chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient (older than 65 years old) who experienced rash around the injection site and a "hard lump"., rash around the injection site and a "hard lump"., my shoulder "hurt badly, when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been., cuff injury and upper arm for the pain, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Rubber sensitivity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT lot number, expiry date not reported. On an unknown date, post vaccination patient developed a non-serious rash around the injection site and a "hard lump", rash around the injection site and a "hard lump". (vaccination site induration), my shoulder "hurt badly (musculoskeletal discomfort), when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been. (vaccination site erythema), cuff injury (rotator cuff syndrome), upper arm for the pain. Lab data not reported. Final diagnosis was upper arm for the pain, cuff injury, when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been., my shoulder "hurt badly, rash around the injection site and a "hard lump". and rash around the injection site and a "hard lump". It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown for rash around the injection site and a "hard lump"., as Unknown for rash around the injection site and a "hard lump"., as Unknown for my shoulder "hurt badly, as Unknown for when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been., as Unknown for cuff injury and as Unknown for upper arm for the pain.
Redness, swelling, warmth, & pruritus at the site of injection. The area was larger the day after vaccine, than today, so improving w/o treatment. Recommended warm compress, cetirizine.
pt recvd Hep B vax in 1982 approx 23APR91 pt recvd 2nd dose; next day pt devel a visual disorder consistent w/retrobulbar optic neuritis; MRI showed T-2 densities consistent w/early multiple sclerosis;
Mom noted pt's leg that got the vaccine to be swollen from knee to groin the next evening. She wouldn't bear wt and was tender. It was not red or warm. Pt had trivalent flu vaccine 12/17/2012 and leg got swollen from site to top of thigh with mild rash. No tenderness or problem walking then. Dr. diagnosed local reaction at that time. This time another Dr. saw pt on 11/15/13. Mom states pt's swelling was slightly improved, not tender and pt was walking fine on 11/15/13. Dr. notes patient's thigh to be slightly swollen not tender and pt walking ok. Mom spoke with pt's allergist, who told mom that she did not think it was a local reaction, and patient would be ok to get in the future. Pt. got flu vaccines on 1/5/11, 2/7/11, 10/20/11, 12/17/12 and 11/13/13. She was diagnosed as egg allergic as an infant, by positive skin test per allergist. She was declared no longer egg allergic on 8/30/12 after passing a graded egg challenge per the allergist.
Sore arm after 6 hours of injection  Swollen, large welt where shot was injected (also warm to the touch) Fatigue Sore shoulders Unable to lift my arm past shoulder
On June 11, 2021,  I went blind in my right eye. On that date,  Dr said I had "central retinal artery occlusion."  He said the vision would not return.
Case number: PHEH2015US017649, is an initial spontaneous report received from a nurse on 09 SEP 2015. This report refers to a 48 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated wit FLUVIRIN (batch number: not reported) and was well tolerated. He was vaccinated with 0.5 ml of FLUVIRIN 2015/2016 (batch number: 157103) pre-filled syringe (PFS) intramuscularly into the left deltoid on 08 SEP 2015. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 SEP 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up report received from the nurse on 27 OCT 2015: updated patient demographics, vaccination history, vaccination details and other clinically relevant information.
Muscle pain, joint pain, fever, chills, shortness of breath, headache, fatigue, starting the morning after the vaccination that was provided around 4:30 in the afternoon, used Tylenol for the pain and fever. Better the next day but still not well. Missed work
The patient reported having a painful pinkish-red rash that looked like a line across her arm a few inches below the injection site.  She reported noticing this symptom the next day or a couple days after the vaccine.  The rash-like mark lasted for 1 and 1/2 weeks before it went away.
Headache, restless, mild fever, swelling, red spots on arm about an inch below injection site to the shoulder, discomfort.
Potential allergic reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of ALLERGY TO VACCINE (Potential allergic reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Potential allergic reaction). At the time of the report, ALLERGY TO VACCINE (Potential allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The treatment information were unknown.
fever w/temp 103 & rash on lt ant thigh & lt lower back;fever resolved p/3d, rash resolved spontaneously w/in 1wk;
2" diameter red circle below injection site While waiting the 15min, experienced itchy feeling. Itchy areas in legs and arms. Not all the time, usually at night. A area not designated to one limb or area at any one time. Some times I have to scratch so much that I am causing scratch marks on my skin, if not breaking the skin slightly. Hard, swollen injection site for approximately 48-96 hours, has since gone away. Reaction similar to annual flu vaccine. The itchiness/side effects are not usual for ANY vaccines I've received as an adult 18+yrs of age.  Below box area does not allow me to add:various OTC vitamins / multi vitamin Vaccine given by County Health Department.
15 hrs after injection severe body aches, chills, muscle and joint pain. Lasted 24 hrs.
covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It had been a while since reporter friend had Covid-19 and was still coughing and had congestion. The Reporter did not have any other information to report about friend. No dates of administration of the vaccine or other adverse reactions after each Moderna Covid-19 vaccine are known of at that time. No lot numbers of the vaccine are known of at that time. No treatment information was reported.
Initial report received on 18 November 2010 from a physician, who is also the patient. A 58-year-old female patient received an influenza vaccine in mid-October 2010 (exact date of vaccination, manufacturer, and lot number not reported). She had a history of well-controlled hypertension. On 04 November 2010, while outside, she reported that her eyes "felt heavy". Her husband, who was also a physician, noted that her eyelids were swollen and felt that she might be suffering from an allergy to grass. The following day the patient reported diplopia while driving, and was evaluated by an opthamologist. Visual acuity and fundoscopic exam were normal, and she was diagnosed with allergic conjunctivitis. She was seen by another opthamologist the next day, and was prescribed steroid drops. She consulted a neurologist, who thought that she might have cranial nerve involvement; however, an MRI was normal. At the time of the report, the symptoms had completely resolved. Additional documents held by sender: None.
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient.   A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization.   There were no known medical history or concomitant medications.  The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN).  Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product 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.
I started having a lot of sinus congestion and coughing that wasn't getting any better. After taking three COVID-19 that came back negative, my daughter insisted I go to the doctor, I called my primary care physician who wanted me to go to the clinic so they could listen to my chest. She said she heard congestion but not fluid in my lungs, she did prescribe amoxicillin to help clear up the infection. I do have some congestion in my nose but I am feeling better.
Patient developed hives on L forearm approximately 20 minutes after injection that progressed to face, B/L arms, neck, and chest. Patient was given 50mg oral benadryl. At approximately 30min post-injection, patient was transported to the emergency department. En route to the ED, the patient developed sensation of throat and chest tightness and difficulty breathing. Patient also developed lip swelling at this time. HR was 115, SpO2 was 96% on RA. One 0.3mL epipen was administered in the L thigh. The patient was treated in the ED with solumedrol, famotidine, 1L NS, and zofran. She recovered within 60minutes. She was observed for another 60 minutes and then discharged from the ED without further sequelae.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was COVID-19
Began with headache, fever 101-102 degrees, nausea, vomiting, backache a few hours after injection.
Information has been received from a consumer concerning of her daughter, a 17 year old female with no pertinent medical history and without concomitant medication.  Who after received the first (MAR-2008) and second dose (date unspecified in 2008) of GARDASIL (site and route unspecified) had injection site reactions (soreness and swelling).  Subsequently on early October, the patient was vaccinated with the third dose of GARDASIL (site and route unspecified).  About a week after vaccination the patient started experiencing tingling and weakness in her arm and legs, dizziness, tiredness, nausea.  The patient has been seen by a neurologist but no cause of the problem could be found.  On an unspecified date in 2008, the laboratories studies perform were a blood work, MRI and Lymes test which were negative.  At the time of reporting, 20-NOV-2008, the outcome of the patient was not recovered.  1/16/09 Reviewed PCP medical records for 3/27-12/22/08. FINAL DX: Records reveal patient experienced usual state of good health on 3/27/08 when received HPV#1, MCV4 & varivax.  On 4/27 seen for erythematous itch rash x 4 days & dx w/probable Fifth's disease.  Tx w/topical meds.  RTC 6/9/08 w/sore throat & fatigue x 3-5 days, HA resolved, occ cough, oral intake reduced.  Rapid strep neg & dx w/viral pharyngitis.  RTC 6/12 w/continued sore throat & tiredness & tender cervical lymph node hyperplasia.  Dx w/pharyngitis & tx w/oral antibiotics as leaving country next day.  RTC 10/13 w/nausea, stomach ache & heavy numb hands & legs.  Dx w/dysmenorrhea.  RTC 10/26 w/continued fatigue, nausea, stomach ache, lightheaded & extra heavy menstruation x 5-6 days.  Dx w/dysmenorrhea, malaise & fatigue & considered BCP.  Referred to neuro prior to starting BCP due to hx of migraine HA.  Neuro consult 10/24/08 for paresthesias/tingling of hands/feet, balance difficulties, gen. weakness all beginning approx 10/12/08.  Neuro exam completely WNL & no dx provided. Returned to neuro 11/11/08 for review of abnormal MRI, no change in physical assessment.  Returned to neuro 12/22/08 for LP with no change in physical assessment. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow up information on 29-DEC-2008, has been received from a certified medical assistant concerning a 17 year old female patient with no known allergies or pertinent medical history who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL (Lot: 659655/1486U) intramuscularly, and on 06-OCT-2008 the patient was vaccinated with the third dose of GARDASIL (Lot: 560620/0571X) intramuscularly. The medical assistant reported there was no adverse event. Additional information has been requested.
huge welt on her arm that is hot and itchy; This spontaneous report was received from Consumer and refers to a 19-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-JUL-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 14-JUL-2023, the patient experienced huge welt on her arm that is hot and itchy. No treatment was given for huge welt on her arm that is hot and itchy. No additional details were given. At the time of reporting, the patient had not recovered from the event of huge welt on her arm that is hot and itchy. The action taken with VARIVAX regarding huge welt on her arm that is hot and itchy was reported as Not Applicable.   The causal relationship between huge welt on her arm that is hot and itchy and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Mother describes hives for 3 days after MMR & Varicella administered on 2/23/11, with fever for approx. 3 days.
PREPARATION AND ADMINISTRATION ERROR. PATIENT RECEIVED 180MCG OF PFIZER COVID 19 VACCINE IMx1.
Patient admitted to my hospital 4 days after second dose of Pfizer vaccine for Covid with imaging confirmed myopericarditis
Pain, redness & swelling at shot site, severe chills, fever of 100, fast heartbeat, nausea, thirst. Extreme fatigue the following 2 days afterwards.
1 day post: awoke with mild myalgias, local site injection redness warmth and pain, temp 99.9 4/2/18: Woke up this am with pruritic bumps shoulders back of left leg and both buttocks. Husband states buttock rash comes and goes frequently for years, flares in hot environment. Red bumps on bilateral shoulders and one on back of left thigh new this am. 4/11/18, ER follow up to rash: had SHINGRIX 3 weeks ago, local reaction left upper arm with edema redness warmth. Low grade temp, fatigue. 1 week later developed diffuse trunk rash, hives, pruritus which spread to upper thighs and upper arms as well. 4/20/18: Hives returned 2 days ago right shoulder not itchy feels hot large indurated welt, rash on shoulder right axillary area and trunk. Upper lip and outer nose started to swell last evening. No tongue, oral or throat swelling. 6/11/18: hives returned
POSSIBLE BLOOD CLOT; INCREASED HEART RATE; CHEST TIGHTNESS; HIGH BLOOD PRESSURE; NECK PAIN; ARM PAIN; HEAD PAIN; BODY SHAKING; CHILLS; HIP JOINT PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, osteoarthritis, fibromyalgia, non smoker, and non alcohol user. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, 1 total, administered on right arm on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14- MAR-2021, around 9 pm the patient experienced body shaking,   and chills for which she took Theraflu. On 15-MAR-2021, morning the patient experienced high blood pressure, chest tightness and increased heart rate of 156 BPM for which she went to the ER. She also experienced neck pain, arm pain and head pain. lung and chest examination was normal. Laboratory data included: Blood pressure (NR: not provided) increased, Fibrin D dimer (NR: not provided) 780, and Heart rate (NR: not provided) 156 pm. As the- d dimer test result was high, the doctor said she has a blood clot. She was given a shot of Toradol at the ER. On 17-MAR-2021, Laboratory data included: Fibrin D dimer (NR: not provided) 650. On 30-MAR-2021, She had another episode, she was in a lot of pain. She went back to ER. Laboratory data included: CAT scan (NR: not provided) normal. They sent her home and prescribed her Meloxicam. The patient went to see her Cardiologist after that, She stated that her cardiologist didn't do any blood work or mention anything regarding a blood clot.   Treatment medications (dates unspecified) included: ketorolac tromethamine, acetylsalicylic acid, meloxicam, and dextromethorphan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, chest tightness, increased heart rate, body shaking, chills, and  head and neck pain and arm pain on MAR-2021, had not recovered from hip joint pain, back pain, and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-possible blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sore  arm and swollen at the side of injection  Chills and tiredness  General flu symptoms   Runny nose
Tingling in my entire body, started with hands and feet, then arms and legs, then face and mouth
I got hives and rash one week after my first dose on my left arm. the rash expanding up to my arm. It took 4 days to go away. the instructions from my doctor was to take Benadryl and cold compresses.
This spontaneous report was received from a medical assistant refers to a patient of unknown demography. On 09-APR-2014 the patient was vaccinated with expired dose of VARIVAX lot # H006529 (Expiry: 09-MAR-2014), 0.5 ml, subcutaneous. No symptoms reported. No other details provided. Additional information has been requested.
Left upper arm became red, warm to touch swollen and sore. pt had also developed nausea, vomiting, and headache. Red area 5 inches x 7 inches indurated.
HEART RACING  (ALMOST LIKE FLUTTERING OR TWITCHING; SLEPT UNTIL NOON; HEART FEELS LIKE BEATING FAST; COUGH; HEADACHE; FEELING HOT / CHEEKS FEELING WARM UNDER; FELT OFF; CHILLS; MUSCLE ACHES; This spontaneous report received from a patient concerned an adult female. 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination to the Left Arm.  No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling hot / cheeks feeling warm under. On 20-MAR-2021, the subject experienced felt off. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced muscle aches. On 21-MAR-2021, the subject experienced heart feels like beating fast. On 21-MAR-2021, the subject experienced cough. On 21-MAR-2021, the subject experienced slept until noon. On 21-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced heart racing (almost like fluttering or twitching. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide, loratadine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, feeling hot / cheeks feeling warm under, felt off, muscle aches, headache, cough, heart racing (almost like fluttering or twitching, slept until noon and heart feels like beating fast was not reported. This report was non-serious.    .; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
pt recv vax 20NOV97 & 24NOV97 devel diffuse rash especially on trunk 1/2-3/4yr;varicella-like + rt warm, swollen
Ongoing nausea - started two days after vaccine. Similar to "morning sickness" - starts the moment I rise in the morning (4:30 / 5:00am) and continues to approximately 11:00 am each day.  Some days are worse than others.  Enough of a feeling of queasiness to keep a small vial of peppermint oil with me at all times to quell the nausea (oil placed under nose helps).  I need to pace myself , a banana will take me over an hour to finish.  I did NOT have this prior to receiving vaccine and pray this will eventually go away.  It has been 2 weeks since vaccine.