chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemia, and smoking who presented to the ED yesterday morning with 1 day history of chest pain. Patient described the CP as moderate aching in the substernal area that did not radiate. The pain was intermittent, with each episode lasting 1-2 minutes. The CP was associated with LUE numbness and SOB on exertion. The chest pain and LUE numbness have now resolved. Patient also reports a three week history of RUE swelling. The swelling gradually worsened and is now associated with pain and proximal RUE bruising. RUE pain is rated 5/10. In the ED, patient was found to have NSTEMI and small right lower lobe segmental pulmonary artery embolus. Venous Doppler was positive for occlusive thrombosis in the R subclavian, basilic, and cephalic veins. Patient was started on IV heparin. Patient is scheduled for cardiac cath today. Hematology is consulted regarding PE and RUE DVT. Patient denies personal or family history of blood clots or recent travel. Reports receiving COVID vaccine in LUE approximately three weeks ago. Also admits to being more sedentary recently due to being unemployed. Denies nausea, vomiting, bleeding, bowel changes, fever, or chills.  Significant PE findings: RUE edema, firm and tender to palpation, ecchymosis on proximal RUE, distal sensation and active ROM intact
Body shaking; Chills; Tingling; Nauseous; Body ache; Tiredness; having like little sweat; This is a spontaneous report from a contactable nurse (reporting for herself). A 59-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration from 08Jan2021 07:40 at single dose for COVID-19 immunization. Medical history included hypertension, high cholesterol and COVID-19  survivor from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had historical vaccine of first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient stated, "I am calling to report a side effect from the vaccine (Clarified COVID-19 vaccine). I am a health care worker, I got the first dose I was fine but I got the second dose last Friday and I woke up hour later with terrible chills, tingling, my body shaking. It was not half an hour later, it was hours later. I took it at 07:40 in the morning at work and then I came home, I was fine but then chills woke me up in mid night Friday it was Saturday, let's say Saturday morning 12 am. I woke up with chills like, I am in refrigerator and I felt like I wanted to warm it but I did not, I felt nauseous, it happened like two different times and after that I took like Motrin (treatment) I did not have any temperature but I have like body ache and after that I started having like little sweat and tiredness. I just call my job now. Having the same symptoms now." The patient took Motrin and Tylenol and underwent lab work at the hospital with unknown result. The patient think that the events were related to COVID as the patient stated, "I think so because I woke up with the chills extreme chills. I never felt that way, it's like the last time when I felt it, when I had COVID, I woke up with extreme chills the only difference between this one was that I didn't have a temperature with these chills but with COVID I have temperature but this one was extreme chills." The outcome of the events was unknown.
SORE ARM; LITTLE FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-JUL-2021, the subject experienced sore arm. On 01-JUL-2021, the subject experienced little fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and little fever was not reported. This report was non-serious.
High fever, got the shot on the 31st and the next morning I felt weak, dizzy, vomiting, and I could not walk. I was taken to the ER and I had a 102 fever. My arm was swollen at the site of the shot. I was given Tylenol, Zofran. The next day I still had swelling on my arm and a swollen lymph node under my under arm. size of a peach. Lasted about three days. I had chills and a cold sweat on the third day and I was soaked in sweat. My fever finally broke. On the sixth day I finally started feeling better.
Started with rash at 0430 on right hand then spread to right shoulder and right thigh. Went away at noon then returned on left side at 13:30.
Developed a quarter size welt at site of injection. Home from school hot to touch. Ice pack applied. By 7:30pm, grew to baseball size. Raised and firm. Benadryl given. In am at 6:30 on 10/27/15, measured 4 inches x 4 inches. Was instructed by doctor's office to keep ice on 20 minutes every one hour. By 3pm on 10/27/15, continued to grow in size. Went to Urgent Care. Physician Assistant outlined swelling. Was instructed to start amoxicillin next am if extends below the line. Patient had no appetite that day. Benadryl given at night and continued with ice when able. On 10-28-15, started antibiotics. Swelling measured 7 inches by 7 inches. He did not feel well and stayed home from school. Was home with mom who is a family medicine nurse.
Initial information received on 26-Sep-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to case 2018SA271104 (same reporter). This case involves an unknown age male patient who experienced flu like symptoms after they had higher dose of flu vaccine last year which didn't work. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient reported to had serious flu like symptoms with Unknown latency following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event on an unknown date. It was unknown what flu shot this patient had received. Lab data was not provided. Final diagnosis was flu like symptoms and drug ineffective. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender- none. Sender's Comments: This case involves a patient of unknown age and developed flu post vaccination with Influenza vaccine produced by unknown manufacturer. Time to onset is unknown. The time to onset, immune status of the patient, lab test ruling out other infectious etiologies are not provided. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Pt recv vax on 10/23/98; 7 hr post vax pt exp indurated knot at vax site, continuous crying, restless, whining, moaning
Patient received 0.25ml of Moderna bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.   It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received patient age group, narrative updated.
he has not stopped vomiting since 1-2 hours after receiving the vaccine; Patient got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VOMITING (he has not stopped vomiting since 1-2 hours after receiving the vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient got expired vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bee sting hypersensitivity, Drug allergy (Hydralazine), Drug allergy (METOCLOPERAMIDE), Drug allergy (NORVASC), Drug allergy (LASIX), Coronary artery disease and Congestive heart failure.    On 28-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced VOMITING (he has not stopped vomiting since 1-2 hours after receiving the vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient got expired vaccine). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) (intramuscular) ongoing since an unknown date for Vomiting, at a dose of UNK (Zofran shot). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient got expired vaccine) had resolved. At the time of the report, VOMITING (he has not stopped vomiting since 1-2 hours after receiving the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow-up includes: Patient Demographics, Medical history and Suspect information were updated
This spontaneous report has been received from a 66 year old male patient concerning himself. Information regarding the patient's medical history, and concurrent conditions was not reported. Concomitant therapies included ascorbic acid, vitamin d  and calcium. Drug reactions or allergies included aspirin. On 23-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 ,5 ml, in the upper arm, by intramuscular route (strength, lot # and expiration date were not provided) for prophylaxis. Then on an unspecified date in 2018, reported as "a couple of days later", the patient developed pain and soreness at the injection site (injection site pain) and also a slight headache. The outcome of injection site pain and headache was reported as not resolved. The causality assessment between therapy with PNEUMOVAX 23 and the events was not reported.
Initial case received from a Health Care professional, who is also the patient, on 01 April 2014. A 49-year-old female patient, with a reported medical history of migraines and allergy to penicillin (reported as "allergy PCN") and no reported concomitant therapies, had received a dose of FLUZONE on the left deltoid on 30 September 2013 (batch number UH910AC, route of administration not reported). She had previously received several yearly flu shots. On 18 March 2014, the patient experienced flu-like symptoms. She was tested positive for both the A and B strains of influenza. Substrains were not identified. Results were negative for H1N1. Chest X-ray was normal. The patient took self-medication with ZITHROMAX for an unspecified productive cough. The patient recovered from the events. Documents held by sender: none.
Marked erythema, pain, swelling from R side of neck to just below elbow.
Patient came to pharmacy on 03/31/2023 and informed that she had redness,bump and swelling after she got the boostrix vaccine on 03/18/2023 which became worst after 4 days. It was itchy, painful and swollen. Now she is getting better, but she is still a little itchy, has redness and some pain. Patient also informed me that the redness traveled down her arm. Recommended patient to see a doctor.
pt recv vax 17MAY95 & was hospitalized the following day w/pain in chest, arm, neck, & jaw; heart attack r/o; pt also devel inj site rxn consisting of swelling, erythema, warmth @ site; pt remains hospitalized as of 22MAY;
Initial unsolicited report received from a nurse on 09-Jul-2018. This case involves a 2 months old female patient who experienced who was vaccinated with a 0.5 ml first dose of ACT-HIB (batch number: UI799AAB, expiration date: 08-Jul-2018, dose in series was not reported) via intramuscular route in the left thigh on 09-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included ROTAVIRUS VACCINE and PREVENAR, PARACETAMOL for an unknown indication. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient had experienced any adverse events or not. 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. Documents held by sender: none.
This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (Lot No. L007228 exp. 03-SEP-2016) (dose, frequency and route were not described). No concomitant therapies were reported. No adverse event information was provided. No product quality complaint was involved. This is one of two reports received from the same source (MARRS# 1508USA003868). Additional information has been requested.
Mother called this reporter, wanting to seek advisement about daughter if she was having a reaction to vaccine?  Mother reports that daughter was fine after waiting 15min period and completed errands before heading home when mother noted her beginning to have increased breathing and began to hit herself.  Mother reports that daughter has diagnosis of OCD and is prescribed Zoloft.  Writer asked if this was a first dose and mother reported that this was her booster and had no reaction to the last two doses but states that she has not had a flu shot in the last 2 years but to her knowledge no previous reactions.   Mother denies daughter having difficulty breathing, no rash or redness noted, and no facial swelling noted.  This reporter still recommended daughter be assed but as mother was finishing call with this reporter mother stated "oh, she says she feels better".   Writer still advised caution and seek medical attention if persists and to use v-safe to report incident.
developed a rash 5 days after the vaccine; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated their wife developed a non-itching rash five days after the vaccine. The patient was prescribed prednisone and "now" (as of 26Jan2021) the rash was significantly less. The reporter inquired if the patient should get the second dose. The reporter also inquired about clinical trials; how many "does" was it before they reported side effects, and if the people in the clinical trials that reported rash as a side effect got the second dose. The clinical outcome of rash was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I have problems with my first vaccine, I did it on the 19th and I'm still in a lot of pain; This is a spontaneous report from non-contactable consumer (patient) via Pfizer Sponsored program. A patient of unspecified age and gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch no.: not reported, expiration: not reported), via an unspecified route of administration on 19Jan2021 date at 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had problems with first vaccine, patient did it on the 19Jan2021 and was still in a lot of pain. Patient asked should I get my second vaccine done on the 8th. The outcome of the events was not recovered.  No follow-up attempts are possible. Information on the batch/lot number cannot be requested.
Large area of erythema, approximately 12cm x 7cm, on upper left thigh and warmth.
his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 pounds; energy level changed drastically; weak; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EH9899, via an unspecified route of administration in left arm on 21Dec2020 09:00 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertensive and diabetic, both ongoing. Concomitant medication included metformin for diabetic and olmesartan medoxomil (BENICAR) for hypertensive. There were no prior vaccinations within 4 weeks. The patient received the covid vaccine first dose on 21Dec2020 and started developing covid symptoms on the 27Dec2020. He was tested positive for covid on the 28Dec2020. The patient wanted to know what is next. He patient stated that it has been 10 days and he wanted to know if he is still contagious. He is scheduled to get the second dose on 11Jan2021. He wonders if he can get the second dose or does have to start the process over again. He works in a doctor's office. He is a technician. While providing height and weight he commented it has changed drastically. He later clarified it was his weight that changed drastically. He lost ten pounds. His weight and energy level changed drastically, and this was after getting the COVID Vaccine. His symptoms started the weekend after taking the vaccine. He had COVID symptoms. He later clarified and stated they all started on 27Dec2020. He clarified his symptoms as: body aches and fever. The body aches and fever started the night of 27Dec2020 and recovered from 08Jan2021. He was unable to provide an exact time of onset. These have resolved, but at the time of report he was just weak. He had a COVID test done on 28Dec2020 he tested positive. He confirmed he has not had a follow-up COVID test done afterwards. The patient also mentioned that his brain was still a little cloudy since an unspecified date. The patient had not recovered from the event weak; while outcome of "lost ten pounds", "his brain was little cloudy" and "tested positive for covid" was unknown.
Localized nodule/swelling at injection site immediately following administration. Treated with cold pack and monitoring, no change following 30 minutes.
pt recv vax OCT96 & a few days to 2wk later pt presented to MD w/ one vesicular lesion rash on cheek;It was also noted that pt brother presented w/a chicken pox like rash on buttocks & legs;
Cold chills, diarrhea, vomiting, shortness of breath, muscle soreness, light headed
Information has been received from a registered nurse concerning a 77 year old male patient with no drug allergies and no medical history who on 03-MAR-2011 was vaccinated subcutaneously in the left arm with 0.65 ml (cc) ZOSTAVAX (Merck) (lot # 669536/1387Z). In the morning of 07-MAR-2011 the patient felt itchy on his back near his shoulder blade. His wife looked at his back and he had a circular patch of small blisters on one side of his back near his shoulder (which side of the back was not identified). The circular patch of small blisters was not painful, there was no burning and it was just described as itchy. No treatment was given to the patient. Lab diagnostics studies were performed. The patient was referred to his family physician. At the time of reporting, the patient did not recover from the adverse events. Additional information has been requested.
His left arm  is bright red (about the size of a baseball), his arm is very hard, swollen and warm to the touch. There are also little blisters all around the injection site.
mom called and said that her son got 1st dose pfizer vaccine 2 days ago now his neck is very stiff and in a lot of pain and sensitive to light (mom said he has always been sensitive to light). she called the pedicatrician but cannot be seen today and called us for recommendation. I told her that this sounds urgent since he is also in a lot of pain and bring him straight to the ER. Mom said she will.
pt recvd flu vax 11AM on 19NOV92; 24NOV92 blotches appeared on face then spread to neck; blotches were present for 1 wk;
4 hrs p/vax pt became ill w/gen'l aches, sore throat, congestion; nodes tender & swollen 2-3 hrs;
Sudden swollen lymph node located in left armpit.  Very tender and hurts to touch.  Took Advil and applied ice pack.   Did not seek medical attention.  Waiting for issue to resolve on it's own (hasn't been 24 hours yet since the date of this entry).  It's uncomfortable, but would not categorize as severe.
Information has been received from a consumer regarding a 4 to 6 year old child who may have been vaccinated with a dose of varicella virus vaccine live. The reporter indicated that a child at the day care center where his children go had developed chickenpox over the past two to three weeks. The reporter believed that the child may have been previously vaccinated. It was unknown if medical attention was sought. A product quality complaint was not involved. The consumer also reported up to nine other children at the day care center that had similar reactions after being vaccinated with a dose of varicella virus vaccine live. He also indicated that the cases were mild, however he did not know that two of the cases were not mild. Additional information has been requested.