chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 25-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine).    No concomitant medications was reported.  Dosage text of suspect Moderna vaccine was reported Additional Booster.  No other adverse reactions are reported.  No treatment medications was reported.
Day after (Tuesday morning) I was crying in pain, I had chills, weakness, body ache, fever of 102, migraine . I couldn't move my arm where the vaccine was given. I took Tylenol for the pain.  Tuesday I went to the Clinic at my work and they advised me if was from the vaccine and to continue to rest and drink water. Wednesday I woke up and felt completely fine just a little nausea.  On December 10,2020 I did test positive for Covid.
Breakthrough case admission after 3 vaccines ; Pfizer 4/5/21 lot# Ew0150;  Pfizer 4/26/21 lot# ER8735;  Pfizer 8/20/21 lot# Ew0180
Patient went to the urgent care for hives all over the body. (Hands, abdomen, back).
herpes zoster cutaneous disseminated; body temperature increased; pain; SHINGLES; injection site rash; shingles lesion; Information has been downloaded from Agency(US-GlaxoSmithKline-A1077948A) on 06-JUL-2020.  This spontaneous report was received from a health care professional referring to a female patient of unknown age. The patient's medical history included chickenpox. The patient's concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), methotrexate, and prednisone. Information regarding the patient's historical drugs and drug allergies or reactions were not provided.  On 21-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, via subcutaneous as prophylaxis (concentration, dose, dose number, frequency of vaccination scheme, anatomical location of vaccination, and expiry date were not reported; lot number was reported as unknown). Other suspect therapies included belimumab (BENLYSTA) solution for injection, which was started on an unknown day in July 2013 via intravenous route for the treatment of systemic lupus erythematosus at a frequency reported as "VA" (strength, dose, and lot number were reported as unknown, expiry date was not reported).   On an unknown date in 2013 the patient experienced injection site rash and shingles lesion (herpes virus infection).  On an unknown day in July 2013, the patient experienced shingles (herpes zoster).  On 24-SEP-2014, the patient experienced herpes zoster cutaneous disseminated, pain, and increased body temperature. Her body temperature was 100 (units not provided) on an unknown date in 2014.  The action taken with belimumab (BENLYSTA) was not reported.   The outcome of herpes zoster, herpes zoster cutaneous disseminated, body temperature increased, and pain was reported as not resolved. The outcome of injection site rash and herpes virus infection was reported as unknown.        The reporter considered herpes zoster and herpes zoster cutaneous disseminated to be related to belimumab (BENLYSTA). The causal relationship between belimumab (BENLYSTA) ,and the occurrence of body temperature increased, pain, injection site rash, and herpes virus infection was reported as unknown.   The causal relationship between zoster vaccine live (ZOSTAVAX) and the occurrence of all the events was not reported.  The reporter/agency considered all the reported events to be medically significant and disabling/incapacitating events.
Two days after vax, stiff neck. August 4th-present, extremely swollen neck and lymph nodes, diziness, fatigue, brain fog. Currently taking  second prescription of prednisone to help the effects.
Very nauseous; Confused; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma. The patient had allergies to animals and dust. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 09:15, the patient experienced very nauseous, confused, vomiting. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very nauseous, confused, vomiting was recovered with lasting effects  on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recvd 3 doses of Engerix-B on 18JUL90 & 24AUG90 & 23JAN91; 17JUL91 titer was found to be neg; pt recvd 2 booster doses on 18SEP91 & 11OCT91; 9JAN92 titer was re-checked & again found to be neg;
4d later with right sided submandibular & parotid gland swelling to face with fever up to 100F
fever at 100 degrees F; extreme headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever at 100 degrees F), HEADACHE (extreme headache) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Azor                                                           for her blood pressure for Blood pressure high, VITAMIN D NOS, CALCIUM CARBONATE, COLECALCIFEROL (Hydroxychloroquin) and AZATHIOPRINE for an unknown indication.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (fever at 100 degrees F), HEADACHE (extreme headache) and CHILLS (Chills). At the time of the report, PYREXIA (fever at 100 degrees F), HEADACHE (extreme headache) and CHILLS (Chills) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details include 200mg of Advil total of 4 tablets after she got home   This case was linked to MOD-2021-116398.
Product storage error; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. HCP stated that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code is scanned.It was mentioned that the vial was initially place in refrigerator was on 18 Nov 2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events. No treatment medication was provided by the reporter.
father states pt devel poss sz activity several hr p/vax; seen in ER @ hosp;hosp x 24hr;d/c dx by father;hx febrile sz no hx of temp taken nor antipyretic given prior to vax;
left eye started to have severe pressure on it; The following day at approximately 7:30 PM, my left eye started to have severe pressure on it, turned red,; The following day at approximately 7:30 PM, my left eye started to have severe pressure on it, turned red, was painful when I tried to move it,; The following day at approximately 7:30 PM, my left eye started to have severe pressure on it, turned red, was painful when I tried to move it, and vision was blurred.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) in the left arm on 02Apr2021 at 17:15 as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), acetylsalicylic acid (ASPIRIN) and vitamins nos (MANUFACTURER UNKNOWN); all for unknown indications since an unknown duration. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) in the left arm on 05Mar2021 at 17:15 as a single dose for COVID-19 immunisation. On 03Apr2021 at 19:30, the patient had experienced severe pressure on left eye, it turned red, was painful when he tried to move it and the vision was blurred. The next day it was less severe but was present. Later, there was no pain anymore. The patient thought that the vision wasn't quite as good as before but had not validated it with an eye appointment. It just felt like the treatment might be a little different then. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse event. The clinical outcome of the events severe pressure on left eye, eye turned red, painful when tried to move it and vision was blurred was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Pain in arm and hips that effected ability to walk. Also complained of numbness in the fingers.
Fever began approximately 15 hours following injection, including chills. Fever lasted until late afternoon 10/28/21, ranging from 99.1 - 101.0.  Left arm extremely sore, developed swelling and bright red area from shoulder to elbow, arm hot to touch.  I had no energy for 3 days and felt extremely fatigued. Finally felt like the worst was over Friday morning 10/29/21 but arm still somewhat red and itches.  Much improvement as of today, 10/30/21.
On 3/13 went to bed early, by midnight diarrhea and nausea started. Arm was swollen and red at site of vaccination. On Saturday lost appetite had diarrhea all day and was running a low grade fever. Sunday felt a little better and recovered by the afternoon (3pm). On Friday face was red and flushed. Called doctor on Saturday and quit taking antibiotic when got sick as well.
Malaise, weakness , headache, chills, severe abdominal pain, this continued through the night. Unable to sleep due to abdominal pain, considered calling ambulance.   In morning, diarrhea, nausea, poor appetite.    Now 2:30 pm. , pretty much recovered
I had my yearly flu shot at a pharmacy on September 22, 2009. Within approximately one week I began to have strange sensations that I had never experienced before. These were mainly in the lower torso. My first experience was thinking I had stepped in water and gotten my foot wet, only to see that it was not wet at all. I would experience hot spots, wet and or cold sensations and tingling sensations. I had many of these but they were brief in duration. In late November my toes began to go numb. I first dismissed as maybe my shoes being too tight. At this point the numbness spread into my legs and I could feel it moving upward into my stomach area. I began to feel like I had a tight corsett like feeling in my stomach area. The numbness then began in my hands, and my back muscles became very week. I began to have spasm if I stood for any time. I got a list of neurologists that my insurance company recommended and called through until I found a doctor that could see me right away. The Dr evaluated me. He ordered an MRI of my spine and brain. He did a spinal tap and many blood tests. His diagnosis was that I have post inoculation transverse myelitis.
a patient inadvertently received ADACEL instead of DTAP with no ae; Initial information received on 24-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced a patient inadvertently received adacel instead of dtap with no adverse event  while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  On 07-Dec-2021, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6830AA via (unknown route, strength) (expiry date:17-Sep-2022)  in unknown administration site for prophylactic vaccination.  On 07-DEC-2021 the patient developed a non-serious event "a patient inadvertently received adacel instead of dtap with no adverse event " (wrong product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported"the nurse who administered the vaccine was unsure of which patient received the ADACEL instead of DTAP, it was one of the reported two patients. Caller reporting the nurse was falsifying records, she had a pocket full of vials at the end of the day and had to sort out who received what vaccination. See related case on second patient #00946669".  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (a patient inadvertently received ADACEL instead of DTAP with no ae).  At time of reporting, the outcome was Unknown for the event a patient inadvertently received adacel instead of dtap with no ae.   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 the guidelines. 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.
headache; body aches; This is a spontaneous report from a contactable consumer (patient) via a regulatory authority. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 09Feb2021 09:45 (lot number: em9810; expiry date: unknown) at the age of 46-years-old, as dose 1, single for Covid-19 immunisation. The patient's medical history was not reported. The patient was not taking concomitant medications.The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 09Feb2021 12:00, the patient experienced headache and body aches. The patient did not receive treatment for the events. The patient recovered from the events on unspecified date.
Came to site with headache and reported anxiety Pt. stated she was feeling warm and dizzy Brought to medication screening  to lie down Left at stable condition at 15:25 p.m. Recorded by RN. Evaluated
shingles onset. Actually started feeling bad-tired, exhausted on Monday 3/15 right after second dose of Moderna.    Problems included exhausted from exercising, heart rate up, working harder to accomplish my normal exercise routine but the shingles pain and onset did not occur until the following weekend.  Woke up Saturday late night (3/21) with terrific pain and I went to the doctor on Monday morning (3/23). My doctor diagnosed shingles bc a rash had started on my torso and provided antiviral prescription and pain medicine.
Strong, constant taste of salt in mouth appearing about 2 days post-vaccine #2.  Still persisting after 4 weeks.
respiratory distress; rash on face; wheezing; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 2023SA133327 (Sanofi).  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein) (PREVNAR 13), as dose number unknown, single (batch/lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY DISTRESS (medically significant), outcome "unknown"; RASH (non-serious), outcome "unknown", described as "rash on face"; WHEEZING (non-serious), outcome "unknown".  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM 197 protein) has been requested and will be submitted if and when received.
shooting pain in the middle of my back; shooting pain radiating downwards; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (shooting pain in the middle of my back) and PAIN (shooting pain radiating downwards) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (shooting pain in the middle of my back) and PAIN (shooting pain radiating downwards). At the time of the report, BACK PAIN (shooting pain in the middle of my back) and PAIN (shooting pain radiating downwards) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.
mild confusion; memory issues; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-year-old male patient received first dose of (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) (Lot Number: Unknown) via intramuscularly on Left arm on 25Mar2021 16:00 (at age 96-year-old) as single dose for COVID-19 Immunization. Patient medical history and concomitant medications were unknown.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.Patient experienced mild confusion, memory issues on unspecified date in Mar2021. He received the first dose of the vaccine three weeks ago at the hospital. Two-three days later after receiving the vaccine he had symptoms. He developed mild confusion that has not passed. This was very unusual for her father. It continues today. It was very sudden and abrupt. He had been waking up the last three weeks asking what the hell was he doing. Caller calls her father every morning to say good morning, He forgets that she had called and then he will call her. He had never done anything like this in the ten years of them living together. He had been confused 11-12 times in the past 19 days. He forgot about a big business that he had when he was younger. These were changes or memory issues that her farther has not had in his entire life. Caller stated that her father was scheduled to receive the second dose on Thursday. Caller was hesitant to have her father receive the second dose. Caller was asking what the maximum time for her father was to get the second dose as he has received it 3 weeks ago and experienced an unsolicited side effect. Treatment given to these events were unknown. Outcome of event mild confusion was not recovered and memory issues was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient received 1st dose of vaccine a approximately 1435. 1500 approximately 25 minutes post vaccination patient started feeling upper midsternal chest pressure, worsened with swallowing. Patient's skin with redness to upper chest and neck.
2 Hrs after: upset stomach, shivering. 12 Hrs after: headache, muscle pain, joint pain. 24 Hrs after: fever, hives above and below injection site. 3 days after: Ringing in ears.
Myalgia, Arthralgia,  INJECTION SITE SORENESS  Narrative:  INJECTION SITE SORENESS DAY 1 DAY 1-3 BODY ACHES
Immediately after the vaccine, my left arm was shooting pain and cramped up. That faded after a couple minutes and I felt fine afterwards. Starting at 7:00PM (April 6/same day), I suddenly felt extremely dizzy, nauseous, and my entire body is aching to the point of tears. My lower abdomen and spine/hips are also in terrible pain. I?m in too much pain to sleep even though I?m exhausted and for a little while, I was struggling to catch my breath. I also have chills and feel that a fever is not far off.
Dizziness, nausea. 8/5 c/o headache not relieved with TYLENOL. Feels disoriented. Sent to Emergency Room.
30 minutes post vaccination adminstration, patient complained of tingling and throat thickening.  Patient treated with benadryl 50mg by PharmD.  Pt refused further medical treatment and stated she thought she was feeling better.  Contacted the next day.  Patient treated with another dose of benadryl at home and states she is feeling well at this time.
About 10-15 minutes after the shot my left hand began to feel like it was falling asleep. As of today it still tingles (2/4/10).