chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLEEP EXCESSIVE; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and had been requested expiry: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced sleep excessive. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and nausea, and the outcome of chills and sleep excessive was not reported. This report was non-serious.
he doesn't want to get the second injection if he was going to have that problem.; he took his blood pressure and it read 197/100/ he checked his blood pressure today and it was 195/92; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot number was not reported expiry date was Not Provided) via an unspecified route of administration on 08Mar2021 as a single dose covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient took his blood pressure and it read 197/100/ he checked his blood pressure today and it was 195/92 (hypertension) (medically significant) on 09Mar2021, blood pressure measurement: high, 195/97  on 09Mar2021, blood pressure measurement: 135/70 on an unknown date in Mar2021 His blood pressure last week was 135/70. He took BP medicine. His blood pressure last week was 135/70 and he is concerned as to whether that could be associated with the vaccine. He wants to know because that is high, 195/97 and he doesn't want to get the second injection if he was going to have that problem. He clarified he was calling about the Pfizer COVID 19 vaccine. He has trouble hearing. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccination with improperly stored ZOSTAVAX lot # M026874, 19-JUL-2017, 0.65 ml, subcutaneous. No adverse effects were reported. Temperature was 8 degree centigrade for 21 days. Previous excursion was no. Additional information has been requested.
pt got light headed and took a tumble after the 15 minute weight, stated she felt light headed and dizzy. after recovering from the light headedness she stood up and complained of chest tightness and difficulty breathing, ems stated blood pressure increased and heart rate as well. she complained of a shakey feeling. she was sent on ambulance to the hospital after 45 minutes in EMS tent.
Initially, pain, swelling, redness at injection site. Itching at injection site began on 9/4/2021 in the morning. Eased after taking Tagamet for chronic urticaria. Mild asthma symptoms around 3 pm. Itching at injection site returned around 6 pm and spread to entire body (face, ears, arms, legs, back, stomach) with a few small hives. Itching eased after taking Singulair and Tagamet at 8 pm. Itching at injection site, mild itching of face and body, and mild asthma returned about 10 am on 9/5/2021. Eased with administration of Tagamet. Swelling and redness at injection site spread to approximately 2 in in diameter by afternoon on 9/5/2021.
5 minutes after getting vaccinated patient stated having issues seeing "seeing black" I offered to call 911 but he did not want me to.  I got him candy and water. 5 minutes later he vomited - he said he felt better but I asked him to stay for continued observation.  I called him this morning and he said he just had a sore arm
Right thallamic Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THALAMIC STROKE (Right thallamic Stroke) in a 91-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 0 microgram. On 13-Nov-2022, the patient experienced THALAMIC STROKE (Right thallamic Stroke) (seriousness criterion medically significant). At the time of the report, THALAMIC STROKE (Right thallamic Stroke) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.; Reporter's Comments: This spontaneous case concerns a 91-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of thalamic stroke (AESI) one month after the fifth dose of mRNA-1273.222. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.
Vaccine was not diluted prior to administration. The LPN administered 0.2 mL of undiluted vaccine.
After my 2nd vaccine on 2/2 /21 I was fine, the next day just a little tired but nothing bad.  2 weeks and one day later, we flew back to our other home.  The next day (2 weeks and 2 days after my 2nd vaccine) I woke up with extremely heavy tight legs .  When I got out of bed, I got a sharp pain in my lower buttocks.    I was due to have a scheduled massage the following week so I waited the best I could until that time.  My massage person said he had never seen me so tight.  I felt a little better after that but 3 days later I was in agony and had to call him and went to see him again.  After about a week of this I finally called my dr and he saw me.  I was convinced I had MS or something but he seemed to think it was muscle related and gave me a muscle relaxant pill for 7 nights.  I continued again to see my massage person but then it still was bothering me so the dr prescribed another 10 days of muscle relaxant and PT. The PT dr checked me and said it was extremely tight in my lower buttocks and felt it was my piriformis muscle.  I began PT 2x/week and I am beginning after 2 weeks to feel a little better.  Before this I was very active, exercising every day, tennis 2x/wk....walking a lot;   I had to stop tennis, I couldn't run and thought I might fall because my legs were so stiff and when I bent over to get the ball on the ground, my pain was intense, felt like what I would think a pinched nerve would feel like.  This feeling happened even when I moved in bed or just walked many times.
Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On 07-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R009821 with expiration date in 03-APR-2020 which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -9 degrees Celsius (°C) to 8 °C (2.8C) for the time frame of 37 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1812USA008007: US-009507513-1812USA010604: US-009507513-1812USA010606: US-009507513-1812USA010603:
This is a 72 yrs old male comes to clinic complaining of redness and swelling on the left arm for the past few days after Injection. Patient came to clinic for Physical exam. He got Pneumonia, Tdap and Zoster vaccine on the right deltoid area. Next day, he noticed mild swelling. Yesterday, he noticed redness and mild pain. He comes to clinic for medical recommendation. He denies skin rash, no SOB, no difficult to breath Start Benadryl Allergy Tablet, 25 MG, 1 tablet as needed, Orally, every 8 hrs, 5 day(s), 15 Tablet, Refills 0 ;  Start Naproxen Tablet, 375 MG, 1 tablet with food or milk as needed, Orally, every 12 hrs, 10 day(s), 20 Tablet, Refills 0. Notes: Immune response material was printed.
patient received vaccines on monday1/24/2022,  patient was fidgeting around and didn't want to get injections, kept moving around even after we explained the importance of holding still. vaccines were given, 1/25/2022  mom stated he was c/o of his left anterior  chest hurting, no redness noted at that time the following day, mom applied vicks vapo rub on his  chest and arm.  on the 26trth they noticed that his are was hot , red and sligtly swollen. Saw provider she advised for them to use cool compresses and rx'd bendadrylo
Our son had fever mild fever on evening of injection and next day following injection. Cough and increase in fever late afternoon of 1/14/2011 - Administered Tylenol at 4:45 and 11:30pm and Xopenex at 9:15PM. Administered Xopenex inhaler at 4:45AM on 1/15 for coughing. He cried out at 7:30 AM and with high Fever of 106.4 degrees and coughing up clear mucus. Placed him in warm tub and administered Motrin and Xopenex. Took to pediatrician and continued alternating Tylenol and Motrin every 3 hours - and Xopenex nebulizer every 4 hours. Fever continued between 102 and 105 until AM of 1/16.
Dizziness; Pain; Runny nose; Sore throat; Tired; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), PAIN (Pain), RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) in a 33-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Pain), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), PAIN (Pain), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test: unknown (Positive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.Other treatment for the event included juice.
not comforting; This spontaneous case was reported by an other and describes the occurrence of DISCOMFORT (not comforting) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (not comforting). At the time of the report, DISCOMFORT (not comforting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Patient reports that when she returned home from receiving injection she developed red, itchy, dry eyes. She laid down and when she woke up she felt drugged and had fever and chills. Patient said she was having a little difficulty breathing and when she took a deep breath she would cough.  Patient took Benadryl but still has cough when deep breathing.
Systemic: Body Aches Generalized-Mild, Systemic: Fever-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient stated arm was squeezed and it hurt being administered. Patient said it was deep, not subcutaneous. Her arm did not hurt at injection site, it hurt under arm and was swollen. Fever was 104. She will take covid test. Felt sick for about 5 days
The day after receiving her second shot in the SHINGRIX series for the Zoster vaccination the patient began having fever, chills, and malaise. Additionally, the patient developed pain, swelling, and erythema near and around the site of injection. The symptoms of fever, chills, and malaise lasted 48 hours but began to subside after 48 hours. The symptoms of pain, swelling, and erythema have gotten a little better she said, but they still continue as of 48 hours from when she was administered the vaccination.
Pt vaccinated w/DTP/HIB/MMR/OPV as reported by phone by MD at Hosp 4-6 hrs after administration. Temp of 103, possible seizure activity.
Itchy arm; Bilateral arm muscle pain; Fatigue; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy arm), MYALGIA (Bilateral arm muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported by the reporter.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Bilateral arm muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache). On an unknown date, the patient experienced PRURITUS (Itchy arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy arm), MYALGIA (Bilateral arm muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included High Blood Pressure Medications, Antihyperlipidemic Medication.   This case was linked to MOD21-047783 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 03-MAY-2021, new event updated, outcome of the events were updated form unknown to recovered. Treatment details updated.; Sender's Comments:  MOD21-047783:
In October of 2022, we were attending a clinic for artificial insemination. They noticed that I had a number of uterine polyps and an abnormally heavy blood flow. They took a look and noticed a congenital uterine septum. I later had surgery to treat that and remove the polyps in January. When they looked at the biopsy of the polyps, there was endometrial hyperplasia without atypia. I am on a follow up course now of progesterone to take care of that issue.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. rec' Pfizer-BioNTech on 1/26/21, 2/20/21, and 11/02/21. Admitted 8/12 2/2 for pelvic mass and bil hydronephrosis c/b AKI on CKD. Found to have a UTI. Tested Covid + on 8/17. Bilateral nephrostomy tubes placed in IR on 8/19, in PACU placed on bipap. Resp status cont'd to decline requiring transfer to ICU for emergent intubation on 8/31 c/b fungemia and distributive sepsis w/shock. Paracentesis removed pus-like fluid. Transitioned to comfort care. Tx'd  w/micafungin, meropenem, vancomycin, cefepime, ceftriaxone, metronidazole, zosyn, remdesivir, and decadron. Expired 09/02/2022.
Diffuse rash on abdominal region and chest wall. Pruritic in nature, plaque like, non vesicular, without pain. Not associated with fever, body aches. denies: bites, new food or product exposure, or contact with grass/plants..
Approximately five minutes after receiving the shot in my left arm, the muscles in my right arm became noticeable weaker. I was unable to make a very tight fist and hang on to my car's steering wheel with my right arm.  My left arm felt normal. This muscle weakness in the arm opposite of my injection site occured for approximately 54 hours. In addition, I ran a fever, had nausea and upset stomach, and severe headache for 48 hours after receiving the vaccine. I currently am not noticing any of the aforementioned symptoms at this time but am monitoring muscle activity.
This spontaneous report was received from a registered nurse refers to a pediatric patient of unknown age who on 13-SEP-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 0363AE, Exp. Date: 16-MAR-2013) instead of intended VARIVAX (Merck). This would have been the patient's second dose of VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Developed a rash where the itching got increasingly worse. Skin red and very itchy. Finally went to the emergency room on February 8 and was prescribed two medications Famotidine and Hydroxyzine. Everything cleared within 3-4 days.
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis.   On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 6 months after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The age was not provided but captured an adult as per vaccine indication. The patient was vaccinated with dose of SHINGRIX a few months ago. After vaccination patient experienced arm pain. This case was linked with case US2020AMR199031 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR199031:same reporter
extreme headache  Needed to go to urgent clinic for medical care. received Toradol IM     my headache lasted over a week.
A significant outbreak of what felt like cold sores (?), internal within the tissues of the lower lip, which lasted about 1.5 weeks.  This has recurred two or three times since getting the second booster, usually if I am under stress or have a mild cold.  I have also experienced cold sore outbreaks (blisters) on the roof of my mouth, concurrent with the internal lip swelling.  Since the issue recurs, I don't know if this is a condition that resolves, and wonder how to proceed with the bi-valent booster that has just become available.
Starting in December of 2021, I developed calf cramps at night. Starting in February of 2022, I had "wads" of hair falling out. I went for a regular exam at the end of march and she ran regular tests. My blood test showed I am iron deficient and I am now taking iron supplements. My hair is no longer falling out as much and I am still having foot cramps at night.
ANGINA, UNSPECIFIED ACUTE NON ST ELEVATION MI ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
pt recv vax MAY95 & 29MAR96 pt devel a chickenpox rash w/about 150 lesions;no further details were provided;
My fingers and joints kept swelling and swelling (fingers, knees, hips and elbows) and I contacted my doctor to find out if I needed to do anything. She placed me on oral steroids. I was referred to an Orthopedic Specialists who did injections to get the swelling down in my knees.  My elbows and fingers continue to swell during the day and I have to ice/elevate the to relieve the soreness/swelling.
Information has been received from a Nurse Practitioner (N.P.) concerning a 11 year old female patient who was vaccinated with a first dose of GARDASIL. The NP reported that the patient fainted after receiving the first dose of GARDASIL. No further information is available. The outcome was unknown. Additional information has been requested.
Patient complained of severe body aches; joint pains; flu-like symptoms; arthritis; Condition aggravated; This non-serious case was reported by a physician via sales rep and described the occurrence of general body pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On 27-FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: Patient complained of severe body aches), joint pain (Verbatim: joint pains), influenza-like symptoms (Verbatim: flu-like symptoms), arthritis (Verbatim: arthritis) and condition aggravated (Verbatim: Condition aggravated). The outcome of the general body pain, influenza-like symptoms, arthritis and condition aggravated were not reported and the outcome of the joint pain was not resolved.   It was unknown if the reporter considered the general body pain, joint pain, influenza-like symptoms, arthritis and condition aggravated to be related to Shingrix.     It was unknown if the company considered the general body pain, joint pain, influenza-like symptoms, arthritis and condition aggravated to be related to Shingrix.   Additional Information: GSK Receipt date: 25-JUL-2023 The physician reported that a patient received only one shot of vaccine and no 2nd dose given. Patient complained of severe body aches, joint pains, flu-like symptoms that persisted for weeks to months per patient reporting.  Patient was afraid that the second dose of shingrix might "accelerate" her arthritis as her symptoms got worse after the first dose. Patient still had joint pains. The reporter consented to follow up.
It had to be half (0.25ml) of the original dose for booster, but was given full dose (0.5ml) that are usually given to the immunocompromised patient. Followed up with the patient. No unusual ADR notified at this time.
Fever 100.4 F; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.4 F) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (Fever 100.4 F) and HEADACHE (headache). At the time of the report, PYREXIA (Fever 100.4 F) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 100.4 f (High) Body temperature increased.         Concomitant medication was not provided. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  in response to the events were not applicable.   This case was linked to MOD-2021-085521 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR doc is added on 24-MAY-2021 where no new information.