chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse (patient's mother) via a Pfizer sales representative. An 11-month-old patient of unspecified gender received the second dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose on the right arm for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of meningococcal group b rlp2086 for immunization on an unspecified date. It was reported that the patient had fever 102 (highest) for 2 days and fatigue for 3 days. The patient also experienced redness, swelling and was hard to touch on the right arm 3 inches below injection site and eye redness. Outcome of the events fever and fatigue was recovered on an unspecified date while unknown for the events redness, swelling and was hard to touch on the right arm 3 inches below injection site and eye redness.
12-1-11 woke up with left thigh red and swollen - swelling decreased - has bumps only - was given BENADRYL.
10/12/15 - 14:15 - light headed, diaphoretic, chills; rest. 19:30 - body aches, temp - 101.7, 2 TYLENOL taken. 10/13/15 - 02:00 - temp - 100; 2 TYLENOL taken. - 11:30A - temp - 99.0; Physician seen.
patient contracted COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient contracted COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced COVID-19 (patient contracted COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with CASIRIVIMAB, IMDEVIMAB (REGEN COV) on 02-Sep-2021 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (patient contracted COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive for COVID-19.         Patient does not takes any daily medications. The patient had no known drug or food allergies and had no risk factors for COVID-19 infection. The patient was not hospitalized for COVID-19.  The reported had heard that the Moderna booster dose might be made less effective after receiving REGEN-COV infusion. The patient has not yet received the booster dose of Moderna vaccine.; Sender's Comments: This case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected events of COVID-19 and Drug Ineffective. The events occurred approximately 7 months  2 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The two doses were administered at approximately 30 days interval. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) in not affected by this report.
Morning of vaccine sneezing by late afternoon tired headache Tuesday Headache sneezing sinus pain Wednesday fatigue headache sinus pain dizzy Thursday confirmed covid previous symptoms including chest congestions
Client c/o bumps on cheeks of face on both sides of nose and a blister in the mouth.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 14-OCT-2012 09:13, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
she had arthritis/shoulder problems and pain/that her shoulder got so bad "I couldn't move my shoulder"; she had arthritis/shoulder problems and pain; Worsening shoulder pain with need for cortisone injection following administration of her first vaccine dose/it got significantly worse after her first dose; I'm very stressed; This is a spontaneous report from a contactable consumer (patient) reported for herself. An 80-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller asked whether a Cortisone shot that she just got in her shoulder would interfere or interact with the second dose of the vaccine she will be getting tomorrow. The caller reported that she received her first vaccine dose about 3 weeks ago, specific date unknown at the time of this call. She reported that she had been having shoulder problems and pain but it got significantly worse after her first dose, although she stated that she don't think the shoulder had anything to do with the shot. The caller reported that her shoulder got so bad, she couldn't move her shoulder and she was told she had arthritis and was administered a Cortisone shot to the shoulder for pain. The caller now reported, she was very stressed because she doesn't know if she messed up the effectiveness of the vaccine by getting the cortisone shot in her shoulder. The caller reported that she spoke with the doctor who said there shouldn't be an issue but she worried about her second dose tomorrow. Worsening shoulder pain with need for cortisone injection following administration of her first vaccine dose. The caller asked whether there was any difference in effectiveness if the second dose was given later than 3 weeks. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Several days after injection, I felt severe pain on the left side of my head around the ear.  It felt like I had been in a fist fight and someone had pummeled me on the left side of my head.  I scheduled an appointment with Dr., my ear doctor, because I originally thought I must have a problem with my left ear.  He checked my ears and determined that they were normal.  Then he felt around my left ear and told me that I had lymphadenitis, inflammation or swelling of the lymph nodes around my ear.  There was no treatment prescribed either by Dr. or by facility.  After about one month the pain and discomfort on the left side of my head subsided.
Generalized weakness to the extent she could not walk unassisted or speak clearly. Fatigue Incontinence (perhaps as result of weakness and fatigue) bowel and bladder not usual in this individual.
2.5"X2.0" red, swollen 8 days after injection on left deltoid. Itching, warm to touch. As of 4/25 starting to fade.
This pt came to office for flu and pneumonia shot. Within 24 hrs pt had red blotches all over with itching he assumed it was from flu/Pneumo shot. Rash continue to get worse seen primary care doctor on 12/8/02 has had numerous office visit with primary care MD. Today's date 3/11/03-pt continues to have a rash but is seeing dermatologist agreed on a strict diet. Pt ahs not been able to work for three months due to rash.
@ approx 1900 on 02 Nov became SOB, edema around face, chest tightening, waited until AM come to clinic & was immediately sent to ED. Assessment done. Pt had stridor. Given IM epipen, solumedrol 125, & 25 Benadryl IVA. NS at 150 started. Then given 1mg Ativan IVP. EKG & Labs done SVT seen- 4 hrs she was then monitored in ED x 12 hrs.
huge red blotch at the injection side and red blotches all over left arm and hand. Itching all over body, including both hands, ankles, legs, and ears, and a nasty red rash eruption on chest.
pt recv vax 6MAR97 & same day pt devel diffuse raised erythematous hives disseminated on the upper & lower trunk;pt also devel puffy eyes;48hr p/onset hives were almost completely gone;
pt recvd vax SEP93 & devel cellulitis in the inject arm;
Delayed hypersensitivity.  Topical rash, ~6in down arm, hot to touch, moderately swollen.
It started after the night of Easter I started having palpitations, I have a hx of this due to caffeine, but I gave up all of that. It started around midnight, it was fluttering and heart pounding and palpitations and so forth. I took my BP and it was like 179 over 80 or 90.  I knew something was up, as the heart monitor on my watch showed my HR was way up. I waited a few hours and I called my PCP, but he did not call me back. At that point I went to the ER and they hooked me up to the heart monitor which showed I was in A-Fib. My heart rate was going up to 150. They took x-rays and echo cardio grahams, EKG. They said they saw a little hardening of my heart wall. I got out on Tuesday and came home with 2 medications and I see the cardiologist on Thursday 05/05/2022. I am finally out of A-Fib. Eliquis 5mg BID and metoprolol 25mg BID. I had a few issues last night, I had palpitations, but my heart rate was not up. I have an app on my phone that will let me know if I am i n A-Fib. I may need to do a stress test when I go to the cardiologist.
Outbreak of shingles.  Blisters on right side of torso, tremendous pain, went to our gent care and given Valtrex, which did not relieve symptons.  Subside over next eight weeks.  Three recurrences since. Not as severe as first outbreak.
April 4, 2021:  Prickling like pins and needles/tingling in hands, forearms, lower legs, lips, tongue, roof of mouth, back of throat.  Difficulty swallowing.  Pale gums. Dizziness.  Vertigo.  Heavy legs.  Tinnitus - severe.  Feeling like electrical current moving throughout entire body.   Reactions started 4/4/21 and continued throughout 4/30/2021.  Reactions came in waves.   On April 4, 2021 sudden onset.  Called 911; transported to Emergency Room.  Symptoms subsided; released.  April 8, 2021: again called 911 transported to ER.  Waited 3 hours; symptoms subsided so I went home.  I have seen my PCP 4 times.  10/27/21 appt. with a Neurologist who said nothing was wrong with me and I should take a second vaccine; consider Moderna.  A 11/16/21 appt. with an Immunologist/Allergist with a follow-up appt. in February.
Patient reported having red splotches on her skin that crust over and also rise up a little bit. They last for a few days and then disappear. Spots keep coming up in other places on the body. This has happened since she got her shot. Patient does not report any other adverse events and is going to see PCP tomorrow.
A bit of  soreness  below the site of injection. Discomfort in right eye disturbing sleep which started around midnight and lasted until the next morning around 10am
LOSS OF VISION; SEIZURE; DIZZINESS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1805031, and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced loss of vision, seizure and dizziness. The seizure was for few seconds. The patient was not sent to hospital.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, loss of vision and seizure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417122, 20210417456, 20210417469, 20210417550, 20210417620 and 20210418457.; Sender's Comments: 20210417209-covid-19 vaccine ad26.cov2.s-Loss of vision, seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a nurse concerning a 53 year old female with DARVOCET allergy history and no medical history who on 13-NOV-2008 was subcutaneously vaccinated with 0.5 ml dose of PNEUMOVAX (lot number #661065/1021X). Concomitant therapy included influenza virus vaccine (unspecified). On 13-NOV-2008, after receiving PNEUMOVAX, the patient developed red and swelling area approximately two inch in diameter at the injection site. The area was also hard and bruised. The patient was radiated from her arm onto her shoulder. The outcome was recovering. The patient sought medical attention by calling the office. This is one of 3 cases from the same source. Additional information has been requested.
Menstrual period started 2 weeks early. This has not happened to me previously for any reason.
Patient started to experience tinnitus about 3 days after receiving the second vaccine.  He states that he recently went to the doctor to have his hearing checked and that he has experienced  approximately 8000 Hertz drop in his hearing function.
Had flu like symptoms, headache, body aches, chills, sweating, irritated throat,   Today I?m having heart palpitations
4 days worse, 1st 2 days bodyaches, headache (base of skull) low grade fever 99.5 degrees- 100.5 F, loose stools 1-2 days, hyperactive bowel stones.
after 5 minutes of receiving the shot, he felt weak. He stared at me without any response. He came out of it for a couple seconds then stared at me again without an response. We call 911 but the pt had fully recovered by the time they arrived. EMTs took vitals and pt left under his own power.
Less than 24 hours after the second dose of the Moderna vaccine, I developed tingling and sensitivity all over my body, fatigue, and tachycardia. I reported to the ED of UPMC Shadyside with a bmp of 130. My heart rate remained above 100 bmp throughout the course of the day. The ED team did not find signs of infection, blood clots, or heart inflammation after a multitude of lab tests. After a series of IV fluids and pain medications they were unable to lower my heart rate or find a cause and so I was discharged with instructions to hydrate and rest. The following day my heart rate remained elevated from my typical resting rate. It is not until today (6/27/2021), nearly 72 hours after the injection, that my heart rate has stabilized down to a more typical resting bpm for me.
Initial unsolicited report received from a non-health care professional on 13 Oct 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu shot (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 13 Oct 2016. Patient's medical history as Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was also not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 13 Oct 2016, six hours following the vaccination, the patient had experienced shivering and nausea. It was reported that patient received Flu shot previously in yearly basis. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
This spontaneous report as received from a healthcare worker refers to a 19 year old female patient. Medical history was not reported. On 09-JUN-2014 the patient was vaccinated with GARDASIL (0.5 ml, intramuscular, lot # H016960, expiration date: 02-DEC-2013, anatomical location was not reported). Concomitant medications were not reported. The reporter stated that expired GARDASIL was administered to the patient on 09-JUN-2014. No adverse effects noted. The patient did not seek medical attention. Additional information has been requested.
very severe COVID symptoms starting 8 days after my second vaccine shot; seven days later I am bedridden; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported. A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated to experience very severe COVID symptoms starting 8 days after my second vaccine shot. I have all symptoms except for loss of taste & swell, and still seven days later I am bedridden. My question is what is the time spread post shot where symptoms can show. My dr follows 2-3 days but I believe this is the norm and that I may be an outlier. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax & devel a fever of 101.6 & an inj site rxn characherized by redness & swelling;the redness & swelling eventually extended from hip to calf;tx w/ATB & recovered;
Patient fainted in chair after receiving both vaccines (Approx 1-2  minutes After), for Approx 30 sec. She then laid on floor for A few minutes until feeling better. BP was checked (Normotensive). She Sat in pharmacy for 15-20 min before leaving
My right leg became in pain, unable to walk. I had a fever that would not go away.
This case was reported by a pharmacist and described the occurrence of rash-whole body in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). Immediately after vaccination with FLUARIX, the subject experienced rash-whole body, swelling all over body, swelling-feet and rash neck area. The pharmacist reported that the subject, an employee of the hospital, had immediate systemic reactions after receiving the FLUARIX vaccine. The subject reported a severe reaction with a rash on the neck and body immediately after receiving the vaccine. The subject also reported swelling in the feet and all over the body. At the time of reporting the outcome of the events were unspecified. This is one of three cases reported by this pharmacist, see cases A0809614A and A0809778A for the other reports.
Adult Pfizer was administered to patient & he was 9 years old.  He did receive the pediatric pfizer for his second dose. He was tired after both doses mom said otherwise he had no other side effects.  Mom had made the appointment for patient on the adult platform (pediatric platform was not yet available) and we did not catch his age.
Moderna Covid Vaccine Dose 2 received 2/12/21.  7/24/21 - Developed "spot" in right eye's field of vision. Determined by Retina Specialist to be Choroidial Neo Vascularization, due to high myopia and other structural integrity weaknesses in right eye.
7 months after mandated (IHS) injection  suffered 95-99% blockage of LAD STEMI in otherwise healthy active duty patient. resulted in hospitalization, cardiac stent, numerous medications
15 yo male with history of asthma who presented to the ED on 6/5 with pleuritic chest pain and shortness of breath and admitted for further evaluation and management for suspected COVID vaccine associated myocarditis.  Elevated troponin levels peaked 9.12 on 06/06/21, but on discharge decreased to 0.51.  Pleuritic pain was also improved on 6/8.  Echo demonstrated mild tricuspid valve insufficiency and trivial pulmonary valve insufficiency, but otherwise normal function.  EKG on 06/06 with nonspecific T-wave abnormality, likely related to myocarditis.  Follow EKG was stabel from 6/6. Cardiac MRI was read preliminarily and had evidence of edema, but good LV function and an LVEF of 61%.
Extreme exhaustion still after almost 4 weeks Headaches continue still after almost 4 weeks Brain fog, cognitive/memory issues, trouble concentrating & thinking, feel disconnected still almost 4 weeks out. Rash on both forearms 9:00pm 04/29/2021.  raised bumps and one water filled blister about the size of a pea. raised bumps gone by morning but redness and blotchiness continue. Sleeping 9 to 11 hours per day and still exhausted.
Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Additional Details: It seemed that patient was experiencing anxiety and mild syncope from the vaccine.  His BP was 106/57 with pulse 59.  I had him stay seated until the color came back in his face and he stopped sweating.  He was much better by the time he left the store.
Muscle joint aches, terrible headache, 106 fever and slept for 36 hours. I had hives spots again and i grabbed the leftover predinione and took them. I went to the doctor and she gave me another prescription of predinisone.
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that in an unknown date unknown number of patients were inadvertently vaccinated with M-M-R II (unspecified dose and route) lot # K005110 expiry date 04-APR-2016. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknonw. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
angioedema, lip paresthesia, tongue swelling, dry eyes, chest tightness
06/06/05 Left thigh lump, red, with 2 small vesicles.
Pt developed hives about 2 hours after receiving the vaccine at vaccine injection site, then spread up arm and to chest and last 1 week; face and ears also got hot and red