chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever for 3 days followed by seizure/altered mental status requiring hospitalization. 10 days in hospital, including 5 days in PICU.  11/2 & 11/5/09:  Hospital records and consultation reports received for dates of service 10/23/09 to 11/1/09. Dx:  Acute disseminated encephalomelitis. Assessment: A couple of days after receiving the H1N1 vaccine, and 3 days prior to admission the pt. began to have fevers up to 103.5.  On the day of admission he vomited, developed a cough and congestion and became unresponsive with arm jerking, shaking and nystagmus. Spent 5 days in the PICU. CT and MRI scans of the brain were abnormal as was an EEG.  Placed on steroids and IVIG, and made rapid improvements.  Will require speech, occupational and physical therapy for rehabilitation.  Discharged to home after 10 days.    11/9/09:  Discharge Summary and medical records received for dates of service 10/23/09 to 11/1/09.  Final Dx:  Acute disseminated encephalomelitis. Four days of IVIG and high dose steroids.  In addition to the above, NGT was placed and transitioned to enteral feeds for nutrition.  Cleared to full PO Diet by speech.  There was a concern for visual acuity and possible optic neuritis.  Seen by opthalmology who did not see any evidence of neuritis on exam.  Had a brief period of apnea requiring positive pressure on one day.  Condition on discharge stable, improving.  No restrictions on diet or physical activity.
patient received  Moderna dose after receiving Janssen; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received  Moderna dose after receiving Janssen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine (as primary series) on 22-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine.    On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received  Moderna dose after receiving Janssen). On 25-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received  Moderna dose after receiving Janssen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2022-456266 (Patient Link).
63-year-old male who complains of sudden mid upper back sharp tightness pain sensation worse with inspiration unlike pain ever felt before that occurred while he was exercising on the rowing machine earlier today.  The patient denies any injury or fall and he does not take any anticoagulation therapy.
Information has been received from a certified medical assistant (CMA) concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently the patient experienced swelling, pain at injection site and hot skin to touch.  The outcome of the events was not reported.  In follow up, the certified medical assistant reported that this patient had not developed hotness of swelling as originally reported.  The 44 year old female with diabetes mellitus, an allergy to codeine and hypercholesterolemia was vaccinated in the right arm on 07-NOV-2005 with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included influenza virus vaccine (unspecified), also given in the right arm the same day and tetanus toxoid, given in the left arm on the same day.  On 08-NOV-2005 the patient's right arm ached through to breast and chest.  There was no redness.  The patient's outcome was not reported.  No further information is available.
pt recvd vax;sterile abscesses or possible cellulitis;severe inject site rxn of swelling & erythema;tx keflex & ice packs;
HAIR LOSS; FATIGUE; PSORIASIS FLARE-UPS WITH NEW LESIONS AND IN NEW AREAS OF BODY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-FEB-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose was not reported, 1 time every 12 weeks, therapy dates were not reported for moderate to severe chronic plaque psoriasis. Age at time of vaccination 50 years old. No concomitant medications were reported. On APR-2021, the patient experienced psoriasis flare-up. On an unspecified date, the patient experienced hair loss, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient had not recovered from hair loss, psoriasis flare-up, and fatigue. This report was non-serious.
I thought I had a cold and it started getting worse. I went to the Emergency Room, and they put me on a Z-Pack, and it just kept getting worse. I went back to the Emergency Room and was evaluated there and diagnosed Bilateral Pneumonia and Sinusitis. They did a culture and it showed up with Pseudomonas Bacteria. I was hospitalized for 5 days. They gave me a Pic Line and I was given Cefepime through it. I did this for 2 weeks and then the Pic Line was removed. I did not test positive for COVID-19, RSV or Flu.
Approximately 2inch reddened area at injection site. Hot to touch, pt denies pain.
Rash noticed all over patients body.  Flat, red to pink dots everywhere, but concentrated on belly, groin area, back, and neck.  Patient had 100 to 101 degree fever for three days prior to rash onset.  Childrens Advil .75 tsp given once during the three-day fever period.
wheezing & difficulty breathing for about 1 1/2 hrs p/inject; took Proventil inhaler, 2 puffs, 1 seldane dose; h/a for 4 hrs & itching @ inject site for 2 hrs; muscle aches, joint pains & malaise 4 days;
Patient has been experiencing fasciculations of her face in front of her left ear area since 2-3 days after she received the vaccine.  No numbness, tingling or weakness is present.
Chills, headache at night and during the following  day. Severe acid reflux the following day starting in the evening which was an intensity I have not experienced before.
I got the vaccine and still got shingles/ Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine and still experienced shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Pt devel pimple like rash on chest w/in 24 hrs of receiving MMR; Rash is itchy; Mom called MD may be allergic rxn to vax;
This case meets vaccine breakthrough criteria.  SXS SOB, HYPOXIA, COUGHING
mild headache in back of my head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache in back of my head) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (mild headache in back of my head). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (mild headache in back of my head) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-367092, MOD-2021-367114 (Patient Link).
pt recv vax 31OCT96 & w/in half an hr post inj pt devel a narrowing of visual field (homonymous hemianopsia) followed by lightheadedness & fatigue;all sx abated w/in a few hr;
Cried at time of injection and continued for 4 hours.  Napped for 1 hour then continued to cry.  Injection site with swelling or redness, no fever with recheck.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 11:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 14:30 as dose 1, single (Lot number: EL1283), in right arm, on 10Feb2021 at 10:30 as dose 2, single (Lot number: PFIZER), in right arm, on 26Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 06Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Breast Cancer Stage 3 in 2012", start date: 2012 (unspecified if ongoing), notes: Other Medical History: Breast Cancer Stage 3 in 2012. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Mar2023) Negative, notes: I tested negative in the morning; (05Mar2023) Positive, notes: I tested positive day 5 in the morning. Therapeutic measures were taken as a result of vaccination failure, COVID-19 with Paxlovid from 24Feb2023 to 28Feb2023. Additional information: The patient has no known allergies.
9JAN95 started having watery blisters last nite swollen glands-fever of 100 this AM; watery blisters all over body; pc to mom dx chicken pox
THROAT TIGHTENING POSSIBLY DUE TO PEANUTS EATEN EARLIER THAT DAY, HX OF PEANUT ALLERGY Narrative:
leukocytoclastic vasculitis - within hours developed an intense purpuric and painful rash.  Has been seen by both Dermatology and Allergy who confirm that this is likely due to the flu shot.
bulging veins in wrists and hands; Neck pain; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for patient (husband) that a 60-years-old male patient received bnt162b2  (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0183; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient had no medical history. Concomitant medications included fluvoxamine (FLUVOXAMINE) taken for obsessive-compulsive disorder (Has been taking over 20 years); clonazepam (KLONOPIN) taken for obsessive-compulsive disorder, anxiety (Has been taking maybe about 5 years). On 18May2021, the patient experienced bulging veins in wrists and hands; while on 17May2021 neck pain. Patient was treated with Tylenol. Patient taking Pfizer COVID  19 vaccine because he wants his mask off. Consumer reported that patient know about his feet or legs, he was sleeping. She noticed his hands this morning. It was reported that patient had the neck pain last night and woke up with it this morning. Everything has now gone away. He took a Tylenol this morning. It was reported that vaccine scheduled around 10:30 am, was probably around 11:30am. History of all previous immunization with the Pfizer vaccine did not considered as suspect. Additional Vaccines was not administered on Same Date of the Pfizer Suspect. Patient was not visited to emergency room and physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not had any illness at the time of vaccination. Patient did not had any family medical history. Patient did not performed any lab test. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested
First time  flu shot 5mins after injection patient became very pale and felt nausea. Face became very flushed = hives around face and neck complained of throat feeling itchy and tight. Epi given and called 911.
4SEP91 pt given DT & became itchy & swelling 7SEP91; Returned 11SEP91 approx 30-40% of lateral aspect pt arm inc warmth no drainage; given meds;
Pt reports burning, stinging pain in the L mid-deltoid area ever since her flu shot on 10/27/2020.  (reported 2/11/2021) Initially had her "whole arm" swell up & get tingly & painful for several days. For at least a month after the shot, it was still sensitive if bumped, which stirred up the whole-arm pain again.  It has gradually improved, but she still has a searing pain in the injection site even now, when she uses that arm.
Patient received first dose of Moderna Covid-19 Immunization vaccination 1/11/2021. Patient reports pruritic red rash that is hot to touch developed 1/15/2021 and has been moving from L. deltoid towards axillary area. Patient reported incident 1/18/2021 reports rash still present. Instructed patient to contact provider.
This spontaneous report as received from a pharmacist refers to a paediatric patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patient was vaccinated with a 0.5 ml pediatric dose of VAQTA (route not reported) from a 50U/1-mL single use VAQTA vial intended for adult patients. No adverse symptoms reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reporter stated that improperly stored doses of PROQUAD, Lot number M014302, expiration date 22-SEP-2017 (dose, route, and anatomical location were not reported), were administered to an unspecified number of patients on unspecified dates since 19-OCT-2016, for prophylaxis. The vaccine was exposed to a temperature of 10.8 Fahrenheit (F) for 4 hours and 56 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA006080.
Several hours after administration, pt became lethargic and febrile experiencing myalgias and arthralgias. He was given antipyretic, anti-inflammatories and sent home from work.  After no improvement in symptoms and development of productive cough, he reported again 48 hours later where CXR revealed a right lower lobe air space process.  He was uneventfully treated for pneumonia and recovered completely.
Very confused, out of it, brain wasn't working, couldn't think, pain of injection site, eyes swollen, very bad headache, very dizzy, nausea 7 AM - trouble breathing, very difficult to breathe, very dizzy, very confused, brain fuzzy/not working right, shortness of breath, leg aching, bad stomach ache, body hurt.  That lasted all day and into the next day.  Very, very worried and scared patient!!  Doctor on call said to take Zyrtec and 2 Benadryl and see if that helped.  Patient was very sleepy but still had symptoms... got a bit better, then worse with confusion.  Very confused at times.  Still on 3-25 - still confused and brain not clear.
Patient suffered acute Appendicitis on 6-16-21 and upon arrival  at local hospital ER and after performing tests, he rec'd an emergency Appendectomy performed by Surgeon with complete recovery
Information has been received from a consumer concerning her son a male patient who on 10-JUN-2008 at 11:00 was vaccinated with VARIVAX (Merck) (route and site of administration was not reported), TETANUS TOXOID (manufacturer unknown) (route and site of administration not reported) and MENINGOCOCCAL (unspecified) (route and site of administration not reported). On 10-JUN-2008 in the middle of the night the patient experienced fever, body aches, rib pain, stomach, dizzy, weak and felt "faintish". The patient did not like to sit because of the pain in his stomach. Mom is treating the ADVIL and was calling the doctor office for follow up with the advice nurse. The patient's fever and body aches and rib pain and stomach pain and dizzy and weak and felt faintish persisted. The reporter felt that fever, body aches, rib pain, stomach pain, dizzy, weak and felt faintish were related to therapy with VARIVAX (Merck). No further information is available.
pt recv vax 9OCT97 & 26OCT97 pt exp approx 10 bumps;
8am: woke up with a moderate headache and it subsided after taking 2 advil 6pm: blurry vision, hard to focus on computer screen, lasted for about an hour 7pm: fatigue, lightheaded 8pm: very sensitive to light, wanted to lie down 8:30pm: chills, mild fever, slight cough 11pm: some sweating while sleeping, felt very dehydrated *didn't take any other medicine throughout the day, slept it off and felt much better the next morning besides tolerable headache
My daughter received tetanus, meningitis, and a new vaccine called HPV (GARDASIL). Within 5 min. she passed out and had a seizure lasting approx. 10 seconds. She was extremely weak - dizzy for a few days after vaccinations.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' concurrent conditions, concomitant medications or medical history was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ that underwent a temperature excursion of 0° centigrade to 1° centigrade, during 4 hours, (lot # N014980 with an expiration date in 16-NOV-2018) orally, for prophylaxis. No adverse effects were reported. Data logger was involved. No product quality complaint (PQC) was involved.
This non-serious initial spontaneous case was received from Other Non-Health Professional on 30-Oct-2017, concerning a 54-year-old, adult, female patient. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, trade name, manufacture: not reported. On an unspecified date, the patient experienced severe reaction and hence she was advised not to take the flu vaccine. The outcome of the event was not reported. The reporter assessed the event as non-serous.
Headache, nausea, chills, vomiting on same day/night of vaccination. Vomiting was severe and occurred repeatedly, resulting in bile coming up. Headache, nausea and vomiting ended within 24 hours of vaccination. Chest tightness/discomfort over following days continuing into Friday (three days later). No treatment, doctors office was fully booked for day during attempted visit.
5/24 37 year old female w/ hx of sickle cell disease, cholelithiasis, who presented to BHS-RO ED w/ c/o chest and back pain. Symptoms started 2 days prior to admission.
experiencing symptoms exactly like covid symptoms; slept the day away; never ate or drank; lips was looking dehydrated; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (experiencing symptoms exactly like covid symptoms), HYPERSOMNIA (slept the day away), DECREASED APPETITE (never ate or drank), DEHYDRATION (lips was looking dehydrated) and FATIGUE (Tired) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included ATORVASTATIN, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), FINASTERIDE, LISINOPRIL, TAMSULOSIN and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced SUSPECTED COVID-19 (experiencing symptoms exactly like covid symptoms), HYPERSOMNIA (slept the day away), DECREASED APPETITE (never ate or drank), DEHYDRATION (lips was looking dehydrated) and FATIGUE (Tired). At the time of the report, SUSPECTED COVID-19 (experiencing symptoms exactly like covid symptoms), HYPERSOMNIA (slept the day away), DECREASED APPETITE (never ate or drank), DEHYDRATION (lips was looking dehydrated) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 100.2 (High) 100.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not take any treatment.  The patient had COVID-19 in Oct-2020. It was 8 days prior to fulfilling the 3 month waiting period when he received the vaccine.  He was very ill with the covid symptoms for about 12 hours the next day. This happened for just one day. The patient did not take anything for his symptoms.
Case number PHEH2014US006398 is an initial spontaneous report received from a pharmacist on 29 Mar 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13017 and expiry date: 30 Sep 2014), at dose of 0.5 ml intramuscularly on 25 Mar 2014. The MENVEO reached 32 to34 F for up to 25 hours (at different time increments) within 8 day period and was subsequently administered to patient. Reporter does not believe vaccine was frozen. No adverse event reported following this administration error.
Chills, fever, headache, fatigue, nausea & body aches- Bed rest and Advil - Relieved some symptoms -
Rash on legs. Gradually spread all over trunk and limbs. 11-30-15 - mom was called rash was completely gone by 11-25-15.
Patient recieved vaccine, went to the cash register to finish transasction, stated she "couldn't breathe" . patient sat down and was cyanotic, and unable to catch breath. epinephrine was administered, and ems called. patient left under her own power and free will to follow up at emergency department.
Intermittent, severe, spasmodic neuro muscular facial contracture and eye closure, worse on right side began approximately 3 weeks after 2nd Covid-19 vaccination injection.