chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; throat is swollen; feels achy; tired; sleeping a lot; His chest feels restricted while breathing; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired) and HYPERSOMNIA (sleeping a lot) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired), HYPERSOMNIA (sleeping a lot) and CHEST DISCOMFORT (His chest feels restricted while breathing). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved and PHARYNGEAL SWELLING (throat is swollen), PAIN (feels achy), FATIGUE (tired), HYPERSOMNIA (sleeping a lot) and CHEST DISCOMFORT (His chest feels restricted while breathing) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Contact has received 3 prior doses of the Moderna COVID-19 vaccines without any symptoms. He received his most recent Moderna COVID-19 vaccine on 25 OCT 2023. On 11 NOV 2023 he started feeling flu like symptoms, throat swollen, feels achy, tired, and sleeping a lot. His chest feels restricted while breathing. Went on to my provider website which said that symptoms may be related to the COVID-19 vaccines for 3 weeks after receipt of the vaccines. Has taken there flu once a day for the past couple of days. Got a shingles shot the same day. 2 weeks prior got a flu vaccine.  Company Comment: This is a spontaneous case concerning 71-year-old male patient with no reported medical history, who experienced the non-serious unexpected, AESI event of hypersomnia, together with other non-serious events, which occurred approximately 15 days after a dose mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, received as the fourth dose of COVID-19 vaccination schedule. It was reported that patient got a shingles shot the same day, and that 2 weeks prior he got a flu vaccine. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
maybe miscarriage; 2 months after my second vaccine shot - 17 days late period; after delay whole month heavier flows with big clots; This is a spontaneous report from a contactable consumer (patient).     A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), via an unspecified route of administration in Arm Left on 10Apr2021 at 15:00 (at 40 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  No known allergies. Not pregnant at vaccination time. Previously on 20Mar2021 at 15:00 patient received first dose of bnt162b2 (BNT162B2; Lot Number: EP7534, at 40 years), in Arm Left for covid-19 immunisation.On 19Jun2021, 2 months after the second vaccine shot, she had 17 days late period, which was unusual, maybe miscarriage, and after delay whole month heavier flows with big clots. Events caused doctor or other healthcare professional office/clinic visit. Ultrasound was done on an unspecified date in 2021, no result reported. Treatment included birth control pills (as reported). Outcome of the events was not recovered
Client called on 07-12-2010 to report a Tdap vaccine reaction. Client received Tdap on 7-7-2010 on left deltoid. Left arm started with pain and swelling the next day in the evening. Swelling continued and went under her left arm, neck, leg and ankle. Client was taking Benadryl and Ibuprofen. Client did not go to doctor. Client was referred to go to Clinic and told her also to come into our office. Client did not come in our office. Client called back and said unable to be seen today at Clinic. Client was recommended to come to our office but never came in. A follow up call was made (voice mail left) to come into our office or go to ER/ED if symptoms continued or worsen. Client denied any breathing problems at all.
Has a low grade to mid grade fever up to 101.6 and generalized rash raised to chest & back. Irritability & malaise also.
Day 1: Hot flashes in head. Day 2: Mild itchiness around left arm. Day 3-5: Itchiness more frequent around upper body. Day 6-14: Constant itchiness throughout body/eyes. Day 14 to present: Minor fatigue. Doctor visit 12/9/2021. I was prescribed loratadine and prednisone.
A week after receiving second dose of pfizer vaccine I started to feel muscle twitching and arm weakness in mainly my right arm, some weakness in my left arm and occasionally twitching in left arm and both legs. The right arm is mainly where I feel the muscle twitching. Not able to see the twitching but I can feel it. Worse when resting and lying down or sitting doing  nothing.  Weakness in arm is all day.
Patient with left upper extremity pain and tenderness. Materna Covid vaccine given initially in April and then second dose was on May 22.  After first dose she noted left upper back and neck pain in the early mornings which would resolve throughout the day.  This continued until the second shot.  After the second shot she had a fever and chills for 1 day.  She was doing okay after the second shot up until a little over 2 weeks later last week on May 8 where she developed significant pain in her left upper extremity she went to Medical Center.  At the time there was no redness apparently and it did not appear to be cellulitis.  They felt it was a muscle strain and they gave her muscle relaxants and steroids.  She had minimal if any improvement with that.  The area started become red 3 days ago and therefore she presented here.  She has not had fevers recently.  Appetite has been poor since May 8 when pain started.
5 days following 2nd dose, patient developed nausea, headache, body aches (especially from hips down), malaise, shaking, slurred speech, difficulty walking secondary to shaking.
Local site reaction - red wheal surrounding injection site with firm, tender center. Resolved after 7 days without treatment.
A pain/soreness started in my right arm while sitting in a work meeting. Over the course of the day, the pain spread in my arm eventually extending from my shoulder to my finger tips.   The sensation continues to this day. Its primarily a constant numbness or tingling in my fingers
High fever and rash 8-10 days after administration of Varivax and MMR.
FINE RED RASH AT BOTH WRISTS, NECK- FEELS LIKE LITTLE STINGS"  REDDENED AREA BELOW SITE OF INJECTION ON LEFT DELTOID
Pt stated he was nervous about drs office/vaccines.  Shortly after (1 or 2 mins) patient got shot he got warm around the face and said he felt slightly dizzy.  So we laid him on his back and elevated his feet.  We put cold compress around his neck.  This only lasted about 5-10 mins.  Called pt couple hours later with no concerns.
mild fever of 100 degrees F.; headache; severe body aches and loss of energy;
Discharge Physician: MPH Primary Care Physician: MD  Date of Admission: 9/22/2022 Discharge Date: 9/24/2022  PRESENTING PROBLEM: Near syncope [R55] Acute kidney injury (HCC) [N17.9] Nausea vomiting and diarrhea [R11.2, R19.7] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 73-year-old male who presented for evaluation of nausea, vomiting, diarrhea and near syncope. In the ER the patient was found to be COVID positive. He was hypotensive and found to have AKI. CXR showed bilateral perihilar airspace opacities. The patient was hypoxic on room air requiring supplemental oxygen. The hospitalist team was contacted for admission and further management. The patient was started on IVF and decadron. His renal function improved with fluids and his nausea, vomiting and diarrhea resolved. He was weaned off of supplemental oxygen. PT/OT advised no additional needs identified. Electrolytes were monitored and repleted throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days.  He will complete 2 additional days of dexamethasone then return to home prednisone dose. Patient voiced understanding was agreeable with plan of care discharge.
The patient was found collapsed in her home. Did not have any muscle function, but could talk and respond. Went to the emergency room and had lab work and X-rays done. Nothing was found to be wrong. Muscle function returned about an hour later so patient was discharged home.
Patient reports that since her vaccination last Wednesday woke up at 2 am on Thursday am with HA and fatigue began running fever, then Friday another HA, fever and fatigue, along with the HA, fever and fatigue, rash began on arms Saturday, Sunday the rash blistered, then Monday am called clinic for appt. And noticed lymph node swollen on side where she received vaccination on. The highest temperature was 101.0 which reduced with tylenol or motrin.
DOES NOT SEEM LIKE HIMSELF; VOMITING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced does not seem like himself. On SEP-2021, the patient experienced vomiting. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vomiting, and does not seem like himself. This report was non-serious.
Loss of balance, double vision, dizziness, nausea, abnormally high blood platelet count.  3/12/09 Received ER medical records of 11/28/2008. FINAL DX: migraine HA; dizziness Records reveal patient experienced dizziness & blurred vision right eye, nausea x 3 days.  Seen by neuro, dx w/migraine & scheduled for ophtho eval all as outpatient.  PCP requested CT scan.  Remained stable in ER & d/c to home w/PCP & neuro f/u.    4/16/09 Received vaccine & PCP medical records of 6/21/07-3/12/09. FINAL DX:  likely TIA due to thrombocytosis Records reveal patient experienced good general health on 9/19/07 for HPV #1 & tol well.  RTC 11/20 only for HPV #2.  RTC 12/11/08 for Heme consult & dx w/thrombocytosis & on baby ASA; had lump left arm x 1 mo.  RTC 12/30 w/ double vision.  Neuro consult done 1/8/09 reveals pt w/dizziness & double vision & seen in ER.  Previous optometry exam revealed stroke/clot right eye.  Now w/double vision intermittently.  Tx w/meds.  RTC 3/12/09 meds changed.  RTC 3/19/09 states 2 days s/p HPV#2, lost balance, lost vision right eye x 3 days & nauseated.  6/16/09 Received Neuro-Ophtho medical records of 6/4/09. FINAL DX: episode of sudden vision loss on 11/23/08; episodic diplopial blurriness; ataxia & imbalance; episodic numbness, tinnitus; daily migraines; r/o vertebral/basilar insufficiency; questionable right 4th nerve palsy.  6/17//09 Medical and neurology records received DOS 9/29/03 to 4/23/09. Assessment: Dizziness, migraine, diplopia. Patient c/o dizziness, migraine, diplopia, lightheaded, headache.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority. The reporter is the patient. A 63-year-old male patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "soreness right where the shot was in the arm". Additional information: Patient stated that he was scheduled for his second dose on 03Apr2021; however, he was also scheduled on 18Mar2021 to have dental work done (had a dental appointment) and believed they may prescribe an antibiotic for him to take beforehand, although he's not certain if they really will or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was to receive the HPV vaccine but the provider gave them the TDAP vaccine.  When the error was identified, they also received the HPV vaccine during the visit.
PATIENT RECEIVED FLU VACCINE AT DR OFFICE EARLIER IN THE DAY. CAME IN FOR COVID BOOSTER AND FLUZONE HD WAS ADMINISTERED BY MISTAKE.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age an gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles (date unspecified). On an unknown date in 2015, the patient was treated by the same physician for a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 57 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Prev dose product: COVID-19, Prev dose lot unknown: True, prev dose brand name unknown: COVID19 Vaccine, Prev dose dose number: 1), for COVID-19 Immunization; Covid19 vaccine (Prev dose product: COVID-19, Prev dose lot unknown: True, prev dose brand name unknown: COVID19 Vaccine, Prev dose dose number: 2), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Tongue swelling. Tongue and lip tingling. Off and on from 10 minutes after the shot for four days.  Nine days after the shot, an egg sized red lump, hit to the touch, at the site of injection and a return of the tongue tingling.
post herpetic neuralgia; Herpes Zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided) for routine health maintenance and the prevention of shingles. On an unknown date, the patient suffered a painful rash. As a result of these symptoms, he presented to a medical provider and was diagnosed with herpes zoster and postherpetic neuralgia. Thereafter, the patient continued to suffer the effects of herpes zoster and post herpetic neuralgia. As a result, he suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms and diagnoses resulted in physical limitations not present prior to using the vaccine. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt suffered severe and permanent personal injuries. Further, 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.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The events were considered to be disabling.
Symptoms began with mod to severe coughing, sneezing, feeling of throat closing, mucous from eyes, nasal congestion; then later, mild fever, body aches, chills.   Feeling of throat closing never amounted to much. Symptoms lasted thru the night.
Red, swollen, hot to the touch, painful, itchy NP prescribed antibiotics, antihistamines, and ibuprofen
Woke up the following morning with terrible body aches, especially to upper back, neck, lower back and legs. Headache, diarrhea, and tiredness. Was unable to "function", and slept most of the day. Was still having some of those symptoms the second day, but not as bad.
Redness around the injection site; very sore; Also itchy; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness around the injection site, spot of 2inches wide and 6 inches long,, really red, very sore, also itchy.  The patient's medical history was not provided. Concomitant medications reported were clonazepam 0.5 mg, ezetimibe 10mg, paroxetine 20mg, migraine Medication 25mg 6times a day, vitamins for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event(s) redness around the injection site, spot of 2inches wide and 6 inches long,, really red, very sore, also itchy.  Treatment details included none  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), redness around the injection site, spot of 2inches wide and 6 inches long, really red, very sore, also itchy was unknown.
I had a slight headache, general malaise, body aches and pains, fever of 101F. I. used a home COVID-19 test that came back positive. I called the doctor to discuss my symptoms and positive result. I decided against taking the antiviral after hearing all the side effects, she advised me to take Motrin as needed. In three days I was feeling better. I stayed in quarantine for the five days.
This spontaneous report as received from a pharmacist via Company Representative refers to a 75 year old female patient. Medical history and concurrent conditions were not reported. On either 17-MAY-2014 or 18-MAY-2014, the patient was vaccinated with ZOSTAVAX Lot # J014566; expiration date 18-FEB-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. On an unspecified date after this 9approximately in May 2014), the patient experienced "a 2-3 inches in diameter area at the injection site, that was red, itchy, painful, swollen, and warm". The patient was given an unspecified antihistamine (manufacturer unspecified). The present status of the patient was unspecified. The present status of the patient was unspecified. No lab diagnostics studies were performed. It was reported that patient sought medical attention calling the pharmacist. This is one of two reports received form the same reporter (MARRS# 1405USA011320). Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. Since 12-AUG-2014, improperly stored ROTATEQ oral liquid, was administered to an unknown number of patients (dose, dose number, dose schedule, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. The outcome if the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. presented with rash, redness, swelling and induration in left deltoid area (area of vaccination). Vaccine PSV23 and flu shot given 3 days ago. Given cephalexin.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 13Mar2021 as dose 2, single (Lot number: EN6199), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Apr2022 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL, start date: 01Oct2020. Past drug history included: Relafen, reaction(s): "Known allergies: Relafen".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sore arm for 14 days, joint pain in shoulder for 3 weeks, rash starting 48 hours after injection.  Rash is continuing to spread down both legs,  from top of thigh to knees, inside and outside of legs.  rash on neck and arms.  I am so concerned about the rash that I saw a dermatologist and she said this is a known problem with Moderna