chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/21 - 10 week old male went for well care visit and got immunizations below. 4/28 - See H and P on additional sheet. Also progress in house. Patient is an 11 week old ex 37.4 week male infant. Prenatal care obtained, pregnancy reportedly unremarkable, infant born at Hospital. BW 2722 g. DC weight 2637 g. Baby exclusively formula fed with Enfamil GentleEase. Patient was well until approx 0300 on 4/27/14 when he vomited up his 0300 feed of 3 oz. His last "good feed" had been at 2100 the evening prior - 6oz. Parents later tried offering another 2 oz which he also vomited up. The called the advice RN who suggested PEDIALYTE via syringe. Parents tried all morning and initially it seemed to work, however he had an emesis at 1500 that appeared to be the entire volume of PEDIALYTE he had previously consumed. At that time he also had a 'wet fart' that was bloody and mucous-like. Parents took him to hospital for evaluation at approx 1730 pm. There his stool guaiac was grossly positive. Labs as follows: CBC 14.4/1.9/36 Chem-7 133/5.2/102/23/14/0.4/93 C-reactive protein elevated at 11.2. Urine bag sample is pending. Stool cultures pending. ED unable to obtain IV access. Office contacted Pedi HBS for transfer and admission. KUB requested by MD. Reportedly unremarkable save a dilated loop of bowel in RUQ. No free air, no pneumatosis intestinalis. Allergies: No Known Allergies. Patient is a 5KG week old boy admitted at 1 AM from hospital with emesis. The emesis was copious, non-bilious, blood tinged. No pain to mom and dad's recall. Has a 2 year old brother but no-one else ill in family. On exam he is afebrile, pulse 150, peeking out from blanket burrito. Well rehydrated with moist mucosa and Flat fontanelle. Abdomen soft, non-tender. No hernias. Normal anus. No labs recorded. We proceeded to UGI: Normal sized stomach (not large like seen with HPS). Normal ligament of Treitz location. Normal infant reflux. A/P: 11 week old with emesis. No evidence of the common surgical etiologies for this age such as HPS, volvulus, or incarcerated hernia. We then headed to US where intussusception was discovered. Proceeded on to BAE where intussusception confirmed but could not be reduced. To OR for laparoscopic, possible open reduction of intussusception with incidental appendectomy. 11 week old male presented with emesis and hematochezia. Malrotation and pyloric stenosis were ruled out with upper GI. Ultrasound showed intussusception, which was unable to be reduced by contrast enema. The patient was therefore taken to the operating room for laparoscopic exploration. Intraoperatively it was found that his intussusception had already reduced. Appendectomy was performed incidentally. Post-operatively, the infant had 2 normal stools and consistently passed gas. He tolerated regular feeds and was discharge home with parents, who are well aware of signs to watch for should he develop recurrent intussusception.
fever p/vax then resolved then devel erythematous macular rash ?roseola;
Signs/Symptoms: Tingling in mouth, swollen tongue but looks fine   Treatment: Benadryl PO (12.5mg); less symptoms.
PT IS 11 YEARS OLD.  VACCINE IS APPROVED FOR 12 YEARS AND OLDER AS OF TODAY. PT WILL TURN 12 IN 8 DAYS. PT WILL BE 12 YEARS OLD FOR 2ND VACCINE
Red, swollen, tender square-shaped site around injection site, about 2 inches in width. Warm to the touch. Came on about 20 hours after injection occurred. Pt called 10 am on 12/8 received shot on 12/7/12 advised pt to go to urgent care.
- Had left knee ACL allograft in 2007.  Knee had been fine for 15 years. - Woke up on February 1, 2022 and could not walk on left leg.  No injury.  No swelling.  Nothing out of ordinary the preceding days. - Assumed it was nothing and would go away but did not go away.  Made appointment with doctor. - Doctor examination - no swelling, no injury, not sure what is going on but will run an MRI. - MRI showed that my immune system had randomly attacked allograft ACL and there was only 20% of ACL in place and would require surgery. 3/16/2022: Had ACL reconstruction surgery and had to use quad tendon autograft due the strange immune system response to previous allograft.
8/6 in the evening. Severe joint pain, headache, body aches. Both sides of my body. 8/7 in the morning no noticeable symptoms. In the evening: joint pain, chills, headache, occipital pain (painful to the touch), parathesia, neck pain/swelling. Fever which increased over the course of the evening to over 100 degrees. Pain was bilateral. 8/8 Symptoms continued, swollen lymph nodes in neck. Fever increased to 103 degrees (oral temperature). 8/9 Fever & aches resolved in the morning. Joint pain and fever returned in the afternoon. New face pain along cheeks along with swelling and a rash. 8/10 Temperature was lower, but still above normal. Facial pain worsened over the course of the day and temperature reached 100 degrees. 8/11 Facial pain continued, temperature increased in evening. 8/12 Slightly elevated temperature (98.7 vs normal 97.7); face very red and itchy; left ear also red, swollen and hot to touch. 8/13: Headache in a.m.; mostly normal temp; face still has swelling in new locations - mostly on the left side, bridge of nose & eyebrows painful to the touch; facial redness/rash much diminished, but still some patches. 8/14: No headache in a.m., normal temp; left cheek still swollen, nose swollen & red, and swelling around tear ducts. 8/18 Temperature back to normal all day. Left side of face still slightly swollen, but no pain.
Initially patient felt itching and after 24 hrs post injection she developed localized redness with mininal swelling, tiny blister on injection site.
chills; vomiting; diaharrea; fever; dizziness; aches and pain; intense fatigue/Complete exhaustion; no energy for days; headache; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Oct2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the third dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) an unspecified route of administration, administered in Arm Right on 20Aug2021 14:30 (at the age of 86 years old) (Lot Number: FC3180) as dose 3 (booster), single for COVID-19 immunisation. Medical history included nasal polyp in Feb2021. No COVID prior vaccination. No known allergies. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No other medications in two weeks. There were no concomitant medications. The patient took the first dose of BNT162B2 (Batch/Lot number: FL0142) Intramuscular administered to Arm on 06Jan2021 (at the age of 85 years old) for COVID-19 immunization. The patient took the second dose of BNT162B2 (Batch/Lot number: FL8982) Intramuscular administered to Arm on 27Jan2021 (at the age of 85 years old) for COVID-19 immunization. On 20Aug2021 16:00 (also reported as 4 hours after vaccination), patient experienced chills, vomiting, diarrhea, fever, dizziness, aches and pain, intense fatigue/ complete exhaustion, no energy for days, headache. Patient could not move for three days-just slept. On the 4th day, patient had some ginger-ale and husband had to help her get into shower and dress. Patient still lacked energy. No treatment was given for the events. Patient was not Covid tested post vaccination. The events required visit to Physician Office.  The events were reported as Serious, Important Medical event, Persistent/Significant disability/ incapacity. The last reported outcome of the events was recovering.
Severe Chills/Fever; Severe Chills/Fever; Nauseous; Severe Migraine; Body Ache; Major fatigue; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 13:45 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies. No other vaccines received in four weeks. There were no concomitant medications. The patient had covid prior vaccination. The patient was not pregnant at the time of vaccination. On 17Apr2021, the patient experienced severe chills, fever, nauseous, severe migraine, body ache, major fatigue. The migraine was so bad, she almost went to the hospital for relief. She was seriously concerned about the effects of the second shot, as this was terrible. The patient did not receive any treatment for events. The patient was not tested for covid post vaccination. The patient underwent lab tests and procedures which included covid test: positive on an unspecified date. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
A couple days after my second dose the hearing in my right ear became muffled and I have had a ringing in it.  It feels as if I have water in my ears.
Felt arms asleep; Felling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Felt arms asleep) and DIZZINESS (Felling dizzy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Hematuria and Cyst of kidney.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPOAESTHESIA (Felt arms asleep) and DIZZINESS (Felling dizzy). On 11-Mar-2021, DIZZINESS (Felling dizzy) had resolved. At the time of the report, HYPOAESTHESIA (Felt arms asleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood pressure decreased: (Inconclusive) Blood pressure decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient historical condition includes Infundibulum cerebral. No Concomitant  information was  provided. No Treatment information was  provided.
Sore arm; Felt heavy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and DISCOMFORT (Felt heavy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and DISCOMFORT (Felt heavy). At the time of the report, VACCINATION SITE PAIN (Sore arm) and DISCOMFORT (Felt heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
No additional AE details were provided.; the patient is a 2 month old infant who received a dose of VAXELIS and a dose of RECOMBIVAX HB on the same day on 3OCT2022.; This spontaneous report has been received from a medical assistant concerning to a 2-month-old infant patient of an unknown gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not provided.  On 03-OCT-2022, the patient received a dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme frequency, route of administration, and anatomical site of application were not provided; lot number T032918 that was verified to be valid for vial formulation with an expiration date reported and established as 12-NOV-2022) as prophylaxis; and on the same date, received a dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, at a dose of 0.5 ml (strength, vaccination scheme frequency, route of administration, indication and anatomical site of application were not provided; lot number U7205AA that was verified to be valid with an expiration date reported as 24-OCT-2023 but upon internal validation established as 23-OCT-2024) (overdose).    By the reporting time, the patient did not have any adverse reactions. There was no additional adverse event (AE) reported (no adverse event).
Urticaria/pallor within minutes of shots. Faded quickly without Rx. Clear within 10-15 mins. Fed well, lungs clear. No distress-home. Brother had a few ? that cleared and shots. Pt's skin clear?
So on Friday 9/2/22 I just had a little bit of drainage but I get that with my sinuses and drank an Emergence and on Sunday I was lying down and when I got up I felt like my sinuses were full. On Monday I was feeling congested and I took a home COVID-19 test and it was positive and I went to the urgent care and took a PCR COVID -19 test and it was positive and they prescribed me a Anti-viral Molunpiravir and a nose spray.  I am totally better an walked 2.5 miles this morning.
fever to 102 lasting 2 days crying & fussy for 1 wk;
Pt. received HPV (GARDASIL) at well check on 2/16/11. Pt was found to be pregnant on 2/28/11.
Date of vaccination as recorded in item 4 relates to the 2nd shot.  I also had reactions after the 1st shot.  1st shot was given to me on 07/06/2021.  Reactions between both shots were not exactly the same but were similar.  Reactions include: 1) Very quick, short instances of blindness in the eyes (like when one blinks, except I wasn't blinking); 2) Diarrhea;  3) Ringing in the ears;  4) Dizziness;  5) Rapid heartbeats, which sometimes beat so hard and fast that my chest ached;  6) Issues with breathing;  7) Joint pains;  8) Feeling extremely tired;  9) Numbness or buzzing in the fingers and/or toes;  (Continued on page 2)
I received the moderna vaccine around 3pm and at 5pm I started getting a red splotchy rash on my stomach, then on my left arm the same arm as injection, then my shoulder. It went away after a couple hours.  24 hours after the shot I noticed a golf ball size lump at the injection site that was painful to touch and it lasted three days.  Also 24 hours after the shot I felt very achey and so tired I had to lay down and fell asleep for 5 hours. I also experienced shortness of breath days after the shot.
PT had headaches and dizziness on the first day. Since the second day, she has been suffering from bad dizziness, nausea, loss of appetite, fatigue, and abdominal pain. Her fatigue is so bad that she has to sleep for over 12 hours a day. Her normal body temperature is 36.5 degrees celsius, but it has been between 35.5-36.1 degrees.
Developed erythema multiforme 2 days after vaccination. Then developed vomiting, diarrhea, malaise.
I could not lift my arm away from my body for about 12 hours and it progressively went away until it felt normal about 48 hours later. I also got a rash on the same arm where the vaccine was administered about 24 hours later that lasted 5 days. I had chills and a fever 12 hours after the injection lasting about 6 hours. I had a feeling of sinus congestion with coughing and sneezing starting 24 hours after the injection and lasting for about 4 days. Lastly, I had a rash on my upper face that started 36 hours after the vaccination. The skin felt very dry, was red, and eventually became scaly and flaked off from my eyelids and upper cheeks a few days later.
Patient is a 76 y.o. male patient of DO with history of CAD, HTN, OSA not on CPAP, DVT, COVID (4/2022), gout, and stage IIIb CKD who presented to ER with weakness and shortness of breath in setting of known COVID dx.     Acute Respiratory Failure with Hypoxemia Covid-19 Virus Infection Sepsis R/o superimposed Bacterial Pneumonia Date of onset of symptoms: Middle of January Symptoms present on admission: Nonproductive cough, weakness, poor PO intake Date of covid positive test: 1/30 with home test Vaccination status: vaccinatedx2 Imaging: CT with mild peripheral bilateral GGO with emphysema Oxygen requirements on admission: 2 L O2 Current oxygen requirements: 2-3L Tmax 103 with WBC 6.26, currently afebrile Either protracted COVID course or new infection. Continue decadron Was previously on rocephin/azithro -- stopped on 2/13 due to negative w/u and procal No indication for  Paxlovid or Remdesivir based upon timeline   Hyperkalemia K 5.5 on 2/13 No obvious cause EKG reviewed by me does not show any peaked T waves K stayed around 5.2-5.3; he says he has been told he has hyperkalemia before   AKI on Stage IIIb CKD Cr baseline 1.4 - 1.5; follows with Dr. (Nephrology) Cr 2.32 s/p 30 cc/kg, Cr down to 1.45 by discharge Hold nephrotoxins and trend daily   HTN With softer BPs Holding Lisinopril and imdur Ok to resume Toprol xl given BP trending up  CAD S/p remote CABG, continue Aspirin and Lipitor Resume Toprol    Elevated Troponin TnT 31 -- > 31 in setting of COVID and AKI EKG NSR, normal axis, globally flat ST segments and QTc 436   Insomnia NARx reviewed, continue Ambien 5 mg nightly PRN
1st dose Sep2021, 2nd 1dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in unknown arm intramuscularly in September 2021).   On 1st December 2022, the patient received the 2nd dose of Shingrix. On 1st December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: Nothing else was reported. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Pt received shot on 1/6/10. Later she was treated from UTI by Cipro, Fluconazole, cranberry. She had rash on neck, hip, back on 1/31/10 she is not sure if its from shot or other Rxs.
Had second vaccine on 1/21/21 and then on 2/3/21 had a high risk exposure and was asymptomatic. on 2/8/21 tested positive for COVID
Patient reported throat itching, lump in throat at 1738, 20minutes into observation period after first dose of pfizer vaccine. Denied any shortness of breath or difficulty breathing.  Vital signs were initiated at 1744, BP slightly elevated. Water and crackers were provided. Benadryl 25mg IM was offered, patient accepted, administered in Left deltoid at 1745. Patient reported improvement in symptoms at 1751; complete resolutions of symptoms at 1759. Last set of vital signs taken at 1800, blood pressure still slightly elevated, verbalized feeling better and ready to leave. Patient left at 1800 with daughter, stating they would take uber home together. Was educated to follow up with primary heathcare provider and if symptoms return or worsen to seek emergency medical care, patient verbalized understanding.
Localized reaction to injection site. Red area 2"X2" diameter, sl raised & warm to touch.
8 days after MMR, VARIVAX and PREVNAR vaccines had a simple, febrile seizure - seen in ER - no physical findings.
Dizziness; BP 137/86 (pulse 72), O2 sat 98%. Given water.
Patient received a 3rd booster dose of Pfizer Covid Vaccine.  First two doses were Moderna. No Adverse reactions reported.
Fever, body ache, joint pain, fatigue first two days, Sore Throat, headache abdominal pain, bowel changes and fatigue 3rd and 4th day.
This has been going on since 2020.  After I got my first vaccination I ended up with bi lateral leg edema.  I?ve had every test including biopsy?s and no one can figure out why it?s happening .  Both my legs and feet swell for weeks after and then it will go away and flare up for weeks and then go away and flare for weeks.  It?s happened after every vaccine I?ve gotten for Covid.  I am unable to work and are in the doctors due to debilitating pain in my legs and feet.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On 08-SEP-2016, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (lot # M001745, expiration date 07-APR-2017; dose was unknown) subcutaneously. The vaccine was exposed under temperature of 31 degrees Fahrenheit for 5 hours. The previous temperature excursions were 35.7 degrees Fahrenheit for 3 hours, total cumulative excursion details: 35.7 degrees Fahrenheit for 8 hours. Data Logger was involved. No adverse effects were reported. Additional information has been requested.
No additional AEs were reported; Improper storage of product in use; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 05-JAN-2022, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # T028582, expiration date: 04-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided).   The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (Product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown to the reporter. There was no previous temperature excursion. No adverse events (AE) were reported, and no further information was provided.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000533: US-009507513-2205USA000540: US-009507513-2205USA000544: US-009507513-2205USA000564: US-009507513-2205USA000560:
Nurse injected the vaccine slowly.  Immediately after shot I started coughing - then had trouble catching my breath & difficulty breathing (felt like I could only take very short breathes & couldn?t get anything in my lungs), felt panicked & a warm flush & then after a couple of minutes I was able to start getting my breath back, but then could feel my heart pounding & felt lightheaded.  The nurse was ready to use an epi pen, but I started feeling better, asked her to wait.  This all took about 5 minutes.  Rested for another 15 minutes & went home.  It has now been 2-1/2 hours & I feel fine.  I had no adverse effectswith first 2 shots.  ? This was a very scary reaction, I?m assuming it was an allergic reaction.
Muscle spasm in left shoulder. (IM and SQ vaccine administered in the left arm.) No other systemic or local reactions reported or noted.
PREVNAR 1/28 - Next AM, thigh visibly raised, pink, well defined, non, tender 21/2 X 3 cm area. No fever. 2/2/09 Swelling gone, looks like a bruise.
Had only arm soreness for two days but then 8 days later (9th day today and still continuing)  have profuse nausea and non stop diarrhea and stomach cramps possibly related to the PEG in the vaccine.