chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SPOUSE REPORTS THE FOLLOWING FOR PATIENT  4/21/2021 @ 9PM GENERAL MALAISE  4/22/2021 APPROX 4AM SEVERE HEADACHE TOOK IBUPROFEN  4/23/2021 AFTER LUNCH, PATIENT WAS UNABLE TO WALK AS PREVIOUS AND HAD 4 FALLS, ALSO COMPLAINED OF A SORE THROAT. 4/24/2021 DID NOT FEEL WELL, TEMP UP TO 100.4, NAUSEA AND VOMITTING X 1 AND CHEST PAIN, CALLED EMS AND WAS TRANSPORTED TO MEDICAL CENTER ER.  4/26/2021 PATIENT WAS DISCHAGED HOME AFTER TREATMENT FOR RHABDOMYOLYSIS AND RETURNED TO THE HOSTPITAL AGAIN ON 04/27/2021 WITH RHABDOMYOLYSIS AS PRIMARY DIAGNSOSIS. RESIDENT DISCHARGED TO SNF ON 04/28/2021.
Child had his first DTAP on 7/20/01. Child's mother called on 7/22/01 and said that her son's leg was swollen, red and was the size of a grapefruit. The child had no fever. Mom was instructed to use cold compresses and use Benadryl and to call us if symptoms worsened.
later that evening mom reports woke pt up from longer than usual nap-pale, limp minimally responsive, would not stay awoke;taken to ER full sepsis w/u done because of fever to 100.9;no tx given as pt was back to baseline;
Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five-year-old female patient who was vaccinated with an expired 0.5 mL dose of DAPTACEL (fifth dose in series) frequency once lot C5117AA, 19 Jan 2019 via unknown route in the left deltoid on 04-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE INACT (IPV) for Immunisation; MMR for Immunisation; and VARICELLA ZOSTER VACCINE for Immunisation. It is an actual medication error case due to expired vaccine used. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
pt recv vax 26AUG96 & c/o chills, pains to site, area red about 45inch;applied cold packs;swelling decreased;
pt devel itching on legs that devel into a maculopapular rash on thighs each day;looked like poison ivy type rash w/ vesicles of serum;body aching especially in legs, pain;muscle spasms;muscle & joint pain;required crutches to move around;
Following AM after vaccine admin arm at site was red swollen sore to touch, localized to arm no pus or discharge at inj. site. Called pt 10/8/13 states arm still looks red and like inj site is bruised. Pt has not as of 10/8/13 seen PCP. I suggested having inj site looked at by PCP.
Fainted after vaccination - got back up and left store. Contacted wife, she said he has a history of fainting with needles / blood draws.
Pt devel t103 ax 13.5 hrs p/vax; tx w/APAP & temp dec but never lower than 100.9 ax despite tx w/APAP q 4 hrs; 30 hrs p/vax t 103 pt being sponged every 1/2 hr; seen by MD 48 hrs p/vax; pt devel rash dx measles rash; pt crabby;
I got a migraine on Thursday, January 21, the day after my injection.  I treated it with Sumatriptan and Aleve as I always do when I get a migraine.  When I get migraines, it's usually 1-2 times a month.  Once I treat it, it doesn't come back.  This headache returned about 7 hours later on January 21.  I treated it again.  I got another headache today, January 22 at 11 AM.  I treated it again with my medication.
Information has been received from a health professional concerning a 15 year old white female student who on 27-FEB-2007 was vaccinated in the right deltoid with Gardasil (lot # 655503/0012U) concomitantly with a dose of MENACTRA (lot # U2135AA) in the left deltoid. On 28-FEB-2007 the patient experienced "achey and sore all over", vomiting, dizzy, fever and diarrhea. On 05-MAR-207 the patient was seen in the doctors office and the family nurse practitioner prescribed PHENERGAN TABLETS/SUPPOSITORIES and diagnostic laboratory tests were performed. After 5 doses of PHENERGAN TABLETS/SUPPOSITORIES symptoms resolved. A diagnosis was provided of viral infection versus reaction to Gardasil. The patient's mother does not wish for her to continue the Gardasil series. Additional information has been requested.
Received both MENACTRA and BOOSTRIX 1/23/2009 in left deltoid approx 1 cm apart. Area became red, hot and indurated after next day. No SOB, wheeze or other s/sx.
Started feeling a scratchy throat, and feeling tired; Took a home COVID-19 test and it was positive; Had a Telehealth appointment next day and was prescribed PAXLOVID; Tested negative 2 weeks later.
Approximately one week after 1st dose of Pfizer covid19 vaccine, patient developed a rash all over torso. Today, 3 weeks post vax#1, rash is still present. It is pruritic, covers entire torso (ant/post) from base of neck to pelvis/buttocks. Lesions are  variable from small (5mm diam) raised, erythemic lesions to large (2-3cm diam) hives. Lesions on the back are coalescing to cover entire back. Pt's mother stated the individual lesions are coming together-rash worsening over past 2 weeks. OTC Topical cortisone helping with itch, but not with lesion resolution. Enc pt to reach out to PCP-Pediatrician and discuss possible systemic treatment such as PO anti-histamine or steroid taper. Pt rescheduled for dose #2 which will continue to be delayed until rash is completely resolved. Suggested 30 minute observation at next vaccine appointment.
Severe Left Arm pain, numbness & tingling.  All symptoms will shoot down arm into thumb and fingers.
Pt had sz approx 6hrs p/receiving immun; became very pale, lips were blue, palms very pale; taken to MD temp 101; admitted to hospital same afternoon; dx ear infect;
Huge red, itchy, red, swollen patch on my upper arm extended down to my elbow. Since urgent care was not open, my husband took me to the ER at Hospital where i was given a 10 day prescription of KEFLEX.
The patient developed a large red circular rash above the injection site which is itchy and swollen and tender. On 8/8/2016 when the patient reported it to the pharmacy he also saw his doctor who advised him to take benadryl and monitor  for any changes.
11yF administered Pfizer covid 19 vaccination w/no adverse events.  Error discovered at eligibility check for dose #2.
The night after flu vax was given patient developed redness, pain, and swelling. Was seen 2 days after injection. Treated for possible soft tissue infection.
lower than authorized dose volume; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (lower than authorized dose volume) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (lower than authorized dose volume) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (lower than authorized dose volume) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (lower than authorized dose volume).    No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Acute onset Psychosis that started 08March 2021 (2nd dose of Moderna was on 27February 2021. Symptoms could not recall the events during the 2-3 days of psychosis but his coworkers explained that he was acting very odd, shifting his weight, looking up and around without making much eye contact. He began repetitive behaviors such as saying he wants to finish the movie they were watching, continually repeating that phrase. After the movie, he began to tear up saying he wanted to get to the end of the movie even though the movie was over. Later on in the day his tone of voice changed from his normal tone and he became more talkative and beginning unusual conversations with anyone around him.  Later on after he was evaluated by medical, he wanted to be left alone outside on the ship. He denied any Suicidal ideation or homocidal ideation. They convinced him to come inside and was put on a one to one watch but became aggressive at one point as they tried to calm him down.
they plan to administer Hiberix to a 37 year old patient; Circumstance or information capable of leading to medication error; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 37-year-old male patient who received Hib (Hiberix) (batch number EN2Y7, expiry date 1st April 2023) for prophylaxis.   The patient's past medical history included splenectomy.   On an unknown date, the patient did not receive Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced drug prescribing error and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the drug prescribing error and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK receipt date: 12-Apr-2022 Reporter's comment: Pharmacist called in to inquired and report about any information over the age of 4 years for Hiberix. The reporter stated they had planned to administer Hiberix to a 37 year old patient on date of reporting (12th April 2022) who had a splenectomy. The reporter asked that it could be administered. Did not consent to follow-up. Additional Supportive Information: The pharmacist planned to administer Hiberix to a 37 year old patient on date of reporting, which led to drug prescribing error and circumstance or information capable of leading to medication error.
Left side of lips went numb; Pain in neck, back, and knees; Pain in neck, back, and knees; Pain in neck, back, and knees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jul2021 15:00 (Lot number: FA7484) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic kidney disease stage 3" (unspecified if ongoing), notes: Diagnosed for six years now. Only one kidney is affected.; "Problem with blood pressure", start date: Mar2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA ORAL (non-serious) with onset 28Jul2021, outcome "recovered" (28Jul2021), described as "Left side of lips went numb"; NECK PAIN (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 28Jul2021, outcome "recovered" (28Jul2021) and all described as "Pain in neck, back, and knees".  Additional Information for Other Conditions: Blood pressure doesn't go high. If she's laying down and gets up, it goes up and then goes back down. It makes her dizzy. Diagnosed this year, she thinks Mar2021, prior to her COVID-19 Vaccines. Caller was previously saying she had the COVID virus, clarified she has not been diagnosed with COVID-19 Virus. She was referring to the COVID-19 virus vaccine. Confirmed again she has not been diagnosed with COVID-19 virus.   No follow-up attempts are possible. No further information is expected.
admitted to the psychiatric facility for 21 days; diagnosed with bipolar disorder; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (admitted to the psychiatric facility for 21 days) and BIPOLAR DISORDER (diagnosed with bipolar disorder) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included ADHD, predominantly inattentive type and Major depressive disorder.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced HOSPITALISATION (admitted to the psychiatric facility for 21 days) (seriousness criterion hospitalization). On an unknown date, the patient experienced BIPOLAR DISORDER (diagnosed with bipolar disorder) (seriousness criterion medically significant). The patient was hospitalized from 10-Jun-2021 to 02-Jul-2021 due to HOSPITALISATION. On 02-Jul-2021, HOSPITALISATION (admitted to the psychiatric facility for 21 days) had resolved. At the time of the report, BIPOLAR DISORDER (diagnosed with bipolar disorder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. An alternative explanation is that the serious unexpected event of Bipolar disorder was more consistent with increased risk due to underlying psychiatric history. The hospitalization was probably related to Bipolar disorder.; Sender's Comments: An alternative explanation is that the serious unexpected event of Bipolar disorder was more consistent with increased risk due to underlying psychiatric history. The hospitalization was probably related to Bipolar disorder.
Patient left the health department and went to store with her sister.  Stated her right arm at injection site started hurting while she was shopping and continued to be increasingly painful.  Patient reported taking an Aleve around 2:30 PM without relief.  Patient returned to Health Department at 3:15 PM, expressing severe pain to right upper arm with any movement.  Noted shortness of breath.  Patient stated pain makes it hard to get her breath.  Blood pressure 154/80.  Advised patient to see her physician as this facility has no in house physician.  She stated her physician was not in town today and she did not feel like she could drive.  Did not want her daughter called.  Voiced being dizzy and light-headed, turned pale and became diaphoretic.  Place in lying position on exam table, applied cool wash cloth to forehead. Pulse 74, respirations 20.  Ambulance was called.  Patient's daughter was notified, and came to health department.  Patient was transported to Hospital by ambulance at approximately 4:00 PM.
23OCT92 t102, URI  MD gave ATB; 26OCT92 rash x 4 days; 27OCT92 MD dx of MMR reaction confirmed;
Right after my 1st shot in left arm 3weeks earlier at same site (EW0162) I became dizzy, nauseous and had tingling/numbness from the knees down to my toes for about 3 hours. Next day sore arm and fatigued. This 2nd shot, had tingling/numbness from the hips down to my toes with shooting intermittent hip pain for about 4 hours after shot. Arm became excruciatingly painful and throughout the night developed fever, chills, migraine, body aches, nausea, sensitivity to light and sound, loss of appetite and taste, extreme fatigue. Continually got worse into Sunday and not feeling much better today. Today little fever but am experiencing everything else and am very jittery and have double vision. Painful having my glasses on.
I started having a migraine headache around 8pm. That evening I started to experience body aches, chills, stuffy head, post nasal drip and a scratchy sore throat. I contacted Dr. who did a tele-med call and I explained my symptoms. He prescribed Paxlovid after I advised him that my home test was positive. I had been contacted and advised that someone that I was in their company tested positive as well. I have completed the medication. I had fatigue for a few days along with post nasal drip but I feel that I have recovered.
My son had painful swollen glands in his neck, with pain swallowing any food or drink. Contacted doctor at 3:30 PM on 11/28. He said the body was fighting off an infection and did not suggest any action. But the pain was getting unbearable, so finally on 11/29 my son decided to start taking Advil for the pain. It took 5 days (Nov.27 - Dec.1) for the pain and the swelling to subside.
Pain/soreness at injection site (much worse than first vaccine), Flu-like symptoms: fever, body aches, headache, fatigue, loss of appetite for about 48 hrs following vaccination, starting am after.
No additional AEs were reported; A patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker referring to a 4-months-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 24-AUG-2022, the patient was vaccinated with one improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot numbers W004504 and  W002562 has been verified to be a valid lot numbers, with expiration dates reported and established as 16-JUN-2023 and 12-OCT-2023 respectively) (exact dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis, that underwent a temperature excursion of 11.3 Celsius degrees for 34 minutes (product storage error). The reporter did not know which of the reported lot numbers received the patient. There was no previous temperature excursion. No additional adverse events were reported.
Moderna COVID-19 Vaccine EUA  - Symptoms: loss of appetite, nausea, head pressure and pain, ears feel like they have liquid inside/pressure/sore, eyes sensitive to light, pressure/ liquid in throat, chest pain, stomach pain, chills, legs go numb/muscle issues, dizziness/vertigo, sensation of passing out, eyes feel heavy/sleepy, and fatigue. - Result: Inflammation in both ears. More in the left ear than the right. - Prescription: Amoxicillin  - Symptoms: Similar to 5/6 symptoms. Additions: Pain behind eyes, neck pain, chest pain, balance issues, difficulty standing, sensitivity to lights/sounds/scents, teeth/mouth are numb. - Result: Doctor found inflammation in ears. Thought that I may have an allergy of some sort/immune system raved up from vaccine. - Prescription: IC Meclizine 25 MG Tablet- Take 1 tablet by mouth three times a day for dizziness and Sudafed 6/11- ENT Doctor:  - Symptoms: Head pressure/pain and ear pressure pain - Result: Found ear inflammation in both ears. - Prescription: IC Methylprednisolone 4 MG Tablet- Take 6 tablets on day 1 and decrease by 1 tab each day for a total of 6 days.   - Symptoms: Pressure/pain in head and extreme neck pain - Result: CAT scan of head and X-ray of neck came back with nothing - Prescription: Given pain patches and IC Methocarbamol 750 MG Tablet- take 2 by mouth 4 times a day  - Symptoms: extreme chest pain and pressure in ears/head - Result: Costochondritis and inflammation in ears - Prescriptions: Zyrtec, IC Naproxen 500 mg Tablet,  IC Cyclobenzaprine 5 mg Tablet, and Flonase  - Follow-up appointment - Keep taking Flonase twice a day 8/12: 2ND Eye doctor visit for the year:  - Symptoms: double vision, sensitivity to light, checking for any potential sinus pressure issues - Result: Tested for sinus pressure and looked at photos from April appointment, both of which look normal.  - Symptoms: numb/tingling inside of mouth, hands, arms, and legs; legs feel weak/not able to walk or stand for long periods of time, off balance, upper neck pain, muscle soreness over entire body, vision changes: seeing double, sensitivity to light, pinching feeling on scalp, memory issues/confusion. - Result: Referred to neurologist and there is still inflammation in ears. - Prescription: IC Prednisone 20 MG Tablet  - Symptoms: difficulty breathing, shortness of breath, and chest pains - Result: Oxygen level was normal, checked lungs and heart-both normal Sep. 9/14- Neurologist: Consultation 9/16- Primary Care: Online call-given an inhaler and Covid test came back negative  Primary care: Given IC Sertraline HCL 50 MG Tablet October 10/5-8 Neurologist: Went over results and diagnosed with ADEM. Started IV treatments and given steroids 10/7- Primary care: Follow up about MRI results and how other medication is going 10/24- Neurologist: Follow up appointment  11/30: Follow up with Neurologist after 2nd MRI: Future 12/3: Neurologist: Future (2nd opinion)
About (6) days after shot administered I began to feel sick. Became progressively sick - (Eyes itched; sneezing; nose ran; some fever; Loss of appetite) went on for about a week.
numbness in fingertips, bilaterally. Lasted several hours for one finger before happening to another finger.  This continued for 6 weeks until I saw a practitioner who provided the treatment called Frequency Specific Microcurrent to help with nerve issues. Symptoms resolved after this treatment.
PATIENT HAD MILD PAIN, SWELLING AND REDNESS AT INJECTION SITE(ON LEFT ARM), RED STREAKS THAT WENT INTO ARMPIT ON LEFT ARM WAS DIAGNOSISED WITH CELLULITIS AT ER AND TREATED WITH VANCOMYCIN IV & DOXYCYCLINE 100MG BID X10 DAYS.
Headache 20 mins after injection. The next 2 days my entire body ached, and my headache continued. Very sore arm. Felt like i had the flu. Then i got pneumonia for almost 3 months.
Received Tdap  and Hep B .on Nov. 26,2008.  When she returned for her second Hep B vaccine one month later she reported that  approximately 48 hours after receiving the vaccines, she had swollen lymph nodes  in both axillae.  She had received both vaccines in the same arm since she had a large keloid on the other arm. ( From infected site of polio vaccine as a child ) She is a large woman weighing 231 lbs. so there was a large muscle for injection.  She said the Left armpit was swollen,and painful and som swelling extended nearly to the elbow.  The Right arm had a " little" swelling in the armpit.   She reported it to her PCP but he did not see her.  She applied ice packs to the the area .
Sickness; fever; nausea; vomiting; chills; joint pain; Skin pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020 and Thyroidectomy. Concomitant products included PANTOPRAZOLE and VITAMINS NOS for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ILLNESS (Sickness), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), ARTHRALGIA (joint pain) and PAIN OF SKIN (Skin pain). On 10-Mar-2021, ILLNESS (Sickness), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), ARTHRALGIA (joint pain) and PAIN OF SKIN (Skin pain) had resolved. Unknown      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.   Concomitant product also include Thyroid pill daily as patient's thyroid gland was removed.  No treatment information was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-056389 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056389:Cross-linked cases