chrisvoncsefalvay/vaers-outcomes huggingface dataset:
complete swelling of the arm at the injection site; complete swelling of the arm at the injection site and cellulitis; This spontaneous report was received from a 70 year old female patient, reporting on herself. The patient's medical history included injections site swelling and injection site cellulitis with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVENAR). The patient's historical vaccines included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVENAR). The patient's historical drugs included thimerosal. The patient's concurrent conditions included thimerosal allergy. The patient's concomitant therapies included  venlafaxine hydrochloride, gabapentin, levothyroxine sodium, rosuvastatin and famotidine.  On 23-NOV-2020, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, for pneumococcal disease(strength, dose, route, frequency, lot# and expiration date were not reported).  On the same date (reported as "less than 3 hours after administration"), the patient experienced complete swelling of the arm and cellulitis at the injection site (injection site swelling and injection site cellulitis). The patient sought medical attention and visited her doctor after the reaction and was administered a 7 days high dose series of antibiotics for relief.   The outcome of injection site swelling and injection site cellulitis was reported as resolved on an unknown date in 2020.  Additionally, the causality assessment between injection site swelling and injection site cellulitis with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Pt found in crib unresponsive and cyanotic baby. CPR started by EMS and transported to local hospital. Pt stayed in asystole even after 3 epi doses and 2 atropine CPR. Pronounced DOA at ER and medical examiners office notified and body transferred.
Woken up around 2am the following day by arm pain at injection site, Arm was very sore and involved all the upper arm at the shoulder. Treated with Ice pack and acetaminophen so I could sleep. At 7am the same morning, arm was still very sore, slightly swollen and hot to the touch. Also experienced body aches and high  fatigue. Ended up resting and napping for the balance of the day . Today 4/11 only have a slightly sore arm at injection site and no fatigue or body aches.
Experiencing moderate fatigue; This is a spontaneous report based on information received by Pfizer (Pfizer colleague). A contactable consumer reported that a patient of an unspecified Gender and age received second dose BNT162b2 (Comirnaty, Formulation: Solution for injection), via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. The patient medical history and Concomitant medication were not reported. Historical vaccine included BNT162b2 (Comirnaty) for Covid-19 immunisation. On an unspecified date, patient reported that they were experiencing moderate fatigue (tiredness) after their 2nd COVID vaccination (Pfizer/BioNTech). Outcome for event was unknown.  Information about lot/ batch number has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient reports itching/hives hives starting on trunk and abdomen that spread to limbs the day after vaccination. Denied respiratory symptoms, swelling, vocal changes, vomiting, diarrhea, vocal changes, and palpitations. Symptoms resolved with home care, including diphenhydramine, within 36 hours of onset.
Pt received Varivax. Pt began wheezing <5 minutes retraction (severe), urticaria followed <15 min. Pt received racimicepl and 6 mg IM Decadron x 1. Pt improved. Placed in hosp for observation. Placed on cont pulmox, Benadryl, Zantac.  05/01/2007 MR received for o/n hospital stay 4/12-13/07 for bronchospasm and urticaria 10 minutes after Varivax imm. despite pre-med with Benadryl. Began wheezing with retractions. Txd in office with Decadron IM and epi via inhalation.  O2 sats remained 94% on RA. Admitted for observation a D/Cd the following am. DX; Allergic reaction to immunization.
Patient is a previously healthy child without known chronic medical conditions and is full-immunized. He received his first Pfizer COVID vaccine on 7/9 which he tolerated well with the exception of a sore arm. He received his second Pfizer COVID vaccine on Friday, 7/30. He endorses a headache and arm soreness that day but otherwise felt well. Saturday (7/31) he was in his usual state of health until that night when he woke up with central chest pain that was worse with laying down. The pain was not worse with deep breathing, coughing, or other activities. Sunday morning the pain improved slightly but was still there. Sunday night to Monday morning the pain significantly worsened and parents took him to a clinic for evaluation. Dad reports that while they were checking in, patient was very short of breath and significantly fatigued. Denies fevers, chills, myalgias, abdominal pain, n/v, diarrhea, sore throat, rashes.   Chest x-ray at an outside clinic was normal and EKG showed diffuse ST elevation, concerning for pericarditis, , possibly postvaccination. Dad reports that the clinic arranged for patient to be directly admitted to hospital for further evaluation. Following the clinic visit and prior to arriving at hospital, his pain did improve slightly as did his SOB. Upon arrival to hospital, he was hemodynamically stable. Labs were notable for a troponin 9.24 and BNP 26. Viral respiratory panel was obtained and negative. CRP slightly elevated at 2.5. and a normal ESR at 2 CBC had a WBC 7l.2 without evidence of a shift, Hgb 16.4, platelets 277, ANC 4. Electrolytes were appropriate and creatinine was 0.81. LFTs were notable for a normal alk phos 197, slightly elevated AST at 61, and normal ALT 28. Since admission patient reports that his chest pain has resolved and that his energy has returned. His troponin continues to be elevated but is downtrending (6.56 this morning). He has been afebrile and his blood culture is currently no growth.   The week prior to his admission, patient denies any diarrhea, nasal congestion, cold symptoms, or recently illnesses. His Dad does endorse having a cold over the past week with nasal congestion and a mild sore throat. Please see below for full exposure history but largely, exposure history is benign with no recent travel, no significant bug bites or concern for rickettsial diseases, and low risk for Salmonella or other bacterial infections.
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT PRODUCT ADMINISTRATION DURATION (scheduled to receive 2nd dose of the moderna vaccine 50 days instead of 21-42 day after 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INCORRECT PRODUCT ADMINISTRATION DURATION (scheduled to receive 2nd dose of the moderna vaccine 50 days instead of 21-42 day after 1st dose). At the time of the report, INCORRECT PRODUCT ADMINISTRATION DURATION (scheduled to receive 2nd dose of the moderna vaccine 50 days instead of 21-42 day after 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the first dose of Moderna covid-19 vaccine on 20-Jan-2021 and reported that she is scheduled on 11-Mar-2021 to receive the second dose which is a 50 days instead of 21-42 days. Patient stated that she hadn't scheduled yet.  No concomitant medications were reported.  No treatment information was reported
Cognitive disorientation, hand paralysis, confusion, slurred speech, major stroke in right hemisphere frontal cortex
patient received a dose of YF-VAX via intramuscular route/no AE; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA233343, 2019SA233344 and 2019SA233337 (same reporter).  This case involves an 16 years old patient (gender not reported) who a received a 0.5 mL dose of YELLOW FEVER VACCINE - US [YF-VAX] (LOT UI933AA, and expiry date not reported) via intramuscular route in the left deltoid on 13-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate route of vaccination as patient received a dose of YF-VAX via intramuscular route.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
2 days post vacc, the left thigh was red, warm.  Pt brought to clinic. Day 3 - thigh red and blue in color 10 x 12cm area - indurated, slightly painful.
HOSPITAL COURSE: The patient was a 77 yr/o-year-old male  with a history of  CKD, COPD and OSA who presented to hospital 10/20/21 with cough, fatigue, and overall decline. Labs showed WBC 11.3; Hg 7.1; BUN/Cr 71/5.03, eGFR 11; COVID negative. Chest xray showed cardiomegaly and multifocal airspace disease bilaterally. He was treated for volume overload and was initiated on hemodialysis. His hospital course was further complicated by acute cardiopulmonary arrest requiring ACLS with ROSC after 6 minutes. He was intubated as part of post-arrest care. He was extubated 10/28/21 but failed to improve. His family ultimately opted for comfort-focused care. He was transferred to the Inpatient Care Center for continued care.   Upon admission to the Hospital the pt had a PPS of 10% and prognosis judged to be limited to hours to days.  Parenteral medications including fentanyl were ordered for comfort.  The interdisciplinary team provided ongoing pt and family support.  The pt continued to decline and died on 11/1/21 @ 12:33.
Onset w/cough & sneezing; t101 x 2 days; Seen by MD who prescribed meds;
Shingles; I had a small rash or irritation inside right armpit.; Achy; Fatigued; Migraine like symptoms; Became more painful; Condition worsened; Still not up to working or physical activity; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0150, patient was 55-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 04Apr2021 at 09:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included degenerated discs L4-L5, L5-S-1, neuropathy (feet), anxiety, depression, Benign prostatic hyperplasia, high cholesterol, Known allergies: penicillin. Concomitant medication(s) included alfuzosin (ALFUZOSIN); atorvastatin (ATORVASTATIN); bupropion (BUPROPION); clomiphene citrate (CLOMIPHENE CITRATE) all were taken for an unspecified indication in two weeks of vaccination, start and stop date were not reported. The patient previously took amoxicillin and experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 04Apr2021 at 09:30 as DOSE 1, SINGLE for covid-19 immunisation and experienced pain and fatigue. No other vaccine received in four weeks. It was reported that similar to first dose, started feeling achy and fatigued, around 48 hours after receiving second dose. On the 4th day, had a small rash or irritation inside right armpit. That spread to chest by day 5 and suspected shingles. On day 6 had a video appt with a doctor who confirmed shingles and prescribed Valtrax, which took twice daily for 7 days. The condition worsened and became more painful, and developed migraine like symptoms for several days. Today day 23 of feeling these ill effects, had some improvement but am still not up to working or physical activity. No Covid prior vaccination, no Covid tested post vaccination. On 08Apr2021, the patient experienced i had a small rash or irritation inside right armpit, on 09Apr2021, the patient experienced shingles, on 06Apr2021, the patient experienced achy, fatigued at 18:00 with outcome of recovering, on an unspecified date in Apr2021, the patient experienced migraine like symptoms, became more painful, condition worsened, still not up to working or physical activity. AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for all reported events with Valtrax. The outcomes of all reported events were recovering.
Patient heard moaning, leaning against father's shoulders, extremities drawn up and rigid, unresponsive, pale, Respirations normal. Child laid on floor and cold compress applied. Remained unresponsive for 2 minutes, slowly awakened able to answer questions appropriately. Remained in clinic lying down for 45 min. Drank 6 oz of water and piece of candy. Father states child had a similar episode after a penicillin shot at physician's office. Child able to walk out of clinic without assistance.
Ct was to receive PPD 0.1cc ID on 8/16/04 instead Ct received Adult Td 0.5 cc ID to left forearm. Ct. experienced edema, redness and pain left forearm. Ct. was to follow up with MD.
Developed urticaria approximately 12-16 hours after last HPV vaccination. Was back at college at the time. Went to urgent care - prescribed steroids to treat and advised not to get HPV#3.
Tightness of the chest\heart area.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 23:30, the patient experienced tightness of the chest\heart area. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tightness of the chest\heart area was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
administered expired Havrix (exp:6/20/22) dose to a pt on 6/27/2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAV (Havrix adult) (batch number unknown, expiry date 20th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 27th June 2022, unknown after receiving Havrix adult and Havrix 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: 28-JUN-2022 Reporter's Comments: The pharmacist reported that they inadvertently administered a dose of Havrix was given to the patient and it was already expired. The pharmacist inquired how to proceed with revaccination. The reporter did not consent to follow up. Additional Supportive Information: The use of Havrix dose which was already expired on 20th June 2022, which led to expired vaccine used.
Blacked out; fell to ground; swelling; sores / Right wrist, Right arm underarm back; itching / Itching is intense; outbreaks of hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Dec2021 (Lot number: FH8027) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anaphylaxis bee sting", start date: 1980 (unspecified if ongoing), notes: Other medical history: Anaphylaxis bee sting 1980 ER. Concomitant medication(s) included: FIORICET; TYLENOL; BENICAR. Vaccination history included: Bnt162b2 (lot number: ER2613, dose number: 2, vaccine location: Right arm), administration date: 26Mar2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (lot number: EN6199, administration route: Intramuscular, dose number: 1, vaccine location: Right arm), administration date: 05Mar2021, when the patient was 81 years old, for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 08Dec2021, outcome "not recovered", described as "Blacked out"; FALL (medically significant) with onset 08Dec2021, outcome "not recovered", described as "fell to ground"; URTICARIA (non-serious) with onset 08Dec2021, outcome "not recovered", described as "outbreaks of hives"; PRURITUS (non-serious) with onset 08Dec2021, outcome "not recovered", described as "itching / Itching is intense"; SWELLING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "swelling"; SKIN LESION (non-serious) with onset 08Dec2021, outcome "not recovered", described as "sores / Right wrist, Right arm underarm back". The events "blacked out", "fell to ground", "outbreaks of hives", "itching / itching is intense", "swelling" and "sores / right wrist, right arm underarm back" were evaluated at the physician office visit. Therapeutic measures were taken as a result of loss of consciousness, fall, urticaria, pruritus, swelling, skin lesion. Therapeutic measures were taken as a result of loss of consciousness, urticaria, pruritus, swelling, arthralgia, pain in extremity, axillary pain, back pain, fall. Clinical course: The patient had no other vaccine in four weeks and no known allergies. As of the time of report, the patient was still having outbreaks of hives, itching, swelling and sores two months after last dose in the right wrist, right arm, underarm and back. Doctor's prescription of Triamcinolone Acetonide cream .5% was not helping. Blacked out 08Dec2021 briefly and fell to ground. Itching was intense. The patient had no COVID prior vaccination and was not tested post vaccination.
Herpes Zoster; products liability: defective design/manufacturing defect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, the patient was administered zoster vaccine live (ZOSTAVAX) by a healthcare provider at a Private's Doctor's Office (dose, route of administration, vaccination site, lot # and expiration date were not provided). On an unspecified date, the patient was treated by a physician at the Private's Doctor's Office for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. The outcome of the events was unknown. The causality assessment between the event of Herpes Zoster and zoster vaccine live (ZOSTAVAX) was reported as related. The causality assessment for product quality issue was not reported.
I was lethargic, fatigued, had headaches, runny nose, and I felt feverish. That lasted for a week. I just stayed in bed. On December 27th I had headaches and was fatigued again. I also had a sore throat this time. I felt like I had the symptoms of omicron, but I tested negative for it.  Me and my doctor was surprised that I didn't have it. I was prescribed steroids for a 7 day course which I am still on now. The steroids are helping. Back in March 2021 I had covid, but I had three different covid test that were all saying negative. The doctors still diagnosed me with covid because I had the covid lung. I had difficulty breathing when I had covid. As of now I still have mild headaches and fatigue, but the sore throat is gone.
Pt stated he began to itch and swell shortly after injection. The next day Pt came into the clinic: Induration measured 40mm with Pos redness, swelling, and warm to the touch. Pt is Dx with cellulitis and given Rx Keflex. Pt began taking Medication on Fri 17Apr2015. At that point Pt's swelling and redness had lessened but was still warm to the touch. Pt F/U on Tue 21Apr: Redness, swelling, and warmth are no longer present. Induration is still visible and 2cm.
muscle aches; weakness; flu-like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included immunoglobulins nos (Ivig).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle pain (Verbatim: muscle aches), weakness (Verbatim: weakness) and influenza-like symptoms (Verbatim: flu-like symptoms). The outcome of the muscle pain, weakness and influenza-like symptoms were recovered/resolved.   It was not reported if the reporter considered the muscle pain, weakness and influenza-like symptoms to be related to Shingrix.     It was not reported if the company considered the muscle pain, weakness and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-02-2023 The caller stated her husband received dose 1 of Shingrix 2 months before date of reporting.  He experienced muscle aches and weakness and flu-like symptoms for 2 days. She stated he was immunocompromised and receives IVIG.  He would be getting dose 2 of Shingrix next month.  The caller did not want to provide any patient identifiers or demographics.  The reporter did not consent to follow-up. No additional information provided.
Pt recvd measles & rubella vax 7AUG91 & 4 days following vax pt exp fatigue; 12AUG91 pt devel fever & diarrhea; next day pt devel rash & cervical adenopathy;