chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous reprot as received from a health care professional refers to a patient of unknown age and gender who on 10-APR-2015 was vaccinated with an improperly stored dose of oral, ROTATEQ lot # K011663 (dose and route were not provided) which were exposed to 12 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
24 hours after second dose I started feeling sick with, fever, chills, hot/cold flashes, body aches, very sore arm.  Except for my arm, the chills, intense body aches and hot/cold flashes with sweating have continued, now at day 10 after 2nd injection.
hives and rash at injection location. swollen joints within 24 hours of injection, problems breathing, low grade fever, headache.
Hot at injection site; Itchy at injection site; Red at injection site; Swollen at injection site 5.5 X 5.5 inches in diameter; Very red at site of injection; Very swollen at site of injection 2.5 X 2.5 inches in diameter; Very hot at site of injection; Very itchy at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE WARMTH (Very hot at site of injection), VACCINATION SITE PRURITUS (Very itchy at site of injection), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Very red at site of injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant concomitant medications reported. .     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Very hot at site of injection), VACCINATION SITE PRURITUS (Very itchy at site of injection), VACCINATION SITE ERYTHEMA (Very red at site of injection) and VACCINATION SITE SWELLING (Very swollen at site of injection 2.5 X 2.5 inches in diameter). On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site 5.5 X 5.5 inches in diameter). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 21-Feb-2021, VACCINATION SITE WARMTH (Very hot at site of injection), VACCINATION SITE PRURITUS (Very itchy at site of injection), VACCINATION SITE ERYTHEMA (Very red at site of injection) and VACCINATION SITE SWELLING (Very swollen at site of injection 2.5 X 2.5 inches in diameter) had resolved. On 03-Mar-2021, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site 5.5 X 5.5 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant treatment included Ice packs, prescription steroid cream. No relevant concomitant medications reported.
within 8 hours of second shot, ran slight fever and had chills. On March 4th, began to feel queasy, hot flashes, headache, shortness of breath, dizziness. March 7th, admitted to hospital for anemia, internal bleeding, shortness of breath, racing heart, dizziness, queasiness. Stayed in hospital for 5 days.
My left hand in the pinkie finger and ring finger are numb ,as well as my right hand is sore and hard to grip very painful,  my throat glands are swollen,  today I went to pass a bale movement and much strain so I removed it only to discover blood in it. I'm very worried about these health issues that have never been experienced,.  March28,2021 Sunday morning bale pass blood seen and noticed around 9:30 am.
PATIENT RECIEVED MODERNA VACCINE ON 9/16/22 AT A DIFFERENT LOCATION. PT MADE AN APPOINTMENT THROUGH OUR CENTRAL PROCESSOR AND WHEN SHE PRESENTED TO OUR STORE SHE HANDED A VACCINE CARD THAT DID NOT HAVE THE VACCINE SHE RECIEVED ON 9/16. SHE WAS GIVEN THE PFIZER VACCINE AND THE WHEN HER SHOT WAS PROCESSED AFTER THE FACT, HER INSURACE DENIED THE CLAIM STATING IT WAS TOO SOON AND IT WAS DISCOVERED SHE HAD RECIEVED THE VACCINATION ON 9/16.
myocarditis; This is a literature report.  A 17-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: Body temperature: 101 Centigrade; C-reactive protein: elevated; Echocardiogram: LVEF 65 percent, notes: no RWMA, normal diastolic function; LVEF 68 percent, notes: no RWMA, normal diastolic function, follow up; Ejection fraction: 65 %, notes: on presentation; 68 %, notes: follow-up; Electrocardiogram: ST elevation in inferolateral leads; Sinus arrhythmia, notes: Follow-up; Electrocardiogram ambulatory: Normal; Exercise test: Normal; Magnetic resonance imaging heart: Edema, patchy, notes: midmyocardial and sub epicardial late gadolinium enhancement; Resolved edema,, notes: Small patchy low intensity late gadolinium enhancement; Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event myocarditis  and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Patient experienced fainting symptoms immediately after administration of vaccine. Further investigation showed patient had low blood pressure 73/57 mm Hg.
Facial paralysis diagnosed on 12/21/20.  Pt. started having facial drooping 12/18/20.
After a few minutes receiving Janssen Vaccine at 12:45pm . Patient had syncope, patient fainted for about 10 seconds sitting on chair, regain conscious after. Decline additional treatment or call for emergency. Patient refused to stay for 30 minutes because of her anxiety.  contacted patient at 1:55pm. Patient was back to home resting without any addition symptoms. Patient was instructed again to contact MD or emergency if any symptoms worsen ie skin rash , SOB, swelling or severe dizziness.
Febrile seizure 10/30/13. Vaccines given 10/23/13.
I spoke with the pharmacist prior to the shot and expressed my concerns with getting it due to having reactions to the flu shot and pneumonia shots that I have had in the past.  In the past, my asthma flares up for a least a week afterwards and almost immediately after I start having bad head to toe itching, and labored breathing about an hour afterwards.   After it was administered, at 4:50pm - she suggested I wait additional 30 minutes so she can monitor me to make sure if I needed an EPI pen or help ,she would be able to administer it.  Around 5:10, she came to check on me and she noticed that I was starting to itch, she offered Benadryl but after she went to look for, she came back and told me they did not have any behind the counter; so my husband had to buy some and give it to me. At this point, my oxygen level was reading about 94% according to my watch,  15mins after this, the itching did not stop and I asked her if I could go home with my husband, she said yes but I should continue taking the Benadryl. When we got home around 5:30 I needed my rescue inhaler, my throat felt like it was getting very heavy and my breathing started to become labored, but not to the point of needing to go to the ER.   I woke  up at 5:45 11/12/21 and my breathing was still not normal, it felt very tight as I tried to deeply inhale, I once again needed my rescue inhaler.
About 12 hours after I have very serve fatigue. About 12-18 hours still tired and couldn't think clearly.  About 24 hours after I was having chills. The next day still tired but improved. Randomly on and off I was having high BP. For the next week  I had off and on high BP and palpitations. The injection site hurt for 1-2 days but very mild.  I took Tylenol and Ibuprofen before the shot.  The most disturbing was the increase blood pressure and palpitations.  It was on and off.
Approximately 12/01/2021, I began to notice intermittent stiffness and weakness in both hands upon waking. More recently, they symptom has been more consistent. I went to the doctor recently. I had surgery on September 22, 2022 on my shoulder and I also had COVID-19 right after that surgery, on October 5, 2022. I had an allergic reaction to medications during surgery, which lowered my immunity. I have an appointment with a neurologist in March.
This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 01-NOV-0216, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M022077 with expiration date 10-MAR-2019, dosage and route of administration were not reported, which was exposed to temperature excursion (temperature: 51.3 degrees F, time frame: 1 hour) because of data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date, in September 2015, reported as "sometime during the month of September 2015", the patients were vaccinated with unspecified improperly stored doses of MMR II lot # J013316 and expiration date 22-OCT-2015, lot # K022285 expiration date 12-NOV-2016, lot # L009213 expiration date 17-MAR-2017 and lot # K024035 expiration date 26-NOV-2016, (dose, route of administration and anatomical location were not provided). There were not concomitant medications reported. There was not product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Patient admitted to hospital on 12/3/2021 weakness, shortness of breath and decreased appetite   Patient tested COVID positive on 11/26/2021 she reported being ill for about 9-10 days  Initially she had a cough, then later diarrhea with worsening dyspnea. No fever, chest pain.  Admitted to ICU need for heated high flow oxygen.  Received remdesivir and dexamethasone
Injection site is slightly red, and has hardened under the surface. An oval of about 3 inches by 2 inches wide is red on the surface. And it is very itchy. When I first got the injection it was red and has stayed red. The itchy hardness just started today, 9 days after.
Patient began experiencing a tingling feeling to the roof of her mouth shortly after receiving the 1st dose of Pfizer covid vaccine.  Patient stated that she had anaphylactic reactions in the past and this feels like past experiences.  Patient has an epi pen available if needed.  Patient was given 25 mg Benadryl with symptoms resolving.  Patient refused transport to the emergency room.  Patient was stable and released to the care of her husband.  Patient was advised to go to the ER later if symptoms persist or worsen.
Narrative:  I received notified from the Coroner that the patient died of natural causes on 4/22/21 which was 2 weeks after receiving the COVID vaccine.
Pt presented to clinic 2 days after adm of vac with annular, flat, macular and large lession to rt thigh anterior aspect mildly sensitive to touch, cbc done results wnl sent home with otc tylenol and cool pads./ MTB.
PATIENT HAD MORE PAIN THAN EXPECTED ESPECIALLY ON THURSDAY 4/7, 4/8 I CHECKED W/HER, SHE SAID GETTING BETTER BUT NOT 100%. I CHECKED AGAIN ON SATURDAY SHE SAID ALL GOOD-NO MORE PAIN.
Erythematous rash, flushing, warmth, and pruritis of cheeks that continued throughout following day. No exposure to new foods. Grandmother applied cortisone cream to cheeks 11/14/14 afternoon with no effect. Patient was seen in clinic on 11/14/14 evening. Prescribed Benadryl and instructed to call 911 if having signs/symptoms of anaphylaxis.
This spontaneous report was received from a nurse and refers to a 4 year old male patient. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with his first dose of M-M-R II for routine vaccination (dose, route of administration, lot number and expiration date were not reported) with no apparent side effects. Then, on an unknown date, in August 2018, reported as 3 weeks ago, the patient was vaccinated with his possible second injection in the series of M-M-R II for routine vaccination (dose, route of administration, lot number and expiration date were not reported). Immediately, the patient began sneezing repeatedly, his eyes started watering and a large swelling appeared around the injection site (sneezing, lacrimation increased and injection site swelling). A clinician gave the patient BENADRYL and sent the patient to an emergency hospital room. In the emergency room the patient received an unspecified dose of DECADRON. On the same day, in the evening, the physician called the patient's home and the patient's mother reported that the patient was doing fine and had fully recovered from the events. The causal relationship between M-M-R II and the aforementioned events were not reported.
Shingles around the eye; Experienced an outbreak of Shingles; Tender; Bumps; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 71-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number TS3A9, expiry date 4th June 2022) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingles vaccine. In September 2020, between 3 and 4 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, tenderness and raised rash. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the shingles, tenderness and raised rash were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, tenderness and raised rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient had experienced an outbreak of Shingles three weeks and a half after receiving the first dose of Shingrix. The patient still was under care having symptoms (tender and bumps) at the time of reporting. Pharmacy technician later reported that the patient had reported an outbreak of shingles around her eye following dose one of Shingrix. Health care professional did not provide outcome of shingles outbreak. The reporter consented to follow-up. This case had been linked to US2020229504 which is deleted from the database.
This report was received and was assigned manufacturer report number A0425732A. A 2 week old female was vaccinated with a first dose of hepatitis B virus vaccine. The patient experienced a seizure following receipt of the vaccine. The reporter stated that the neurologist explained that the child was ok and the patient received a second dose of hepatitis B virus vaccine at a later time with no side effects. The patient received a first dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (lot # DTPA542A2) on 8/28/02, at two months of age. The reporter stated that two or three days post-immunization, the patient developed diarrhea. The diarrhea resolved after an unspecified period of time. The reporter indicated that the patient also experienced failure to thrive and decreased motor skills. The reporter suspected that the vaccines the patient received contributed to the failure to thrive and decreased motor skills. The reporter stated that the patient had been evaluated by several physicians, who would not provide any additional information as they do not feel this has anything to do with the vaccines given. However, the reporter decided to stop all vaccinations at four months of age. The failure to thrive and decreased motor skills persisted as of 9/12/03. Upon internal review, seizure, failure to thrive, and decreased motor skills were determined to be other important medical events (OMIC).This was originally reported by a consumer, the patient's mother. Information was received on 9/29/03 which pertained to events that occurred approximately one and a half months after vaccination with hepatitis B virus vaccine. This information contained the following adverse experiences: failure to thrive, decreased motor skills, and diarrhea.
Severe shoulder pain to L shoulder with onset at 2:15 a.m., in the morning after receipt IIV on 16 Oct 2016. She states the pain awoke her, was severe, burning, hot across her shoulder blade and shoulder the size of her palm. It was worsened by motion. It came in waves with periods of improvement followed by exacerbation. She was seen in Urgent Care 18 OCT 2016 and treated with MOTRIN and tramadol. Required PT. Symptoms: Pain in left shoulder.
This spontaneous report was received from a healthcare professional and refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions and concomitant medications were reported. On an unknown date, the unspecified number of patients were vaccinated with unspecified number of improperly stored doses of GARDASIL lot # H020901 with an expiration date of 05-JUL-2015 (also reported as 08-JUL-2015), administered through an unknown route. The outcome of the event was unknown. No PQC was involved. Additional information has been requested.
Intense headache, chills, fever, intense back pain where chronic pain is already an issue from a severe injury , whole body pain, shallow breathing
General malaise starting almost immediately, and then about 12 hours after vaccine, developed: -Fever (102.0) -Chills -Numb digits (toes and fingertips) -Sore joints and muscles -Headache -Lightheadedness and loss of vision -Memory loss and difficulty concentration. With Tylenol (no ibuprofen, allergic), was resolved within 36 hours.
Rec'd Imm around 11:30.  Also received meds in clinic.  Around 8:30pm heavy breathing, dizzy, rapid heart beat, iron taste on back of tongue.  Went to ER, symptoms worsened esp. dizziness.  Stated MD said K+ level borderline low.  S were WNL.  Told to eat bananas & OJ.  Told to f/u with MD.  Has appt in January at hospital.  Pt continues to have tingling feeling & rapid heart rate intermittently.
she has not been the same since; still feels sick; Has not been able return to normal activities; Lack of energy; Intermitted muscle ache all over body; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she has not been the same since), MALAISE (still feels sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has not been able return to normal activities), ASTHENIA (Lack of energy) and MYALGIA (Intermitted muscle ache all over body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced FEELING ABNORMAL (she has not been the same since), MALAISE (still feels sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has not been able return to normal activities), ASTHENIA (Lack of energy), MYALGIA (Intermitted muscle ache all over body) and NAUSEA (Nauseated). At the time of the report, FEELING ABNORMAL (she has not been the same since), MALAISE (still feels sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has not been able return to normal activities), ASTHENIA (Lack of energy), MYALGIA (Intermitted muscle ache all over body) and NAUSEA (Nauseated) had not resolved.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-547047.
Flushing, sweating, anxious, tingling in ears, nausea, blurry vision. Vitals within normal limits. Patient stabilized.
back discomfort; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (back discomfort) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (back discomfort). At the time of the report, MUSCULOSKELETAL DISCOMFORT (back discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.   She said her friend got the second shot a couple of weeks ago and can't walk. She said her friend tried to call Moderna but hasn't received a call back.
Dizzy, fatigue, headache, back pain, heart beating fast and a warm sensation in my chest and throat with a heavy chest.
'covid arm" large hard spot on the site of the injection. very itch and hard. lasted from 3/12 to3.14.
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a patient of an unspecified age, race/ethnicity received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose for immunization. Relevant medical history and concomitant medication were not specified. On unknown date the patient experienced Feeling abnormal. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Lightheadedness, fatigue and dizziness. This lasted most of the day on the 18th and 19th. Then on the 20th, in addition, I started to get a lot of mucus build-up, heaviness in the chest and fever. It felt like Pneumonia. I almost went to emergency on the night of the 20th, but went to bed instead with 2 Tylenol and most of the symptoms disappeared by morning on the 21st. But it was scary!