chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid-19 test/tested positive again; COVID-19 virus test positive; This is a spontaneous report from a Pfizer sponsored reported by a contactable female consumer (patient) reported for herself.  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 24Feb2021 at a single dose for covid-19 immunisation. Medical history included covid 19 from 01Dec2020 to an unknown date (got infected with Covid-19 last year December 1). The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 on 05Feb2021 at a single dose for covid-19 immunisation. The patient tested positive after getting the 2nd dose of the covid-19 vaccine in Feb2021. She underwent a covid-19 test on 15 Mar2021 and tested positive again. The events were considered serious with seriousness criteria medically significant. She wants to know why she was tested positive. She had the 1st dose last 05Feb2021 and 2nd dose was on 24Feb2021. The outcome was unknown for the events.  Information on the lot/batch number has been requested.
Thickening of blood.  Diagnosed with Polycythemia Vera 10/4/2021
Anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccine dose (Gardasil). This was dose #2. Dose #1 was given on 6/8/2011 with no reported adverse effects.  Pt was seen in local ER. She was intubated and transferred to ICU on 29 May 2012. She was extubated on 30 May 2012. The plan is to transfer her from the ICU to the regular medicine ward for observation later today if she continues to do well. Currently, this is hospital day #2. No other exposures were thought to be responsible for her signs/symptoms.
Covid pfizer Bivalent  6months-4 years, vaccine was undiluted at time of admin.
40 minutes after receiving vaccine had severe warmth and intense redness to the face and scalp with increased heart rate. Returned to clinic immediately. Vital signs monitored and suggested transport to ER. Family member drove me to ED. Treated in ED and received IV push Prednisone and Benadryl.  Discharged  3 hours after being treated in ER. Severe redness subsided after receiving Benadryl and Prednisone.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: Rash/Shingles
Information has been received from an RN concerning a 16 month old white female with a history of premature birth at 34 4/7 weeks and no known drug allergies who on 7/20/01, in the morning, was vaccinated, IM, in the right thigh, with a 2nd dose of MMRII (lot 633597/1657J). There was no concomitant medication. It was reported that on 4/13/01, at 13 months of age, the pt was vaccinated with the 1st dose. This does not comply with the recommended administration schedule. There was no adverse event reported. Follow-up information from an RN indicated that the pt was seen on 7/23/01 with a low-grade fever, a rash on her trunk and occasional loose stool. On 7/27/01, it was reported that "the rash left in a few days as well as the loose stool". The nurse stated that there was "no untoward effect from the 16 month injection noted". She also indicated that the child had a well baby visit at 18 months and "received appropriate 18 month immunizations". No further information is expected.
Patient is a 46 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Moderna vaccination in the right deltoid muscle.   During her 30 minute waiting period after the injection, the patient began to experience migraine.  She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, itching, lightheadedness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality .
Lost hearing in left ear, same side as shot. Came back 2 days later. Right side of neck sore for 2 weeks.
irritation to arm at injection site: redness, swelling, blister/whelps. patient indicates symptoms at worsening by day rather than improving.
Redness, itching, bumps on arm administered. On 10/03/2016 patient received a FLUZONE intradermal flu shot in her right upper arm and Tdap (ADACEL) injection in her right upper arm. Subsequent patient states she developed a erythematous itchy dry rash in the area of the injection. Patient also states she had a separate rash mostly on her upper extremities she feels is consistent with poison ivy. This rash has subsequently resolved but the rash of her upper arm where the injections were given has persisted. She feels that she was exposed to poison ivy from her husband who was out hunting. Patient denies any other associated symptoms, such as fevers chills nausea vomiting diarrhea or constipation. Patient is use several different topical Ivy dry and over-the-counter cream and lotions on this area for symptomatic relief this has not improved the rash. The location of the rash has been continuous and he continues to have the same appearance to her. SKIN: Details: On the patient's right upper arm the patient has a diffuse erythematous fine prior rash. Appears to be some very fine areas of telangiectasias in the rash and the overall size of the rash is approximately 15-18 cm. The rash is not palpable. There is no tenderness or point tenderness noted in the injection site. There are no surrounding areas of vesicles or open draining areas. There is some secondary signs of excoriation from her scratching at it. There is no signs of increased warmth or infection.
About 48 hours after receiving the vaccine the patient started to experience chills and sweating. About 63 hours after the chills and sweating was more extreme. patient had a fever of 103.9 degrees. Patient did take Tylenol for the fever. The next day the patient stopped experiencing chills and sweats. Felt better but a little weak. Per wife patient had an episode which prompted her to take him to the emergency room. Patient had developed a kidney stone that caused sepsis. Wife wanted to report the reaction suspecting the vaccine may have contributed to the kidney stone.
Erythema and hive on the site of VARIVAX and Hep A injection (Rt thigh). Erythema on the site of MMR injection (left) thigh.
After receiving Hepatitis A vaccination on left arm, within several seconds patient stated she felt light-headed, slumped over and became unresponsive for several moments.  Patient may have had a seizure.  Patient was stabilized and released to father to see a private physician.
She received vaccine 7/31. On 8/4 she began to have joint aching, nausea, diarrhea, fever and then a low-grade cough. When she came to ER she had temp of 101, rapid A. Fib and a RUL infiltrate. Treated for CAP but no organism identified and fever persisted 4 txs with IV LEVAQUIN.
IN THE 15 MINUTE WINDOW AFTER VACCINATION PATIENT DEVELOPED SWELLING AND REDNESS ON HER RIGHT LEG, THAT WAS WARM TO THE TOUCH. PATIENT HAD AN INCREASED BREATHING RATE, AND REPORTED FEELING STRANGE. PATIENT WENT TO ER, ER CONFIRMERD SWELLING IN LEG WAS NOT DUE TO A CLOT. PATIENT TOOK BENADRYL.
HIVES AND RED SPOTS ALL OVER BODY, DESCRIBED AS REACTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced hives and red spots all over body, described as reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives and red spots all over body, described as reaction was not reported. This report was non-serious.
Redness over her neck, jaw, and face; Itching over her neck, jaw, and face; Hives over her neck, jaw, and face; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness over her neck, jaw, and face), PRURITUS (Itching over her neck, jaw, and face) and URTICARIA (Hives over her neck, jaw, and face) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced ERYTHEMA (Redness over her neck, jaw, and face), PRURITUS (Itching over her neck, jaw, and face) and URTICARIA (Hives over her neck, jaw, and face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness over her neck, jaw, and face), PRURITUS (Itching over her neck, jaw, and face) and URTICARIA (Hives over her neck, jaw, and face) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information received on 02-Aug-2021 contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient was given an expired vaccine. The vaccine expired on 9/13 and was administered on 9/20.  A report with Pfizer was filed (Pfizer case number - 8X40L61H) and the Patient's parent was called and informed. As per CDC guidelines the patient will return to site to received a dose of the vaccine.
family hx-vomiting, t101-104 3hrs p/vax; had abd pain; exam 23AUG95 24AUG95 neuro exam WNL t101, vomiting,lethargic by hx of family; had hallucinations by family hx; oriented and alert on exam by MD
now bump is from shoulder to elbow; looks bruised in the middle; dark outline of red; was itchy; burned; cellulitis; big red bump; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis (vaccination site cellulitis), big red bump (vaccination site reaction), bump is from shoulder to elbow (peripheral swelling), burned (vaccination site pain), looks bruised in the middle (vaccination site bruising), dark outline of red (erythema), and was itchy (vaccination site pruritis).  The patient's medical history was not provided. No relevant concomitant medications were reported.       On 03 Feb 2021 the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 10 Feb 2021, The patient experienced vaccination cellulitis (big red bump) and pruritus (itchy) with seriousness criteria of hospitalization  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event is unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded.
Hives (face/neck/truncal area) within several minutes of Varicella vaccination.  No wheeze/SOB/anaphylaxis, vitals WNL.
Painful lymphadenopathy (cervical, supraclavicular), unilateral on same side of injection. Began on Day 5-6
flush; lips tingling; heart was racing; high blood pressure; Felt dizzy; A spontaneous report was received from a physician concerning a 47-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness/dizziness, flushing/flushing, lips tingling/ paraesthesia oral, heart racing/palpitation and high blood pressure/hypertension.  The patient's medical history, as provided by the reporter, included sleep apnea. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (011L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient immediately began to experience dizziness. He also reported being flush, lips tingling, a racing heart and increased blood pressure. Treatment for event included loratadine.    Action taken with mRNA-1273 in response to the events was not reported.   The events, dizziness, flushing, lips tingling, heart racing and high blood pressure, was considered recovered/resolved on 04 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, further information has been requested.
Stiff arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff arm) and VACCINATION SITE PAIN (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff arm) and VACCINATION SITE PAIN (Sore arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff arm) and VACCINATION SITE PAIN (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and medication information provided.   No treatment information provided.  The more patient  used the arm the better it got.   This case was linked to MOD-2021-380920 (Patient Link).
Patient required proof of immunity to varicella for school. Titers done 6/26/14 - not immune. Varicella vaccine administered 7/10/14. 7/21/14 -positive preg test. LMP 6/6/14 per patient. Pt reports she did not know she was pregnant at time of vaccine.
Arm is swollen and burning; Arm is swollen and burning; Red across her arm; Injected her subcutaneously instead of intramuscularly; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm is swollen and burning), INJECTION SITE SWELLING (Arm is swollen and burning), INJECTION SITE ERYTHEMA (Red across her arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected her subcutaneously instead of intramuscularly) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected her subcutaneously instead of intramuscularly). On an unknown date, the patient experienced INJECTION SITE PAIN (Arm is swollen and burning), INJECTION SITE SWELLING (Arm is swollen and burning) and INJECTION SITE ERYTHEMA (Red across her arm). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected her subcutaneously instead of intramuscularly) had resolved. At the time of the report, INJECTION SITE PAIN (Arm is swollen and burning), INJECTION SITE SWELLING (Arm is swollen and burning) and INJECTION SITE ERYTHEMA (Red across her arm) outcome was unknown.            Concomitant medication were not provided. Patient has been icing it for the treatment. The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-043127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Additional Information received on 22-JUN-2021. Reporter's email id was added. It contains non significant information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patients administered temperature excursion doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered temperature excursion doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered temperature excursion doses). On 23-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered temperature excursion doses) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-148248, US-MODERNATX, INC.-MOD-2021-148279, US-MODERNATX, INC.-MOD-2021-106651 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148248: US-MODERNATX, INC.-MOD-2021-148279: US-MODERNATX, INC.-MOD-2021-106651:
113 Bivalent doses administered after the BUD to patients 12 and up.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medicine were reported. No treatment medicine were reported.
Patient noticed sore raised area on the posterior upper part of her arm day after injection (at injection site) about the size of a 50 cent piece. Day two (11/5/09) indurated area was 10 times bigger, red and sore to touch.
Varicella titer on 06/27/2012 revealed pt. non-immune. No varicella vaccine received between then and now. Pt incorrectly received zoster vaccine when they turned 50.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB lot # L044694, expiration date 04-FEB-2018 (route was not provided). Concomitant therapy information was not provided. On unknown dates, the patient received improperly stored doses of RECOMBIVAX HB. No adverse event was reported. At the time of the report, the patients' status was unknown. Additional information has been requested.
arthritis; I can barely dress myself, wash my hair or do any of the everyday things I used to take for granted like bending over to pick up something.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "arthritis"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I can barely dress myself, wash my hair or do any of the everyday things I used to take for granted like bending over to pick up something.".  Additional Information: Patient had been extremely healthy my whole life until I got vaccinated. The first 2 vaccines gave me a mild boast of arthritis, but the booster has made me practically an invalid. I'm 76 so I needed to be careful and heed the covid warnings. Now I am trying to find a solution for arthritis that doesn't say it will give me stroke, heart attack, or death. I can barely dress myself, wash my hair or do any of the everyday things I used to take for granted like bending over to pick up something.  The lot number for bnt162b2 was not provided and will be requested during follow up.
VACCINE RECEIVED ON 1/18/2021 NO S/S OF ADVERSE REACTION UNTIL 1/25/2021 WHEN LEFT DELTOID INJECTION SITE BECAME RED, RAISED AND INFLAMED. ITCHING NOTED TO SITE
Started 4/3 - 4/4. Slight redness and became worse with swelling, itching, more redness. No fever. (L) delt. warm to touch. No open areas or drainage. Prescribed BENADRYL 4/4/18.
Initial misuse report received from a healthcare professional on 11 November 2013.  It was reported that the patient had received FLUVIRIN on 3 October 2013 and FLUZONE on 21 October 2013. No adverse event was reported. List of documents held by sender: none.
swollen hands, fever, chills, strong body aches, weird taste in mouth. Tylenol 500mg every 6 hours for pain and fever. black circle under eyes. fever and hand swelling resolved. Body aches improved. Taste in mouth more noticeable today.
6:20 PM Clients lips were swollen, left eyelid was swollen, red body rash. Had several what looked like "bug" bites on left arm. Mom denied these before imm visit. Were not "wheal" in appearance. Denied difficulty breathing. 630 PM Refer to EMS. Clinic was at fire station with SMS present.