chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a registered nurse regarding a 12-month-old patient of an unspecified gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002601, expiration date: 24-JAN-2024, product quantity 1, (dose, injection anatomical location, and route of administration were not provided) administered as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion for 1 hour and 45 minutes with previous excursions. No adverse events were reported (No adverse event).
A non-serious spontaneous report of tested positive for influenza A with symptoms of fever, runny nose, congestion and cough has been received from a mother/consumer concerning her son, a four-year-old male subsequent to H1N1, Intranasal. The patient's medical history included breathing issues. Concomitant medications have not been reported. The patient first dose of H1N1, Intranasal on 23-Oct-2009 and second dose of on H1N1, Intranasal on 25-Nov-2009. On 28-Oct-2009, five days after first dose, the patient had symptoms of fever, runny nose and congestion. On 29-Oct-2009, the patient was tested positive for Influenza A, the patient was experiencing a cough and fever of 100.5 F. The patient was treated with acetaminophen and ibuprofen. The reporter took him to the clinic at 10 pm. On 30-Oct-2009, the patient began treatment with oseltamivir phosphate. The reporter was not sure if her son experienced adverse reactions to the H1N1, Intranasal or if he was infected with the circulating novel H1N1 strain. The outcome of reported event was unknown. Additional information was received on 23-Dec-2009 and incorporated into the narrative: adverse event, event description and outcome.
The vaccine expires 6 hours after the vial is first punctured. The patient received 1 dose of the vaccine 72 hours after the vial had been punctured. The patient was observed for 15 minutes at the clinic after the vaccine was administered. The patient stated he felt "light headed" 5 minutes after the vaccine was administered. Patient was given water and then became asymptomatic. Patient was then discharged home. No other events have been reported by the patient at this time.
03/22/2023 AS INFORMED, I EXPECTED TO HAVE A SORENESS, MINOR WEAKNESS, SO IN ARM MUSCLE WITH POSSIBILITY OF FEELING FATIGUED/TIRED FOR A SEVERAL DAYS.  UNFORTUNATELY, THESE SYMPTOMS PERSISTED. ON 03/29/2023, MY WATCH NOTED CONSTANT AFIB.  HOSPITAL ER CARDIOVASCULAR TEAM VERIFIED CONSTANT AFIB.  IN SEP 2020, I CONTRACTED COVID-19 CAUSING SEVERE NARCOLEPSY FATIQUE TIREDNESS. IN AUGUST 2021, CARDIOLOGY TREATED ME FOR SEVERAL DAYS.  DOCTORS DIAGNOSED CONSTANT AFIB AS A CONSEQUENCE OF SEP 2020 COVID-19 INFECTION OR POSSIBLE prior COVID VACCINATIONS.  IN SEP 2021, A SUCCESSFUL TEE-CARDIOVERSION WAS PERFORMED. VACCINES PRIOR Pfizer COVID-19 vaccine (PF), 12y+, 30 mcg/0.3mL (Given 3/18/2021, 4/8/2021, 9/24/2021) VACCINES PRIOR Pneumococcal Polysaccharide 07/23/2015                                Pneumococcal Conjugate (Prevnar 20)  SEP 2021 TEE-CARDIOVERSION RESULTED IN SUCCESSFULT HEART RHYTHM.  MY FAMILY BOUGHT ME AN WATCH AFTER SEP 2021.  I CONSTANTLY CHECK MY ECG APPLICASTION ON MY WATCH.   THEREFORE, NO AFIB UNTIL SOON AFTER  03/22/2023 PREVNAR 20 VACCINATION. AS PREVIOUSLY STATED, I NEVER RELAPSED INTO AFIB UNTIL 03/29/2023.    ON 04/14/2023, DR PERFORMED A SUCCESSFUL TEE-CARDIOVERSION.   AS OF 04/26/2023, NO AFIB. AS OF 04/26/2023, MY LEFT UPPER ARM MUSCLE PERSISTS IN SORENESS, SOME WEAKNESS, AND SOME LIMITED RANGE OF MOTION.
Sore arm 2 days immediately following the shot.  New onset erythema Lupper arm at 8days post vaccine.  Redness has spread down over 1/3 of lateral portion of L upper arm, with slight tenderness, tender lymph node behind L ear.
Came in to office on 7/2/18 with fading urticaria that started the evening before he came in.
Hepatitis B component was given in the PEDIARIX dose as well as an additional Hepatitis B single antigen dose within the same time frame on the same day. No reported adverse effects from vaccination. Infant without S/S reaction.
Patient came in with her mother and sister for flu shots and had to be seen for a rash. I notice that she was due for Hep-A 9/12 but I failed to notice that it wasn't due until the 20th. I gave her a Hep-A shot 13 days too soon, I told the doctor and called my manager and notified them, no symptoms.
As transcribed from the patient's chart: "Achy, feeling chills, arm hurt after shot."
Received DTaP on 08/12/08 in left leg, the next day had small lump at injection site, 2nd day had 7cm red, hard circle.  Reported to staff/Dr.
Patient received Pfizer vaccine after previously receiving J&J  vaccine. No adverse events to report.
Sedation, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:
unable to eat cereal - milk dripped out of mouth, left side of face drooping, unable to react to sunlight, slurred speech, called primary care doctor - referred to ER, where diagnosed with Bell's Palsy. prescribed prednisone and acyclovir.
Body aches, headache, top of left shoulder got a bump that really hurt (not the site of injection).  Still painful two days later but as of now bump feels smaller.  Pain in left kidney when trying to lift or bend at the end of the day.  I drank lots of water and took Tylenol to help.
itching down vaccine administered arm and forehead and lower back, said whole inside of arm got red. Occurred 15 minutes post administration, face is warm. Gave BENADRYL 50mg observed for 15 minutes. No escalation
t104 x 3 days, lethargy, rash & facial swelling devel MD believed sx due to viral infect;
Pt recv vax on 10/13/97; 6 hr post vax pt exp shaking chills, fever (102.2F), body aches, rigors & headache
This spontaneous report was received from a 71 years old female patient, who was reporting on herself. The patient's pertinent medical history included scoliosis. The patient had drug reactions or allergies to COMPAZINE, sulfa, clindamycin and amoxicillin. On approximately 16-APR-2018 (reported as "2 weeks ago"), the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration, lot # and expiration date were not reported). The patient's concomitant medications were not provided. On the same day, five minutes after receiving the PNEUMOVAX 23 injection, the patient experienced dizziness and pain, redness and swelling at the injection site. On an unknown date in April 2018, she also developed a "pocket of fluid below her elbow" and subsequently went to the emergency room for unspecified treatment. Then, on an unknown date in April 2018, the patient developed stiffness in her fingers and dizziness (reported also "and hand"), and returned to the emergency room for unspecified treatment. She was treated in the emergency room (ER) with BENADRYL and other medication for the swelling. All treatments were received via the ER. Unspecified laboratory diagnostics were performed. The outcome of the events was reported to be recovered/resolved at the time reporting time (on an unknown date in 2018). The relatedness between the events and PNEUMOVAX 23 was not reported. No further information is available.
No adverse event noted. Rotavirus vaccine initiated after 14 weeks 6 days. CDC recommendation is to initiate prior to this age.
My arm bones started hurting (similar to when a broken bone hurts in the cold), and now my shoulder feels very sore to the point where I can only lift up my arm half the distance. Also it's hard for me to move my fingers, and my elbow hurts too.
Rash, fever, irritability, waking up 4-5 times a night with fits of crying like in pain, excessive itching, sun-burned skin, lack of sweating, excessive thirst, colic behaviors, loose bowels, clingy behaviors-wants to be held all day.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 67-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (older shingles shot was received at 62).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported but the pateint was around 65 years. The patinet took the newer shot of shingles and had shingles.
Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in urine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy since an unknown date. Concurrent medical conditions included Cancer.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD URINE PRESENT (Blood in urine). At the time of the report, BLOOD URINE PRESENT (Blood in urine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that 4 days after receiving vaccine she experienced the event. No relevant concomitant medications were reported. No treatment information was reported.
Patient became lethargic, feverish and was vomiting uncontrollably- this lasted for two days when she returned to doctor's office. Tantrums/aggression/irritability followed, eventually diagnosed with Sensory Integration Disorder.
Large amount of redness going from the pts hip to his knee along with swelling, and inconsolable. Mom was advised to administer tylenol and gave a warm bath. "Left leg"
Mom reports today (7-24-12) that pt. had "altered mental status" after receiving GARDASIL on 8-5-2011. She describes pt being "dizzy, not knowing where he was spacey". Mom reports patient was totally recovered next day.
Thrown up once; it had blood in it; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8736) via an unspecified route of administration on 14May2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient got his second shot on 14May2021 of the Pfizer and he just threw about 15-20 minutes ago, and it had blood in it. The wife was just wondering is this something that they should be concerned about. "Should I take him to the emergency room? He got his second shot yesterday. He has thrown up once. But it had blood in it." Outcome of the event was unknown.
I became very chilled, could not get warm yet was hot to touch, had a fever close to 102, shortness of breath and coughing, urinated approximately 10 times in 2 hours, nausea, blood pressure dropped and heart rate went up (typically heart rate runs around 60, went up to 80-83 consistently, fatigued, ached all over. This started the evening of the shot, the severity of the symptoms lasted throughout the entire next day, and the fatigue, nausea and achiness is continuing still today. The first night I thought I was going to have to go the ER, but finally got a little sleep and fever went down by morning.
Contracted COVID19,  symptoms began on 04/18/2022 and tested positive at that time
Initial non-serious report received from a health care professional on 09 November 2010. A 36-year-old male patient, with a history of sleep apnea, obesity, tendonitis and Osgood-Schlatter's Disease, received on 03 November 2010 a left arm intramuscular injection of FLUZONE, lot number U3737AA. The patient had no known allergies (NKA) and had no illness at the time of vaccination. He had not received any previous doses of flu vaccine or H1N1. The patient's concomitant medications included ADVIL and methocarbamol. On 05 November 2010, he developed mouth lesions, rash on body, fever and chills. The outcome was reported as recovered. Follow-up information received from a health care professional on 17 December 2010. From the following information received, this case was upgraded to serious. The patient had not received any other vaccinations within 4 weeks of 03 November 2010. Per the reporter, the patient left their clinic (date not reported) and went to the emergency room where he received Epi injection and prednisone. He returned to their clinic 9 days later with diffuse coalesced areas of hyperpigmentation that were worse on the patient's back and thorax. At that time, the mucosal "lesions" had resolved, and per the reporter, the patient had decreased pruritis. The patient is to have a dermatology consult on 10 January 2011. Per the reporter, the patient has not recovered (previously reported as recovered). Documents held by sender: None.
has only had one DTaP dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 6-year-old male patient who received DTPa (DTaP vaccine) for an unknown indication.   Previously administered products included DTaP  (received only one DTaP dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 8-Nov-2022 Reporter's comment: The registered nurse reported that the patient come in their clinic on the day of reporting and want to administer Kinrix on the day of reporting. The reporter did not know what DTaP, the child had received, so unknown DTaP as first dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of DTaP, which led to incomplete course of vaccination.
bladder infection; This spontaneous case was reported by a patient and describes the occurrence of CYSTITIS (bladder infection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A214) for COVID-19 immunisation.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CYSTITIS (bladder infection). At the time of the report, CYSTITIS (bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment medication included antibiotics.
After she received the shots, her periods became very bad. Extremely short cycles, began getting them ever 15 days. very painful and very long lasting. This hadn't happened before
Following a  3rd dose of Haemophilus B given on 6/23/99, pt developed signs of meningits on 8/5/99 and was hospitalized.  Pt was d/charged with a dx of Flu-B type meningitis on 8/14/99.  Pt fully recovered.
For 2 days I had a huge welt on vaccine site. Then, on day 5, I developed low grade fever, cough, pain and soreness in muscles.
Pt stated "my left hand is itching." Within a matter of minutes, pt stated, "my whole arm is itching, now my right arm and legs are itching".
a staff member had given ActHib diluted with sterile water instead of normal saline/no ae; Initial information received on 05-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 month old female patient who received 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [Act-HIB] diluted with sterile water instead of normal saline (Product preparation error) (lot UJ118AA, of unknown Expiration date) via unknown route at  the left thigh for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient recieved DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [Daptacel] on 04-Feb-2020 as concomitant medication   It was an actual medication error due to Wrong solution used in drug reconstitution.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication
Patient  fainted and fell off chair and hit head on floor. Patient was treated by paramedics.  The patient recovered from faint and did not need go to the  hospital. The time was 12:10 PM.
patient started to feel itching and swelling of tongue. 25mg Benedryl give and monitored for additional 30 min
MEMORY PROBLEMS; This spontaneous report received from a consumer concerned a 6 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced memory problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from memory problems. This report was non-serious. This case, from the same reporter is linked to 20210755330.
After receiving shot, sat down and felt dizzy and then syncopal episode lasting less than 30 seconds.  After felt nausea and weak.  Initial BP 88/60, P 56.  Placed patient supine on cot and gave 2L O2 via cannula. BP rose to 120/80 , P 68.  After 15 minutes patient sat up.  Was able to maintain BP but began to feel dizzy and nauseous again.  Lay back down and felt better.  After several attempts over 30 minute period to sit up, pt determined that she did not feel well enough to remain upright.  BP stayed consistent around 124/82 throughout.  Pt. transported to Hospital per her request.
Patient is an employee who is a nurse who works in ED. Reported to me today that she had severe pain all over her body, deep "crushing" bone pain and limited range of motion in arms. No treatment. Resolved in 24 hours.
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 23Mar2021 at 09:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes, neuropathy and the patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN) and dulaglutide (TRULICITY); started on an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 04Apr2021 at 09:00, about 2 weeks after the second shot, the patient's arm went numb in the area where she got the injection and if her life with her left arm needles and pins shoot through her upper arm and the upper part of the arm always felt like it was asleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events arm went numb in the area where she got the injection and her left arm needles and pins shoot through her upper arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events her arm went numb in the area where she got the injection and her left arm needles and pins shoot through her upper arm were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
The medical history, concurrent conditions and concurrent medications were not specified. On an unspecified date, the pt received an injection of Engerix-B. It was not known if the pt had received previous injections of Engerix-B. In 1 part of the claim, the attorney alleged that the pt was immunized "during the time from 3/93 and 9/94". In another part of the claim, the attorney alleged that the pt was immunized "during the period from 8/97 to 12/98". The pt also received injections of DTP vaccine adsorbed (Tri-Immunol); DTAP vaccine adsorbed (Acel-Immune; MMR; Hib type B conjugate vaccine (Hib-Titer) and Hep-B vaccine recombinant (Recombivax-HB). The pt's attorney alleged that "Through the thimerosal-containing vaccinations administered to him during the 1st 2 years of his life, (he) was poisoned by cumulative doses of mercury in the thimerosal. As a result of the thimerosal-containing vaccination received as an infant, (he) now suffers and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." This report of mercury poisoning is considered to be "Medically Serious".
3 days after the vaccination, started with shortness of breath, and dysphony. The shortness of breath gets worse walking on stairs and the dysphony worsens when talk. I also noted a hotness sensation, but when used the thermometer the temperature was normal. When checked both lungs didn't have any abnormal sounds. On the absence of these symptoms, I started using Fluticasone with Salmeterol, that improved the shortness of breath, but it came back after 12-14 hours, requiring use of 2 inhalations mornings and nights, the dysphony was related to the hotness and light tiredness. I used the medicines from January the 16th to February 6, when noticed that the shortness of breath improved and didn't required the dose for the night, then stopped the dose for the morning. Regarding the hotness sensation, is still present but the dysphony disappeared.
31DEC91 pt recvd 1 dose of Engerix-B & approx 8 hrs p/vax 8PM went to Er w/urticaria & itching; tx DPH & as of 7JAN92 pt fine;
PATIENT STATED THAT SHE HAD A RASH ALL OVER HER BODY AS WELL AS BRIUSE ON THE INJECTION SITE. PATIENT STATED THAT THE SYMPTOMS STARTED 2-3 DAYS AFTER RECEIVING THE SHOT AND AFTER SHE TOOK BENADRYL, THE RASH DISAPPEARED. I SPOKE WITH STAFF AT DOC (PATIENT'S FAMILY DOCTOR) AND REPORTED THE INCIDENT ON THE SAME DAY PATIENT REPORTED THAT (9-8-20). STAFF STATED THAT SHE WILL SEND THE INFO TO THE DOCTOR.
Blood in stool x 3 diaper changes starting 05/31/16 at 9 pm.