STATED HER TOP LIP FELT KINDA FUNNY. DID NOT NOTICE ANY SWELLING
trouble producing enough saliva to swallow.  observed for 30 minutes. mild improvement with grape juice, ems called to continue to observe.
40 x 40 mm erythema, site tenderness cool compress (localized reaction) To call if area becomes worse
Embolic stroke 2 clots found, 1 in right MCA, 1 in right vertebral artery which also had dissection
Tinnitus in left ear, started on Weds 10/27/21, tinnitus is constant in left ear
This spontaneous report was received from a registered nurse referring to a 15 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD lot # N015625 with expiration date: 15-NOV-2018 (strength, route and anatomical location were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK) (strength, dose, route, lot #, expiration date and indication were not reported). The reporter stated that the patient was administered PROQUAD when the he/she was already 15 year old. No adverse effects reported.
Fever to 102, night of GARDASIL and 2 Varicella 2 MENACTRA., resolved with Tylenol, no other symptoms.
I had my injection 5 minutes after, I fainted and began hyperventilating. Heart spiked to 160bpm, blood pressure 180/90, Temperature spiked to 38.9. Heart rate kept spiking on and off for hours I was transferred to hospital for monitoring and after and I was dizzy for 4 days still after vaccine.
HIVES, AND FAST HEART BEAT, ON GOING THROUGH OUT THE DAY, TREATMENT: HAVE TO MAKE A DOCTORS APPT.
Pt devel fever 2-3hrs p/shot & had febrile sz; no sequelae noted; had hx febrile sz w/high fever & OM;
2 weeks after first vaccine: Large rash suddenly appeared on upper arm (looks like subcontinent). Very stiff neck and shoulder on left too.
PATIENT FEELS NAUSEATED.  CHECK BLOOD SUGAR, ADDITIONAL 15 MINUTES ADDED TO TIMER. NO APPARENT DISTRESS. FINGERSTICK BS IS 65. A COKE AND CHEESE CRACKERS WAS GIVEN TO PATIENT. PATIENT IS BETTER WITH NO NAUSEA. DAUGHTER IS A NURSE WHO WILL RE-CHECK BLOOD SUGAR AT HOME. TEN MINUTES PATIENT WANTED TO LEAVE.
pt recvd vax; woke up from nap,would not walk,crawl;high pitched cry x 3-4 hrs;T 104;apap brought T down;very irritable;would not cry  when nursing;MD notified;much improved in the am; no apparent problems now;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 01-JUL-2015, the patient was inadvertently vaccinated with expired M-M-R II (lot # not reported, expiry date 17-APR-2015, dose not reported). No adverse effects were reported. Additional information has been requested.
31 year old with past medical history of peroxisomal vasovagal vértigo was vaccinated on left deltoid area.... With light headedness 1 minute after vaccine... layed on floor for about 8 minutes untill complete improvement  and than seated on a chair, 2 minutes after patient felt light headed again and subsequent fainting patients legs were raised and sternum got rubbed and patient woke up 5-19 seconds with mild disorientation that lasted about 3 seconds patient was layed on floor for about 15 minutes sith compete resolution of symptoms. 20 minutes after patient had another episode of lightheadedness and again got layed in the floor for 5 minutes this time with ko major events.