chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest x-ray, 1/29/92 showed mild cardiomegaly with biventricular enlargement, pleural changes left lung base occasional chest pain, progressing to daily moderate to severe chest pain chest x-ray 9/98 showed greatly enlarged heart shadow, dx of idiopathic pericarditis 10/98 by cardiologist, no relief with ibuprofen, steroids pericardial window surgery 10/98, greater than 300 cc fluid removed peristent daily chest pain continues,varying in intensity from moderate to severe, to the present time treated with Indocin 100-125 mg/d with only moderate relief of pain.  Nurse follow up on 11/01/04 states: "There is no new information."
Fever of 102 degrees, muscle tremors, heart racing (resting heart rate 120), chills, sore arm, diarrhea   Took 2 Tylenol every 6 hours to reduce fever
Caller states his booster dose was .5; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Caller states his booster dose was .5) in a male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Caller states his booster dose was .5). At the time of the report, ACCIDENTAL OVERDOSE (Caller states his booster dose was .5) outcome was unknown.            No concomitant medication information was provided. It was reported that patient's first booster was 0.5 ml instead of 0.25 ml. It was not confirmed that patient was immunocompromised or not. No treatment medication were provided.   Reporter did not allow further contact
rash across chest. numbness tingling across arm (injected arm).  Bendadryl & solumedrol given, returned to ed the next day with tightness in throat & trouble swallowing - Benadryl & solumedrol given - improvement
Information received from the review of scientific literature on 02JUL2018. This is case 6 of 6 (18000138LT, 18000139LT, 18000140LT, 18000141LT, 18000142LT, 18000143LT) The article notes an otherwise previously healthy 19-year-old male who presented to the ED with centrally located pleuritic chest pain approximately 10 days after receiving ACAM2000. His pain started the previous night and had been constant and sharp. The patient's ECG was normal without any PR depressions or ST elevations. His troponin-I was positive at 0.83. A transthoracic bedside echocardiogram showed no pericardial effusion and a normal gross ejection fraction. Cardiology from an outside hospital was consulted and the patient was transferred for further evaluation and treatment of myocarditis. An echocardiogram as an inpatient showed systolic dysfunction without signs of heart failure. The patient was discharged 4 days later with instructions to take colchicine and metoprolol. He was being followed by cardiology as an outpatient, was started on ibuprofen, and was placed on activity restrictions for 30 days pending cardiology follow-up, and made non-deployable. The patient's outcome was not reported in the article. Additional information has been requested.
Splitting headaches; General body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HEADACHE (Splitting headaches) and MYALGIA (General body aches) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (Splitting headaches). In February 2021, the patient experienced MYALGIA (General body aches). At the time of the report, HEADACHE (Splitting headaches) and MYALGIA (General body aches) 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.   Concomitant medications were not reported.  Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
titer tests done on unspecified dates still show her daughter to have "no immunity."; This spontaneous report was received from a pharmacist via company representative referring to a female patient of an unknown age, who was the pharmacist's daughter. The patient's concurrent conditions and concomitant therapies were not provided. The patient's medical history included unspecified "surgery".     On an unspecified date, the patient had three vaccinations with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, frequency, route, lot# and expiration date were not provided) for prophylaxis.        On an unknown date, titer tests were performed, and the patient still showed to have "no immunity" (antibody test negative). No treatment was prescribed for the event. At the time of the report, the outcome of the event was not reported.    The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided.
Scattered wheals on face, arms, sacral and legs. Subdermal edema noted. Benadryl 12.5mg/5ml- 1tsp PO q 6hours prn.
SWOLLEN HANDS AND FEET; TROUBLE WALKING; LUMP ON THE BACK OF THE NECK; This spontaneous report received from a patient concerned an elderly female. 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: Unk) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced swollen hands and feet. On 30-APR-2021, the subject experienced trouble walking. On 30-APR-2021, the subject experienced lump on the back of the neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen hands and feet, trouble walking, and lump on the back of the neck. This report was non-serious.
have an allergic reaction on the skin of the entire body; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Feb2021 (lot number and expiry date: unknown) as dose 2, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunisation; and influenza vaccine which caused allergic reaction. On 22Feb2021, the patient experienced an allergic reaction on the skin of the entire body. It itched a lot and was reddish. She took an unspecified anti-allergy as treatment. She also had an allergic reaction to the flu vaccine before, but this time the allergic reaction was immediate, and she does not know if this allergy was a vaccine reaction or not. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information expected.
pt recvd vax & exp weakness & muscle cramps; when pt recvd 2nd dose, pt exp myalgia in both arms & a recurrence of previous symptoms;
A minute after I got the dose, I felt my hands tingling- lasted about a minute. About 5 minutes later I felt a headache was coming on and getting work. I asked the nurse to take my BP and it was 170/90, its normally 110/60- I sat for another 15 minutes and came down a bit, about 1/2 hour later it was 130/50. I went back to work and worked the whole day. I had a low grade headache. The next on my way home my neck got stiff and had this ponding headache- I drove straight to a Dr. office.  The Dr. took my BP and was 170/90, and said he would put me on BP medication.  The BP reduced the headache a lot but I still have a low grade headache all day everyday. I tried to come off the medication twice and the headaches came back worse and pounding headache. I tried to lower the dosage and it still was serve and my BP went up again.
Received MMR #1 on 9/20/07 and on 9/21/07 mother reports a skin-colored papular rash appeared to child's trunk, arms, and face. No other s/s present. Child was in no distress as per mom, so she did not bring child in until next appointment today on 10/23/07. MMR #2 was held today.
moderate body aches, headache, arm very sore, I was tired.  I developed a hot, red, raised rash(hive)  2" below injection site approx 2.5" x 2.5" on arm.
Patient came in with an order to administer first dose of Janssen in split dose, 7 days apart because she developed anaphylactic reaction to Pfizer vaccine at the hospital. RPh administered first half dose (0.25ml) on 02/28/22. Patient was observed for 1 hr and went home without any complications. Rph instructed patient to go to a hospital location where she can be monitored and treated if needed for the next dose .
Temp of 102 degrees (Temporal artery scan), started 5 hrs after (about 8 pm 10/27/14) the immunizations were administered and fluctuated for 24 hrs. Last temp 100.2 degrees (TA) at 7:30 pm 10/28/14. Vomited x 4 in 24 hrs from 10/28/14, 1:45 am to 10/28/14 5:30 am. No history of diarrhea. Fussy/cranky for 24-36 hrs, starting 5 hrs after imm.
2 hours after injection, patient complained of pain up the arm that was injected and pain continued to middle of back, bp checked and was normal, pulse normal NO chest pain--30 minutes after onset of pain, patient returned to normal
Information has been received from a physician concerning his friend's daughter (age not reported), who on unknown dates, was vaccinated with the three doses of GARDASIL (lot number and route not reported). The reporting physician stated that patient received the first injection of GARDASIL without adverse experience. Shortly after receiving the second injection of GARDASIL, the patient complained of muscle and joint pain. The patient continued to complain even more so after receiving the third injection of GARDASIL. Per one of the physicians, the patent is an accomplished athlete, but after receiving the second and third dose of GARDASIL, she has had difficulties running with muscle pains in her legs and leg joints. At the time of reporting, the patient's final outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Before I left doctors office on Oct. 15, 2010, after receiving the mist, I was experiencing sore throat, felt like my nasal passages & throat were on fire, voice very gravelly & started mild cough (20 minutes w/i) I was extremely sick & required medical intervention a number of times in 7 months after FLUMIST. My norm is once or twice a year I get a sinus infection, once in a while a nagging dry cough w/it. However, I have never had chest/lung problems as I have had after FLUMIST. In the 7 months post FLUMIST I had only a couple of weeks that I was not experiencing problems w/cough & breathing issues. Sometimes a fever presented w/coughing. I did not go to the doctor every time the coughing & breathing issues flared up. I only went when the symptoms were so bad I could not rest. I had the FLUMIST Oct 15, 2010 & was sick pretty much until June 10, 2011. I have been well since then experiencing occasional bouts of coughing & feeling like I can't take a full breath, but after several days the symptoms disappear. This report is not intended for any complaint against the medical facility, Dr, or nurse, I only wanted to report what I have experienced in taking the FLUMIST.
Few hours after vaccine on (L) thigh (either VZ or hep A) red rash to shot site then over 2 hours spread of rash to chest. No other sxs. initially in UC noted to have red throat -> sent to ER (no oral findings). Given IM DECADRON and sent home.
migraine 4hr p/vax student hlth ctr 30OCT96-still had migraine & nausea;h/a sl better 31OCT96;neuro w/u -went home;
Pt reports that he began experiencing (L) arm discomfort at 48 degrees after injection of H1N1 vaccine. It has continued to date with pain on lifting arm above shoulder in any position and involve (L) shoulder front and back; no noticeable swelling at site of injection or underarm today.
Pt got a bloody nose.  This patient received and H1N1 mist four and half weeks earlier and the same thing happened to the patient at the same time of night.  When pt came in for the booster on 12/10/09 it was decided to give an injection instead of a mist to not aggrivate a bloody nose.  This patient has never had a bloody nose in her life.  Both times the parent was able to control the bleeding.  No other reactions or problems noted after either vaccine.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 64 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
15 min after vaccine, I felt dizzy and lightheaded. 2 hours after vaccine, I felt nauseous and lost my appetite  The following morning I felt like I had been run over by a truck. I had a low grade fever of 99.9 that went up to 100.0 measured by ear thermometer  I had joint pain and over all muscle pain By the evening I had mucous in nose, post nasal drip and slight difficulty breathing. I took 2 advils which relieved the fever and body aches On Saturday and into Sunday, I continue to have an over arching malaise, I do not feel healthy.  I feel like my body is fighting something, I developed a slight sore throat and my head feels heavy and foggy. I've continued to take advil.
Headache; extreme muscle aches; joint pain; nausea; burning sensation all over body; This is a spontaneous report from a contactable consumer (patient). This 25-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL1283) at single dose in left arm on 22Jan2021 at 07:30 A.M. for COVID-19 immunization. Medical history included fibromyalgia; GERD (gastrooesophageal reflux disease); known allergies to wheat and coconut oil. Patient had known allergies to cefprozil (CEFZIL), amoxicillin, acetylsalicylic acid (ASPIRINE), aripiprazole (ABILIFY). Concomitant medications in two weeks included escitalopram oxalate (LEXAPRO), venlafaxine, omeprazole, diphenhydramine hydrochloride (UNISOM), ibuprofen (ADVIL). There was no other vaccine in four weeks. There was no COVID prior vaccination, no COVID tested post vaccination. Patient experienced headache, extreme muscle aches, joint pain, nausea, burning sensation all over body on 22Jan2021 at 07:00 P.M. There was no treatment received for the adverse events. The outcome of events was unknown.
This spontaneous report as received from a registered nurse refers to a 14 years old female patient with drug allergy to AUGMENTIN. The patient's medical history included anemia in 2008 and "passing out" seen by cardiologist in 2010. The patient was vaccinated with the first and second dose of GARDASIL (lot number reported as h011350, EXP 21-FEB-2015) intramuscular 0.5 ml respectively on 12-JUL-2012 and 12-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 13-SEP-2012 the patient complained of nausea, vomiting, and severe stomach pain. The patient had sought medical attention via got to urgent care clinic. No treatment was given for the adverse event. There were no laboratory diagnostics studies performed. The outcome of severe stomach pain, vomiting and nausea was unknown. Additional information has been requested.
I have started feeling bad. I had various times where I feel bad. I wasn?t sure if it was physical or related to. My doctor has no expiation for not feeling well. Every six or so I feel general malaise, muscle aches and fatigue. I had COVID-19 in April of 2022. It?s kind of a general feeling as I did before. The difference between last year and last year I have felt an extreme decline in my energy. I take care of myself, so there is no pronounce thing I can describe that could have caused this. I do feel worse I do not know what it is caused by. I saw my doctor just recently and It was mentioned that this could be happening because I had COVID-19.
Case number PHHY2012US079994 is an initial literature report received on 12 Sep 2012. The author discussed about the safety and immunogenicity of H1N1 Influenza vaccination in patients infected with human immunodeficiency virus-1 (HIV-1) via perinatal route. This report refers to a patient whose demographics were not reported. The patient's current conditions included HIV-1 infection via perinatal route. The patient was vaccinated with first dose of S-OIV FLUVIRIN (each dose of 30 micro grams of vaccine) (pandemic influenza vaccine, batch number: not reported) at a dose of 0.5 ml intramuscularly on to unspecified site of unknown date in 2009. It was reported that 14 days after the first dose, the patient experienced grade 2 herpes virus reactivation with dermatomal herpes zoster eruption. Immunogenicity was assessed as specific hemagglutination inhibition titers in serum collected at baseline, 21 to 28 days and 7 months after first vaccination. The outcome of the event was not reported. The causality was assessed as suspected to be possibly related to administration of suspect vaccine. The author concluded the article stating that two doses of double strength H1N1 vaccine were safe and immunogenic and might provide improved protection against influenza in perinatally HIV-1 infected children and youth.
Shingles / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2023 This case was reported via interactive digital media. The reporter stated that everyone he/she know who got this Shingles shot still got Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case had been linked with US2023AMR063830, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR063830:Same reporter. Flux vx case
This case was reported by a physician and medical assistant to a sales representative and described the occurrence of fever in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On an unknown date on or before 19 April 2006, the subject received an unspecified dose of Pediarix (unknown). On an unknown date on or before 19 April 2006, after vaccination with Pediarix, the subject experienced fever and knot in leg at site of administration. The physician and medical assistant reported that "these events possibility happened with several patient's, but did not indicate a specific number of patients at the time of reporting. They also reported that "the fever happened with vaccine purchased with public, as well as, private funds because it could have happened on both sides of the clinic (one part is 'VFC'- public). The fever resolved by the second day after the Pediarix was administered. The outcome of the knot at the site of administration was unknown. The physician considered the events were probably related to vaccination with Pediarix.
patient initially devleoped joint pain, fever, chills, vomiting abd distention on 7/11/21 then on 7/14/21 awoke with diffuse maculopapular rash over entire body and came to ED.
Experienced chills and shaking about 7:30pm, mild and subsided in about 15 min, Then about 1/2 hour later started again with more intensity and lasted half hour to 45 min.  During this second episode I experienced shortness of breath, like I had been running and panting  trying to catch my breath.  Extreme discomfort, then ran a fever most of the night, did not take temp. Everything hurt all night, back, skin, bones. By morning started to ease and am recovering.
Pt expereinced a pustular pox-like rash on right arm and right cheek area.
pt recv vax 18SEP97 reportedly that evening, pt got cellulitis, pt has hx of cystic fibrosis, skin was tough, they gave the vaccination over forearm area;
About 5-10 minutes after receiving Tdap vaccination, patient leaned forward in chair, became pale, unresponsive, and eyes deviated to the left.  The episode was witnessed by the clinician.  The episode lasted about 5-10 seconds.  The patient was not injured.  The patient's heart rate and blood pressure dropped, his SpO2 remained 99-100%.  After about 5-10 seconds the patient became alert and oriented.