chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single), for COVID-19 Immunization; Bnt162b2 (Dose 1, Single), for COVID-19 Immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "Pericarditis". Clinical course: Patient took the Pfizer Covid-19 vaccine and booster and she stated that she developed pericarditis, and now she was asking if there was a coloration or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
runny nose; chill; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced a runny nose, had a chill and had 97.8 degree Fahrenheit body temperature. Outcome of the events was unknown.   Information on Lot/batch number has been requested.
I had a heart attack on June 3rd 2021.  Not sure if it had to do with vaccination?
Receive MMR, VZV and PREVNAR on 8/12/08. Developed fever 8/14, doctor visit 8/15/08, had URI symptoms. stuffy nose, fever 103.3. No swelling at site of vaccine. Pharyngitis +, and tonsillitis, nl color, started Amoxicillin, swabs sent to lab for strep. Developed rash 8/23 over face, scalp, neck, trunk, extremities (maculopapular), blanching, no fever then, workup  + cat well. 7 day course of antibiotics completed on 8/22. BENADRYL started.
persistent, inconsolable crying lasting ? 3 hours within 48 hours after receiving  the vaccines
This literature marketed report as received from a health professional refers to 4 patients of unknown demographics. The purpose of this study is to evaluate the effect of ZOSTAVAX on the incidence and complications of Herpes Zoster (HZ). The patients' previous history of shingles, vaccination and clinical courses were recorded. Outcome measures were the age of incidence of HZ, ZOSTAVAX vaccination, clinical signs, symptoms and complications of HZ 341 patients (114 males, 227 females) were enrolled, mean age being 56.0 plus or minus 17.6. 165 patients developed HZ; the mean age at the first episode being 59.0 plus or minus 15.6. The mean age of HZ vaccination was significantly higher at 66.7 plus or minus 12.5 (p=0.008). The current cut off of eligibility for ZOSTAVAX is 60 years; number of patients more than 60 was 148. Out of the eligible patients, 112 (75.7%) did not get the vaccine and 47.3% of this group developed shingles, while out of the 36 (24.3%) eligible patients who did get the vaccine, only 4% developed the disease. Relative risk of developing HZ was 3.21 in non-vaccinated group compared to the vaccinated group (p = 0.0008). Ocular involvement was seen in 85% of HZ; with complications such as residual corneal opacities, secondary glaucoma and cataracts seen in 70%, 8.7% and 5%, respectively in 3.7 years follow up. Out of the 4 patients who developed HZ after vaccination (vaccination failure), mean age of incidence was 67 plus or minus 14. ZOSTAVAX can decrease the risk of development of Herpes Zoster by 3 times. In current practice, the mean age of vaccination occurs 8 years later compared to the peak incidence of disease. The article concluded that patients should be encouraged to be vaccinated about ten years earlier to minimize the surge in incidence that occurs in the 5th decade of life. Based on this data, it was indicative that zoster vaccine delayed the age of onset of the first episode of HZ and may result in fewer long term complications even in patients who develop disease after vaccination. Large population studies based on systemic data are required to further elucidate vaccine efficacy. The outcome of vaccination failure is unknown. The reporter considered vaccination failure to be related to ZOSTAVAX. Additional information has been requested.
Swelling around injection site--right arm (DTAP and MMR given), 6 hours after imm. Itching - 3/30 but stopped on 3/31/04 but stopped on 3/31/04 with swelling persisting 10cmx8cm. No tenderness.
The area below my elbow became very swollen and a red area appeared around the injection site. I went to an Urgent Care Center and was told that I had "septic bursitis." I was placed on a regimen of prednisone and antibiotics for approximately nine days. As of now I have a large loose sack of material at the base of my elbow. I plan to seek further medical advise.
About 20 hours after the vaccine I started to have pain in my left arm. I then got some itching under my arm on the side. My upper arm was red swollen and painful. On the second day my Lymph node became very swollen. It was very painful. I consulted my doctor on the third day and I took Motrin and used ice. Over the course of the next two days the swelling and pain started to go down.
Patient became pale, diaphoretic, feeling of passing out and had 1 episode of vomiting.
This spontaneous report was received from a pharmacist and refers to a 69 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-SEP-2017 (reported also as 09/19/2017), the patient was vaccinated with expired dose of ZOSTAVAX lot # M028798, expiration date on 18-AUG-2017, for prophylaxis (dose, site and route of administration were not reported). Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects were reported.
patient received Daptacel instead of Adacel with no reported adverse event; 37 year old patient received Daptacel instead of Adacel with no adverse event; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from other health care professional and consumer/non-healthcare professional via Medical information (under reference number - 00778953).  This case involves a 37-year-old female patient who was accidentally vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] with no adverse event (Wrong product administered) (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 17-Sep-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination (Wrong product administered) (Product administered to patient of inappropriate age).  It was reported "caller asks when can the Adacel be given? Also, when would the patient get an Adacel booster?."  There were no laboratory data/results available.  It was case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency was on same day)  At the time of report, no adverse events were 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. 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.
I experienced fever like symptoms and body aches which lasted approximately 12 hours  Shingles vaccine was given at the same time as the influenza vaccine
The day following the vaccine I was very tired,  very achy but not headachy or nauseous - just a lot of body aches and fatigue for 14 or 15 hours. I was totally fine the next day. About 16 days later, I woke up in the middle of night with a lot of pain on my upper right side. It wasn't getting better.  I went to Urgent Care that Saturday and the next day, I woke up with a rash. I did a virtual appt over video call - through my insurance - and she said it was Shingles -Prescribed: Valtrex that I took for 7 days. The pain started getting pretty bad a few days after. The Doctor said to take Tylenol and Ibuprofen for the pain interchanging them every four hours. I am still taking them at this point every six to eight hours. The rash is still very painful but it's going away - it's not nearly as bad as it was a week ago.
Received KINRIX (DTaP/IPV) Rt thigh on 4/1/09, red, sore, itchy indurated warm spreading rash developed.  14x10cm likely allergic, but AUGMENTIN given.
tested positive for covid and pneumonia in the ED; tested positive for covid and pneumonia in the ED; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I Have COPD/emphysema" (unspecified if ongoing), notes: I Have COPD/emphysema; "I Have COPD/emphysema" (unspecified if ongoing), notes: I Have COPD/emphysema. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 PNEUMONIA (medically significant), outcome "not recovered" and all described as "tested positive for covid and pneumonia in the ED". The events "tested positive for covid and pneumonia in the ed" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive for covid; (30Nov2022) Positive, notes: The caller states he tested himself today and continues to test positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 pneumonia. Clinical course: The patient has COPD/emphysema and had an acute COPD attack, went to the ED and tested positive for covid and pneumonia in the ED.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient started to go pale and said she was getting dizzy while in the chair and said she was going to faint.
On day 9 the injection site started itching and was very aware of the exact spot. The next morning I woke up with a visibly raised area on and around the injection site. It feels itchy and achy. I have a slight tingling sensation  down the underside of my right arm from my armpit to my palm.
Chief Complaint: 69 y m c/o feeling punky for a week and his sugars are elevated, respiratory complaints cough, dyspnea (SOB) and URI symptoms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 4 (booster), single (Lot number: E49702) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 25Oct2021 as dose 2, single (Lot number: 014F21A) and on 26Apr2022 as dose 3 (booster), single (Lot number: 056A22A) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 09Mar2021 as dose 1, single (Lot number: 1805022) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Clobetasol proprionate, notes: Occasional use of clobetasol, proprionate. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2022) Positive; (22Oct2022) Positive; (26Oct2022) Positive; (01Nov2022) Negative; (05Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Healthy adult 66 y/o adult male. Physically active an in good health. No oral medications.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2, BNT162B2 OMIBA. 4-5 to drug ineffectiveness and COVID-19 cannot be ruled out.
Client received 1st dose of Pfizer back in April. She had no reactions from the first dose and when she arrived to our clinic, requested for J&J initially but notified client that she must get another mRNA vaccine which we only had moderna. Client decided and consented to get moderna as second dose. We double checked CAIRS for first dose record which was not there but client provided proof of first dose of Pfizer from pharmacy and we proceeded to give second dose moderna. Client had no reactions after 15 min of monitoring.
I have the standard sore arm/some muscle aches; Bad headache; My temp is holding steady at 100; sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (I have the standard sore arm/some muscle aches), HEADACHE (Bad headache) and PYREXIA (My temp is holding steady at 100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney failure.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (I have the standard sore arm/some muscle aches), HEADACHE (Bad headache) and PYREXIA (My temp is holding steady at 100). At the time of the report, PAIN IN EXTREMITY (sore arm), MYALGIA (I have the standard sore arm/some muscle aches), HEADACHE (Bad headache) and PYREXIA (My temp is holding steady at 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (Inconclusive) holding steady at 100.         No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
pt recv vax 23DEC97 & on 23DEC97 pt devel hives all over body;
Patient presented to Hospital on 09/26/2021 reporting GI bleed at SNF.  The patient was Covid positive at SNF.  In ED patient had large blood stool.  CT scan of chest showed bilateral PE's.  CXR showed multifocal PNA.  Patient was admitted and transfused in ED.  Patient expired on 09/26/2021 at 2335.
Fever, muscle pain, abdominal cramps,  diarrhea, dry cough
2 days after receiving immunizations child twitched for 10 seconds while breast feeding. Fell asleep never unarousable.
Vertigo. ER visit. Meclazine & Diazapam.  Still experiencing dizziness on departure. Mild dizziness and balance issues while still taking the same medication following day. Today mild balance issues without using above medication.
Arm is red; Arm is painful; Arm is itchy; Rash on neck; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities, pain in arm, itchy upper limbs and rash. On an unknown date, the outcome of the erythema of extremities, pain in arm, itchy upper limbs and rash were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm, itchy upper limbs and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingles vaccine on last Sunday and The patient's arm was red, painful, itchy, and had rash on neck area. Additional Supportive Information: This case was reported via interactive digital media. Follow-up would not possible as no contact details were available.
Anxiety; Felt tight for about 5 minutes while in the shower, then felt better, Tightness was not in chest, they were just nervous, it was their nerves; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety) and NERVOUSNESS (Felt tight for about 5 minutes while in the shower, then felt better, Tightness was not in chest, they were just nervous, it was their nerves) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety) and NERVOUSNESS (Felt tight for about 5 minutes while in the shower, then felt better, Tightness was not in chest, they were just nervous, it was their nerves). At the time of the report, ANXIETY (Anxiety) and NERVOUSNESS (Felt tight for about 5 minutes while in the shower, then felt better, Tightness was not in chest, they were just nervous, it was their nerves) had resolved.            No concomitant medications were reported. Patient received second dose and had no problem with it. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Follow up received contains no new information.
This spontaneous report a received from a certified medical assistant refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with the doses of the improperly stored PNEUMOVAX23 (doses, routes, lot numbers and expiration dates were not reported). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
12 hrs after vaccine had severe chills, very cold, slight fever, aches. Chills subsided and continued with fatigue and overall achy feeling the next day. Symptoms subsided about 24 hrs from onset.
Patient presented 9/9/14 for care due to persistent severe intermittent arm pain following vaccine administration. Dx Brachial Plexus Neuritis in hospital.
Fatigue, Anxiety, and numbness/tingling of lower extremities. Patient transfered to Hospital. Epiniphrine and Benadryl given pror to transport.
patient died recently after getting the vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died recently after getting the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: patient died recently after getting the vaccine
Pfizer vaccine syringe detached from needle. Needle remained on patient's left arm at the deltoid region. Content of vaccine sprayed from syringe onto patient's skin. Site supervisor and physician were notified immediately.
Patient c/o Rt arm being red, sore, and swollen. Pt. instructed to apply cool compress to Rt arm. Rt arm noted to be swollen & red.
1st dose more than 6 months ago, have not received their 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (first dose received more than 6 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, till the time of reporting, 1 or 2 patients did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter had no patient identifiers for patients and did not provide any additional information. The reporter did not consent to follow up.
This spontaneous report was received from a nurse practitioner via company representative and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported). Concomitant therapies were not reported. On an unknown date, after the vaccination, the patients developed shingles. The outcome of shingles was unknown. The relatedness between ZOSTAVAX and the event was not reported. Additional information has been requested.
8/29/02 2:30p picked up from school, L upper shoulder at deltoid red, swollen, warm to touch. Appt. to see MD this evening.
Began to have a runny nose and itchy throat around 8:30 p.m. Escalated through the night into a cough and hoarse throat. Work up around 6:30 a.m. with conjunctivitis in both eyes (both eyes were red, matted shut and very swollen). Face and hands were slightly swollen throughout the morning. Left work around 2:30 p.m. on 10/14/2014 and took a Benadryl. Took a nap and awoke around 7:30 p.m. and my eyes were beginning to recover. On the morning of 10/15/2014 woke up feeling much better.