chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in the foot (right); This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (swelling in the foot (right)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in the foot (right)). At the time of the report, PERIPHERAL SWELLING (swelling in the foot (right)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment products reported. Patient has swelling in the right foot. It does not hurt and did not have a fever. Consent for safety follow up given. Consent for safety follow up with health care professional given.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up information was received on 13 May 2021 in which fax number was updated.
Received second dose on Saturday, woke up on Tuesday at 5 AM with chest pains. Went to the emergency room around 4PM Tuesday,  transferred to another hospital, diagnosed with myocarditis, and treated and monitored there for 2 days and then discharged. On medication for the next 3 months due to condition.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Pregnant (newly pregnant) patient fainted upon vaccination. She stated she has a history of fainting with injections from when she was younger, but did not inform the immunizer since it had not happened in a long time. She fainted and pharmacist and pharmacy intern lowered to safety, she was responsive within about 20 to 30 seconds. Made patient wait about 30 minutes before having family member drive her home, and informed her she should let her OB know this happened.
Wheezing, occasional coughing, and head ache until 2 AM when I finally got to sleep.
Patient, was overdue for dose 2 of primary series for manufacturer Pfizer. First dose of Pfizer primary series given 1/20/22. Patient received Pfizer Bivalent booster on 9/15/22  instead of Pfizer monovalent/dose #2 of primary series. Medical provider, Dr. and Medical Officer, Dr. both made aware of situation. Mother of patient called and notified no harm done in patient receiving bivalent booster, which includes monovalent and variant. However, it still needs to be reported.
pt had injection site reaction with swelling and intense pain also extending to below where the vaccine was given. pt also had a rash and itching as well around the injection site as well.
This is the progress note from 5/25/21 @ 3:40p.m. - She is now very lethargic.  Temp. was 100.8° this a.m. & has accepted very little food or fluids. It has been noted that her breathing pattern has changed.  Resident is taking three deep breaths and then having periods of apnea. She continues to be lethargic, she does respond to verbal stimuli. Staff is sitting with her awaiting the ambulance arrival. PCP. has seen her and requested she be sent in to ER for evaluation.
Developed GUILLAIN BARRE Syndrome - MILLER FISHER Syndrome after multiple vaccinations in Basic Training. Symptoms: Neuropathy, Weakness, Hypo-reflexia, Headache, Migraine, Muscle Pain.  7/27/09 Multiple records received including hospital records and f/u consults. Hospital DOS 4/3-6/09 with D/C DX:  Miller-Fisher variant of Guillain-Barre Syndrome.  Pt presented with c/o weakness in legs, lower back pain and stumbling gait as well as diplopia, dysarthria, paresthesias of the fingertips.  PE (+) for  facial nerve paresis, leg weakness, wide-based gait, ataxia with absent DTRs. Tx with IVIG with partial resolution of sx. Transferred to rehab with continued H/A and back pain.
Day 1: As soon as I got it: Dizzy, light headed, blurry vision, pounding head, going to faint, adrenaline, then seizure no more than 30 seconds later. Jolting legs, couldn't hear anything, couldn't understand, confusion, felt like I was dreaming, uncomfortable, no memory of what had happened or where I was, no control, emotional disturbance. Later that day before I went to bed: Felt like I was going to throw up, light headed, blurry vision, very loud buzzing sound in my ears, felt hot, couldn't stand up so I laid down, had hard time saying what I was feeling, pounding head, headache, dry mouth. Day 2: Sore arm, lost balance when I got off of the school bus, headache, low energy in class and arm went numb several times, sensitive hearing, hard to concentrate, poor memory of even simple things, low appetite, always thirsty, wanted to rest. Day 3: Sore arm, arm went numb several times, sometimes my arm was hot and the area I got the shot felt hard, tiredness. Day 4-6: Sore arm and brain fog.
Patient complained of a hard lump 2 weeks after the injection. I instructed her to try a heat pack over the weekend. She awoke Monday morning with redness and swelling to right upper arm. Seen and prescribed and antibiotic.
This spontaneous report was received from a pharmacist regarding a 69 year old female patient. No historical or concurrent conditions were reported. The patient did not have any drug reactions or allergies. On 28-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# unspecified), intramuscularly, in the left arm. No concomitant medications were reported. On an unknown date approximately in October 2015, the patient developed "severe" pain at the injection site to the point that the patient was "unable to lift her arm over her head." No Product Quality Complaint (PQC) was reported. No lab diagnostics studies were performed. The pharmacist was called to seek medical attention. No treatment was given. The outcome of the events was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
fever to 104 by 8AM day of vax (about 7hr later);difficult to console-nearly constant cry;spacey looking;adm to hosp from Er dx w/vomiting/diarrhea, dehydration;during course of stay MD said could find no cause for fever;lt leg swollen;
This medically confirmed health authority report (initial receipt 15-DEC-2014) concerns a 37 year old female patient. The patient's past drugs included acetylsalicylic acid, penicillin, ibuprofen, indomethacin and iodine. On an unspecified date in 2012, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date later, the patient had unspecified adverse events. The outcome was not reported. Linked case: 2014047529 (same patient).
Narrative: SORENESS CONTINUES AS OF 1/29/2021 Symptoms: & SORENESS AT INJECTION SITE Treatment:
some kind of back pain, behind her heart; heart pain; pretty strong chest pain; fatigue caused by the vaccine was so profound; This is a spontaneous report received from a contactable consumer(reporting for her daughter) A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 expiry date 31Mar2021 via an unspecified route of administration on 08Jan2021 (at the age of 29-year-old) at single dose for COVID-19 immunisation. The first dose of bnt162b2 was taken on 17Dec2020. The patient's medical history included bipolar disorder. Concomitant medications included quetiapine (QUETIAPINE). The patient experienced some kind of back pain, behind her heart, heart pain and pretty strong chest pain on 08Jan2021 with outcome of recovered. In addition experienced "fatigue caused by the vaccine was so profound that was advised to not take her bipolar medication, quetiapine" on an unspecified date with outcome of recovered. It was reported that "It took 36 hours for the extreme fatigue to stop. This was very frightening because being without the medication could cause auditory hallucinations to return after 36 hours. There should be a warning for people who must take sedative medication regularly so that they can make an informed decision about whether or not to receive the vaccine".
atrial fibrillation with Rapid Ventricular Response; Initial information received on 25-Oct-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a 69 years old female patient who experienced atrial fibrillation with rapid ventricular response after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Atrial fibrillation with previous event of A-Fib, that was 3 years ago, she underwent a cardiac ablation, which successfully resolved the condition. The patient's past vaccination(s) included INFLUENZA VACCINE. The patient's past medical treatment(s) and family history were not provided.   On 19-Oct-2022, the patient received 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once (formulation, strength, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 19-Oct-2022, (latency: same day) the patient developed a serious event of atrial fibrillation with rapid ventricular response (atrial fibrillation) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   It was reported, patient received a FLUZONE HIGH-DOSE QUADRIVALENT vaccine on 19-Oct-2022. She states that she has had many flu vaccines, but this is the first time that she has gotten the High-Dose. Later that day, she went into Atrial Fibrillation with Rapid Ventricular Response. She is a retired ICU nurse and recognized what was happening, so she presented at the Emergency Department. She states that with the RVR, her rate reached 170. Treatment with Amiodarone was initiated but was unsuccessful at controlling the atrial fibrillation. She underwent synchronized cardioversion, which was effective. She spent about 5 hours at the hospital but did not require an overnight admit.   Action taken was not applicable.  The patient was treated with AMIODARONE (AMIODARONE) for Atrial fibrillation with rapid ventricular response.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: This event of atrial fibrillation was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 01-Nov-2022: This case involves a 69 years old female patient who experienced atrial fibrillation with rapid ventricular response same day after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The time of event onset was compatible with the time of vaccination. The patient had history of Atrial fibrillation which could be a confounding factor in the event occurrence. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Pt received PNEUMOVAX 23 vaccine on Tuesday (8/1/17) on right arm. Pt reports on 8/4/17 of "black and blue" bruise on right arm, that is warm and painful. Pt also reports cold s/sx.
Patient was to receive her second dose in primary series but was administered a bivalent booster dose. No adverse reaction was noted. Parent was notified. Patient is considered up to date on COVID vaccinations.
Initial case was retrieved from the scientific literature on 28 November 2012. This case was linked to 2012-11464 and 2012-11468. A male patient (age unknown) received an injection of IPV (lot number, route, site, and date of vaccination not reported) and an unspecified amount of time later experienced lethargy, a full body macular papular rash and fever immediately after administration. Patient had not been vaccinated since these episodes. Skin testing with the vaccine and physician supervised challenges were offered. The patient's outcome was not reported. Documents held by sender: none.
Arm swell up; Couldn't use her both arms; Fell on the floor; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swell up), LIMB DISCOMFORT (Couldn't use her both arms) and FALL (Fell on the floor) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swell up), LIMB DISCOMFORT (Couldn't use her both arms) and FALL (Fell on the floor). At the time of the report, PERIPHERAL SWELLING (Arm swell up) had resolved and LIMB DISCOMFORT (Couldn't use her both arms) and FALL (Fell on the floor) 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.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR received on 14 JUL 2021 and added patient took 2nd does a month later after 1st dose without any adverse event. event outcome updated.; Sender's Comments: There is not enough information to assess the event of fall as patient state at the time of fall and reason for falling was not provided.  The event of couldn't use her both arms, and arm swell up is due to the fall, therefore assessed as unlike related to mRNA-1273 use.
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 25-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J013324, expiry date: 12-FEB-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
pt recv vax 2PM 8OCT96 & pt expired 5AM on 9OCT96;pathology negative per Medical Examiner presumed SIDS death;
July 2022, he was very nauseous and had a headache. Then he started vomiting and I thought it was just a stomach bug. I brought him to the pediatrician and he tested positive for COVID-19. He was sick for about a day and a half and he got better after. It was just the nausea and vomiting and everything else was fine. In the beginning of September, he had his first seizure while we were driving in the back seat of the car. We called the ambulance and he was taken to the hospital. He was monitored for a few hours then was sent home. We had orders to follow up with a neurologist. We had testing done 9 days later and an EEG was done and confirmed that he had epilepsy. He was prescribed KEPPRA 500mg. His neurologist cannot confirm or deny that this was brought on by his COVID-19 infection. He had another seizure after the EEG. He's had two seizures all together so far. His neurologist thought that was significant and odd that he had two seizures that close together.
Per parent, child had routine immunizations on 02/11/09.  Infant jerked right leg slightly at the time of getting the shot, and small bruise appeared on right thigh after immunizations.  On 02/21/09 child developed a dime-sized, slightly raised, red spot on right thigh.  She has no fever, no tenderness to touch, or any other symptoms. Parent reported to county health district on 02/23/09.
Patient tested positive covid-19 next day the vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive covid-19 next day the vaccination) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (Patient tested positive covid-19 next day the vaccination). At the time of the report, COVID-19 (Patient tested positive covid-19 next day the vaccination) 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.   No treatment information was provided.  No concomitant medication was provided.
Hives starting in April, almost nightly. Now diagnosed with chronic urticaria since l have had them over 6 weeks. Local NP treated me, then saw dermatologist, Now on Allegra, Xyzal,  Famotidine, and hydroxyzine and still having hives most nights. Have appt with allergist/immunologist July 28th. Not sure if related to vaccine but I have never had anything like this before.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sweating, cold/hot alternating, localized pain as well as shooting pain down entire arm and up neck. Joint pains, nausea, dizziness, anxiety, tiredness, shivering, high fever (101 next day).
softball size knot on her arm that's red; feverish; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) dose unknown via an unspecified route of administration on unspecified date in as dose number unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. On specified date patient had softball size knot on her arm that's red and feverish. The outcome of the events was unknown.  Lot number/Batch number has been requested.
1 hour after eating breakfast, while crawling, seated on floor. Patient became suddenly unresponsive and hypotonic for 2-3 minutes. Mom started CPR. Ambulance called. Patient awake when ambulance arrived.  Nurse follow up on 06/16/04 states: "ADD: febrile seizure."
Initial report received on 04 November 2009 from a healthcare professional. A 17 year old male patient, with no known allergies and no medical history, received a first intramuscular left deltoid injection of MENACTRA (lot number U3079AA) on 26 October 2009. On the eve of vaccination, the patient had weird dreams, and upon awakening the next morning, he had a fever (temperature not reported), muscle cramps and he became depressed. He was seen at his doctor's office on 02 November 2009 and symptoms were still persisting at that time. At the time of the report, 04 November 2009, the patient's recovery status was reported as unknown. Follow-up information received on 07 December 2009 from a health care professional. The patient had diagnostic tests of CBC, CMP, CMV virus, and "EBV-1SM" on 02 November 2009 that were negative. Per the reporter by phone discussion on 08 November 2009 the patient had recovered.
After receiving the immunizations the patient noted phlegm in his throat that was different than before receiving the vaccines. He was given 50mg diphenhydramine and observed for an additional 15 minutes. After feeling well following observation he returned home.
Patient was given an empty needle without the vaccine. When the nurse realized that, the patient was explained what happened. The nurse then pull the dose in the syringe and administered the vaccine. The patient was observed for 30mins. The patient then left with no complaint
Patient showed a marked decline in functioning starting about 12 hours after the vaccine was administered.  Pt was shaky, weak, could not put words together.  Pt's doctor was contacted on Sept 8, ruled out UTI.  Seen by doctor on Sept 24. Pt was unable to stand or use legs, so she was taken to the hospital on Oct 8. Pt was admitted to hospital Oct 8 at Hospital, admitted to hospice on Oct. 13, and passed away Oct 17.  11/9/09:  Medical records and discharge summary received for dates of service 10/8/09 to 10/13/09.  Dx:  End stage Alzheimers Dimentia, dysphagia, HTN, arthritis, hypothyroidism, scoliosis, and sundowners.   Assessment:  Presented unable to ambulate that morning, not able to communicate.  Pts. baseline is to ambulate using walker, toilet and converse but over past 3-4 weeks she has steady decline and is no longer lucid and has no insight.  Urine, blood work and CXR all used to rule out infectious process.  Patient unable to improve in any way, palliative care discussed and hospice home decided on by family for comfort care measures only.
On 3/25/08- client returned to office for second Hepatitis B dose. Pt. stated that 6-7 days after receiving her initial vaccines of hepatitis A and B, Polio, Typhoid oral and Yellow Fever, she said the site that the YF vaccine was given started itiching and had a small brownish bruise and the area was tender. She stated that it bothered her and she did not expect that since she did not have any issues prior to that 6th or 7th day. She stated that it went away in 2 days and no further problems noted. No medications taken or visits to the doctor.