chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her arm was very sore at the injection site; felt achy/very painful; felt like flu; severe itching; nerve pain on the inside of her arm her lower back and the top of her left thigh / the nerves were painful; nerve pain in her tongue; she had a hard time getting dressed; was a little past the 6 months when she got the 2nd dose; felt like a mild case of Shingles; got bruises from all the scratching; from all the scratching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose little past the 6 months).   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, 3 days after receiving Shingrix, the patient experienced shingles, contusion and scratch. On an unknown date, the patient experienced injection site pain, general body pain, influenza like illness, pruritus, nerve pain, tongue pain, activities of daily living impaired and drug dose administration interval too long. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the shingles, pruritus, nerve pain, contusion, scratch, tongue pain, activities of daily living impaired and drug dose administration interval too long were unknown and the outcome of the injection site pain, general body pain and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the shingles, injection site pain, general body pain, influenza like illness, pruritus, nerve pain, contusion, scratch, tongue pain and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in early January 2020 and her arm was very sore at the injection site, such that she had a hard time getting dressed. She also felt achy like she had the flu for a day afterwards. About 3 days after getting the vaccine she developed severe itching and nerve pain on the inside of her arm above the elbow, her lower back and the top of her left thigh. The nerve pain in her arm was the same arm where she received the injection.  The itching on her arm was so bad she got bruises from all the scratching.  The patient went to a minute clinic and was given steroid, which relieved some of the itching for about 1 week. It was very itchy and very painful and the symptoms lasted about 2 months. She thinks it felt like a mild case of Shingles. There was never any breakout on her skin, but the nerves were painful. Separate from the nerve pain, she also had pain at the injection site that also took a long time to resolve. In the past week to 10 days she has started having the same nerve pain in her tongue. It was not in the same part of her tongue all the time, it moves around.  The patient went to her dentist, and her dentist did not see any signs of infection on her tongue.  The reporter consented to follow up. Emergency room visit required.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-AUG-2017, the patient was vaccinated with one improperly stored dose of PNEUMOVAX 23 (route of administration was not reported) lot # N010106 and expiration date: 15-NOV-2018. No adverse effects were reported. The vaccine was exposed to temperature from 47 to 77 degrees Fahrenheit for 1 hour and 20 minutes, which was detected by a data logger. There was no previous temperature excursion.
Feeling like a heavy weight on the body, Red, hot, swollen arm. The redness spread to 3 areas of the upper arm. They were not connected. Pain in the left shoulder so much so she couldn't sleep and when the doctor touched it she winced and pulled away.
Extreme chills.   I was not cold but shook with every breath for about two hours.  Got up in middle of night and my legs would not support me, had to hold onto furniture in order to pull myself across room.  Morning, I get up and tend to lean forward when walking causing me to try and control my balance while walking at an excelerated speed.
Severe pain at injection site. Right arm - arm was incapacitated. Pt stated he got weak and fainted. ER ov - Oxycodone, Percocet;IV.
armpit is swollen and tender/lymph nodes in the arm pit and that could be the swelling and tenderness; armpit is swollen and tender/lymph nodes in the arm pit and that could be the swelling and tenderness; This is a spontaneous report from a contactable consumer (patient). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route, administered in the right deltoid on 11May2021 at 13:50 (at the age of 23 years old) (Batch/Lot Number: EW0179) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient did not receive any prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 13May2021, around 17:00, the patient experienced his armpit was swollen and tender/ lymph nodes in the arm pit and that could be the swelling and tenderness. He got his shot-on Tuesday afternoon in his right shoulder and then he started to notice on Friday, 3 days after shot the arm he got the shot in, his arm pit was swollen and tender. The patient stated there are lymph nodes in the arm pit and that could be the swelling and tenderness. He was wanting to know if this is normal or a side effect. He took Advil a day before this report and he had not taken any on the day of this report. The patient was treated with Advil. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
1322- during 15 minute observation period, patient noted feelings of lightheadedness, chest tightness/pain.  BP was 110/70, HR58.   1330- EMS arrived, lung sounds clear, biox WNL, BP 135/94 1333- additional EMS arrive with stretcher, CP had improved, HR 80, sinus rhythm, still lightheaded, (all per EMS) 1336-denied departure with EMS, husband picked her up.  1340- EMS departed, Husband to pick up 1342- CP resolved 1346- headache but otherwise ok 1352- gave her a cold compress, she then got chills so we provided a blanket and CP returned 3/4, "tight", reassessed BP= 122/74, HR 62, clear lungs, BIOX 100, HR62 1400- husband arrived and she felt safe to leave with husband
3 hrs p/shots were given pt was pale, limp & would not respond to mom; approx 1/2 min or so shook legs & breathed in mouth; finally responded mom called 911;
Child was very healthy infant. Received many vaccines on 3/3 or 3/5/02 at 14 months. Within 4-5 weeks, he lost all speech, became distant, and unresponsive to environment as well as very colicky, vomiting and bowel problems within 2 weeks of vaccines. Diagnosed by many 12/02 through 3/03 as severely autistic. Was completely normal before shots. Also cannot eat wheat or dairy products.  Nurse follow up on 07/19/04 states: "None."    Per annual follow up report, Many allergies, severly delayed, communication and socialization. Is receiving Chelation, positive for mercury and other heavy metals. Many dietary issues.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015 11:05, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.1 and 2.0 respectively. This is one of the several reports from the same reporter. Additional information has been requested.
I feel weak. Is this from the shot; This case was reported by a consumer via interactive digital media and described the occurrence of feelings of weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feelings of weakness. On an unknown date, the outcome of the feelings of weakness was unknown.   It was unknown if the reporter considered the feelings of weakness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-OCT-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient feels weak and asked was this from the Shingles shot. Additional Supportive Information: The follow up would not possible as no contact details were available.
This spontaneous report was received from a medical assistant refers to a 38 year old male patient. On 20-JUN-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23, (lot # 672074/1502AA, expiry date 19-MAY-2013, route was not reported). Concomitant medications were not reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID, start date: 01Apr2005. Past drug history included: Allergic to clindamycin, reaction(s): "Allergy"; Allergic to tetracycline, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 20Feb2023 to 24Feb2023. Clinical course: the patient was taking other medication within 2 weeks of starting COVID-19 treatment. After taking Paxlovid, she experienced symptoms of a sore throat and a runny nose, and subsequently tested positive again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Redness and swelling of left thigh at PENTACEL site approx. 5 hrs after vaccination - resolved after TYLENOL.
One dose of postmenopausal bleeding That required further evaluation bleeding happened within days after 2nd moderna covid vaccine  Moderna SARS-COVID-2 Vaccination, 4/9/2021 (60 y.o.), 5/7/2021 (60 y.o.), 8/30/2021 (61 y.o.). Fluad Quad (high Dose 65+), 9/13/2021 (61 y.o).
Acute hypoxic respiratory failure secondary to acute on chronic diastolic - Patient was subsequently admitted and diuresed with IV Lasix.  Her sodium did improve to 129 on day of discharge.  She was back on room air.  She did require oxygen at night.  Patient reports she has oxygen at home. In regards to her bronchitis she was treated with oral prednisone.  Urine retention did resolve. And day of discharge, patient again reported feeling well.  Therapies were recommending home without services. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
After an outbreak of COVID at my daughter's summer camp, both her (5 yrs old - unvaccinated) and myself contracted COVID. This was on 8/17/21. I was ill for about 7 days and was unable to work for many of those days due to being sick. I definitely had more symptoms and more severity than my daughter did who is unvaccinated due to her age. We remained in quarantine for 10 days.
cried 1-2hr p/vax;no fever;cried again for 1hr slept 1/2hr then cried again for 1/2hr;no pallor;no sz;eating less;next day 20FEB98 had severe prolonged periods of crying & eating less;
This client's mother called and state that she noted a rash approx. a quarter size around the vaccine area. Child is not having any problems. The area noted in left increase leg.
Large purple bruise on right shoulder, red & swollen at injection site open wound at injection site size of a dime.  Cleaned injection site  covered with neosporin and bandaid.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in approximately 2014 (also reported as since May 2014), an unspecified number of patients were administered VAQTA (dose, route of administration, lot # and expiration date were not provided) that fell to temperature of 33F. This excursion was supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Vomited on the way home and then had a seizure. Called 911. Taken to the ER and admitted to hospital.  7/6/07 Received vax record which confirms RO lot & dose #.  7/24/07 Received hosp med records from inpatient stay overnight 6/8-06/9/07 after patient experienced seizures on day of vax.  Patient spit up, choked, eyes rolled back, slumped over & then looked dazed for a while.  Additional episodes witnessed by EMS & hospital personnel.  Afebrile.  Neuro consult done.  Tx w/IV antibiotics prophylactically x2.  Seizure w/u was to continue as outpatient. FINAL DX: none provided, neuro consult suggests new onset seizures. 8/10/07 Received ER hospital records which reveal patient experienced sudden onset of limpness, eyes rolling back, possible seizure vs aspirations w/GERD.  Noted to have post ictal period & spastic UE movements.  Tx w/IV antibiotics & transferred to higher level of care for available peds neurologist. FINAL DX: possible new onset seizures vs aspirations w/GERD.
Pt. describes an indentation in upper deltoid. Felt indentation approximately one inch in diameter. She also experienced radiating pain down arm & tingling for about 30 days post vaccination.
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender (also reported as who were a couple). On an unknown date reporter was informed about two patients were vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). On an unknown date the patients experienced shingles. The outcome of shingles was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Hives about 3 hrs after vaccine. Treated with oral antihistamine with resolution.
swelling in her left leg below the knee; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in her left leg below the knee) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (swelling in her left leg below the knee). At the time of the report, PERIPHERAL SWELLING (swelling in her left leg below the knee) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had X-Ray- No results were provided.  No concomitant medications information was reported. No treatment medications were provided.  For the event swelling in left leg, patient was prompted to seek medical attention at the local hospital.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received contains no new information.
Patient was administered full vial of vaccine without the vial being reconstituted. No adverse reaction at this time.  MD monitoring.
27 y/o AD WM calls clinic on 17SEP09 concerned about "red, warm, tender area on my right upper arm "under my smallpox vaccination scar."  There is no documentation of patients primary SPV date in DEERS or MEDPROS, but historically, the patient states he received his primary SPV just before he deployed over seas in JAN of 2008, the same day he got his AVA #1 (09JAN08) per DEERS.  He has a scar on his right upper arm, which is now covered by an extensive, elaborate tattoo, which the patient has placed, in stages, over the past 6 weeks (deltoid of RUE).  The patient reports a normal 2-3 week evolution of his primary SPV from papule to pustule to a scab, which dried and fell off without complications in JAN 2008.  Thus, it appears that the current area of erythema, edema, and pus on his RUE represents a new infection, secondary to the patients recent tattoo placement on his RUE and is NOT in temporal association with the placement of his primary SPV in JAN of 2008.  The patient was seen at the clinic on 17 Sept 09 by NP and Dr., who agreed with assessment.  The patient was treated with KEFLEX 250 mg po qid x 10 days and given 800 mg ibuprofen tid po WF #30 prn pain.  He was instructed to apply warm compresses 2-3 times a day over the affected area and to F/U with his PCP at clinic the next morning for TD booster, as his last TD was given on 12JUN2001.  The patient did as instructed and saw seen by PA-c on SEP 18 09 at clinic and was given a TDAP and instructed to continue the compresses and KEFLEX.  The PA-C who saw the patient felt that an I&D of the area was not necessary, as the patient reported that it ruptured spontaneously that evening before after applying the warm compress.  NP f/u with patient by phone on 18 SE) 09 and he was doing better, applying the warm compresses and taking the KEFLEX.  By second f/u call on 22SEP09, the SM reported that the area was no longer red or warm, but that he could feel a bump, perhaps from scar tissue.  SM was in another state at the time.  Advised to f/u prn at clinic.
8 days later the pain came back in my left arm and todsy, 10 days later the injection site amd upper arm it feels very hot and is red about 6 inches around site. A little itching snd burning and tender.
Swelling of armpits esp on left side. Swelling and pain up left side of neck and lymph nodes at base of neck on left side, looked like a pillow.
This spontaneous report as received from a pharmacist via field representative refers to 3 or 4 patients of unknown demographics. On unknown date in October 2013, 3 or 4 patients were vaccinated with PNEUMOVAX23 vial (dosage, lot and expiry date were not reported) for vaccine. The reporter's partner had seen 3 or 4 patients with injections site reactions (onset date approximately October 2013). Some patients sought medical attention-called the pharmacist. The outcome of event was not reported. This is 3 of 3 reports received from the same reported. Additional information has been requested.
Patient with significant swelling at vaccine site x 3 days after injection.  Developed fever 18 days after injection along with oral lesions suspicious for HSV gingivostomatitis.  Reportedly exposed to HSV several times in past without infection.  Concern for primary infection after vaccine.
1 1/2 weeks ago had flu shot, when shot given-no pain.  Within a few hours swelled up and sore.  Still sore - hardened size of 1 1/2" circle. 1:50 p.m.
Pruritic rash with signs of early anaphylaxis. Symptoms occurred 5 hours after vaccine administered.
3 days post vacc, pt cam in and presents a large elevated rash of about 3" in diameter on back.  1" diameter rash center of back.  Pt stated it started hours later than shots and also pain under ribs. Pain now in ribs.
I developed a red mark at the site of injection by the next day. Over the course of 7 days it quadrupled in size, became swollen, red, warm, itchy and painful with pressure. By day 11 it was beginning to consume my upper arm and I contacted my PCP.  He filled a prescription for a steroid (Methylprednisolone 4mg) and day two of taking steroids swelling and itchiness had gone down.
On the noc following vax pt began running a fever up to 104 then the early morning hrs had a sz described by mom as more violent than a/; controlled on Tegretol last year;
She has been experiencing extreme fatigue; She has been sleeping non-stop; gets up to eat barely; she has been in bed; body aches on bright side of the body/aches on entire right side of her body; This is a spontaneous report from a contactable consumer.  A 76-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection) via unknown route of administration at left arm on 28May2021 at 14:00 (lot number: EM9809) (age at vaccination 76-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history heart disorder, blood pressure abnormal, mental disorder, vitamin supplementation and colitis. The patient concomitant medications included aspirin, bentyl, atenolol, atorvastatin, escitalopram and vitamin D. The patient did not had prior vaccinations (within 4 weeks). The patient had no medical history including any illness at time of vaccination. The family medical history and relevant test were reported as none. The patient experienced aches on entire right side of the body and has been in bed on 01Feb2021, got the first dose of the COVID 19 vaccine Sunday 31Jan2021/next dose of the vaccine is scheduled for 28Feb2021, experienced extreme fatigue, sleeping non-stop and gets up to eat barely. The patient did not required a visit to physician or ER for AE(s). The outcome of the event aches on entire right side of her body, has been in bed was not recovered and the outcome of the other events was unknown.  Follow-up attempts completed. No further information expected.
Bell's palsey. To be treated with prednisone valacyclovir Referred to neurology
Redness and swelling to injection site (left arm) measuring 3 1/2 inches by 2 1/4 inches. Rash and discharge was also noticed on the injection site. Measurement became larger ( 4 1/2 " X 3 1/2 " ) on 30 Jan 2014.
received first dose at 17 years old; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at 17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Disabled child.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at 17 years old) outcome was unknown. Not Provided      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.   Concomitant medications were not provided.  Treatment medications were not provided.
Moderna COVID-19 Vaccine EUA  Left posterior triangle lymphadenopathy, enlarged right submandibular and left submental lymph nodes.  Localized swelling,mass and lump, neck. Palpable lumb in neck. Tender to the touch
Pt developed a rash (little pink bumps) on cheeks, arms and legs for about a week. This could have also been a reaction from amoxicillin which pt was taking at the time.