chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Proquad Vaccine & pt experienced redness & swelling around site. Lasted 3 days treated for cellulitis with Cefdinir.
Muscle ache; Joint pain; Fatigue; This is a spontaneous report from a contactable Physician. A 66-years-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on 02Nov2020 at 0.5 ml single to protect against pneumococcal pneumonia. There was no medical history. There were no concomitant medications. He got a dose of Prevnar 13 and experienced the typical muscle aches, joint pain and fatigue that may arise, he thinks that happens typically it is nothing major but he thought he should report it. He says the muscle aches, joint pain and fatigue better now than it was this morning and he is assuming that by tomorrow he will be back to baseline because it is better tonight than it was this morning. He says this is his first time reporting and he just experienced it today, it started today 03Nov2020. He says it was nothing from the shot itself. He received the injection yesterday (02Nov2020) and then the muscle aches, joint pain and fatigue started today. He says he has no reason to believe there was a problem with the product or anything was defective, he thinks this is just something that happens. He believes the dose 0.5 ml one time injection. It is just one time injections for adults, he believes kids have to get more frequent scheduled injections of it but for adults it is just once. Causality was not provided. He believes these are very common things that happen and aren't serious, they happen all the time. He says if for some reason it gets worse he would call back but he assumes it will be going away. Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot obtained.
fever; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Boostrix. On 22nd September 2020, 1 days after receiving Boostrix, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were recovering/resolving.   It was unknown if the reporter considered the fever and fatigue to be related to Boostrix.  Additional details were provided as follows:  The age at vaccination was not reported. The following day of vaccination, the patient experienced fever and fatigue. At the time of reporting, the patient was recovering. Health care professional did not provide lot number and expiration date of the 1st dose. The did not consent to follow-up.
Psychiatric symptoms; Talking really fast; Not being with it, acting strange; Not coherent; A spontaneous report was received from a physician who was also a 34-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed psychiatric symptoms, talking really fast, acting strange, and incoherent.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 05 Jan 2021 in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, she experienced psychiatric symptoms. She started talking very fast, not being with it, acting strange, and incoherent. The symptoms got progressively worse by that evening and was taken to the emergency room. She was treated with an intramuscular antipsychotic and observed overnight.   On 07 Jan 2021, the patient was discharged from the hospital. Since she has been released from the hospital, she has been fine.   Action taken with mRNA-1273 in response to the events was not provided.   The events, psychiatric symptoms, talking really fast, acting strange, and incoherent, were considered resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of 34- year-old female patient who experienced serious unexpected events psychiatric symptoms, talking really fast, "not being with it," acting strange, and incoherent 13 hours after administration of mRNA-1273, lot # 026L20A, Exp date-unknown. Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded.
The following week, patient developed sore throat, fever and abdominal pain and was ultimately diagnosed with appendicitis.
Pt. became pale and unresponsive, she slumped against her mother, preventing her from hitting her head, she became alert within 5-8 seconds. She laid down for 30 minutes with cold cloth on her head, had some water and juice. She reported she had not had breakfast or any fluids this am. After 30 minutes, she sat up with no adverse symptoms, mother took her home with instructions to call MD or go to ER for any further problems.
Pt was fussy, not moving his right leg, developed red and swollen ears and hives that were located all over his body.  One day post vax the pts eyes became swollen. Pt was treated with Benadryl.
PATIENT LEFT ARM BECAME RED AND VERY SORE. SHE STATES THAT SHE WENT TO DOCTOR AND WAS DIAGNOSED WITH CELLULITIS. SHE WAS GIVEN A RX OF CLINDAMYCIN AND MEDROL DOSEPAK.
her husband (72 y/o male) also tested positive for Covid; her husband (72 y/o male) also tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 08Oct2021 as dose 3 (booster), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "her husband (72 y/o male) also tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had significant bruising with a knot at the injection site.  Patient stated that she was on an anti-coagulant. She was worried about a blood clot occuring causing serious harm.
pt recvd vax 28APR94 & exp flu-like sx x 3 days;
Anxiety reaction vs. fear of shot. Physical exam negative. Ovservation only: no treatment. Per check noext day, patient was asymptomatic.
About 10 min after vaccine was given patient fainted next to brother on the chair. Lost consciousness about 1-2 seconds and patient came back. Laid him on the floor and elevated his feet for 10-15 minutes until we helped patient walk to the exam room next door and laid down and elevate his legs again. After 20-25 minutes patient return to normal vitals and color and was discharged.
Pain at injection site within 5 minute Red rash on entire left arm after 3 hours, lasted for about 12 hours Severe pain in left arm for 3 days,  could not touch injection site/lay on left side without pain Joint pain in left shoulder, right shoulder, left elbow, left wrist, seemed to be spreading out from injection site, previously had Covid in September and was still experiencing "longhaulers" symptoms of severe random joint pain, usually occurring at night, had never experienced this previous to having Covid and severe joint and body aches were most predominant Covid symptom.
Patient has 4 in X 3 in dark pink patch at injection site. Arm is very painful from shoulder to elbow. Patient used ice packs and BENADRYL still monitoring symptoms.
Hives and itchy skin starting on face, scalp, and back of ears. Eventually progressing to arms, hands, neck, inner thighs/groin and buttocks regions.
Headache, Myalgia, NauseaVomiting, fatigue Narrative:  Employee reports headaches, fatigue, body aches, and nausea.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided
04/08/23 presents to ED for "fatigue". PMHx of "HTN, COPD, OSA, CAD, CHF, addison's disease"
constant fever of 103 degree F with constant screaming for 10 days starting the day of 4 month vaccinations.
Breakthrough case admission after 5 vaccines Pfizer 2/17/21 Lot# EL9267;  Pfizer 3/9/21 Lot# EN6199;  Pfizer 10/19/21 Lot# EW0164;  Pfizer 8/3/22 Lot# FMQ173;  Pfizer 10/5/22 Lot# GH9702
Asthma attack; A spontaneous report was received from a consumer (patient) which concerns a 64-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced an asthma attack.  The patient's medical history and concomitant medications were not reported.  On 02-Mar-2021, the patient received his first dose of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 25-Mar-2021, the patient had an asthma attack.  Treatment included prednisone and levabuterol nebulizer breo ellipta for 5 days.  Action taken with mRNA-1273 was unknown.  The outcome of the event asthma attack was unknown.
pt rec vax & became feverish & high pitched cry & convuls;family MD said never lte pt have pertussis shot again;5APR95  another MD crossed it out on pt files & pt recv vax & went into convuls, high fever, loss of speech & unable to walk;
Head began to itch before bed.  Next day whole body seem itchy especially my back.  Took 50 mg Benadryl at 8:00 pm.
Myalgia, inj site pain, discomfort, body aches, malaise, chills Narrative:
chest tightness; breathlessness; Was sick; In the bed the whole day; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness), DYSPNOEA (breathlessness), ILLNESS (Was sick) and IMMUNISATION REACTION (In the bed the whole day) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Patient had no COVID plus test or diagnosis. He was tested periodically and he did not have any symptoms.  Concurrent medical conditions included Allergy to antibiotic (Tetracycline).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced CHEST DISCOMFORT (chest tightness), DYSPNOEA (breathlessness), ILLNESS (Was sick) and IMMUNISATION REACTION (In the bed the whole day). In January 2021, ILLNESS (Was sick) and IMMUNISATION REACTION (In the bed the whole day) had resolved. At the time of the report, CHEST DISCOMFORT (chest tightness) and DYSPNOEA (breathlessness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. It was reported that patient thought he was scheduled to get the stress test on 25-Oct-2021. They found out that there was blockage of greater than 70 percent in 5 areas of his heart but he was told that there was no heart damage and only the blood vessels were affected. So they advised him to see a doctor right away and he was already scheduled for his 1st booster dose on 26-Oct-2021. He does not think that this was related to the vaccine. Patient medical history related to mentioned AE and both acute and chronic illness at the time of vaccination.  Cardiac related signs and symptoms: Chest pain/pressure/discomfort/angina pectoris: yes, Dyspnea/shortness of breath/pain with breathing: yes. Symptoms were still ongoing even after quadruple bypass.   This case was linked to MOD-2022-571226, MOD-2022-571162, MOD-2022-571165 (Patient Link).
Client developed  itchy rash to face, neck and chest approximately 15 minutes after injection.  Client then reported that she had similar experience after her flu vaccination the past 3 years.  Client took 25mg of Benadryl and was monitored for an additional 30 minutes at clinic site until rash was resolving.  Client denied any issues/ complications with swallowing or breathing.  Rash and itching was resolving prior to client leaving vaccination / monitoring site.  Her significant other had brought her to the clinic and was available to drive her home.  EMS was also on scene but did not need to provide assistance.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium
Injection site soreness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to molds, Allergy to antibiotic, Drug allergy, Drug allergy and Drug allergy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-336776, MOD-2021-344344 (Patient Link).
Patient  was approximated 10 weeks pregnant and received her second dose of the Pfizer vaccine on 6/16. Four hours later, she began cramping  and spotting. This worsened over 3 days. She began hemorrhaging hours prior to her  ER visit . She was hypotensive and required an urgent suction curettage
Approximately 30 minutes after the vaccine, my vision became blurry, but only last about an hour, if that.  The following day, off and on throughout the day I would get lightheaded and feel like I was going to pass out. From Sunday, April 11 until April 28, this feeling was ongoing.  I never actually passed out, I just felt like I would. The faster I moved, the worse it felt.  I was staying hydrated, but it didn't make a difference.  My bloodwork didn't show anything abnormal.  WBC 7.9, RBC 5.13
1st dose in Oct2021, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in October 2021).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: The reporter did not provide the lot number an expiration date of the first dose administered. A pharmacist asked for information about a patient who received the first dose of Shingrix and then never received the second dose. The pharmacist asked if the patient needs only a booster dose of Shingrix or if it needs to start over with the vaccination. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Axillary gland swelling on shot side, fever of 99, fatigue and nausea. Not mentioned on app because didn?t know a Il lady gland swellings was a known side effect. Also had 3?X5? red itchy hive around vaccination site, took Xyzal and Allegra through today and the hive has now gone away completely.
At night I had a temperature of 101 and my heart was racing so fast it felt like it was going to beat out of my chest. I laid my phone on my chest and it was moving up and down and was visible to my wife. I did not seek medical care. My second shot is scheduled for 4/7 @ 9:45 AM.
J96.00 ACUTE RESPIRATORY FAILURE 5/20/2022 HYPERLIPIDEMIA
Patient turned pale after 2-3 minutes of receiving all 3 vaccinations and recovered slowly next few without intubation.
After receiving the first shot on 2/3/2021 - I felt a general overall tired, headache, and achy.  After receiving the second shot on 3/3/2021 - I felt overall sick with body aches, headache, and chills. I also experienced stomach upset and nausea with feelings of throwing up.  I also experienced dizziness. I expereinced leg cramps throughout the first night that accompanied the body aches. I felt bad for about 52 hours meaning that my daily activities were difficult to maintain and function. I depressed appetite for 48 hours. Dizziness and nausea accrued randomly throughout the following 4 days.
a 52 y.o. male sent for evaluation due to symptoms which have now lasted for months and began occurring shortly after he received his second Materna vaccine.  He had his first Madrona vaccine on 3/26/2021, and his second vaccine on 4/23/2021.  Initially he noted headaches, neuralgia, chills and sweats, and just suspected these would dissipate as had been described in the media.  His headaches and neuralgia did resolve, but he continued to have significant night sweats and fatigue.  He had one episode where he passed out and struck his head.  This has not recurred for over a month.  He has had 2 episodes of vomiting bilious material these were significantly spread out.  He has noted a 20 pound weight loss and difficulty sleeping.  He does report that in the last few days his symptoms seem to have improved, and his appetite has improved as well, but he has not noticed any weight gain yet.  He did have low-grade fevers the highest being in the 101 range.  He had no visual, taste, pulmonary, genitourinary, rheumatological, or dermatological complaints.  Apart from the 2 episodes of vomiting he has had no GI issues.  His wife is present and concurs with his history.  He has had a significant work-up from his primary care provider who included an LDH in late May that was normal, CBC with differential which was benign, a Monospot which was negative, CRP that was elevated at 85 with 0-10 being the reference range, a negative ANA, negative RA, and a sedimentation rate of 42, blood cultures were performed and were negative.  Labs earlier in the month noted similar findings.  His basic metabolic panel and liver enzymes were also normal.  He was also reportedly screened for Lyme and was negative but I do not see this test result.   He denies any childhood infections of significance. The also went to a safari in 2019.  They traveled recently prior to the onset of his symptoms but he reports no known bites or scratches by ticks, insects, mosquitoes, or other animals.  No one else in the household has been sick.  He did receive the BCG vaccine as a child.  They also report a chest x-ray was performed and was benign.  He was given a 10-day course of amoxicillin and reports no significant improvement while on this.
Patient complained of throat constriction 30 mins post vaccine, became pale. Vials signs wnl. Epi administered and EMS called, patient taken to hospital for observation. Per patients mother report given benedryl and steroids in the hospital, under observation.
Approximately two (2) hours after the shot, I experienced extreme fatigue and lethargy and went to bed at 7:00 pm and slept until 4:45 AM.
First Dose regular symptoms, fever, server sweats, chills, body aches.  Second Dose same as above accompanied chest pain and shortness of breath. The chest pain and shortness of breath lasted a week, a full 7 days after the vaccine/
Itching, blotchy arms Neck and chest itching benadryl at 1754 Reversal of symptoms at 1815
going through the side effects; 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 VACCINATION COMPLICATION (going through the side effects) 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 VACCINATION COMPLICATION (going through the side effects). At the time of the report, VACCINATION COMPLICATION (going through the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
TIA (small stroke); This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA (small stroke)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L02A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA (small stroke)) (seriousness criterion hospitalization). The patient was hospitalized on 05-Jan-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA (small stroke)) 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.   Treatment information included she was currently under medical examination for the causes and treatment of the stroke.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of TIA, a causal relationship cannot be excluded.   This case was linked to MOD-2021-066107 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of TIA, a causal relationship cannot be excluded.