chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her fogginess dissipated, things became clearer; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. Medical history included depression and anxiety from an unknown date and unknown if ongoing. She just got the Pfizer COVID vaccine, and she wanted to report something to Pfizer. She states she suffers from depression and anxiety, and one of the things that happens to her is that she gets befuddled- things get very foggy and don't seem straight, she gets in a big rut. She does take other drugs for it that she has been on for a couple of years. She went to get the first dose of her COVID-19 vaccine and did the 15-20 minutes of being monitored. She could taste the vaccine as soon as she got it. When she was waiting her 15-20 minutes to be monitored for any immediate side effects, the caller states things started to become clearer. When she went home and the next few days afterwards, her fogginess dissipated. She became clearer, she remembered things. She made lists and remembered them. This lasted for almost 3 weeks, maybe 2.5 weeks. She went and got her second shot and she could taste it almost immediately. She did her 15-20 minutes of waiting. She got home and she got clear again. It has been such a long time since she felt this way and she was so excited. She didn't want it to go away. She thought to herself should she get another shot. She clarifies further after the first shot, she became clear and this dissipated within 2.5-3 weeks. After the second shot, she became clear again. She became so much clearer. She clarifies what she means by clearer is that she was not sitting around lost in herself. She was not depressed. She wanted to get up and do things. She still remembers a lot. She was not sitting around lost in herself, she was not depressed; wanted to get up and do things. Outcome of the event was unknown.  Information on lot/batch has been requested.
Patient reports breaking out in hives and itching all over that subsequently led to her going to the ER. This started 10 days after she got the H1N1 vaccine.
2 days after receiving flu shot; dizziness, that evening feeling cold & nauseous & weak. The nausea and weakness lasted 3 more days. I rested and ate lightly. Consulted with doctor but did not go to him.
This spontaneous report as received from a consumer refers to a 13 years old male patient. On an unknown date in 2001 (also reported as when the patient was 15 months old) the patient was vaccinated with M-M-R II (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date approximately in 2001 (also reported as when the patient was 15 months old) the patient experienced blood in stool (hospitalization), stopped breathing (hospitalization and medically significant), had night crying jags (hospitalization) and he stopped talking (hospitalization and medically significant). The consumer stated that on an unknown date the patient recovered from his physical illness (hospitalization). On an unknown date approximately in 2001 the patient began showing signs of autism (hospitalization). The reporter stated that the patient was hospitalized on an unknown date (hospitalization date, amount of time spent in hospital was unspecified). The outcome of he began showing signs of autism was reported as not recovered. The outcome of he had stopped breathing, he had night crying jags, blood in his stool and he stopped talking was reported was unknown. The outcome of physical illness was reported as recovered. The relatedness of the events to the therapy with M-M-R II was unknown. There was no product quality issue reported. Additional information has been requested.
it could have been "Long Covid".; My husband and I both had Covid for the first time in December, 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (My husband and I both had Covid for the first time in December, 2022) and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid".) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Mitral valve disease, Atrial fibrillation (which got repaired through doing an add on "maize procedure".) and Mitral valve repair (by using a minimally invasive and robotic approach at facility.) in March 2019. Concurrent medical conditions included Allergy.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2022, the patient experienced COVID-19 (My husband and I both had Covid for the first time in December, 2022). On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid".). At the time of the report, COVID-19 (My husband and I both had Covid for the first time in December, 2022) had resolved and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid".) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient was planning to travel in the coming weeks and concerned about to get another booster as will be among many people in their apartment. Additional patient have scheduled cataract surgery upon return back to state. So certainly don't want to have a problem with covid before the surgery.  Patient was concerned about taking the more recent bivalent booster which has been available for quite some time and read about issues with those who have allergies and also about people who had experienced any previous heart issues. Patient also fall into both categories and also seem to have a low heart rate so that is always a concern.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732538 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2023: Non significant information received. On 09-Jul-2023: Non significant information received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732538:Linked husband case ID MOD-2023-732538, same reporter
4JUN93 MOC came to clinic stated did not want to proceed w/immun; pt was unusually irritable following shots on 23APR93; @ approx 1030PM fever was 102 A w/APAP; went to ER-temp 103 R described pt as lifeless;
Injection site reaction/pain:  Swelling, muscle stiffness, soreness, and itching at the injection site (left deltoid) within 15 - 20 minutes following injection on 9/7/2021.   No treatment administered; as of 1:45 pm on 9/8/2021, symptoms have not resolved.  Painful itching and hives left shoulder blade, upper back, neck, and right arm occurred approximately 1.5 to 2 hours following injection on 9/7/2021.  No treatment administered; as of 1:45 pm on 9/8/2021, symptoms have not resolved.  Muscle spasm in right foot and leg - duration: approximately 20 - 30 minutes; occurred at approximately 1:30 am on 9/8/2021.  No treatment administered; symptoms resolved.
Rotateq vaccine 1st dose given at 4 months of age, dosing information was not clear. I thought 3 doses given between 2 months and 8 months were the guide lines. Pt had temp of 100 day after vaccination and a little fussy. No symptoms on 2nd day of vaccination
School nurse called health department and reported to RN that patient's left deltoid streaking, red, and raised.
Swelling at site of injection, redness the size of a 50 cents piece, hard lump underneath and fever. Treated with Tylenol and Benadryl.
Pt received COVID-19 vaccination from Pfizer on 3/19 and 4/9 at the immunization clinic at the LIbrary  hospital.   On 6/5 she presented to the hospital with stroke like symptoms, workup now consistent with an acute demyelinating process suspected to be tumefactive MS but could also be consistent with ADEM. Unclear that this is related to vaccination.
SEPTIC SHOCK ACUTE LIVER INJURY ENCEPHALOPATHIC PRESENTED WITH BLOODY DIARRHEA.  TRANSAMINASES IN THE 1000S.  IN SEPTIC SHOCK.  INTUBATED AT PRESENT
PT Received Moderna 3rd shot on the left deltoid muscle. PT complained of dizziness, PT started becoming diaphoretic, pale. PT lost consciousness pupils and mydriasis is pt had a partial seizure, for approximately 1-minute pt then placed on a cot by 3 EMS crew. PT then came to, started speaking, stated he ate 1 hour ago, PT stated he had dental work on MOnday 12/27/21, and crurently is on Amoxicillin and hydrocode, pt was given water and advise to breathing exercises pt stated he suffered from anxiety, pt vitals became stable. PT was taken to a private area, pt was advised to seek further medical evaluation, pt was released and escorted to vehicle by ems.
10/3 - started with mental changes 24 hours after influenza vaccine. Dx with encephalitis.
I began feeling bad on or about the 15th of October with slight chills, feeling I was going to get sick and tiredness, malaise.  I was stumbling over my words and couldn't recall some of the things I said. Late on the 20th of October I developed painful swollen lymph nodes under my right arm, which is the same arm the vaccine was given.  The swelling is beginning to subside.  I received a H1N1 flu vaccine last year as well.
15 minutes after vaccine, patient starting having itchiness and eye pain, looks like starting to develop hives. Benadryl 50mg IM given x 1 dose.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable consumer or other non hcp reported for her daughter.  A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension, asthma, hypersensitivity. It was unknown if the patient was pregnant at time of vaccination. Prior to vaccination the patient was not diagnosed COVID-19 positive. The patient's concomitant medications were not reported. The patient had a covid tested positive on 06Jan2021 with outcome of recovering. The patient was previously tested negative on 04Jan2021. Facility where she worked had outbreak. The events resulted in both emergency room visit and physician office visit. She was improving but her respiratory status still wasn't good. Pulmonologist just restarted 2nd round of steroids, and additional BP med started.  Can now sit up but quickly gets wiped out. She was not currently hospitalized.  No follow-up attempts are possible. No further information is expected. Batch/Lot numbers can not be obtained.
Pt. had difficulty breathing, hypotonia, and diminished level of consciousness; was taken to local ED where leukocytosis to 33.  Transferred to tertiary care, rec'd fluid resuscitation and LP.  LP showed protein to 86, otherwise nl.
Within 45mins pt felt sweaty, had a HA, felt nauseated and felt body aches. Pt vomited x 2 within an hour. Pt presented to medical. Vitals were stable. Pt was given 1L NSS and anti emetic. Pt was discharged home for the day.
IMMUNIZATION GIVEN IN LEFT ARM(08-05-2008)REACTION NOTED WEDNESDAY. PT SEEN IN OFFICE THURSDAY AM NOTED 6 X 6 CM RED SWOLLEN AREA AT IMMUNIZTION SITE. WARM TO TOUCH NO RX GIVEN. ADVISED TO MONITOR AND USE COOL COMPRESSES.
Zoster vacccine was found sitting on counter in med prep room at room temp. Zoster vaccine was received on 06/23 and was found one day later.
Follow up information received from a health care professional provided patient demographics and additional vaccine details. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine(diphtheria crml97 protein) injection) was received form a healthcare professional regarding a 4 month old patient who developed a temp of 100.3 degrees Fahrenheit and was screaming. At 4 months of age, the pt received the 2nd dose on 07/19/2004. The pt also received the 2nd dose of Pediarix (DTaP/ HepB/ polio virus inactivated) (GSK) and the 2nd dose of ActHib (Haemophilus B conjugate vaccine (tetanus) ) (Aventis) on 07/19/2004. Event Details: on 07/20/2004, one day post immunization, a 4 month old female pt developed a temp of 100.3 degrees Fahrenheit. The pt's mother reported that her daughter had been screaming for one hour. Treatment consisted of Motrin "60mg Q 6H". This report was received from Merck. No additional information was available at the time of this report.
Next day red, arm swollen, hard knot appeared (looked like blood under skin) - turned black and warm - went to MD within one week (express care) and went to current MD today 11/12/13 told her she had bacterial infection got cream and oral abx.
Aggressive behaviors; This is a spontaneous report from a contactable consumer (patient's parent). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 26Mar2021 at 12:00 PM (at the age of 17 years) (pending clarification), as dose 1, single, for COVID-19 immunization. The patient's medical history included severe autism. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was fine up until he received his first dose Pfizer vaccine. In Mar2021 (also reported as 25Mar2021 at 01:00 PM, pending clarification), the patient developed aggressive behaviors. The event resulted in disability or permanent damage (also considered medically significant). It was unknown if treatment was received for the event. On 13Apr2021 at 12:00 PM, the patient was administered with the second dose of BNT162B2 in left arm. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 14-year-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 13-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Headache, Myalgia, Fever, Rash, Fatigue/ redness/ swelling/ chills Narrative:  Other Relevant History:
This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown. It was unknown if the reporter considered the pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that they the patient who experienced pruritis after their 1st dose. The reporter gave consent to follow up. No product expiry date or lot number was given for SHINGRIX.
Per mom, child developed increased pain at site compared to past vaccine doses, and fever around 100 degrees.
Is dry mouth a side affect; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Is dry mouth a side affect) 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 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced DRY MOUTH (Is dry mouth a side affect). At the time of the report, DRY MOUTH (Is dry mouth a side affect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Injection site swelling/rash. Pt cannot take BENADRYL so went to hospital ED. Pt. given prednisone, hydroxyzine, & BACTRIM DS.
PT STARTED HAVING FEVER, NAUSEA AND VOMITING A COUPLE OF NIGHTS AFTER GETTING VACCINATION. DID NOT TAKE ANY MEDICATION FOR SYMPTOMS, REPORTED THAT FEVER IS GETTING BETTER. IN AREA OF INJECTION PT REPORTS A TENNIS BALL SIZE DIAMETER OF RASH/REDNESS AND ELEVATED.
injection site rash; A spontaneous report was received from a Consumer who is the patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rashes at the injection site  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. Mild symptoms appeared and resolved within 15 days. On the 13th day i.e, 18-JAN-2021, the patient got 2 by 2-inch rash at the injection site.  The patient took Benadryl. As reported the rash has not resolved but has not gotten worse.  No Laboratory details provided. No other treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  As per the report the event has not resolved.
I was diagnosed with shingles on 3-18-21. I started having a rash on 3-15-21. I have been prescribed medication that I just started. I am breastfeeding and my son developed a rash on 3-15-21. The rash spread from his stomach to his entire body. The rash turned bright red and bumps were visible on his entire body. The redness decreased starting on 3-17-21. He was seen by a doctor on 3-19-21 and told it is a viral rash likely from the vaccine but nothing can be done.
2hr p/vax had fever & 3min gen sz;seen in ER w/fever to 104.6;
Sore arm visited ER given pain med and antibiotic. Nausea, headache.
I was feeling very achy, coughing, sore throat and diarrhea. I decided to go to the Urgent Care and have a COVID-19 test done, as well as a strep throat test. The test COVID-19 test came back positive my strep test came back negative. They advised me that I had come in too late after the symptoms had started to have medication prescribed. I was sent home since I had mild symptoms and advised to treat it as common cold. It took me another seven days to get rid of the symptoms completely. I am still a bit tired at times and my throat will hurt and have congestion.
after the injections experienced severe muscle spasms , back , neck, shouder arms and legs, pain levels 9-10 severe fatigue , pain at injections site left arm, headaches , severe fatigue, nausea, muscle pain joint pain, super sensitive to touch and clothing hurt by touch, worse pain ever bowel issues, after 1st dose took a couple days off of work to recover then tried to work through 2 days thinking it was a normal fibro flare, when I went back to work after taking a couple days and it was no improvement it got worse couldnt concentrate , had to take many breaks , constantly shifting , wasnt able to focus with the extreme pain , headache nausea , stomach issues and severe muscle spasms, severe fatigue,  ending up  going out of work since then, treated like normal fibro flare, rest, many epsom salt baths, aleve, trigger point injections , physical therapy went to dr as normal to report flare up
BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 7/20/2023 Discharge Date: 7/22/2023 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] Generalized weakness [R53.1] Failure to thrive in adult [R62.7] COVID-19 virus detected [U07.1]   HOSPITAL COURSE: Patient presented to the emergency department on 7/20/23 with complaint of weakness and fall at home. He was also utilizing his PRN oxygen more than normal.    In the ER vital signs were stable with appropriate oxygen saturations on room air.  Initial labs showed relatively unremarkable CMP, hemoglobin 12.9.  He tested positive for COVID-19 in the ER.  A UA was negative.  A CT head was negative for acute intracranial hemorrhage.  Chest x-ray showed chronic coarse lung markings but otherwise no acute findings. X-ray of the lumbar spine showed severe compression fracture at T9 which was progressed from 11/18/2022.  Patient received a total of 1 L normal saline in the ER and was admitted to the hospitalist service for further management of weakness, COVID-19, and T9 compression fracture. For the compression fracture at T9, case was discussed with Dr. of Ortho Spine and he recommended no further intervention or brace at this time and out patient follow up as needed.    During hospitalization, he remained on room air. PT/OT recommended SAR due to continued weakness and risk for fall. Unfortunately, patient was unwilling to go to COVID appropriate SAR facility due to distance from home.   Remainder of chronic medical conditions remained stable.    Today, he was in bed during examination. Please see today's progress note for examination and further information.   Patient has opted for discharge home with home PT/OT which was arranged by care management. Family and patient understand risks due to his continued generalized weakness which includes additional falls. Please see discharge instructions for further information.