chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2022 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included: SYNTHROID; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Negative; (18Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient was treated for COVID-19 with Paxlovid from 08Mar2023 to 13Mar2023. Then, the patient was well and tested negative for COVID. 5 days after finishing Paxlovid and 3 days after testing negative, she became sick again and tested positive for COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My husband has a pre-existing condition. He did not have a reaction to his first Pfizer vaccine. One week after receiving his second Pfizer vaccine his pain level went from relatively none to a 10/10 pain level. It slowly reduced after a few months to an 8/10 but did not resolve. Due to this reaction he has not planned to receive a booster, however he takes night classes and it was mandated or he would be dropped. At this time unless the reaction is anaphylaxis there is not medical waiver. He received his 3 rd vaccine and 1 day later he was back to a 10/10 and shaking from the pain. Roughly 3 weeks later the pain still has not resolved.
This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 03Nov2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to walnuts and pecans. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamins (one a day) (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2290) via an unspecified route of administration in the left arm on 13Oct2021 at 13:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021 at 08:00, the patient experienced burning sensations in her joints hands, wrists, ankles and knees, traveling bone pain, bones in hands and wrists hurt and electricity-like nerve zaps in muscles and joints. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 05Nov2021, the patient underwent BinaxNOW (nasal swab) test and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the events burning sensations in the joints hands, wrists, ankles and knees, traveling bone pain, bones in hands and wrists hurt and electricity-like nerve zaps in muscles and joints was not resolved at the time of this report.
On 11/16/2021, at 3:58 pm, patient's wife called to report the following: Patient had flu-like symptoms, injection site soreness and fever for 8 days following vaccine administration. Wife says  on morning of 8th day, patient woke up with complete hearing loss in left ear. Patient did nothing for weeks but decided to see a doctor after hours about hearing loss in May. Patient treated with antibiotics for an ear infection. Patient returned to the doctor in August where he was referred. Wife says tests were ran that confirmed hearing loss. The new doctor then referred him to see another doctor for more tests and an MRI. Patient in scheduled for an MRI in December of 2021.
Right foot presented with a strange numb feeling, when sock and shoe were off it felt as if I still had a tight sock on. Couldn't really feel light stimulation on foot. Within a week the sensation spread to halfway up my lower leg. Sensation lasted around 4 weeks then deminished.
Patient developed abscess on (R) thigh at injection site about 6 days after vaccine administration. Afebrile in office on 4/22/14 4 x 5 cm erythematous, fluctuant painful nodule noted.
This spontaneous report was received from a healthcare worker refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients was vaccinated with an improperly stored VARIVAX (Merck) (Lot number, expiry date, dose and route of administration were not reported). No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Redness, swollen, hardness to left deltoid, arm was also warm.  Per NP, warm compresses and cold may be alternated and Tylenol for pain.
This spontaneous report as received from a consumer refers to herself a 68 year old female patient with COPD and emphysema who on 04-DEC-2014 was vaccinated with ZOSTAVAX. Concomitant therapies included COUMADIN. The patient reported, "the day after I received ZOSTAVAX on 05-DEC-2014, the area around the injection site was pink and warm to touch. The area has since gotten larger, my arm is pink down to the elbow and there is a knot underneath. My blood pressure has gone up about 4 points and my breathing has become labored." The patient called her physician's office. The patient was treated with BENADRYL and other unspecified medication (dosages/frequencies/manufacturers unknown). The outcome of area around injection site pink and warm to touch, injection site area has gotten larger, my breathing became labored, my blood pressure has gone up about 4 points were reported as recovering/resolving. No further AE information was provided. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 09-JUN-2016, the patient was inadvertently vaccinated with expired dose of PROQUAD (lot # K025761 and expiry date: 08-JUN-2016. No adverse effect was reported. No product quality complaint (PQC) was reported from PROQUAD. Additional information has been requested.
The patient presented to the emergency department on 5/8/2021 with 2 days of chest pain.  He had ST segment elevation on ECG consistent with pericarditis.  A troponin was elevated at 9.9 ng/mL.  He was admitted to the hospital from 5/8 to 5/10 to observe on telemetry.  Echo was normal without pericardial effusion.  Troponin trended downward.  He was discharged home on naproxen and colchicine with scheduled follow up.
PATIENT HAD A LARGE, RED, SWOLLEN AREA ON HIS ARM COVERING MOST OF HIS BICEPT. TOWARD HIS ELBOW THE LESION WAS PURPLE. THE REACTION OCCURRED OVERNIGHT AND WORSENED THROUGHOUT THE DAY WHILE HE WAS AT WORK. HE STATED IT DIDN'T ITCH BUT IT WAS VERY PAINFUL. HE WENT TO URGENT CARE AT 6PM AND HAD THE REACTION ASSESSED. HE WAS TOLD TO PUT ICE ON THE AREA TONIGHT AND IF IT WASN'T BETTER TOMORROW TO START CEPHALEXIN 500 MG TWICE DAILY FOR 7 DAYS. HE IS ALSO ON BENADRYL AND TAKING A PROBIOTIC DUE TO A HISTORY OF C. DIFF FROM ANTIBIOTIC TREAMENT.
She is not feeling good again today whenever she tries to eat, couldnt keep anything down; Couldn't eat; Next day, she was very sleepy; Starting Thursday night, she was very dizzy; Disoriented; On same day, she had little pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (She is not feeling good again today whenever she tries to eat, couldnt keep anything down), FEEDING DISORDER (Couldn't eat), SOMNOLENCE (Next day, she was very sleepy), DIZZINESS (Starting Thursday night, she was very dizzy) and DISORIENTATION (Disoriented) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, CLOPIDOGREL BISULFATE (PLAVIX), INSULIN LISPRO (HUMALOG), LOSARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 03-Nov-2021, the patient experienced VACCINATION SITE PAIN (On same day, she had little pain at injection site). On 04-Nov-2021, the patient experienced SOMNOLENCE (Next day, she was very sleepy), DIZZINESS (Starting Thursday night, she was very dizzy) and DISORIENTATION (Disoriented). On 09-Nov-2021, the patient experienced GASTROINTESTINAL DISORDER (She is not feeling good again today whenever she tries to eat, couldnt keep anything down) and FEEDING DISORDER (Couldn't eat). On 07-Nov-2021, DIZZINESS (Starting Thursday night, she was very dizzy) and DISORIENTATION (Disoriented) had resolved. At the time of the report, GASTROINTESTINAL DISORDER (She is not feeling good again today whenever she tries to eat, couldnt keep anything down) and FEEDING DISORDER (Couldn't eat) had not resolved and SOMNOLENCE (Next day, she was very sleepy) and VACCINATION SITE PAIN (On same day, she had little pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: low (Low) sugar went down.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.
injection site itching; injection site rash; A spontaneous report was received from a other Health Professional who was 71-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site rash and injection site itching.  The patient's medical history included were allergic to dust, cats and contrast dye from an unknown date. Product known to have been used by the patient, within two weeks prior to the event, included was levothyroxine from an unknown date for an unknown indication.  On 15 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L207) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 21 JAN 2021, the patient developer a rash and itching in the left deltoid- injection site. Treatment information was not provided.  The Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, injection site rash and injection site itching were considered as unknown.
12/22 Telephone call to patient, relative reports generalized aches, feeling better today.
Pt received vaccine and felt light headed and dizzy immediately after. She kept nodding off. EMS was called and pt was in ER. Received fluids and was discharged.
Patient states that he felt dizzy a few minutes after receiving shots, patient denied any other symptoms, patient did not eat prior to coming in for the shot. Patient was given apple juice and animal crackers.  Vitals 1:38pm laying down      1:48 sitting                         1:54pm standing Heart Rate 51                    Heart Rate 62               Heart Rate 90 BP 121/72                           BP 125/76                      BP 110/77 Oxygen SaT 96%            Oxygen Sat 99%           Oxygen Sat 97%
Redness, swelling and a bit of pain on the injection site, 7 days after the injection, and pain by my lymph node on the side of the injection
Admission Date: 12/8/2022 Discharge Date: 12/16/2022 Positive Covid Date: 12/8/2022  PRESENTING PROBLEM: Hypoxia Anemia, unspecified type COVID COVID-19 virus infection   HOSPITAL COURSE BY PROBLEM:   COVID-19 virus infection Assessment & Plan The patient is a 82-year-old with past medical history significant for ESRD on HD( MWF), CHF, HTN,COPD, former tobacco use, paroxysmal AFib, left pleural effusion, who presents to emergency department on 12/08/2022 with a complaint of generalized malaise and fever of 1 day duration.   In the ED patient was hypoxic  with activity.  ProBNP found to be 59,999, but clinically patient appears euvolemic.  She was positive for COVID-19.  Chest x-ray showed a left pleural effusion which increased compared to previous chest x-ray in June.  Rhythm on EKG was consistent with rate controlled Afib. A dose of Decadron IV  and lasix 40mg and 250cc normal saline  were given in the emergency department and admitted to internal medicine with Nephrology on consult for dialysis.   Patient did really well and was weaned off oxygen in the 1st 24 hours.  Decadron was initially discontinued.  However had up trending inflammatory markers with worsening symptoms, so Decadron resumed with plan to complete a 10 day course.   Patient is vaccinated, with COVID-19, breakthrough infection.   She is admitted to the hospital medicine service, and responded well to dexamethasone.  She was able to wean off of room air.  She was nearly asymptomatic from a respiratory status on the day of discharge.  Had occasional cough.   Completed 8 of 10 days of dexamethasone during the hospitalization, and we elected not to continue this at discharge given she was doing so well from a pulmonary standpoint.  CRP was trending down.   Patient underwent a CT angiothorax was obtained with no PE and Doppler bilateral LE negative for DVT.   Patient doing well on room air
Information has been received from a consumer reporting on her daughter who in June 2010 was vaccinated with a dose of ROTATEQ (lot number dose and site of administration not reported) and in August 2010 was vaccinated with a dose of ROTATEQ (lot number dose and site of administration not reported). Concomitant vaccines included ACTHIB, ENGERIX-B, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid "dtap vaccine" in August 2010. In June 2010, the patient experienced diarrhea and in August 2010 the patient also experienced diarrhea. This is one of several reports received from the same source. At the time of the report, the patient outcome was unknown. Additional information has been requested.
doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported.  On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant drug details were reported. No treatment details were reported.
Arm was hurting really badly; Couldn't move it; Feels discomforted/doesn't feel good; Had a little bit of a fever; Inappropriate Dosing schedule; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting really badly), LIMB DISCOMFORT (Couldn't move it), FEELING ABNORMAL (Feels discomforted/doesn't feel good), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Dosing schedule) and PYREXIA (Had a little bit of a fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Dosing schedule). On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting really badly), LIMB DISCOMFORT (Couldn't move it) and FEELING ABNORMAL (Feels discomforted/doesn't feel good). 01-Apr-2021, the patient experienced PYREXIA (Had a little bit of a fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Dosing schedule) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was hurting really badly), LIMB DISCOMFORT (Couldn't move it), FEELING ABNORMAL (Feels discomforted/doesn't feel good) and PYREXIA (Had a little bit of a fever) outcome was unknown.            No concomitant medication was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Pain in upper left arm where vaccine was administered.  It was painful within minutes following both doses, and continues now, some 3 months out.  It's getting worse, not better.  It hurts when I raise my left arm. The pain starts when my arm gets perpendicular to my body.  I've tried stretching and other therapy, but nothing has helped.
LIGHTHEADED; SORE ARM; MUSCLE SORENESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced lightheaded. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, muscle soreness and lightheaded was not reported. This report was non-serious.
3 events: #1 ~10 days afer Gardasil injection #1 on 7/26/07,, pt awoke with nearly complete amnesia of events of the day before and confusion as to her whereabouts lasting ~ 1 hour; was somnolent , fell asleep, improved within a few hours after awakening. No history of any such episode previously. Event #2- 5 minutes after receiving Gardasil injection #2 on 9/18/07, patient became faint, diaphoretic and nearly lost consciousness. Quickly recovered. No prior history of such reaction to vaccinations. EVENT #3 - ~ 5 DAYS AFTER SECOND GARDASIL VACCINATION ON 9/18/07, PATIENT EXPERIENCED A GENERALIZED SEIZURE, NEW ONSET. FULL EVALUATION IN ER REVEALED NO OTHER ABNORMALITIES. RESULTS OF 48 HOUR AMBULATORY EEG MONITOR ARE PENDING. SHE HAS BEEN RECIEVING AED, TOPAMAX, AT LOW DOSE WITHOUT RECURRENCE OF SEIZURES.
by that afternoon my arm was bright red around the injections site..and then spread down to my elbow and width of my arm..and very very soreNEVER had such a reaction and i take the flu shot every year and had my first pneumonia shot @ 60..i used bendryl cream and cortisone cream and bio freeze and ben gay.,,wow it hurt
administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that 168 doses were administered with Lot number 048C21A. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up documents received includes insignificant information (reporter details).
Patient given siblings 0.5 ml dose of flu vaccine instead of Hib vaccine due to multiple children receiving vaccines at the same time.
minor pain in the arm; Little tired but not too tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor pain in the arm) and FATIGUE (Little tired but not too tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (minor pain in the arm) and FATIGUE (Little tired but not too tired). At the time of the report, PAIN IN EXTREMITY (minor pain in the arm) and FATIGUE (Little tired but not too tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant was not provided  Treatment was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-052007 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052007:Crosslinked with husband case
Fever or Chills  Cough  Fatigue  Headache  Congestion or running nose  Nausea or vomiting
4/28/21  second dose Pfizer administered No Issues 4/28- 5/3/21 noon 5/3/21 All muscles arms legs back locked up hard 5/4/21 most symptoms passed still had very sore calves hard to walk 5/6/21  ( 1:00 PM EDT)to now.  Massive ankle and foot swelling  came on almost instantly no warning not too painfull but i can not put shoes on.
Vaccine had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 69-year-old male patient who received HAB (Twinrix) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 6th May 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: The patient administered with Twinrix and the then noticed the vaccine had expired. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Twinrix beyond it's expiry, which led to expired vaccine used.
Inconsolable crying and general fussiness, no treatment given, lasted 4 days.