chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumococcal vaccine, Date of vaccination 30-JUL-2015 and 02-MAY-2019; This spontaneous report was received from a 68-year-old female patient, concerning to herlself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On 30-JUL-2015, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "Pneumococcal") for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On the same date, she was vaccinated with zoster live vaccine (ZOSTAVAX) and experienced herpes zoster and other events (captured in MARRS 1910USA006737). It was reported that another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "Pneumococcal") was administered on 02-MAY-2019 (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1910USA006737:
Patient got the vaccines and was fine, parent and the patient went to check out and that is when the patient told mom she was feeling dizzy and light headed, patient was asked to have a seat and was given some juice, and the provider went  and talked a little bit with mom and found out that patient did have a heavy/hard workout and skipped lunch patient. After about 10-15 minutes patient was feeling better and was discharged from the office.
red rash on arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash on arm) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031M204) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash on arm) and CHILLS (chills). At the time of the report, RASH ERYTHEMATOUS (red rash on arm) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-044787, MOD-2021-044787 (Patient Link).
The patient called stating that half her arm is red, hot, and swollen from an immunization she received the day before. The patient states that she usually has swelling and redness on injection sites but she is not sure if it's normal for the redness and swelling to reach down to the elbow. I instructed the patient to apply ice and to take Ibuprofen as well as informing her physician of the reaction.
Extreme headache left side of head and left eye. Vaccine was given on Thursday March 18th  and the headache started on Friday the 19th and got worse of Saturday the 20th and Sunday morning got better Sunday evening. A rash developed on the left side  of  my forehead Sunday afternoon (looks like bloody pit marks). The left side  of my  head hurts, and my left eye continues to throb.
A red, round lesion about two inches in diameter at the place where I had the shot. It is raised and very itchy. It appeared almost 7 days after I had the vaccination. It is very hot to the touch and tender.
1st Moderna vaccine 3/20/21 Tested positive for Covid-19 on 04/12/2021 2nd Moderna Vaccine 04/30/21 That evening full body ache, later in the night 102 degree fever, deep chest cough, extreme exhaustion, extremely severe reaction could not get out of bed until Saturday Evening.   Fever stayed at 101-102 until it  broke on Sunday May 2nd 3:00 a.m.   Symptoms getting better.
The vaccine was expired on 19-May-2023, and the vial was initially tored in the refrigerator, thawd and injected on 31-may-2023; No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vaccine was expired on 19-May-2023, and the vial was initially tored in the refrigerator, thawd and injected on 31-may-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 19-May-2023, and the vial was initially tored in the refrigerator, thawd and injected on 31-may-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vaccine was expired on 19-May-2023, and the vial was initially tored in the refrigerator, thawd and injected on 31-may-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine was expired on 19-May-2023, and the vial was initially tored in the refrigerator, thawd and injected on 31-may-2023).    No concomitant medications were reported. They were all in intact carton. Vial size was 2.5 ml and the vial did not underwent any temperature excursions. No adverse reactions were reported. All the patient were qualified the age and or immunocompromised. No treatment medications were reported.  This case contains information for the 1 of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:OCCC (patient 3 out of 20) Master
PATIENT HAD NO SYMPTOMS AT TIME OF SHOT, HOWEVER HE HAS BEEN BOTHERED EVER SINCE THE SHOT WITH MUSCLE SORENESS IN UPPER BODY, AND BOTH ARMS AS IF HE HAD WORKED OUT. PAIN IN RELIEVED WITH MOTRIN, BUT HAS NEVER FULLY GONE AWAY SINCE SHOT.
Patient traveled  to obtain immunization.  Family of 5 came to get immunization.  Patient filled out information on website stating that date of birth was 10/13/2002 .  When patient arrived she put that date of birth was 10/13/2004.  Patient received vaccine which should have been for 18 and up.  Drug company was contacted and stated that drug was ok to be given to this patient.  Attempted to contact guardan but phone number was incorrect.
Mild to moderate soreness/ache in arm, sunburn-like sensation and red mark under shot site (with minimal exposure to sun). It has been over a week since the shot was administered.
Case previously recorded as MA2009-4298. Initial case report received from a nurse, via Novartis Medical Communication, on 13 NOV 2009. A 2 year-old patient was vaccinated with 0.5ml of S-OIV FLUVIRIN (batch no. unknown) i.m. on 13 NOV 2009, an off-label indication. No adverse event was reported. Agency reference no.: NA09-008210.
Pfizer COVID- 19 vaccine booster was stopped administration two days ago. No symptoms or side effects.
At about 9pm, patient started to lie down but couldn't because of stomach issues. Temp increased to 102. Periods of intense vomiting all night and all day. Patient body aches, fever, chills, headache. Symptoms lasted till 10/1/2020 in the afternoon, temp started to stabilize. Started to feel better but very weak.  Advised by PCP to drink plenty of fluids, tylenol as-need and rest.
The reaction involved her developing 3 autoimmune disorders in 2011; This spontaneous report was received from a consumer regarding to herself;  a female patient of unknown age.    Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date in 2009,  the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unknown date in 2011, the patient experienced 3 autoimmune disorders.  The outcome of autoimmune disorder was unknown.    The reporter considered autoimmune disorder to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the autoimmune disorder event was determined to be medically significant.
This spontaneous report as received from a female office manager of unknown age. There was no information about the patient's concurrent conditions, medical history, any known allergies, reactions or concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, after completing the full dose series of GARDASIL (dose, route of administration, lot number and expiration date were not reported) given on an unknown dates, the patient was diagnosed by her obstetric gynecologist "ob/gyn" physician with cervical intraepithelial neoplasia (CIN) grade 2 (cervical dysplasia); however, it was not confirmed if the cervical intraepithelial neoplasia (CIN) grade 2 diagnose was cancer (cervix carcinoma). She received treatment for the event (date and type of treatment were unspecified), but it was reported that they were not able to remove it all. The patient did not recover from the events. No additional information was provided. No overdose and no product quality complaint were involved. Upon internal review, cervix carcinoma was determined to be medically significant. Additional information is not expected because there was no consent to contact physician.
pt recvd vax & 3 hrs after vax had chest pain on & off; 15oct94 had fever; 16oct94 had hives; top lip started to swell; went to er;
Patient is a 80 y.o. female patient of, MD with history of arthritis, CA, diverticulosis, diverticulitis, HTN, hysterectomy and s/p exploratory laparotomy, lysis of adhesions, small bowel resection, functional end to end small bowel anastomosis 6/15/2021, who presented to General Hospital with abdominal pain.   Assessment and Plan   Recurrent Small Bowel Obstruction, resolved Secondary to adhesions Admission CT abdomen/pelvis with dilated small bowel loops 10/23 s/p operative adhesion-lysis Surgery has signed off Analgesia Toradol as needed History of multiple abdominal surgeries PT OT Tolerated diet Remove PICC line and discharge   Acute hypoxic respiratory failure, improved Severe COVID 19 Infection Respiratory status stable hypoxia resolved On room air for 24 hours now continue 40 mg Lasix daily Continue Decadron 6 mg for another 3 days Stop Zosyn; oral doxycycline 100 mg twice daily for 3 days Completed remdesivir Pain under control Incentive spirometry PT OT   Acute Kidney Injury, resolved Creatinine elevated to 1.7 on admission, baseline of about 0.8 Likely pre-renal in the setting of abdominal pain and SBO Now back to baseline No evidence of UTI; discontinued ceftriaxone Urine culture negative   Hypertension Continue home medications
Pt recvd vax & 4 days later exp h/a, fainting, dizziness, swollen glands & devel the flu; approx 1 1/2 mo following vax pt c/o SOB; MD found asthma w/ or w/o COPD; etiology viral illness; adm to hosp 1MAR93 w/SOB; dx bronchospasm, COPD, anx
One day post vaccination the pt experienced a localized reaction in her left arm including pain that radiated to the shoulder area, redness, and swelling. The pt sought unspecified medical attention. Additional information ha been requested.
For a week after my shot I was ok and then I started to get a cough. I though it was just my allergies. I then called my doctor to see what was going on and she tested me for Covid and Pneumonia and the results came back negative. She then tested me for bronchitis which came back positive.
Developed fever of 102 and muscle aches in both legs eight hours after receiving vaccine. Symptoms have now improved.
Breakthrough case admission after three vaccines Moderna 2/27/21 Lot# 010A21A;  Moderna 3/27/21 Lot# 017B21A;  Moderna 12/6/21 Lot# 029H21B
Left arm pain Unsure about anything else- have left voicemail for pt to call clinic back
Had flu and pneumonia vaccine at same injection. Temp 101, vomiting, red line circling halfway across upper left bicep where injection was made. Dizziness and near syncope. Nausea. Headache. Very sore left arm.
finding out I tested positive; finding out I tested positive; I was an emotional wreck after the exposure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Crohn's patient" (ongoing), notes: I am an Inflectra Crohn's patient. Concomitant medication(s) included: INFLECTRA [INFLIXIMAB] taken for crohn's disease. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "finding out I tested positive"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "I was an emotional wreck after the exposure". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Patient was on Inflectra Crohn's patient and received the Pfizer COVID vaccine. The patient was unfortunately exposed to COVID last week. This was an emotional wreck after the exposure and then finding out tested positive. The patient received Paxlovid immediately. It was a miracle worker. The patient basically bleed Pfizer blue at this point with all medicines patient was on, but, the patient just wanted to send a heartfelt THANK YOU for putting my Crohn's in remission, developing a great vaccine and now a life-saving antiviral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 23-OCT-2012 12:32, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Neck tightness/swelling (exterior) rept'd by pt without dyspnea or other cardiopulmonary difficulty. Found EGC abnormal consistent w/STEMI. Underwent cardiac catherization-> normal coronaries, abnl ventriculogram Next day echocardiogram (TTE) normal, Troponin peak @ approx 5. Completely asymptomatic w/in 24 hours.  1/4/08 Reviewed hospital medical records which reveal patient experienced lump in throat when swallowing, swollen neck lymph nodes & chest tightness.  Left deltoid vaccine injection site red, swollen & indurated.  Admitted8/25-8/29/2007  FINAL DX: myopericarditis, smallpox vaccine induced.
pt recv vax 26FEB96 & 29FEB96 pt devel a fever of 102.5;no further details were provided;
Patient administered Covid vaccine shot 1 today and site of injection "hurt more than any other shot"; This is a spontaneous report from a contactable nurse.  A male patient of an unspecified age (reported as 28, unknown unit) received bnt162b2 (BNT162B2), via an unspecified route of administration on 15Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient administered the COVID vaccine shot 1 on 15Dec2020 and site of injection "hurt more than any other shot" on an unspecified date in Dec2020. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
There is no adverse event. This is reported for vaccine administration error. Patient received 1st dose COVID vaccine as Moderna on 3/3/21 at another facility. For second COVID dose at this facility, patient inadvertently received Pfizer (instead of Moderna) on 4/13/21.
Scrotal swelling and pain, leading to abdominal pain and a forty pound weight loss. He saw a urologist who ordered an ultrasound and treated him with antibiotics and ibuprofen. He is not any better as of today. His scrotum swells if he exercises, has intercourse, moves the wrong way, wears clothing that is too tight, or sometimes for no apparent reason.
Patient reported received flu shot now has tenderness, itching, and swelling to injection site 1.5in x 1.5in Acetaminophen 325mg, diphenhydramine 25mg night, loradamed 10mg day, hydrocortisone 1% prn for symptom and comfort control per package directions. Follow up with physician.
Menstrual cycle started two weeks early.  Menstrual cycle is normally very regular and not experiencing perimenopausal symptoms.
Patient was admitted to the Hospital on 08/09/2021 w/ nausea, fatigue and vomiting.  She tested positive for COVID-19 on 08/09.
Itching; Big red spot; Swollen; Hot; Swollen left hand; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Big red spot), SWELLING (Swollen), BURNING SENSATION (Hot) and PERIPHERAL SWELLING (Swollen left hand) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, ZINC (VITAMIN C + ZINC) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen left hand). On 07-Mar-2021, the patient experienced ERYTHEMA (Big red spot), SWELLING (Swollen) and BURNING SENSATION (Hot). On 08-Mar-2021, the patient experienced PRURITUS (Itching). On 06-Mar-2021, PERIPHERAL SWELLING (Swollen left hand) had resolved. At the time of the report, PRURITUS (Itching), ERYTHEMA (Big red spot), SWELLING (Swollen) and BURNING SENSATION (Hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included ice.   This case was linked to MOD-2021-037454 (Patient Link).
Within 1 hour of receiving the Anthrax vaccine, Typhoid vaccine I began to feel very light headed with slight nasua. Shortly after I developed a heavy dry cough which quickly switched to shortness of breath, wheezing, runny nose, headache and chest pain. These symtoms continued all day from Sunday until Wednesday until I was first seen by a medial provider. In his opinion I had suffered a severe allergic reaction to most likely the Anthrax vaccine.  I was prescribed Albuteral Sulfate and Benzonatate. After returning home on Wednesay night my symptoms persisted well into Friday the 12th. My wife drove me to hospital as I was having a very hard time breathing and could no breath. The Dr. prescribed Doxycycline Hyclate, Fluticasone, and Hydrocodone Homatropine. Medical opinion again was a mix of allergies and allergic reaction to vaccines.
Hives and bumps painful burning allergic reaction Dermagran. Prednisone, Benadryl. Claritin which seemed to help. Had no current allergies.
Information has been received from a health professional concerning a 69 year old male with hyperlipidaemia, hypertension, a history of prostate cancer, and no drug allergies, who on 28-AUG-2007 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658074/0961U). On 31-AUG-2007 the patient developed an injection site reaction with left arm swelling, redness from the left elbow to the shoulder, and fatigue.  The patient called the physician and was instructed to apply ice to the injection site reactions and to take TYLENOL or ADVIL for discomfort.  No laboratory diagnostics were performed.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  This report is 1 of 3 reports from the same source.  Additional information has been requested.
This spontaneous case reported by a healthcare professional, describes the occurrence of paresthesia (now her finger is tingling) and lymph node pain (pain in her lymph node, which then moved into her right arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 1, 2021, patient experienced paresthesia (now her finger is tingling) and  lymph node pain (pain in her lymph node, which then moved into her right arm). At the time of the report, paresthesia (now her finger is tingling) and lymph node pain (pain in her lymph node, which then moved into her right arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment medication.
High pitched screaming of 3 1/2 hrs duration; 1st DTP no past hx of sz; No family hx of sz; Had subsequent sz starting 3mo post inject;
Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Irregular menstrual bleeding, cramping. I have a Mirena IUD as birth control and have not had menstrual bleeding since May 2021. I was told by my OB that the IUD would stop all bleeding for periods. Two days after receiving the shot, I had menstrual bleeding.
dehydration, head ache, cotton mouth, joint pain, chills, fever, cough, upper respiratory sputum, taste of metal, loss of taste, loss of smell, food does not taste the same still to this day and it's been nearly a few weeks, muscle aches, felt pretty sick and was down for like a week sick.