chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe muscle weakness; Joint pain; Vertigo; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 82-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as single dose (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "knee replacement surgery", start date: Apr2023 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "severe muscle weakness "; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown". Additional information: Patient had the RSV(Abrysvo) vaccine and then the following day she had a steroid shot.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Pt Received MMR, Dtap and polio vaccine.  Approx. 10 minutes after vaccine red areas noted on pt. 1 small behind right ear, 3 on right arm near the elbow, 2 on left arm near the elbow, 1 large area on left chest, and 1 med size area on right side of abd.  Areas were marked with an ink pen.  Observed pt for 35 mintues.  Red areas went away.
All over redness, swelling, itchy, blisters, patch appearing as dark color.
Fourth vax received on 09/17/1999. Post vax, previous reactions became worse (burning sensation and pain where shot was given, fatigue, dizziness, headaches, cysts on scalp) and developed new ones. Lost  50 pounds since 4th vax. Sought medical attention but no resolution. Began eating anything and everything and weight finally stabilized. Noticed red bumps on arms and legs, experiencing dizziness and felt as if would pass out on daily basis. Vision was blurry and narrowing down. Ears started ringing periodically and experienced chills frequently. Have been unable to gain any weight previously lost. Still experiencing dizzy spells, ear ringing, and headaches. Also severe abdominal pains when going to the bathroom, shin pains which last for a few hours for no apparent reason, and fatigue.  Is so tired in the afternoon, that taking a nap doesn't do any good. Began experiencing short term memory loss with the dizziness a couple of days ago and lasts for 10 to 20 minutes. Physician stated that cysts could be caused from working out. Something to do with sweating. He also doubts that it might be anthrax related but said he is uncertain.  Dizzy spells are more frequent, eventually turning into seizures lasting from 10-30 minutes. First occurred 02/30. Vision narrowed and then all black. Was taken to hospital, tests scheduled and released. Was restricted from driving. Over the weekend experienced dizzy spells, light headedness and the blank stare with no response for several minutes. Later found out these were a different form of seizures. Following an additional seizure on 03/04, pt wash hospitalized overnight and tests scheduled all of which came back negative. After heart rate readings during seizure were obtained, physician concluded diagnosis of Sinus Tachycardia. Was prescribed heart, anxiety, and sleep medication. Was placed on convalescent leave for two weeks.  03/08 experienced seizure, eyes rolled back, eyes dilated, rapid pulse, and breathing stopped. Wife began CPR until revived. Same afternoon at commanding officer, experienced another seizure. Breathing ceased for 5 minutes and CPR was performed. Was hospitalized and referred to cardiologist. Was instructed to wear events monitor and not to drive, go to work, or to be alone. Experience fatigue and shortness of breath easily and often. Feel confused, irritable, disoriented dazed, and forgetful daily. 60 Day FU indicates still suffering chronic insomnia/sleep deprivation with secondary neuropsychological deficits
Patient received his vaccine while sitting down at 5:50 pm, when he got up to move to waiting area he passed out and hit his head against the floor.  We called 911, he woke and we had him just sit in room until they arrived.  They arrived and took him out on the Guenery.
no adverse effect; unspecified 10 years old patient inadvertently received an adult dose of VAQTA; unspecified 10 years old patient inadvertently received an adult dose of VAQTA; This spontaneous report was received from the medical assistant, concerning to a 10-years-old patient of unknown gender. The patient's medical history, concomitant therapies, concurrent conditions and past drug allergies or reactions were not reported.   On 14-JUN-2019, the patient was inadvertently vaccinated with and adult dose (incorrect dose administered/product administered to patient of inappropriate age) of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/ml (lot # S001832 has been verified to be a valid lot number for hepatitis a vaccine, inactivated with expiration date on 12-MAY-2019), one dosage form, via intramuscular route for prophylaxis (anatomical site of injection was not reported).  It was reported by the medical assistant, that it was the first dose of the series. No adverse event reported nor product quality complain involved.
Sore arm; slight headache; slight fever; slight nausia; wild upward spikes in blood glucose levels; appears that the Shingrix is affecting the immune response such that the infusion set is rendered; insulin pump not working / insulin infusion difficulties; This case was reported by a consumer via call center representative and described the occurrence of infusion related reaction in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 19th February 2020, the patient received Shingrix. In February 2020, unknown after receiving Shingrix, the patient experienced infusion related reaction, blood glucose increased and immune disorder (nos). On 20th February 2020, the patient experienced pain in arm, headache, fever and nausea. On an unknown date, the outcome of the infusion related reaction, pain in arm, headache, fever, nausea, blood glucose increased and immune disorder (nos) were unknown.   It was unknown if the reporter considered the infusion related reaction, pain in arm, headache, fever, nausea, blood glucose increased and immune disorder (nos) to be related to Shingrix.  Additional details were provided as follows: The patient had type I diabetes mellitus over 35 years. The patient received Shingrix vaccine in the afternoon of 19th February 2020. In the beginning morning of 20th February 2020, the patient experienced pain in arm, headache, fever, nausea. Less than a day after vaccination, the patient experienced  infusion related reaction, blood glucose increased and immune disorder (nos). The reporter stated that, changing the infusion set followed by additional insulin slowly reduced blood sugar level after several hours, but then the blood sugar level would shoot up again. No sugar or carb intake, so diet should not be a factor. These symptoms have continued into 22nd February 2020. The reported batch number G7224 for Shingrix did not exist and was updated to G72Z4 as per the sales database. The reporter consented to follow up.
This spontaneous report was received from a registered nurse, referring to a an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions or concomitant medication were not reported. Since 01-JUN-2017, the patients may have been administered incorrect storage doses of PEDVAXHIB (dosage information, route, lot number an expiration date were not informed) for prophylaxis. No adverse effects were reported. It was also reported: temperature/time: 49.8F for 30 minutes. There was no previous temperature excursion. "Data logger" was involved. The outcome was reported as: supported. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004962: US-009507513-1706USA004960: US-009507513-1706USA004961.
pt states woke up 9AUG96 AM w/arm red & swollen reported to MD 13AUG96 4PM was seen by MD 14AUG96;lt upper arm swollen red & base approx 6" extending lateral;itching;
Shingles like rash on back, very painful even when shirt touches back, at time of reporting not known case of shingles.
I received the vaccination #2 -02/27/2021 , Reaction began on about 04/11/2021, when I was up and about getting ready for the morning, about 30 minutes after I would feel light headedness and felt like I was going to pass out. I would sit down and once It passed I was able to carry on. On 04/16/2021, I have a long drive to work and I was almost to work and I had this almost swooshing feeling from my head to the bottom of my feet and I had some chest pain. I drove myself to the ER and they did a number of tests. EKG, Echo cardio graham, stress test on the treadmill, chest x-rays and blood work. Everything looked good. After that episode my sx kind of cleared. I did not have anything after that other some heart palpitations. I am a really healthy person.
States started as "deja-vu" like feeling, tunnel vision and progressed to blank stare.  Last 30 secs to 2 minutes, now with increasing frequency.  Seen in Er with negative head Ct on 02/27/2010 and referred to neurology.  Seen by neurology with abnormal EEG and started on. Keppra.
Body aches, headache, abdominal pain, nausea, insomnia and nightmares, pain at injection site.
15 mins following vax pt exp SOB, rapid heart rate, hives on chest & back, mouth tingling;
pt recvd vax; on 7oct94 had small 1/4 cm red area to inside of rt forearm; later more red areas to inside of both upper arm; cont to enlarge to 1/2 - 1cm size very red & itching; took meds; rash is less red & is drying up to this time;
On 4/4/2020 patient then "got a rash (they were little pink bumps) on arms, legs and lower torso".; This spontaneous report as received from a medical assistant refers to a 14-month-old female patient. None pertinent medical history, concomitant medications and drug reactions/allergies were provided.  On 31-MAR-2020, the patient was vaccinated with dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left leg, lot # S020158 and expiration date 30-JUN-2021 and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Recombinant human albumin (rHA), subcutaneously in the left leg, lot # S005249 and expiration date 20-FEB-2021 for indication of routine vaccination. On 04-APR-2020 (reported also as 31-MAR-2020), the patient got a rash (they were little pink bumps) on arms, legs and lower torso. The patient sought for medical attention. The physician advised the treatment with cetirizine hydrochloride (ZYRTEC). The three hours after administration of treatment the rash was gone. No lab diagnostics/studies performed. No product quality complaint (PQC) was involved. The outcome of rash was reported as recovered/resolved on 04-APR-2020.  The causality assessment between the event and the suspect therapies was not provided.
Pt complained of hand & wrist numbness on left side of body, also tingling of fingers (patient reported to pharmacist on 12/9/2011).
9 days later woke up again arm sore with a hot spot feeling at the area of the shot. Felt like a small ball under it , swollen  , slightly red, fairly itchy for about 2 into 3 days.
Arm/shoulder pain where injection received (left arm).  Remainder of week pain and inability to function/lift items.  Required rest in bed and at home.  Still laid up as of 11/10/2015.
26JUL94 mom gave APAP 6AM, pt had sx lasting few seconds; second sz 830AM w/screaming; seen @ hosp ER @ 855AM; dx febrile reaction to immun w/sz;
This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a patient of unknown age and gender. On 12-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees centigrade for 19 hours. This was one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006246, 1307USA006247, 1307USA006245, 1307USA006249, 1307USA006250 and 1306USA007793. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. The patients' pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. The patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L029306 and expiry date 26-MAR-2017) on an unknown date after 20-JUL-2016. Excursion was at temperature of 48.7 F for 5 minutes. No previous temperature excursion was noted. The call was due to digital data logger. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Anatomical landmarks used for vaccine administration. Acromion process of left humerus identified, vaccine administered 3 finger width below acromion process. Immediately after vaccine administration the patient expressed he felt discomfort and pain in the left shoulder. Patient was able to tolerate pain and maintained full range of motion in the affected extremity. After waiting 15 minutes post vaccination I reassessed patients symptoms and he stated that there was still discomfort in the left shoulder, however it was tolerable. Reeducated on ROM activities. Patients shoulder had no visible/apparent deformity. No hematoma noted, no swelling noted, no redness noted, no bleeding at the site. Patient left the Health Center in stable condition with persisting left shoulder discomfort with vaccination record in hand.
Information has been received from a physician concerning a female patient who in 2007 was vaccinated intramuscularly with three 0.5 mL doses of GARDASIL (Lot number was not provided). Subsequently the patient had been diagnosed with an abnormal pap smear. The patient sought unspecified medical attention. The physician performed a colposcopy on an unspecified date but the results were not provided. The 2009 pap smear was positive for HPV high risk for types 16, 18. The patient did recover from the abnormal pap smear. Additional information has been requested.
Headache, abdominal pain, muscle aches, chills. Symptoms started 2 hours after vaccine administration and lasted for 7 hours. No treatment was provided.
Headache, fever, chills, body aches  the night of and the next day after getting the vaccine
One week after the injection, I had urticaria and angioedema near the site of the injection. I still have it. It goes between better and worse but hasn?t gone away.
LIGHTHEADED; This spontaneous report received from a patient concerned multiple patients. 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 not reported, batch number: 207A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced lightheaded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lightheaded was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566.
The whites of my eyes turned completely red and I lost all energy and felt like I could not put one foot in front of the other. Over the past several weeks I have been in the ER twice, admitted to Hosp for 3 days, I am slowly losing use of my arms and legs due to extreme pain.
July 29, 2021 tickle in throat progressed from their til  09/01/202 that is when you did rapid test at Pharmacy and they contacted local heath department who surveillance team reached out with instruction on Quarantine and taking care of the symptoms.  Still experiencing a coughing, tightness lung,  difficulty  breathing , and tiredness and brain fog
vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
severe soreness at injection site (still exists, going on 48 hours) joint aches, 19 hours to  31 hours chills, off and on, 19 hours to 31 hours skin sensitivity (all over like flu), off and on, 19 hours to 31 hours these symptoms/signs were helped by ibuprofen (which is why they were on and off)
Flu like symptoms: headache, fever over 100 degrees for 24 hour period (even when taking Tylenol and Advil), extreme body pains, fatigue, brain fog.
Pt received vaccine 4/11/2021 had some redness on first 2 fingers and thumb and up towards wrist on arm that vaccine was received. Was seen by primary MD day or two after where her PCP prescribed oral prednisone. Rash did not get better or resolve with oral prednisone so pt presented to ER a day or two later. ER doctor diagnosed pt. with Covid Arm/ Allergic reaction and prescribed Hydroxyzine 50mg and some Cream but was not provided any treatment at the ER. As of 5/6/2021 pt reports that she has really dry spots and cracking/flaking at the originally affected sites, but that the redness and swelling has diminished significantly.
Received expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-362834 (Patient Link).
Initial information reported healthcare office to nurse on 08-Nov-2013: A pregnant female patient received FLUZONE QIV (Lot U4789AA and expiration date unknown) on 17-Oct-2013 and 07-Jul-2013. Reporter stated patient inadvertently received 2 of the FLUZONE QIV vaccinations. The estimated date of delivery is 08-Dec-2013. No further relevant information reported.
Body aches & fatigue X 3 days.  Symptoms developed 3 hours after receiving the inj.
93-year-old gentleman who is being admitted for shortness of breaths secondary to COVID 19 pneumonia
bruising around vaccination site; soreness of the right arm which was injected; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE BRUISING (bruising around vaccination site) and VACCINATION SITE PAIN (soreness of the right arm which was injected) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ENALAPRIL, CARVEDILOL, SOTALOL (SOTALOL AF [SOTALOL]) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE PAIN (soreness of the right arm which was injected). On an unknown date, the patient experienced VACCINATION SITE BRUISING (bruising around vaccination site). At the time of the report, PRURITUS (itching) and VACCINATION SITE PAIN (soreness of the right arm which was injected) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes use an ice pack- exercised by running the vacuum and arm exercises of youtube by nurse.
Sore arm left site started at 8 PM 3/16. Then after midnight had chills and fever and nausea, temp 101.6  shivering,  body aches, dizziness when sat up. Took Advil, slept some more  Hard time sleeping. 7:45 AM 3/17 had fever 102.1 F this AM, and took  Tylenol. Now temp 101.1 F.
second dose given only after 1 week apart from first dose, tried calling patient numerous times but no one picks up
The patient experienced body aches and headache within the first 24-48 hours of receiving the vaccine. On 4/1/2021, the patient had swelling around his eyes at around noon. He stated that he feels that the swelling worsened that night but this morning (4/2/21) the swelling has improved. He came to the clinic this morning to check in regarding his symptoms. I called in PA to assess the patient. She assessed the patient and he stated that he had some SOB yesterday but denied any SOB today. The patient's O2 sat was 99% and HR was 98 bpm. She recommended that the patient take Claritin BID and return for follow up on 4/5/21 to see her in clinic. She advised him to go to the ER if he experiences any SOB, increased swelling, or difficulty breathing and he verbalized understanding. The patient has a hx of HTN and takes Lisinopril 10 mg daily. He did take his medication this morning. The patient denied taking any new medications. He also denied any previous vaccine, drug or food allergies.
Headache, chills, fever, muscle weakness, loss of appetite, nausea, diarrhea
4/17/21 ER HPI: 56 y.o. male who presents with asymptomatic tachycardia.  The patient purchased a home blood pressure monitoring device approximately 2 weeks ago and at that time he noted that the machine recorded his pulse at 150-160 beats per minute.  The patient has repeatedly taking his blood pressure at home with this device and every time and has recorded his pulse in the same range.  He denies fevers chills chest pain palpitations syncope  lightheadedness peripheral edema or dyspnea.  He presents today for evaluation of this as the machine again indicated that his pulse was 100 50-160 beats per minute
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jun2022 at 07:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 62 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: METOPROLOL; HYPOTHIAZIDE. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 17Jun2022 at 22:00, outcome "not recovered", described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 17Jun2022 at 22:00, outcome "not recovered", described as "swelling of lymph nodes onset within 15 hours of injection"; PAIN (non-serious) with onset 18Jun2022 at 23:30, outcome "not recovered", described as "Severe pain"; SWELLING (non-serious) with onset 18Jun2022 at 23:30, outcome "not recovered". Therapeutic measures were not taken as a result of pyrexia, lymphadenopathy, pain, swelling. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. No known allergies. The patient experienced fever and swelling of lymph nodes onset within 15 hours of injection.