chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site became red, swollen, and warm to touch; injection site became red, swollen, and warm to touch; injection site became red, swollen, and warm to touch; injection site became red, swollen, and warm to touch; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA053856 (same reporter).  This case involves a 59 years old female patient who experienced injection site became red, swollen, and warm to touch (vaccination site inflammation), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Jan-2020, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6628AA and expiry date: 04-Apr-2022 via unknown route in the left arm for prophylactic vaccination.  On an unknown date, injection site became red, swollen, and warm to touch (vaccination site inflammation) (unknown latency) with symptoms (vaccination site erythema), (vaccination site swelling) and (vaccination site warmth) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Laboratory data was not reported.  Final diagnosis was vaccination site inflammation.  The patient was given antibiotics as corrective treatment and told to use cold compresses.  The patient had recovered from event on an unknown date.
PLATELET TRANSFUSIONS; BRUISES ALL OVER BODY; GAINED WEIGHT; FELT MISERABLE; This spontaneous report received from a consumer 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included eltrombopag olamine. On an unspecified date, the patient developed bruises all over her body, she did not look healthy and was hospitalized with platelet transfusions. She was in the hospitals for 7 days or so after getting the shot and had to stop working. It was unknown if the patient was discharged from the hospital. At the time of the report, she was also on Promecta and had gained weight and was just miserable, The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruises all over body, platelet transfusions, gained weight and felt miserable was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20220514980-covid-19 vaccine ad26.cov2.s-Bruises all over body, Platelet transfusion. 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). Therefore, this event(s) is considered unassessable.
Lightheadedness and tachycardia noted 20 minutes after administration of Covid Vaccine.  Emergency drugs available. Airway assessment done, vital signs obtained, cold, damp cloth placed on patient's head and neck.  Husband requested EMS to transport patient to ER for further evaluation.  Patient stable when EMS arrived.
Information has been received from a health professional concerning a 17 week old pt who was vaccinated with a first dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
On 6/18/2022 Pt. was taken to the hospital due to febrile seizure.  Was subsequently diagnosed with right otitis media and complex  febrile seizure.  Another seizure was witnessed at the ED.  She was admitted for observation and did have an EEG that was read as normal and was discharge 6/19/2022.
Mom notice today 2/20/09 vaccine Tdap has reaction swollen and redness, - as per phone call with mom.
Tdap given in (L) deltoid on 3/19/13. That night deltoid area where immunization was given developed some redness. The redness got bigger. Came to clinic 3/21 for evaluation. (L) deltoid area warm to touch with induration - measures 10.5cm across and 11.0cm up and down. Normal movement - tender to touch. Given ibuprofen.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.98.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.   On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt recv vax 14APR97 & 18APR97 pt devel chickenpox w/4-5 lesions on face;
Exactly one week after vaccination, my entire body broke out in hives/rash.  Nothing like this has ever happened before.  The hives lasted for 2 days before I set up a virtual appointment with my healthcare provider. They said I was experiencing an allergic reaction and prescribed me with a steroid (prednisone, 10mg) that I took for four days. It helped while I was taking it and then I started getting hives again, but not as intense.  It's been almost 10 months since I got the shot and I still take allergy meds at least once a week because I start to itch randomly.  I know it's because of the vaccine because nothing else in my life has changed at all and I have never experienced an allergic reaction to anything before.  I have done plenty of research online and there is a whole community that has been experiencing chronic urticaria from the Moderna booster.  I also think it's worth nothing that I was fine after I received my initial two vaccinations.  By the time I got the booster though, I had gotten covid twice despite being fully vaccinated.  The allergic reaction began after the booster, not the original vaccinations.
This spontaneous report was received from a 19 years old non pregnant female patient regarding herself. Pertinent medical history was reported as hypothyroidism. Drug reactions/allergies were reported as none. The patient reported that she had received M-M-R II on 12-DEC-1997 and 16-JUN-2001 (dosing details not reported). On 14-AUG-2000, the patient received VARIVAX (dosing details were not provided). Concomitant medications were not reported. In September 2016, the patient was informed the titer level for measles, mumps and rubella and varicella titers were low. No treatment was given for the events. The patient sought medical attention by talking to the physician. On an unknown date, the patient underwent unspecified blood work with results unknown. Outcome and causality of the event was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Swelling at injection site at the day of vaccination, fever for 8 hours on the following day accompanied by whole body muscle aches, swelling of both feet about couple of months later, elevated cholesterol levels treated by primary care physician after a blood test which has been brought down to normal within three months, pain on bottom of feet while standing or sitting for longer than an hour, occasional swelling of one or both hands, numbness of all extremities while sleeping and waking up, or pain under finger/toe nails until circulations restores, numbness or swelling sensation during the day, overall lower physical stamina.
Soreness in right arm, fatigue, swollen armpit for at least 1 week
The patient presented to Hospital ED on 01/31/2022 with c/o SOB, and tested positive for COVID 19 5 days prior.  The patient also c/o nonproductive cough, fever, chills, HA, and myalgia.  The patient was admitted to the hospital with PNA d/t SARS-Coronavirus.  Chest X-ray showed interval development of patchy bilateral mixed density, predominately interstitial infiltrates. On 2/1/22 code was called to the patient's room.  The patient received chest compressions and was noted to be in V. Fib on monitors.  The patient received one shock.  The patient received 3 rounds of Epi, 2 amps of bicarb, and 2 G of calcium gluconate.  The patient's family member requested the patient be made comfort care.  Patient expired.
I received my booster vaccine the 28th of December. Approximately 10 days later I started breaking out in hives in random patches all over my body. Treating with antihistamines and topical ointments with only temporary relief. No sign of improvement. No known allergies or Illnesses and no changes in my diet/routine/or detergent.
No adverse event; Expired vaccine that was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients).    Concomitant medication was not reported.  Patient age was reported as 66 years and 8 months.  Reportedly, the number of patients at facility that received Moderna vaccine between 08Apr2022 and 15Dec2022. Additionally, in the second list, reporter discovered a past lot that had also been expired and administered to patients with batch number as 065F21A. Treatment medication was not reported.
Tenesmus both urinary and rectal; Tenesmus both urinary and rectal; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 04Mar2021 at 12:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included UTI (urinary tract infection). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included nitrofurantoin (MACROBID), for an unknown indication from an unknown date and unknown if ongoing. On 05Mar2021 at 07:00, the patient experienced tenesmus both urinary and rectal. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events tenesmus both urinary and rectal was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a 7 months 27 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours), oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MA-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Bilateral pulmonary embolism. Coumadin/CT Scan. 10/14/09 Hospital records received for dates 7/14/09 to 7/21/09. DX: Bilateral Pulmonary embolism, UTI.  Presenting SX: chest pain x1 week, shortness of breath, lightheadedness, "almost fainting" feeling.  Assessment: relatively normal will perform labs/diagnostics. Pt has desk job, and 2 short flights within past week. Gardasil vax 5/08. Pt treated with anticoagulation therapy and dc. ICD9 codes: 599.0, 427.89, 415.19
Approximately 1 week and 4 days after my 2nd booster shot (Dose 4) I tested positive for COVID-19 and have the following symptoms: Sore throat, Fatigue. I took Chloraseptic Sore throat spray to numb the pain in my throat and drank a lot of water. It slightly improve my sore throat - but after a few days I consulted with my family doctor and got a prescription of Paxlovid and that helped me to start feeling better.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. There was no pertinent medical history and current conditions, drug reactions/allergies reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB (1st dose 2.5/0.5 strength, route, lot# dose not reported). No concomitant medication reported. The pharmacist reported that a patient received a first dose of RECOMBIVAX HB on an unspecified date and never went back to the physician's office to receive the remaining doses. The pharmacist stated the patient would now like to receive the remaining doses of RECOMBIVAX HB. Additional information has been requested.
Received second dose of Moderna vaccine. While in the observation area, I started to feel flushed and like something was not right and reported to the lead onsite RN.  My BP was 235/131, pulse 140, Pulse Ox 99%, and was having difficulty swallowing and breathing.  A code was called. I was given EpiPen with some relief but not total.  The emergency team administered Methylprednisone 60mg IV and 911 transported me to the ED where I remained for observation for about 5 hours with no further treatment required.
This spontaneous prospective pregnancy report has been received from an unknown age female patient referring to herself. The patient's current condition, concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 05-NOV-2018, the patient was given 0.5 milliliter GARDASIL 9 injection (strength,  route, batch/lot # and expiration date were not reported) for prophylaxis at her doctor's office and during this doctor visit, the patient was informed that she was pregnant. The last menstrual period (LMP) was estimated in 2018 and the estimated date of delivery (EDD) was not provided (Vaccine exposure during pregnancy). The outcome of pregnant was pending.
The patient received a Moderna primary vaccine instead of a Moderna Bivalent booster. The Moderna primary syringes were placed in the Moderna Bivalent spot.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
BOWEL MOVEMENT; NOT ABLE TO SLEEP; DIARRHEA; NO APPETITE; This spontaneous report received from a patient concerned an 88 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at around 12:00 noon for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced no appetite. On 10-MAR-2021, the subject experienced not able to sleep. On 11-MAR-2021, the subject experienced bowel movement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and no appetite, and the outcome of not able to sleep and bowel movement was not reported. This report was non-serious.; Sender's Comments: MAC Comment: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
24 hours after the first shot i was extremely tired. at three different occasions between the first shot and the second one i got Dizzy  ...Doctor told me it was onset of vertigo.  7-10 hours after the second shot I was tired,  12 hours i had chills, fever and body ache until Friday 03/02.  on Saturday 03/03 Vertigo was really bad, head out of place, I took Allergy pills on Sunday, sinus rinse, and 5 mig of prednisone, on monday it got better Its been 23 days after the second shot, and all week this week I've had sporadic shortness of breath,  and felt lightheaded the entire time.
Information has been received from a consumer concerning a 64 year old female with fibromyalgia, allergic rhinitis and benign colonic neoplasm who on 31-JUL-2007 at 08:35 was vaccinated with a second dose of PNEUMOVAX 23 (lot# 656222/0381U). There was no concomitant medication. On 31-JUL-2007 at 19:00, the patient experienced large swelling of the right arm. There were no laboratory diagnostic studies performed. Subsequently, the patient recovered. Additional information is not expected.
RASH: On 2/20 (after dose 1) I had a small itchy bump and pale rash about 4? below the injection site.   It lasted 2 days and faded.  (Also, the site of my tdap vaccine on the opposite arm a month earlier was now red and itchy).  The same injection site rash returned 4? below the site on 3/12 after dose 2.  It was tender and itchy.  It lasted a few days and faded, but returned about 2 weeks later and faded over a week.    RA FLARES: Rheumatoid Arthritis symptoms flared mildly after first dose of the vaccine, but got progressively worse beginning 1 day after the 2nd dose.  Systemic flares of swelling, pain, and inflammation in multiple joints, including: both elbows, both knees, multiple fingers, both wrists, right side jaw, and left toes.   Symptoms increased in severity as time progressed, causing difficulty with daily activities and intense pain up to level 8-10.     After using a medrol dose pack to try and reduce flares, pain returned when the pack was complete.  5mg/ day of Prednisone was added but removed after 1 week due to not feeling well.  At that point it  was determined that my current treatment was no longer working and the Enbrel was dropped from my regimen and replaced with Xeljanz XR.  10mg daily Prednisone was added back in to bridge the 6-8 week timeframe of waiting for the new treatment to kick in.  As of the current date, the prednisone is being tapered off as flare symptoms have all but disappeared with the effectiveness of the  Xeljanz.     **NOTE: my Rheumatoid Arthritis was not completely controlled at time of the vaccine and there had already been discussion between my doctor and me regarding possible treatment change.  To receive each dose of the  vaccine I had to stop taking both the methotrexate and Enbrel each week of the shot.  We believe that the combined lack of meds with the disease activity made my immune system go hyperactive when it woke up to create Covid antibodies, which also caused my immune system to attack me.
Pt recvd vax & exp & exp 7 days of flu-like sx; p/that exp a severe case of shingles which lasted 1 month;
pt was pos for core antibody folloiwng vax w/1st, 2nd & 3rd dose of vax; No further details were provided;