chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 52 year old female admitted on 12/6/2021. She presented to the emergency room with concerns of fever and possible hypoxemia.  Patient has cerebral palsy with spastic quadriplegia.  Concern for the facility is a possible Covid and she was initially noted to be hypoxemic later not requiring oxygen.  Patient is immunized and did test positive for Covid in the ED.  Lung imaging demonstrated no active pulmonary process but there was noted a large left ureteral stone in the calyx with hydronephrosis.  Urine was abnormal with lab work showing a normal lactate, mildly elevated white count with urine grossly abnormal with large LETand greater than 182 white cells.  Patient clinically meets the criteria for sepsis.  With a diagnosis of an infected obstructing stone with sepsis, patient was transferred from hospital where they had no beds to our hospital.  Urology, Dr. has been alerted and is planning stent placement later today.  Currently being treated with broad-spectrum antibiotics, Rocephin, fluids.  Patient is n.p.o. and is medically cleared for surgery and anesthesia when able.
chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient).  A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization.  Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil.  The patient previously took clindamycin and methimazole and experienced drug allergy.  On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative   on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020.  No treatment received for the adverse events.  The outcome of the events was resolved on an unspecified date.
Patient was unaware of timing of first COVID-19 dose and signed up to take her second dose for the COVID-19 Moderna vaccine. After the patient was adminsitered the vaccine, it was noted the patient's first dose was on 3/11/2021 and received her second dose that day on 3/31/2021. This means her COVID-19 vaccine was administered 8 days earlier than it should have been.
I have been extremely itchy all day.  It hasn?t been around the injection site. I had hives for about an hour then they went away but the itching stayed. I had it on my head, stomach, chest, wrists, neck, feet and back. I spoke with a pharmacist and took Benadryl and it helped.
Headache on the right side of the head, tingling on the right side of the face, facial paralysis, loss of sense of taste,
A serious post-marketed study report of severe dehydration with anion gap metabolic acidosis and pneumonia was received from a physician concerning a four-year-old male subject.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The subject has a past medical history significant for congenital glaucoma, cataracts of both eyes, and adrenal insufficiency at nine months of age to exogenous steroid administration for management of glaucoma.  Past medical history is significant for four prior hospitalizations for similar symptoms described below.  Exposure history is significant that the subject attends daycare with exposure to other ill children.  Also subject's mother and 18-month-old brother both had a recent upper respiratory tract illness.  There was no information on concomitant medications.  The subject received FluMist on 29-Nov-2007.  On 10-Dec-2007, the subject developed cough, congestion, and runny nose with occasional emesis and shortness of breath.  On 22-Dec-2007, the subject had increased non-bilious and non-bloody emesis, diarrhea, and fever.  The subject was seen at the urgent care clinic on 24-Dec-2007 and was diagnosed with right middle lobe pneumonia and started on Azithromycin.  Because of continued symptoms with fever and decreased oral intake and urine output, the subject was reevaluated in the emergency room on 25-Dec-2007.  Physical exam was notable for dry mucous membranes and capillary refill of two-three seconds.  His breath sounds were clear without rales, wheeze or decreased breath sounds.  Chest X-ray was consistent with right middle lobe atelectasis versus pneumonia.  His white blood cell count was 13.8 with 76 percent neutrophils.  The subject had a significant anion gap (metabolic acidosis), and negative rapid tests for RSV, influenza, and rotavirus.  The subject received normal saline bolus, a dose of Rocephin, and was admitted for intravenous hydration and observation.  The subject had an unremarkable hospital course, was able to tolerate food without emesis or diarrhea, and was discharged the following day, 26-Dec-2007.  The subject was discharged on Azithromycin and topical drugs for his glaucoma.  The discharge diagnoses were severe dehydration with anion gap metabolic acidosis, and pneumonia.  No further details of the outcome for the events were provided by the reporter.  Rechallenge is not applicable to this adverse event.  The reporting physician assessed the events as not related to FluMist.
This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2, via an unspecified route of administration, administered in Arm Right on 21Apr2021 (Lot Number: EN6204) as DOSE 1, SINGLE at the age of 44 years old for COVID-19 immunization. Medical history included iodine dye sea salt allergy from an unknown date. Concomitant medications included testosterone taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient has not been COVID-19 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 21Apr2021, the patient experienced having blood pressure stayed about 161/110 for 4 days until given steroid shot. Sea salt allergy went from mild to anaphylaxis in 2021. Trip to ER on 29May2021. Two trips to ER in June with abnormal heart beat and breathing issues in 2021. Now having diabetes issues in 2021. Doctors are puzzled that it all started with first Pfizer shot. No blood pressure issue at that time. Blood pressure randomly goes high and pulse will drop as low as 36 bpm in 2021. The events resulted in doctor or other healthcare professional office/clinic visit; and emergency room/department or urgent care. The outcome of the events was not recovered. No treatment given to the patient for the events.
rash - scattered papules -> Probable chickenpox *Child rec'd 2 doses of VARIVAX dose #1 age 12 mos. dose #2 age 6 yr.
05/15/2021 woke up and lost partial vision in the right eye and it happen overnight. Went to the 05/15/2021 optometrist diagnosed incorrectly to macular degeneration to the Retina specialist the following week on 05/18/2021, diagnosis with stroke and sent to ER for the stroke protocol. Treated her in the ER and sent her home on Aspirin and Plavix. Gave her the Plavix at the hospital. 05/19/2021 went to local ER since she was having blurry. l retinal artery and loss vision in her Eye. Neurologist, hematologist, cardiologist and Retina specialists (Privacy) stroke the Antiphospholipid antibodies IGM that was produced and possible involvement involvement. Eye is improving but loss some of the vision and body is improving.
Couldn't sleep night after shot, chills, body aches, light fever symptoms throughout the day, upper arm ache (minor)
Pt received the vaccine on 8/27/04 and was seen for followup on 8/29/04. The patient reported with a hard, hot swollen, induration measuring 4x2 3/4 inches. The injection was administered to the left thigh. Pt was given Benadryl 25mg to be taken every 6-8 hours if needed. Parents were told that if the area became squishy to call the clinic. And that precautions would be used for the next Tetanus booster.
Vasovagal syncope event 18 hrs post injection.   Severe headache Muscle pain and weakness Slight swelling in injected arm and hand
Shoulder pain and arm weakness, treatment at urgent care clinic 11/11/2008?  Included NSAIDs and oral corticosteroid medication per patient. Stated physician recommend MRI if not improved by 11/18/2008.
The patient presented with a script for MMR and chicken pox vaccines from her provider. She had been informed on the phone that we stocked them both. When she arrived, she was told that we did not have them both, but that we stocked a combo vaccine that would cover both vaccines. I was not the pharmacist who communicated with the patient or the provider. After administering the vaccine to the patient, I realized when completing the paperwork that the vaccine that I had just given came from an expired lot.
itchiness at the injection site followed by swelling/welts one week after the injection; 3 days after the injection, the right side of my right breast was sore.
feel terrible/ feel like I can hardly go; headache; legs are achy; feel like I can hardly go; This case was reported by a consumer and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st July 2020, the patient received the 2nd dose of Shingles vaccine. In July 2020, less than a week after receiving Shingles vaccine, the patient experienced feeling bad, headache, leg pain and mobility decreased. On an unknown date, the outcome of the feeling bad, headache, leg pain and mobility decreased were unknown.   It was unknown if the reporter considered the feeling bad, headache, leg pain and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got second shingles shot yesterday, and patient was felt terrible,  legs were achy and headache. The patient felt like she could hardly go.  The patient had asked anybody else had any problems with it? The patient asked her if it was Shingrix, but the patient was not sure.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid administered from 19Sep2023 to 24Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162 vaccines in this patient cannot be completely excluded.
DIARRHEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
Information has been received from a health professional concerning a male pt who was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt experienced a mild breakthrough of chickenpox, characterized by about 20 lesions. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Red blotch on  left arm , 9 days after vaccine given.  Tenderness, itching, swelling, warm to the touch.  These symptoms were not consistent varied from day to day.
Experienced delayed-injection site reaction characterized by redness, hardness, and tenderness exactly 7 days after receiving the Moderna Covid 19 vaccine.
Fever 102F, vomiting, diarrhea, couching, whole body chills and body aches.
Rash over entire body but severe  primarily on hands, legs and buttock.  Several days before rash, extreme tiredness,   As rash appeared two days of fever going as high as 102.  Several doctors visits to diagnose rash.   Biopsy done.   Oral Prednisone and prescription strength cortisone cream.
Pt received vaccine at 1210.  At 1220 said her throat was feeling a little scratchy.  She stated that it just felt like she "needed to clear her throat".  NP was called to assist, evaluated and epinephrine 0.3ml IM was given.  Benadryl 50mg and Zantac 40 mg was also given po.  Pt was monitored, 9-1-1 was called and arrived in 10 minutes.  Pt was sitting up, stating that it just "feels like my throat is thick".  After EMS arrived and assessed pt, she began to ease her anxiety and stated she was feeling less tightness and felt better.  Pt was observed, VSS.  She denied going to the hospital stating she was feeling better so called for a ride home.  EMS left and within 10 minutes she began to feel a tightening sensation in her upper chest, not in her throat this time.  She said she felt the tightness again and the back of her throat was scratchy.  NP evaluated, Epi 0.3ml IM was given again and 9-1-1 was called again.  Upon arrival her vitals were stable, although tachycardic running 100-120 after the epi, but her breathing was not labored or difficult. EMS loaded pt and took to hospital for evaluation where she was monitored, received IV steroids for edema in the back of throat and uvula.
Fatigue; Veryigo; Dizziness Having hartime to moving around; easy to fall down; loss of energie and concentration problem   Hello, Please see attachment per requested. If any question regarding of his report, please contact patient at email or number listed.
Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil (Lot# not provided). It was reported that the patient fainted at the check out. The patient was treated with smelling salts of ammonia and drank a Mountain Dew soda. Her parents picked her up at the physicians office. Subsequently, the patient recovered. Additional information has been requested.
body is full of bumps; eyes get swelled up; hives; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received bnt162b2 (Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 16Apr2021 16:00 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Since the day he received first dose of Pfizer's vaccine, his body was full of bumps and eyes get swelled up, before this he did not have any type of allergy, now wake up every day full of hives on 16Apr2021. The event required to emergency room visit. Treatment was not received for events. The outcome of events was unknown.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
About 15 min post vaccination patient reported feeling tingling sensation, confusion, and swelling in throat.  Paramedics were called and arrived in less than 5 min. Patient was observed for about 15-20 min before paramedics released patient. She was told to take benadryl and continue to monitor symptoms.
Patient is oriented to person and place; but not to time. He is febrile here at 39.6 degrees Celsius. The patient has a difficult time participating in history but endorses a cough, shortness of breath, diarrhea and fever that all began within the past day. 3rd vaccine 09/28/2021.
Nausea, chest pain, numbness in arm, vomiting and diarrhea.
Had extreme joint pain; Had extreme muscle pain; I was unable to get out of bed or dress myself; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 09:00 (Lot number: FC3181) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Controlled high blood pressure" (unspecified if ongoing), notes: Verbatim: Controlled high blood pressure; "GERD" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; PANTOPRAZOLE; VITAMIN D3; ZINC. The following information was reported: ARTHRALGIA (non-serious) with onset 23Aug2021 01:00, outcome "recovering", described as "Had extreme joint pain"; MYALGIA (non-serious) with onset 23Aug2021 01:00, outcome "recovering", described as "Had extreme muscle pain"; BEDRIDDEN (non-serious) with onset 23Aug2021 01:00, outcome "recovering", described as "I was unable to get out of bed or dress myself". The events "had extreme joint pain", "had extreme muscle pain" and "i was unable to get out of bed or dress myself" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, myalgia, bedridden.  Additional Information: Three days after first dose Patient had extreme joint and muscle pain. Patient was unable to get out of bed or dress herself. The symptoms gradually got somewhat better over three weeks and then Patient had  2nd dose of vaccine. Following this dose Patient was unable to walk without assistance and had extreme full body muscle and joint pain. Patient was formerly very active, teaching martial arts and personal training. Within three days Patient was reduced to showering and dressing with aid from her spouse. Patient had numerous Dr. appointments, tests and scans and it was concluded that Patient had severe reactive arthritis from the Covid-19 vaccination. This has dramatically affected Patients life in many aspects. Patient have had to be placed on high dose steroids and other medications. The inflammation was so bad in Patients hands and wrists that Patient had to have double carpal tunnel surgery. Patient have been in constant pain for 5 months.  No follow-up attempts are possible. No further information is expected.
rt deltoid became red Friday evening Saturday 17OCT98, arm worse, T103.6 ear;seen by MD 19OCT98 w/6" long x 3 1/2" wide are of cellulitis @ inj site;med given;2NOV98 had croupy cough & fever seen MD dx pneumonia placed on cefzil;
HIVES 8/21/16 IN THE EVENING, STILL PRESENT MONDAY AND PT REPORTED SHORTNESS OF BREATH, SEEN OUT OUTSIDE ER 8/22/16, GIVEN PREDNISONE INJECTION AND ORAL PREDNISONE, WHICH HELPED, HIVES LASTED 2 DAYS AND THEN RESOLVED.
Pt developed a swollen, indurated area over left thigh at injection site 4 X 4 cm and a blotchy red rash on trunk. Pt was treated with Benadryl.
patient felt dizzy, hot, clammy, nauseous, shaky. she did end up vomiting a few minutes after feeling symptoms.
No patients experienced symptoms.; Impropertly stored doses of varivax were administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 01-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX), subcutaneous (dose and frequency were not provided; Lot number reported as S032357 has been verified to be valid; expiration date reported and validated as 14-OCT-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).    The vaccine underwent a temperature excursion of -17.2 Fahrenheit for a period of 14 hours and 2 minutes. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The nurse reported that the patient did not experience any adverse event.   This is one of several reports received from the same source; Sender's Comments:  US-009507513-2006USA001819: US-009507513-2006USA001817: US-009507513-2006USA001816: US-009507513-2006USA001815: US-009507513-2006USA001818:
Vertigo started on April 20th; Tinnitus started on April 18th; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 15Apr2021 at 20:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, sulfonamide allergy to sulfa drugs and seasonal allergy.  Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included loratadine (CLARITIN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 14:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 13:15, the patient experienced tinnitus and vertigo started on 20Apr2021.  Therapeutic measures were taken as a result of events and included treatment with unspecified exams and prescription for meclizine. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in emergency room/department or urgent care. The clinical outcome of the events tinnitus started on 18Apr2021 and vertigo started on 20Apr2021 were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.