chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received Moderna 12+ dose which was incorrect - MA did not scan the correct product and manually entered the 12+ dose.  Pt should have received Mod 6-11yr.  VAERS report filed.
This spontaneous report as received from a physician via field employee refers to a female patient about 80 years old. On an unknown date the patient was vaccinated with ZOSTAVAX (dose not reported, one single shot). No concomitant medications were reported. On an unknown date the patient developed mild case of shingles. The outcome of the event was unknown. The patient sought medical attention - saw the doctor. It was not reported if the patient was given a treatment for the event. The relatedness between mild case of shingles and ZOSTAVAX was not reported. This report is linked with the case MARRS#1405USA007471 via same reporter link. Additional information has been requested.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "depression" (unspecified if ongoing); "colitis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Day 10-11 after the vaccination, my husband started developing tingling in his legs and arms with increased numbness and weakness in his leg muscles. He had a hard time breathing. He was admitted to the ER at Hospital. He is diagnosed with Guillian Barre Syndrome. His arms and legs are near paralyzed. He has been in the ICU for 6 days and is on a respirator
slight itchy, tingly, red rash on R foot (plantar surface) and ankle. No blisters. Also some tenderness in lower calf but no rash there.  No treatment d/t it being mild reaction
FLUZONE HIGH DOSE was administered on 10-30-18. He had flu-like symptoms like achiness from left arm up to his neck.
A few weeks after receiving the second dose of the vaccine my ears started to ring.  Went to my PCP who referred me to an ENT .  However, I don't have an appointment till June 21.n/n
Hospitalized for community-acquired pneumonia and sepsis 6 days following administration of COVID-19 vaccine, complicated by acute hypoxemic respiratory failure and acute kidney injury requiring.  Admitted to ICU, treated with intravenous antibiotics and initial pressor support.  Intubated on hospital day #3, extubated on hospital day #8.  Remains in ICU at time of this report.
patient received a dose that was premixed the night before, so it was administer 12 hours after expiration time
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) CF. In March 2022, the patient experienced COVID-19 (COVID-19). In 2022, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  The reporter causality for the events of COVID with Humira was no reasonable possibility. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.
This case was reported by a nurse and described the occurrence of fever in a 13 year old male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 8/5/03 the pt received the 1st dose of Engeirx B in the right arm. The pt also received an injection of tetanus and diphtheria toxoids in the left arm. Later that day, at an unspecified time post-immunization, the pt experienced fever of 103 deg F, pain in both arms, vomiting, and headache. The pt's mother treated the events with Motrin. The events resolved on 8/8/03. The nurse considered the events were possibly related to vaccination with Engerix B and tetanus and diphtheria toxoids. The Engerix B immunization series was discontinued.
Flu; Fever of 101.1°F; Itchy rashes; bumps on his armpit; lumps all over his arm; pain in the arm; discomfort; This spontaneous case was reported by a health care professional and describes the occurrence of INFLUENZA (Flu), PYREXIA (Fever of 101.1°F), RASH PRURITIC (Itchy rashes), AXILLARY MASS (bumps on his armpit) and LIPOMA (lumps all over his arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017D21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis since an unknown date.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INFLUENZA (Flu), PYREXIA (Fever of 101.1°F), RASH PRURITIC (Itchy rashes), AXILLARY MASS (bumps on his armpit), LIPOMA (lumps all over his arm) and PAIN IN EXTREMITY (pain in the arm). 02-Apr-2021, the patient experienced DISCOMFORT (discomfort). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 4 tylenol. At the time of the report, INFLUENZA (Flu), PYREXIA (Fever of 101.1°F), RASH PRURITIC (Itchy rashes), AXILLARY MASS (bumps on his armpit), LIPOMA (lumps all over his arm), PAIN IN EXTREMITY (pain in the arm) and DISCOMFORT (discomfort) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 02- Apr 2021 patient had fever of 101.1 °F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter.
I received my Shingrix on Tuesday at the Health Department but they did not have the Moderna, PCV20 or the high Dose (I made appointment for all vaccine. the next day they announced that they had it! ) so that Friday I went to the pharmacy and received the other vaccines.  Saturday I had a headache as expected from previous Moderna vaccines, Sunday and Monday I had intermittent chills followed by sweats and fever as high as 101.8 and I am tired,  no body aches.   Today is Tuesday so far I am just tired with minor headache.  But usually the chills and sweats happen after 4:00pm until 12:00 midnight. I know I have read that you can get all vaccines that you need with the COVID vaccine,  but I now feel it was to much to soon.  My husband had the same vaccines minus the PVC 20 and he is fine.
This spontaneous report was received from a registered nurse and refers to an unspecified 25 year old male patient. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. In February 2016 (reported as "12 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not provided). On 01-FEB-2017, the patient was vaccinated with the second dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not provided). No adverse effect was reported. Product quality complaint was not involved. Additional information has been requested.
Had normal symptoms except tachycardia that was noticed 2/18/21 at about 10am.  My heart rate is usually between 68 and 72 and it was between 110 and 120 all day yesterday.  No chest pain, numbness, shortness of breath.  Just felt like I was going to faint and found it when I checked my blood pressure ( which was normal).  Had an EKG 2 weeks ago as part of a screening and it was normal.
Information has been received from a healthcare worker concerning a 14 month old male with no pertinent medical history who on 14-APR-2008 was vaccinated with VARIVAX (Oka/Merck) (LOT# 658575/1270U). There was no concomitant medication. On 28-APR-2008 the patient experienced chickenpox. The patient was seen by the physician and there was no product quality complaint. Additional information has been requested.
pt recv vax 4SEP97 & approx 15min p/vax pt devel a 2cm hives or wheal type area on the lt thigh;  Follow-up information received from a health care professional concerning a 13 month old Causasian patient with a rhinorrhea who on Sept 4, 1997 was vaccinated with the first dose of varicella vaccine in the left thigh. Approximately 5 to 10 minutes following the injection, the patient developed a 2 cm wheal (hive) at the injection site. It was reported that two more wheals appeared on the thigh area within the next 24 hours. The patient was treated with diphenhydramine hydrocholoride (Benadryl) and ice was applied to the area. The reporter stated that this was not a varicella rash, but a hive. Subsequently, the patient recovered within 24 hours. Urticaria was added as an adverse experience.
Tinnitus; This spontaneous case was reported by an other and describes the occurrence of TINNITUS (Tinnitus) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history ).    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 TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
I was practically unconscious, I was not hungry, I couldnt move and barely go to the restroom and it took a long time to get a very small distance to the restroom. Very sore and achy. No appetite for 48 hours and I regularly eat very good. I am recovered now-9/13/23. ***I choose not to list DOB and Age***
Only received one dose; Irritation around injection site; rash around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of skin irritation in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included egg allergy.   On 20th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 22nd May 2019, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced skin irritation and rash. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with benadryl (nos) (Benadryl) and fexofenadine hydrochloride (Allegra). On 25th May 2019, the outcome of the skin irritation and rash were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the skin irritation and rash to be related to Shingrix.  Additional details were received as follows: The patient developed an irritation and rash around injection site. The reporter instructed the patient to take Benadryl then Allegra and within 3 days the symptoms were gone. Till the time of reporting patient has not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
At approximately 9 AM on the morning after receiving the second dose, the patient became dizzy at school.  As she was walking to the teacher's desk, she lost consciousness and fainted, hitting her head on a desk, scraping her neck on a desk, and suffering several other minor injuries from the fall.  She was immediately seen by school nurse and released to my care for the rest of the day. She rested at home and then was seen in at Walk-In Clinic to be evaluated for a concussion.  On Day 2 after receiving the vaccine, the patient reported a sore throat, but no other symptoms.  She was seen on the third day post-vaccine by our pediatrician's office for possible strep.  She tested negative for strep and a concussion from her fainting episode was confirmed due to the lingering headache.
Fever of 102, body aches, extreme chills, extreme headache all that lasted for 24 hours.
received the first dose of the GARDSIL 9 series on an unspecified date in 2/2020 and the second dose of the series on 8/10/2020; This spontaneous report was received from a pharmacist, concerning an adult male patient in his mid 20's. Information regarding concomitant medications, pertinent medical history and drug reactions/allergies was not reported.   On an unspecified day in February 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported= On 10-AUG-2020, the patient received the second dose of the series (Inappropriate schedule of product administration).
first dose of Shingrix on 2019 / has not received the second dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   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 to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow up.
Shortness of breath; Dizziness; This is a spontaneous case, reported by other non-health professional to Agency (reference number: SEQW20-00415) on 18-May-2020, concerning a female patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On 29-Dec-2019, the patient was administered Flucelvax Quad [influenza vaccine, subunit influenza virus vaccine polyvalent, anatomical location: left deltoid muscle, batch number: reported as 261922 (Seqirus batch number: 261222), expiry date: Jun-2020, dose and route of administration: not reported] for influenza prophylaxis.  On the same day, after vaccine was administered, the patient started to complain of shortness of breath and dizziness. The patient was transported by ambulance for medical attention and received treatment for the events. No details regarding treatment were provided.  At the time of initial report, the outcome of the events shortness of breath and dizziness was unknown.  Per company, the events of shortness of breath and dizziness were considered serious due to the criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax Quad.  Company comment: The patient developed dyspnoea and dizziness on the same day after vaccination with the suspect product, Flucelvax Quad. Chronology is suggestive. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed dyspnoea and dizziness on the same day after vaccination with the suspect product, Flucelvax Quad. Chronology is suggestive. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Moderna COVID-19 Vaccine EUA: patient with relapsed AML and right upper extremity deep vein thrombosis (DVT) presented to clinic with headache and found to have subdural hematomas and a cerebral venous sinus thrombosis of unclear acuity. Patient admitted for management of AML, subdural hematomas, and upper extremity DVT. Discharged home improved and medically stable.
Noon following day flu like - High Temp 103.8 5pm. Next morning fine.
CHILLS, COUGHING, NAUSEA, BURNING OF EYES, HAND NUMBNESS, FAINTING AND BODY ACHES FOR 1.5 WEEK. JOINT PAIN IN HIPS AND KNEES CONTINUES UNTIL TODAY. ON 10/14 DIAGNOSED WITH HIP AND KNEE TENDONITIS AND REFERRED TO A RHEUMATOLOGIST. CHILD EXPERIENCES ACHINESS ALL OVER.
Extreme body aches. Slight Fever (101). Excessive unproductive coughing. Loss of appetite. Vomiting. Diarrhea.  All symptoms continuing on 4/9/2021 except fever is gone.
Right side of back, 2 large blisters, 1 small blister. No pain, no itching. Pt F/U MD but no treatment prescribed. Blisters reduced.
Narrative:  90yo male pt with hx of chf, v tach, cad, aki, anemia, copd,htn, memory loss, & copd who was discharged from inpatient on 6/3/21 to home with diagnosis of Acute on chronic heart failure exacerbation. Pt dies at home on 6/4/2021. Pt had received covid vaccinations on 1/21/21 & 3/4/21. Appears death is not related to vaccinations.
Right hip pain lead to sciatica like nerve pain.  Using ice and lidocaine to reduce pain. Severe, recurring nasal discharge and minor amount of sneezing first night after shot.  After the discharge ended after a few hours I felt that my (prevaccine) sinus infection congestion in upper sinuses actually got better. I have taken a lot of prednisone for chronic sinusitis and asthma and after the vaccine (espec first night and second day) I felt similar (unable to sleep--jittery--flushed). Slight fever that never exceeded 100 degrees first night and second day.  Normal temperature 48 hours later.
headache; fatigue; body muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headache"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; MYALGIA (non-serious), outcome "recovered", described as "body muscle aches". Therapeutic measures were taken as a result of headache, fatigue, myalgia. Additional information: Clinical course: Headache, fatigue, and body muscle aches, 24 hours after receiving second dose. Took paracetamol (TYLENOL) and events were resolved by 10 PM that same night.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 4/11, began having abdominal pain, fatigue, nausea, and diarrhea.  These symptoms lasted for two days.  Overwhelming fatigue and muscle aches continued until 4/17.  On 4/19 I still am more tired, but i am able to function and work.
stiff neck; swollen glands; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MUSCULOSKELETAL STIFFNESS (stiff neck) and LYMPHADENOPATHY (swollen glands) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO MEDICAL HISTORY PROVIDED).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (headache). On 08-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and LYMPHADENOPATHY (swollen glands). At the time of the report, HEADACHE (headache), MUSCULOSKELETAL STIFFNESS (stiff neck) and LYMPHADENOPATHY (swollen glands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided
Pt received the vaccine and shortly after began to feel dizzy. Pt was laid down for sometime and patient resolved the symptoms 20 minutes later with no issues.
Headache, Arthralgia, inj site sore, pins and needles; headache, chills, joint pain, R hand swelling/tender Narrative:
Within 10 minutes of vaccine pt developed urticaria. There were no other factors to attribute the urticaria to.
1st dose: A few hours after the shot the arm turned fiery red and the patient felt sick for three days, her body ached all over, and she felt like she was in a fog. She delayed getting the second shot because she was worried about a repeat of the episode. (a different location, lot number unknown) 2nd dose: Her arm was not as red as the first time, but the muscles and bone hurt bad enough that she had difficulty sleeping and it hurt for four days. She only felt tired the second day rather than in a sort of fog, and it only lasted for one day.
Dizzy, tingling in left arm, chest tightness and heaviness, tongue feels weird
No adverse event, just diagnosed with Rotavirus after 3 doses of Rotateq...Vomiting and diarrhea, stool positive for Rotavirus.1/27/09-records received for DOS 1/18-1/20/08-DC DX:Viral gastroenteritis with mild dehydration. otitis media. C/O several days of vomiting and diarrhea.
Itchy eyes, followed by itching in her mouth and swelling of the back part of her tongue, trouble speaking and swallowing within minutes of receiving the COVID 19 Moderna vaccine.  Sent to ER and admitted for overnight observation.
Patient was given Pfizer bivalent vaccine that had been left on the counter from the night before......
One of five pt (B/W JUL-AUG 1990) experienced inject site rxn which included erythema & swelling. Tx included ice packs @ the site of inject & Tylenol PRN. Pt afebrile.
So it started the night of my vaccine, I had headache and body aches. It was really bad headaches for the whole week, the body aches went away after about 3 days though. Then in the week I started feeling the tingling in the right side of my body, just tingling like all over that part of my body and I still have that tingling now. It had gotten a little bit better but it is still prominent, I also get a lot of itching which will not go away. I had a telehealth with my DR on 5/20/2021 and he asked me to go in person on 5/28/2021 and he asked me to go for an MRI and they said they did not see anything. I have another follow up with him in a few days. At this point, half of my right leg and half of my right arm are tingling. I take a bunch of migraine medications and literally nothing is helping with the headaches either.