chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The night of the 24th around 1:30AM, I woke up with severe chest pains and I did not seek medical attention. Ever since that same night I started to experience short episodes of where I could not breathe. On June 15th I experienced two sharp chest pains that caused me to not be able to walk. I did seek medical attention and I decided to go to the emergency room, where they found out that I had a very large blood clot that had formed in my right leg. I was admitted on the 16th and they did a scan of my leg where they found the blood clot. They prescribed me Eliquis and I was able to leave the hospital on the 18th of June.
Patient developed significant nose bleed after receiving vaccine.  Required emergency department visits x2 and hospitalization.
Pt vaccinated with TTOX developed hives over entire body, angioedema lip & face.
Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus. He was treated appropriately with iv insulin, iv fluids with resolution of his DKA. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
fever; 3 bumps: one in the palm and two big ones in the lower arm; big rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (3 bumps: one in the palm and two big ones in the lower arm), RASH (big rash) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (3 bumps: one in the palm and two big ones in the lower arm) and RASH (big rash). On 11-Apr-2021, the patient experienced PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (3 bumps: one in the palm and two big ones in the lower arm), RASH (big rash) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Possible cause of AE was covid infection as patient was tested positive.
Giving the full dose instead of the half dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Giving the full dose instead of the half dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. In October 2021, the patient experienced ACCIDENTAL OVERDOSE (Giving the full dose instead of the half dose). In October 2021, ACCIDENTAL OVERDOSE (Giving the full dose instead of the half dose) had resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient received full dose of booster dose instead of the half dose.   This case was linked to MOD-2021-366267, MOD-2021-366289, MOD-2021-365955, MOD-2021-365960 (Patient Link).
BP 129/86, 71, 97, Nominal sinus.  Client c/o pain on left upper arm where the Pfizer vaccination was administered.  Writer gave client an ice pack and client had an Advil tab that she took orally.   Client then complained her right arm was hurting as well.  Code red was called and the paramedics arrived and took client's vitals.  Client's BP was 129/86, pulse 71, 20 breaths/min., pulse 97.  Client once hearing her vitals were normal stated she felt better and was ok to go home.
cold; chills/Shivering; swelling on my upper left arm down to my bicep; Sore throat; Coughing/ thick mucous; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on my upper left arm down to my bicep), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing/ thick mucous), NASOPHARYNGITIS (cold) and CHILLS (chills/Shivering) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced PERIPHERAL SWELLING (swelling on my upper left arm down to my bicep), OROPHARYNGEAL PAIN (Sore throat) and COUGH (Coughing/ thick mucous). On 02-Jun-2021, the patient experienced NASOPHARYNGITIS (cold) and CHILLS (chills/Shivering). At the time of the report, PERIPHERAL SWELLING (swelling on my upper left arm down to my bicep), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing/ thick mucous), NASOPHARYNGITIS (cold) and CHILLS (chills/Shivering) outcome was unknown.            No concomitant medication was provided.  Treatment medication include Cough drop.
rosacea was aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ROSACEA (rosacea was aggravated) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included T-cell lymphoma (6 or 7 years) and Rosacea.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced ROSACEA (rosacea was aggravated). The patient was treated with DOXYCYCLINE for Rosacea, at a dose of was prescribed doxycycline, 30 days supply and METRONIDAZOLE for Rosacea, at an unspecified dose and frequency. At the time of the report, ROSACEA (rosacea was aggravated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient taking doxycycline and metronidazole cream as corrective treatment . There is no product complaint associated with this case. There is no concomitant list Reportedly the patient's blood counts were relatively stable. He went to the dermatologist on 25-Jan-2021.He was prescribed doxycycline, 30 day supply and metronidazole cream. Consent given.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female with no medical history or allergies who on 10-JUL-2007 and 11-SEP-2007 was vaccinated IM with the first and second doses of GARDASIL (lot# not reported) respectively. On 09-APR-2009 the patient received the third dose of GARDASIL (IM, lot# 661703/0651X). There was no concomitant medication. On 04-MAY-2009 the patient called the office to inform that she was pregnant. No lab diagnostics studies were performed. No adverse event was reported. Unspecified medical attention was sought. Follow-up information was received from the Office Supervisor, who stated this patient has not been seen in their office again since April 2009, when she was in for a Well Clinic visit and her GARDASIL dose 3. The patient reported irregular menses at that time, and was referred to a Gyn office. The physician did not find out the patient was pregnant, but was informed of the pregnancy by the Emergency Room at the hospital. The reporter did not know for certain who the prenatal HCP contact person might be. This case is now considered lost to follow up. No further information is available.
3 days after the 1st vaccination I began experiencing tightness/stiffness in both sides of my neck which continued through to my shoulders for several weeks after. The top of my right shoulder is tender to the touch and very sore with limited range of motion. All the symptoms still remain to this day.
Administration error: Vaccinator: Paramedic, diluted 5-11 year Pfizer with 1.8mL of saline instead of 1.3mL and administered 0.3mL intramuscular deltoid.
Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness at injection site. These symptoms persisted for 48 hours.
pt recvd vax & had fever of 105 (R); was limp & cyanotic around mouth approx 2 hrs; gave apap after vax given; to MD;to hosp; stayed 1 day; t of 103;
Redness and swelling at the injection site; Redness and swelling at the injection site; This spontaneous report was received from a safety clinical coordinator refers to a 5 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 13-AUG-2019, the patient was vaccinated with (therapy type rHA) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) of one dosage form via subcutaneous route (lot # S006833, exp.date : 02-SEP-2020) for prophylaxis. Other suspect therapies included sterile diluent (DILUENT MRK INJ) of one dosage form (Lot No. N028746 has been verified to be a valid lot number for [sterile diluent], expiration date reported as 17-MAR-2020, but upon internal validation established as 10-MAR-2020). The patient immediately experienced injection site erythema and injection site swelling. The swelling was treated with Benadryl and ice. Exact diluent used to dilute the vaccine was unknown. The patient sought medical attention. No product quality issue was reported. The nurse reported that they are unable to point to specific lot of sterile diluent that was used for a specific vaccine. Sterile diluent was placed in a bin and vials are pulled as necessary from the bin to be used. The lot number for diluent was not recorded with a specific patient. The process has been changed. The four originally shared lot numbers for the diluent have been taken out of the bin, but it was not listed as product in the case product tab. The outcome for injection site swelling and injection site erythema was reported as recovered. The causality assessment between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  and events was not reported.
Faulty syringe, liquid leaked into internal syringe when giving dose - unable to determine how much of dose was administered at the site.
Patient had PCV 13 on 5/21/2016. 12 hours later, patient had body ache, chills and fever, and then resolved in 1 day. 24 hours later, patient had erythema and itching on left upper arm.
Asthma exacerbations without any triggers. I could be sitting watching TV, doing absolutely nothing and not around any triggers, and my chest becomes tight. Had to use ProAir Albuterol inhaler at least 3 times a day.
Severe pain at lower base of my skull,the evening after my shot, worst pain ever, lasted through the night until 2nd Tylenol the following morning. Pain left UNTIL Covid positive November 4, 2022, same head pain returned & is still causing pain at the base of my skull & neck.
Patient was asked if there was any interaction with flu vaccine he said no. He mentioned he did pass out once when he gave blood but with no issues with flu vaccine. When vaccination complete patient walked back up into his work building and reportedly felt light headed passed out and hit head on elevator. When pharmacists came back up to his location, patient was eating a cookie and water. Security came by with a wheel chair and we all walked back down to the work clinic seen by physician assistant. Physician assistant asked if he saw blood when given the shot and patient said yes. PA mentioned it a common occurrence when patients see blood. We had to leave the room there after. Will be following up with patient.
Approximately 36 hours after first dose, he developed generalized hives, no angioedema, no anaphylaxis.  He did go to urgent care and was given oral steroids prior to my visit with him, hives had mostly resolved at my visit on 1/27/21-- although he remained dermatographic. He has no prior h/o hives or allergies
on January 22nd my vaccine site began to turn hard, red and a bit swollen.  it also has been  itchy ..today is Sunday and is still the same. it doesn't hurt.
Information has been received from a nurse concerning a 21- year-old female patient with a medical history of papanicolaou smear abnormal who on 01-APR-2009 was vaccinated with GARDASIL (Lot # 661954/1496X).  There were no concomitant medications.  The patient had recently become pregnant.  She found out she was pregnant on 01-JUN-2009.  This information was previously reported in WAES 0906USA00715.  Follow up information was received from the licensed practical nurse, via medical record reported that on 13-JAN-2010 the 22 year old female patient delivered a normal female infant without any congenital anomaly.  The abnormal lab data for the mother is Chlamydia positive.  The lab data for the baby is apgar score 9 for 1', 9 for 5', birth weight 3391 gms, length 52.1 cm, OFC 33.17 cm, Hgb 12.9/37.2 to 11.8/39.0, skin exam showed mongoliem on buttracks, head fontanets exam showed molding, eyes showed b/c kk, chest lungs exam showed small left nipple skin tag, GU exam showed large labra, spine/back exam showed closed sacral dimple.  The baby was vaccinated with a dose of hepatitis vaccine on 13-JAN-2010 and was discharged on 14-JAN-2010, discharged weight was 3222 gms.  Upon internal review, mongoliem on buttrack was considered to be a congenital anomaly.  The mother's information was captured in WAES 0906USA00715.  Additional information has been requested.
Autoimmune hemolytic anemia resulting in hospitalization, treatment with prednisone and diuretics. Later weekly infusions of monoclonal antibodies  stopped the autoimmune destruction of red blood cells, allowing the body to rebuild the RBC counts.
I was given the vaccine and when the pharmacists removed the needle I felt a cool feeling running down my arm to my elbow and I told her that and when I looked at my arm I seen a droplet almost to my elbow and I wiped it and asked her what it was and she said I do not know. I was concerned that I did not get the full 3 millimeters of the vaccine and I asked her if that was possible and she said that maybe the muscle wasn't strong enough and pushed some back out and she asked me if I wanted another shot and I asked if we should or is it ok to do that. she replied I don't know then she came back and gave me another shot but the second shot was only 1 millimeter. My question is how do we know how much of the vaccine did I actually receive and what I am I supposed to do because she didn't really seem like she knew.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other medication in 2 weeks. Treatment included Paxlovid from 06May2023 to 10May2023. Symptoms include sneezing, runny / stuffy nose, itchy eyes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events
Father reports that one hour after vaccine administered, patient has chills and teeth were chattering and later developed a fever. Father took patient to ER and they diagnosed him with fever, but father feels it was an adverse reaction. All symptoms have resolved.
Had emesis after returning to daycare on date of administration of 2nd dose (9/13/2007).  Developed diarrhea 10/4/2007 with low grade fever to 100.1.  Tx with pedialyte.  10/9 developed rash on right side of torso and continued with diarrhea/low grade fever.  Tested positive for rotavirus at that time.
a few min p/vax pt devel a wheal & erythema 3cm in size below SC inj site
A got vaccinated 2 weeks ago and yesterday I started with an extreme headache and body pain.; A got vaccinated 2 weeks ago and yesterday I started with an extreme headache and body pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Apr2021 11:30 (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Glucose tolerance impaired" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior vaccination. The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), PAIN (non-serious) all with onset 23Apr2021 05:00, outcome "not recovered" and all described as "A got vaccinated 2 weeks ago and yesterday I started with an extreme headache and body pain.". Therapeutic measures were not taken as a result of headache, pain.  Additional information: The patient was not tested for Covid-19 post vaccination. The patient was not aware of known allergies and past drug history. The reporter reported that It has been two weeks since she got the vaccine and yesterday, 15 days later, she started with an extreme headache and body pain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
coughing; sinus pressure headache; swollen lymph nodes; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), SINUS HEADACHE (sinus pressure headache), LYMPHADENOPATHY (swollen lymph nodes) and SNEEZING (sneezing) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced COUGH (coughing), SINUS HEADACHE (sinus pressure headache), LYMPHADENOPATHY (swollen lymph nodes) and SNEEZING (sneezing). At the time of the report, COUGH (coughing), SINUS HEADACHE (sinus pressure headache), LYMPHADENOPATHY (swollen lymph nodes) and SNEEZING (sneezing) outcome was unknown.
Information has been received from a healthcare worker referring to a 5 year old patient of unknown gender. The patient's concurrent condition and medical history were not reported. On 24-JUN-2015 the patient was vaccinated with one dose of PROQUAD (lot# L002213, expiration date 21-JUL-2016, strength, dose and route were unknown) which was exposed to temperature conditions outside of the recommended range. No adverse effects were reported. Additional information has been requested.
For more than a month (up to today), after receiving the new COVID booster and Flu (for senior) shots together. I don't feel normal. Symptoms:  Flu like feeling, chill, fatigue, no energy, lost 13 lbs,
dentist today and had an implant. They gave him Amoxicillin for the infection; gave him Amoxicillin for the infection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DENTAL IMPLANTATION (non-serious), outcome "unknown", described as "dentist today and had an implant. They gave him Amoxicillin for the infection"; INFECTION (non-serious), outcome "unknown", described as "gave him Amoxicillin for the infection.". Therapeutic measures were taken as a result of dental implantation, infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gas; Vomiting; Vicious headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (Gas), VOMITING (Vomiting), HEADACHE (Vicious headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PROBIOTICS NOS and MAGNESIUM, VITAMIN E NOS (VITAMIN E + MAGNESIUM) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FLATULENCE (Gas), VOMITING (Vomiting), HEADACHE (Vicious headache), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FLATULENCE (Gas), VOMITING (Vomiting), HEADACHE (Vicious headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
7/30/04 hives developed 40-48 hrs after vaccine given. 4-5cm area raised and red on left arm and shoulder +tender +warm. Orapred 30mg=2 tsp given 4:45PM. Benadryl 1 1/2 tsp given (20mg)
03/25/2008 Client's grandmother telephoned to report client c/o left arm and hand discomfort since injection on 03/12/2008.  Referred to PCP.
Patient reported when she got home after getting vaccinated she started experiencing rashes around the injection site, left arm that continued to spread. cold sweats and throat itchiness that she related to prior allergic reaction to other medications or foods. The injection site has area of redness and  induration of 30mmx30mm. She is been taking Benadryl and steroids inhalers at home.
He received vaccine about 14:00.  he had no immediate symptoms such as urticaria, oral face, throat tongue swelling, red watery eyes, SOB, wheezing, CP, n/v/d. He states about two hours after receipt he developed generalized redness and hives with pruritis whole body except scalp. He recalls tongue lip and throat swelling. He also had fever of 102. He self treated with tylenol and went to ER. He reports he received a steroid shot and oral steroids . After 5-6 days the urticaria returned. he was seen in ER and treated with three medications (hydroxyzine, famotidine prednisone).  Per chart review, there is no immunization note. He was seen in ER at 18:44 on 09 MAR 21 day of anthrax vaccine receipt. HR is 104, sat 97%.  BP 117/58 Resp 18 and unlabored. Triage documented c/o head to toe erythema., Temp 99.5. Provider exam at 20:37 is normal, and he was diagnosed with post anthrax vaccination fever and instructed in self care with tylenol and motrin and discharged at 20:53.  There is a second ER visit 11 MAR at 0218 (32 hours post receipt anthrax #4). VS are HR 86, RR 16, sat 99% BP 120/73.  This not document c/o urticaria, swelling of lips and scrotum starting this morning (would be morning after ER #1 and estimate 15-18 hours after vaccine receipt). ER note states multiple erythematous wheals and hives to trunk and extremities, with focal edema to left anterior tibia, edema to scrotum and erythema across groin. He was treated with medrol dose pack, Zyrtec and  and solumedrol 125 mgs.  He reports symptoms are now resolved but continued to have outbreaks or urticaria until last week. He  is still taking hydroxyzine and famotidine (he does not know his medications and can only describe by pill color). There are instructions to taper off, which he has started.