chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Information has been received from a male consumer of unknown age referring to himself. There was no information about concurrent condition, concomitant medication and medical history. On unknown dates in March 2016 and May 2016, the patient was vaccinated with the first and the second doses of GARDASIL 9 (0.5 ml, intramuscular) (lot# and expiration date unknown) respectively for prophylaxis. The patient moved GARDASIL 9 was not available. The patient had missed the third dose of of GARDASIL 9. There was no adverse event reported. Additional information has been requested.
Patient went to ER. Sx developed about 1 hour after shot. C/o heartburn & cough 1st then, chest tight tongue swollen, high fever (101), achy, chest congestion & hoarse. Seen in ER. Medicine given: Prednisone, BENADRYL; PEPCID.
he has been coughing; had weakness in his joints; has felt sick; Initial information received from 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 65 years old male patient who has been coughing, had weakness in his joints and has felt sick while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Had flu shot and pneumonia shots last year and he was healthier before he got the flu shot. He spoke with the doctor and had a hard time convincing them it was not COVID. Wanted to know if it was a bad batch?  Concomitant medications included SALBUTAMOL (ALBUTEROL HFA).  On 28-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot number not reported in unknown administration site as Immunization.  On 29-SEP-2022 the patient has felt sick (malaise) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date the patient has been coughing (cough) and had weakness in his joints (asthenia)  (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  He stated he was going to schedule an appointment for a chest x-ray to make sure everything was clear.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (he has been coughing, had weakness in his joints, has felt sick).  At time of reporting, the outcome was Unknown for all.
pt devel fever 105 w/in few hr;pt irritable;pt was adm to hosp on 18OCT96 to r/o sepsis & swelling @ inj site;
swollen red & bump @ site of inj;approx 1x1cm sl raised area w/erythema approx 3x5cm;raised area resolved p/ 5" of ice given DPH;
Rash on arm where shot was administered. Also rash developed on tops of feet, hands, arms, and legs. Rash consists of red raised bumps.
Information has been received from a physician concerning an 18 year old female who in December 2010 (within the last 2 weeks), was vaccinated with her second dose of 0.5ml GARDASIL (route, lot# not reported). The patient fell forward off the exam table 30-60 seconds after receiving the injection, and she lacerated her left eyebrow. The patient was taken to the Emergency Room (ER) by her mother and received 17 stitches. The patient was unconscious for 10-15 seconds after falling off of the table. At the time of report, the patient was recovering and her mother had already scheduled her third injection of GARDASIL. Follow up information has been received from a company representative concerning an 18 year old female who was vaccinated with her second dose of 0.5ml GARDASIL (route, lot# not reported) and fell and split her head open (initially reported as lacerated her left eyebrow). No further information was provided. Additional information has been requested.
Had a fever of 100.3, chills, headache, severe fatigue.  Aproximately 24 hours after vaccination
tested positive for covid-19 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid-19 after first dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced COVID-19 (tested positive for covid-19 after first dose). At the time of the report, COVID-19 (tested positive for covid-19 after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter Treatment information was not provided by reporter
NIGHT SWEATS; SWEATS; LEG PAIN; FATIGUE; BODY ACHES; CHILLS; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced pain at the injection site. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced night sweats. On 10-APR-2021, the subject experienced sweats. On 10-APR-2021, the subject experienced leg pain. On 10-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at the injection site on 10-APR-2021, had not recovered from chills, body aches, leg pain, fatigue, and night sweats, and the outcome of sweats was not reported. This report was non-serious.
Severe rash/The rash occurred on 90% of the patient's body.; This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  It was reported that a patient was treated (treatment not reported) because of severe rash which occurred in a patient within 24 hours of receipt of the vaccine. The rash occurred on 90% of the patient's body. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Caller reports patient received his first dose of MMR II in 2020 at 9 years old and his 2nd dose on 12/15/2022.; no adverse event; This spontaneous report has been received from a pharmacist concerning a 9-year-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On unspecified date in 2020, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 milliliter, subcutaneously, (Lot # and expiration date were not provided), and on 15-DEC-2022 the patient received a second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 milliliter, subcutaneously, Lot # U039664 (rHA), expiration date on 15-DEC-2023, both doses administered for prophylaxis purposes (inappropriate schedule of vaccine administered). No additional adverse events were reported.
First chills.  Later continued chills, nausea, body aches and bad headache.  Lasted alprox 36 hours.
Information has been received from a RN concerning a female "in her twenties", with a sulfa allergy, who was vaccinated SC on an unspecified date with a 0.5mL dose of MMRII (Lot # not reported). About two weeks post-vaccination the pt developed a rash all over her body. The pt did not seek medical attention. The pt's outcome was reported as not recovered. Additional information is not expected.
Visual field defect and hazy vision. Retinal exam revealed superotemporal branch of retinal artery occlusion in R eye along with posterior vitreous detachment.
0918 Called to front lobby. Found patient unconscious lying on floor. Unconscious 15-30 seconds. No facial swelling and no difficulty breathing.  Per witnesses she fell. Code called. Pale and diaphoretic. C/O hot and dizzy/ VS Resp 14 HR 78 BP 106/66 O2 Sat 100% on room air.  No history of syncope with vaccines or needles. Instructed parent to remind us this happened when returns for #2 so we can administer vaccine with her lying down. Verbalizes understanding.  0920 Cleared cspine by Dr. who was fist physician on scene.   0925 Transferred to gurney via walking with two person hands on assist. Transferred to ED accompanied by ED personnel and mother.
crying w/o stopping for 10 to 12 hrs 24 hrs p/vax; mom does not remember pt having fever; did not report to anyone;
This non-serious spontaneous case, was initially received from other health professional (nurse) on 27-Sep-2017, concerning a 52-year-old, adult female patient. The patient's medical history included: allergic to tegaderm and had received flu shot in the past. On 20-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00444611A, expiry date: 30-Jun-2018, route of administration, anatomical location: not reported). On 22-Sep-2017, after 3 days of vaccination, the patient complained of redness, itching and pain on touch. Injection site described as being red, raised, tender to touch and the size of a half dollar. No pain was experienced while raising the arm. The patient was treated with BENADRYL and hydrocortisone cream. The outcome of the events was not reported. The reporter assessed the report as non-serious. Non-significant case correction received 27-Sep-2017: Batch number (00444611A) was added on the screen and updated expiry date. The narrative was amended accordingly.
Patient reported fever, redness, pain and swelling at injection site. Symptoms/adverse reaction started on 4/24/2023 approx 8 pm and lasted for 4-5 days post-injection administration. Patient further reported that injection solution radiated to her free-style libre sensor located under left arm. Patient reported above on 5/11/2023.
Severe headache; pain in thighs; dizziness; extreme fatigue; This is a spontaneous report from a contactable consumer (patient, self-reported). A 68-year-female patient (age at vaccination was 68 Years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown and expiry date was not provided), via an unspecified route of administration, on 03Feb2021, as a single dose for COVID-19 immunization. The patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 24Feb2021, as a single dose for COVID-19 immunization. The facility was unknown where the most recent COVID-19 vaccine was administered. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes mellitus. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications were not reported. It was unknown if patient had vaccine in four weeks and unknown if other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that on 06Feb2021, the patient had severe headache, pain in thighs, dizziness, and extreme fatigue. The patient received tyelonol as treatment for the adverse events. On 27Feb2021, the patient experienced unknown symptoms which was resolved on 28Feb2021. Outcome of the event severe headache was unknown and for all other events, it was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
I took Tylenol 500 mg because of my sore arm around 9 pm on December 27.  The next day when I got up, I was very dizzy to even get up. So then I drank a cup of milk and lay in bed for an hour. Then I went to go eat breakfast, Felt dizzy again and my ears went muffled and my vision went blurred. Then I put my head down on the table. After this, I don't know what happened but my mother told me that I went unresponsive but was sitting up but with my head down and both of my hands were bent inwards with stiffness and shaking and was not responsive when my mother was calling me. This happened for about 1 minute. I woke up in confusion and didn't know this had happened and my mother gave me a spoon of sugar but my blood pressure was 104/67.HR 67. I started sweating a lot. My mother is an RN and she told me this was like a seizure reaction. I never had a seizure before until today in my life.
Has been passing out since the first dose of the vaccine in Mar2021; Stops breathing; This is a spontaneous report from a contactable consumer (reporter's wife) and from a Pfizer sponsored program.  An unspecified age male patient received the first dose of BNT162B2 (PFIZER-BIONTECH  COVID-19 VACCINE) via an unspecified route of administration in Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. In Mar2021, the patient had been passing out since the first dose of the vaccine. He was still having issues with passing out and he stops breathing. He was seen and the determined in the ER it was a reaction to the vaccine. But recommended he still receive the second dose. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Child was fussy and very tired for over 24 hours. Mom stated he would lay on her and couldn't calm him down. Temperature was 99.
Fever, malaise, aches. redness, warmth, swelling, induration of arm (near site).
THIS PERSON WAS GIVEN H1N1 FLU MIST AT CLINIC STAFFED BY MEDICAL CENTER PHYSICIAN ASSISTANT STUDENTS.
Significant swelling and tenderness in lymph node in the underarm of the right arm (same side as the shot). Tenderness subsided within 24 hours and swelling subsided within 48 hours.
SLEEP THE WHOLE DAY; FEVER; FATIGUE; This spontaneous report received from a parent concerned a 35 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sleep the whole day, fever, and fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever, and fatigue, and the outcome of sleep the whole day was not reported. This report was non-serious.
Skin sensitivity all over body; Fever; Chills; Myalgia; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Skin sensitivity all over body), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Myalgia) and HEADACHE (Headache) in a 39-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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SENSITIVE SKIN (Skin sensitivity all over body), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Myalgia), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, SENSITIVE SKIN (Skin sensitivity all over body), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Myalgia), HEADACHE (Headache) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient took acetaminophen and ibuprofen for treatment.
Slight headache beginning a few minutes after vaccination and almost completely recovered by 20 minutes following vaccination.
This case was considered medically important for urine culture positive for Streptococcus pneumoniae. Information regarding PREVNAR was received from a healthcare professional regarding a 3-month-old patient who experienced fever, high white blood cell count, urine culture positive for Streptococcus pneumoniae and increased c-reactive protein. The patient received a dose in 2008. Relevant medical history was not provided. Concomitant medications were not reported. On an unspecified date in 2008, the patient experienced fever, high white blood cell count, increased c-reactive protein and was evaluated at the Emergency department. During the evaluation, a urine culture was found to be positive for Streptococcus pneumoniae. The patient's chest x-ray was found to be negative along with all other (unspecified) cultures. The reporter questioned whether PREVNAR (reported to have been given recently) could have caused the positive urine culture or the patient's current illness. In 2008 test results were: c-reactive protein (results: high); white blood cell count (results: high); culture (results: all other cultures negative); chest X-ray (results: negative); and body temperature (results: fever). No additional information was available at the time of this report.
Initial report received from a nurse on 13 Jan 2010: This patient (under four years of age) was vaccinated with 0.25 ml of FLUVIRIN (batch number: 102133P) intramuscularly on 13 Jan 2010. No adverse event was reported. The reporter also reported two other companion cases (See case PHHY2010US01708 and PHHY2010US01744).
WEDNESDAY: HA, BODY ACHE,  FRIDAY:  FACE SWOLLEN.  HA.  FRIDAY WENT TO ER. MONDAY: SEVERE HA, NAUSEA, SEVERE ACHES.  WENT TO DR OFFICE.
Initial misuse report received from a healthcare professional on 22 May 2013. It was reported that a dose of MENACTRA that had expired on 07 May 2013 was administered. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: none.
Burning; itching; fever; soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning), PRURITUS (itching), PYREXIA (fever) and INJECTION SITE PAIN (soreness at site of injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for an unknown indication.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Jan-2021, the patient experienced BURNING SENSATION (Burning), PRURITUS (itching), PYREXIA (fever) and INJECTION SITE PAIN (soreness at site of injection). At the time of the report, BURNING SENSATION (Burning), PRURITUS (itching), PYREXIA (fever) and INJECTION SITE PAIN (soreness at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
After the second vaccine, day after I felt extremely drained and fatigued, had to go home early from work, and didn't feel like eating for about 48 hours after vaccine.  However, I did have a strange smell that stuck around for about 2 months. Headache, a little nauseous, and fatigue stuck around for a while. Same symptoms came about with the first vaccine and booster vaccine as well. Third booster came with body chills and aches.
The patient has tested positive for COVID-19 via rapid test on 04Aug2021; The patient has tested positive for COVID-19 via rapid test on 04Aug2021; This is a spontaneous report from a non-contactable Other HCP. A 47-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via intramuscularly in right arm on 31May2021 at 07:00 AM as dose number unknown, single (at the age of 47-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. It was unknown, the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that prior to vaccination, the patient was diagnosed with COVID-19. On 04Aug2021, patient had tested positive for COVID-19 via rapid test. It was unknown if patient received treatment. Since the vaccination, the patient had been tested for COVID-19 via Nasal swab resulted positive on 04Aug2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available,The casual association between the reported event Covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.
Patient called clinic today after receiving Influenza vaccine on 11-07-07 saying that she had a non-raised rash under her arms, breasts, and around her waist area that was itching. She said that it comes and out on 11-10-07 and has been there since. She also reported that she had swollen lymph nodes under her arms. She was instructed to call her MD and report back to us the outcome.
Information has been received from a physician concerning a child who was vaccinated with Varivax (Oka/Merck). "In the past 2 weeks", in approximately March 2006, the patient experienced breakthrough chicken pox with more than 100 lesions. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Large rash on left arm at vaccination site. Soreness, slight swelling and slight itchiness. Rash came on five days after Pfizer COVID 2nd vaccination injection. Rash still present.