chrisvoncsefalvay/vaers-outcomes huggingface dataset:
there was a tender area on my left breast that became more painful and I could feel a mass; there was a tender area on my left breast that became more painful and I could feel a mass; the mammo turned diagnostic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2021 as dose 1, single (Lot number: EW0191) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Degenerative Disc Disease" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies:Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Skelaxin, reaction(s): "Known allergies: Skelaxin". The following information was reported: MAMMOGRAM ABNORMAL (disability) with onset 18Jul2021, outcome "not recovered", described as "the mammo turned diagnostic"; MASS (disability), BREAST PAIN (disability) all with onset 18Jul2021, outcome "not recovered" and all described as "there was a tender area on my left breast that became more painful and I could feel a mass". The events "there was a tender area on my left breast that became more painful and i could feel a mass" and "the mammo turned diagnostic" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: (18Feb2022) Negative, notes: Blood test; Mammogram: (Jul2021) stable, notes: This is concerning as I just had a stable mammogram 1 week prior to the first vaccine; (03Aug2021) Unknown results, notes: Unfortunately, the mammo turned diagnostic; SARS-CoV-2 test: (28Feb2022) Negative, notes: Nasal Swab; (31May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of mass, breast pain, mammogram abnormal. The vaccine was administered in hospital. The patient did not receive any other vaccine in past 4 weeks.  Clinical course: Three days post first vaccine, there was a tender area on patient's left breast that became more painful and patient could feel a mass. This was concerning to patient as she just had a stable mammogram 1 week prior to the first vaccine. Patient contacted her GP and he ordered another mammogram, which was performed 03Aug2021 (2 days before the 2nd vaccine was due). Unfortunately, the mammo turned diagnostic. Since that time, the situation escalated and patient since had 2 general anesthetic procedures, multiple in-office local anesthetic procedures and now another procedure in the next month to remove a significant portion of my breast including the nipple.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The pharmacist was the vaccine coordinator for pharmacy in her area. She had no details about the patient. The age at vaccination was not reported. The patient had no history of shingles. This case has been linked with the case US2018166391, reported by the same reporter.
I started to have muscle weakness to where I could not even stand, and then my muscles went weak and tingling from my waist down to toes and from my wrist top my fingers. Extreme muscle weakness and I am unable to walk without a walker.
Temp beginning 1-2 hrs after injection 99 reaching 104.8 by 10pm unable to bring down. Lethargy.
got the shots and have had more breakouts than before / Suspected Vaccination failure; had more breakouts than before. Got about 4 that time.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles (patient had shingles for about 6 years).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient would get a break out about every 3 weeks. The patient got the shots. After the first shot went a month and was feeling good and no headaches (which are daily). Then got the second shot and have had more breakouts than before. Last time as soon as one spot cleared up I had another one. Got about 4 that time. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Recvd vaxs 22Mar90;evening of next day had fever(not measured)red"splotches"on arm from shoulder halfway to elbow.C/O arm hurt,child felt ill.Given APAP&Benadryl.Next day rash improved,felt warm to touch,pt felt better.Rash resolved 25Mar91
NauseaVomiting Muscle aches, joint pain, vivid dreams Narrative:  Other Relevant History:
Case number PHEH2016US008614 is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 8 year old male patient. Medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELAX (batch number: 174087A) intramuscularly on 02 Dec 2015 instead of FLUARIX (manufacturer unknown, batch number: 9JX2N, expiry date: 16 Jun 2016) on an unknown date. No adverse event was reported following this maladministration. It was reported that, there were no reported adverse reactions or event of the FLUCELVAX. Follow up information received from nurse on 22 Jun 2016: Added new suspect drug FLUARIX and its details (lot number and expiry date), added new event (wrong drug administered), deleted the event inappropriate age at vaccine administration and updated narrative accordingly. Follow up information received from nurse on 23 Aug 2016: Updated reported comment.
vaccine syringe was mistaken for PPD syringe and given subcutaneously in right forearm
Patient stayed for the 15 minute time period. Five minutes later her tongue became completely numb. She also stated that her friend described her as flushed. This occurred for almost one hour and then resolved on its own. This numb tongue sensation is not abnormal for this patient as it has occured when she eats seafood.
Case number PHEH2014US016306 is an initial spontaneous report received from a nurse on 11 Aug 2014, with the follow-up received from physician on 19 Aug 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with a dose of MENVEO  (batch number: not reported) intramuscularly on an unknown date. It was reported that after vaccination, she complained of throat closing up and she was transported to the emergency room. The event outcome was unknown. The seriousness and causality were not reported. Upon the follow-up, physician reported that, patient did not receive the MENVEO. The patient received Sanofi Aventis product MENACTRA. Therefore case would be deactivated. Follow-up received from physician on 19 Aug 2014: Upon the follow-up, physician reported that, patient did not received the MENVEO. The patient received Sanofi Aventis product MENACTRA. Therefore the case would be deactivated.
A week after vaccine, I experienced my right arm hurting and having tingles. This has not gone away and I currently feel my right arm still not the same way it was before the vaccine.
4-6 inch red, hot to the touch area at injection site, did not contact dr, took benadryl, went away in about a week
flu like symptoms; This is a spontaneous report from a contactable Other-HCP and a contactable consumer. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Since starting therapy the patient had been having slight headaches and neck pain at times symptoms come and go and not bothersome also reported that she has received her covid-19 vaccination, and experienced flu like symptoms on an unspecified date after lasted about 24 hours then went away without medical intervention. The patient agreed to monitor her symptoms and notify the physician if her symptoms persist or worsen. Treatment regimen was given as a result of the adverse event. The outcome of event was recovered on an unspecified date.   Follow-up attempts completed. No further information expected.
IPV was ordered. Pt was supposed to receive PREVNAR. Pt received IPV as ordered. Mother of child notified that incorrect vaccine was ordered/administered. No adverse event occurred.
Next day had ringing in my left ear- Tinnitus  Ringing has not stopped
Fever 101 + 4 days;Tightness in chest + 6 days;Headaches + 5 days;Tiredness + 6 days;No appetite + 6 days (lost 3lbs);Cannot exercise without losing breath and chest tightness day 5 Sleeps 14 + hours on and off;Lethargic + 6 days.
Information has been received from a registered pharmacist concerning an 81-year-old male with no known allergies who on 28-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included aspirin.  On 29-JAN-2008 the patient experienced bloating, gas, burping, flatulence and difficulty breathing following vaccination. The patient sought medical attention via an office visit.  On an unspecified date the patient had an "unspecified blood test" performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Miscarriage; Sore arms and lymph nodes; Sore arms and lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 14:30 (Lot number: ER8736) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 12Mar2021. The patient was 7 weeks pregnant at the time of exposure to bnt162b2. The patient is expected to deliver a baby(s) on 16Dec2021. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 08Apr2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Miscarriage"; PAIN IN EXTREMITY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Sore arms and lymph nodes". The events "miscarriage", "sore arms and lymph nodes" and "sore arms and lymph nodes" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abortion spontaneous, pain in extremity, lymph node pain.Clinical course: If other vaccine in four weeks was reported as no. if Covid prior vaccination and if Covid tested post vaccination was reported as no.  No follow-up attempts are possible. No further information is expected.
Pt arrives with 2 weeks of covid and was on 5 day of steroids. Pt has been off steroids for a few days now. Pt blood sugar has been rising due to this and in the 300s. Pt is a smoker and has no plans on stopping. Pt has not been on abx. Pt has had covid vaccine. Pt has lost smell and taste. Pt room air sat was 88%. Pt has no chest pain> pt is on coumadin for history of dvt. pt is not a good historian.
Patient reported pain in hand and arm. Described as athritis like pain at first then swelling in arm and pain in hand radiating up her arm. Swelling went down in upper arm but she then notice swelling in her forearm. Presented 11-25 and seemed to not be under any apparent distress but complained of some lingering pain.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Things were relatively mild, headache, joint pain, fatigue, nausea. they continues for about 4 days and I felt good again (by 02/15/222). On 02/13/2021 I developed conjunctivitis.
Dull headache and tired immediately following injection on 2/27 and throughout the day.  Then at 1am that night(2/28), started having sharp stabbing pains in left arm, back, neck and left side of jaw.  Very weak and chilled.  No fever.  Symptoms lasted until about 4pm on 2/28 then started to subside and mostly gone by 2/29 A.M.  Continue to have sore arm at the injection spot.
Itchy rash along collarbone on both sides that lasted approximately 10 days then went away for about 10 days then returned for approximately 20 days.  After rash disappeared, I began experiencing severe pain in most every joint...Both shoulders, both wrists, hands, fingers, hips, and knees.  Saw a physician after about 6 weeks.  Had blood work done.  Put on prednisone for 2 rounds and now have an appointment with a rheumatologist.
HAS NOT HAD A MENSTRUAL PERIOD FOR 7 MONTHS; This spontaneous report received from a patient via a company representative concerned a female 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: Unknown) dose, start therapy date were not reported 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 patient experienced has not had a menstrual period for 7 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of has not had a menstrual period for 7 months was not reported. This report was non-serious. This case, from the same reporter is linked to 20210818191.
Stated he got weak and nauseous about 30 minutes after flu injection. EMS reported this to me. I called him later that day and he said he was fine and did not go see a doctor.
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient) via . A 55-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jul2021 14:30 (Batch/Lot number was not reported) at the age of 55-years-old as single dose for covid-19 immunisation. Medical history was none. No family medical history relevant to the event. There were no concomitant medications. No prior vaccinations (within 4 weeks). No history of previous immunization with the Pfizer vaccine considered as suspect. The patient got the first dose of the Pfizer Covid-19 vaccine and about a month later she actually got Covid. On 31Aug2021, she thought it was sometime around there, she tested positive for covid. She wanted to know what was the longest time between the first and second dose and if she should get the second dose or start over.  The event did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included Covid test on 31Aug2021: positive. Outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Received Hep A vaccine, walked back to work and dressed in PEP to start work in animal room; he started to feel hot and sweaty, dizzy, and fatigued.
This spontaneous report was received from a nurse referring to a 5 year old patient of unknown gender. On an unknown date the patient was vaccinated an expired dose of with PROQUAD lot # M002053 (expiration date: 11-JUL-2017) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event reported.
Started losing his hair in the front of his head. By June 28,2016 he had many bald spots all over his head. By July 23,2016 his hair was completely gone. By September 7, 2016 he had no hair anywhere on his body including eye lashes and eye brows. He is currently being treated with Clobetasol Propionate topical solution. He has been on this about 2 months it is not working thus far.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the improperly stored dose of PNEUMOVAX23 (lot # N003993 and expiration date 20-OCT-2018; dose and route of administration were not reported) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 72 degrees Fahrenheit for 18 days. Data logger was not involved. There were no previous excursions reported.
Easy bruising for a few days after the PCV 7 shot.  Patient has cutis marmorata telangiectatic congenita.
pt recv vax & 7-14 days p/vax pt broke out in chickenpox;mom reported rxn to drug company;mom did not call clinic;
administered on 12/Jul/2021/expiration date of 05/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired Bexsero vaccine. The reporter consented to follow up.
Patient stated that the night of 8/10/18 her right arm was red, swollen, and itchy. At home patient was using an ice pack. When patient came into the health center (8/11 at 1:15 PM) the redness was decreased and was no longer itchy. Treatment from health center was to continue with ice packs and take ibuprofen, return to center if symptoms get worse.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 24-SEP-2015, the patient was vaccinated with an improperly stored doses of VAQTA (dose, route, lot number and expiration date were not provided). The vaccine was exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mother states: "uncontrollable" rying x 2 hours, fever ?101. Pt apparently talked but doesn't anymore. His mouth doesn't work. This lasted at least a week.
Pt called in for nurse triage d/t increased heart rate 130-150, severe headache, chest pressure. Pt did not obtain vaccine via our clinic. Pt unable to provider lot #
She received her booster shot two months early. I followed up with her days after her shot and she reports that she is completely fine. Aside from a sore arm, she had no other symptoms or issues. She was confused by the vaccine mandate the the hospital has for everyone to get their booster shot by 3/1/22. She didn't understand that it didn't apply to her.
Patient stated he had a PREVNAR 13 and flu immunization on Monday. He reports on Tuesday he began to have flu-like symptoms, and a low grade fever. Patient c/o having a rash around his waist, forearms and chest. He reports his temp last night was 101.2, and today it is 99. Patient stated his joints are achy, pain 2/10. Ibuprofen 800 mg BID.
Pox located on stomach and chest of child on 11-03-04.  No temperature or itching noted.  "Acting normal" per grandmother.  No treatment.  Did seek physician diagnosis at clinic (grandmother is an MA).
I had all of the standard expected side affects of chills, fever, muscle aches and headache beginning 10 hours after vaccination.  The headache persisted until Friday however the unlisted side affect of the all body muscle trembling/spasms began on Friday evening 4/2/21 and is still continuing as of 4/5/21 as I write this.  I will not be able to get to speak to my Dr. until Friday 4/9 due to his vacation.  The nurse was not helpful today and suggested I go to a walk-in clinic.
Malaise and fatigue - ED visit and then Biliary obstruction due to malignant neoplasm, ED visit to hospital admission. These visits were within 6 weeks of receiving the COVID vaccine.
PATIENT REPORTS THAT HER ARM BECAME SWOLLEN AND PAINFUL THE EVENING AFTER HER VACCINE AND DID NOT SUBSIDE FOR 1 WEEK. THE SWELLING AND PAIN WENT FROM THE TOP OF HER ARM TO HER ELBOW. MOVEMENT AND SHOULDER WAS UNAFFECTED. SHE ALSO REPORTS THAT SHE HAD A FEVER THROUGHOUT THE SAME WEEK. SHE DID NOT TAKE MEDICATIONS OR DO ANYTHING TO RELIEVE THE SYMPTOMS. AFTER 1 WEEK SHE SAYS THAT IT RESOLVED AND THERE ARE NO MORE SYMPTOMS.
Patient was given 1 DTap, 1 IPV, 1 Hepatitis B, and 1 MMR at about 5:15 PM.  Father had denied any illness in the last 24 - 48 hours, or any reaction to previous vaccination.  His English was broken and understanding minimal.  Family had just arrived in this country on 12/01/04.  Patient tolerated the vaccination well, did not cry or resist, was quiet.  After the shots, she sat on her dad's lap back in the waiting area.  The sponsor came over to me to tell me that she was nauseated.  I brough the safety bag and smelling slats with me to the child.  Patient was pale and vomited a small amount of phlegm. RN came over to assist, and we decided to have her carried over to the corner to lie down on the floor.  BP 64/40, P 44.  She fainted.  I called 911 at~5:26 pm while smelling salts were used.  She aroused ar ~5:27 pm. P was 60. At 5:30 pm BP 94/60, pulse 60. Bangs ambulance arrived at ~5:33 pm.  Child evaluated, given 02 by Bangs.  Responsive.  Meanwhile an interpreter arrived and we determined that the child was in no pain but was scared.  Child had not eaten since 1 pm.  She sat up on her dad's lap and drank one whole glass of orange juice, didn't vomit or get nauseated from it.  Dad states that she has been extra sleepy in the last few days.  Bangs crew thought that child did not need transport to ED, but Dad concerned, so Bangs took her to the hospital ED with dad and interpreter.  She was seen at ED for syncopal episode and released.