chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner concerning a 4-years-old patient of unknown gender. The patient's historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patient was inadvertently vaccinated with a dose of PROQUAD subcutaneously, reported lot number R002932, expiry date 29-JUL-2019 (strength, dose and frequency were not reported) and VARIVAX (strength, dose, route, frequency, lot number and expiration date were not reported) both vaccines for prophylaxis. It was also reported, that the patient's sibling was vaccinated on the same date with the same vaccines (refer to case 1809USA008251). The nurse practitioner reported that it was a medication error as well as a product confusion. She stated that the PROQUAD was confused with M-M-R II, and that "the nurse who administered these vaccines did not realize the PROQUAD was not M-M-R II, as the PROQUAD also contained measles mumps and rubella". It was unspecified which dose in the measles mumps rubella and varicella vaccination series the dose of PROQUAD or VARIVAX were. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1809USA008251: Patient's sibling.
SORE ARM; This spontaneous report received from a consumer 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 and expiry date: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Some vaccine came out of the injection site post removal of the vanishing point needle which failed to retract.  Patient did not appear to have any adverse outcome related to this.
Child crying inconsolably, right thigh from thigh to knee red and swollen. Cried for 30 minutes. Afebrile.
1st event was feeling  tired 2nd event was feeling like I might be coming down with something 3rd event was chills and a fever that reached 100.3 4th event was headache
Mom says day after Flu shot child's arm had red spot & swollen size of 1/2 dollar, it spread & doubled in size & knotted lip. She took child to Dr, he told her she had an allergic reaction & had parent give BENADRYL. Symptoms went away in a few days. Mom says H1N1 vaccine 1-4-10 child was admitted with RSV hosp 3 days.
pt recv vax & devel a sore, swollen rt arm @ site of vax;mom states that swelling involves total upper arm, is swollen w/3-4" area of redness w/fever @ site;onset was approx 24hr post vax;if no improvement in 2-3 days consult MD;
Patient described having some lip tingling at 5:35.  BP taken and was 143/80 and HR was 87, O2 98%.  Patient given diphenhydramine 25mg orally x1 at 5:40pm.  Rechecked vitals at 6:00pm - HR 66, o2 99%, BP 138/80.  Patient states lips still tingly but not worse.  At 6:10 patient states still the same, but not worse.  At 6:20 patient stated still the same, but no worse.  Patient relaxed, no trouble breathing.  Patient decided to leave.  Advised to call 9-1-1 if have any trouble breathing.  Explained potential vaccine adverse effects such as fever, aches, headache, sore arm, and fatigue. Patient expressed understanding.
Immediately after receiving your vaccination, she developed an itchy rash over her left arm, which is the same side as the vaccination. She was given Allegra 100 mg oral x 1.  Heart rate was initially in the 130s, but  no hypotension. Lungs were CTAB.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bmi>30" (unspecified if ongoing), notes: Bmi>30. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022 at 11:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) > 30; SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Treatment of COVID-19; (unspecified date) Negative; (12Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had symptoms while having negative test results then tested positive again many days after ending treatment. Patient did not received any other vaccine in two weeks.Device times tamp: 13Jul2022. No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01/03/2022:  55-year-old gentleman with history of MRSA cellulitis and reported Fournier's gangrene presents emergency department for evaluation of groin abscess. His symptoms worsened he had swelling in his scrotum yesterday.  This was associated with chills.  Patient denies any fevers, decreased oral intake. Patient denies:  vomiting, Diarrhea, fever, urinary symptoms, blurred vision, sore throat, back pain, palpitations, dizziness, shortness of breath, rash.
Sudden acute vertigo presumably triggered by vestibular neuritis.  Symptoms include nystagmus, dizziness, nausea and loss of balance.  Symptoms are slowly subsiding at day 4.
Felt tight around right shoulder joint centered on 1st injection site; Right side of body didn't work correctly. Right leg and arm felt odd, muted sensation in right arm and leg not numb, tingling or pins and needles feeling; Lack of fine motor control in right fingers; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8727) via an unspecified route of administration in the arm left on 30Mar2021 at 12:00(at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included  borderline diabetes and body mass index (30BMI). Patient had no allergies to food, medications or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN), ascorbic acid, copper gluconate, zinc oxide, tocopheryl acid succinate, xantofyl, zeaxanthin (AREDS 2 VISUAL ADVANTAGE), cetirizine hydrochloride (ZYRTEC), cannabidiol (CBD OIL) and glucosamine (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6205) via an unspecified route of administration in the arm right on 09Mar2021 at 12:00(at the age of 61-year-old) as a single dose for COVID-19 immunisation Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 07:00 the patient experienced lack of fine motor control in right fingers and right leg and arm felt odd, muted sensation in right arm and left; not numb, tingling or pins and needles feeling. On 06Apr2021 the patient experienced tight around right should joint. He woke up 2nd day after the second dose, the right side of his body didn't work correctly. Lack of fine motor control in right fingers which got better during the day, almost 100% . He called  and doctor said  he has heard several cases like this and prescribed anti-inflammatory medications. Symptoms lessened each day and by 06Apr2021 he was  walking normally, right fingers regaining fine motor control but feel tight around right shoulder joint centered on 1st injection site. The event lack of motor control and tingling resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tingling and lack of motor control and included treatment with (SULINDAC) 200mg twice daily. The clinical outcome of the event lack of motor control, tingling and feel tight around right shoulder was recovering.   No follow-up attempts are needed. No further information is expected.
Tunnel Vision; Pain behind eyes; blurry vision; black vision; nausea; sweating; headache; dizziness; dry heaving; vomitting; shakiness; chills; metallic taste in mouth; This is a spontaneous report from a contactable other hcp (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 03Oct2021 11:00 (Batch/Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Non-alcoholic fatty liver disease, gallbladder removed from 2011, covid, and known allergies: penicillin and codeine. Patient is non-pregnant at time of vaccination. There were no concomitant medications. The patient experienced tunnel vision, pain behind eyes, blurry vision, black vision, nausea, sweating, headache, dizziness, dry heaving, vomitting, shakiness, chills, and metallic taste in mouth and all on 04Oct2021 06:30 with outcome of not recovered. Events resulted in Emergency room/department or urgent care. Treatment was received for all events. Sedated at ER with medication for optical migraine. No COVID tested post vaccination.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported event Tunnel vision cannot be completely excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Rebound or may have caught covid again; Rebound or may have caught covid again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 at 12:00 as dose 1, single (Lot number: ER2613) and on 15Apr2021 at 12:00 as dose 2, single (Lot number: ER8729) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Nov2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 20May2022 at 18:00, outcome "recovering" and all described as "Rebound or may have caught covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Information: Patient had no other medications in two weeks. Treatment was started on 05May2022 and was stopped on 09May2022 for Covid-19. Rebound or may have caught covid again. No Known allergies. No Other medical history was reported.  No follow-up attempts are possible. No further information is expected.
Post vax, the vaccinee developed amyotrophic lateral sclerosis. The vaccinee had extensive evaluation by neurologist. The vaccinee is experiencing a progressive decline.
PATIENT FAINTED. WAS SEEN BY PHYSICIAN AFTER FAINTING EPISODE. QUICKLY REGAINED CONSCIOUSNESS AND WAS BACK TO HIS NORMAL SELF WITHIN A FEW MINUTES. BP WAS 100/70 AND WAS OKAY TO BE DISCHARGED HOME.
Received 2nd Pfizer shot 2/25/2021.  To stave off side effects, I took 2 Ibuprofen before bed. In the morning, I was more wobbly than usual, but could make it to the bathroom and return to bed. A couple of hours later I had chills, bladder was not functioning well. I could not walk or stand and, could barely maneuver in bed. Went to hospital by ambulance, where I was given 125 MG of IV Solumedrol intravenously. Less than an hour later, I could walk and leave the hospital using my quad cane and the arm of a loved one. I continued to improve and am currently at the condition I was in before the 2nd vaccine injection . Walking was impaired after the first injection two weeks prior, but I was not forced to call an ambulance for help.
Patient 5 years old came for his first dose of covid pfizer vaccine. After administration by technician, technician alerted me patient looked pale and comotose. I assed the patient immediately and notice cyanotic lips and very comotose presentation in his eyesight. I asked the mother if he had any medical conditions like type 1 diabetes and she indicated patient is a healthy individual. I recommended to call 911 and she accepted. During this time, I advised member of management and had one of my technicians and I looking at patient and not losing vision of him. Ambulance came and parents did not want to take him indicating he was fine after we let him lick lolipop and wet his lips with water. Paramedics alerted parents that they should take child to er and eventually they agreed. The parents appreciated our fast response and took off to the er.
The patient states that this morning she had sudden onset of severe, stabbing, nonradiating left chest pain that is worse with deep breathing and movement. She's never had pain like this before. She took ibuprofen at home without any improvement. Patient had her shingles shot 2 days ago and yesterday was feeling very poorly with chills and myalgias. She has not had any shortness of breath, cough, congestion, vomiting or new diarrhea. Patient has colitis and has problems with chronic diarrhea. She has not had any problems with eating and drinking and denies nausea. No current fever. Patient states the pain is significantly better when she sits up or leans forward and becomes unbearable when she lies down. No known cardiac history. No trauma.   Final Diagnosis: acute pericarditis
Four days after receiving flu shot, Ms Katz noticed that she was having difficulty raising her left arm. She reported this to me on 11/21/01. She had no visible signs of redness or swelling and ROM was WNL. Seen by dr on 11/27/01. No signs of infection. No treatment. On 01/29/01, arm was "much better".
MILD REACTION TO VACCINE; This spontaneous report received from a patient concerned a female 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced mild reaction to vaccine. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) antibodies from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild reaction to vaccine. This report was non-serious.
Received shot 1 of Pfizer (Covid). Ten days later developed severe cough, shortness of breath, severe fatigue malaise, loss of appetite Primary MD prescribed 40 mg po decadron daily for 2 weeks and refills on inhaler. Recovered at home successfully. Many periods of dyspnea on exertion and rest. Generally felt terrible. No one else in household developed symptoms. Duration of illness approximately 10 days. I still have dyspnea with rigorous exercise and am working on lung function. I am a runner Before this event, 3 to 5 miles each day. Since recovering 3 miles 4 to 5 days a week is all I can tolerate.
Nauseous; lethargic; tired; sore arm; feel out of it; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 26Mar2021 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was allergic to sulfur. Concomitant medication included magnesium (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN), ester C (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) for unspecified indications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 09:00, the patient experienced tiredness, lethargic, nauseous, sore arm/pain in arm, feel out of it/confusion state. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of tiredness, lethargic, nauseous, sore arm and feel out of it/confusion state was not recovered at this time of report.     Information about lot number cannot be obtained. No further information is expected.
large area erythema, pain, 2cm area of induration persisting 2 weeks later Sx came on within 24hrs.
possible diagnosis of lung cancer or walking pneumonia; possible diagnosis of lung cancer or walking pneumonia; she had a high temperature; This is a follow up spontaneous report. This is a report from a contactable consumer (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, on 18Feb2021 via unspecified route as a single dose for COVID-19 immunization.  Relevant history and concomitant medications were not reported.  Following first dose and on an unspecified date the patient got a possible diagnosis of lung cancer or walking pneumonia. Her doctor advised her to cancel her appointment for her second dose and reschedule it for later, she had a high temperature and she missed her 2nd dose of the vaccine. She wants to reschedule the 2nd dose of her vaccine.  Patient declined to confirm contact information or provide address, or email and wanted to only reschedule her second appointment.  Outcome of event possible diagnosis of lung cancer or walking pneumonia and high temperature was unknown.    Information about lot/batch number has been requested.
pt recvd 3rd dose or Recombivax & exp tenderness in the joints of rt hand; exp stiffness in joints-legs, arms, shoulders; seen by MD, who prescribed Feldane; tested pos for rheumatic fever;
Pfizer vaccine was administered outside of Facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------------- G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 11/15/2022 PANCREATIC MASS G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT 12/14/2022 PANCREATIC MASS I95.9 HYPOTENSION 10/10/2022 PANCREATIC MASS R57.9 SHOCK, UNSPECIFIED 1/13/2023 PANCREATIC MASS G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 11/15/2022 PANCREATIC CANCER, UNSPECIFIED SITE G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT 12/14/2022 PANCREATIC CANCER, UNSPECIFIED SITE I95.9 HYPOTENSION 10/10/2022 PANCREATIC CANCER, UNSPECIFIED SITE R57.9 SHOCK, UNSPECIFIED 1/13/2023 PANCREATIC CANCER, UNSPECIFIED SITE G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 11/15/2022 HEMATEMESIS G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT 12/14/2022 HEMATEMESIS I95.9 HYPOTENSION 10/10/2022 HEMATEMESIS R57.9 SHOCK, UNSPECIFIED 1/13/2023 HEMATEMESIS
Chills, shakes, 99.8 fever. Slept almost 24 hours. No specific treatment.
Fever over 103 continuing at present Extreme muscle pain and weakness over entire body Chills and confusion Bedridden
hair fall; little body aches; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair fall) and PAIN IN EXTREMITY (little body aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 042B212A) for COVID-19 vaccination.     No concomitant medication reported.  Concurrent medical conditions included Hypertension and Cholesterol.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient experienced ALOPECIA (hair fall) and PAIN IN EXTREMITY (little body aches). At the time of the report, ALOPECIA (hair fall) and PAIN IN EXTREMITY (little body aches) outcome was unknown.
Severe skin rash outbreak on right forearm, spreading and worsening, additional spots followed on subsequent days on left forearm, spreading to both biceps. Abdominal spots also appeared.
plaintiff alleges that as a result of vax 23OCT90, pt was hospitalized on 3NOV90 w/dx of post vaccination focal encephalitis @ time of litigation OCT92; reportedly has permanent brain damage w/severe vision problems;
Got shot on Tuesday, Friday develop reaction neck stiffness, airway closing, throat swelling, could not swallow saliva. Was seen Saturday (ER visit) sent home. Hospitalized x 1 day (Monday).
After reviewing her paperwork, my intern administered patient's COVID booster first in her left arm followed by her flu shot in her right arm during which time patient mentioned that she gets nervous during shots.  After administering her flu shot, Patient passed out and slumped to the left and and my inter caught her but she bumped her head on a portable table we had set up for vaccinations.  At this time I came back and she came around and started to talk to us and we put her feet up.  However, she proceeded to loose consciousness again.  With this loss she had dilated pupils, rapid eye movements and rapid mouth movements.  It also took her more than 5 minutes to come out of it so we called EMS.  She came to while they were on  their way but EMS determined that her blood pressure was still low at 90/65 so transported her to the hospital for fluids and monitoring.
Patient experienced syncope and collapsed. He regained consciousness within 15 seconds. He was stable and received chocolate and water.
Onset 28OCT91, fever 103, cough, copious sputum, anorexia, pneumonia;
Patient reported to pharmacy on 1/2/21 with chief complain of hives and itching on both arms and trunk that he noticed the day following vaccination.  He also c/o itching.  No difficulty breathing, swelling in mouth or throat.  No wheezing.   Patient reports that rash appears to be staying consistent, not getting worse or better over time.  Patient has attempted no self treatment at home.  Patient reports he has signs of a possible contact dermatitis that he has a dermatologist appointment scheduled for in the coming week.   Advised patient to use hydrocortisone cream for topical relief of itching as well as oral benadryl for systematic relief in the event the patient is experiencing.  Addtionally, advised patient to seek emergency medical attention if symptoms worsen or if there is signs of swelling in the mouth or throat or difficult breathing.  Patient verbalized understanding.