chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; SINGULAIR; ORAL CONTRACEPTIVE NOS.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included anti-viral drug Paxlovid from 15Sep2022 to 29Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. No Treatment medication reported.
uncomfortable shooting sensation down her arm repeatedly throughout the day every day since first shot.   5/4 entered the hospital and diagnosed with Sepsis and MRSA.  They cannot explain the source of this infection and cannot get it under control
Left deltoid redness, swelling, hot to touch, painful - localized. Cellulitis.
Redness initially with minor swelling on 3/22/17. After 3/23/17 into 3/24/17, the area of the swelling is increasing between armpit and elbow. The area is painful but decreasing. Patient can not tolerate cold; so she is using ibuprofen and BENADRYL.
dyspnea, anxiety, P56, R36, BP 200/90, 02 on transferred to hosp; causes of death-cardiac failure, CHF, Ischemic cardiomyopathy, COPD; also exp discomfort & tingling in arms; R36 shallow & labored;
History:  Covid-19 illness 02/2020, Long Covid symptoms started 03/2020. Long Covid symptoms recurred following initial 2-dose vaccination (2/23/21 & 3/23/21), subsided slightly, recurred again following dose 3 (8/27/21), had almost completely subsided prior to dose 4 (1/28/22). Symptoms since Dose 4:  chronic fatigue, extreme post-exertional malaise, joint pain (mostly elbows & knees), severe body aches, headaches, disturbed sleep I can't find a specific Long Covid site to report this to.
Patient states that around 3:00 AM the morning after the injections she started to feel cold and was sweating. The patient says that about 4 days later she passed out and busted her face and had to be hospitalized. Patient went to hospital and was transferred to another hospital. Pt. is unaware of any tests that were ran. Pt. said she had no markings or swelling at the injection site. Pt. had re-hab for about 6 weeks following her fall. This was the 2nd dose of SHINGRIX for the patient. She received the 1st dose of SHINGRIX on 4/24/18 and did not have any signs or symptoms of an allergic reaction. We first learned of the patient's allergic reaction via fax from her primary care physician. Dr. stated in fax that he gave the patient instructions not to get 2 immunizations in same day and he is upset with us B/C we told the patient 2 injections of non-live immunizations in the same day was ok per CDC guidelines. The patient asked before getting the immunizations if it was ok to get both in the same day and I told her it was ok per CDC guidelines but it was up to her if she wanted to space them out. Dr. also stated the patient is immunocompromised and he sent in prescriptions for both immunizations but neither Rx stated the patient's disease state or gave instructions to space out the 2 immunizations.
These events were reported by the mother 3/19/04. Pt developed hives- apparently isolated areas- not generalized with itching. No respiratory problems. She was treated with Benadryl.
Extreme headache for 2 days. Worse than any migraine I?ve ever had. Severe pain in neck, shoulders and spine. My heart heart. Extreme nausea, vomiting and diarrhea. Extreme fatigue. Couldn?t move or eat for 2 days. Didn?t think I was going to recover.  3rd day feeling light headed and tired but feeling better.
Fussiness, inconsolability lasting 4 days. Also developed change in stools: dark green, sticky.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient who experienced administered the vaccine to a patient SQ instead of IM, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via subcutaneous route. It was a case of actual medication error due to vaccine administered at inappropriate site. The patient outcome is reported as Not Applicable for administered the vaccine to a patient SQ instead of IM. 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.
Patient stated that on vaccination date the site was warm and a welp started.  Patient took Zyrtec and it did not progress.  Patient called on 10/8/09 to say that she has a bruise the size of a quarter at the injection site and that a new welp was developing a few inches below the injection site.  Pt states that it is not getting any worse and that she had already taken Benadryl and no action was necessary but that she wanted to let us know.
Ringing (tinnitus) in the left ear that started insidiously on the night of Friday, April 16 (five days after the vaccine administration), that is progressively increasing, along with ipsilateral hypoacusis.
Systemic: Confusion-Mild, Systemic: Dizziness/Lightheadedness-Mild, Systemic: Seizure-Mild.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot # K020215, expiration date: 15-MAY-2016, route and dose were unknown) between 15-JUN-2015 and 24-SEP-2015 (incorrect product storage). No adverse effected were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Event occurred after 2nd vaccine. First vaccine was on 1/14/21 and the second one on 2/11/21.Pt tested positive for COVID-19 on  12/1/21.
redness and swelling of injection site. is still present and currently spreads out more every day. It is painful but lessens each day. is slightly itchy.  Swollen lymph nodes. Very swollen in right under arm. Painful to the touch. appeared 2 days ago (4/29/21) Tiredness that went away after 24 hours
Silver dollar sized red mark at injection site, warm to touch, itchy and red. Medrol dose pack was ordered by PCP along with hydrocortisone cream and benedryl
Vaccine administered around 11 June 2008 prior to deployment.  Pregnancy diagnosed during deployment.  Pt returned upon dx of pregnancy.  No known adverse events.
Case number PHEH2014US000912 is an initial spontaneous report received from a pharmacist on 08 JAN 2014. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. He was erroneously vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly on 07 JAN 2014. No adverse event was reported following the inadvertent administration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 08 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
patient missed  the recommended window for her second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
flare-up of Oral Lichen Planus: blisters on her tongue; flare-up of Oral Lichen Planus: blisters on her tongue; flare-up of Oral Lichen Planus: blisters on her tongue; has yet to get the second shingrix shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of oral lichen planus in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included oral lichen planus and tongue blistering.   On 01-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced oral lichen planus (Verbatim: flare-up of Oral Lichen Planus: blisters on her tongue), tongue blistering (Verbatim: flare-up of Oral Lichen Planus: blisters on her tongue), condition aggravated (Verbatim: flare-up of Oral Lichen Planus: blisters on her tongue) and incomplete course of vaccination (Verbatim: has yet to get the second shingrix shot).  The patient was treated with metronidazole (Flagyl) and fluconazole (Diflucan). The outcome of the oral lichen planus, tongue blistering and condition aggravated were resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the oral lichen planus, tongue blistering and condition aggravated to be related to Shingrix.     The company considered the oral lichen planus, tongue blistering and condition aggravated to be related to Shingrix.   Additional Information: GSK receipt date: 9-Oct-2023 The reporter was the patient.   She had a shot of Shingrix but did not had the lot number available but did provide the contact information for her physician's office where she got the shot. A couple days after Shingrix shot and had a flare-up of oral lichen planus: blisters on her tongue.  She saw a dermatologist for this and a biopsy was taken of her tongue.  She was told that if she was to receive 2nd shot of Shingrix that she should pre-medicate herself for two weeks with Flagyl and Diflucan before the immunization to prevent another oral lichen planus flare.  She did not want to share her email address. The reporter consented to follow-up. Till the time of reporting the patient did not receive the 2nd shot Shingrix, which led to incomplete course of vaccination.
p/ recv vax on 4/7 pt devel approx 12-15 varicella type lesions. rpt lesions were ``insect like''. no treatment given
The patient stated her arm started swelling and turning red the evening of her immunization. Then the reaction progressed to aching and hurting joints all over the body. Her hands also began to swell. She went to an ER 2 days after the immunization. They prescribed her Naprosyn and Amoxicillin each for 5 days. She reported her adverse reaction to me on 4/14/18. I told her to take BENADRYL as well.
35 year old female, no significant medical history, developed skin rash on 28JAN04, rash started on right hand, then to left hand, both elbows, both knees and right foot, associated with itching. Pt admitted for observation to rule out possible small pox adverse reaction. Rash biopsy (find Dx) features compatible with / vaccinia innoculation. Treated with Atarax 25 mg po.
On 2/28/2022 at 3:35 pm , Pharm.D. administered the Pfizer vaccine(3rd dose)  to Patient. She seemed fine at the time of vaccination. I told her she had to wait 15 minutes before leaving for observation. At around 3:50 pm she seemed to be falling asleep. I went over and started talking to her. She reported feeling weak, unable to get out of chair, could not stay awake. I informed her I would call 911 to have her evaluated, she agreed. While waiting for the ambulance to come I kept a conversation with her and that's when she said she had a mild stroke, she said she was not diabetic or did not have high blood pressure. She said she had a bad taste in her throat like when you are in the hospital and they "flush your IV".  She continued to almost fall asleep and seemed weak. The paramedics showed up  around 4:05 pm and they took over the situation. She was taken to the hospital for further evaluation.
Day 0: Migraine, body aches, fever Day 1: Migraine, body aches, lack of energy, light sensitivity Day 2: Lack of energy, headaches Day 7-present: Splotchy skin, swelling, and itchiness at the injection site
felt a lot of pain on the injection arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt a lot of pain on the injection arm after first dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (felt a lot of pain on the injection arm after first dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (felt a lot of pain on the injection arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: 32-36°F (Fahrenheit degrees) for 8 hours and 12 hours respectively. There were no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005002: US-009507513-1702USA005003: US-009507513-1702USA002890.
Patient presented for a flu shot. Flu shot was given today 02/07/23, then was discovered after injection was given that the patient had been given a flu shot December 2022.
1/8/2023 I was feeling terrible with a bad cold. I was coughing, nasal and chest congestion. I was also experiencing lower back pain. I took cough medicine and put me on an antibiotic. I started to get better. I went for my regular appointment for bloodwork and discovered I was anemic. I went back into the doctor's office and was given prednisone for the lower back pain. On 2/23/23, I had a Colonoscopy and an EGD and they were okay. I went to a GI doctor who did bloodwork which was abnormal. I was sent to a hematologist at the end of March, and I had an iron transfusion. Then I had a small bowel series which on May 1,2023 and everything was okay. I had more bloodwork, which was improving. I went back to the GI doctor who wants me to swallow the pill. I have bloodwork on June 2,2023 with the Hematologist.
Red rash, slight swelling, slight heat started almost immediately after injection and continued to spread up to 3 days after injection.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. On 12-MAR-2014 the patient was administered her first dose of PNEUMOVAX 23 0.5 ml, intramuscular, and was inadvertently administered a second dose of PNEUMOVAX 23 on 19-DEC-2014. No adverse effects reported. Additional information is not expected because the nurse did not allow us to be contacted.
Localized erythema, tenderness, increased warmth, edema, 11cm in diameter. Bullous lesion-1.7cm in diameter. Body and joint aches.
2/14/22 pt had a positive COVID test; 3/12/22 pt to ED with SOB and cough; using 4L of O2 at home and O2 saturation was 83%; O2 increased to 8L via NC in ED; pt transferred to another Hospital due to there not being any beds available at this hospital. Pt seen for AHRF, post COVID syndrome, and multiple pulmonary nodules consistent with metastatic disease; pt then dc'd to home where he passed away
Menstrual cycle thrown off, duration is irregular/Irregular periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101564005 (Pfizer Inc), US-PFIZER INC-202101564011 (Pfizer Inc).  A 14 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 26Jul2021 (Lot number: EW0168, Expiration Date: Aug2021) at the age of 14 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acne" (unspecified if ongoing). Concomitant medication(s) included: ERYTHROMYCIN taken for acne. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Aug2021, outcome "unknown", described as "Menstrual cycle thrown off, duration is irregular/Irregular periods". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstruation irregular.  No follow-up attempts are possible. No further information is expected.
Initial physician report received on 13 Aug 2010: This patient was vaccination with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml) intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error.
pt recv vax 25AUG95 & approx 1mo later pt exp chickenpox which subsequently resolved;approx 1yr later pt exposed to wild-type varicella in school;1AUG96 pt exp zoster type rash on bilat lower extremities;
pt recv vax & noticed arm itched @ site of inj;did not exp joint pain but did run a sl temp;nodule also noted @ inj site;a red sl raised 2x1 ring noted around inj site;
20MAR96 pt recv vax & c/o arm hurting since;took APAP w/o any relief;mom states has been crying w/arm/shoulder hurting;also has had fever;22MAR96 bruised area @ site of inj only-referred to MD
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 20-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient developed redness and tenderness at site of injection. Area grew up a 6" x 3" hard bump. Was treated with hydrocortisone and BENADRYL creams and the area cleared up over 5 days.
Patient came into pharmacy to receive her second Pneumococcal vaccine (Pneumovax 23), pt was administered Prevnar 13 inadvertently.  No adverse affects, no malaise.
pt recv vax & about 20-30min later mom back in office w/pt w/hives on face & trunk was coughing persistently;sent to ER given DPH;
felt like she had the flu; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient. A female patient of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she saw a lady on tv got her second dose of the pfizer COVID 19 vaccine and the lady said on an unknown date, she felt like she had the flu after the second dose. The reporter wanted to know if the side effects to the second dose were worse than the first dose. The reporter wanted to know if the different phases of the vaccine distribution were the same vaccine and stated the information provided was very appreciated. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.