chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dry skin rash on both sides of the neck and around the eyes; Dry skin rash on both sides of the neck and around the eyes; vaccine location Right leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in leg right, administration date 23Dec2021 15:30 (Lot number: Fk5127) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fz0007, Location of injection: Leg Right, Vaccine Administration Time: 03:15 PM), administration date: 30Nov2021, when the patient was 6 years old, for COVID-19 Immunization, reaction(s): "vaccine location=Right leg". The following information was reported: DRY SKIN (non-serious), RASH (non-serious) all with onset 24Dec2021, outcome "recovering" and all described as "Dry skin rash on both sides of the neck and around the eyes"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 23Dec2021 15:30, outcome "unknown", described as "vaccine location Right leg". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dry skin, rash.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Approximately 1/2 hour after receiving injections, pt and her father returned to clinic to have nurse look at wheals that had come up on child. The wheals were very apparent and were on entire body distributed evenly. Referred to PMD ASAP.
I woke up early on a Saturday morning with heavy nausea and feeling achy with the flu but no fever; however, my temperature was 96.2 the duration of my symptoms. I was really cold and my stomach was growling and it was very much like the symptoms of the flu. I was exhausted and could not walk to the restroom. I slept 8 hours straight that Saturday which is very unusual for me. I called my doctor via a tele-health call three days later once I was better and he suggested that I get a COVID test and I took the test and it came back negative. The next day I felt better and was able to get up, get something to eat, and run some errands. I took Ibuprofen for a migraine that I experienced but it did not do anything. I was very pale because my blood pressure was so low (was not tested or checked). I had loose stools for three days (was sick for approximately 4 days). I have never had such progression of symptoms where each day was very odd. I also experienced a runny nose.
Urticaria eczema; Urticaria eczema; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Urticaria eczema) and ECZEMA (Urticaria eczema) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 016m20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 05-Jul-1980 and Penicillin allergy. Concomitant products included VITAMINS NOS (MULTIVITAMINUM) from 09-Jan-1980 to an unknown date and VITAMIN D3 from 04-Jan-2019 to an unknown date.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced ECZEMA (Urticaria eczema). On 22-Jan-2021 at 8:15 AM, the patient experienced URTICARIA (Urticaria eczema). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Urticaria eczema) and ECZEMA (Urticaria eczema) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up received on 27-Apr-2021: Patient demographics, medical history, concomitant medications and event outcomes were updated.
muscle spasms; felt incredibly nauseous; puking; severe bladder discomfort; overheated and felt flushed without any fever; needing to pee every hour; she was also overheated and felt flushed; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included gastritis, irritable bowel syndrome (IBS), polyps, asthma and allergy to fruits, vegetables, nuts and seeds. 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 vaccination. Concomitant medications included paracetamol (TYLENOL) started on an unknown date for unknown indication and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021, 6 hours after vaccination, the patient experienced muscle spasms and felt incredibly nauseous, at around 5:00, the patient began puking every hour and needing to pee every hour, she couldn't stand without vomiting but she had to in order to keep peeing. She felt severe bladder discomfort, she was also overheated and felt flushed without any fever. She still cannot eat without severe nausea and vomiting. She felt like this was important to note due to the fact she had a heightened risk of stomach cancer, so anyone with the same digestive issues should be prepared to have this reaction just in case it effects them similarly. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle spasms, felt incredibly nauseous, puking every hour and needing to pee every hour, severe bladder discomfort and overheated and felt flushed without any fever was not recovered 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.
11hrs after  vaccine1/04/ 21  chills temp 102.6 while  taking  tylenol, headache  muscle, Hr 140  01/05/21chills, lightheadedness, 01/06 diarrhea
Patient experienced a brief simple febrile seizure 48 hrs after immunization. Seen in ER diagnosed with feb. seizure & OM.
Pt recvd vax 21AUG91 & suddenly fell forward to the floor striking forehead; body & neck stiff; arms stiffly out stretched & hands clenched into fists; turned pt over, but remained stiff for 30 sec; gradually relaxed; pt lethargic and dazed
tested positive and have symptoms of COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive and have symptoms of COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history).   On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive and have symptoms of COVID). At the time of the report, COVID-19 (tested positive and have symptoms of COVID) outcome was unknown.      No concomitant medication reported.  No treatment information was provided.
Information has been received from a male who is a pharmacist who on 07/09/03 was vaccinated with a dose of MMRII.  Subsequently the pt experienced testicular pain. The pt is awaiting results of an ultrasound. He was not hospitalized. According to the pt he is not experiencing pain.  No additional information was provided.  Unspecified medical attention was sought. Additional information has been requested.
Catatonic-like behavior. Patient is a 57 YO female who presented with decompensated unspecified mood disorder and catatonic-like behavior.  PMHx of schizophrenia, generalized anxiety disorder with previous episodes of catatonia, prior CVA, unspecified seizure disorder, essential hypertension, urinary retention, hypertension, T2DM.  Patient was admitted on 10/13/23 from facility due to AMS, poor oral intake, debility.  Has been admitted several times for this chief complaint before.  However was unable to admitted to Facility due to physical debility.  Imaging of head was negative, workup negative for medical etiology.  Psychiatry was consulted inpatient.   During hospital stay, patient weaned off Invega long-acting injectable.  Psychiatry recommends further initiation of antipsychotic following washout period.  She was transitioned off of Keppra for unspecified seizure disorder, to Depakote with concern of exacerbating mood disorder.  Psychiatry recommended beginning Ativan trial for catatonia. Patient continued to have poor oral intake, debility.  Was initiated on memantine, SSRI for concerns of decompensated mood disorder vs. Atypical catatonia.  Cogentin was added regimen for intermittent extrapyramidal symptoms. Patient failed Ativan trial, was weaned.   On 11/03 patient remained medically stable, was accepted to Facility for further psychiatric management.  Unfortunately patient developed fever overnight and was found to have COVID.  Required 10 day isolation.  During this time patient became more alert, but still with frequent atypical catatonic symptoms.  Psychiatry continued to recommend ECT.  Patient was discharged medically stable on 11/14 to Facility.
Information has been received from a nurse practitioner concerning a 6 month old female who on 29-JAN-2007 was vaccinated with the third dose of Rotateq. The NP reported that on 30-JAN-2007 the patient was hospitalized as she developed dehydration, colitis and tested positive for rotavirus. The patient was continuing to be treated on an outpatient basis with IV fluids for her dehydration. At the time of this report, the patient's dehydration, rotavirus and colitis persisted. Additional information has been requested.
No adverse event; they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes; Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes).    Concomitant medications were not reported.  None of the patients have reported any adverse reactions at this time.  Treatment medications were not reported.  This case contains information for patient 04 out of 06.   This case was linked to US-MODERNATX, INC.-MOD-2023-742028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742028:Patient 4 out of 6
50M presented 8/17/22 with hx sarcoidosis, NICM/HFrEF s/p ICD, AF, CKD5, current smoking came to the EC 8/17 with fever and intractable nausea/NBNB vomiting/watery NB diarrhea. He tested COVID positive 2 days prior and is vaccinated against COVID x3 with this being his first COVID infection. He denied respiratory complaints. In the EC he was AFVSNL and examination noted scleral icterus. Labs revealed only mildly elevated PT/INR but AST 6520, ALT 2444, T bili 1.7, BUN/Cr 91/6.2, and hyperkalemia 5.8. MICU and GI were consulted and further imaging and labs were ordered with consideration for transaminitis secondary to shock, viral hepatitis, congestion, drug-induced etiologies. Ultimately he was admitted to Facility acute COVID infection c/b significant transaminitis in the thousands, rhabdomyolysis, AKI on CKD5, and hyperkalemia 5.8. His acetaminophen and EtOH levels were undetectable and he was not hypotensive though tachycardic on presentation. He had normal hepatic morphology on MRI abdomen 2022. GI's current leading diagnosis is acute viral hepatitis with transaminitis compounded by rhabdomyolysis versus shock liver versus AI liver disease versus vascular pathology. GI recommended BCx, viral serologies, ANA/ASMA/AMA/LKM/ceruloplasmin, empiric IV NAC, hydration for rhabdo, doppler US to r/o vascular pathology, echo, tending LFT's/PT/INR/daily MELD labs, neurochecks. His acetaminophen and EtOH levels were undetectable and he was not hypotensive though tachycardic on presentation. He had normal hepatic morphology on MRI abdomen 2022. GI's current leading diagnosis is acute viral hepatitis with transaminitis compounded by rhabdomyolysis versus shock liver versus AI liver disease versus vascular pathology. GI recommended BCx, viral serologies, ANA/ASMA/AMA/LKM/ceruloplasmin, empiric IV NAC, hydration for rhabdo, doppler US to r/o vascular pathology, echo, tending LFT's/PT/INR/daily MELD labs, neurochecks. Nephrology consulted for AKI on CKD5 and rhabdomyolysis c/b hyperkalemia, hyperphosphatemia, hypocalcemia. Cardiology consulted for NSTEMI with troponin 0.51 and ST-T abnormalities. He had elevated d-dimer 9753 with thrombocytopenia 121. His home bumex and metoprolol were held while hydralazine continued and coreg initiated given his HFrEF. He was noted to have chronic anemia around Hb 9-11 for which outpatient iron studies should be considered. ID was consulted given his COVID infection: Paxlovid precluded by CrCl <30, remdesivir not recd 2/2 transaminitis, no currently available mAb, ideally vax prevent declining resp disease in this setting; liver damage could be COVID, consider hypovolemia/hypotension; consider babesiosis, ehrlichiosis, anaplasmosis, RMSF; check parasite smears and RMSF serology, started doxy 100 mg IV q12 8/18.His CK was ~4500 and declined on repeat. For electrolyte abnormalities in context of his CKD5 he was continued on Renvela 800 mg TID. He was discharged in stable condition with renal function at baseline, acidosis significantly improved, liver function tests down-trending, and appetite adequate without further nausea/vomiting/diarrhea.
couldn't get out of bed; always hot now; sweats profusely; achiness started; running a fever for 2 days; achy joints; very tired; that evening he was sick/he says he's never been so sick in his life like after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (that evening he was sick/he says he's never been so sick in his life like after the vaccine), BEDRIDDEN (couldn't get out of bed), FEELING HOT (always hot now), HYPERHIDROSIS (sweats profusely) and PAIN (achiness started) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (on Christmas 2020 for 2 days, mild) in December 2020.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ILLNESS (that evening he was sick/he says he's never been so sick in his life like after the vaccine). On an unknown date, the patient experienced BEDRIDDEN (couldn't get out of bed), FEELING HOT (always hot now), HYPERHIDROSIS (sweats profusely), PAIN (achiness started), PYREXIA (running a fever for 2 days), ARTHRALGIA (achy joints) and FATIGUE (very tired). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (that evening he was sick/he says he's never been so sick in his life like after the vaccine), BEDRIDDEN (couldn't get out of bed), FEELING HOT (always hot now), HYPERHIDROSIS (sweats profusely), PAIN (achiness started), ARTHRALGIA (achy joints) and FATIGUE (very tired) outcome was unknown and PYREXIA (running a fever for 2 days) had resolved.            No concomitant medication details were provided.   This case was linked to MOD-2021-294579 (Patient Link).
Information has been received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 28-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # M018958, with expiration date reported as 03-MAR-2018,  for prophylaxis (dose and frequency were not reported). No adverse effect was reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature of - 1 Celsius degree (°C) or bellow (-1.1 °C) for 285 hours, and 0C for 3 hours. The call was placed because of a Digital Data logger report. Additional information is not expected as the reporter did not consent for further follow up.
Approximately 3 hours after vaccination I experienced fatigue, soreness, headache, and sound sensitivity. The next morning as my headache subsided I began to experience ringing in the ears (tinnitus). For the following 2 months (to this day) I have been experiencing a low grade headache, racing heart rate and dizziness upon standing, persistent tinnitus, and intermittent hyperacusis.
Sitting down on bleachers immediatly after receiving COVID vaccine - started feeling lightheaded and had a witnessed syncopal episode.  Patient hit his head on the back of the bleacher and passed out for a few seconds. Reports twitching movements. Reportedly does have a history of passing out with injections and piercings in the past.  He had not had anything to eat or drink that day.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 26-NOV-2012, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Patient came in on 11-12-19 and said she was having arm pain and trouble lifting it up high. She was wondering if it would have correlation with her vaccines she received on 10-14-19. Suggested she take Tylenol and contact her provider or go in to urgent care if this continues in the next day or two.
I begin to have coughing and runny nose 10/29/2022 took test 10/31/2022 came up positive, immediately quarantined and wore mask reported symptoms tested again 11/2/2022. Symptoms remained with sore throat mild fever only on 10/31/2022 and weakness with head cold feeling. Treated with DAYQUIL, NYQUIL.
This spontaneous report was received from a nurse. The nurse reported that PROQUAD (Merck) (lot# K023363, exp. date: 20-MAY-2016) was placed in the refrigerator because another nurse saw M-M-R II on the PROQUAD (Merck) cartoon and confused the product with M-M-R II. The reporter stated that the boxes of both vaccines were of the same color. No patients received any doses of PROQUAD (Merck). Additional information has been requested.