chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/7/11 after waking up 6:30 am, welts on chest. At 2:30pm- welts spread all over body. Feels like "fire ants stinging". May or may not due to shots. These symptoms presented on 8/7/11. Shots given 8/3/11.
Next day site turned red and swollen making a circle - The entire area red and swollen. Site was hot - as if fever in it.
Patient was seated on a chair in the hallway following administration of Janssen vaccine. Staff heard a noise and found the individuals on the floor to the left of her chair. She was blinking her eyes and diaphoretic. She held her position for a short time and then started talking to staff and sat up on the floor. She had a bump on her left side of her head.  Recovering quickly, she was alert and oriented to person, place and time. BP was 102 /60's. Speech was clear. She denies any pain, changes in vision or dizziness following the event. She was given some water, snacks and observed for 30 minutes at which time she stated she wished to leave and was feeling fine.
I have hives and swelling in hands, outer elbows, knees, and toes
Fine, erythematous, pruritic rash over most of body including face and scalp.  No fever, redness or swelling at injection site or other symptoms.  No known allergies, no new meds or foods.  Pruritis relieved with Benadryl but still has rash several hours after Benadryl.
2 days after vaccine received, patient developed tics.  She has no prior history of tics.  Tics characterized as quick jerking movements (almost a shiver) of her arms, shoulders, and head.
I have a bumpy, itchy rash on my chest and back that has become somewhat painful because of the itchy/scratchy nature.  It has lasted for 3 days and continues today.
pt recv vax 5FEB99 & 6FEB99 pt devel a rash;
Offender receive his second moderna vaccine 7 days early.  No adverse symtoms or treatment
pt recv vax 9OCT96 @ 9:00 & 11:00 pt c/o dizziness, arm throbs, shakiness & light-headedness;sx cont as of 9OCT96;
26Apr90 pt vax; 02May90 devel fever 103F & irritability.
Diarrhea, fever, vomiting x 3 days after each dose of H1N1 vaccine.
PT STATED SHE NOTICED A SKIN RASH AT THE SITE OF INJECTION. WHEN SEEN BY VACCINATOR ON 1/25/2012 (48 HRS LATER) THE AREA WAS OBLONG, RED, APPROX 60 MM BY 20 MM. THERE WERE 2 RAISED FLUID FILLED BLISTERS VISIBLE OF LESS THAN 10 MM. SHE STATED IT DIDNT HURT, BUT ITCHED TREMENDOUSLY. RECOMMENDED BENADRYL, COVERAGE WITH ABSORBANT, NON-IRRITATING BANDAGE, AND FOLLOW WITH MD IF DOES NOT IMPROVE IN 48 TO 72 HOURS, OR BEGINS TO SHOW SIGNS OF INFECTION.  THE SHAPE OF RASH SUGGESTS POSSIBLE BANDAGE ADHESIVE ALLERGY, WHICH PT SAID SHE HAD A PAST REACTION TO IN THE HOSPITAL.
1 st injection: metal taste in mouth for three hours after. Next day started heavy menstrual period even thought it was not schedule for two more weeks.  2nd injection: Received 2nd injection 18 days later than within 48 hours received very heavy menstrual period though it was not scheduled for another week.
Feb 01, 2022 developed Bell's Palsy in the left side of my face. Hospitalized to check for stroke until Feb 03, 2022. Bell's Palsy recovered over the next 2 months, face returned to the 95% normalcy.
Erythema, swelling of (R) upper arm, up to about 4 1/2 x 3 inches.
Pt had Janssen vaccine at 1:30 pm on 9/16. at clinic. Presented to Emergency Department at 1:45 am after fainting episode x 2.
vaccine details and exact dates not known, pt unable to provide. thinks he had pfizer. states he has had headaches since he got the vaccine about 1 year ago. was reported today over a tele visit for acute covid infection and will be f/u with PCP
patient described large patch of redness and inflammation around the injection site. Patient seeking care from her provider.
Sick; Initial information received on 29-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a patient.   This case involves an unknown demographics patient who was sick 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 (dose, formulation, strength, expiry date and lot number not reported via unknown route in unknown administration site) as prophylactic vaccination  On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got mine about 2 months ago and I can't remember being that sick before! I always get mine, now I'm thinking never again! I'm 80 and rarely get colds and I've never had pneumonia nor Covid"  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Sick).  At time of reporting, the outcome was Unknown for the event sick.
Patient stood to approach her father, when she slumped over and lost consciousness and was unarousable. She had normal breathing and pulse. The clinical team transferred patient to the Assessment Tent, where she was observed to have seizure-like jerking of her upper & lower extremities and fluttering of the eyelids while she remained unconscious. She had normal pulse and respiration during this time, no tongue biting or urinary or stool incontinence. Within approximately 10 minutes her seizure-like movements resolved, and she gradually regained consciousness. I spoke with the patient afterwards: she recalls having stood to meet with her father, and then she has no recollection of the event.
Developed hives above injection site within 10 minutes, post vax. It spread to shoulders, neck and scalp within 30 minutes. Treated with Cortisone creme locally; Benadryl 50mg q 6-8 hours X 36 hours. Persistent scalp itching X several weeks. It is still itching.
Tingling, numbness in face, arms, hands and down front of both legs. Started second day after shot and starts first thing in morning, continues throughout day and subsides in evening. I?m in my eight day and problem continues. Made calls to my oncologist and MD and solution or advice received as of this time.
Pt wife called today stating 1-5-18 yellow fever shot, 1-7-18 headache and elevated BP 150-160/70-80's. This continued for another week then saw PMD 1-16-18 and was started on HCTZ. Today still has headache and they wondered if it was the vaccine. I explained that it was a low probability and they need to continue follow up with PMD. She stated he wanted him to get a CT scan. I said she should follow the doctors orders. She was very thankful for the discussion. Dr. aware.
AE is being filed for potential lack of efficacy claim; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE is being filed for potential lack of efficacy claim) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE is being filed for potential lack of efficacy claim) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE is being filed for potential lack of efficacy claim) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE is being filed for potential lack of efficacy claim).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. It was reported that the vaccines stock available expired on 15-MAY-2023. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Pt has redness, swelling, and mild tenderness at injection site. Asked if painful. Pt stated no, just tender.
Patient developed infection site rash that appears to be cellulitis. Responding to doxycycline.
This spontaneous report was received from a male patient of unknown age referring to himself. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, strength and route of administration were not reported). There was no concomitant medication reported. On an unknown date, the patient experienced peripheral swelling, blister and rash generalised. It was reported that on an unspecified date, the patient sought medical attention. At the reporting time, the outcome of peripheral swelling, rash generalised and blister was unknown. Additional information has been requested.
Tachycardia, dry mouth, itching, weak heart rate, insomnia x3 days.
Patient received the flu shot on 12/3 and later that evening had severe pain in her hip bone.
I am breaking out in hives !!!  I was a little bit earlier  this year, but never associated  it with possible  Janssen shot connection. After the Moderna  booster, seems hives are not going away.  I've rules out foods high in histamine, yet this morning, such a mess!!!  I also have stopped wine.
A report has been received from a Health Professional concerning a 14 year old female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The Health Professional had stated that the patient had been administered expired FLUMIST Quadrivalent on 02-JAN-2015. The outcome of the event of patient administered expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
Information has been received from the authors in a published literature article concerning a child patient who on an unspecified date was vaccinated with the three doses of ROTATEQ. On an unknown date, the patient experienced rotavirus and was hospitalized. At the time of the report the outcome of the patient was not reported. The article also discussed the experience of another child patients while on therapy with ROTATEQ (WAES # 1108USA01482, WAES # 1108USA02150, WAES # 1108USA02151, WAES # 1108USA02153 and WAES # 1108USA02154). Additional information has been requested.
Initial unsolicited report received from a nurse on 31 May 2018. This case involves a patient (age and gender not reported) who was vaccinated with two doses of IPOL (batch number, expiry date, dose, dose in series, site and route of administration were not reported for both doses) on unspecified dates. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to extra dose administered as patient was vaccinated with second dose just nine days apart from first dose. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Cough, runny nose, chills, myalgias, headache, fatigue.
Site: Pain at Injection Site-Mild, Systemic: Vomiting-Medium
Autoimmune Hemolytic Anemia; Bell's Palsy; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. In or around October 29, 2012, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered severe symptoms of fatigue, dizziness, jaundice, and a syncope episode he also had very dark urine and was diagnosed with sudden onset of autoimmune hemolytic anemia. Patient additionally suffered right side facial paralysis and was diagnosed with Bell's Palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using the product. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, 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. As a direct and proximate result of company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, the events of autoimmune hemolytic anemia and Bell's Palsy were considered to be medically significant.
SHORTNESS OF BREATH; THROAT SWELLING; TONGUE SWELLING; UNCONTROLLED SHAKING; LEG NUMBNESS; This spontaneous report received from a patient concerned a 40 year old 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Vaccinated on Left arm. No concomitant medications were reported. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced throat swelling. On 09-MAR-2021, the subject experienced tongue swelling. On 09-MAR-2021, the subject experienced uncontrolled shaking. On 09-MAR-2021, the subject experienced leg numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swelling, and tongue swelling on 14-MAR-2021, and uncontrolled shaking on 11-MAR-2021, and had not recovered from shortness of breath, and leg numbness. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Drug induced lupus as direct consequence of Covid 19 Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUPUS-LIKE SYNDROME (medically significant), outcome "unknown", described as "Drug induced lupus as direct consequence of Covid 19 Pfizer vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Since last year, after I received two doses of Pfizer vaccination, I have gradually developed tendon/muscles pain throughout my body. Pain in the bearing limb including feet, legs, thigh, bottoms were more severe compared to other parts. I also felt sore by the lower back muscles and intercostal muscles. In April of last year, the pain was unbearable after massage and foam rolling  that prevented me from walking, standing and sitting for five days. During  this time,  I also experienced frequent urination, which never happened to me before.  I?ve also developed headache ,  more frequent skin allergic reaction, hematoma in tongue and side of mouth after eating, and fatigue on a daily basis. Also, a week after both doses, I developed severe fatigue, tingly feelings and twitcing  in my muscles.. Over the next 6  months, I have difficulty standing, walking and sitting  due to pain.  My life now is characterized by three days feeling good, three days feeling fatigue and pain. Headache and nasal congestion and inability to breath  comfortably when lying down  is common particularly at night time.   I?ve seen several doctors, including internist, neurologist, and rheumatologist, podiatrist, gastroentologist, allergist  to  help me determine the cause of my pain and to manage my pain. I  have been placed on Cymbalta, Naltrexone, cerebrex.. I?ve done several blood tests to rule out autoantibody, inflammatory diseases, multiple sclerosis Lyme, Epstein bar virus, syphilis, HIV, vitamin B deficiency, MRI. The tests were mostly normal.  The medication I?m on now has helped me significantly but has not cured my pain. I?ve also seen physical therapist for four months. Each exercise sessions I had requires great effort due to continual pain.  I still feel uncomfortable throughout my body.  So far, the specialists have concluded that my pain may have been due to Ehler Danlos syndrome, a diagnosis given to me fifteen years ago when I saw a neurologist  to solve my three month episode of foot pain.  The foot pain that occurred then resolved by its own and I haven?t experienced this for almost ten years until last year, in addition to pain in other parts of my body, I have been healthy  otherwise prior to this episode and rarely paid a visit to doctors. Since last year, my body hasn?t been the same.
fever; This is a spontaneous report from a contactable nurse (patient). A 48-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EJ1646), dose 2 via an unspecified route of administration on 19Jan2021 as dose 2, single (at the age of 48-years-old) for COVID-19 immunisation. The patient's medical history included 2 previous gastric bypass surgeries. Last gastric bypass surgery in 2011; hernia repair in 2018; and very low iron stores requiring infusions. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EJ1686), dose 1 via an unspecified route of administration on 29Dec2020 as dose 1, single (at the age of 48-years-old) for COVID-19 immunisation and experienced severe chills for approximately 2 hours. On an unspecified date in Jan 2021, the patient experienced fever for 7 days, and sporadically running fever at various times during the day every day since the second dose. The patient underwent lab tests and procedures which included fever: 99-101.8 Fahrenheit on an unspecified date in Jan2021, and Antibody serum test: 0.1 % on 09Mar2021. The patient had not recovered from the event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021295269 Same patient, drug / different events
This report was received from Pfizer and was assigned manufacturer report number US-WYE-H17670610 for PREVNAR 13. Information has been received from a nurse concerning an approximately 12 week old (3 months) male patient who on 17-AUG-2010 was vaccinated orally with a single dose of ROTATEQ (lot# 667461/0500Z). Other suspect therapy included a single dose of PREVNAR 13 (lot# E57642) intramuscularly in left leg on 04-AUG-2010. Concomitant therapy included a single dose of ACTHIB (lot# UH125AB) intramuscularly in the right leg on 04-AUG-2010, and a single dose of PEDIARIX (lot# AC21B249AA) intramuscularly in the right leg on 17-AUG-2010. Illness at the time of vaccination included haematochezia and possible cow's milk protein allergy. The patient's current weight was 7.4 kg. At the time of the event, the patient was 3 month old male with birth weight of 8 lbs 7 oz with head circumference of 36.1 cm and length of 52.1 cm. Gestational age at delivery was 40 weeks. Relevant prenatal history included C-section for failure to progress and foetal distress. It was reported that patient experienced upper respiratory tract infection (URI) with fever on 17-SEP-2010. On 18-SEP-2010 the patient's condition worsened with fussiness, pale, bulging fontanelle and otitis media. On 19-SEP-2010, the patient had strep pneumo meningitis (drug ineffective) and experienced a seizure on the same date. The patient was hospitalized for 14 days since 21-SEP-2010. On an unspecified date, the patient had head computed axial tomography (CT head), spinal tap (lumbar puncture), "biochem work", magnetic resonance imaging brain (MRI brain), electroencephalography (EEG) and brainstem auditory evoked response (BSAER) (all results not reported). The vaccine was administered by a healthcare professional. Medication was stored appropriately and not altered in anyway. The patient's developmental milestones and physical growth was all normal. The patient was recovering from the events with mild hearing loss. Additional information has been requested. Additional information has been requested.
The first week after the Moderna 1st shot, I got my period which I didn't have for more than 6 months. I had it with an alarming amount of blood cloths. Right after, the second week after the modern 1st shot and after that period,  all of my joints started to hurt really bad. Shoulders, elbows, knees & fingers. Manly stronger pain is on both shoulders to the point I went to the Emergency Room.
This spontaneous report has been received from a Pediatrician referring to a 4 year old male patient. The patient had no medical history, concurrent conditions, drug, allergy history to be reported. On 02-MAY-2018, the patient was vaccinated with PROQUAD lot # N028445, expiration date 09-APR-2019), intradermally into the thigh for prophylaxis (strength, dose and frequency were not reported). Concomitant therapies included sterile diluent (MRK STERILE DILUENT). It was reported that on 02-MAY-2018, the injection created a bubble on the skin (injection site nodule) and a local reaction which was 3cm by 3cm across and was a "deep pink red" color (injection site erythema), which became more red on 03-MAY-2018. The physician reported she did not see any vesicles. Treatment included an unspecified dose of ibuprofen and cool compress. There was no laboratory diagnostics or studies performed. It was reported that the patient sought medical attention for the events. The outcome of local reaction, injection site erythema and injection site nodule was reported as not recovered. At the time of the reporting, the causality between the aforementioned events and PROQUAD was not reported.
Pt received her 2nd Moderna vaccine. Felt fine for 3 days. On the 3rd  day woke up to vertigo, nausea and headache. The dizziness was profound - she had an appt with doctor. Resolved 2 days later.
Moderate to severe bicep muscle pain on right arm that developed the day after receiving the vaccine. Still currently an issue. Muscle cramping, swelling, redness, bruise formed at injection site.
Low grade fever, swollen arm and itchiness around the injection site- possible mild case of the shingle.
Rash  blister formed at injection site, opened and left a red are.  Narrative:  stated the site was painful but healing. used a warm compress