chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bruising; other serious neurological problems; issues with immune system; pneumonia; herpes zoster/ rashes; Information has been received regarding a case in litigation from a lawyer and referred to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster, rashes, bruising, other serious neurological problems, issues with immune system and pneumonia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster/rashes, bruising, other serious neurological problems, issues with immune system and pneumonia was considered as not recovered. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.   The lawyer considered all the events herpes zoster, bruising, other serious neurological problems, issues with immune system and pneumonia to be disability. Other serious neurological problems was considered to be medically significant by the lawyer. Upon internal review, pneumonia was determined to be medically significant.
pain in right leg below the knee; 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 PAIN IN EXTREMITY (pain in right leg below the knee) 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 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in right leg below the knee). At the time of the report, PAIN IN EXTREMITY (pain in right leg below the knee) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Exhaustion fatigue weight loss joints aching limit range of motion in arms especially right arm neck pain feet hurt elbows pain knee pain hand weakness anxiety depression worse headaches IBS has come back
Syncope patient had her first Covid vaccination today waited 15 minutes stood up to leave and had a syncopal event she really did not have any prodrome with this she was not aware of feeling nauseated and awoke on the floor.  She did not strike her head.  On awakening she had chest pain that is typical of her known coronary artery disease and she presents here by ambulance for further evaluation. Patient does have periodic angina although this is been worse pain and longer duration than is typical for her. Patient had her last stenting done in late 2020. Transported to hospital for evaluation.  Troponin and EKG negative.  Discharged to follow up with cardiologist.
Approximately 36 hours post vaccine dose #1,  lower back pain began. About 3 hours later a pine and needles sensation began in hands and feet and continued throughout the night and remain consistent at present time.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Mild, Additional Details: Within a few minutes after receiving second dose, she threw up and was very pale. She was drinking water and we got her crackers and candy. She laid down on the floor for about 10 minutes and started to vomit again. I asked her dad if he would prefer me to call an ambulance to have her checked out. He said yes so they were called. Her vitals were good when they checked her when they got here. They did take her to the hospital.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive again with symptoms; Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Irregular, very heavy menstrual cycle for every cycle since the vaccine was taken. I have undergone IV iron treatments
Dec 2 developed tooth pain on one tooth, Dec. 3 all lower teeth aching, Dec. 4 excruciating spikes of pain which where triggered with eating, talking, hot cold and random
Narrative:  73yo male died at community hospital on 12/29/2021 with hx of: Problem List: Cerebral infarction Deposits [accretions] on teeth (ICD-10-CM K03.6) Diabetic neuropathy Diabetes mellitus Essential hypertension Obesity Arthritis Hyperlipidemia Aortic valve stenosis - per cardio APRN note - "severe aortic stenosis" - requesting TAVR vs SAVR Pt had received covid vaccines on 2/12/21 & 3/12/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
pt recv vax 9DEC96 & 11DEC96 pt devel a rash w/over 1000 lesions all over body & a fever;
Inconsolable crying and refusal to eat, pain at injection site. Later in the evening, fever and consolable crying, and slept for more than usual at night and following morning.  Treated with Tylenol once same day of vaccination. Following day, noticed increase in acid reflux and significantly more spit up in frequency and amount.  Third day, showed signs of a rash on scalp, shoulders and chest, also noticed regression of eye contact, smiling, and vocalization. Maintained fever through the end of week.
Sore arm. Fever chills and extreme fatigue at 6:00pm that evening of the vaccine.
pt recv vax & 3 days p/vax pt exp t104.5;pt was taken to ER;pt was thought to have the flu & therapy w/an ATB was initiated;
Few hives on my legs; Rash all over; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Few hives on my legs) and RASH (Rash all over) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (Few hives on my legs) and RASH (Rash all over). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Few hives on my legs) and RASH (Rash all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash with fever at injection site, muscle weakness, itchy red eyes, cognitive "slowness".
Patient requested Booster Moderna after Pfizer series, informed Pfizer is available, vaccinator delivered the Moderna vaccine.
Bells Palsey (right facial dysequilibrium with standing, ambulatoin Headache, cervical trigger points
DIED; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  The reporter stated that, "the patient died 30 minutes after vaccination." On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause of death. This report was serious (Death). This case, from the same reporter is linked to 20211229952.; Sender's Comments: V0: 20211230647 -COVID-19 VACCINE AD26.COV2.S- Died .This event(s) is considered unassessable .The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
The patient reportedly experienced left arm pain, a burning sensation and swelling on 01/11/2001 after being seen by a private physician. The patient was treated with ibuprofen. From additional correspondence received on 02/27/2001, it was reported the patient is currently being treated for bursitis. The Dr advised these symptoms were not caused by the flu vaccine. No further information is anticipated. This case is closed.
FIRST SHOT: INJECTION SITE MUSCLE SORENESS; 24 HOURS POST VACCINE THE SKIN AROUND THE INJECTION SITE WAS PAINFUL TO TOUCH LASTING ABOUT 12 HOURS SECOND SHOT: 20 HOURS POST VACCINE MILD NAUSEA AND HEADACHE
This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a male patient who received SHINGRIX. On 6th March 2018, the patient received the 1st dose of SHINGRIX. On 6th March 2018, 40 min after receiving SHINGRIX, the patient experienced myalgia, fever, tiredness, sleeplessness and general body pain. On an unknown date the outcome of the myalgia, fever, tiredness, sleeplessness and general body pain were unknown. It was unknown if the reporter considered the myalgia, fever, tiredness, sleeplessness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient complained of myalgia and stated his body hurt all over, including his hair. He also said he had a fever and was extremely tired but also not sleeping. No further information was provided.
This morning after breakfast (around 9:00-9:30am) my right eye started feeling strange, but looked fine.  The sensation was a sense of pressure or slight numbness.  After about 20 minutes, that sensation disappeared and then my right arm  started feeling strange, too, as if my joints were swelling and the ulnar nerve was irritated. The right forearm near the ulnar nerve felt slightly numb to touch, as if I were touching Playdoh, or molding putty.   All my joints started feeling swollen and heavy, my knees visibly showing swelling.  I?ve done some work to alleviate the inflammation, but my right side arm and joints are still feeling heavy and a little warm, with some lingering weird feeling of Playdoh (molding putty) numbness when I touch the area.  The numbness is not so noticeable when I?m not touching the area. It seems that it will go away with time and not too serious, but wanted to report in case others experience the same thing.  Also, I should mention that the day after getting the vaccine (2/5/21), in the morning when I woke up (7:00am), I experienced an intense one-sided headache behind my right eye that lasted until I gave myself some acupuncture in the late morning.  I also experienced extreme arm pain at the site of the injection the day after the vaccine which lasted until yesterday (2/6/21).  This morning when I woke up (7am), I felt some local numb feeling (when I touch it, it feels like I?m touching playdoh) at the injection site on the left arm, with minor soreness.
1/14/21- 6am - migraine, dizziness, nausea 1/14/21 - 9am - chills, body aches Lasted all day into 1/15/21 1/15/21 - 6am -mild headache and body aches, seems to be getting better
Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 6 months old male patient who was vaccinated with a 0.5 ml third dose of PENTACEL (Batch number: C55458A and expiry date: 10-Jun-2019) via intramuscular route (site of administration not reported) on 24-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate reconstitution technique because the Pentacel Hib lyophilized powder portion with sterile diluent water was given instead of the actual DTAP diluent to. No reaction was reported. 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 Directive and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by the sender: None.
pt recv vax 13APR99 & 14APR99 low grade temp;15APR99 hives;only treatment recommended DPH as needed for hives;
Most of the dose leaked out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Most of the dose leaked out) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Most of the dose leaked out). At the time of the report, UNDERDOSE (Most of the dose leaked out) outcome was unknown.        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.
Hives on back from buttocks to above the knees on both legs, on back of arms. Patient also had swollen upper lip. Patient took BENADRYL and saw his Dr whom prescribed a MEDROL dose pack.
Influenza IIV4 (fluarix 6Mo+) 0.5 ml was given im in Left deltoid. Pt developed itching and redness to upper extremities shortly after receiving vaccine. Benadryl 50 mg im stat given, relief noted (less itching + redness) vital signs T 97.8 P 86 R 25 B/P 136/83 O2 sat 98%. Pt stable, no apparent distress.
DPT given in left arm Student moved during administration and solution given sub q instead of im. Friday left arm hard hot an redden in 2in around administration site Recommended MD if not improve
Patient completed Moderna COVID-19 vaccination on 4/23/21. Patient was admitted to the reporting hospital on 9/13/21 due to altered mental status. Patient was hypoxic upon arrival and admitted for Severe adverse effect of COVID-19 vaccine, Altered Mental Status, Cough, Acute hypoxemic respiratory failure due to COVID-19, and High anion gap metabolic acidosis. Admission test for COVID was positive per PCR NP swab on 9/13/21. Patient is still currently admitted.
Rash near injection site, swollen lymph node on right side of jaw line, gums not healing from dental work done one week ago (now bleeding, wasn?t before the shot). Symptoms are still ongoing.
Pfizer monovalent Covid 19 vaccine given inadvertantly as booster dose instead of Bivalent.  Patient tolerated well.
Joint pain for 2 weeks then intermittent. Joint pain, tiredness since injection and muscle aches of right arm since injection
Pt recvd vax & 1-2 wks p/3rd dose exp malaise & arthralgia in knees, wrist & hands;
Severe reaction to influenza vaccine (FLU *20-21 FLUZONE HD) Lot UJ512AB. Administered 10/26/2020. Five hours after receiving the vaccine sudden onset of very high fever (up to 103.6) and violent shivers. Fever still high after 24 hours.
In May 2021 patient reports tinnitus. She also reports that she developed a recurrent DVT/PE in August of 2022 and feels this is related to the vaccine. She also feels her menstrual periods were more irregular after the vaccine.
Slight chest pains on the left side at night on the 24th, left hand pains.  Chest pains subsided by the morning.
Mininmal side effects with any of them; Initial information from received on 11-Feb-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case involves Adult and unknown gender patient who experienced mininmal side effects with any of them while receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Kidney disorder.    In October 2021, the patient received a dose of suspect INFLUENZA VACCINE and COVID-19 VACCINE produced by unknown manufacturer (Formulation, Strength, lot number and expiry date not reported) via unknown route in and unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious mininmal side effects with any of them (adverse drug reaction) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Mininmal side effects with any of them).  At time of reporting, the outcome was Unknown for the event mininmal side effects with any of them.
Pt was given vaccination at 1100 and at 1105 patient experienced a vasovagal episode and lost consciousness for approx. 5 seconds.
I woke up with a pain on the inside of my right knee and there was a little lump there. When I got up in the morning, it was red. I thought it might be a blood clot. I did go to the emergency room and they confirmed it was a blood clot. They said I could go see the doctor at the vascular clinic. I did go there and they did another ultrasound and they said there were two blood clots and they had not moved. They were in a small vein in the leg. They advised to wrap up the leg, elevate it, and apply heat to it.
Within a few weeks of receiving my innoculation, I began to exhibit loss of muscle strength and control in my extremities.  I was having difficulties with basic functions such as walking, climbing stairs, holding a glass in one hand, picking up heavy items, etc.  I initially saw my internist, who ran a complete blood panel for 11 items.  All ranges were normal. Dr. referred me to a neurologist, who did a complete evaluation in January, 2019.  He was unable to identify the cause of the condition and discussed the possible need for nerve conduction tests if the condition did not resolve itself.  I had additional blood work done in March, 2019  by Dr. with no change in the results.  In May, 2019, Dr. performed a nerve conduction test and found no systemic issues.  However, my condition persisted without improvement.  It wasn't until I mentioned to Dr. that I had received a flu shot in October, 2018, about two weeks prior to the onset of my symptoms, that he suggested that my condition was the result of the innoculation - that my body was reacting as if it had the flu without all of the side effects. He suggested that my symptoms could take up to 9 months to resolve after the shot.  It wasn't until July, 2019, that I was nearly fully recovered.
This spontaneous report was received from a medical assistant and refers to a 16 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 02-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Neuropathy type pain/tingling to brain, both hands ans feet. Legs cramps in am. Achey x1 week
Starting Wednesday night, August 11, 2021, felt excessive pain in my abdomen with high fever that continued till Friday, August 13, 2021 when I ultimately admitted to ER that ended up with laparoscopic surgery to remove my appendix on Saturday, August 14, 2021 at 08:30 AM.
No additional AE information reported; HCP called to report that ROTATEQ vaccine that expired on 7/14/2022, was inadvertently administered to two patients after the expiration date.; This spontaneous report has been received from a medical assistant, referring to a 9-week-old female patient. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 22-JUL-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml  orally (lot number 1742080 has been verified to be a valid lot number, expiry date 14-JUL-2022) (strength, and frequency were not provided) indicated as prophylaxis (expired product administered).   Furthermore, the reporter stated that the vaccine did not experience any temperature excursion prior to administration and no additional adverse events were reported.
Initial physician report received on 03 Dec 2010: This patient with an unknown medical history was vaccinated with MENVEO (batch number: unknown) on 06 Nov 2010 which was stored for around 2 months at 30 F. No adverse event was reported following this incorrect storage.
Joint pain elbow, wrist, fingers left side throbbing/burning. Weakness in (L) arm prevented use of her left arm/hand for 2-3 weeks, over which time the weakness gradually faded and full use of the arm was restored.