chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up with a bumpy, itchy, raised red rash all over my anterior and posterior trunk, breasts, both flanks, down both arms and down my legs stopping half-way down my thighs. The rash proceeded to get worse as the day continued, with it spreading up my neck and onto my ears and cheeks by 12:30 PM. I took zyrtec at 03:40 PM, and the rash disappeared by about 25%. I took 50mg Benadryl at bedtime, and I woke up on 09/26/15 with a very limited rash on just my low back, my abdomen, and my neck. The rash has yet to fully resolve. There is no more redness, but I have small patches of sandpaper like skin that itches in two fist-sized areas on both sids of my low back. This is where the rash was the worst at onset.
pt recv vax 10DEC97 & w/in 24hr pt exp an allergic rxn;pt had inflammation & calor w/ a 4x4 inch, raised erythematous lesion that blanches around the inj site;11DEC97 itching began;
The cause for pt's death has yet to be determined.  6/8/07 Rceived medical records & vax records from PCP which confirms vax as reported.  Patient had episode of whooping cough at 6 wks of age.  Dx w/URI 1/5/07, constipation 1/10/07.  Seen in ER 2/19/07 & dx w/fever, cough but was dx w/UTI & started septa.  Returned to PCP 2/20 w/fever 104.2, pale w/shiners & was advised to continue antibiotic & symptomatic tx.  Returned to PCP on 4/11/07 as well child but had not been gaining weight as expected despite parent report of good appetite.  Dx w/failure to thrive & advised lactobacillus qd.  Next seen on 4/17 & continued w/constipation, sallow color complexion, had only gained 2# in 4 mos at that time. 10/30/07 Reviewed Autopsy Report which reveals COD as undetermined.  Patient had clinical features of failure to thrive w/o source.  Possibility of asphyxia by overlaying during co-sleeping w/parent or rare functional disorder, metabolic or otherwise could not be ruled out.
Received other vaccines 1 month prior but in another facility. Redness and itching at injection site on 5/17. On 5/18 redness turned into dark purple same size.
pt recv vax & exp viral infect & flu w/sx such as body/joint pains, fever, h/a, swollen glands;also exp swelling of toes, rash, numbness of hands & bump beneath the hairline & back of head;
Excruciating left side of face/head pain. In jaw, neck, face, above and around eye. Extreme  sensitivity to light and sound. Began around 19:00. Tried OTC Motrin and Tylenol with no relief. Tried Orajel since the pain felt similar to maybe a toothache but have had no teeth issues. No relief from anything. Pain was 9/10. Around 5am pain completely went away. No more issues since then.
Diarrhea; Vomiting; Headache; Sore throat; 99.5 degree F/ 103.3 degree F on Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2022 03:45 (Lot number: FK5618) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 03:45 AM), administration date: 11Feb2022, when the patient was 5 years old, for COVID-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 25Mar2022, outcome "not recovered", described as "Sore throat"; PYREXIA (non-serious) with onset 25Mar2022, outcome "not recovered", described as "99.5 degree F/ 103.3 degree F on Sunday"; DIARRHOEA (non-serious) with onset 27Mar2022, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 27Mar2022, outcome "not recovered", described as "Vomiting"; HEADACHE (non-serious) with onset 27Mar2022, outcome "not recovered", described as "Headache". The events "sore throat", "99.5 degree f/ 103.3 degree f on sunday", "diarrhea", "vomiting" and "headache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain, pyrexia, diarrhoea, vomiting, headache.  Additional information: Started with sore throat 2 days after. 99.5 degree F. It evolved to diarrhea, vomiting, headache, 103.3 degree F on Sunday. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Patient presented with fevers, chills, then developed generalized tremors which were of unexplained etiology, extensive neurological testing included MRI brain, EEG, CSF testing which were unrevealing. a serum autoimmune panel was sent which demonstrated elevated Acetylcholine ganglion Receptor Antibodies but patient's symptoms did not correlate with this finding, and was felt to be a false positive test. his INR values were also significantly deranged on arrival, despite him being on coumadin long term prior to this with stable INR values previously. Further workup revealed evidence of positive cardiolipid IgM and IgG antibodies, which confirmed findings of antiphospholipid syndrome. a follow up MRI also revealed a punctate cerebellar infarct which was not thought to be responsible for his diffuse tremors. His tremors were felt to be related to cardiolipiin antibody positivity (there are case reports/series describing above). The positive anti-cardiolipin antibodies were felt to be related to recent vaccination and potential molecular mimicry. he was treated wit steroids with a tapering dose, with eventual resolution of symptoms. repeat cardiolipin antibody testing has shown normalization of values.
Fever of 101 degrees, body aches, nausea, vomiting, abdominal cramps two hours after vaccination
Started itching at injection site. Soon after had a large (apple sized) red, swollen, hard patch. It looked like what happens when I get bit by an insect or spider, but I'd had long sleeves on all day. Applied some cortisone cream to stop itching. Will take a Benadryl is swelling doesn't come down today.
8x7 cm area of induration with redness - infection with warmth. Advil/Heat/Benadryl
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 18-OCT-2013 the patients were vaccinated with ROTATEQ lot number J002505. Dose, route and frequency were not provided. On 18-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Nausea, diarrhea, EXTREME VERTIGO, chills and body pains in my joints,.  Saw a PA and was told to drink plenty of fluids and get rest.
pt recvd vax & exp weakness in legs; pt states that did not feel it was related to vax; No further details were provided;
On Thursday April 25, 2019 at around 10:00 am I started to feel nausea coming on which increased to the point where I could not drink any fluids without the continuing nausea. I did not vomit although I tried. I drank around 4 or 5 sips of water, cranberry juice and 7-Up during the 10 hour period. I took 2 Tums with no relief. Around 10:00pm the nausea started subsiding and I had a few tablespoons of chicken broth. Went to bed and was fine in the morning.
After third shot have severe pain behind left ear in head. Intermittently. Pain at injection site 12 days after injection
I tested positive for Covid-19 06/27/2021. I started to have a dry cough and the next day it got worse. I started to get congestion and a runny nose the next day. I never had a fever and did not lose taste or smell. I had some fatigue during the later stages. My doctor scheduled me for an antibody infusion one week after I started to have symptoms. Within 48 hours after the infusion my energy level improved, and I felt normal. The cough had improved after five days and I was only fatigued.
I broke out with Shingles on the right side of my face and woke up with soreness along with being unable to turn my head from left to right because my neck was very stiff (soar), had high fever of 102 (bumps appeared and the pain worsen). I went to the Doctor and he diagnosed me with Shingles. I was given a medication called Valtrex and also prescribe Gabapentin for nerve pain which I had to take for five weeks.
ERYTHEMA & EDEMA TO AREA SURROUNDING INJECTION SITE; VERY WARM & TENDER TO TOUCH.
Narrative: Admission Date: Sep 9,2021 Discharge Date: Sep 22,2021 70 year old male with history of ESRD secondary to HTN s/p renal transplant in 2015 on tacrolimus/prednisone, hx of hepatitis C, DM, prostate cancer s/p XRT, substance abuse (in remission) who presented to the Emergency Department on 09/09/21 with worsening SOB, DOE, and diarrhea in the setting of recent positive Covid-19 test despite being fully vaccinated with Moderna's COVID vaccine 1/4/2021 and 2/1/2021. He was admitted on September 9,2021. ABG on admission 7.49/25/72/19 on FiO2 40% w/ SpO2 96%. He was weaned down to 3L O2 in the ED. CXR without focal airspace consolidation or opacities. Tested positive for Covid-19 on 09/07/21. Received MAB (w/ Regeneron on 09/08/21). Notably upon arrival to the floor, the patient was w/o a supplemental oxygen requirement and was SpO2 >94% on RA. He was treated initially was vancomycin (9/18) and greatly improved clinically; sputum culture grew MRSA, so was transitioned Bactrim; he will finish Doxycycline 9/25/21 for an 8-day course of Abx. Otherwise, he was given supportive care and was eventually discharged on 9/22/2021 to a rehab facility.
vomiting, altered mental status, confusion, delirium, total body pain, fever, ER visit
Felt faint, sat down with loss of consciousness for seconds x 2 ,estimated . She felt her heart rate was fast. B/P 98/48 - 87/40  HR 92 weak , per pt.
Vomiting. Loose stool. High fever. Muscle shakes and chills. No treatment. Fever broke by midnight.
This spontaneous report was received from a nurse referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot # and expiration # was not provided). Other co-suspect or concomitant medications were not reported. On an unknown date, a year later the patient received another dose of GARDASIL which was outside of the prescribing information (inappropriate schedule of drug administration). The outcome of inappropriate schedule of drug administration was unknown. Additional information is not expected as no consent to obtain follow-up information was provided.
Pt had fever of 103 degrees for 24 hours, treated with IBP. PRN.
Muscle pain, head aches, loss of sleep,  nausea, loss of motivation, of concentration, anxiety. After 1 week finally feeling better.
newly diagnosed nephrotic syndrome; This is a spontaneous report from contactable physician via. This physician reported that an 8-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. The patient's medical history and concomitant medications were not reported. Patient was fully vaccinated with PCV 13 earlier as a baby-some resources mention an additional Prevnar would be needed in addition to a PPSV23. The patient was newly diagnosed nephrotic syndrome on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The association between the event nephrotic syndrome with PREVNAR 13 use can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Awakened with severe nausea and vomiting at 1 am the morning after the injection (approximately 9 hours after injection). Significant local swelling, redness and tenderness also present at injection site. Persistent emesis for hours over the course of the day of 5/18/2023. No other notable reaction.  Resolved without medical intervention.
Developed hives 12/14/2021 13 days after receiving the vaccine. Began taking Zyrtec and Benadryl. Had rapid COVID test 12/13/21 and was negative. Saw Dr. on 12/15/2021. Continued Zyrtec and Benadryl and began 7 day dose of Prednisone.  This dose was extended to 14 days as hives were still present. Final does of prednisone was 12/30/21 and hives were present but very minor and was taking only Zyrtec once daily. By 1/2/2022 hives were flaring again and requiring Zyrtec and Benadryl and very uncomfortable.  Called Dr. on 1/3/2022 and referral made to dermatology.  Saw dermatologist Dr.  on 1/7/2022 and began treatment with Allegra 1x/day in PM; Zyrtec 1x daily in AM; and Hydroxyzine HCL 25 MG PRN at night.  Hives continue to be present but are mild-moderate
02/03/2021 At 2PM began to feel anxious, nauseous, and chills began. Sweats and general body aches and headache began around 3:30PM. 800mg of Motrin taken and 2 Tums at 4PM. By 5 PM a fever of 102.5 with severe fatigue. Chills & sweats, rash on same arm as injection given, severe headache, abdominal cramping, sore muscles to touch. Began to alternate acetaminophen 1000mg & ibuprofen 800mg every 3 -4hours, pepcid for GI upset, cold packs to rash, hydrocortisone cream topically to rash, benadryl 50 mg ever 8 hours.  On morning of 2/5/21 symptoms most severe and rash spread all over the arm. Meds continued with bed rest and pushed oral fluids.  On 4/5/21 symptoms lessened and fever broke. Headache. Mild fatigue and muscle aches with rash only symptoms on 2/6/21. Benadryl doubled and rash dissipated and ibuprofen only other med take every 8 hours for headache and body aches. 2/7/21 only mild headache, fatigue and slight small pink rash remains.
Next day felt slightly ill, fatigued, but the 24th of Sept was worst with hoarseness, increased resp effort, increased heart rate (90's); systemically ill with resp. illness. No fevers no localized reaction. Pt. currently feeling better. S/s took no localized reaction. Pt. currently feeling better. S/s took approx 1 wk to mostly resolve. Still not "100%". Pt requested report be completed.
Healthcare business professional is reporting the administration of improperly stored vaccines; No additional AE reported.; This spontaneous report was received from an office manager regarding to an unknown number of patients of unspecified age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported  On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II) lot #U017524, expiration date reported as 26-FEB-2023 but upon internal review established as 03-JUN-2023 and lot #U006489, expiration date reported as 03-JUN-2023 but upon internal review established as 26-FEB-2023 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis; and/or varicella virus vaccine live (oka/merck) (VARIVAX) lot #U019904, expiration date: 24-JUN-2023 and lot #U039948, expiration date: 16-DEC-2022 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (Product storage error).  The improperly stored doses underwent a temperature excursion (temperature was not provided) for an unknown time frame. No adverse events were reported.  This is a non-valid report due to lack of patient's identifiers.  Follow-up information has been received from an office manager on 14-SEP-2022 concerning a 5-year-old female patient.  On 30-AUG-2022, the vaccines measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II) (lot# U017524) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U039948) were administered subcutaneously on left deltoid (LD) and right deltoid (RD) respectively. The patient had one previous dose of each vaccine (unknown dates of administration).  This case was previously considered non-valid but per follow-up information it was determined to be valid as patient's details were provided.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated intramuscularly with a 0.65 ml second dose of GARDASIL (lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient's tongue swelled up after receiving her second dose of GARDASIL on 16-OCT-2012. The patient went to the emergency room. No treatment information was reported. The outcome of tongue swelled up after receiving her second dose of GARDASIL was unknown. The relatedness for the reported event was not provided for GARDASIL. Additional information has been requested.
Rt shoulder pain, swollen, swelling into fingers, cannot close fist or lift arm, redness over deltoid. Ultrasound showed huge glenohumeral joint effusion, tapped it = WBC 86K, 90% poly. No organism seen. Surgery - Irrigation & debridement of shoulder - 20mL purulent material.  11/21/2008  MR received for DOS 10/8-10/2008 with DX: Right septic shoulder. Pt presented after several ER and PMD visits with c/o severe R shoulder pain.  Pt had pain immediately after injection with worsening pain, swelling into the fingers, and inability to lift arm and close fist. PE (+) for R deltoid swelling and erythema, decreased ROM.  Shoulder was tapped following presence of joint effusion on US and placed on abx. Dramatic improvement by POD#1.
Moderna vaccine was administered - reported by patient ? NO LOT NUMBER WERE SUPPLIED  HYPOXIA 7/9/2022 HYPOXIA
Develop recurring angioedema; She gets to carry an epipen just in case she goes into anaphylactic shock.; This case was reported by a consumer via interactive digital media and described the occurrence of angioedema in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced angioedema (serious criteria GSK medically significant) and anaphylactic shock (serious criteria GSK medically significant). The patient was treated with ambiguous medication nos (Epipen (Nos)). On an unknown date, the outcome of the angioedema was unknown and the outcome of the anaphylactic shock was not recovered/not resolved.   The reporter considered the angioedema and anaphylactic shock to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient received the vaccine and it caused her to develop recurring angioedema. The patient had to carry an Epipen for the rest of her life just in case she would go into anaphylactic shock.
4cm reddened, indurated area;pt c/o itching @ site 4 days p/vax;MD recommended take DPH for itch;
I contracted COVID-19 on 05/21/2022 with  symptoms of difficulty breathing, chest congestion, and slight cough. I was prescribed Paxlovid and an Albuterol inhaler on 05/23/2022. I was ill for 8 or 9 days before I recovered, but I had lingering symptoms of difficulty breathing. I am fully recovered now with no lingering symptoms.
diagnosed with Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (diagnosed with Shingles) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HERPES ZOSTER (diagnosed with Shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (diagnosed with Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Headache; 17-year-old got his first dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old got his first dose of moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (Headache) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old got his first dose of moderna vaccine). On 01-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old got his first dose of moderna vaccine) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. The patient was supposed to get Pfizer vaccine but was accidentally given Moderna vaccine, site of vaccination has said that they will not give him  the second dose.
vertigo, heaviness in eyelids as if her eyes were tired though she doesn't actually feel fatigued, hearing loss in R ear.
This spontaneous report as received from a pharmacist refers to three patients of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 lot # reported as L003188, expiration date 06-JUL-2016 (dose, strength, frequency were not reported). Secondary suspects and concomitant therapies were not reported. The pharmacist reported that upon administration of PNEUMOVAX 23 to the patients, they experienced injection site reaction described as swollen, red and rasied area with blisters. No treatment was received for the events. It was reported that the patients sought medical attention by tellling the pharmacist about the events. The outcome of the events were not reported. The events did not required intervention to prevent serious criteria, did not produce signficant disability or incapacity, did not required hospitalization and were not life threatening for the patients. No product quality complaint was reported. Additional information has been requested.
O2 level was 89-91, sent to hospital for CT scan,,checking for blood clots. Covid test negative 2 days prior to all the tests performed on 6/12/2021,several X-rays , no pneumothorax. Was ill for 1 week before going to doctor. Shortness of breath
pt became listless & limp approx 3hr p/vax & devel fever of 103 lasting 3 days;pt was seen in hosp ER on 21FEB97;lab work done reports were negative;mom was instructed to report this to MD on next visit;