chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red, large raised rash, tight and swollen arm with pain; red, large raised rash, tight and swollen arm with pain; Raised red warm and painful rash; Developed a rash that got bigger and now covering the whole elbow; soreness at injection site; injection site was red; shoulder was hurting; swollen arm from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (red, large raised rash, tight and swollen arm with pain), PAIN IN EXTREMITY (red, large raised rash, tight and swollen arm with pain), RASH ERYTHEMATOUS (Raised red warm and painful rash), RASH (Developed a rash that got bigger and now covering the whole elbow) and VACCINATION SITE PAIN (soreness at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo on 02-Jun-2010, Oscillopsia on 02-Jun-2010 and Migraine on 12-Aug-2008. Concomitant products included MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) from 02-Jun-2010 to an unknown date and VITAMINS NOS for an unknown indication, PROMETHAZINE from 02-Oct-2014 to an unknown date and SUMATRIPTAN from 02-Oct-2014 to an unknown date.    On 18-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). 28-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site was red), ARTHRALGIA (shoulder was hurting) and VACCINATION SITE SWELLING (swollen arm from shoulder to elbow). On 29-Mar-2021, the patient experienced PERIPHERAL SWELLING (red, large raised rash, tight and swollen arm with pain), PAIN IN EXTREMITY (red, large raised rash, tight and swollen arm with pain) and RASH ERYTHEMATOUS (Raised red warm and painful rash). 29-Mar-2021, the patient experienced RASH (Developed a rash that got bigger and now covering the whole elbow). The patient was treated with CEFADROXIL for Rash, at an unspecified dose and frequency. On 15-Apr-2021, PERIPHERAL SWELLING (red, large raised rash, tight and swollen arm with pain), PAIN IN EXTREMITY (red, large raised rash, tight and swollen arm with pain) and RASH ERYTHEMATOUS (Raised red warm and painful rash) had resolved. At the time of the report, RASH (Developed a rash that got bigger and now covering the whole elbow), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE SWELLING (swollen arm from shoulder to elbow) had resolved and ARTHRALGIA (shoulder was hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-120732 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient demographics updated, medical history updated,  concomitant medicines included, 2nd dose details, additional events reported and outcome of the events updated.
Spinal pain, soreness and pain at injection site, tiredness, and asthma attack.
Patient's left arm was red, swollen, and warm to the touch from the shoulder down to his elbow. Arm was very painful and difficult to lift. Did get better on its own after several days.
Fever and chills all day on day after shot was given. Slight arm soreness.  Fatigue all day Day 3-6 after shot was given woke up with headache.
After 3 to 4  minutes of vaccinations & blood test. Patient felt dizzy got seizure like convulsions lasted app 2 minutes.
Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & neck, severe back ache low temp 99-100.3 Day 3: @ 0300 fever 101.5, chills (rigors 3hrs), very bad headache, neck pain, joints and lymph swelling.  Had both regular and Rapid covid test and rapid was negative.  Awaiting FLU swab and regular Covid test. Day 4: continued fevers 99-100.9, back and neck pain, milder headache.
esophagus and trachea closed; experienced some heavy breathing; some pins and needles sensation around her outer thigh, hip bone, liver, and abdomen; arm felt like someone took a brick and kept pounding it; arm had hardness; the area was hot, hard, and heated; couldn't swallow saliva; Couldn't raise arm over shoulder; tongue felt like it was numb; Couldn't walk or stand up straight; A spontaneous report was received from a healthcare professional (HCP) concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced esophagus and trachea closing/tracheal inflammation, heavy breathing/dyspnea, pins and needle sensation around her outer thigh, hip bone, liver and abdomen/paraesthesia, arm felt like someone took a brick and kept pounding it/limb discomfort, arm had hardness/injection site induration, area was hot and heated/injection site warmth, couldn't swallow saliva/dysphagia, couldn't raise arm over shoulder/injection site movement impairment, tongue felt like it was numb/hypoaesthesia oral, and couldn't walk or stand up straight/gait inability.  The patient's medical history was not provided.  Concomitant medication history was not provided.  On 03 FEB 2021, one day prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot number: 043L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 04 FEB 2021, the patient experienced her esophagus and trachea closing.  She had some heavy breathing along with pins and needle sensation around her outer thigh, hip bone, liver and abdomen.  She stated that her arm felt like someone took a brick and kept pounding it.  Her arm had hardness and she couldn't raise it over her shoulder.  The area of her arm was hot, hard and heated.  The patient couldn't swallow her saliva, couldn't walk or stand up straight and her tongue felt like it was numb and stretched out.  An ambulance was called, and she was taken to the hospital.  She stated that she had never had such a reaction to a vaccine before.  She stated that since the event, her memory has been affected.  Treatments of these events included saline solution, a medication for relaxing and pain, and oxygen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, esophagus and trachea closing/tracheal inflammation, heavy breathing/dyspnea, pins and needles sensation around her outer thigh, hip bone, liver and abdomen/paraesthesia, arm felt like someone took a brick and kept pounding it/limb discomfort, arm had hardness/injection site induration, area was hot, and heated/injection site warmth, couldn't swallow saliva/dysphagia, couldn't raise arm over shoulder/injection site movement impairment, tongue felt like it was numb/hypoaesthesia oral, and couldn't walk or stand up straight/gait inability were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: did not pass out
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: itching, rash and bumps developing on lower extremity of left arm - not on the injection site. 1 bump started forming monday evening and then a 2nd bump formed tuesday morning
After four days of flu-like symptoms which began on evening of second Pfizer vaccine experienced hearing loss and tinnitus. DIAGNOSIS:  SUDDEN RIGHT-SIDED HEARING LOSS AND TINNITUS (ICD-H91.20 AND ICD-H93.11) TREATMENTS:  Primary Care Doctor, Dr., 3/4/21, Prescribed ZPAC and if no improvement see ENT No Improvement ENT Appointment, Dr., 3/18/21, Prescribed High Dose Prednisone beginning with 60 mg for five days and titration after from 3/18/21 to 4/8/21.  Also conducted audiological evaluation which indicated moderate to severe Sensorineural Hearing Loss (SNHL) in right ear. Ordered MRI with contrast. ENT Appointments, Dr., 3/25,/21, 4/6/21 and 5/10/21. SECOND OPINION ENT, Dr. who conducted audiologic evaulation and performed prednisone injection into right ear, 5/12/21. Followup ENT appiointment with Dr. on 6/9/21 in which he referred me to an Otolarynologists, Dr. at facility in another area. OTOLARYNOLOGIST APPOINTMENT, Met with Dr., 7/6/21 for evaluation.  He indicated that hearing loss and tinnitus are permanent and suggested I move forward with trying hearing aids, two types, which he indicated would not work.  He said the only solution that would restore my hearing and eliminate the tinnitus is a cochlear implant.  In order to be considered a candidate it is necessary to try the hearing aid route first.   ENT APPOINTMENT with Dr. and Audiologist is scheduled for 7/29/21 to explore hearing aid options and path forward.
DIES; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 13 years old and unknown gender patient who dies while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event dies (death) (unknown latency) following the administration of Influenza Vaccine.   It was reported that it's happening everywhere, and is not normal. 13 year old dies during practice  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event Outcome : At time of reporting, the outcome was Fatal for the event dies. It is unknown if an autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) dies..; Sender's Comments: Sanofi company comment dated 04-Feb-2022. This case involves a 13 years old and unknown gender patient who dies while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.; Reported Cause(s) of Death: DIES
tingling and numbing of hands and legs. Weakness of muscles, numbing of back and butt.  Difficulties to hold even a cup of tea. While laying down numbing is worse.
Initial report received from a physician on 02/Mar/2006.  A 60-year-old female patient with a history of drug allergies developed local injection site itching followed by a pinkish rash, warmth and "indurated (well demarcated)" area 5 x 8cm seven days following the injection of DECAVAC, lot number U1620AA in the right deltoid on 22/Feb/2006.  Per reporter there was no nodule present.  A one inch needle was used to administer DECAVAC.  The patient had no illness at the time of vaccination.  She was seen by a physician on 02/Mar/2006.  Her last Td booster is unknown.  It was reported she had the same local reaction following the flu vaccine in 1996.
Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacture), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal; Electrocardiogram: Unknown result; Imaging procedure: Unknown result; Magnetic resonance imaging heart: unknown results.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient;
felt dizzy; hip pain/extreme muscular and joint pain; nauseat; pale; Insomnia; extremely thirsty but not wanting water; extreme muscular and joint pain; This is a spontaneous report from a contactable nurse (patient) reported that a 32-year-old female patient (non-pregnant) received BNT162B2 (COVID 19, brand: Pfizer, lot unknown reason was Unable to locate or read the details) via an unspecified route of administration on 09Feb2021 at 13:15 on Right arm for Covid-19 immunization. Patient medical history was not reported. The patient received other unknown vaccines within 4 weeks prior to the COVID vaccine on 19Jan2021 on Left arm. Concomitant medications were not reported. Patient previously had allergies to medications, food, or other products: Tramadol. Covid test post vaccination (covid test type post vaccination was Nasal Swab). Covid test name post vaccination was Aeon, covid test date was 04Feb2021 and Covid test result was negative. The most recent COVID-19 vaccine was administered in Nursing Home/Senior Living Facility. It was reported that, on 09Feb2021 at 14:30, after injection 1 hour she felt dizzy and had hip pain, nauseat and pale. Insomnia, extreme muscular and joint pain. On a scale of 1-10, with 10 being the worst that evening after injection 2, that night while trying to sleep. Around 13.5 hours after injection the pain was about a 5 more uncomfortable then anything. 23 hours from injection pain at a 10. Mpap helpful with headache Advil effective for all pain to make it tolerable, cyclobenzaprine slightly effective. Have no eaten since last night, extremely thirsty but not wanting water on 09Feb2021 at 14:30. No seriousness criteria was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with Test Aeon. Outcome of events was unknown.  Information on the lot/batch number has been requested.
On 30Mar-2021 received a tetanus shot due to a dog bite; This spontaneous case was reported by an other health care professional and describes the occurrence of ANIMAL BITE (On 30Mar-2021 received a tetanus shot due to a dog bite) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ANIMAL BITE (On 30Mar-2021 received a tetanus shot due to a dog bite). At the time of the report, ANIMAL BITE (On 30Mar-2021 received a tetanus shot due to a dog bite) 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 product use was not provided by the reporter.
A report has been received from a Physician concerning an adult, female subject, who had been receiving FLUMIST Quadrivalent (intranasal). Started during SEP-2014. The patient experienced MD and children received FLUMIST Quadrivalent and they all tested positive for influenza which started during NOV-2014. The patient recovered from the event of MD and CHILDREN received FLUMIST Quadrivalent and they all tested positive for influenza on an unspecified date. The report was considered to be non-serious.
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. Medical history and current conditions not reported. On an unknown date the patient was inadvertently vaccinated with 1 ml (overdose) of VAQTA dose 2 (reported as a booster dose), intramuscular (strength, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Pt recv vax on 1/11/96; on 4/1/99 pt exp chicken pox
Nasty oniony/garlicky/metallic taste in the back of the throat that slowly developed between my 1st and 2nd COVID-19 shots in March. Everything except coffee and whiskey now smells like this, including my own body odor, but my wife and daughter (who also got COVID with me in mid-December 2020) don't smell it.  It is now August with no improvement. I have reported this to my doctor Dr. but she says all I can do is wait.
fever of 102; feeling unwell; This is a spontaneous report received from a non-contactable consumer via Pfizer Colleague. This consumer reported for a male patient (boyfriend) that.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of vaccine BNT162B2 (formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. During a group discussion, an acquaintance mentioned that after receiving the 2nd injection of Pfizer BioNTech COVID-19 vaccine, her boyfriend (Name) had a fever of 102 for a number of hours and was feeling unwell during that time. Once the fever was gone, (Name) felt fine again. The patient experienced fever of 102 and feeling unwell both on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 102 on unspecified date. The clinical outcome of the events was unknown.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Within 10 min. of vaccines pt. had cough, sneezing. Tongue and mouth pain. Doctor found periorbital edema with wheals, no swelling of lip or tongue no wheezing. 25 mg BENADRYL given; then pt. had dyspnea with cough and stridor. .5mg Epinephrine sq. EMS transport to ER. 3/20/09-records received for DOS 3/17-3/18/09-DC DX: anaphylaxis following vaccines. Shortly after receiving vaccines developed anaphylactic reaction with hives and difficulty breathing. Angioedema. Obsrved overnight.
On day 2 I developed rash over entire body. Today is day 4, rash has worsened.
"Covid arm" - itchy, red, swollen rash near injection site, 3-4 inches in diameter
Initial report received on 17 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3784AA on 11 April 2011, lot number C3802AA on 09 June 2011, and lot number C3930AA on 10 August 2011, and one dose of TRIPEDIA; lot number U3749AA received on 09 May 2012 (routes and sites of administration not reported). The subject developed a paroxysmal cough on 01 August 2012, approximately 3 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 20 August 2012. Chest x-ray was negative for pneumonia. Corrective treatment consisted of azithromycin starting on 20 August 2012 for an unknown duration. At the time of final contact on 04 October 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient is a 85 y.o. male who presented to the  ER on 8/5/2021 complaining of dizziness, dysarthria, double vision and lower extremity weakness. Daughter states that symptoms started 2 days ago and he has just become progressively weaker. Patient currently not able to stand on his own when typically he is able to ambulate with a walker. Speech has become progressively "slower". Patient having difficulty with word finding. He denies any associated nausea, vomiting, dyspnea, chest or abdominal pain. He does have a history of arthritis and currently is having some joint pain. CT of the head was done showed no acute intracranial event. Patient was seen by teleneurology here and neurologist was concerned that patient may be developing Guillain-Barre syndrome. Patient  transferred to higher level of care for further care including the need for an LP and IVIG.  Patient received Pfizer COVID vaccine on 3/21/2021 (first dose) and second dose on 6/28/2021.  At the time of submission the patient is still hospitalized and on Day 4/5 of IVIG.
Left upper arm to mid lower arm swollen with scattered red bumps; decreased after 2 days to swelling of deltoid, red bumps only in deltoid area. Right upper arm with swelling deltoid without red bumps with no symptoms on Sunday (2 days). Mother applied warm compresses and cream for itchiness.
Pt complained of redness and soreness 8 hours after vaccine given. Next day went to health center to seek care- stated that there was a ring around the site, swollen to 3x3.5cm. NP RX for Keflex 500 QID x 7 days and advised to use cool compress for comfort and Tylenol PRN. By 8PM 04/27/05 site was better, recovering well.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/24/2021 DM 2 W UNSPECIFIED COMPLICATION  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/24/2021 HYPONATREMIA
I went to the recreation park for my first vaccination course. Within 5 minutes of getting the vaccine I started to feel bad. I started seeing cloudy, my pressure went down, I started with a lot of pain in my head. I felt that the body did not respond to me. The paramedics came and checked me out. They kept me under observation for a while until my heartbeat normalized and then I was able to go home. When I got home I started feeling dizzy and cold at night I had a fever. The next day I am short of breath and have a lot of pressure on my head. On the 3rd day the symptoms worsened and I went to see a doctor who gave me some medicine. Within a week I didn't feel any better so I went back to the doctor. It was when he did a blood test that my liver was inflamed and my lungs were inflamed and they gave me medicine. It almost took me 2 months to recover. Then I got attacks of depression and anxiety. I went to see a doctor but I didn't take the medicine myself, I got better. Today I still have sequela but I'm better.
Long COVID, dizziness, shortness of breath, chest pain Prior to vaccine able to run 5 miles/day; now unable to run more than 100-200 meters without shortness of breathe