chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 25-Jul-2018 regarding an unsolicited valid serious case received from a consumer or other healthcare professional. This case involves Adult female patient (age not reported), who experienced began to seize/ she had fluid on her brain causing uncontrollable seizures, while she received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date (reported as in 1989), the patient received a first round of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine a safer alternative (a-cellular pertussis) (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious seize/ she had fluid on her brain causing uncontrollable seizures (seizure) 48 hours following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. This event was assessed as medically significant. It was reported that they would have to wait and see if their baby girl would be handicapped. On an unknown date, the patient developed a non-serious temperature dropped (body temperature decreased) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. It was reported that the doctors children was also had an intolerance from which the mother of the child was consulted at hometown. Other relevant tests included No Lab data was reported. Final diagnosis was within 48 hours my sister began to seize/ she had fluid on her brain causing uncontrollable seizures. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for within 48 hours my sister began to seize/ she had fluid on her brain causing uncontrollable seizures and as Unknown for temperature dropped. Documents held by the sender: None. Sender's Comments: This case concerns a patient who presented with seizure episode within 48 hours after vaccination with DAPTACEL. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Information has been received from a pharmacist concerning a 23 year old female who on 22-APR-2010 was vaccinated with the first dose of GARDASIL and the patient developed facial numbness. The patient was given BENADRYL and would be going to an unspecified emergency room on 23-APR-2010. The patient's facial numbness persisted. Additional information has been requested.
Fever over 100F on the third day. Ear infection, chest congestion, sore throat, and sinus infection.
had a sore arm for 1-2 days; Yesterday, she developed a rash on her back on the left side where she had received the injection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history included as shingles outbreak, about 10 years ago, where it radiates to other parts of the body. The patient's concomitant medications were not reported. It was reported that patient would like to know whether the reaction she experienced is from the Pfizer covid shot. It was reported that patient received first dose of the covid vaccine and had a sore arm for 1-2 days. Yesterday, patient developed a rash on her back on the left side where she had received the injection. When asked about the under her shoulder, under left thigh, no information was provided. On an unspecified date, the patient experienced had a sore arm for 1-2 days, on 04Feb2021, the patient experienced, yesterday, she developed a rash on her back on the left side where she had received the injection. Follow-up attempts are completed. No further information is expected.
itchy rash in her back; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (itchy rash in her back) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (itchy rash in her back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (itchy rash in her back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: TCR attached: Outcome of the event was updated to resolved
Patient is an 83-year-old female presenting to the ED due to elevated heart rate.  She states she was sent in by her PCP.  On arrival patient's EKG did show concern for A. fib however patient denies any history of this.  Patient also complaining of shortness of breath and has a history of CHF and COPD and is normally on 3 L of oxygen at home.  Complaining of chi
passing black blood through her stool; Stevens-Johnson Syndrome; GI distress; arthritis; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (passing black blood through her stool) and STEVENS-JOHNSON SYNDROME (Stevens-Johnson Syndrome) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder.    In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOCHEZIA (passing black blood through her stool) (seriousness criterion medically significant), STEVENS-JOHNSON SYNDROME (Stevens-Johnson Syndrome) (seriousness criterion medically significant), GASTROINTESTINAL INFECTION (GI distress) and ARTHRITIS (arthritis). At the time of the report, HAEMATOCHEZIA (passing black blood through her stool), STEVENS-JOHNSON SYNDROME (Stevens-Johnson Syndrome), GASTROINTESTINAL INFECTION (GI distress) and ARTHRITIS (arthritis) outcome was unknown.            No concomitant medication was reported. Treatment medication was not provided by the reporter.  Company Comment : This case concerns a 72-year-old female patient with past medical history of Autoimmune disorder who experienced the unexpected events of passing black blood through her stool and Stevens-Johnson syndrome. The events occurred on an unspecified date second the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there was no details about the first dose.  The reporter did not provide the causality assessment with product use. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events are assessed as serious (medically significant) per regulatory reporting.  Stevens-Johnson syndrome is an adverse event of special interest; Sender's Comments: This case concerns a 72-year-old female patient with past medical history of Autoimmune disorder who experienced the unexpected events of passing black blood through her stool and Stevens-Johnson syndrome. The events occurred on an unspecified date second the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there was no details about the first dose.  The reporter did not provide the causality assessment with product use. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events are assessed as serious (medically significant) per regulatory reporting.  Stevens-Johnson syndrome is an adverse event of special interest
Information has been received from a physician concerning a 4 1/2-month-old male who was vaccinated with a first 2 ml oral dose of ROTATEQ. He was vaccinated with the second dose 6 weeks later. It was reported that this happened at another practice and no other details are known. No product quality complaint was involved. Additional information is not expected.
Unsure whether a patient received a dose from a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unsure whether a patient received a dose from a vial that was punctured more than 12 hours ago) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No medical history was provided by the repor.    On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unsure whether a patient received a dose from a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Unsure whether a patient received a dose from a vial that was punctured more than 12 hours ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.
Post vaccine patient C/O wanting to pass out. Also C/O ringing in her ears.
Sore throat, decreasing intake, signs of dehydration, persistent fever, symptoms not improving over next 3-4 days.
Nine days after receiving first injection, I experienced severe sciatic pain in left leg and to the present time.  I am receiving second injection Jan., 29, 2021.  Am concerned. Also, to say that my gluteus minimums was torn in 2010, upon taking Ciproflaxin, so I guess is compromised.
Painless swelling of left hand & wrist, onset 2/14/12. Evaluation in process as symptoms persists. Neg orthopedic & vascular & rheumatology evaluations, will bee seen for possible lymphedema.
Pt has generalized urticaria - 50 red lesions erythema (may not be vaccine related).
fever & swelling of lt upper arm; temp in clinic 101.6, erythema & mild tenderness 4" diameter lt arm, palpable lt ax lymph node; also rash; imp: ? secondary infect inject site;
general fatigue and body ache.  Nausea and diarrhea over three days
approximately 4:15 pm immunizations given well tolerated by student.  4:18 pm student was moved to a seated position in a chair for recheck of B/P.  4:20 pm Student noted to began starring and dropped his head backward began involuntary jerking movements eyes rolled backward mother and nurse practitioner witnessed.  Student was unresponsive less than one minute and was aroused with yelling his name.  He was able to state where he was at and drink water.   Student complained of bilateral "hands feeling funny."  B/P 120/88 HR120.  4:22 pm EMS called.  Cool cloth to forehead and neck .    4:25 pm B/P 120/90  small oscillating movements of both eyes noticed mother states student has had this in the past this was not new.  4:33 pm EMS present student is A& O x3 he is able to stand unassisted states "feel strange"  after speaking with mother rescue and mother have decided mother will drive student in POV to ER.  4:37 pm student was taken to POV via wheelchair no change in status en route to ER.  4:38 pm called ER to provide report of occurence after immunizations given.
About 1 1/2 days after vaccines, mom noticed (B) indurated areas in thighs where vaccines were given. Progressively worsened & overlying skin became papular.
Day 1 and 2 = Fatigue/Fever, Day 3 = Palpitations, Day 4 - Shortness of Breath
Multiple vesicular lesions on trunk with scabbed over lesions. - Varicella break out after vaccine.
Starting with the night of the vaccination for a full 7 days I had a terrible roaring in my ear. the noise was coming outward from in my ears, I was very dizzy and needed help to go to the bathroom and outside. i was very nauseous and lost 5 lbs. this all lasted 5-7 days. day 8 the side effects subsided but the roaring in the ears comes back 1 every 10 days as opposed to 10 -12 times a day for 1/2 hour. I have a sensitive immune system in the past my entire life I've had allergies and needed steroid and epi pen. when I've had vaccine in the past or been sick sometimes it takes my immune system to calm down a little bit. and this happened a little bit after the 2nd dose. but after the 3rd dose I've had the hives and we haven't figured out what caused it. I'm unable to tolerate anything with histamine or I get red welts and hives, things like oranges.
I was fine initially but Sunday night my right eye became bloodshot and was crusted shut when I woke up. I went to the eye doctor and was advised that I had a viral infection as a result of getting the shot. I was given antibiotic eye drops and steroid drops for my eye. This condition lasted about 3 months and I had to see 4 different doctors and provided with an array of medications
Slight right  facial numbness half hour post administration lasting 30 mins. Chills and Rt arm site pain and swelling on the first night. 2nd night, chills and increased swelling, pain to right arm site with slight weeping, warm to touch and redness. Throughout the first two weeks, I would have intermittent chills and right arm site redness, swelling, pain, warmth was gradually getting better but did not have any fever the first 13 days.  The night of 2/15/2021, I felt the chills, body aches and went to sleep. All night I felt I was about to get a fever. I was in bed until 1pm the next day on 2/16/21 when I started to have the severe tremors with my chills, back spasms, abdominal pain, and nausea. I got out of bed, took my temp and it was 101.5 F orally. I tried to take Tylenol but I could not because as soon as I sipped some water, I started vomiting yellow emesis first and then later on I was already vomiting greenish bile. I was getting weaker, lethargic and my tremors and chills were getting worst as well as my back spasms and abdominal pain. My husband, then brought me to the ER around 2:30-3pm. I was admitted in ICU for septic shock with unknown source on that day, 2/16/2021. I was on levophed drip via right chest central venous catheter for 48 hours and was given multiple antibiotics until discharged to home on 2/20/21. I developed red facial rashes more prominent to the right side on the second day of admission. Two days after discharge, I had headaches for two days with right shoulder pain. But, on the next day which was the 3rd day post hospitalization, I broke out with generalized reddened, raised, itchy and burning rashes. My husband brought me back to the ER on that day on 2/24/21. ER MD loaded me with dexamethasone steroid IV and Benadryl IV and sent me home with oral dexamethasone and anti-histamine orally. I saw my primary MD on 2/26/2021 for hospital follow up and referred me to Infectious disease MD and Endriconologist. On March 3rd, I was started on insulin SQ due to my blood sugars running 300?s to almost 400. As of now, my MD is still adjusting my insulin dosage due to persistent high blood sugar readings of 300-400 mg/dL.
at thigh with 4cm x 7.5 cm erythema and induration 7.2cm x 4 cm at Hep A site.
The caller's father reported soreness in his arm immediately for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The caller's father reported soreness in his arm immediately for couple of days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (The caller's father reported soreness in his arm immediately for couple of days). At the time of the report, PAIN IN EXTREMITY (The caller's father reported soreness in his arm immediately for couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
1/29 Redness, swelling, itchy; mom administered Benadryl - no effect.  1/30 - returned to office.  Area 15% larger, red, indurated, warm area.  *Reaction to DTAP*.
This spontaneous report was received from a pharmacist refers to a 19 year old patient of unknown gender. Information regarding medical history and concurrent conditions were not reported. On 21-AUG-2015, the patient was vaccinated with first dose of RECOMBIVAX HB (Lot# L000717 and expiry date: 15-APR-2017), 1 ml. On 21-SEP-2015, the patient was vaccinated with second dose of RECOMBIVAX HB (Lot# L000717 and expiry date: 15-APR-2017), 1 ml. This was outside the recommendations per the RECOMBIVAX HB prescribing information. No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for leukocytosis within 6 weeks of receiving COVID vaccination.
DEVELOPED PAIN IN LEFT DELTOID AREA ON 1-28-21. PAIN BECAME WORSE IN NEXT 12 HOURS. BARLEY ABLE TO RAISE  LEFT ARM. WENT TO ER 1-29-21 AND ADVISED ARTHRITIS IN SHOULDER. ON 1-31-21 PAIN HAD INCREASED , CONTACTED FAMILY DOCTOR. GIVEN RX FOR GABAPENTIN AND X RAYS OF SHOULDER AND NECK. X RAYS DONE ON  1-31-21. NO MEDICATION OR OVER COUTER MEDS HELPED WITH PAIN.  CALLED FAMILY DOCTOR AND ADVISED  NEEDED MRI OF CERVICAL AND LUMBAR AREA AND INCREASE IN MEDICATION.  SLIGHT DECREASE IN PAIN. MRI SHOWED PINCHED NERVE IN CERVICAL (C6) AND ADVISED TO SEE NEUROSURGEON. SAW NEUROSURGEON 2-22-21. CONFIRMED PINCHED NERVE, INCREASE IN PAIN MEDS AND WILL FOLLOW WITH ? PHYSICAL THERPHY, INJECTIONS, AND/OR SURGERY IN FUTURE
3 to 4 scattered scabbed lesions, no TX. Low grade fever, irritability.
BODY ACHES, STUFF NOSE, SORE THROAT, FEVER, HIVES, LOSS OF APPETITE.
Pt developed an urticarial lesion 19x8.5cm with pruritus on posterior left upper arm. No systemic reaction. (Lesion is same arm as immunization given.) Given Lidex ointment topically for treatment.
Hives all over with mild wheezing. Treated with 25mg po Benadryl.
I have rashes on my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 17:30 (Lot number: WS3960) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), when the patient was 28 years old, for COVID-19 immunization; Bnt162b2 (2nd dose), when the patient was 28 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Dec2021, outcome "unknown", described as "I have rashes on my body". The event "i have rashes on my body" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash.  Additional information: Patient went to urgent care and showed it and discussed with them, they provided some allergy medication but still don't see any change actually. Patient don't know the LOT# but could provide the brand what patient was using. The first one was the Allegra and another one they prescribed me, Pepcid and another one is Benadryl allergy one, that's it. Patient did not reported any prior Vaccination (4 Weeks).  No follow-up attempts are possible. No further information is expected.
1) Cup right ear with hand; Arc described from thumb to little finger, 1/2 -1" depth.  Needle sharp jabbing pain, lasts for an instance, yet whole arc "lights up"/pain felt throughout arc. Jabbing every 10-15 secs.  Started ~08:00pm 03/03/21 (day after vaccine administered), and continued through the night, till mid-next day 04th.  2) Headache 3/02/21 6pm  for the week ( through to 3/9/21)  3) right arm, site vaccine administered, bruised to the touch.
In the arm where I received the shot and my body: Pain from shoulder to fingertip Swelling Tiredness/fatigue Headache  Muscle pain Chills Fever Nausea Armpit pain Lymph nodes swelling (size of an egg) discomfort with arm movements Itchiness Lack of appetite Pain in shoulder blade
I developed Belle Palsy after receiving the vaccine.  I had very similar symptoms to having a stroke. I have a droopy mouth, slurred speech, I couldn't blink my eye. I had a reaction to the steroid that was given to treat my Belle Palsy diagnosis from the ER visit.  I also experience horrible headaches. And hearing issues in the effect side.
No further information provided. This is patient four of five. Cross reference cases: 02218306, 02218421,02218430 and 02218450.; HCP reported PROQUAD was administered after a temperature excursion to a patient. PROQUAD was administered on Aug 2, 2022.; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 02-AUG-2022, measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA) (PROQUAD) subcutaneous injection (lot number: W007748, expiration date 04-SEP-2023; strength, dose, and route of administration were not reported) was administered to the patient once after a temperature excursion of -8.1 Celsius degree for 1 hour and 58 minutes (product storage error). There was no additional adverse event (AE) reported, and no further information provided.   This is one of five reports received from the same reporter.     ; Sender's Comments:  US-009507513-2208USA002443: US-009507513-2208USA002433: US-009507513-2208USA002737: US-009507513-2208USA002739:
Two hours after vaccine I felt symptoms of indigestion, as if the food I was eating was spending very little time in my stomach. Felt that again the following night. I had watery stool on the morning of the 2nd day after the vaccine.
PATIENT GOT FLUZONE DOSE ON 10/13. CALLED ME ON NOV 1 SAYING SHE HAS HAD UPPER ARM PAIN SINCE SHE GOT SHOT. HER DR PUT HER ON DARVOCET N 100. ON NOV 1, DR ALSO PRESCRIBED DARVOCET N 100 & MEDROL DOSEPAK. DR TOLD HER THE NEEDLE EITHER HIT BONE OR NERVE. PAIN MOVED TO AREA JUST ABOVE ELBOW, FEELS LIKE TIGHT RUBBER BAND AROUND ARM. FOLLOWED UP WITH DOCTOR 11/3. WHO IS REFERRING HER TO NEUROLOGIST. FOLLOWED UP WITH THE PATIENT 11/3, SAYS SHE IS FEELING BETTER TODAY, HAVE NOT TAKEN DAVOCET TODAY, BUT USUALLY IS WORSE AT NIGHT. TOLD HER TO KEEP IN TOUCH WITH US
43-year-old female patient with a past medical history of bronchial asthma presented for evaluation of COVID-19 infection.  Patient had a prior history of Roux-en-Y gastric bypass surgery, nutritional deficiency associated anemia.  Patient started to develop fever, chills, worsening fatigue baseline along with lightheadedness and decrease in appetite.  She was admitted  for further evaluation for her thrombocytopenia.  ITP likely due to COVID-19 infection.  Patient received 10 day course of dexamethasone.