chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching after her flu shot, it started at the injection site and spread to all over her body.; itching after her flu shot, it started at the injection site; Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves Elderly female patient who had itching after her flu shot, it started at the injection site and spread to all over her body while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Methylprednisolone and Dupilumab (Dupixent) for Nasal polyps.  On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (Unknown formulation, lot number, strength and expiry date) via unknown route in unknown administration site for prophylactic vaccination. Information regarding batch number has been requested.  On an unknown date the patient developed a non-serious itching after her flu shot, it started at the injection site and spread to all over her body. (pruritus) (vaccination site pruritus) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.
Although my injected arm was stiff in the morning following the vaccination, I felt okay.  However, roughly 18 hours post-injection, I began to feel a loss of energy and mild body aches.  These symptoms grew worse as the hours wore on, eventually feeling exhausted, flu-like, cold with shivers, as if most body joints were inflamed/aching, transient cramping sensations in the back side of my left thigh, episodic shooting pains from my left lower abdomen into my groin.  I stayed in bed for 10 hours (8pm-6am), took Motrin only in the final hour.  Finally, with some coffee I felt fully functional again 34-ish hours later.
Tested Positive for Covid on 8APR2021, after receiving the first dose of the Covid vaccine on 30MAR2021.; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318, Expiration Date: 31May2021), via an unspecified route of administration on 30Mar2021 (at the age of 57 years) as single dose for covid-19 immunisation. The patient had no medical history and concomitant medications. On 08Apr2021, the patient was tested positive for covid-19, after receiving the first dose of the Covid vaccine on 30Mar2021. On 09Apr2021, the patient received infusion for covid antibodies as treatment. The patient was due to get second dose tomorrow and asked if it was okay to still get second dose of the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Apr2021. The report is not related to a study or program. There was a product complaint. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mother states after injection pt had a headache, neck ache, and previous low grade temp. 8/17/05 mother states neck "still sore" but is improving.
multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  No information was provided regarding concomitant medications, concurrent conditions or medical history.   On an unknown date, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) vaccine (dose, anatomical location, lot number, expiration date  and administration route were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified, the patient experienced multiple outbreaks of herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct result of the vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also sustained severe and permanent personal injuries. The outcome of the event was not recovered, and the causality assessment was reported as related.
As reported by mom redness, swelling in legs; fever around 102; irritable crying; sx lasting through most of night; Seen by MD next AM; was dx as having ear infect & was treated w/ATB & liquid advil;
Heart racing redness, swelling started on left arm (4 finger widths below injection site) size of silver dollar increased to 4 inches by next day. Aching arm. Painful joint from shoulder to elbow.
Pt received flu vax, some redness, approximately 2m, and warmth noted. Pt instructed to return if any increase. Minute increase in size of redness next day. Pt referred to physician who also gave him instructions to return if any increase in reaction.
Injection site sore for 24 hours,  slight headache beginning 12 hours after injection that resolved after acetaminophen, and fatigue 24 hours after injection that lasted 8 hours.
Chills; Nausea; Headache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 09-Feb-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). In 2021, CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
FACE TURNED RED-STARTED COUGHING, SHIVERING AND DIFFICULTY BREATHING-PATIENT STATES THAT SHE FELT LIKE FISHBONE STUCK IN HER THROAT
Individuals reported hives at the injection site. Fever. Itchy spot on right shoulder and right ear.
Patient received COVID 19 vaccine at 1636 12/19/2020. Patient returned to clinic at 1733 complaint of throat closed and hard to clear. Patient had declined observation period and returned to work. Vitals 131/79, HR 90, 97.7 F, 98%, RR30. Complaint of dyspnea and palpations and occasional chest pain. Patient states history of asthma and hypertension.
Rash, itchiness, tightness of the chest, difficulty breathing, and throat narrowing. Given epipen injection, Benadryl injection, and steroid. All IV.
These case reports were previously actioned by Crucell (CRX-2014-000869). The data was taken directly from the database repository and entered verbatim (including labeling and causality assessments) on to the safety database. Where labeling and causality assessments were absent, database took the decision to assign according to company guidelines. This case version was created on 22-OCT-2014 for the purposes of quality improvement. Upon review the following corrections were made: Version date, Received by Case Processing Center, was amended to 04-JUL-2014 for the initial case version (previously it was recorded as 02-JUL-2014). Case version 4 was created using 16-JUL-2014 as the ICH date to action case quality corrections to legacy data. The following fields were updated in the database: reporter information, reported disease, country where vaccine obtained, dosage information, action taken with suspect drug, company unit identification number (2014-CRU259), initiating company narrative. Revision to the information received on 02-Jul-2014. Upon review the following corrections were made: The event of 'cellulitis' was upgraded to serious, other medically important condition (previously it was considered as non-serious).
big lump on the right arm, lump is size of golf ball, getting bigger,; lump is super hot; lump is super itchy; lump is red; This spontaneous case was reported by a nurse and describes the occurrence of MASS (big lump on the right arm, lump is size of golf ball, getting bigger,), FEELING HOT (lump is super hot), PRURITUS (lump is super itchy) and ERYTHEMA (lump is red) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced MASS (big lump on the right arm, lump is size of golf ball, getting bigger,), FEELING HOT (lump is super hot), PRURITUS (lump is super itchy) and ERYTHEMA (lump is red). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, MASS (big lump on the right arm, lump is size of golf ball, getting bigger,), FEELING HOT (lump is super hot), PRURITUS (lump is super itchy) and ERYTHEMA (lump is red) had not resolved.        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 relevant concomitant medications were reported. No treatment information was provided.
Aarm reddened and warm to touch about 3 inches below and to left of injection site.
third shot; fatigued; low grade fever; This is a spontaneous report from a non-contactable consumer (patient) via company representative.  A 60-years-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation .  The patient medical history was not reported.     The patient's concomitant medications were not reported. The patient previously took first and second dose bnt162b2 (PHIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for covid-19 immunisation.   The patient had 12 hours of mild symptoms following his third shot of our COVID vaccine. Symptoms began about 24 hours after receiving his shot and lasted for about 12 hours. He felt fatigued and had a low grade fever. The outcome of events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
High-pitched screams, high fever, sleeplessness, ear infection, sick for about a week. Follow-up report on 2/25/03: Autism.  Annual follow up on 01/06/2004: "Vaccine recipient has not recovered from the adverse events that were reported for this vaccination.  Pt has autism."
Erythema, urticaria at injection site. No systemic symptoms, (L) deltoid.
patient died on 9/13/21. He was healthy prior to sudden cardiac arrest at approx. 8:00 am on 9/9/21. His CT scan showed multiple clots in his right lung. Patient had no history of clots. He had no heart disease or lung disease. Origin of clots is unknown. Patient was 9 months post 2nd Covid vaccine. COULD THE VACCINE CAUSED THE CLOTS AT 9 months post vaccine?
9 days after my vaccine I developed a rash at the injection site in my left arm that was swollen, itchy, and hot to the touch. I also had some mild headaches with pressure behind my ears during this time. Both of these symptoms lasted for 2 days (April 10th and April 11th).
Information has been received from a nurse, referring to a female patient of unknown age. The patient was pregnant on an unknown date. Information of medical history and concomitant therapy was not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis. On an unknown date, the patient was "not showing immunity levels". The patient visited physician's office. The last menstrual period (LMP) and expected date of delivery (EDD) were unknown and could not be calculated. The pregnancy outcome was outcome pending. The causality assessment was not reported.
4/5/2021- 7:30pm  - small amount of soft palate swelling + top lip tingling.  Took   2 Benadryl - at 7:50pm by midnight - symptoms dissapated. No SOB, throat swelling.
This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 21-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to sulfa drugs. On 31 October 2011 the subject received a dose of FLULAVAL (intradermal, left arm), and experienced inappropriate route of vaccination. The vaccine was administered intradermally instead of the indicated intramuscular route. On 31 October 2011, immediately after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritus and raised area injection site, followed by cellulitis type appearance at the injection site. At the time of reporting, the subject had a 3-inch raised area that was unresolved. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up was received 28 November 2011 from the nurse practitioner. The diagnosis provided was "cellulitis as vaccine given intradermally". The outcome of the events was unknown. A complete blood count was performed on 2 November 2011 and was normal. No biopsy was performed. The nurse practitioner assessed the event as non-serious and associated the events "most likely" to erroneous administration.
1st day headache. 2nd day headache, sore throat, hoarseness. 3rd day muscle aches, fatigue. 4 day dizziness, aches. 5 diarrhea, dizziness. Lasted 5 to 6 days. Didn't feel better for 2 weeks. Different symptoms every 24 hours.
she had received PNEUMOVAX 23, on an unspecified date and was now experiencing swelling at the injection site; This spontaneous report aws received from a consumer referring to herself, a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies. On an unknown date, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and she experienced swelling at the injection site for 10 days.   Now, on an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, dose number, route of administration, anatomical injection site, lot number expiration number were not reported) and on an unknown date, the patient started to experience swelling at the injection site.  At the time of the report, the patient had not recovered from the event and she wanted medical advice for the treatment. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and injection site swelling was not reported.
7/18/2013 Dizziness immediately after injection followed by some soreness of injection site 7/19/2013 - 7/21/2013 swelling of injection site, pain and very hot to touch, turned bright red. Swelling progressively got worse to the size of fried egg around injection site arm swelling, itching and very sore to touch. Also, headache and body aches. 7/22/2013 Swelling of arm went down, redness subsiding however arm very sensitive to touch and very itchy. Headache and body ache continued. 7/23/2013 Redness gone, arm sore to touch, slight rash appeared on arm, tingling and pricking of skin began and more itching on arm. Called Doctor and showed pharmacist. Doctor recommended oral BENADRYL and cortisone cream on injection site. 7/24/2013 Soreness and itching of area almost completely gone. Feeling better but feel very weak. Will continue BENADRYL and cortisone cream for a few more days.
PARENT PROVIDED WRONG BIRTH YEAR SO THAT CHILD COULD RECEIVE THE COVID VACCINE. NO ADVERSE EVENTS REPORTED.
discomfort; swollen lymph node (lump) in left armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 19:00 (Lot number: EN6205) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; VITAMINS NOS. The following information was reported: DISCOMFORT (non-serious) with onset 23Mar2021, outcome "not recovered", described as "discomfort"; LYMPHADENOPATHY (non-serious) with onset 23Mar2021, outcome "not recovered", described as "swollen lymph node (lump) in left armpit". Therapeutic measures were not taken as a result of discomfort, lymphadenopathy.  Additional information: The patient's concomitant medication included unspecified insulin. The patient has no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
I have a bruise at the injection site and a lot of redness. This is on my right arm and it burns as well as warm to the touch. Sometimes it itches as well. I did have chills and fever the day after the injection but that went away on Sunday.
MILD MYOCARDITIS; This spontaneous report was received from literature:  Myopericarditis After Covid-19 Booster Dose Vaccination. This report concerned an adult female (age between 18-24 years). The objective of this study was to provide a more timely and complete case ascertainment of myopericarditis after Covid-19 booster vaccine in populations aged 18 to 39 years The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received non-company suspect vaccine: Pfizer Biontech Covid-19 Vaccine (tozinameran, dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. Interval between prime series to booster was 196 days. No concomitant medications were reported.  On an unspecified date, the patient experienced chest pain after four days of booster. The patient presented with mild myocarditis after a heterologous series of JNJ vaccine followed by a booster dose of Pfizer vaccine (dose number in series 2). The patient visited to emergency department. Laboratory data (dates unspecified) included: EKG (NR: not provided) ST elevation positive, Echocardiogram (NR: not provided) left-ventricular end-systolic function 60 to 65 percentage, and Troponin (Normal troponin range: less than or equal to 03 mcg/L) 0.04 mcg/L. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of mild myocarditis was not reported. The authors discussed that myopericarditis occurs after booster doses and may be underreported by current surveillance methods. Completeness or high sensitivity of these case estimates are essential when modeling risk and benefit for wide-scale vaccine implementation and sequential COVID-19 vaccinations for the general population. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220402436-covid-19 vaccine ad26.cov2.s-mild myocarditis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS.(non-company suspect vaccine: Pfizer Biontech Covid-19 Vaccine). Therefore, this event(s) is considered not related.
Patient presented with similar symptoms after receiving the 2nd dose of the vaccine in 03/21. Her illness then was self limited and she had a short 2 day hospitalization stay where she received supportive therapy.  Following the booster, she woke up extremely nauseous, severely SOB, and then vomited 2-3 times prior to her hospitalizations. She felt extreme full body fatigue and weakness, and cannot ambulate which is not her baseline.
HPV9 was administered to patient outside the recommended age. Patient is only 6 months old. Vaccine was given by mistake.
Pt called the office on 10/27/14 - 10 AM to report that approximately 1 hour after leaving her appointment started with feeling cold, shaking, chills, muscle weakness, fatigue. Pt took XANAX 0.5 mg x 2 doses  (hx panic attacks) slept for 4 hours, fatigue 3 days.
Developed flu-like symptoms-headache and body ache.  Symptoms lasted 3 days.  I was sick for my 2 days off from work and had to call in sick the 3rd day of illness.
Moments after receiving the vaccine (#3 of 3 in the series), patient fell backwards, arms and hands curled up into her chest and started babbling. Her eyes remained open the entire time. This only lasted for about 20 seconds. After the event, patient did not recollect any of it.
MALAISE, MYALGIA, CHILLS, HEADACHE, NAUSEA Narrative:   Other Relevant History:
By early October I developed extreme pain and stiffness in both shoulders & hips.  I was unable to lift arms or even sit down without excruciating pain.   After diagnostic testing my primary care doctor diagnosed Polymyalgia Rheumatica on 11/23/2021 and prescribed Prednisolone dose packs, in addition to referring me to a rheumatologist.   On 12/07/2021, I started experiencing extreme pressure headaches, jaw pain, eye pain, dry cough.  By the time I finally was able to see the rheumatologist, on 01/20/2022, she stated that I have all the symptoms of Giant Cell Arteritis, and prescribed 60mg of Prednisone.   Since that time, I have been on a prednisone reduction plan, in an attempt to eventually get off of prednisone and hope for a remission of this painful and debilitating disease.   High doses of prednisone have led to diagnosis of osteoporosis, high eye pressures, prediabetes, extreme exhaustion, in addition to other side effects.   The pain & symptoms of PMR & GCA are controlled by prednisone, but not gone by any means, a full year after this nightmare started.
RECEIVED YELLOW FEVER VACCIN SQ, NOTICED REACTION SEVERAL DAYS LATER. REACTION CONSISTED OF URTICARIAL REACTION (MACULAR, PAPULAR, 3 INCH DIAMETER, WITH PRURITIS).                       PT PRESENTED TO CLINIC WITH SYMPTOMS 2/1/09 AND WAS GIVEN DIPHENHYDRAMINE 25MG PO 1-2 PO Q4-6 PRN & PREDNISONE 20MG TID FOR 3 DAYS, THEN TAPER OVER 6 DAYS.
11/05/21 presents to local ED "without significant past medical history for chief complaint of right scrotal pain".