chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received ROTATEQ (lot #, expiration date and dose were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the sane reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received BNT162B2 (COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, in her left arm on 24Feb2021 12:00PM (Batch/Lot Number: EN62026/21) (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient medical history was reported as none and had no known allergies. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On the second day after the first vaccination dose (on 26Feb2021), the patient experienced pain throughout the GI system, sharp pain, swelling, gassy of course and all around feeling ill. It lasted for about 24 hours. The onset occurred on the second day after the 1st vaccine dose. No treatment was given for the events. The outcome of the events was recovered on an unknown date in Feb2021. No follow up attempts are possible. No further information is expected.
about noon on Saturday site became reddened, itchy; area 3-4 inches in diameter cont itchy 1NOV94 when reported red, warm, no swelling or "lump";
No adverse event; Bivalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patient).    Concomitant product use was not provided by the reporter.   No treatment information was provided.
I had an exposure to COVID by family member who tested positive. I then began to feel unwell on 01/23/2022 and  Tested positive for COVID 01/25/2022. My experience on the fourth day, the virus went into my chest and I had trouble breathing and coughing pretty bad. Went to see physician in parking lot and I was prescribed Z pak and prednisone. By that evening my cough was gone and my condition was improving.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 08-JUL-2014, the patient was inadvertently administered VAQTA (0.5 ml, intramuscular) (lot# and expiration date were not reported) that had been improperly stored. No adverse effects reported. Additional information has been requested.
administered dose 08Aug2022, expiration date of 07Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HAB (Twinrix adult) (batch number X239D, expiry date 7th August 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 8th August 2022, the patient received the 1st dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Twinrix adult 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: 08-AUG-2022 Reporter's comment: The pharmacist reported that a nurse had administered a dose of Twinrix and after administration, the nurse had noticed that the vaccine had an expiration date of 7th August 2022.This was the patient's first dose in the series. At the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional supportive information: The patient had received an expired dose of Twinrix, which led to expired vaccine used.
fainted; very light-headed; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153) via an unspecified route of administration at left arm on 29Apr2021 10:45 (20-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included anxiety, ADHD, and allergies to amoxicillin. Concomitant medications in two weeks included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL) and Vitamin D3. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153) via an unspecified route of administration at left arm on 07Apr2021 10:30 (20-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. The patient was very light-headed and fainted on 29Apr2021 15:45. Adverse events resulted in Emergency room/department or urgent care. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included "Ruled out heart issue, checked blood sugar level". The outcome of the events was unknown.
pt recvd vax & devel a react which resembled cellulitis; 2 out of 3 pts receiving injects from the same vial developed similar reacts;
Moderna COVID-19 Vaccine EUA  Beginning roughly 29 hours after vaccination, began feeling significant pain on left arm and shoulders (side of injection site), making it difficult to raise arm. At 36 hours, pain when laying on that side or putting pressure on it. Cold chills and elevated temperature throughout second day, culminating in low grade fever that lasted one hour.  General fatigue and dehydration throughout this period as well with periodic headaches. Symptoms mostly vanished by 48hr mark.
Around the injection site, patient's arm was hot, bright red, raised and painful. The diameter of affected arm was about 2 inches around the injection site on Saturday 12/15 and by Sunday, it spread to about 3 inches below injection site. Patient's primary care doctor treated her for cellulitis.
42 hours (Sunday, 9/25) after injection, woke-up with                worst headache of my life-got-up,                took 2 Tylenol & it subsided in 1 hour               later.  54 hours (Mon., 9/26) after injection, woke up                 with Full Facial numbness & tingling                took Advil & it subsided in 1.5 hrs
8 days p/vax pt had a prolonged apneic episode requiring resuscitation w/subsequent sz & neuro damage;
Fever, chills, body aches, headaches.  fever persistent for 2 days and headaches still having up to now.
Developed thyroid issues causing me to have hyperthyroidism, had to take medication and still not completely at stable thyroid levels off the medication.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 58 years, in right arm 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: "Obesity" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "gall stones" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid as COVID 19 Treatment from 01Apr2023 to 06Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300158076 same patient, different drug/event;
Headache, Sedation, Diarrhea, NauseaVomiting, Pain, redness, swelling, itching at the injection site Narrative:  Seems like after injection psoriasis flared.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------------  DEMAND ISCHEMIA 9/3/2022 HYPERKALEMIA  DEMAND ISCHEMIA 9/3/2022 CKD STAGE 4 (GFR 15-29)  DEMAND ISCHEMIA 9/3/2022 CHOLEDOCHOLITHIASIS
Case number PHEH2014US012397 is an initial spontaneous report from the nurse received on 13 Jun 2014, and with a follow up report received from a nurse on 18 Jun 2014. This report refers to a male patient of unknown age. He was vaccinated with MENVEO (batch number: A13012) 0.5 ml intramuscularly into right deltoid on 18 Jun 2014 at 14:00. On the same day, after vaccination he developed cellulitis at site 8 cm diameter. On 19 Jun 2014, KEFLEX 500 BID was used as treatment drug. On 21 Jun 2014, KEFLEX was changed to SEPTRA DS BID for 7 days and the event was resolving. The final outcome of the event was recovered. The seriousness and causality of the events were not reported. Follow up report received from a nurse on 18 Jun 2014. Updated patient details, vaccination date and deleted events (red, painful mass at the injections site).
patient was treated for shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 22-APR-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were unknown) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (prophylaxis).   On an unspecified date, the patient experienced shingles, which led to hospitalization. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Additional information has been requested.
Sudden body temperature drop.; Uncontrollable shaking; body felt cold; woke up groggy but ok; Dose number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 10:00 (Lot number: FH 8030 or FM) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pulmonary Fibrosis" (unspecified if ongoing), notes: Pulmonary Fibrosis; "penicillin" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Diabetes Interstitial lung disease" (unspecified if ongoing); "Diabetes Interstitial lung disease" (unspecified if ongoing); "latex" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM [DILTIAZEM HYDROCHLORIDE]; FUROSEMIDE; POTASSIUM; FLU VACCINE VII, administration date Oct2021. Past drug history included: Iodine, reaction(s): "Known Allergy: Iodine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER 8729, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 02May2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 04Apr2021, when the patient was 78 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 10:00, outcome "unknown", described as "Dose number 3"; BODY TEMPERATURE DECREASED (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "Sudden body temperature drop."; TREMOR (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "Uncontrollable shaking"; FEELING COLD (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "body felt cold"; SOMNOLENCE (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "woke up groggy but ok". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature decreased, tremor, somnolence. Therapeutic measures were taken as a result of feeling cold.  Additional information: Sudden body temperature drop. Uncontrollable shaking, body felt cold as tho suddenly in sub zero temp. Inside entire time added more clothing not enough then added heating pad direct to body and fell asleep. Woke up groggy but OK. AE resulted in: None of the above. If covid tested post vaccination: No, Location of injection for vaccine received within 4 weeks PRIOR: Flu shot - Left arm, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store, List of any other medications the patient received within 2 weeks of vaccination: Diltiazem 240mg, Furosemide 40mg, Potassium 10meq,  Follow-up attempts are completed. No further information is expected.
sixth nerve palsy to the face; face was paralyzed / drooping face; Intentional dose omission; This spontaneous case was reported by a consumer and describes the occurrence of VITH NERVE PARALYSIS (sixth nerve palsy to the face) and FACIAL PARALYSIS (face was paralyzed / drooping face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-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 VITH NERVE PARALYSIS (sixth nerve palsy to the face) (seriousness criterion medically significant), FACIAL PARALYSIS (face was paralyzed / drooping face) (seriousness criterion medically significant) and INTENTIONAL DOSE OMISSION (Intentional dose omission). At the time of the report, VITH NERVE PARALYSIS (sixth nerve palsy to the face), FACIAL PARALYSIS (face was paralyzed / drooping face) and INTENTIONAL DOSE OMISSION (Intentional dose omission) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.  It was reported that few days after the vaccination subject experienced  sixth nerve palsy on face, her face was paralyzed and face was drooping down, Subject chosen not  to get the second dose No Concomitant medicines were provided No Treatment medicines were provided.  company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Vaccines given at 2:30 PM. Mom called advised nurse at 5:20 PM stating patient had developed rash on back, which spread to abdomen and then behind ears. Described as bright pink spots. Mom states rash spread rapidly. Patient brought back to clinic for recheck. No fever or resp. symptoms. Benadryl given. Mom called next day for f/u instructions.
received lot number involved in the Recall; received lot number involved in the Recall; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   The reporter considered the recalled drug administered to be unrelated to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The pediatric office receptionist reported that between 18th July and 25th August 2021, the patient received recall Engerix-B lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. This case was 1 of 20 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224975:same reporter
I received the annual influenza inoculation in early November 2009. It was not the H1N1 vaccine. About two weeks later my feet became numb. I paid it no mind as I thought I had banged them rearranging furniture in my home. Day's later my shins became numb and I began rubbing them as I thought there was a circulation problem. My colleagues at work were keen to notice this and urged me to see my doctor. At that time I did not visit my doctor as I have always been in good health. Days later my thighs became numb and I was having difficulty walking. I made an appointment with my Primary Care physician at the clinic. The doctor wrote two scripts, which I had filled and told me: "Don't be surprised if you lose your ability to walk." I was very taken aback by this comment. A couple of days later my knees felt like they were buckling, I was falling, losing time at work, not eating and eventually became bed ridden. I lost my locomotion. The medication the doctor prescribed for me did nothing to help. I eventually phone Dr., at the clinic and spoke with him directly. During our conversation and with me describing what had and was happening to me he said he wanted to check a couple of things and he would call me back immediately. Approximately 15 minutes later I received a telephone call from a social worker at the clinic. This individual instructed me: "After this call is finished to immediately dial 911 and tell the operator you have been instructed by the clinic to get to the nearest emergency room immediately. Do you understand me?" I said: "Yes." After dialing 911 moments later two police cruiser, a fire engine and EMT ambulance were at my front door. I was carried out in a stretcher and taken to the ER, where I currently resided at that time. I was told, in the ER, that I was being admitted to the hospital immediately as of 28-NOV-2009. I lay in the ICU for one month with initial diagnosis's until I could safely be moved, where I spent the following six months. I was eventually diagnosed with the following: 1. Guillain-Barre. 2. Pneumonia. 3. Hole in my right lung. 4. Septic shock. 5. Paralyzed larynx. 6. Stroke. 7. Blood clots in both lungs and both legs. 8. Central Pontine Mylenoysis. 9. Short and long term memory loss. All of this because of a flu shot that was given to me as a benefit to keep myself healthy, my co-workers and the general public from becoming ill.
flu-like illness 8FEB99 w/cough, nasal congestion & inc temp;treated w/pseudoephedrine & APAP;
pt recv vax & devel fever, flu sx, & being sick for one wk p/vax;
At 14:45, after 20 minutes, pt's right leg was with swelling and a 4.5cm reddened area. Cool compresses were applied to the right leg. At 15:05, the reddened area was 2.5cm. Pt was observed for 1 hour, post vax, with no other symptoms of allergic reaction noted. On 8/9/01, mother reported all redness and swelling was gone.
Pt lethargic, not eating, could not hold head up, glassy eyed, very still and not smiling. Seen 8/20/12 pt had normal neurologic and physical exam.