chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a physician referring to a 4 month-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 04-SEP-2015 at 15:55 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
SOB; leukocytosis; acute onset of fever (101.2); CXR = bilateral vascular congestion; This is a spontaneous report from a contactable consumer. An elderly NH resident patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced shortness of breath (SOB), leukocytosis (17,800), acute onset of fever (101.2), bilateral vascular congestion. The patient was admitted with acute onset of fever (101.2), leukocytosis (17,800, no eosinophilia) and SOB, all beginning 3-4 hours after BNT162B2 administration. CXR showed bilateral vascular congestion. No facial or SQ edema. No evidence of myocardial damage or CHF based on BNP and troponin, respectively. The patient was treated with brief (3 days) pulse of methylprednisolone sodium succinate (SOLUMEDROL) with improvement. Chalking it up to acute capillary leak syndrome 2^2 vaccine. The final events outcome was unknown. Information on lot/batch number has been requested.
Arm hurt; Slight headache; Felt tired; Diagnosed with Mononucleosis; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), INFECTIOUS MONONUCLEOSIS (Diagnosed with Mononucleosis), HEADACHE (Slight headache) and FATIGUE (Felt tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included AFib.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced INFECTIOUS MONONUCLEOSIS (Diagnosed with Mononucleosis). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired) had resolved and INFECTIOUS MONONUCLEOSIS (Diagnosed with Mononucleosis) outcome was unknown.            No concominant medication is provided.   This case was linked to MOD-2021-290723 (Patient Link).
DTAP administered to Left deltoid and a large welt formed at injection site over next 24 hours.  Site was hot to touch and tissue was hard underneath.  Welt did not start to diminish in size for about 48 hours and it took another 3-4 days for it to disappear completely.
increased frequency of menstrual period. Periods began on Feb 1, Feb 22, March 6 and March 23, 2021.  Each cycle was significantly less than the normal 28 days. Each period lasted normal length of time and flow was normal, but the cycle time between was reduced. Patient has no history of abnormal cycles.
My left arm where I received my 2nd Covid-19 Vaccine was sore after I received it which was 5:00pm Friday night.  Saturday morning the area where I received my shot was RED and the area was Hot.  It hurt by the touch and feels sore of hard around that area.
Couple days later began to feel fatigued again, ear pain, brain fog, 101.4 temp so was sent from work to  and tested neg for COVID and Flu.  I was advised I had fluid on my ears and was advised I may have and Upper Respriatory infection and was given antibiotics and advised if the symptoms didnt get any better to return but I am still taking the antibiotics to date and still experiencing the no taste and smell, brain fog, fatigued and tired but feeling a whole lot better today.
Patient was taken to hospital for severe vomiting; was given an antiemetic by IV. Patient states she also suffered dizziness, sore throat, and body aches. Patient also states that she has redness and swelling at site of injections and it is also red and hot at the site of injections.
A nurse reported that a 9 month old male received Prevnar and Hep-B vaccine on 8/17/00 and subsequently, developed redness and swelling at the site of Prevnar administration. This is 1 of 5 pts from this facility who had an adverse experience following receipt of Prevnar lot 471654.
This case was reported by a consumer (subject) and described the occurrence of celiac symptoms nos in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline), unspecified vaccine. A physician or other health care professional has not verified this report. On 12 September 2013 the subject received a dose of FLUARIX (unknown details), unspecified dose of vaccine (unknown details). On 13 September 2013, 1 day after vaccination with FLUARIX and vaccine (unspecified), the subject experienced celiac symptoms nos (described as a "celiac attack"). The subject stated that the "celiac attack" onset "24 hours after vaccination." The subject refused to provide details regarding her experience as she "was not sure" if her "celiac attack was related to the FLUARIX vaccination or another vaccine she received on the same day." No further details were provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
on AM p/vax pt awoke w/blanching macular rash, periorbital edema;no fever, stridor, resp distress;pt to MD;MD states pt playful, active in spite of rash, edema improving;
Patient noted to be COVID positive which also raises concern for pulmonary embolism as the etiology of her arrhythmia and exertional dyspnea/chest pain symptoms
Information has been received from a Nurse Practitioner concerning a 21 year old female  patient who on 03-AUG-2007 was vaccinated in the left arm with a first dose of Gardasil vaccine. Concomitant therapy included hormonal contraceptives (unspecified). The patient experienced tingling, numbness and pain in her arm within minutes of receiving the dose. The patient sought medical attention. On 04-AUG-2007, the patient recovered. The Nurse Practitioner requested information on whether she should administer the 2nd dose, but was not involved in the administration of the first dose which was received at a health clinic. Additional information has been requested.
Classic erythema multiforme lesions developed on bilateral hands and feet starting 24 hours after immunizations, then spread up to legs, surrounding both vaccine sites, trunk, arms and by 5 days post-immunizations, present on cheeks.  Raised erythematous target lesions.  Afebrile, good output, no swelling.
1130AM 31OCT97 pt recv vax;4PM hives on both arms red & itchy called office-referred to PMD;5PM saw MD PDH given hives disappeared spontaneously;
pt states about 8 hours after taking the vax she felt completely exhausted along w/ muscle aches and body pains. She feels like she has a fever but does not have a fever.  The next she woke and is still having these symptoms.  Pt has taken Tylenol and also take some ibuprofen to help w/ her body pain.
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022L0N/D) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment provided no concomitant medication given   This case was linked to MOD-2021-137785 (Patient Link).
I had some coughing up clear phlegm and sneezing. I took a COVID-19 on 03/27/2023, but the results came back negative. I called my doctor where I received a prescription for Benzoate and Bactrim DS to settle my symptoms.
Child developed some episodes of opening his mouth wide like trying to scream but no sound came out lasting for few second within 24 hours of vaccination, total of 5 episodes witnessed by family, lasted with 28 hours of immunization. Reported awake and alert during these episodes.
Swollen fingers in arm of injection Stabbing pains in neck  Pain in rotator cuff
epileptic seizures; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (epileptic seizures) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were not given.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced EPILEPSY (epileptic seizures) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 14-Jul-2023 to 18-Jul-2023 due to EPILEPSY. The patient was treated with BRIVARACETAM (BRIVIACT) for Seizures, at a dose of 50 milligram twice a day and ESLICARBAZEPINE ACETATE (APTIOM) at a dose of 900 milligram, in the morning. At the time of the report, EPILEPSY (epileptic seizures) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received 2 Moderna COVID-19 Vaccines between Feb 2021 and Mar 2021 with no specific dates, and she thought it was the primary series, but did not have the lot numbers on hand. About 3 weeks after the 2nd dose of the vaccine she experienced epileptic seizures with no previous history of seizures, and it happened again approximately 2 months later, once again 4 months later, again 3 months later and again 2 months later. It caused her a gigantic bill in the hospital because she needed hospitalization during 5 days from 14 Jul 2023 to 18 Jul 2023. The treatment given has been quite a few medications that did not work.  Company comment: This spontaneous case concerns a 31-year-old, female patient with no prior medical history of seizures, who experienced the unexpected serious (hospitalization and medically significant) AESI of epilepsy (epileptic seizure). The event occurred approximately 3 weeks after the second dose of mRNA-1273, with repeated occurrence of seizures (4 episodes with 2-4 months in between). As reported, about 3 weeks after the 2nd dose of the vaccine patient experienced epileptic seizures with no previous history of seizures, and it happened again approximately 2 months later, once again 4 months later, again 3 months later and again 2 months later. Reportedly, patient was treated with different medications which did not work and was currently of anticonvulsants. No further information about the events was provided. No information about any diagnostic tests results were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
HEAVINESS ON UPPER TORSO UPON STANDING / FELT LIKE LOWER SPINE OR BACK WAS COLLAPSING OR BUCKLING UNDER WEIGHT; MUSCLE WEAKNESS; JOINT PAIN IN LOWER BACK / KNEE AND RIGHT HAND KNUCKLES; CHILLS; MUSCLE ACHES; MILD HEADACHES; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight. On APR-2021, the subject experienced muscle weakness. On APR-2021, the subject experienced joint pain in lower back, knee and right hand knuckles. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced mild headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mild headaches on APR-2021, and the outcome of muscle aches, muscle weakness, joint pain in lower back, knee and right hand knuckles and heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight was not reported. This report was non-serious.
Initial information was received from a health care professional on 08 August 2008.  A 14 year old male patient with an allergy to AMOXIL received a first dose, intramuscular injection of MENACTRA (U2659AA) in the left deltoid on 05 August 2008.  On 06 August 2008 the patient complained of pain and tenderness in the left axilla with soreness in the entire arm with a 3x3 cm raised red injection site.  He was seen by the doctor on 07 August 2008 regarding the above symptoms.  At the time of the report the patient's recovery status was unknown.  Follow-up information was received 29 September 2008 from a health care professional who reported that the patient had recovered from the event.  No additional information was provided.
Patient complained of chest tightness, L hand tingling and throat tightening less than 10 minutes after receiving the vaccine. Patient received Benadryl 25 mg IM and NS IVF. EMS transport to ED. In ED, Solumedrol 125 mg IVP and Famotodine 20 mg IVP. Patient monitored in ED for approximately 4 hours. Discharged home on Prednisone.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unspecified date in 2011, the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route of administration, lot number and expiration date were not reported). On 06-JUN-2016, the patient was administered with the second dose of series GARDASIL 9 (lot L013429, expiration date 21-JUL-2017). No adverse effect was reported. Additional information has been requested.
3-5 min p injection , pt reported  felling dizzy.  was attended by  paramedic , Felt well by the time he left , "dizziness" resolved  within 15 minutes
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 12:00 as dose 1, single (Lot number: EP6955), in right arm, on 09Apr2021 at 12:00 as dose 2, single (Lot number: ER8729), in right arm and on 10Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
08/13/10 swelling & redness of arm. Seen by PA at PCP office: Dx: "local dermatitis following varicella vaccine". Tx: PRELONE, cool compress prn & local hydrocortisone.
since the day after being vaccinated has had constant dizzness, lightheadness, chills, body shakes, wheezing, lung inflammation, feverish 99.5, bronchial cough and chest tightness even 72hours after. Is still having symptoms of dizzness, lightheadness, chills, body shakes, inflammation of lung and chest tightness. Bronchial cough has subsided. Whessing is acute.
only received adjuvant; only received adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 49N3S, expiry date 24th August 2023) for prophylaxis.   On 22nd March 2022, the patient received the 1st dose of Shingrix. On 22nd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that a patient only received a single-dose vial of adjuvant suspension component and they did not reconstitute the vial of lyophilized gE antigen component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Patient Checked back into pharmacy 15 minutes post injection complaining of tingling and numbness in vaccinated arm (Right arm). She was not complaining of SOB or other allergic reaction symptoms. Told patient to keep eye on it and if it worsened to proceed to medical care. I called after 30 minutes and patient said symptoms were about the same. 2 hours post vaccination patient said symptoms were improving but were still present, I referred on to medical care such as an insta-care.
Forty eight hours after KINRIX injection was given in upper right arm, patient's arm swelled at shoulder. Covered 1/2 of upper arm between elbow and shoulder. Very red and inflamed. Very hot to touch. Felt like a giant blister according to MOC. Saw doctor. Improved in 24 hr with BENADRYL. Now gone completely.
Local reaction site hot, swollen, and 2 in raised area per pt. description, headache, nausea, no fever. Reported day after injection by pt.
I had my first shingles shot (Shingrix 50MCG/0.5ML INJ GLAX) at pharmacy on March 17, 2022. On March 26 I came down with Shingles. Was this coincidence or a reaction to the injection?
Pt had c/o swelling, numbness, tingling to face, mouth and tongue area less than 5 minutes after receiving first dose of vaccine. Epi pen administered and EMS was called.  Patients symptoms resolved and EMS evaluated patient and recommended patient carry Epi pen around for future incidents.
no adverse reaction, Learned moderna had been approved. Believed this was from the cdc. It was from a committee however.  Patient has had no adverse reaction
BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced body aches. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from chills, and body aches. This report was non-serious.
Extreme pain in left jar and behind left ear. Mild face dropping on the left side, noticeable when I smile and around my eyes.
I started having heart arrhythmias (for the first time in my life) with flu-like symptoms the night of, or 2nd day of having extreme flu symptoms. It felt like my heart irregularly stopped beating for one heart beat. Then it would begin again. It coincided with a fever of 101-102, extreme body aches, profuse sweating, chills and pain that lasted nearly 2 ½ days. The arrhythmia never went away. I also have strong heart palpitations and arrhythmias upon waking up in the morning and falling asleep at night. They were most severe for a month after the shot. They are not as severe now but still very much present.
I started feeling vert tired for a couple days. Then I had chills and body aches. I had sinus headaches and a runny nose. I called a COVID-19 line and they had me come in for an injection for older people who have COVID-19.  My symptoms last about 5 days and then I was feeling about 100% better. The injection helped a lot.
injection site pain; flu like; tired; achy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site pain, influenza like illness, tiredness and pain. On an unknown date, the outcome of the injection site pain, influenza like illness, tiredness and pain were unknown.   It was unknown if the reporter considered the injection site pain, influenza like illness, tiredness and pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. In 2019, 2 months ago from the reporting date, the patient received 1st dose of Shingrix and was reluctant to take 2nd dose of Shingrix just after 2 months. The patient asked whether it was more ideal to wait 4 to 5 months between doses. The patient told that since availability was not an issue and asked whether there are more reactions. The reporter asked if the doses were given after 2 months than 5 to 6 months. The reporter was told that the 2nd dose of Shingrix was recommended to be received between 2 to 6 months after receiving the vaccine, for further assistance they could direct the chat to a Shingrix product specialist. The patient experienced pain at injection site and flu like. On the 2nd day, the patient experienced minimum reaction like very tired and generally achy.