chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Piercing eye pain; Swollen/red left eye; Swollen/red left eye; Extreme photophobia; Body wide muscle pain; Fatigue; Increased dry mouth; GI upset; Nasal congestion; Wheezing; Shortness of breath; This is a spontaneous report from a contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse)  received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9262,), via an unspecified route of administration in left arm on 21Jan2021 at 16:45 as a single dose, for COVID-19 vaccination.  The most recent COVID-19 vaccine was administered at a Workplace clinic. Medical history included rheumatoid arthritis dry eye, hypertension, anxiety and asthma. Concomitant medication included lisinopril (LISINOPRIL), paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), iron (IRON), oxymetazoline hydrochloride (CLARITIN ALLERGIC), montelukast sodium (SINGULAIR). No other vaccines were given within 4 weeks. . Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received the first  dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number:PFR-20364-01; in the right arm on 29Dec2020, at 09:00.  On 22Jan2021 at 05:00, the patient woke the day after at 5AM with piercing eye pain along with swollen/red left eye.  extreme photophobia. body wide muscle pain. fatigue. increased dry mouth. GI upset. nasal congestion. Wheezing. Shortness of breath. No treatment was received given for the events. The clinical outcome of piercing eye pain along with swollen/red left eye.  extreme photophobia. body wide muscle pain. fatigue. increased dry mouth. GI upset. nasal congestion. Wheezing. Shortness of breath was recovering.         Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No  Allergies to medications, food, or other products:no Vaccine Facility information available. Ethnicity information is available. Race information is available.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 31-AUG-2015, the patient was vaccinated with VAQTA (lot # L001445 and expiration date 15-FEB-2016) (dose and route were not reported) which were improperly exposed to the following conditions. 25-AUG-2015: 30.2F for 4 hours 30 minutes; 26-AUG-2015: 31.6F for 5 hours; 27-AUG-2015: 33.4F for 2 hours 45 minutes; 28-AUG-2015: 33.8F for 1 hour; 29-AUG-2015: 32.9F for 1 hours 30 minutes; 30-AUG-2015: 33.0F for 2 hours 15 minutes; 31-AUG-2015: 33.6F for 4 hours. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Approx. 36 hours later she noticed warm, red swollen area approx 3 to 4 inches wide then almost 3 days later developed little white pustules about like pimples just in the area.
raised skin after administration; red, area after the administration; tender, and hot area after the administration; hot area after the administration; knot unther the skin; This case was reported by a nurse via other manufacturer and described the occurrence of injection site swelling in a male patient who received HAV (Havrix) (batch number B23EA, expiry date unknown) for prophylaxis.   On 21st January 2022, the patient received Havrix. On an unknown date, less than 3 months after receiving Havrix, the patient experienced injection site swelling, injection site erythema, injection site tenderness, injection site warmth and injection site induration. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site tenderness and injection site warmth were recovered/resolved and the outcome of the injection site induration was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, injection site warmth and injection site induration to be related to Havrix.     Additional Information: GSK Receipt Date: 14-Apr-2022 Reporter's comments: The patient received Havrix in the left upper anterior lateral thigh. The patient experienced a raised, red, tender, and hot area after the administration of Havrix that was 2 inches in diameter. The patient still had a knot under the skin. The physician recommended treatment with a warm compress. The patient was fine except that the patient still had a knot under his skin and no further recommendations from the Physician was provided.  No additional adverse events reported. No product quality complaints reported. No further details were provided.
Day 2, swelling, and sore on the base of my neck over a vein on the same side as the injection. (left side) Day 8, "COVID ARM" Itching, redness, swelling and tender at the injection site.
A LITTLE TIRED; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a little tired. This report was non-serious.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: rash, swelling of skin areas, itching, rash on face and scalp
Redness at injection site, slightly raised area approximately the size of a quarter, and warm to the touch. Afebrile. Saw Provider via Telemedicine.
Patient experienced chills, shivering, and polyuria starting 6 hours after vaccine was administered. The chills and shivering lasted for one hour.
4 and a half days (108 hours) after receiving a first dose of the Pfizer vaccine, I woke up at 12:30 a.m. and upon sitting up in bed experienced vertigo-like dizziness, which continued for about a half hour until I realized I was likely to vomit, though I had no feeling of nausea. I had no fever. In the 4 and a half days leading up to last night?s adverse reaction, I had neither eaten nor done anything whatsoever unusual. The vomit itself was very dark in color. I was able to fall back asleep after a half hour or so, and on awakening around 7 a.m. felt dizzy again upon sitting up in bed and began experiencing tinnitus, which is as yet ongoing as of 7 a.m.
Headache, Myalgia, Arthralgia, severe pain at injection site; chills. Narrative: Then 11 days after injection: red and itching at site.
pain in arm, severe pain upper right part of stomach, under rib cage. Blood work taken, ultrasound, complete metabolic panel, Lipase serum, Urinalysis, complete blood count. MRI done of torso, amylase serum, continuous RUQ abdominal tenderness and pain. These abdominal symptoms occurred 12 hours after Pfizer vaccine booster injection. Blood work showed no issues. MRI of liver, gall bladder, report not given out at this time.
shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 12-JAN-2011, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the event. The patient received the treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Patient received immunization at approximately 11:00am. Per patient, around 12:00am she began is develop a pounding headache, nausea, vomiting, diarrhea, chills, fever, sweats, body aches, general weakness, redness and swelling of injection site.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   No adverse effects reported.
Resident developed redness and itching at injection site requiring BENADRYL prn. This developed within 2-3 hours after receiving vaccine.
Patient received the Moderna covid vaccine on 3/11/2021. Starting the day after that, the patient's wife reported that the patient began to display confusion, weakness, and fatigue. The patient also presented to the clinic on 4/2/2021 with complaint of "sinus pressure" and was prescribed an antibiotic. He progressively worsened to the point where he was only able to speak a few words, and presented to hospital on 4/7/2021. Given extremely low platelet count on presentation, a diagnostic workup for TTP vs. ITP was commenced. It was determined by the inpatient hematology/oncology service that the patient was likely experiencing alterations in mental status and weakness and thrombocytopenia due to TTP.  Fresh frozen plasma was administered. Plasma exchange daily x 5 days and corticosteroids were initiated.
Excessive fatigue; Malaise; Patient is post menopausal and restarted me stuck cycle; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced excessive fatigue, malaise post vaccine and also patient had post-menopausal and restarted her stuck cycle. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.; no adverse event; The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.), PRODUCT STORAGE ERROR (The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.) 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. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-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 20-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.), PRODUCT STORAGE ERROR (The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.) and PRODUCT STORAGE ERROR (The bivalent booster was administered 32 days after being stored in the refrigerator beyond use date 18-Jan-2023.).    This case belongs to 3 of 3 patient. Concomitant product use was not provided by the reporter. Treatment information was not provided.
15 minutes after the patient received the vaccine she began feeling light headed. She experienced leg numbness. She said that she felt that if she had to stand up that she would fall over. patient has felt this prior when she over took her seizure medication or when she takes her medication early in the morning. We gave the patient orange juice and water. We checked her blood pressure, oxygen, and heart rate. Patient then stated her throat felt like it was getting tight. We then gave the patient 25 mg of chewable benadryl. Patient did not have difficulty breathing. Patient was monitored for over an hour after vaccine administration
Running 102.1 fever,                 Very sick Feeling Throwing up Very achy in the legs Very fatique Pain in Arm
Patients administered from vaccines that experienced a Temperature excursion; Patient received vaccine from a vial which came across temperature excursion with duration of 7 hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered from vaccines that experienced a Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine from a vial which came across temperature excursion with duration of 7 hours) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine from a vial which came across temperature excursion with duration of 7 hours). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered from vaccines that experienced a Temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered from vaccines that experienced a Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine from a vial which came across temperature excursion with duration of 7 hours) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter informed that an excursion occured about a month ago, at the time she didn't ask for a stability report but now she has been asked to send the stability report, The reporter also mentioned that the excursion duration was 7 hours instead 5.  Date of temperature excursion was 10-Mar-2022. Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vaccine was stored in refrigerator at the time of the excursion. There were no changes in visual inspection. Pertinent details: At the time they were unpunctured. Vaccine was administered on 16-Mar-2022 and vials were returned to the refrigerator. Tran date was 16-Mar-2022.The patient did not experience any adverse events post injection.   This case was linked to MOD-2022-54617.
Slight pain on the site of injection; Lymph node might be little bit swollen and that's what I am experiencing right now; Lymph node under the arms where I got the vaccine, It was hurting; Feeling a like little feverish, I do not think I have a temperature; This is a spontaneous report from a contactable Consumer or other non-health professional (patient). A 51-years-old female patient received BNT162B2 (Batch/Lot Number: ER2613; Expiration Date: Jul2021, NDC number and UPC number were unknown), dose 1 via an unspecified route of administration, administered in Arm on 20Mar2021 (Age at vaccination 51 years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension Verbatim Blood pressure high from unknown start date and unknown start date. Concomitant medication(s) included amlodipine besilate (NORVASC) it's 5, omeprazole (OMEPRAZOLE) it's 40, cevimeline (CEVIMELINE) 30 mg start date and stop dates were not reported. The patient reported that I got the first COVID vaccine this past Saturday and I did not have really any feeling for anything on Saturday, but Sunday on 21Mar2021 the patient experienced slight pain on the site of injection (injection site pain) which was then cleared up but then I read on the sheet that I was given that, well the pain of the site, I do not have that pain anymore, lymph node might be little bit swollen and that's what I am experiencing right now; lymph node under the arms where i got the vaccine, it was hurting, the patient stated that I noticed that my lymph node under the arms where I got the vaccine, It was hurting, it's not hurting as much as it was, it seems like it starting to go down and I just feel, feeling a like little feverish, i do not think i have a temperature, But he was just calling to see you know like how long these symptoms should last 21Mar2021. The patient underwent lab tests and procedures which included weight: 199 lbs on I think I am at 199 (pounds). The outcome of the event slight pain on the site of injection and lymph node might be little bit swollen and that's what I am experiencing right now was recovering, while the outcome of the event feeling a like little feverish, I do not think I have a temperature was unknown  No follow up attempts are possible. No further information is expected.
Patient had a high fever - over 104 degrees as documented by ER doctor using temporal thermometer. From day 6/7 to 10) she was listless and drowsy and extremely irritable. Treatment could only be for fever - TYLENOL & ADVIL. Followed with rash all over body on day 10.
Bruising on shoulder, leg, stomach three weeks after vaccine Platelets dropped to 3 ITP diagnoses.
Information has been received from a healthcare worker (also a medical assistant) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients was vaccinated with doses of improperly stored GARDASIL 9 (lot # K026247 with expired date 29-JAN-2017, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.
Patient received shot on 8/30/19 at approximately 2:40pm. She reports starting to get reaction that night. Then the following day Saturday, then area below the injection site was extremely swollen, red, tender, and hot to the touch. On Sunday, the reaction improved but the area was still swollen and tender.
first dose expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On 14th September 2021, the patient received the 1st dose of Shingrix. On 14th September 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient was inadvertently administered first dose of Shingrix vaccine from expired supply, which led to expired vaccine used. The reporter consented to follow up. This case was linked with cases US2021197373, US2021197375, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021197373:Same reporter US-GLAXOSMITHKLINE-US2021197375:Same reporter
Red, raised bump. (L) thigh noticed 1-2 days per Mom. Nickel sized. Noticed 3/26/12.
Rec'd vaccine 3PM 6/23/06, about 24 hrs later started to get red at injection site enlarging from 24-48hrs after injection.
blotchy spots on both of my arms; my arms look a little puffy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (blotchy spots on both of my arms) and PERIPHERAL SWELLING (my arms look a little puffy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Edema since an unknown date and Surgery (Cataract Surgery 2 days ago).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced RASH (blotchy spots on both of my arms) and PERIPHERAL SWELLING (my arms look a little puffy). At the time of the report, RASH (blotchy spots on both of my arms) and PERIPHERAL SWELLING (my arms look a little puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided.
Pt recvd 1st dose of Engerix-B 31OCT91 & 24 hrs p/1st dose of vax exp hives; reporting pt indicated that a MD was called to treat the event; tx w/Pred; event lasted for 3 days;