chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had the vaccination & then later got shingles/Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the vaccination and then later got shingles, luckily had a very mild case. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
h/a, nausea, fatigue (this has seemed extreme & has lasted the longest) rash on arm where recv shot followed by itching in that area, which still is there a month later;
I got every symptom except lost of taste or smell. headache, body aches ,cough, sore throat, fever
Given shot on 2/16/11, on 2/18/11 had area approx. 6cm x 5cm of redness appear. On 2/20/11 blisters started forming area is painful to touch, weeping, and red today. Has had pain and warmth in area since 2/18/11.
they gave a patient their 2nd dose of the Moderna Covid-19 vaccine today, 7Oct2021, that had a manufacturer date of expiry of 6Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave a patient their 2nd dose of the Moderna Covid-19 vaccine today, 7Oct2021, that had a manufacturer date of expiry of 6Oct2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave a patient their 2nd dose of the Moderna Covid-19 vaccine today, 7Oct2021, that had a manufacturer date of expiry of 6Oct2021). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (they gave a patient their 2nd dose of the Moderna Covid-19 vaccine today, 7Oct2021, that had a manufacturer date of expiry of 6Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Headache; Collapsed on the floor; Left arm injection site red; Rash; A spontaneous report was received from a consumer, who was also a 80-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, injection site redness, rash, and headache.  The patient's medical history, as provided by the reporter, included high blood pressure. Concomitant product use reported included atenolol and atorvastatin.  On 11 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient noticed her left arm was getting redder and redder at the injection site. When she turned to look at the clock, the patient collapsed on the floor. She went to the medical center and was prescribed prednisone and diphenhydramine.  On 21 Jan 2021, the patient reported she now had a headache that began on an unspecified date, and that her injection site redness and rash were still present, but getting better.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, syncope, was unknown. The events, injection site redness and rash, were considered resolving. The event, headache, was considered not resolved.; Reporter's Comments: This spontaneous report concerns an 80-year-old, female patient with medical history of high blood pressure who experienced serious event of syncope and non-serious events of injection site redness, rash and headache. The events of syncope rash and injection site redness occurred 1 day after administration of mRNA-1273 (Batch number: 039K20A, expiration date-unknown). On an unspecified date on the event of headache began.  Treatment provided for the events included prednisone and diphenhydramine and the outcome is not resolved. injection site redness, rash and headache are consistent with the known safety profile of the mRNA-1273 Vaccine and hence, based on the temporal association between the events and the vaccine administration, a causal association cannot be excluded
Patient tested positive for COVID on 11/12/2021. Fully vaccinated. Admitting dx acute kidney injury.  COVID-19 pneumonia.  The patient was having difficulty breathing and associated with nonproductive cough. The patient was having severe diarrhea without any fever.  No chills.  The patient has been sick for at least 1 week until his condition got worse.  He came to the emergency room to be found in acute renal failure with COVID-19 pneumonia. 2-week history of lightheadedness, dizziness, loose stools, myalgias and arthralgias.  He also had some dyspnea.  Treatment:  oxygen,  Lovenox.   Discharged to home.
Maternal exposure during pregnancy, gestation period 24 weeks; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24May2021 at 10:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease, allergic to latex, bee venom, gluten and shellfish. The patient's last menstrual date was on 11Dec2020 and delivery date was reported as 17Sep2021. Concomitant medications were not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24May2021, the patient experienced maternal exposure during pregnancy, gestation period 24 weeks. The clinical outcome of the event maternal exposure during pregnancy was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
aches and pain for a day or two; little fever (99°F); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (aches and pain for a day or two) and PYREXIA (little fever (99°F)) in an 83-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     Patient has lots of allergies (not specified), she has a loop recorder. Patient taken medication for blood pressure.  The patient's past medical history included Pericarditis (since 12 years ago) in 2011, GERD and Renal aneurysm. Previously administered products included for Blood pressure: Losartan (80 mg once a day) and Amlodipine (225 mg once a day); for GERD: Prevacid (30 mg once a day); for Hypercholesterolemia: Livalo (2.5 mg once a day); for Product used for unknown indication: HCTZ (25 mg once a day), Vitamin D (500 mcg,), Vitamin B12 (500), Multivitamin, Pregabalin (100 mg twice a day) and Aspirin (81 mg once a day); for an unreported indication: NASALCROM (nose drops twice a day.). Past adverse reactions to the above products included No adverse event with Amlodipine, Aspirin, HCTZ, Livalo, Losartan, Multivitamin, Pregabalin, Prevacid, Vitamin B12 and Vitamin D. Concurrent medical conditions included Angiomyolipoma and Hypercholesterolemia.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches and pain for a day or two) and PYREXIA (little fever (99°F)). At the time of the report, PAIN (aches and pain for a day or two) and PYREXIA (little fever (99°F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 °F.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported,  she already received all her Moderna COVID-19 Vaccines (She did not remember dates) without any major issues, just maybe a little fever (99°F), aches and pain for a day or two. She currently wanted to get Spikevax, but she wanted to know: what was the recommendation if she has pericarditis.  No treatment information was reported.
Patient received  Covid-19 Vaccination today with parental consent  at  mobile clinic. After completion of Vaccine Clinic, writer was notified that patient was under 12 years of age. Writer contacted Parent to inform her that patient was  under the age limit currently  set by state regulations. Parent verbalized that she knew patient was under 12 years of age at time of vaccination and did not mention to health care team. Writer reviewed common side effects of vaccine, and that patient is not currently eligible for the second dose for covid-19 Vaccine - Parent verbalized understanding.  Writer also informed Parent that an incident report would be submitted and  contact information   was provided for future questions or concerns.
REDNESS AND SWELLING MEASURING 170MM X 160MM WITH TENDERNESS AND WARMTH.
Shoulder pain, difficulty moving right arm, shoulder stiffness, ulnar nerve pain, tingling in fingers
Had swelling, redness, pain and fever for several hours, post vax, in right deltoid.
one patient was administered a dose of PNEUMOVAX 23 which was improperly stored. No adverse effects reported.; one patient was administered a dose of PNEUMOVAX 23 which was improperly stored. No adverse effects reported.; This spontaneous report was received from a pharmacy manager and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R027299 with expiration date of 09-APR-2020, for prophylaxis (route and frequency were not reported). No adverse effects were reported.    It was stated that the vaccines underwent a temperature excursion above 47°F (degrees Fahrenheit): 57F 59 minutes. The call was because of a "data logger". No further information was provided. There was no Product Quality Complaint (PQC) involved in this case.
Developed throbbing type sensation in calf right leg. No warmth of extremity developed. Lasted 24 hours then stopped. No residual discomfort at present time.
A 15 month old female received Prevnar, Acel-Imune, Hib-Titer and MMR II vaccines on 7/6/00. That same day, the child developed a fever of 105.7F, "unresponsiveness, periods of blank staring, would not eat, fall over in sitting position and fall down when standing, could not walk for days".
Almost immediately following the second vaccine shot in my left arm, I had an uncomfortable tingling sensation in  my shoulder that ran up through my neck. This lasted several hours. The tingling sensation in my neck went away, but I had a significant lump in my left armpit. It grew so large that it was uncomfortable to put my arm down when walking, because it would chafe against my body. After about two weeks the swelling reduced to the point it wasn't chafing, but to this day is significantly swollen under the arm. It's been there and hasn't disappeared.
Arm swelling at injection site, 5cm in diameter. Hard to lift arm. Also c/o stomach upset and headache. Seen in clinic on 8/11/2014. Started on oral antibiotics.
Headache, Myalgia, Arthralgia, Fever, Shortness of breath Narrative:  Other Relevant History:
This is a spontaneous report from a non-contactable consumer. A 47-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 03Feb2021, at a single dose on the arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not reported. The patient experienced arm injection site pain on an unspecified date in Feb2021. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if treatment was received for the adverse event. Outcome of the event was unknown. The reporter assessed the event as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a certified medical assistant concerning a female in her 30's who in approximately 2006, reported as "5 years earlier", was vaccinated with hepatitis B vaccine. Titers were drawn in 2010 but came back negative. On 23-MAR-2011, the patient was vaccinated with, 0.5ml (lot no. 668061/1632Z, expiration date 30-MAR-2013) again, but only received one pediatric dose instead of 2. The patient did not seek medical attention. No adverse effect seen. Additional information has been requested.
3/18/23 I had a sore throat and tested negative with an at home COVID test. On 3/19/23 I had a headache and a sore throat and tested positive. On 3/20/23 I had body aches, fatigue, heaviness, lethargy that lasted, with mild symptoms, for three or four days. I had a telehealth on 3/20/23 and was prescribed PAXLOVID which I began taking that day. I have continued to test negative.
I received the 1st Covid  vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea,  sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.
Extreme, severe, acute chest pain.  It started suddenly and I was in such distress that my husband had to rush me to the ER.  Then I was transported to Hospital to the PCU.
Patient returned to pharmacy  about 25 hours later said his eyes felt itchy and burning and a bit sore.  Said had a bit of pus exudate in the morning.
On February 23, 2023, at 01:05PM, I was at my desk at work and I started seeing a black web that looked like a string.  I tried to wipe it away.  I changed my contact and it was still there. When I would blink, I would see flashes of white light. I called my eye doctor and they told me to come right in. I drove there and he referred me to an Ophthalmologist. On March 1, I went to see the Ophthalmologist.  He found a leak into the pupil that he said would take 6 to 8 months to clear.
Tuesday morning on 01/23/2021 I checked on my mother and she was sitting on toilet and couldn't get up. She had caked blood in her mouth, and a lot of bruising. She had been on the toilet since the night before on 01/22/2021 at  9:30PM until 7:30 AM in the morning. EMS came and they took her to the hospital. They did blood work, chest x-ray, MRI. She was admitted for four days 01/23/2021-01/26/2021. During that period she did find out she has acute lymphoblastic leukemia. She saw the oncologist on February 1 and admitted again on February 2. On that hospital stay they did more blood work and more treatment. She started vincristine, steroids, and other cancer drugs and she had a lot of tests done everyday. That hopsital stay was from 02/02/2021-02/26/2021.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's family members were tested positive for covid-19 and patient was exposed by his son who was unvaccinated and was currently experiencing severe covid-19 symptoms. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-DEC-2021, the patient was asymptomatic during the day until he had chills at night. The patient had symptoms of light headedness, fatigue, lower part of back was hurting and little congestion (coded as suspected covid-19 infection, suspected clinical vaccination failure). The patient took cold and flu medications and Mucinex which had helped him for a couple of hours. It was reported that the patient has not had any booster dose of any vaccine. On 29-DEC-2021, the patient was tested positive for covid-19 with a home kit test. The patient had not taken polymerase chain reaction (PCR) test yet. (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with regulatory authority.; Sender's Comments: V0: 20211264179-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
It began with soreness at site of injection and traveled down my arm to my hand- where my fingers and hand were sore and had a tingling numb sensation.  Then about two hours later, these symptoms stopped and my heart began racing and I had tightness in my chest/difficulty catching full breath for several hours.  I spoke with my doctor who stated that he  did not believe this is from the shot, I disagree with him and believe that my symptoms were an allergic reaction as I have not ever experienced this before.
Systemic: Dizziness / Lightheadness-Mild, Systemic: vasovagal syncope-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient has a history of vasovagal syncope. Patient fainted a couple minutes after immunization and regained consciousness after 10-20 seconds. Patient BP reading was 102/70 and HR 75 at 10:40am about 40 minutes after administration.
Bumpy rash and lump at injection site on left leg. Advised to continue to give BENADRYL for comfort and apply topical BENADRYL other antihistamine for comfort.
Local reaction around injection site as well as redness, warmth. Treated with Methylprednisolone 4 mg.
atypical chest pain, Left arm erythema that progressed to elbow, diffuse rash on body
I had a headache - which became severe and lasted about 8 days. That started on day two. It worsened each day - by day four it was pretty bad. About day 2 and 3, I felt a little sick in my chest - a little wheezy and breathing mildly labored. Pain and discomfort in my neck (like my lymph). I had some fatigue on day 3 to day 7. The day before I sought care I broke out in canker sores in multiple  places in my mouth and  that's when I sought care because I work by talking. I got that care on Day 5. I have had canker sores before but never  had an outbreak like this before. On my tongue,  cheeks,  lower lip and one up between the gums and the cheek  up on my left back - all over. I called them canker sores but the doctor called them something else - not sure what that was. Related to a Herpes Simplex. San Cyclovir - 1200 mg single dose. Triamcinolone oral paste. Those helped with the symptoms. Three or 4 days after seeing her, the symptoms were resolving and by 5th day after they were pretty much gone. The headache resolved around day 10 after vaccine. Fatigue resolved around day 8.
pt recvd vax & exp fever of 101-102 & fussy; APAP was given; pt was not moving as much; frigid, & non responsive & not self; bluish discoloration; had difficulty breathing; pt crying; RR 20/min
Chills and fever (38.8 centigrade) starting 10 hours after injection. Also body aches, joint pain, fatigue.  Lasted 36 hours
On Friday, Jan. 15th, about a week after receiving the vaccine, the site around the injection became very red, swollen with a lot of heat.  The reaction was not present after the vaccine was given (generalized pain in arm the day after vaccine was  given but no redness or swelling or heat at injection site).  Today is Monday, Jan 18th and the swelling, redness and heat are all still present but not as acute as Friday.  Very visible on my arm.
Woke up feeling unable to breathe, shivering and very chilled.  I am normally on 2 liters of oxygen at all times.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL [IBUPROFEN]; VITAMIN D NOS. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Patient was taking medication for 5 days. Felt good but 3 days after stop taking symptoms return. Other medication in 2 weeks product was Advil and Vitamin d.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 wk after receiving Tdap vaccine, pt began with nausea, vomiting, diarrhea, fever, swelling in arm vaccine received. Pt has had symptoms except fever x 4 days. Fever has been high as 102.
Narrative: Patient reported to nurse 5-10 minutes after getting pneumococcal injection (at 9-05am 8/19/09) stating felt flushed, then turned pale and cool to the touch. Stated felt tingly in his stomach. Also stated that he had not eaten anything since 5-30pm the previous day. After sitting with the nurse for 10 minutes, he state he felt fine and continued on to his next appointment. Symptoms: Symptoms: 1. Dizziness. 2. Flushing, then pale and cool to the touch.
Feet swollen and red spots on the bottom of feet. Looked like broken capillaries. Toes where swollen and a little darker in color. Did not hurt or cause any pain.
I noticed that I got a blister on my lip. The next day I developed pain on the left side of my face under my eye, ear, and jaw line. I had a sore throat and another blister on my tongue. I went into the urgent care 10/13/2022 and the doctor thought I might have either singles, or just bad allergies. I went home and took a BENADRYL and today I am feeling so much better. I still have pain behind my ear, my face is starting to feel better.