chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat; tongue felt fat and it hurt/her tongue still hurts /feels like her tongue is a little swollen; tongue felt fat and it hurt/her tongue still hurts /feels like her tongue is a little swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 as dose 1, single for COVID-19 immunization (at the age of 57-year-old). Medical history included ongoing high blood pressure, ongoing type 2 diabetes mellitus, ongoing hypothyroidism, ongoing chronic depression, ongoing uric acid high, gout and severe reaction to sulfa drugs. Concomitant medications included oral levothyroxine sodium (L-THYROXINE) 50mcg once a day by mouth) for Hypothyroidism, bupropion hydrochloride (WELLBUTRIN) 450mg one time a day for Depression, metoprolol (50mg one time a day) for high blood pressure, allopurinol (300mg one time a day) for gout prevention, linagliptin (TRADJENTA) (5mg one time a day) for type 2 diabetes. On 23Mar2021 (5 days after the vaccination), the patient experienced tongue felt fat and it hurt, just feels like her tongue is a little swollen. On 24Mar2021 (6 days after the vaccination), the patient experienced sore throat. Stated today her tongue still hurts. it just feels like her tongue is a little swollen, says she cannot tell if it is swollen when she looks at it, it just feels that way. Patient stated they monitored her after her dose for 30 minutes instead of 15. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
6/4/98 pt recv 1st dose vax exp red, hot swollen area i@ inject site 2days. p/ 2nd dose approx 10min following pt exp stinging & swelling which p/ 1 day spread to a circle approx 3-4'' in size on upper arm. treated w/ice, motrin, benadryl.
Information has been received from a nurse practitioner concerning a 95 year old male who on August 2007 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck), subcutaneously, 0.65ml. The nurse practitioner reported that on 09-JUN-2008, the patient developed a case of shingles. The rash was on his trunk. He was treated with VALTREX. At the time of the report the patient was recovering. Medical attention was sought. Follow-up information indicated no new information. No further information is available.
erythema multiforme appeared1-1/2 days p/vax was administered; migratory arthralgia thought to represent serum sickness devel about 3 days later; initial treatment was Pred; rash resolved; joint pain persists;
Patient received 1st dose / between September and October, 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix between September and October 2020.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter stated the patient was 65 years and older but did not specify. Till the time of reporting the patient did not receive the 2nd dose which led to incomplete course of vaccination. No further details of patient or vaccine were provided. No further details were reported. The reporter did not consent to follow up. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102193:Same reporter US-GLAXOSMITHKLINE-US2021102195:Same reporter US-GLAXOSMITHKLINE-US2021102197:Same reporter US-GLAXOSMITHKLINE-US2021102198:Same reporter
"This is a 62 Years old Female complaining of redness, swelling, and pain to the left upper extremity for 2 days.  The patient states that her symptoms started approximately 4 days after receiving the pneumococcal and flu vaccinations at the same site 6 days ago. Patient states that her symptoms are getting worse.  Pain is described as dull/aching.  Pain is described as mild in nature and worse with nothing. "
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 02-JUL-2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (lot #, route, and dose not provided). The vaccine was administered by a Registered Nurse at a physician's office. At the time of her vaccination, the patient relied on the warning label affixed to ZOSTAVAX, and the information relayed through her healthcare provider that ZOSTAVAX was effective in preventing shingles on a permanent basis, and did not carry significant risk of adverse effect, which induced her to be vaccinated. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 15-JAN-2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. She was prescribed gabapentin and valacyclovir for the management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
RASH, BLISTERS ITCHING AND DRAINING. RASH ON TORSO, BILATERAL ARMS AND HANDS, DIARRHEA
Patient hospitalized 2/18/21, second dose was scheduled for 2/23/21. Patient expired in hospital 2/27/21.
Patient stated that her tongue  felt numb, then  her whole face became tingly and numb. The patient's left side of her face became droopy and she fainted at one point.
diarrhea; chills; fever; Arm was sore at the injection site; This is a spontaneous report received from a contactable consumer (patient). This 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunisation. Medical history included allergies to sulfate, sulfite and penicillin, all from unknown dates and unknown if ongoing. Concomitant medications were not reported. The patient inquired about the approval status of BNT162B2 and whether diarrhea, chills, and fever were bad or severe side effects. The patient reported she experienced diarrhea, chills, fever and that her arm was sore at the injection site. She reported speaking with other people who also experienced pain at the injection site. She inquired if she should get the second dose since she had side effects after the first dose. The clinical outcomes of diarrhea, chills, fever and her arm was sore at the injection site were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Premature ventricular contractions Tightening of chest Inability to take deep breaths Chronic Low Blood pressure : 90/50
1-2 days after administration of vaccine, the patient had a week-long episode of moodiness and irritability. This culminated in a suicide attempt by hanging in his bedroom that was interrupted by his father. There is no prior history of suicide attempts and no other clear, identifiable triggers to this incident.  After 7 days, the patient returned to his previous baseline of mood.
it hurt more than her first vaccination and much sooner; arm was sore; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced it hurt more than her first vaccination and much sooner; arm was sore on 21Jan2021 with outcome of unknown. Yesterday afternoon at approximately 1 p.m. EST, she saw a post on (Social media name) from a friend who received her 2nd Pfizer COVID-19 vaccine. She stated she received it the day before (20Jan2021) and it hurt more than her first vaccination and much sooner. She stated that her arm was sore that day (21Jan2021) but no other side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 22-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004251 with expiration date 22-SEP-2020 (strength, dose, dose number and route of administration unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Fatigue, soreness of arm, lost of appetite, 12 hours later 8am
Child c/o itchiness of b/l arms.  No rash present.  Child was otherwise well. VSS.  Lungs CTA.  MD was notified.  Benadryl given.  CHild stayed in office x 30 min.  Itching resolved.  No further intervention required.
Swelling, redness, warmth around injection site a few hours after vaccination given.  Given antibiotics for cellulitis, condition improving.
A few days after the same ecema type rash appeared again over both eyelids but was severly worse this time.  I also had itchiness, redness and soreness at the injection site which lasted about a week after and I was administed the steroid cream again which made the rash disappear after about a week
I received the flu vaccine when I was 14 weeks pregnant. I discovered at 16 weeks gestation that my babe had had a fetal demise around 15 weeks gestation. As of now, there is no indication to the cause. All genetic screenings were negative and the fetus appeared normal. We did do further chromosomal testing and the results are not back yet. We will do all possible testing to discover a cause. I am well aware that other factors may have played into this but if felt important to explore all possible causes.
RASH OVER ARMPIT BACK AND RIGHT SHOULDER, BURNING OVER ARMPIT
3 days after injection onset warmth, erythema, tenderness. MD Rx cephalexin 500mg QID. Improved within week.
Pain at the time of injection, and within 24 hours had warmth, tenderness, erythema of the upper arm.
The patient's first shot was given on 7/29/21. The second dose was inadvertently given at the 13 day mark on 8/11/21. This was discovered in the afternoon of her second dose because her husband came in to get the shot at the same interval and his was caught. I called the CDC and they said in retrospective review the dose was not to be repeated, but did not have info to whether it would decrease effectiveness. I called the patient to inform her of the information I received from the CDC. She reported having a low grade fever and headache this afternoon. I explained this could happen with the second dose anyway, but for her to contact us with any further adverse events.
Left lower arm hurting; Hurting into her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left lower arm hurting) and ARTHRALGIA (Hurting into her shoulder) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left lower arm hurting) and ARTHRALGIA (Hurting into her shoulder). At the time of the report, PAIN IN EXTREMITY (Left lower arm hurting) and ARTHRALGIA (Hurting into her shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used rubbing alcohol and heating pad to treat the events.
The patient stated his tongue was tingly within the first 15 minutes after the immunization was given.   On-site he was given 100mg of liquid diphenhydramine.  He was monitored for 30 minutes with no worsening of symptoms.  He stated he was feeling better and left. The pharmacy was alerted on 3/5/2021 of the following sequence of events:  The following day the patient stated he was feeling off. He had joint pain and inflammation thru Wednesday March 3rd.  On Monday March 1st, he stated he felt short of breath and needed to use his nebulizer.  His heart rate was over 100 and he reported having a panic attack due to seeing his elevated heart rate.  He was seen for a routine appointment by his PCP on March 3rd and was told to not receive the second dose of vaccine.  His parents subsequently informed him that he has a history of heart arrhythmia.
The Covid vaccine EXP Date as per the labels on the immunization box is 01/31/2024, but the BUD Expiration date from the pharmacy is 06/07/23. The vaccine was give pass the BUD Expiration date.
Within 2 hours of receiving flu vaccine felt (in L increasing arm bruising 10/17) woke this AM and (L. arm swollen redness and was itchy) Seen in clinic.
Pt developed a local reaction at site which was a red, hot to touch and indurated area on thigh. This began the day after immunizations. It was worse on the 2nd day, then was better.
1st dose a year ago and 2nd not yet administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was received about year and half ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose a year ago and 2nd not yet administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-MAR-2023 The reporter was patient itself. The patient received first dose about a year and half ago but didn't get the second dose. The patient asked if he need to start with the first dose again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
PATIENT COMPLAINED OF MILD PAIN AFTER INJECTION. ON 12/28/2021, PATIENT CALLED TO REPORT THAT SHE HAS BEEN EXPERIENCING MODERATE TO SEVERE NEUROLOGICAL PAIN IN ARM, HAND, AND NECK OF LEFT SIDE. SHE HAS BEEN TO ER AND PHYSICIAN'S OFFICE ON MULTIPLE OCCASIONS AS A RESULT. POSSIBLE GBS SUSPECTED BY PHYSICIAN. PATIENT TO UNDERGO TESTING TO CONFIRM OR DENY.
Narrative: 98y/o received booster dose of COVID19 Moderna vaccine on 11/20/21. Received 0.5ml, however should have received 0.25ml since not considered immunocompromised. Presented to outside ER on 11/21/21 with sudden onset of generalized weakness, chills, fatigue. Was placed in observation and given gently IV hydration. Cleared to discharge the following day.
Pt recvd 3 doses of Engerix-B & was determined to be not immune to Hep B;
Fever ranging from 101-102 started on 4/30/19, after vaccine was administered.  Mylagia, localized swelling around injection site.  Child evaluated in our office on 5/3/19,  all symptoms at the time of this visit were resolved except for swelling of the right deltoid area.
Approximately 2 hours after receiving the shot she reported feeling weak, dizzy, numb legs. She rested and felt better later in the day
Patient arrived at clinic for influenza vaccine. O.5 ml dose administered. Followed up with Patient's father 48 hours later. Child had mild fever over weekend. Treated with Tylenol. To note, older sibling had pre-existing cold symptoms.
Low fever; Chills; All over body soreness; Particularly down the left side where she got the shot; This is a spontaneous report from a contactable consumer (patient's father). A female patient (reporter's daughter) of an unspecified age received second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiration date: unknown) via an unspecified route of administration on 21Apr2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of (Solution for injection, Batch/Lot Number, Expiration date: Not available) for covid-19 immunisation. On 22Apr2021, in the morning she reported a low fever, chills and all over body soreness, particularly down the left side where she got the shot. The outcome of the events was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
15 minutes p/inject, pt started screaming; had high pitched cry almost continuously for 24 hrs; given APAP every 4 hrs & used ice pack per MD; poor appetite; vomited every time took a bottle; unable to move lt leg for over 24 hrs; t100.0;
Patient had red, flat rash on forearm and bicep of the vaccinated arm. Monitored patient for a half hour. The patient had no rash on trunk, difficulty breathing, or tingling in mouth or throat. Rash started to lighten and patient reports to feel fine. Advised patient to keep on eye on rash and to take Benadryl if it worsened and seek immediate medical attention if he had difficulty breathing. Followed up with patient and per sister the rash has resolved.
Initial information received on 07-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves an 88 years old male patient who experienced back pain, while he received vaccines FLUZONE QUADRIVALENT and FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccines were administered. On 10-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the outpatient. On 07-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the inpatient. On an unknown date, the patient developed a serious back pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient was hospitalized for this event. (It was reported that the patient was admitted for back pain but will be discharged back to his nursing home where he resides). It was also a case of actual medication error due to Extra dose administered as patient received FLUZONE QUAD in an outpatient clinic on 10Sep2018 and then received FLUZONE HD as an inpatient today. (Other relevant tests included No lab data). Final diagnosis was back pain. It was not reported if the patient received a corrective treatment. The patient as Unknown for back pain. 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. Documents held by sender: none. Sender's Comments: Patient experienced vomiting after vaccination. Exact time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
pt received the Moderna Vaccine instead of the Pfizer, RN grabbed the wrong syringe
Patient received 0.5mL instead of 0.25mL for Moderna booster vaccine. Provider informed.
Presented to ED on 1/17/22 and found to be COVID positive.Patient presented to the emergency department with complaint of shortness of breath, dizziness, and generalized weakness.  He was found to be positive for COVID-19.  Patient has past medical history significant for coronary artery disease.  Patient had recent echocardiogram and stress test performed for preoperative cardiac evaluation prior to colon resection.  Patient was recently diagnosed with rectal cancer and had surgery and stoma.   Patient noted to have ST depressions on his EKG.  He has had 3 serial troponins which were within normal limits.  Patient's D-dimer elevated 2.6 4. He is being planned for V/Q scan and lower extremity ultrasound. Both came back negative   Pt required short time of oxygen. He refused remdesivir when he was hypoxic initially now he doesn't need it.    Course of dexamethasone Course of azithro metoprolol 50 mg BID To follow with his cardiology for work up when he recovers from COVID; pt refused further work up this admission. Stable for discharge Pt is off oxygen with no symptoms. Discharged on 1/18/22
On 09/25 pt. presents to ER with substernal chest pain with onset 1 hour prior with discomfort radiating to Left jaw and left arm. Incidentally documented that pt. had his 2nd Covid Moderna vaccine on 09/17/2021.  Pt. has no prior cardiac hx.
My child had the Vaccinations for her 1 year old check up. In the night at about 11:30pm, She started having a seizure. I had to do CPR on her. We called the ambulance and she was taken to the hospital.
See attached. Has CPE Friday - got Tdap and ZOSTAVAX. Over the weekend redness at the site increased slightly. Over the weekend began not feeling well with lethargy, nausea - worse today, a real struggle to work. Redness at the site is more. Not itching but used a little cortisone cream. No joint pain, mild HA.
PATIENT EXPERIENCING PAIN AND LIMITED MOBILITY OF ARM BEGINNING DAY OF VACCINATION AND CONTINUING