chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nursing staff was notified today that the patient was in the pediatric intensive care unit with a hx of seizure of 15 minute duration Sept 17, 2006, found to have subdural hematoma with retinal hemorrhage.  Pt did receive immunizations 09-12-2006. 10/10/2006-records received for DOS 8/18-9/27/06. DC DX: subdural hemorrhage, retinal hemorrhage. Pt admitted after seizure activity at home. Child while being held by father was crying and the baby "stiffened" and was unresponsive. Paramedics arrived in less than 5 minutes, and baby regaining consciousness upon their arrival.  HX: Baby is very easy in temperament, barely cries around time of fee. Does cry when mother turns baby over to dad in evenings. On 9/17/06 returned from visiting extended family and later that evening is when the baby was stiff with one or both arms extended and was unconscious, he could not move and no noise was coming from him. Family denies abuse. At about 3 weeks of age the baby rolled off a mattress onto the floor at which time he seemed fine and was alert thereafter. Mother relates that baby seemed to be more irritable past several days, crying more than usual but not more lethargic but rather more awake yet as interactive and normal acting as usual. The head circumference increased between 1-2 months of age which was noted by the PCP but felt to be unimportant and 5 days prior to admission a wheeze was noted at PCP office. Otherwise review of systems appears unremarkable. Hospital course: vomiting, Dobbhoff feeding tube placed. Per 60 day follow up: Recovery status unknown unable to locate at home #.
pt became fussy @ nap/bedtime the following day; site of immun very red, warm, swollen per mom; On office visit 19FEB92 site was very warm, red, & had an area of induration of 7x9 cm diameter;
Joint pain, chills, swelling, tiredness, vomiting, diarrhea, headache.
The week after I was in a fog and had a bad headache and tired. The next week I had extreme muscle pain and then it moved into my foot where it still is very painful to walk. Then 2 months later my hair fell out. I went to the dermatologist and she said that this is common from the vaxx-she is seeing it a lot.
p/vax pt devel encephalopathy & expressive aphasia;pt hosp;while hosp pt exp a paranoid delusional episode;MD indicated that pthas no psychiatri hx;LP revealed nl cerebrospinal fluid, MRI nl;EEG sl abn w/some slowing c/w encephalopathy;
Diarrhea,  Stiff Neck,  Overall feeling not well, Loss of strength
pt says she had an achy left arm w/ fatigue.  Next day she had a low-grade fever and hives on her stomach.  She started taking Benadryl per Teladoc.  She started getting very dizzy and her hives were moving towards her shoulders and her throat was closing up.  911 was called.  She was told her anxiety was very high.  She was transported to Hospital ER.  She was put on fluids and steroids, (methylprednisolone 125mg, famotidine 20mg, sodium chloride 100ml) They did blood work which showed low platelets. Her rash was bright red and spreading down her arms and her stomach while she was being monitored.  She was discharged w/ DX; Acute allergic reaction and given an EPI pen and oral steroids.  She has a FU w/PCP on 5/3/2021 to check blood platelets and will go from there.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. The reporter stated that, on 16-DEC-2015, the patient was vaccinated with the second dose of PNEUMOVAX 23, 0.5 ml intramuscularly, with lot number L019836 and expiry date 24-MAR-2017, instead of PREVNAR 13. The patient had received the first dose of PNEUMOVAX 23 on an unspecified date in June 2014. No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Weakness, muscle aches and joint pain in every joint.  Progressively getting worse everyday.
PATIENT STATED SHE HAD SORENES IN ARM, UNDERARM AND WRIST. PATIENT STATED SHE DEVELOPED A FEVER AND ALSO SHOWED A SMALL BRUISE AT SITE OF INJECTION. PATIENT STATED SYMPTOMS LASTED ABOUT A DAY AND SHE TOOK SOME TYLENOL. PATIENT DOING FINE AT TIME OF REPORTING.
Pt presented with dizziness, nausea and hot flashes following first dose of Moderna approximately five minutes after receiving vaccine. Pt denies vomiting, no known allergies. Hx of Colitis. Vitals assessed SPO2 100% RR14  BP107/42  Skin was cool pale and clammy, he laid down on the stretcher and was observed for 15 minutes,  skin color improved.  Nausea/dizziness dissipated (per pt) vitals remained stable.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-FEB-2016, the patient received an expired dose of PNEUMOVAX 23 (lot # K007826, expiration date: 03-FEB-2016, dose was not reported), intramuscularly. No known adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Information has been received from a female who, in Sept 2005 was vaccianted with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently within a day of vaccine administration, she had a local reaction that included 2 red bands around her arm at the injection site. She also had lymph node involvement on the arm the injection was given. It was reported that the injection was given high on the arm, possible at the joint. The duration of symptoms was about 2-3 days. At the time of the report the patient had recovered. Medical attention was not sought. There was no product quality complaint involved. Additional information is not expected.
Soreness in the left arm for the first few days after Injection on 1/28/21 and then itchy red rash appeared  at and around the injection site on  2/4/21.
Patient is a 65 y.o. female who presented from clinic on 8/21/2023 with COVID-19 and acute respiratory failure. She had been having worsening SOB, non-productive cough, fatigue, myalgias, malaise, and nausea for the past week. She tested positive for COVID-19 on admission to hospital and required 2L NC supplemental oxygen. She was transferred to a different for further care. On admission to hospital, she was started on IV Remdesivir and Decadron. She was able to be weaned off supplemental oxygen on the morning of 8/22, so Remdesivir and Decadron were both stopped at discharge. She was discharged home with instructions to follow-up with her PCP later this week and follow-up with her Pulmonologist in next week.   COVID-19 Acu COVID-19  Acute hypoxic respiratory failure  - Presented with: SOB, non-productive cough, h/a, fatigue, myalgias, malaise, and nausea  - Symptom onset: 7 days   - Positive COVID-19: 8/21 at clinic  - Vaccination status: Moderna x 2, last dose on 3/27/21  - CXR on admission showed no acute findings   - Oxygen status: On admission required 2L NC for O2 as low as 78% on RA. Currently low to mid 90's on RA.  - Decadron: Yes. End date 8/22.  - Remdesivir: Yes. End date 8/22.  - DVT prophylaxis: Lovenox  - Serial COVID labs ordered: No  - Case Management/Social Services consulted: No  - D-dimer only mildly elevated at 0.53. CRP and lactic acid WNL. Fibrinogen 484.     - Encouraged IS and acapella use.  - Remdesivir and Decadron stopped at discharge. Will follow-up with PCP later this week and Pulmonologist next week.     COPD   - Follows with a pulmonologist. Wears 2L NC at night and when she is short of breath.  - No signs/symptoms of acute exacerbation  - Previously on Spiriva, no longer taking.  - Home regimen consists of Symbicort, PRN albuterol inhalers, and prednisolone.  - Prednisolone held while hospitalized since she was on decadron. Continue prednisolone on discharge since decadron stopped.  - Started Dulera in in the hospital since Symbicort is not on formulary. Continue home medication at discharge.  - Continue PRN albuterol     Essential HTN   - BP slightly elevated overnight, but now normotensive  - Continue amlodipine/valsartan and hydrochlorothiazide
vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022).    No concomitant medication information provided. Number of doses/vials: 4 infants doses. Date the vial was initially stored in the refrigerator was 13-Jul-2022. Used by day was 11-Aug-2022. Based on the count, they counted 13-Jul-2022 as day 1. The vaccine was administered before 11 am. The vial did not undergo any temperature excursions. No treatment information provided. This case belongs to second infant out the 4 infants who received a expired vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2022-628906, US-MODERNATX, INC.-MOD-2022-628905, US-MODERNATX, INC.-MOD-2022-628899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628906:Infant patient 4 US-MODERNATX, INC.-MOD-2022-628905:Infant patient 3 US-MODERNATX, INC.-MOD-2022-628899:Infant patient 1
Covid symptoms started possibly 10/21/21; tested positive 10/24/21. Saturday Evening I started feeling bad and Sunday I got up and started feeling bad. I remember I felt a little sick, kind of clammy, severe body aches, and I don't remember if I had a fever but it could've been a low fever. I remember taking TYLENOL and I slept and had just general flu-like symptoms with severe body and kidney pain, particularly in my left kidney. That was pretty much it. The severe body pain and kidney pain lasted about 12 hours and it was that morning I went to the doctor. I would say about 1-2 weeks later I couldn't get rid of a cough and it had just came on and I thought maybe it turned into bronchitis and it had. I needed an extra respiratory inhaler to get through the bronchitis. After the kidney and body pain I had general flu like symptoms that kept me on the couch but nothing severe and that lasted about 2 days and after that I had mild symptoms throughout the week. It was roughly 7 days of symptoms. Anytime I get a cold now I have to use my inhaler and I use it daily now. My husband says it's like I'm sick all of the time and I can get rhinovirus and I know I have it because of bronchial issues. I don't know if this stemmed from having Covid.
immediately after receiving her vaccination, she reported feeling lightheaded. She was taken to a private section of the arena and monitored.
The client reported she developed "shortness of breath, a runny nose, phlegm, and a cough" 2 days after receiving the first COVID vaccine Pfizer. The client stated the symptoms lasted 4 days. The client denied any dizziness. The client has a history of asthma and uses an inhaler as needed. The client did seek care in the emergency department for her initial symptoms. The client states she was prescribed oral steroids and her inhaler medication was changed. The client was unsure of the medication names. The client stated she was diagnosed with lung inflammation. The client has no known allergies.
myocaritis - chest pain with elevated troponin reequiring hospital admission. symptoms started 3 days after vaccination which was his second dose of the Pfizer vaccine. First dose was on 5/1/21.
Owner emailed the following message on 03/23/2021, "Patient was feeling not good after the vaccinations and we call 911.  She refused to go to hospital . Today she did do good and we call 911 and they took her because her oxygen dropped down . As of now she passed away"
Administered Covid 19 pediatric monovalent in error.  Should have been Covid 19 pediatric bivalent booster
Pt. received ZOSTAVAX immunization 11/20/07. Pt. diagnosed with shingles 6/4/10.
101 fever body aches 2nd day 99 fever third day Red hard area on arm 99 fever 4th day
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt said she started experiencing tingling in arm and hand of inj arm about 30 to 45 minutes after receiving inj. tried icing and moving arm but no relief
chest pains; cough; rash; This is a spontaneous report from contactable consumer (patient) via Medical information Team.  A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 22Jan2021 at 14:15 (Lot Number: EL3248) as single dose; dose 2 via an unspecified route of administration, administered in right arm on 12Feb2021 at 14:30 (Lot Number: EN6201) at the age of 79 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 the patient experienced chest pains, and cough, which required hospitalization from 05Mar2021 to 08Mar2021. The patient informed that he had some stress with son and daughter to point where he had some chest pains. After a week or two of conversation involving patients son and granddaughter culminated into this. The patient informed that when he went to the hospital because of chest pains, patient was already use to that and wasn't worried about it. The patient stated he didn't want to go to the hospital, called the doctor but because of Covid, the doctor wouldn't see the patient. The patient stated he shouldn't have been in the hospital at all. In terms of the cough, he simply called the doctor because the patient wanted cough medicine or something for that, temporary thing coming on. Patient stated the cough did not linger, and it was never treated.  The hospital got into the chest pain and jumped on the heart situation and patient thinks they saw dollar signs or something.  The patient wasn't very happy with them. The patient informed that he was given a blood thinner, Heparin IV during time hospitalized. The hospital decided to hold the patient over and they gave the patient Heparin IV for a good part of three days. The patient reported that he was discharged on 08Mar2021, and on 10Mar2021 the patient noticed the rash. The patient reporting experiencing rash after receiving both doses of the Pfizer covid-19 vaccine. The patient was thinking the combination of Plavix and heparin only three weeks after having the Pfizer Covid Vaccine could possibly be a side effect of rash. Therapeutic measures were taken as a result of rash. The doctor gave the patient Clobetasol Propionate and patient did treat rash with that.  The doctor said to apply for 2 weeks and come in on one week.  It has already improved. The patient mentions that he was also taking Calamine lotion and some spray and they all seem to be working.  Patient didn't want to keep taking Clobetasol because it is a steroid and he had been using for a month and didn't want to do that. The clinical outcome of rash was recovering. The clinical outcome of the remaining events was unknown.
Faint; Hives up and down both of her arms; Felt warm; A spontaneous report was received from a healthcare professional, concerning a 80-year-old, female patient who was administered Moderna's COVID-19 vaccine and felt warm, faint and hives occurred afterwards up and down both of her arms. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042670A) intramuscularly, for prophylaxis of COVID-19 infection.  On 19-Jan-2021, right after getting her vaccine patient felt warm and faint afterwards. Approximately, eight or nine days after the injection, patient had hives up and down both of her arms. Patient was concerned if it was a systemic allergic reaction and likeliness of another reaction in future with increased severity. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, felt warm, faint and hives occurred afterwards up and down both of her arms were considered unknown.; Reporter's Comments: This report concerns a 80--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # 042670A , and felt warm, faint and hives occurred afterwards up and down both of her arms. Very limited information regarding this event has been provided at this time.  Further information has been requested
Swelling at injection site with painful rash and itching.  Use of Benadryl cream temporary relief.
pt recv vax; noted small red, swollen knot (not at inject site) but slightly below inject site; occurred on rt leg;site swollen & red when awaken;T 100; to er;was told rxn to vax;amoxicillin given x 7 days;
Information has been received from a female who was vaccinated with PNEUMOVAX. The patient reported that when the pharmacist was taking air out of the syringe, he was "very sloppy" and he squirted out some of the medication in the process and gave her less than the required amount (0.5ml). The patient had slight pain at the injection site but this was minimal. It was unknown if the patient sought medical attention. No further information is available.
I got up around 8 am to use the restroom was the last thing I remember.  I had a syncopal event and my partner found me unconscious on the bathroom floor.  When I fainted I hit my forehead causing a large hematoma.  I also got a laceration on my chin about 2 inches across.   I hit my right cheek as well but no skin was broken just a big bruise.  The chin laceration required stitches.  I have never fainted in my life.  All the medications I am currently taking I have been on for years.
After post-vaccine monitoring x approx 15-20 min, left clinic with parent; report of vomiting outside clinic and in car preparing to drive home; returned to clinic for eval & monitored x approx 1 hour 20 minutes further; vital signs & presentation/affect unchanged from baseline calm/cooperative & only c/o stomach upset x approx 10 minutes; noted to dry heave x 2 occasions during monitoring ; no s/s swelling, rash, respiratory distress, crying or distress noted; reported feeling ok after monitoring & discharged in stable/baseline condition w/ mother
8/4, 8/5,  08/9: rapid  irregular heart rate as high as 140 for periods lasting around 1-2mins, chest pain, sweating, light headed ness, and slight nausea
Patient had HPV #2 on 2/20/13 - (R) upper arm recently developed quarter sized area of firmness and light erythema, warm to touch, tender with direct pressure, ? of cellulitis, localized inflammation (R) upper arm. Treatment - supportive care.
Information has been received from a licensed practical nurse concerning a 31 month old male who on 16-JUN-2005 was vaccinated IM with a dose 0.5 mL dose of Varivax (lot # 648935/0829P). On 03-OCT-2006, the patient was seen by a health department for a rash. On 04-OCT-2006, he was seen in reporter's office with a rash with blisters and no fever with breakthrough chickenpox. He was treated with AVEENO bath. No diagnostic laboratory tests were performed. The patient's mother called days later to report that the child was fine. The outcome was recovered. A product quality complaint was not involved. No additional information is expected.
On 10/30/2000 and 11/30/2000, the pt received first and second doses of Havrix.  On 12/10/2000, the pt experienced diarrhea. The reported stated that the adverse event was moderate in severity and possibly related to Havrix (but doubt). As of 01/02/2001, the outcome of the event is resolved.
30-35 lesions over body (mostly trunk, necks & face) in different phases papules to denuded blisters;small .5mm-1.5mm;
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy Sensation - Neat Injection Site), INJECTION SITE RASH (Rash - Neat Injection Site), INJECTION SITE SWELLING (Swollen - Neat Injection Site) and INJECTION SITE ERYTHEMA (Redness - Neat Injection Site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy Sensation - Neat Injection Site), INJECTION SITE RASH (Rash - Neat Injection Site), INJECTION SITE SWELLING (Swollen - Neat Injection Site) and INJECTION SITE ERYTHEMA (Redness - Neat Injection Site). At the time of the report, INJECTION SITE PRURITUS (Itchy Sensation - Neat Injection Site), INJECTION SITE RASH (Rash - Neat Injection Site), INJECTION SITE SWELLING (Swollen - Neat Injection Site) and INJECTION SITE ERYTHEMA (Redness - Neat Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided.
Developed and still have severe ringing in the ears  or tinnitus several days after vaccine. I never had any symptoms of tinnitus before the vaccine. It is completely disrupting quality of life,
Information has been received from a consumer concerning an 15 year old male who on an unspecified date was vaccinated with MMR II. The reporter stated that she read in a book (name unspecified) that a male had received a dose of MMR II at the age of 15 years old and then was diagnosed with Crohn's disease. This is one of several reports received from the same source. Additional information is not expected.
Not able to move her arm; This spontaneous report was received from a consumer refers to a female patient of unknown age. The patient's medical history, concurrent conditions, historical dugs and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route, lot # and expiration date not reported) for prophylaxis. On an unknown date, the patient was not able to move her arm (injected limb mobility decreased). The outcome of injected limb mobility decreased was unknown. The causality assessment was not provided by the reporter.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005356:
"strange cry" inconsolable for more than 6 hours straight. Fever over 102