chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild Headache, No SOB, No rashes, NO tingling sensation/ Per RN. Advice pt to wait for another 30 mins for further symptoms of adverse reactions. No other adverse reactions noted p 30 mins. Pt discharge to home.
MARKED WARMTH/EDEMA MID-WAY TO BACK OF LEFT LEG. MILD PINK ERYTHEMA DIFFUSELY OVER ENTIRE LEFT ANTERIOR THIGH. FULL ROM OF LEFT HIP.
Got second shot on day 11 of my cycle in September. Day 15 of cycle (September 28) intense sharp quick cramp indicating a cyst. Period came as normal. On day 25 of cycle (October 8).  Missed period on first week of November. Always very regular 25-28 days. Finally got period after a confirmed ovulation on Day 49 of cycle (November 25) got period on day 60 of cycle (December 6)
I had been doing really well with my irritable bowel and stomach issues for several weeks, but, the rash on my neck was in a flair up.  I had some flairing  going on with my upper neck and back area and some burning in my upper legs.  I had gone to sleep on Wednesday night and around 3 A.M., I was awakened by a horrible burning sensation in my upper stomach, back, face, neck, and arms.  They felt like they were on fire inside! My left lower jawbone was hurting up around the front of my ear into my cheekbone underneath my left eye.   I took a terribly burning diaherra, chilling, and aching all over.  I could hardly stand to set straight up in a chair , let alone lay down.  This was terribly bad until around 8 or 9 A.M.  It eased up some and I slept for a couple of hours.  It came back intermittantly for the next four days and nights..So much worse at night.  Even though I have issues with burning sensations and diaherra, etc., I have never experienced anything of this magnitude before!  I am afraid whatever was in a flair up within me was magnified times over!
was really sick,; This is a spontaneous report from a contactable other HCP. This other HCP reported for a 58-Years-Old female patient that:  A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced was really sick. She also said she received both COVID vaccines not long after starting xeljanz and had bad side effects from it, said she was really sick, no other details reported. start of therapy was reported. Mar2021 per initial call but today she said she may have started a bit earlier than that with samples from her doctor. she has not spoken to her doctor but said she plans to call since she feels xeljanz is not helping and she is also due for follow up labs soon. The clinical outcome of event was unknown.  Information on the lot/batch number has been requested.
I recieved vaccine on 12/22 at 1500 and awoke 12/24 at 0500 with a broken blood vessel in my R eye that did not involve pain, blurred vision or irritation.
I woke up that morning and I noticed I had the worst sore throat I have ever had in my life and both ears were hurting and had extreme congestion that day.  I did not have a fever that day but I had a headache with pressure I was blowing a lot of mucus out of my nose and felt it in my back and lungs but did not have short of breath.  I had a bad illness that effected my lungs 21 years ago so since then I can feel things is my lungs.  So on the 13th it was worse and by the 16th I tested positive for COVID-19 with a home test and it was positive.  I contacted my doctor and let her know and she gave me a prescription for Paxlovid.  Due to Kidney Function they decreased the dosage. I had rebound symptoms after the Paxlovid prescription was done and felt bad.
Fever started approximately 22 hours after receiving the shot. The fever was accompanied by chills, body ache, and fatigue.
The pain in my right that is affected with CRPS (COMPLEX REGIONAL PAIN SYNDROME ) became much mor painful than it always is.  I have made some gains in getting relief from an Acupuncturist and  a Neurosomatic Therapist.  The pain made me feel like I had regressed to years ago.  Also, very oddly, my sleep was affected.  I had a lot of trouble sleeping for about a week and had very violent nightmares
1st dose: within 7 minutes hot feeling throughout the body, racing hear rate up to 157 and BP 180/107. Monitored at the site with an oxymeter and bp monitor. Eventually it went back to normal and I was able to leave. The event of my heart BP and pulse rising happened multiple times during that day. Called my doctor after.  2nd dose: same event as first dose, but this time it came on almost immediately after the shot was completed. Elevated BP and heart rate. I was not getting better so I was wheeled in to the hospital where I had some testing done and released maybe 5 hours later. All heart tests were normal.   Within about a week of the 2nd dose I was at home relaxing and my heart rate went up to 150 and then back down to 59 and then back up again. I had an oxymeter on that was monitoring it and it kept fluctuating between 59-150 and I could feel it rise and drop. I was admitted to the ER then discharged. I was told it was a possible vaccine side effect. Cardiologist appointment a few weeks later where again I was told it may have been related.  Since the vaccine I have recurring episodes as detailed above. Racing heart, headaches etc.
Red around the injection site and itchy. Red itchy Also red hive on leg, swollen lymph node in arm pit.
pt recv vax 5JUN97 & w/in 24hr devel muscle aches & pains & arthralgias;
Acute bronchitis; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/ Lot number: EL3248), via an unspecified route of administration on 17Jan2021 (at the age of 75-year-old) as dose 1, single for COVID-19 immunization, palbociclib (IBRANCE, Formulation: Film-coated tablet, Strength: 125 mg, lot number and expiration date were unknown), via an unspecified route of administration from 24Jun2020 and ongoing at 125 mg, cyclic (daily for 21 days, and then off of Ibrance for 7 days) for breast cancer. The patient's medical history included breast cancer from an unspecified date in 2006 and ongoing. Reported she was diagnosed with breast cancer back in 2006 and had both of her breasts removed in 2006. She said she was told in May2020 that her breast cancer had came back in the same place. She said she started Ibrance on 24Jun2020. Concomitant medications were not reported. The patient experienced acute bronchitis on an unspecified date in Feb2021. She was told to stop taking her Ibrance prescription from an unspecified date in Feb2021 to 31Mar2021 by PRIVACY (her oncologist) on 04Feb2021 because she had acute bronchitis. Reporter stated she needed to place an order again for Ibrance. Reported the last time she ordered Ibrance was on 28Jan2021. She stated she had been in the hospital on an unspecified date in Feb2021, was off of her Ibrance from an unspecified date in Feb2021 and didn't come out until Mar2021. She said she restarted Ibrance on 01Apr2021 and needed to place her Ibrance order. She said Dr. (withheld) (her oncologist) had sent in her Ibrance prescription. Patient said she was tested 3 times for the COVID-19 virus test on an unspecified date (clarifying she was negative all 3 times). The event was considered as serious (hospitalization) by the consumer. The action taken in response to the event for palbociclib was dose not changed. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Tiredness started about 1:30 pm 1/26/21 - by evening 1/26/21 felt nauseated - didn't eat evening meal - 1/27/21 -  9:00 am Diarrhea started - very severe until about noon.  By 6:00 pm 1/27/21 was feeling better.
after first booster, developed a really big red welt at the site of the vaccination; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE URTICARIA (after first booster, developed a really big red welt at the site of the vaccination) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 prophylaxis.     Concurrent medical conditions included Gluten sensitivity (was not an allergy), Allergy to antibiotic (medication allergy to Cipro) and Drug allergy (medication allergy to Crestor). Concomitant products included VITAMINS NOS for an unknown indication.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (after first booster, developed a really big red welt at the site of the vaccination). At the time of the report, VACCINATION SITE URTICARIA (after first booster, developed a really big red welt at the site of the vaccination) had resolved.            Patient has not had a positive covid test. Concomitant products included Statin drug, Low dose beta blocker and Antibiotic.  After first booster, patient developed a really big red welt at the site of the vaccination, lasted for 4 days before it subsided.  No treatment was received and had no hcp notification.   This case was linked to MOD-2022-587456, MOD-2022-587428, MOD-2022-587447 (Patient Link).
Fever, chills, febrile illness, dizziness, acute renal failure, pancytopenia, sepsis symptoms, post flu vaccine - 24 hours after vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), in right arm, on 25Mar2021 as dose 2, single (Lot number: EL3247), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: PF2590) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension, treated" (ongoing), notes: hypertension, treated; "Joint Health" (ongoing); "Multi-vitamin" (ongoing). The patient did not have any known allergies. Concomitant medication(s) and other medication the patient received in 2 weeks included: LISINOPRIL taken for hypertension, start date: Apr2007; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN taken for multi-vitamin deficiency start date: Apr2007, stop date: Dec2019; OSTEO-BI-FLEX taken for arthropathy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 06Apr2022 to 22Apr2022.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality product administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to Department of Public Health, VAERS, Immunization Registry and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 09th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
1 wk p/vax pt ran t104 x several hr;11PM febrile seizure x1-temp dec w/cool baths & APAP;seen by MD in AM no further problems noted;mom did not report to MD-had father in law who is MD check pt next day;mom instructed to inform MD also
10 days p/receiving MMR #1, pt developed high fever 103, had sz for about 15min; Mom took child to private MD; APAP supp given to dec fever; Child stayed in MD's office for 60min;
History Present Illness:  26 year old female presents to walk in clinic with c/o feeling dizzy, flushed and heart racing after receiving COVID-19 vaccine earlier today. She took a benadryl about 30 min before receiving the vaccination. She is 11 weeks post partum. She is still breastfeeding her baby and reports she has "not drank very much today." At time of visit, she reports she "feels much better." She denies PMH of heart issues or any prior anaphylactic reactions. She denies shortness of breath or trouble breathing. She does not appear to be in acute distress at this time. Her vital signs are WNL.
Vaccine site reaction redness at the site tenderness. Swelling of the left armpit tenderness
pt noticed fine rash on arm used for immunization, slightly itchy, resolved within 24 hours
mom states pt had no sx until 14MAR97 in AM;pt was crying, irritable, cried w/eyes closed & just didn't act as usual;fed well but cont  crying;no fever was like that for 2 days & began to act like old self;20MAR97 pt had apnea;
Information has been received from a pharmacist referring to an 86 year old male patient. The patient had no pertinent medical history and no drug reactions or allergies. The pharmacist did not know if this patient had ever received PNEUMOVAX 23 in the past. On 13-JAN-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # K010465, expired date 23-MAR-2016, route was not provided) 1 dose. The patient had no concomitant medication. The patient developed a 4-inch-diameter area of redness and warmth at the injection site. The pharmacist thought that the redness and warmth might have developed as soon as the day after the patient received the dose of PNEUMOVAX 23 on 14-JAN-2016, though he was not certain. The patient showed the pharmacist his injection site on 21-JAN-2016 ("today"), because the injection site redness and warmth was not improving. The patient believed that the injection site redness and warmth was getting worse. No lab diagnostics studies were performed. No treatment was given for the events. Causality was not provided. Additional information has been requested.
pt recvd vax 6NOV92 in lt deltoid; 7NOV area blistered red & swollen-ulcer area noted burning down arm; rx in ER given ATB & med for pain;
Large red welt and smaller welts on my upper arm - the same arm I got the shot in. Welts were hot and very painful. I ended up with cellulitus in my arm and had to get antibiotics for it.
10 days after vaccine given, nausea and rash developed on forehead (R) and eye swollen, (R) neck, (L) forearm and antecub, papular, red ? vesicles.
I experienced vomiting and chest pains. Visited Doctor on day 2 of this, who diagnosed pain as pulled muscles from vomiting. I experienced COVID-19 symptoms, Fever 100, fatigue and body aches, chills for about 3 days. Since then, fatigue has lingered, and balance has been much worse. Dark urine has also been present since the booster.
Approximately 2 hours after this infant had his vaccines, the child had redness at the site of injection on his left leg (0 contraindication). the infant had inconsolable crying for 2 hours. The parent put ice on site and the infant continued crying. The infant has no history of crying for a long period of time or any other problem.
Patient is a 74 Y male with a past medical history of  hypertension, paroxysmal atrial flutter, COPD, diabetes mellitus type 2, schizoaffective disorder, depression, pulmonary embolism, pulmonary nodules, asthma, tobacco dependence, alcohol abuse and urge incontinence  who presents to the Emergency Department today with complaints of shortness of breath and leg swelling for the past few days.  He has also been having cough which is productive of clear sputum and has been wheezing.He has been using his albuterol inhalers with relief. He has also noted increased leg swelling more and decreased urination.  He tries to be compliant with his salt and fluid restriction but does not always follow through.  He had just been hospitalized at hospital from February 21 to March 2 for COPD exacerbation, CHF and hypoxia.  Patient has a history of COVID B infection last October and was hospitalized for it.  Yesterday he got a 2nd COVID shot but denies any fever, chills, chest pain, nausea vomiting after that He presented to the ED where he was noted to have temperature of 98.4°, pulse of 76, respiration of 32, blood pressure 19477 and O2 sat of 95% on 3 liters.  Labs showed a white count of 8.8, hemoglobin 12.9, bicarb of 35, creatinine 0.57, potassium 3.6, magnesium 1.6, BNP of 2675 and 2 serial troponins of 55 and 50.  Chest x-ray with chronic vascular prominence unchanged.  Some minimal infiltrates or atelectasis at the left base are improved.  EKG with normal sinus rhythm, heart rate of 76, few PVCs and PACs.  Patient was given a dose of IV Bumex and is now admitted to the hospitalist service
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On unspecified dates, the patient received the first two doses of GARDASIL (lot numbers and expiration dates were not provided), doses, routes, anatomical locations were not reported, on 18-FEB-2016 the patient was presenting to pharmacist's office to receive the 3rd dose in series with GARDASIL 9. No adverse effect reported. No further information was provided. No product quality complaint was involved. Additional information has been requested.
Patient had red rash that spread out all throughout his upper arm. Dark red in the center. Started occurring 6 days after the vaccine and necessitated an ER visit on Sunday
Expired Infanrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 02-MAY-2023, the patient received Infanrix. On 02-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Infanrix administered). 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 Information: GSK Receipt Date: 03-MAY-2023 The reporter informed that a dose of Infanrix administered to a patient but such dose had already expired. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. A dose of Infanrix administered to a patient but such dose had already expired, which led to expired vaccine used.
Mother stated pt had pain at injection site 6/11/03, when immunization administered. In the evening, 6/12/03, mother stated she observed swelling, redness in affected arm. Today mother states area is swollen, red and warm to the touch. Pt verbalizes pain in area. Diagnosed with localized reaction, possible cellulitis. Prescribed Amoxicillin.
Admitted to hospice on 04/07/2021 for Alzheimer's disease. Date of death 05/14/2021
vaccine administered 1/23/07-no initial reaction.  Today 1/25/07 RA red, swollen, warm to touch, itchy down to elbow.
Seven days after my second dose I developed debilitating hives. I've had it for 4 days. Took Zyrtec twice. it seems like when the Zyrtec effect goes away it starts again.
Sites of 2 injections left deltoid area became very red, swollen, hard and painful within 24 hrs of administration; bruise at IPV site. Parent giving Motrin and cold compresses every couple hours.
Started with fever on 8/27/08 - fever got up to 105.6 during the night - gave Tylenol, helped some.  Brought into clinic 8/28/08 to be evaluated.  Questionable reaction to vaccine (Dtap).
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L029631 with expiration date of 14-AUG-2017, dose, strength and route unknown). This is one of several cases reported from the same reporter. Additional information has been requested.
pt recvd vax 21SEP & devel rash on groin & stomach;22SEP MD changed meds pt awakened 23SEP w/h/a, swollen tongue, conjunctivitis, pt to ER pt near syncope
Case number PHEH2015US003423, is an initial spontaneous report received from a nurse on 13 Feb 2015 and with follow-up received from a nurse on 10 Mar 2015. This report refers to a 20 year old male patient. Historical condition and concomitant medication were not reported. His vaccination history included administration of MENACTRA (batch number: not reported, other manufacturer) and was well tolerated. The patient was vaccinated with MENVEO (batch number: M14094) at a dose of 0.5 ml, intramuscularly into left deltoid on 11 Feb 2015. On 13 Feb 2015, he developed swollen lymph nodes under left arm (axilla area) and swelling along left rib cage node measured 2 cm. Outcome of the event was recovered on 17 Feb 2015. Seriousness and causality of the events was not reported. Follow-up received from a nurse on 10 Mar 2015: Patient's demographics (height and weight), vaccination history (MENACTRA), vaccination details (dose and site), outcome and other clinically relevant information updated in the narrative.