chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial solicited report received from a consumer (online market research respondent) in a study on 04 December 2015. The subject (gender and age were not reported) experienced a reaction on an unspecified date, after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). The medical history and concomitant therapy details were not reported. During a prompted discussion it was reported that, the subject had reacted to the HD vaccine for over the past two years. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
The previous night I had hives. I took Benadryl and when I woke up I had blurry vision. As day went on seemed I could not see out right corner of my eye. After 6 hours at hospital the dark spot disappeared.
rapid heart beat; severe anxiety; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 20Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included allergies: artificial orange in food and anxiety. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) for birth control. The patient previously took first dose of BNT162B2 for covid-19 immunization on an unspecified date; and ammonia and experienced allergies. The patient was not pregnant at the time of vaccination. On 20Jan2021 14:00, the patient experienced rapid heartbeat and severe anxiety. The patient didn't go to the hospital and just worked through it herself as she has anxiety anyway. This lasted for about 4 hours. The patient did not receive treatment for the events. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on 20Jan2021.
Mild headache and mild leg pain started on 4/12/2021 at around 23:00. Leg pain can best be described as cramping, shooting pain in the back of the calf and thigh, at times radiating through the rest of the leg. Headache was a dull throbbing on right side of the head. Pain increased to moderate in both areas in the following days. Headache and Leg pain persisted through 4/23/2021. The leg pain continued to be sharp/shooting/cramping, but the headache transformed from a dull throbbing on the side of the head to a moderate sharp, burning feeling in the temples. This was also accompanied by a burning feeling in the nasal cavity and a "pins and needles"/heaviness feeling around the ears. Pain was not severe enough to be debilitating but required frequent pain medication to manage. The headache and leg pain appear to have ceased as of 4/24/2021.
Rapid heart rate 2 weeks after 2nd dose; Palpitations/PVC 3weeks after 2nd dose.
Administered expired vaccine to 490 to 500 people; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 490 to 500 people) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 490 to 500 people). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 490 to 500 people) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. The pharmacist called about the administration of expired vaccine that were given as booster shot to the patients around 490 to 500 people on the last date of 20 Oct 2021 to 29 Nov 2021. The vaccine was stored in freezer, one to two vials were taken out and placed in the fridge each day as needed. The patient was administered 006C21A (10-10-2021).
positive COVID test after previous negative test 6 days earlier; positive COVID test after previous negative test 6 days earlier; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2020 at 09:00 as dose 1, single (Lot number: EL0140), in left arm and on 06Jan2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myocarditis" (unspecified if ongoing), notes: Myocarditis from 2nd dose of initial Pfizer vaccine. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "not recovered" and all described as "positive COVID test after previous negative test 6 days earlier". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive COVID test after previous negative test 6 days earlier; Positive, notes: positive COVID test after previous negative test 6 days earlier. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient received Paxlovid (Lot number: GA1513) for treatment of COVID-19, the treatment start date was captured as 5May2022 and stop date was captured as 09May2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was ordered a zostavax but accidentally received adult Hep B....... discovered during charting check......
the vaccine spilled out on arm when the plunger was pressed/no AE; plunger of a Fluzone High-Dose syringe becoming jammed after the needle was inserted into the consumer/no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on skin while the plunger was pressed (lot UJ301AA via unknown route in unknown administration site) on an unknown date.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was of actual medication error due to exposure via skin contact. It was also a syringe issue case. It was reported that Fluzone High-Dose syringe became  jammed after the needle was inserted into the consumer. The plunger would not press down while injecting but was able to go down after removal of the needle from the skin, during that time, the vaccine spilled out on patient's arm when the plunger was pressed.  A local PTC number CO2019-00390 was issued.  It was unknown whether adverse event was experienced or not.  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.
Syncopal post vaccination, loss of consciousness, no other issues, awoke in seconds, monitored and left AMA with mom
Patient's mom called and said pt was having trouble breathing.  Advised by pharmacist on duty to go to the ER. Mom took pt to ER. ER stated pt was having an adverse reaction to the flu shot they received earlier in the day. ED physician gave pt steriods.  Pharmacist on duty followed up with family before close and pt was back home and doing well.
Information has been received from a physician concerning a 59 year old female with some airborne allergies who on 10-NOV-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine 0.5 mL. Concomitant therapy included alendronate sodium (MSD) and SYNTHORID. Soon after receiving the vaccination, the patient experienced cellulitis. A couple of weeks after vaccination, the patient recovered from cellulitis. It was noted that the patient sought medical attention. Additional information has been requested.
BUMP; angry looking; itchy; REDNESS AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS (BUMP), EUPHORIC MOOD (angry looking), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ABSCESS (BUMP), EUPHORIC MOOD (angry looking), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE). On 29-Jan-2021, ABSCESS (BUMP), EUPHORIC MOOD (angry looking), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Reported feeling SOB, Chest Tightness, Hoarseness, Stuffy nose.
DEATH; SHEER NIGHTMARE THE SPIKE PROTEINS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up was requested for this case. No concomitant medications were reported.  On 14-JUN-2021, the patient experienced sheer nightmare the spike proteins and died from unknown cause of death on 14-JUN-2021, and the outcome of sheer nightmare the spike proteins was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210633197-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
10 days post vax, the pt developed skin eruptions on legs, buttocks, arms, and face.
Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination. Child Had No ill Effects thus FAR
Pt vaccinated with FLUOGEN developed severe headache approx 15 hrs after injection. Numbness & "drawing" of rt side of face 3 days later. Bell's Palsy.
Fever of 102.9 F, malaise, vomiting, shaking, sores in throat, mouth, lip, none on hands or feet, entire course lasted 7 days. Dr. dx was Hand, Foot and Mouth Disease. This pt only received IPV, .5 ml, single dose vial.
The local public health department hosted a small booster and flu vaccine clinic at an independent health care facility at the request of their director. The director sent out a signup to their clients, who signed up on their own. A client signed up for a booster. She did not have a vaccine card with her, but when we looked her up in the database she had Moderna 1st and 2nd doses documented from February and March. These same dates were also provided by the facility, from their records. I proceeded to vaccinate her with a Moderna booster, what I thought was her 3rd vaccine in the series. Unfortunately, unbeknownst to me, this client had received a Pfizer booster at a local Pharmacy on Saturday 11/06, but had no memory of it. In addition, the health care facility is non-medical, so they did not inform us that this client had early-onset dementia. They only became aware of the issue when the client's daughter called. The director also informed me later that there was a miscommunication between her and the client's daughter. The daughter only wanted her mother to get the flu shot, not a booster. The director admitted that was her mistake, but she had no memory of the conversation. The client's daughter informed me that the client's primary care physician has been notified and recommended that she is closely monitored for the next few days, and should go to the ER if she is not feeling well for any reason.
pt recv vax 14JUN94 & 24JUN94 the pt devel a fever of 103 which lasted for 4 days & generalized measles-like rash; pt recovered 30JUN94;
Upon injection reaction was similar to allergies; runny nose and congestion.  Later in the afternoon and overnight chills, fatigue, body ache.  Left arm at injection site was sore and could not be raised over her shoulder.  Thursday - fatigue and body aches and arm sore.  Friday - free range of movement with arm, fatigue no aches no fever no chills, Saturday same but dizziness like vertigo started; Sunday - irritation on left side of body, left foot itched like a rash but no visible rash; Monday morning left side of neck visibly swollen, right side swollen but not as severe; left foot still itches; vertigo still an issue, patient says it feels like the whole left side of body is swollen.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient has a history of nausea and vomiting after codeine use (manufacturer unspecified) on an unspecified date, and rash after penicillin use (manufacturer unspecified) on an unspecified date. The patient recovered on an  unspecified date. On 28-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, intramuscular. Dose and lot number was not provided. There were no concomitant medications. The patient received ZOSTAVAX via the intramuscular route in error. On 29-OCT-2013, the patient developed pain at the site of the ZOSTAVAX injection. The patient went to see a physician. The patient was given ALEVE (manufacturer unspecified) for the pain on an unspecified date. No lab tests were performed. The patient had not recovered. No reporter causality was provided. Additional information has been requested.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves Adult patient who experienced pertussis since the one member was vaccinated while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect ADACEL lot number not reported via unknown route. On an unknown date, the patient developed a non-serious pertussis since the one member was vaccinated (pertussis) following the administration of ADACEL. It was also a case of actual medication error due to inappropriate age at vaccine administration. (Other relevant tests included No lab data.) Final diagnosis was pertussis since the one member was vaccinated. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for pertussis. 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 and Module VI of the 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. List of documents held by sender: none.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 28-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Diffuse papular rash across body with areas of confluence on cheeks and injection site. Development of symptoms on 8/1/2020 (vaccine given 7/27/2020).
19 days later (following first daytime cardio exercise in ages), chills, stomach pains, bad headache that evening. Okay next day and night but then next two evenings chills (not lasting as long) with eventual headache (more treatable). Okay again today, and will contact Clinic about it in case they want me to get a Covid test before the second vaccine. Concerned that the "reactions" have been so long after the vaccine, and that it was only the first vaccine. Can find no info matching this course of events....
Reported that the patient felt the injection site may have been too high. Reported soreness at the injection site and in the arm/shoulder the next day. This was educated as a potential side effect. Was also educated on the proper location of the deltoid muscle and the proper injection site.
Site reaction with redness and swelling; Site reaction with redness and swelling; This spontaneous case was received on 27-Sep-2021 from other health professional via Communications (reference number: SEQW21-02807) and concerned a 21-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 20-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 38518 and expiry date 30-Jun-2022.    On the same day, after receiving Flucelvax Quadrivalent, the patient experienced moderate to severe site reaction with redness and swelling.  On an unknown date, the patient was treated with unspecified antibiotics.  On an unspecified date in Sep-2021, the patient recovered from both events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked to cases 202103207 and 2021103209 due to same reporter.  Company comment: The events of 'vaccination site erythema' and 'vaccination site swelling' were assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of 'vaccination site erythema' and 'vaccination site swelling' were assessed as related to Flucelvax Quadrivalent.
Patient reports burning type pain in upper shoulder and neck 24 hours after receiving vaccine dose.  Patient says she is having difficulty sleeping. and limited mobility of her arm.
Vomited 5x on 4/6/11 - Mom heard choking sound & found baby not responding & ? difficulty breathing. Went to ED by ambulance was discharged but returned having had seizure.
I noticed swellness in my foot, and I had difficulty walking around. It got to the point I was not going up and down my stairs or getting up from my chair. I went to the doctor and he looked at my foot and he prescribed 10mg Prendizone (steroid). I took that and the inflammation subsided. It got to a more acceptable level. I now take Tylenol for the pain and discomfort and I am not sure if it will resolve. I am not even sure if it is related to the vaccine. However, I am not fully functional as I was before the booster vaccine.  Also to note my temperature never goes above 98 degrees. It didn't with any vaccine I have ever taken, and neither with the first 2. However with the booster, I did have a slightly elevated temperature which I found odd. Nothing to major, but odd since I never have a higher temperature.
No additional AE; HCP called to report inadvertent administration of an expired dose of MMR II. MMR II expired on 6/3/2023 and was administered on 6/7/2023.; This spontaneous report was received from a registered nurse referring to a 12-month-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 07-JUN-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) injection (0.5 ml, lot#: U017524, expiration date: 03-JUN-2023; strength was not reported) orally for prophylaxis (expired product administered). No adverse effects were reported (no adverse event).
SYMPTOMATIC COVID-19 - SPO2 64% ON RA, PROGRESSIVE SOB; PRODUCTIVE, PURULENT COUGH
7 and 1/2 days after receiving the vaccine I developed an egg-sized swelling at the injection site.  Area  had a faint 4-5 inch ring around it.  It is itchy and painful, more so below the injection site--forearm, wrist and fingers, as if I had hit my funny bone, but worse.  Note I found this strange given that I had already had the more common reaction approximately 12 hours after receiving the vaccine.  (horrible arm pain,  quarter-sized red spot around the injection site, and fatigue).  That reaction ebbed after 24 hours, so I am puzzled by an even stronger reaction emerging  almost 8 days in.  I do have two "feisty" autoimmune  system disorders--MS and Psoriasis.  I am not on immunomodulators.
Patient is a 33 y.o. male who received the Moderna lot # 001B21A on 3/9/2021. The patient experienced the following reaction(s) during the immediate of observation: Patient c/o "weird taste in mouth, metallic taste." Patient was treated/managed as follows:    PMH of DM and asthma. Patient reports taking metformin and lisinopril at home. Vital signs, monitor 0937 BP 146/92, HR 75, RR 18, O2 sat 97% on room air. Patient reports taste in mouth resolving.  0947 BP 126/90, HR 72, RR 17, O2 sat 97% on room air. Patient reports anxiety and twitching in lips. No swelling noted. Denies numbness and tingling. Water provided. 0954 Patient reports twitching in lips and taste resolved. 1008 Patient reports "feeling better." Patient escorted to car by significant other and documenting nurse. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.