chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; Headache; short-lived drop in body temperature; shaking uncontrollably; hands and feet were like ice; my whole body had tensed up; unable to sleep; experienced sharp, sudden pain in my calf muscles; lower back pain; ringing in my ears; Nauseous; Pain in my left side; Odd sensation in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "short-lived drop in body temperature"; TREMOR (non-serious), outcome "unknown", described as "shaking uncontrollably"; PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (non-serious), outcome "unknown", described as "hands and feet were like ice"; TENSION (non-serious), outcome "unknown", described as "my whole body had tensed up"; INSOMNIA (non-serious), outcome "unknown", described as "unable to sleep"; MYALGIA (non-serious), outcome "unknown", described as "experienced sharp, sudden pain in my calf muscles"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain"; TINNITUS (non-serious), outcome "unknown", described as "ringing in my ears"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; PAIN (non-serious), outcome "unknown", described as "Pain in my left side"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Odd sensation in my head".  Additional information: I only know of two other people who have had very similar symptoms to your vaccine. The reactions detailed above were much worse that first week, and lessened as time progressed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Almost immediately after getting the vaccine, I could hardly breathe, I lost my smell and taste. They recommended I had an x-ray done. I had the x-ray done and it came back with some fluid. I set up an appointment to have a Thoracentesis done. My doctor did it and they retrieved 250CCS. It did not help. The original x-ray showed that I might have developed pneumonia. They finally gave me a prescription for Levaquin and that helped more than anything. I take that after dialysis. I have seen the most effects and results for the better from that medication. I check my oxygen saturation every morning and it is usually at 96-98. But since I got the shot it has not been better than 93. Right now it is 95 and my temperature is 97.8. After the vaccine my temperature did go up to 98.7. They ran a teste for the fluid they took out of my lungs and it came back normal.
Injection given in right deltoid and entire top part of arm red, itchy and on her back as well.
Vaccine #1 4/22/21  #2  5/13/21  On 5/30/21 she noted a golfballl-size lump in her L axillathe same arm in which she had a previous melanoma excised in 2016 (T1b NX) and cancer-free for 5 years. 6/15/21 One biopsy L axilary lymph node reveals metastic melanoma. SOX10 POS, Melana POS. CKAE1-3 NEG.
pt recvd vax;w/in 1 day devel flu like sx lasting for months
Information has been received from a physician's assistant concerning a male patient who on 05-SEP-2011 was intramuscularly vaccinated with the 0.5 mL first dose of GARDASIL (Lot # and expiration not reported). It was reported that on 07-SEP-2011 the patient experienced loss of hearing in left ear. The patient sought medical attention by an office visit to ear, nose and throat physician. Therapy with GARDASIL was discontinued. At the time of reporting the patient had not recovered. Upon internal review, loss of hearing in left ear was determined to be an other medical important event. Additional information has been requested.
major vertigo issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EP6955) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 21Mar2021, outcome "not recovered", described as "major vertigo issues". The event "major vertigo issues" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Additional information: The Patient didn't taken other vaccine in four weeks and Other medications in two weeks.A week after 1st dose patient experienced major vertigo issues for no apparent reason. She went to ER to ensure she wasn't having a stroke. Patient was not taken Covid prior vaccination.Covid tested post vaccination. Patient didn't had known allergies.  . No follow-up attempts are possible. No further information is expected.
Covid19 breakthrough.  1st Vaccine 3/3/2021.  Pt presents with altered mental status, fevers, weakness and dry cough for 2 days.  O2 sat on 4L NC-91%.  Pt treated with IV steroids/abx and Remdesivir.
Blood was in his urine after the first shot; The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on 02Jun2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Lawyer) from legal division. Other Case identifier(s): (court case number).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 27Aug2021 as dose 1, single (Lot number: FD0809) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD URINE PRESENT (non-serious), outcome "unknown", described as "Blood was in his urine after the first shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that because the patient wanted to take his classes in person, needed to be fully vaccinated. He scheduled his vaccine appointment and received his first shot in Aug (2021) and his second in Sep (2021). His parents said he chose the Pfizer vaccine because it was recently fully approved by the Food & Drug Administration. The patient took two doses of the Pfizer-BioNTech COVID-19 vaccine because the school otherwise barred him from attending in-person classes. After his first dose, the patient experienced complications, which he chose to keep to himself. According to his parents, blood was in his urine after the first shot. His dad described him as healthy/athletic, saying he had no underlying medical conditions. Patient experienced medical symptoms after his first dose of the experimental COVID-19 injection that worsened after received a second dose of the EUA Pfizer-BioNTech COVID-19 injection on 17Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200215072 same patient, different dose and different event.;
Pt experienced chills; no site reaction; hot-cold; flu like symptoms; headache; stomach cramps, gurgling with sensation to have diarrhea; increased joint pan. All symptoms lasted 3 days.
My COVID-19 symptoms started on 12/06/2022 I went to a work party at around 08:00PM, where I couldn't feel the drink that I was drinking. It felt weird. On 12/07/2022 I had a fatigue and a sore throat. By the evening my symptom's got worse along with the symptoms I got chills. I did a home COVID-19 test on 12/09/2022 which was positive. On 12/10/2022 I called my doctor's office on Saturday since it was a weekend the office was closed my phone line was transferred to a hotline. They told me to fill out a form which I did it online and said someone will get back to me within 24 hours. The PAXLOVID will be shipped within 1-2 business days since my symptoms already started and it was the 3rd day of my symptoms. The time frame for the PAXLOVID to work was within 5 days of my symptoms. I decided not to wait to the medication. I took TYLENOL for first couple of nights.
Presented to clinic for Hep B vaccine was sitting in chair and upon giving vaccination patient reports not feeling well. She was given water and feet were elevated on a 2nd chair. She proceeded to become diaphoretic and then eyes rolled in back in head and she was mildly shaking (head and BUE and BLE), nonverbal. She would've fallen on the floor but I kept her upright and held her face as well. She came to about 15 seconds after beginning and felt off. Her blood sugar was checked it was 127 and her blood pressure was 100/60 and then after 10 minutes it was 110/62. I was having the asst. call 911 and she told us to hold off and then she refused. Recommended she have someone come and get her as I didn't want her driving on her own. Her neighbor came and took her home.
The day after the vaccine at around one in the afternoon I had chills and achiness, I took ibuprofen and it went away two days after the vaccine the same thing at about the same time. Severe arm pain for two days and armpits swelling for one week
Patient was reported as being flushed prior to vaccine administration. Patient had history of HTN. Received vaccine about 10AM 2/10/03. Reproted not feeling well about 10:35AM. EMS on site checked BP at 10:50AM at 176-109 and at 10:55AM at 171-117. Patient transported to hosptial. Admitted to ER 11:45AM 2/10/03. Stable in ED at 1:45PM. Discharged about 3:15PM.
body aches; sweats; chills; Initial information was received on 24-Oct-2017 regarding an unsolicited valid non-serious case from an other health professional.  This case involves 14 patient with unknown demographics who experienced body aches (pain), sweats (hyperhidrosis) and chills, while patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Patient did not have a history of egg allergy or serious medical illness.  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT5949PA, expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious body aches (pain), sweats (hyperhidrosis) and chills 12 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that, reporter started flu clinic last week and have had approximately 1% of our population have a reaction to the vaccine.  This includes severe rash (the rash was flushing with redness all over the body with itching no hives), itching, high fevers, body aches, chills and sweats within 12 hours of receiving the vaccine but reporter did not have the number of patients who had the rash. It was also reported that, 400+ vaccines to patients some had fever.   Details of laboratory data not reported.  The patients were treated with counter treatments.   On an unknown date, the patients were recovered from the reported events.
I have broke out into hives all over my hands and forearms, my neck and the left side of my face. My face is also warm to touch
Itching at injection site (left arm); rash on left breast; rash on back (upper left side), swollen lymph nodes in left arm pit; bullseye around injection site (around 1 inch in diameter); sore throat; body aches; diagnosed with shingles on 3/24
Approx. 2 weeks after the vaccines, Pt started having urinary frequency. He was diagnosed today with diabetes and is currently getting admitted in the hospital.
I recieved the first dose of Moderna shot March 17th.  Got my period March 22nd and had it regular.. medium to light flow and lasting 4 days which is normal and always has been being on birth control. The 2nd shot I got April 14th.  My period was supposed to come the week after and it didn't. I  had the symptoms of cramping the usual but my period didn't come which has never happened. I took a pregnancy test and was not pregnant. The next month in May I got it but for 2 days. It was extremely heavy the first day which has never happened and light the 2nd day and then done. Like I said my normal patterns are 4 days and medium to light every cycle. The next month June, it came and I had it for 10 days. Medium to heavy flow. Again, has never happened and that is odd for that long. July came and I got it for 3 days.. August, I got it for 2 days. September I had it for 3 days. October I got it for 3 days. My concern and it is not coincidental but after receiving these shots my menstrual cycle has not been the same at all. My birth control is supposed to regulate it all and how many days I have it. I have never had a problem with it until after I got these shots. I'm horrified and don't want to receive my booster shot because what else can it do to my cycle and more.
The patient did not receive the second dose; Pain all over the body was severe; Vaccine triggered migraines; Arm was incredibly swelled; Arm was painful; Arm was red; Patient couldn't move; Throwing up a lot; Very very high fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain all over the body was severe), MIGRAINE (Vaccine triggered migraines), PERIPHERAL SWELLING (Arm was incredibly swelled), PAIN IN EXTREMITY (Arm was painful) and ERYTHEMA (Arm was red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MYALGIA (Pain all over the body was severe), MIGRAINE (Vaccine triggered migraines), PERIPHERAL SWELLING (Arm was incredibly swelled), PAIN IN EXTREMITY (Arm was painful), ERYTHEMA (Arm was red), MOBILITY DECREASED (Patient couldn't move), VOMITING (Throwing up a lot) and PYREXIA (Very very high fever). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (The patient did not receive the second dose). On 10-Jan-2021, MYALGIA (Pain all over the body was severe), MIGRAINE (Vaccine triggered migraines), PERIPHERAL SWELLING (Arm was incredibly swelled), PAIN IN EXTREMITY (Arm was painful), ERYTHEMA (Arm was red), MOBILITY DECREASED (Patient couldn't move), VOMITING (Throwing up a lot) and PYREXIA (Very very high fever) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (The patient did not receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  The reporter stated that the patient experienced significant reaction following the vaccination and thought of the patient would have to be hospitalized.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: TCR Received includes updated Reporter information- Email
Chief Complaint Patient presents with ? Shortness of Breath     have been using inhaler for 5 days with no relief. Hx of asthma 87% on RA in triage.     HPI Patient is a 74-year-old female, past medical history significant for asthma, emphysema, COPD, hypercholesteremia, hypertension, and diabetes, presents to our facility today for shortness of breath.  The patient states that for the previous 2 weeks has been experiencing elevated shortness of breath from her baseline.  She states that she has been seen by her pulmonologist on multiple occasions and given antibiotics and 2 rounds of steroids.  The patient states that she continues to smoke 2 packs a day and denies utilizing oxygen therapy on an outpatient basis.  She states that in the past 48 hours she started developing rust colored sputum and she wanted come to facility to be evaluated.   Patient herself, denies any fevers or chills.  No nausea, vomiting, or diarrhea.  No frank chest pain, however, she planes of ambulatory shortness of breath.  She states that she follows regularly with doctor from cardiology and had a recent echo done with a 65% ejection fraction last year.
Redness/tenderness/pain at site of injection.  Whole body myalgias, severe headache, fever.  Not itching.
Diffuse hyperemic papulovesicular rash, worse on distal extremities - fever 103-104.
Erythema & swelling to the injection site.  101 degree temperature.  Currently the area is still itchy.
Hepatitis B was administered as a 4th dose. Pt was supposed to receive Hepatitis A. Post vaccination symptoms included injection site lump, stomach pain, and 1 day of diarrhea.
used incorrect diluent and administered to a patient; used incorrect diluent and administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA602A, expiry date 31st August 2022) for prophylaxis.   On 17th May 2022, the patient received Menveo. On 17th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information:  GSK Receipt Date: 17-MAY-2022 Reporter's Comment: Health care professional (HCP) reported, Medical Assistant (MA) used incorrect diluent and administered to a patient. The reporter consented to follow up. Additional Supportive Information: The patient received incorrect diluent of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Pt c/o itching, redness, warmth with hard knot & tingling to back of upper rt arm where VZV administered yesterday. Referred to Care Center for eval ASAP.
Warm, red, swollen right arm. Facial redness, frontal headache, nausea, vomiting, fever, dehydration.
large red inflamed area; large red inflamed area; severe pain; upset stomache; headache; What would I expect if it was subQ and not into muscle; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema, inflammation, pain, upset stomach, headache and intramuscular formulation administered by other route. On an unknown date, the outcome of the erythema, inflammation, pain, upset stomach, headache and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the erythema, inflammation, pain, upset stomach and headache to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient never had much of rection to a until patient's last dose of Shingrix and a flu shot. The patient reported that, the people who gave them did it very slowly and patient wasn't sure if they even got into the muscle.  The patient was ever supposed to but have never had them given so slowly (and more painfully because of that). The patient experinced large red inflamed area, severe pain 2 days out, upset stomache and headache. The patient asked, what would expect if it was subcutaneous and not into muscle. The patient asked, can Shingrix and the Flu vaccine be receive at the same time.
A non-viable flu vaccine was administered to the patient due to delay in shipment, no AE; The patient was given two doses of Fluzone Quadrivalent High Dose, no AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 65 year old female patient who was given two doses of a non-viable INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] due to delay in shipment (extra dose administered and product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant medications   On 29-Sep-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ510AB, expiry date: 30-Jun-2021) once via intramuscular route in the left deltoid for prophylactic vaccination   On 30-Sep-2020 the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ510AB, expiry date: 30-Jun-2021) once via intramuscular route in unknown administration site for prophylactic vaccination.  It was of actual medication error due to extra dose administered and incorrect product storage.  The vaccines were deemed not suitable for use due to the shipment that arrived late. The nurse reported that the patient was accidently given the vaccine on 29-Sep-2020 from the batch. The patient was called back to get revaccinated with a vaccine that was suitable for use. On 30-Sep-2020, she was accidently given a dose from the same batch as the day before. The vaccine was put away to avoid being used but was still used. The prescriber was not wanting to revaccinate the patient due to having two doses of the high dose in two days. There were  total  6-pateints that received the doses on 29-Sep-2020. The reporter had information on the above mentioned patient. There were no details about other 5 patients whether they got revaccinated with vaccines that were suitable for use.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.