chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lower abdominal pain; Stomach is swollen, large and firm to touch; bowel movements; Shiver; nausea; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diverticulosis.   On 2nd July 2020, the patient received the 1st dose of Shingrix. On 2nd July 2020, immediately after receiving Shingrix, the patient experienced shivering, nausea, swelling abdomen and frequent bowel movements. On 8th July 2020, the patient experienced lower abdominal pain. On an unknown date, the outcome of the shivering, nausea and frequent bowel movements were unknown and the outcome of the lower abdominal pain and swelling abdomen were not recovered/not resolved.   It was unknown if the reporter considered the shivering, nausea, lower abdominal pain, swelling abdomen and frequent bowel movements to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. Soon after the 1st dose of the Shingrix vaccine she started to experience lower abdominal pain especially when she had a bowel movements and also as of August 2020, she was stating her stomach was swollen, large and firm to touch. She was stating the lower abdominal pain and swollen stomach had been ongoing and has not resolved. The reporter consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020AMR187582.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR187582:2nd dose
Early onset of an extremely heavy period. A few hours after receiving the vaccine I began experiencing cramps, followed by getting my period 9 days early. My period was very heavy, very bloody for approximately 48 hours where I normally have a very light period throughout.
Patient called pharmacy and said her arm was red and swollen around where she got her shot. She also said her arm hurt.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant mediations were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of PROQUAD (lot #, expiration date, dose and route were not reported). No adverse effects were reported. PROQUAD was supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        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 concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-378298 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received contains no new information.
This was a booster shot. Received first 2 shots in spring of 2020. This shot made me break out into a deep red, raised rash from my chin  down to my bottom. The red rash was worse this time than the first (also reported to VAERS). My skin was on fire and hurt to the touch. When it finally started clearing up Thursday night into Friday my skin was peeling! I slept uncontrollably for 48 hours, at time feeling like I was paralyzed. This is the second time I have had this reaction. I will never get another booster.
cracked a molar/cracked her tooth/broken tooth; she had pain in her tooth so she took Tylenol beginning 14Mar2021; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient received the 1st dose of Covid vaccine and then cracked a molar and needs to have this fixed. She heard that you were not supposed to have any surgery before taking the Covid vaccine so she is calling to see if it is ok. She asked that whether she could have her inflamed tooth pulled out today by her dentist. She was inquiring whether it was okay to took antibiotics prior to the said procedure (as prescribed by her dentist). She received her first dose last 27Feb2021 and her second dose is being scheduled on 20Mar2021. What happened was, she unknowingly cracked her tooth a few days ago. She had pain in her tooth, so she took Tylenol beginning 14Mar2021. The treatment was received for the events with Tylenol. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Erythema Multiforme at injection site. Wheal 6cm, flare 12cm
Injection was given too high on the upper arm. Symptoms include pain in the shoulder, inability to adduct or abduct that shoulder, inability to sleep on left side or back without significant pain, tingling and numbness in left arm radiating to left hand. Symptoms began same day as injection and have been ongoing for 2 weeks. When seen by a doctor, it was concluded that vaccine was given in bursa and not deltoid muscle.
Pounding elevated heartbeat, chest tightness/chest pressure. Mild chest pain under breastbone  (but not excruciating). No shortness of breath, which is why I opted not to go to emergency room. That and the achiness from 100ºF fever.
Client received injections 10/12/04.  Over the weekend her mom noticed redness, swelling, and a rash on deltoid area and toward under the arm, around 4" long, no fever noted.  10/18/04 child okay, rash and redness gone.
Apparent shoulder injury.  Felt the needle hit somethin solid (assuming it was bone) during the injection.  No visible signs of redness or bruising on the skin.  Pain was increasing as usual for a flu shot but then it continued until I could not lift my arm above my shoulder.  Woke with shoulder pain in the middle of the night and applied cold packs to the shoulder. This morning, the pain has started to subside.   I am continuing cold pack administration today in hopes that the issue will resolve.  Will seek medical treatment with primary care physician if issue does not resolve within a few days.
This spontaneous report was received from a female patient (who is also a pharmacist) of an unknown age concerning herself via field employee. The patient's relevant medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (lot number and dosage not reported). The patient's concomitant medication included "(unspecified) antihistamine". On an unknown date, the patient developed "hives about five inches in diameter around injection site". The patient did not seek medical attention. The patient did not had any fever or pain. The patient had used "DERMOPLAST with benzocaine which helped reduce the diameter of the hives around the injection site". The outcome of the event was recovering. The reporter did not provide any causality assessment between event and ZOSTAVAX. Additional information has been requested.
Pt recvd Engerix-B on 30DEC or 31DEC91 & 4 hrs later devel h/a, fever, chills, dry burning sensation inside nose, pains in neck, adbominal cramps, diarrhea & vomiting;
Approximately 24 hours after the vaccines were given the patient started to experience low grade fever, dizziness, nausea, painful/sore arm, and rash. The pain was severe enough that the patient states they could not move their arm for 2-3 days. The rash has spread from just around the injection site to covering her arm from shoulder to elbow. She said it is about 27 x 27cm. The fever, dizziness, and nausea only lasted for about 24 hours. The rash is still present today 9/10/18 and has grown to the size indicated previously. Her arm is still achy but she has mobility and can use it. She went to an urgent care clinic because of the rash size and growth. She was given BACTRIM DS for prophylaxis treatment of possible infection. MD was not sure but gave her the antibiotic just in case. The patient will follow up with her GP tomorrow 9/11/18 and followup with us about the progress.
Left eye problem; Daylight affected me; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Left eye problem) and PHOTOPHOBIA (Daylight affected me) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, VALSARTAN and TIMOLOL for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced OCULAR DISCOMFORT (Left eye problem) and PHOTOPHOBIA (Daylight affected me). At the time of the report, OCULAR DISCOMFORT (Left eye problem) and PHOTOPHOBIA (Daylight affected me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported
This spontaneous report as received from a 60 year old female consumer refers to herself with penicillin allergy. On 09-APR-2013 the patient was vaccinated subcutaneously in the left arm with a dose of ZOSTAVAX (1 time vaccine, lot number, expiry date unspecified). Concomitant therapies included CRESTOR and "amaprozol". On 09-APR-2013, the patient experienced 3 red blotches on her left arm (insertion arm). She described them as about 6 inches around, total. She said they were more like blisters, but they were not itchy. The patient did consult with a clinician. Antibiotic doxycycline-mono was given for treatment. The outcome of the event was reported as recovering/resolving. Additional information has been requested.
pt had a positive COVID test on 1/27/22 and was hospitalized at Hospital; pt is a DNR; admitted to Hospice of Care Center, 1/28/22; pt's condition worsened since admission for COVID and respiratory distress; tachypnea; accessory muscle use; comfort care only; pt passed away in hospice
Information has been received from a registered nurse concerning a female patient, who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (lot # and expire date not reported) (dose and route not reported). On an unspecified date, the patient experienced a localized reaction, which included redness, warmth and swelling. This reaction was considered severe by the nurse. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from the registered nurse who indicated that the patient was a 75 year old female retired (registered nurse) allergic to penicillin who on 27-OCT-2009, was vaccinated IM with the first dose of PNEUMOVAX 23 (Lot # 664654/0823Y). Concomitant vaccinations included a dose of Flu (manufacturer unspecified) "received after work". According to the reporting registered nurse, the patient was seen on 30-OCT-2009, she had a right deltoid area of 6cmx11cm approximately which was pink, blanched easily and had some urticaria. It was not raised. The patient called on 31-OCT-2009, she had improved on her own. Additional information is not expected.
Patient called reporting adverse reaction to vaccination being large rash on arm spreading down at least 8 inches from the injection site that she noticed the next day. Described a large rash/hives/swelling. She has never experienced a reaction to a flu vaccination before, had concerns that it may have been because she recieved high dose and because she has some auto immune disorders.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 25-JUN-2014 the patient was vaccinated with expired PROQUAD (Merck) (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested.
Patient is continuing to experience pain in her shoulder with decreased range of motion and muscle fatigue ever since vaccination (about one month ago).
After FLUARIX injection employee c/o pain/warmth to (L) arm injection site. She went to hospital ER on 10/5/12 "just to report incident". Note: Employee on COUMADIN for AVR (L) arm ecchymosis about 6" x 4".
On Friday Jan 27th, patient was administered ActHIB that was diluted with Sterile water instead of diluent that was provided with the vaccine. MA who diluted was unaware that this vaccine was paired with its own diluent. Mistake was caught the following Monday, Jan 30th. Dr was notified and manufacture was contacted. Manufacture stated that per CDC vaccine is invalid and needs to be re-administered. Dr will be contacting family shortly. As far as we know, no adverse reaction has been reported.
early dose administered of FLUZONE QIV NP to a pediatric patient/ medical assistants inadvertently missed the dosing interval time was earlier than recommended,with no reported adverse event; Initial information received on 13-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 17 months old female patient who had early dose administered of fluzone qiv np to a pediatric patient/ medical assistants inadvertently missed the dosing interval time was earlier than recommended,with no reported adverse event after receiving vaccine influenza quadrival a-b vaccine [fluzone qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Jun-2023, the patient received a dose 3 0.5 ml of suspect influenza quadrival a-b vaccine Suspension for injection lot UT7731JA, 30-JUN-2023 via intramuscular route in the left thigh for immunisation.  On 13-Jun-2023 the patient developed a non-serious early dose administered of fluzone qiv np to a pediatric patient/ medical assistants inadvertently missed the dosing interval time was earlier than recommended,with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken was not applicable.  Outcome: Unknown for the event early dose administered of fluzone qiv np to a pediatric patient/ medical assistants inadvertently missed the dosing interval time was earlier than recommended,with no reported adverse event.  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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient; writer was called by family member, patient observed sitting in chair with episode of unresponsiveness.  No head trauma,  No SOB, No respiratory distress.  Paramedic notified. Patient had episode of fainting lasting about 30secs then returned to baseline mental status post covid vaccination. MD notified. Family member present stated that she history of fainting. Patient discharged home, in stable condition.
Left Arm Site Injection was swollen 8 days after injection.; Left Arm Site Injection was with Pain 8 days after injection.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jun2021 at 15:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma and ibs (irritable bowel syndrome). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included travoprost (MANUFACTURER UNKNOWN), timolol maleate, brimonidine tartrate (COMBIGAN), dorzolamide (MANUFACTURER UNKNOWN), glucosamine sulfate (BIOFLEX) and Multi vitamins; all from an unknown date for unknown indications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 30Jun2021 at 14:00, 8 days after injection, the patient experienced left arm site injection was swollen with pain. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event left arm site injection was swollen with pain was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up
death AKI (acute kidney injury) Cerebrovascular accident (CVA), unspecified mechanism Acute respiratory failure with hypoxia Acute kidney failure, unspecified Thrombocytopenia, unspecified
This spontaneous report as received from a physician assistant via a representative refers to an approximately 10 year old male patient. In approximately May 2012 (reported as 2 years ago) the currently 12 year old patient was vaccinated with a dose of GARDASIL (lot#, dose and route not reported), fainted post vaccination. The outcome of the event was unknown. Additional information has been requested.
13 year old male patient who after two minutes of receiving the second dose felt dizziness, he appears sweaty and vomited once He sits in turn to get evaluated.
Large rash above elbow, at wrist and under forearm on the left side (vaccination arm).  After 10 days  the rash area shed the top layer of skin.
A month after the shot starting having itchiness around the neck and body. After a month more decided to see PCP to have it checked during the course of a routine check-up. After a physical it was was determined benign and just to watch and keep tabs on the rash. No progress and I use coconut oil to soothe the rash. Ongoing issue.
2:30 INJECTION, 6:30 Stomach Pain,7:30 Nausea,  8:30 Profuse Sweating, Fainting, Weakness...called ER...Called MD....described symptoms...directed to hydrate and rest...no more fainting after 9 pm....hydrated, rested, stomach ache continued till around 11 pm, next day weak and shaky no fainting or nausea
Localized vaccine reaction on pt's right anterior thigh. Redness, hard lump. Dtap vaccine administered on 3-07-12 at 4:45 pm. Pt. F/U with provider 3-09-12.
sore arm; Received first COVID vaccine 28Jan2021. She is pregnant and is due in Apr2021; This is a spontaneous report from contactable nurse (patient) via Pfizer Representative.   This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no =EL3248), via an unknown route, on 28Jan2021 02:45 PM at a single dose for COVID-19 immunisation. Vaccine location was Right arm. No relevant medical history was not reported. Concomitant medications include Prenatal (1 tablet per day by mouth) from Jun2020 for because she's pregnant, probiotic (2 capsules a day by mouth) on Jan2021 for GBS clarified as Group B Strep, magnesium (400mg 1 tablet daily by mouth) on Jul2020 for low magnesium and Unisom tablet. The patient is pregnant and due in 12Apr2021. She was wondering there are any studies occurring in pregnant women. The outcome of the events was unknown. On 06Feb2021, it was reported that, Patient was not had covid prior vaccination and not covid tested post vaccination. The Last menstrual date was 06July2020 and gestational period was 29. As of 24Feb2021, it was reported that, patient completed the vaccine and the patient is pregnant (Precautionary AE) Patient was 33 weeks pregnant and got her second Covid vaccine dose yesterday on 23Feb2021, she didn't had an adverse event but she was pregnant. Relevant test results, she had a CT scan done in late Jul2020 because she was having palpitations. Patient had sore arm with first Covid vaccine. Patient was 33 weeks pregnant, estimated Date of Conception was 20Jul2020. Other and father did not smoke, drink alcohol or use illicit drugs during this pregnancy, patient had 3 previous pregnancies and 2 children, the outcome of previous pregnancies, questionable miscarriage, she would say yes but more like a chemical pregnancy in Jun2020.   Follow-up (06Feb2021): New information was received from a contactable nurse (patient) includes: Added suspect details (lot no. EL3248), patent details (The Last menstrual date was 06July2020 and gestational period was 29.), full due date of pregnancy (12Apr2021) and clinical information.   Information about Batch/Lot number has been requested.  Follow-up (24Feb2021): New information was received from a Pfizer-sponsored program and from contactable includes: new event, Concomitant details and clinical information added.
cannot think straight; fatigue; short of breathe; weakness; confusion,; brain fog; tiredness,; memory issues; dizziness,; twitching extremities; wake up and eyes unable to stay still for a short time; tight chest; headache; low sense of smell; low taste; pain in spine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 20Sep2021 09:30 (Batch/Lot Number: 301308A) as dose 2, single for COVID-19 immunisation. Medical history included shingles and mono, both from an unknown date and unknown if ongoing. Concomitant medication included sertraline hcl taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 30Aug2021 3:00 PM (Batch/Lot Number:  FC3182) as dose 1 for COVID-19 immunization. On 22Sep2021 06:00, the patient experienced fatigue, short of breathe, weakness, confusion, brain fog, tiredness, cannot think straight and memory issues, dizziness, twitching extremities a few times, wake up and eyes unable to stay still for a short time, tight chest, headache, low sense of smell, low taste, and pain in spine but did not feel like muscular. The outcome of the events was unknown. The patient underwent Sars-cov-2 test: negative on 04Oct2021.
pt recv vax FEB96 & OCT96 pt devel shingles;no further details were provided;
Information has been received from a registered nurse concerning a 34 year old female who at 1 and 5 years of age was vaccinated with mumps virus vaccine live (Jeryl Lynn). In march 2004, the patient experienced parotitis that has not resolved. The patient reportedly has a current mumps IGG of 1.68. Unspecified medical attention. No product quality complaint. Additional information has been received.