chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an LPN concerning a 69 year old female with hypothyroidism, atrial fibrillation, arthritis, mitral valve prolapse and an allergy to sulfa medications who on 05NOV2003 was vaccinated with a first or second dose of dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Betapace, sulindac, Synthroid, and Altace. On 06NOV2003 the pt awoke with a local rxn described as erythema the size of a grapefruit. Unspecified medical attention was sought and the area was treated with ice. No product quality complaint was involved.  It was also noted that another female pt was vaccinated with a dose of peumococcal 23v polysaccharide vaccine and developed cellulitis. It was noted that the physician was concerned about the size of the rxns since both pts received doses from the same lot number. The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingles from Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Felt a hard lump in my breast, same side I received the shot. The lump is very painful and hard. The next day the lump decrease in size and tenderness.
Became I'll with fever and diarrhea, lethargy. Then started having swelling in my lower extremities and heart related issues which I'd hadn't had since I had had a heart attack a year ago this past March.
Per parent, shot site very red, Entire leg turned blue to the toes, Very fussy, Site painful to touch.
feeling lightheaded; I went to bed as I was feeling lightheaded and exhausted; After dinner last night, I started to feel nauseated; vomited a small amount of digested food; immediately developed a headache; immediately developed a chills, required extra blankets for warmth and cycled through hot/chilling cycles all night; required extra blankets for warmth and cycled through hot/chilling cycles all night; I had severe stomach pain; This is a spontaneous report from a contactable nurse.  A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 25Feb2021 at 15:45 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included transient ischemic attack (TIA), tinnitus and lactose intolerance. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included tilactase (LACTASE), magnesium (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN); all for an unknown indication from an unknown dates and unknown if ongoing. On 04Mar2021 at 19:00, the patient felt nauseated after dinner and vomited a small amount of digested food, immediately developed a headache and chills. The patient reported that her husband completed his second Pfizerer dose, ate the same dinner and did not have any effects. On the same day at 20:00, the patient went to bed and was feeling lightheaded and exhausted 2 hours ahead of schedule. she required extra blankets for warmth and cycled through hot and chilling cycles all night, had severe stomach pain, but no diarrhea or coughing. At 06:00, effects disappeared with the exception of light headedness and exhaustion. The patient also reported that her 77-year-old sister received the Moderna vaccine on 22Feb2021 and had a massive stroke on 23Feb2021. That left her to wonder if she should get the second dose on 18Mar2021 or not. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nauseated, vomited, headache, hot chilling cycles, severe stomach pain, and chills were recovered on an unknown date in Mar2021, while the events feeling lightheaded and exhausted were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug allergies were not reported. On 24-APR-2015, the patient was vaccinated subcutaneously with a dose of VARIVAX (Merck) (lot # K011804 and expiration date 21-AUG-2016). The reporter stated that the administered dose of VARIVAX (Merck) was improperly stored. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & 17 days later pt devel mild chickenpox w/a maculopapular rash;no further details were provided;
Complaint of drowsiness & headache. Pulse 100, B/P 104/76. Right arm site no redness or itching.
First day, fatigue and chills. Second day at approximately 3 pm, faver of 101.5, chills and fatigue continued, aches, lower intestinal problems.  Third day at 8 am other symptoms subsided but new symptoms of extreme pressure on glands under ears, horrible ear pressure and pain and ear popping.  The ear pressure continues to periodically happen 5 weeks after the second vaccine.  Yesterday the ear pressure  and ear popping surfaced again.
The pt developed fever of 101.3 deg. F and papular-vesicular rash 10 days after vaccine administration.
Metal or copper taste in mouth, pain in shoulder and neck, unable to raise arm without hurting, not being able to lift anything and very ache all over.
SWEELING AT SITE RESPIRATORY SYMPTOMS : DIFFICULTY BREATHING, SHORTNESS OF BREATH HEADACHE LOT OF MUCUS.
cellulitis; Pain; rash trunk; temperature of 99.5 degrees F; muscle pain; joint pain; massive lump on shoulder big as a grapefruit; itching really bad; Massive Headache; vaccination site erythema; A spontaneous report was received from a consumer,  concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, itching really bad/injection site pruritus, muscle pain/myalgia, joint pain/arthralgia, massive great fruit sized lump/injection site lump, temperature of 99.5 degrees/pyrexia, and massive headache.  The patient's medical history was not reported. No Relevant concomitant medications were reported like  On 18JAN2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On date 18JAN2021, The patient experienced a massive lump on shoulder big as a grapefruit, rash under his chest and arm, major red skin under the arm, temperature of 99.5 degrees F, muscle pain, joint pain, felt like shingles, burning skin, itching really bad, cellulitis, scalded.   Laboratory details not provided.    Treatment information was provided : cephalexin 500mg three times a day for 7 days lidocaine 5% ointment twice a day for 7 days triamcinolone acetate 0.5% twice a day if needed for 7 days naproxen 250 mg twice a day  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events were all recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recvd 1st dose of vax & 3 days later was hospitalized w/pericarditis; addt details are being requested;
48yo presents with c/o possible reaction to flu shot. Patient received flu shot on 10/07/2008 and 2 days later developed facial swelling, swollen gums, muscle aches, diarrhea, cough, headache and right sides spontaneous nasal epistaxis. Patient also receiving lisinopril 10mg po qd. Facial swelling thought to be associated with lisinopril. Lisinopril was discontinued. Symptoms: 1. facial swelling, body aches, diarrhea, cough, headache and spontaneous nasal epistaxis. 12/08/09 ED Records received for DOS 10/07/09. Pt presented with SOB and palpitations attibuted to lisinopril that was taken that morning.  States history of previous reactions to lisinopril. DX: tachycardia; r/o dehydration, r/o lisinopril reaction  12/08/09  PCP Records received for DOS 10/14/09.  Pt c/o facial swelling , body aches, diarrhea, cough, headaches, epistaxis attributed to flu shot received  1 week ago. DX: r/o viral gastroenteritis; r/o allergy to lisinopril
Reports had covid in Janurary. Complained of being lightheaded. Came in waves. Chest tightness 5 minutes. 1040 b/p 136/100 pulse 74 1050 b/p 126/78 pulse 62 1100 b/p 130/90 pulse 67  respirations even and unlabored.
Noticed congested breathing, lethargic, fussy and irritable, normal soothing methods would not calm her after vaccines,  on 7.4.23 woke up to patient deceased.
Inflammatory marker increased; Knee swelling; Persistent cough; Leg pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATORY MARKER INCREASED (Inflammatory marker increased), JOINT SWELLING (Knee swelling), COUGH (Persistent cough), PAIN IN EXTREMITY (Leg pain) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced INFLAMMATORY MARKER INCREASED (Inflammatory marker increased), JOINT SWELLING (Knee swelling), COUGH (Persistent cough) and PAIN IN EXTREMITY (Leg pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLAMMATORY MARKER INCREASED (Inflammatory marker increased), JOINT SWELLING (Knee swelling), COUGH (Persistent cough) and PAIN IN EXTREMITY (Leg pain) was resolving and PYREXIA (Fever) outcome was unknown.            No concomitant medicine were reported. There was no reported medical history. For HUMIRA, the reporter causality for the events of Inflammation level high, Knee swollen, Lingering cough and Heat makes legs hurt was no reasonable possibility and for the event of Fever was not provided. Lab data included Inflammation levels: High  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Light headed within minutes, coughing then wheezing, heart rate increased , around lips became itchy and bumpy. Took my inhaler within 20 minutes better ..6 hours later went into bad bronchitis  white frothy thickish sputum lots brought up and cleared airways neededd nebulizer treatments past four days, fatigue,  fever highest 100.6, extreme chills next morning and slept a lot of 3/6/2021 and fever. Huge tissue pain, and joint pain worse second day
Initial report received from a healthcare professional on 20 August 2013. A 37-year-old female patient had received an intramuscular dose of ADACEL vaccine (lot number: LU464AA (dose in series and site of administration were not reported) on 08 August 2013. The patient was pregnant was pregnant at the time of vaccination. Last menstrual period date was unknown and the estimated date of delivery was 24 September 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs), treatment for infertility, medical history and concomitant medications were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: None.
Began running fever at 11:00 AM. Was up to 102.8 by 7 PM. Had febrile seizure. Seen at ED. Given TYLENOL/MOTRIN and monitored for elevated HR. Temp 102 (ax actual) at 9:35 AM on 4-18-13.
Numbness , Tingling  in my feet, severe leg cramps and now i can't walk came to the ER on June 22 2021 still here in rehab July 13th 2021
Erythematous papules on face 6 total DX Varicella. Supportive care.
Hepatitis A Havrix pediatric/adolescent dose inadvertently given to an adult client instead of the adult dose. The client received a 2nd Hepatitis A pediatric/adolescent dose per guidelines to count as an adult dose.
Rash on 05/18/04: possible atypical varicella papule, erythema, rash on both buttocks.
She received the Moderna Covid-19 vaccine on 4/6/21 and 8 days later on 4/14/21 she experienced painful paresthesias in her hands. A cervical & brain MRI were completed 5/24/21 & demonstrated an incomplete peripherally enhancing lesion in the upper cervical same most compatible with an active demyelinating plaque. The remainder of her imaging was normal w/o evidence of previous or active demyelination.
I do not know if they are related.  Approx  45 days after had weird sinus infection.  Started as chills, sore throat, thought had strep as grandkids did.   Went to chest and then head and ears over 7-8 weeks.    Was treated for strep w amoxicillin, then prednisone and doxycycline over 7 weeks.  Chest X-ray normal.    Loss of sense of smell.   Still not back.    Ears felt full, dizziness, low blood pressure.    Ears still feel off despite primary dr says they look good.    Dizziness low blood pressure better.    Just weird it hung on so long and I did have a neg covid test so never thought it was that until smell is not coming back fully.
This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-SEP-2015, the patient was vaccinated with a dose of GARDASIL (lot # L010596; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hives diffusing with some count, no induration.  Went to ER - given Benadryl, and Prednisone.
When she came to inquire about the Moderna booster shot, she shared that when she got the second dose, almost immediately after her vaccination while in the 15 minute waiting period, she developed tingly around her mouth, "around her heart", and down the front of her shins. She did not report this to anyone in the moment. The tingling lessened after the 15 minutes and patient left facility. She has had no issues since that moment and received no treatment.
Patient came in for a Well child exam on 2/20/2020 and was given 1 year old immunizations (Hep A, Prevnar13, MMRV, Varivax) at 10:30 AM by our medical assistant. Medical Assistant was notified at 11:00 AM. Medical Assistant called manufacturer MERCK (case number 01495615 spoke to RN from Medical Team) at 11:10 AM and reported the event. Event was also reported to RN from Immunization Registry.
I did not have an adverse event following my vaccination. On 12/05/2022, I began not feeling well with a cough, congestion and shortness of breath. I went to the emergency room on 12/07/2022 for six hours and tested positive for COVID-19.
tinnitus; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 34 years old male patient who experienced tinnitus(Tinnitus), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Nov-2019, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE  [FLUZONE QUADRIVALENT] (lot UT6686LA expiry date: 30-jun-2020) via intramuscular route in the left arm.  On 04-Nov-2019, the patient developed a non-serious tinnitus (tinnitus), same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported.  Final diagnosis was tinnitus.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.
Systemic: Flushed / Sweating-Mild, Systemic: Other- Death-Severe
Zostavax vaccine was given IM instead of SQ.  Pt did not report any adverse effects.
Pt. states felt hot, face rashy with red blotches that's moved throughout the day - chin red when in office - to report 10-9-13 4:15pm. VSs BP 130/70 P 70 T 97 ax PO 95% RA.
A non-serious spontaneous report of we gave 14 doses of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 23-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Patient reported fatigue and flu like symptoms within three hours of receiving vaccination. Patient reported then to have severe respiratory issues including coughing, phylum, fever and severe fatigue for up to 5 weeks. (to note that same reaction occurred with spouse except she did not have any phylum).
Admin/Med error - pt was given 0.5mL of FLUVIRIN - which is intended for ages 48 mo and above.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 8/18/21 (EW0179) COVID Positive 8/30/21 Presented to and discharged from ED 8/31/21 Discharged to home 8/31/21  9/6/21: Patient is a 40-year-old male who presents to the ED today for worsening COVID-19 symptoms.  The patient tested positive for COVID-19 on 08/30/2021.  The patient complains of fevers, body aches, fatigue, shortness of breath that have been worsening.  The patient has been taking Tylenol and ibuprofen for relief of symptoms with minimal relief.  Patient also reports diarrhea and decreased appetite.  Patient has a past medical history significant for generalized anxiety, aortic stenosis, tachycardia.   Upon arrival to ED patient's O2 saturation was 88% on room air, patient was placed on 4 L nasal cannula with resolution of hypoxia.  Chest x-ray was performed and revealed marked interval increase in bilateral pneumonia concerning for atypical infection.  Patient's vital signs were as follows temperature 102°, heart rate 116, respirations 22, blood pressure 117/77.  Patient's laboratory results were significant for ESR 32, D-dimer 0.51, CRP 15.3, chloride 96, glucose 150, creatinine 1.48, ALT 77, AST 67, lipase 92. Due to elevated D-dimer, CT angio of chest was ordered to rule out PE.   Patient was seen and examined at the bedside in ED. Patient is lying in bed in no acute distress.  Patient is currently on 4 L oxygen via nasal cannula and oxygen saturation is at 99%.  Patient continues to complain of body aches, fatigue, weakness.  Patient states he has been progressively feeling worse over the last couple of days despite taking Tylenol, ibuprofen for relief of symptoms. Patient denies any history of COPD, asthma.  Patient denies any chest pain.  Patient is being admitted for COVID pneumonia.  9/10/21: The patient, in fairly good health, tested positive for COVID-19 on 08/30/2021.  He was given a pulse oximetry for home and home treatment plan, was noted to have 88% oxygenation on room air, and presented to the hospital for admission on 09/06/2021.  He received IV CAP antibiotics, dexamethasone and remdesivir, and had gradual improvement with him able to get off oxygen.  He did oxygen walk, did not require any supplemental oxygen with oxygenation 93% during ambulation.  Blood pressure 130/80, pulse 74 and regular.  He was afebrile.  He has he had a CT scan of the chest showing no signs of pulmonary emboli.  There were tiny bilateral pleural effusions and multifocal areas suggesting COVID-19 pneumonia.  Since there has been such nice improvement, patient will go home with no new medications.  Continue his activities of daily living.  He may return to work next week for light duty and full duty on September 20th, if he continues to do well.  Otherwise, follow up with doctor next week for re-evaluation.
patient reported feeling hot, sweaty, and lightheaded a few minutes after vaccine. we administered an ice pack. she was feeling better in about 10 minutes
Very serious nasal drip and was diagnosed with sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Very serious nasal drip and was diagnosed with sinus infection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061F21A, 013M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic sinusitis, unspecified (Patient's sinus problem has been on and off for years, something chronic, but over the past months it had turned into an infection).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Very serious nasal drip and was diagnosed with sinus infection). The patient was treated with AMOXICILLIN on 03-Nov-2021 for Sinus infection, at a dose of 500 mg. At the time of the report, SINUSITIS (Very serious nasal drip and was diagnosed with sinus infection) outcome was unknown.            Concomitant medication was not provided by the reporter.  Patient went to the doctor, who prescribed Amoxicillin and Steroids (the latter never took).  Patient received the COVID booster dose on 03-Nov-2021 and on the same day patient started taking Amoxicillin. Patient had sinus problem which turned into an infection over the past months. Patient never stopped taking the antibiotic.
COOL CLAMMY, HYPERTENSIVE 180/102, SUPPORT PROVIDED, COLD WATER PROVIDED, B/P RETURNED TO 127/80 WITHIN 15 MINS.  OBSERVED FOR 30 MINUTES
Hospitalized 11/26/2021  with abnormal Chest x-ray.  2019 Novel Coronavirus RNA detected on 11/23/2021