chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes bilateral neck subsiding. Fever 100.8 orally 10/06/02 lasted 24 hours approximate. Malaise for approximately 2-3 weeks.
VOMITING; This spontaneous case was received from a nurse on 04-Apr-2019. It describes a female patient who experienced vomiting after the administration of Vivotif for an unknown indication.   Case report: The consumer experienced vomiting 10 hours after taking the third dose of Vivotif and again she vomited 2 hours after taking the fourth dose.  Action taken with Vivotif was dosage maintained.   The consumer had recovered from the event vomiting.  Company's Comment: In this case, it was reported that the consumer had vomiting following intake of vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had vomiting following intake of vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
The 28th of April pt was vaccinated with Anthrax, two days after redness and soreness developed, pain, hot and swelling . Sx for one week then a rash (scattered) developed with itching. Symptoms still present.
C1 woke up at 5pm with vomiting. Feels like she could faint. Complains of ears ringing and continued nausea.-1.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patient's involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 10-JUL-2013 (lot # H010915, Expiration Date: 13-FEB-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
Coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs.  7/10/09 Received ER medical records of 5/10/2007. FINAL DX: laryngitis Records reveal patient had chest congestion, dry cough, abnormal taste x 1 week.  Seen by PCP & dx w/allergies.  OTC allergy med not helpful.  Tx w/oral antibiotics & cough syrup.  D/C to home w/PCP f/u. 11/23/09  Merdical recs received for date 5/7/07. OV for c/o sore throat. DX: postnasal drip. OV 5/14/07 c/o sore throat f/u ER visit. DX: postnasal drip.
2 days after injection broke out in a rash on both sides of stomach. Chest and under breast. Rash had small pustule bump filled w/clear fluid. Rashes still present as of 4/5/19. Taking VALTREX.
I developed a rash (that looked like a diaper rash) between the top of my left thigh and the bottom of my belly. Upon scratching it through my PJs I felt a lump further down the thigh. I called my doctor's office and had an appointment with the nurse practitioner who ordered blood tests and an ultrasound. The blood test came back normal. The ultrasound determined the lymph node had grown to about 2 cm. x 2.4 cm. x 2.9 cm. It was determined it should be biopsied so an appointment was made and the surgeon scheduled removal the 21st of June. I am currently waiting for the incision to heal and a follow-up appointment Tues. the 29th of June to discuss the biopsy results.
Immediately after the booster, I went to sit in the waiting area to wait 30 minutes. After just a few minutes, my left side of my jaw started itching really bad and my heartrate spiked. I monitored it on my watch, and it was 156bpm.  I called the nurse over and my chest was feeling tight, and they observed me. Since then, I have had itching on the right side of my face. My bottom lip also swelled up and became red. It was not bad enough to go to the emergency room. I was monitored for 2 hours and then went home once my symptoms subsided. I also had extreme fatigue for days following. I also had a lot of ear pain in both ears, especially my left. My doctor prescribed a steroid cream called Mometasone 0.1% ointment. It does not completely help. I also have ear ringing occasionally.  I still have difficulty breathing when exerting myself. I had bad reactions to all three Pfizer vaccines but the third was the worst.
sl sore throat by end of day 20OCT; missed next 2 day of work due to aches & pains & extreme tiredness;
redness; soreness to arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): EC-2022-113252.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "endometrial carcinoma" (unspecified if ongoing), notes: Endometrial Carcinoma; "Noted with fatigue" (unspecified if ongoing). Concomitant medication(s) included: LENVIMA, start date: 04Apr2022. Past drug history included: Keytruda, notes: formulation infusions. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "redness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness to arm".  Additional information: Patient continues to take Lenvima 14 mg once daily. Stated blood pressure remains within normal limits. Denies nausea and diarrhea. Noted with fatigue. Unknown date of onset of symptoms. Stated received COVID-19 booster vaccine and noted with redness and soreness to arm. Unknown date of vaccine. Diagnosis Endometrial Carcinoma, Lenvima 14 mg once daily, start date 4/Apr/2022. Relevant history includes endometrial carcinoma, Keytruda infusions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4 pts recvd 2 doses of Engerix-B & when donating blood they were informed they were Hep C Surface Antibody Pos;
Approximately 24 hours post vax, the pt began to experience emesis, anorexia, gastrointestinal cramps and fatigue. No treatment was given. The most recent information received reports the condition of the pt is unknown.
pt recv all 3 doses; exp an unspecified rxn; lab testing showed HBs antibody neg;
Patient may have accidentally been given an overdiluted vaccine, which contained mostly saline instead of vaccine.  A previous Pfizer vial that had already been drawn up of most of the vaccine was then re-diluted with saline, and possibly given to the patient.
Rec'd immunizations 12/7/11. Mother notes 12-8-11 until approximately 3-1-12 increased irritability, crying and inability to be put down. She then returned to baseline - happy, playful and able to be put down as she was prior to 12/7/11.
pt recv vax & broke out w/fine rash on abd & chest 1 day later had minor joint ache & felt sl tired but otherwise felt nl occasional temp off 99.7max;
After less then 5 minutes of receiving the Pfizer vaccine I experienced dizziness, difficulty breathing and I could feel my heart rate accelerating rapidly. This side affect lasted for about 5-10 minutes. After which I left and haven't felt right since and it's been about 8 hours since receiving the vaccine and at the time of writing it is now 1630 time.
Approx 2 days after vaccination - cough, fever and vomiting began. Rash to dorsum of both hands/wrists and lower forearms. Same appearance rash to lower 1/2 of both buttocks. "Pinpoint dots" behind both ears. (x) All pics not present at exam re: all about symptoms.
having swollen nodes by the neck; This case was reported by a pharmacist via call center representative and described the occurrence of lymphadenopathy cervical in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the lymphadenopathy cervical was not recovered/not resolved.   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-AUG-2022.  Reporter's Comments: Afterhours webform submitted on 18th August 2022 and retrieved at start of business the same day as follows.  The reporter had someone said that they received first dose of Shingrix having swollen nodes by the neck and not went away. No further details provided. The consent to follow up was granted.
01/17/2021:  2 lumps  started developing on lower extremities bilaterally, no discoloration noted. Pain to touch.  1/18/2021: more lumps developed on lower extremities bilaterally, slight redness noted on lumps, pain to to touch. Benadryl cream applied, no improvement.  1/19/2021: More lumps developed ranging in size to lower extremities bilaterally. First lumps appearing redder than newer lumps, pain to touch. Massaging done to lumps, worsened pain. Slightly painful to walk. Swelling to feet noted  1/20/2021: More lumps developed (>25 at this point). First lumps that appeared have discoloration now, bruise like. New lumps appear red in color. Pain to touch. Painful to walk. Swelling increased from prior day.  1/21/2021:  Primary care provider seen. Blood drawn. Antibiotic shot given. Oral antibiotics given for 10 days.  Pitting edema to bilateral ankles. No new lumps noted. Painful to walk, lumps painful to touch.   1/22/2021:  No new lumps. Swelling increased. Painful to walk, lumps painful to touch. Visited an urgent care. Diagnosed with erythema nodosum, unknown cause  1/23/2021: No new lumps, swelling to bilateral ankles and feet increased. Skin stretching. Painful to walk, lumps painful to touch. All lumps bruise like colored.  1/24/2021: No new lumps, swelling to bilateral ankles and  feet decreased.  Lump discoloration started ceasing. Less painful to walk. Lumps painful to touch  1/25/2021: No new lumps, swelling continued to decrease, color of lumps continued to decrease. This continued for about a week until extremities returned to baseline.
Site of injection and arm become blotchy, red, rash, swollen 1 hour after injection.she reports she got a sensation ?like she was going to have shingles-tingling? shortly after her arm that she received the vaccine in was blotchy/rash from site down to wrist and entire extremity became swollen. It went away by itself by the next day. No other issues. She proceeded to call the CDC and her PCP.
Nausea, hot, sweating, confusion, loss of balance, fainting. Ambulance transported to hospital for possible stroke
PATIENT STATED BURNING SENSATION ON LEFT ARM AND BACK , DISORIENTED AND NUMBING AND TINGLING ON FACIAL BILAT CHEEKS AND AROUND LIPS. ADMINISTERED BENADRYL 50MG BY MOUTH
Injection site beside the little red it's 6 to 8 inch; It's just hurt like too much 4 out of 10/ a lot of pain just 6-8 inch from the injection site; No strength, zero to go do anything/weak; did not eat all day; dizzy; ill; Could not sleep/ being up all night long; fatigued/ tired; headache; Muscle pain; chills; I was cold; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration on 29Dec2020 14:00 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient previously took flu shot and was goofy for the next 2 days. The patient reported that he/she had all the symptoms, side effects of the vaccine. The patient just got his/her first injection on 29Dec2020, 2 o clock in the PM. The first and the second day he was so much okay. The patient doesn't see any swollen lymph node or fever, but the rest all the things he/she stated to have. The patient stated that he/she is pretty ill, could not sleep, cold, fatigued, and had a big "done" (not clarified) headache where low mount of Tylenol could quite that down. It's just on and on and on. The injection site beside the little red it's 6 to 8 inch. It's just hurt like too much 4 out of 10 and it should not be. The patient has no strength, zero to go do anything. The patient did not eat all day. The patient reported that he/she does not have those severe symptoms of difficulty breathing, swelling of the face, and fast heart rate or thing like that, but he/she has been dizzy and very weak. It was further reported that yesterday (31Dec2020), the patient got very sick with the headache which will not go away. The patient had muscle pain, chills, and was so cold. The patient was not sure if he/she had fever last night, but he/she could not get up from his/her bed. Right now, the patient has a lot of pain just 6-8 inch from the injection site, and he/she just wanted to report all of this to the company. He had to call in sick this morning, because he was so tired being up all night long. The patient's second dose is due on the 19Jan2021. The patient wanted to know if he/she should delay the second vaccine. The outcome of the events was unknown.
cervical lymphadenopathy, right greater than left Visit to emergency room, ultrasound of neck done treatment - pain control (ibuprofen), pediatrician follow up, repeat ultrasound in 1 week
Patient presented to  Dermatology,  on 7/29/21 with multiple concentric, violaceous, blistering plaques with extreme tenderness and pain located on her bilateral arms, thighs, and buttocks.  Oral and vaginal mucosa were not invovled.  She denied any additional symptoms.  She denied any recent use of medication or supplements prior to appearance of rash.  2 punch biopsies were performed.
Patient fainted after shot at 09:00, when laid back on bed started clenching fists for less than a minute and stopped. TX: Patient laid on back with feet elevated on pillow vs checked continuously.
Got it anyway! After shot/ suspected vaccination failure; Got it anyway!; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the shingles after Shingles sh ot.  The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This spontaneous report was received on 12-OCT-2016 from a licensed practical nurse who reported that multiple unspecified patients (gender and age not specified) received improperly stored vaccines on either 11-OCT-2016 or 12-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 11-OCT-2016 or 12-OCT-2016, the patients received improperly stored GARDASIL 9 (Lot number M023169, expiration date 13-JUN-2018). Temperature was reported as 34.8 degrees Fahrenheit. Time frame was reported as 5 hours 22 minutes. The vaccines were reported as administered. There was no previous temperature excursion. The Call was because of data logger. No adverse effects was reported. No additional information was available. No product quality complaint involved. This is one of several reports received from same source. Additional information has been requested.
Red spot about 2 inches in diameter where shot was given, semi warm to touch and itchy.
Pt vaccinated w/MMR not aware that she was 2 wks pregnant. Subsequent sonogram showed a subchorionic bleed or residual of blighted gestation. Fetus died at 9 1/2 - 10 wks.
Site of injection was extremely red and swollen. Approximately 3 to 4 inches in length. Patient had no other symptoms at time of presentation to the pharmacy (approx. 4pm 9/25/15).
mom describes high fever 105 (not taken) last night, vomiting, shuttering (tremors), loss of appetite, child didnt fall asleep til 530 am, has reported to MD ,F/U 1Mar91 Seen by MD no confirmation of serious ADR, Dr advises no more DPT
Rash around inject site. Approximately 4 inches by 4 inches.  Lasting until two doses of benadryl were taking, about 7 days.
Swelling and redness of the entire right thigh (where the vaccine was given) and knee. Also warmth.
Felt tired; A very mild rash on chest and neck; Vaccine exposure during pregnancy; Pain was pronounced; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN (Pain was pronounced), RASH (A very mild rash on chest and neck) and FATIGUE (Felt tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included BENZATROPINE MESILATE (COGENTIN), DOCUSATE, VITAMIN D3, ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Nov-2020 and the estimated date of delivery was 23-Aug-2021. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN (Pain was pronounced). On 05-Mar-2021, the patient experienced RASH (A very mild rash on chest and neck). On an unknown date, the patient experienced FATIGUE (Felt tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 01-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 04-Mar-2021, PAIN (Pain was pronounced) had resolved. At the time of the report, RASH (A very mild rash on chest and neck) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.
The patient started to sweat and feel week about 15 min or so after vaccine. The patient began to feel nauseated and then proceeded to vomit for about 10 min off and on. An ambulance came to check his vitals.  The paramedic did not get a good read of vitals and the patient decided to be brought to the ER to be checked out.  I checked on the patient about 3 hours later and he said he was home and feeling fine.
Nasal congestion; fatigue; arm pain; shoulder pain; neck pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 09:15 at the age of 67-year-old as dose 1, single for covid-19 immunisation. Medical history included asthma, monoclonal gammopathy of undetermined significance (MGUS), sinusitis and allergy to tegretol, Lamictal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced nasal congestion, fatigue, neck arm and shoulder pain on 02Mar2021 09:15. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Patient had 3 doses of Pfizer COVID vaccine and was hospitalized on 12/28/21 for cough and weakness.
Patient was administered 0.25 ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient was administered 0.25 ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient was administered 0.25 ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient was administered 0.25 ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient was administered 0.25 ml instead of 0.5ml).    patient wanted to know patient need to administer the second half if it was within a period of time. Pharmacist stated he had no information on the patient.   No concomitant drug were reported.   No treatment drug were reported.
Bleeding at site when needle was removed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old female patient received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: ER8729,Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 12:15 (Age at vaccination-45 yrs) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient had no known allergies. Medical history included hypothyroidism, iron deficiency anaemia from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine,ascorbic acid (VIT C),colecalciferol (VIT D [COLECALCIFEROL]),cyanocobalamin (B12 [CYANOCOBALAMIN]), iron, were taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 08Apr2021 12:15 the patient experienced bleeding at site when needle was removed. Therapeutic measures were taken where given Pressure to stop bleeding as a result of bleeding at site when needle was removed was stopped. The clinical outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Patient began with bloody nose, unable to stop bleeding,   Pressure applied, ice applied, nasal clamp applied.  Did also note some bleeding in foley.  New foley placed, resident removed clamp and bleeding returned, resident was sitting at 90 degree angle in bed, and was swallowing blood.  Suctioning and oxygen attempted.  Family alerted and did come and request to have resident have comfort medications only in place of going to hospital.  Resident expired 11/11/2021 1240.