chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure/had them 4 times, even with the Vax; shingles even with the Vax; painful; secondary infections like staph; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 times ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and staphylococcal infection. On an unknown date, the outcome of the vaccination failure, shingles, pain and staphylococcal infection were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and staphylococcal infection to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient had shingles 4 times, even with the Shingles vaccine. The shingles were very painful but did not itch. The patient stated that watch out for secondary infections like staph. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. Note: The event staphylococcal infection was conservatively capture as it was not clear if the patient had experienced this event or not after receiving vaccine.
I had vaccines 12/17/2020 and 1/6/2021. On 7/27, I began to display symptoms of COVID-19 and went and was tested 7/29, which resulted in a positive COVID-19 result. Symptoms were nasal congestion, cough, fever, chills, headache, extreme fatigue.
I was unable to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Gout prone or had some other inflammatory issues" (ongoing); "Gout prone or had some other inflammatory issues" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer.), for COVID-19 immunization; Bnt162b2 (Dose: 2, was incapacitated for 3 weeks from the 2nd vaccine), for COVID-19 immunization, reaction(s): "incapacitated for 3 weeks from the 2nd vaccine". The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I was unable to walk". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
got moderna full dose after two sinopharm doses; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got moderna full dose after two sinopharm doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got moderna full dose after two sinopharm doses). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got moderna full dose after two sinopharm doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received Moderna full dose after two sinopharm dose  No concomitant and treatment information were reported by the reporter
11/28/2005 PC from patient started with stomach pain and diarrhea 11/22/2005 about 1:00am, continued to have stomach pain and diarrhea. Stomach pain worse after eating food goes straight through. Rash noted on neck more splotchy, not raised, itchy. Advised to contact private MD not side effect of yellow fever vaccine, possibly has low grade fever. May try OTC meds for stomach diarrhea. Should contact MD especially if cont. To Call nurse after talks with MD. 11/29/2005 MD gave RX for Phenergan, feeling some better today. 11/30/2005 feels great today, back to normal states RN.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800; expiry date 24-MAR-2017 (dose, frequency, route of administration were not provided). The M-M-R II was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in between 47 degrees Fahrenheit (F) to 77 F (also reported as: "46.9 F") for 30 minutes. There was no previous excursion. The digital data logger was involved in recording the temperature excursion.; Sender's Comments: US-009507513-1712USA010650: US-009507513-1801USA002560: US-009507513-1801USA002564: US-009507513-1801USA002561: US-009507513-1801USA002562: US-009507513-1801USA002563:
More than 24 hours later, noticed hive like rash over left deltoid (same area where Adacel vaccine given) with redness and warmth to touch; 48 hours later noticed redness in left neck area with a few hive like lesions present.
SOB, Fever, fatigue, cough Hypoxia, tachycardia, HTN Admitted 5 days after the 2nd dose of vaccination  Dx: Myocarditis and Pneumonitis RX: steroid, Diuretic
No adverse event; 47 patients received the vaccines after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, 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 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the vaccines after the use-by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (47 patients received the vaccines after the use-by date).    Patient was over 18 years of age.  No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 28 Jun 2023, 9 doses were administered at administration site 1.  No treatment medication reported.  The case corresponds to 12th out of 47 patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received, updated vaccine administration date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
Redness, pain, swelling right upper arm. Mother noticed the morning after. Pediapred, Keflex, warm soaks.
Wounds on her legs; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 61-years-old female patient received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Lot number-Not reported), via an unspecified route of administration on an unspecified date as DOSE 1,SINGLE for covid-19 immunisation .Medical history included rheumatoid arthritis, immunosuppression, toe operation , diabetes mellitus , neoplasm , wound infection staphylococcal from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported. On an unspecified date, patient was a 61 year old female who go the first dose of the Pfizer Covid 19 vaccine. She has a home health nurse that comes in 3 times per week due to wounds on her legs that are trying to heal. She also has RA, so her immune system is already compromised. If someone is on antibiotics will it effect the vaccine? She's not taking an antibiotic now, but sometimes she does because of prior MRSA. Will the vaccine effect my wound healing. She is not in a immunosuppressive medication now but previously took a medication for RA and she lost toes due to diabetes and has tumors in her neck because of it. She did not give the name of the medication. The outcome of event was recovering.   Follow-up attempts are completed. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Pt recvd Engerix-B vax MAY90, JAN91, & MAY91 & was found to be a non-responder;
Headache, fever, chills, nausea, vomiting, muscle aches, fatigue
Information has been received from a physician concerning a 63 yr old white male in refrigeration with no allergies and no medical history who on 01Nov04 at 18:00 was vaccinated in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot (649732/0513P). There was no illness at the time of vaccination. On 02Nov04 at 08:00 the pt developed inflammation and swelling at the injection site. On 04Nov04 he came into the office complaining of redness, soreness and warmth at the injection site. The physician reported that it was a local reaction. The pt was given a prescription for methylprednisolone (Medrol Dosepak) 4mg. No diagnostic lab tests were performed. Subsequently, the pt recovered. It was also noted that the pt had no adverse events following prior vaccinations. No product quality complaint was involved. No further information is expected.
10-1-14 - Rt. arm started to swell and got hot; 10-2-14 - Swelling from shoulder to elbow; 10-3-14 - Saw my dr and received prescription for antibiotic - daily - one 500 mg Cephalexin 500 mg Caplupi
Pt vaccinated with TD/MMR developed body aches, fever x 4 days. Sore throat.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-NOV-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Intense redness and induration of injection site about 2 days after injection. Child placed on antibiotics to cover for cellulitis.
Headache started the next day. Also tenderness of the  ipsilateral supra-orbital  nerve was present and contributing  to, or the was the cause of the headache. The headache lasted about 7 days.  I have gotten a headache with each Moderna Covid vaccine but this was the first time I notice it was related to the supra-orbital nerve. The headache has been worse and last longer with each of the 3 vaccines. I have also had fatigue with each vaccine which has also been lasting longer with each vaccine.
It happened on 9/29/21, I woke up in the middle of the night with a severe headache and chills. I had a fever of 103.8, I also had coughing and congestion, all of which hit at one time. I had a fever through the 29th, 30th and congestion and headache as well. I called my doctor and he ordered for me to go get COVID-19 tested. On Friday the 1st of October I still had a fever and congestion and headache it lingered. On Monday and Tuesday (4th and 5th) I did not go to work. On October the 7th I still had the congestion and was coughing up stuff too, extremely tired as well. In fact, I did not work that entire week and then I went back to work for half days on the 11th, 12th and 13th. On the 14th and 15th I went back full time. I still do not have any smell or taste today (10/25) as well. By the way, my doctor had given me a seven day supply of Doxycycline 100 mg.
Fever, chills, diarrhea, sweating, muscle pain, fatigue, ringing in ears, pins and needles feeling in hands and feet. Very dizzy on day two accompanied by profuse sweating
10/14/21  0630:  palpitations, tachycardia noted in AM and intermittently throughout the day. 10/14/21  1830:  Increased tachycardia, lightheadedness, A fib noted on smartwatch 10/15/21:  1300:  Saw cardiologist, prelim Dx of A. Fib, placed on Biotel patch monitor x 2 weeks. 10/21/21:  Seen by second cardiologist/electrophysiologist:  NOT A. fib but a left ventricular outflow tract-ventricular arrhythmia.   (LVOT-VA).  Plan to place on flecanide, consider ablation if Sx persist after data from monitor download reviewed
68 year old female patient Fluzone HD that was frozen was administered, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2020SA258066 (same reporter).  This case involves a 68 year old female patient who received a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ462AB and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product storage error.  At the time of report 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 holder's 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.
I95.9 HYPOTENSION 3/23/2023 FAILURE TO THRIVE SYNDROME, ADULT
Case number PHHY2011US35373 is an initial spontaneous report received from a nurse on 26 Apr 2011 with a follow up report on 16 May 2011. This report refers to an adolescent female patient. She was given only the MenCYW-135 liquid component MENVEO (batch number X10034) intramuscularly into the right arm on 25 Apr 2011. She was not given the MenA lyophilized conjugate vaccine component. On the same day she was also vaccinated with Tdap (batch number: AC52B069FA) intramuscularly into the left arm. No other adverse reaction was reported. Follow up information received from a nurse on 16 May 2011: Updated information about patient demographics, vaccination date and concomitant medication.
no addtional adverse event were reported; patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 13-JUN-2022, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot # 1821791 confirmed to be valid with expiration date: 26-JUL-2022, for prophylaxis. The vaccine underwent a temperature excursion of 50.7 degrees Fahrenheit for 35 minutes (product storage error). There was no previous temperature excursion. There were no additional adverse events reported.
pt recv vax & pt devel a mild case of chicken pox-like lesions;w/in 2 wk pt father devel shingles;
Patient described an extensive (3 hrs after injection) localized reaction involving her entire upper arm with swelling symptoms suborned in 72 hours.
Sharp pain in arm (L) pain varies from 3-6/10. Patient is two weeks out from getting vaccine. Patient was sent to his primary care doctor for possible X-ray/MRI.
a magnet will stick to her injection site.; This is a spontaneous report from a contactable other hcp. A 46-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN5318; Expiration Date: unknown), dose 2 intramuscular, administered in Deltoid Left on 05Feb2021 as 2nd dose, 0.3 ml single dose for COVID-19 immunization. The patient took the Historical BNT162B2 vaccine on 14Jan2021 (Lot EL3248), 0.3ml, intramuscular, administered into the left deltoid. The patient medical history was not reported. The patient's concomitant medications were not reported. On 20May2021,  the patient experienced a magnet will stick to her injection site (vaccination site discomfort). The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable consumer reported for herself. A 75-year-old female patient received PREVNAR 13 for Immunisation on 05-OCT-2017 10:30 via an unspecified route in the left arm at single dose and influenza vaccine in the right arm. Concomitant medication included COUMADIN it could be 2.5mg and then next be 3.9mg. Relevant medical history included blood clots, diagnosed in 1965, atrial fibrillation diagnosed probably a year ago, body height decreased. On unknown date in Oct2017 the patient experienced no appetite at all, she did not eat anything for one solid week, she only wanted Coca-Cola, diarrhea, complete fatigue, on 06Oct2017 Sweats (That Friday night she woke up and she was wet/her head would be wet and she'd have sweat on her forehead), on 05Oct2017 headaches (she woke up the next day and her head was splitting open) on unknown date lost weight, Feeling abnormal (she does not have any desire for sweets and things almost make her feel like she will throw up, just like nausea) and asthenia (she was too sick to go to the family doctor/she got to where she could not walk from one room to the next because she has no breathe/she was too weak to get up/She still has no energy and is not herself and it has been almost two months). She went to her cardiologist and he run every kind of test there was, thyroid and all blood work, echocardiogram and lung scan. This all went through Dec2016 and nothing really showed up. Information on the batch number has been requested.
Information has been received from a physician concerning a 13 year old female who on 27-MAR-2008 was vaccinated with GARDASIL (65994/1978U). Concomitant therapy included HAVRIX (lot# not reported). On 27-MAR-2008 the patient experienced wooziness and began crying. Subsequently, the patient recovered from the wooziness and crying. The patient's sister had the same AE after receiving GARDASIL. See SR# 1-2774239123. Additional information has been requested.
pt recv vax 11JAN96 & pt exp soreness @ the inj site, which subsided & was followed by aching all over, gen malaise & a sore throat;pt soreness @ inj site then returned;
Diagnosed as being "HPV positive"; This spontaneous report was received from a licensed practical nurse and refers to a 22-year-old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On 22-SEP-2019, the patient was diagnosed as being Human Papilloma Virus (HPV) positive.  The outcome of the event and the relatedness between the event and the suspect therapy were not reported.
DTaP Vax on 12/17/99, both legs. Hib,Polio,Hep-B. Sxs began at time of shot-cried x 1 1/2 hrs, diarrhea from 12/17 to now, pale looking, eyes are "sickly",fussy, anorexia, vomits formula ( was changed on 12/14). She was born 1 mo premature.
Patient had large red patch that started near the immunization site and continuted down the arm. It was warm to the touch and itchy. The reaction started about one day following the immunization. She came to the pharmacy four day after the vaccniation and the red area was continuing to spread. She has followed up with urgent care yesterday (10/6/18) and again today (10/7/18) and was put on antibiotics and a steriod. The red area is decreasing in size and the area does not feel as warm.
Swelling and redness that started on site of my injection that progressed distally as per pt. On exam, note of pain on palpation of her site of injection. Left arm w\o any redness/swelling over the area; redness/swelling/tenderness/warmthness over inner upper left arm.
Blisters on the skin grafts on my reconstructed leg, but not the other. Also, slow-healing wounds and other problems that people with diabetes experience. I've always had high-normal blood sugar in blood tests, but never pre-diabetic or diabetic levels. Blisters would come and go for about a month after each of two doses and one boost.
On day 16 after vaccination patient experienced sudden dyspnea, stridor, and respiratory distress/respiratory arrest followed by cardiac arrest. ACLS by paramedics, patient in PEA in field. Extubated on arrival to ER with no residual deficits
Sore arm at injection site, mild body soreness, stomach upset, fatigue, lasted for 48 hours
muscle pain,cognitive impairment,severe headache, fever, joint pain,chills, shaking,drenching sweat,fatigue,chest pain,eye pain,nausea
Facial swelling, neck swelling, dizziness, shortness of breath, nausea, warm feeling, lips itchy, face itchy
Swelling, warmth, erythema at injection site. Unsure if allergic reaction or cellulitis. Given hx of cellulitis (recent), we will treat as cellulitis.
Rash near injection site n itchy. It?s hard at injection site Yesterday it started off the size of a dime next day the size of a quarter tonight about the size of a half dollar. Doesn?t hurt n isn?t sore.  I feel fine, no fever or drowsy.
Left Axillary lymph node is swollen and below the injection site is red and warm.
I have had a history of indigestions in the past but after taking the nasal spray for the H1NI this actually triggered a worse reaction to my indigestion problems (IBS). This has resulted in me missing a work day on 02/10. This reaction carried on until 02/12 after a week of trouble , when I finally recovered.