chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was provided by the reporter.  No treatment information was provided.
I developed chronic urticaria and angioedema, starting on October 1.    I have had urticaria almost every night since then - so far for six weeks.  I spoke to my infectious disease doctor and he blew it off saying it would probably resolve itself.  It hasn't.  I went to the emergency room on October 24, 2021 because it went to my face on October 23 and got steadily worse.  I had trouble breathing as well.  The doctor put me on steroids and antibiotics, which gave me relief for a few days and then the hives came right back.
Awful..terrible  itchy rash similar to poison ivy that has lasted from 2/14/21 until today 06/20/21.  I have been to dermotoogist twice with very little relief. I have tried every lotion known including one prescription one.
After she took the shot she went to sleep she had difficulty of breathing . 2 weeks later when she was at daycare at nap time she had a seizure. EMS was called and child was taken to ER. Mother was told it will go away. 14 days later the seizure happen again. Child was taken to the ER again. Parents was told that there was nothing abnormal in her body. All this started happening after she took the vaccine. She is still having these seizures.
Vaccine expired on 09/04/2022. two days before administration on 09/06/2022 didnt catch it prior to administration refreshed account after administration and vaccine was counted as valid so did not think it needed to be readministered with different vaccine.
Information has been received from a registered nurse concerning a 35 year old female with atropine, tetracycline, phenergan and aspirin sensitivity and a history of seizure who on 02/09/2001 was vaccnanted with a first dose of hep b vaccine recombinant IM in the right upper arm. There was no illness at the time of vaccination. The registered nurse reported that the pt presented on 04/12/2001 for her second hep b vaccine recombinant; however, prior to receiving the injection, reported that as a child, she wasn't able to complete her series of any childhood immunizations due to convulsions after the second or third doses. The pt reported that approx. 27 hrs after receiving the vaccine on 02/09/2001, she experienced soreness and discomfort across the shoulders and neck. This soreness was accompanied with enlarged cervical glands. The registered nurse reported that the pt reported that the most intense discomfort lasted 10 days with vague discomfort lasting approx. one month. She also reported that there was no reaction at the site of injection. In follow-up the pt reported to the registered nurse on 04/12/2001 that she is experiencing no symptoms at present time. No further info is available.
No adverse events with the patient. This immunization was administered by a certified immunizing technician (they can only give Flu and COVID shots) instead of the pharmacist.
Pronounced (but non-allergic-appearing) swelling, redness, soreness at injection site.
Same day: diarrhea (2 events); headache, chills, sleepiness, feverish feeling.  Following day and night: joint aches, severe nighttime sweating, fever (temperature not taken)
Extreme joint pain around injection site and entire left side of my body. Shingles  along my right side torso
Initial report received from a non-healthcare professional on 14 OCTOBER 2014. A 65-year-old female patient, whose medical history was reported as unknown and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE QIV, (batch number: UT158AA, expiry date unknown and cycle in series not reported) in left deltoid on 08-OCT-2014. On 08-OCT-2014, patient experienced tingling, red/thick and hot to touch and itchy. All symptoms are gone. Illness at the time of vaccination was reported as unknown. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none.
FEVER; CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (had few beers today). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. Batch number for covid-19 vaccine ad26.cov2.s cannot be requested as reporter unable to follow up. No concomitant medications were reported.  On an unspecified date, the subject experienced fever and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
I've noticed, she was not acting like her normal self when I took her to the doctor four days before she passed. I explained to the doctor about these mysterious spots that had shown up on the white part of the eye. The doctor diagnosed it as a eye injury, gave me antibiotics and sent us home. She died four days later. I feel the spots could have been her brain hemorrhaging.
INFECTION DUE TO VACCINE SWOLLEN, HARD, TENDER TO THE TOUCH, REDNESS (GROWING) PATIENT VISITED URGENT CARE FACILITY WHERE SHE WAS GIVEN A COURSE OF ANTIBIOTICS. UPON REPORTS FROM PATIENT, THE INJECTION SITE APPEARS SLIGHTLY BETTER.
Red splotches on face and lips-it burns, itches and is painful. Red on left arm shingle shot given in right arm. Shot given 1pm 6-28-15 and got reaction few hours later. Went to doctor 6-30-15 and received BENADRYL, ZYRTEC and ZANTAC.
3 days after receiving vaccine, rash developed at injection site that quickly spread to both arm then both legs. Rash started as red bumps and itchy patches on both arms, legs, neck and trunk and now forming clusters of fluid filled blisters on both hands. Rash progressed over three weeks with no improvement until I finally went to Urgent Care and was given a Prednisone Taper and Triamcinolone 0.1% cream.
Vaccination administration error - patient is only 15 and received Moderna bivalent booster that is only approved for 18+
I day after shot, a warm swollen raised red area appeared around injection. Since then, the spots have been increasing in number and size
Severe rash with hive type welts on top of the rash. Extremely itchy. It appeared as a rash with welts covering the right side of rib cage and has progressed to covering scalp to ankles.
The pain started on the upper chest cavity right below the ribs, on both sides. The pain was sharp and throbbing. After a couple of days of the initial start of the pain, it moved to purely the mid-abdomen on the right side. After the second dose of the Pfizer vaccine, the next day pain was more intense, centered on the center-right abdomen. Up to the current date (1/19), the pain has now been centered around the lower pelvis on the right side.
Per vaccinating nurse, LPN written report to this Charge Nurse, RN: ?At 1042am (3rd dose) patient mother did not secure child's leg properly. Child moved leg out, needle came out. No vaccine was administered. Was 2nd nurse working with me, she went and advised Charge Nurse and Site Supervisor, as well as draw nurse. Vaccination site was inspected by both nurses, needle intact, no injury, advised to use other leg. 2nd attempt successful at 1050am.  Second Nurse, RN and pediatric draw nurse was, RN. Site Supervisor, RN advised spoke with the family and advised vaccinating nurse, LPN, who stayed with the patient the whole time, to vaccinate the opposite leg at the left thigh site which the nurses reported to Charge Nurse, RN as successful. Patient tolerated post-observation well, patient walked out of clinic safely with parent.
Vaccine administered to patient 10-13-2010. Patient was admitted to hospital 11-28-2010. Patient's wife stated he was paralyzed from face to toe and was diagnosed with Guillian Barre Syndrome after 4 days of being in the hospital.
10 days after my first shot I have been experiencing dizziness, headaches, increased blood pressure, muscle pain, fatigue, difficulty breathing
Feeling like crap; Fever of 101; A spontaneous report was received from a male patient of unknown age concerning himself, who received their first of two planned doses of mRNA-1273 and experienced a fever of 101 and feeling bad.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On an unknown date in Dec 2020, the patient experienced  fever of 101 and felt bad. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, a fever of 101 and feeling bad were unknown.    The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Information has been received from a physician and a registered nurse concerning an 8 year old female student with no allergies and no past medical history who on 09JUN1998 was vaccinated with a dose of varicella virus vaccine live. It was not known if there was illness at the time of vaccination. On 10NOV2003, the pt returned to the office with "full blown" chickenpox. The pt was diagnosed with varicella and an onset date of 07NOV2003 was noted. On 17NOV2003, the pt recovered. The reporter mentioned that several of the pts classmates had chickenpox two weeks prior to her breakout. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Additional information is not expected.
covid test date 30Dec2021 covid test result Positive; covid test date 30Dec2021 covid test result Positive; Pfizer-administration date 06Apr2021, dose number 2; Moderna vaccine same date vaccine date 06Apr2021; Pfizer-administration date 06Apr2021, dose number 2; Moderna vaccine same date vaccine date 06Apr2021; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from regulatory authority.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm right, administration date 06Apr2021 (Lot number: 066F217) as dose 3  (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Bone Spurs" (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing); "adhesive tape" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL HFA; AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]; BUDESONIDE; ALPRAZOLAM; ESCITALOPRAM; SERTRALINE; TRIAMTERENE HCTZ; PANTOPRAZOLE; METHOCARBAMOL; MONTELUKAST; KLOR-CON M20; ONDANSETRON; LISINOPRIL; MELOXICAM; OXYCODONE AND ACETAMINOPHEN; TRIAMCINOLONE; GABAPENTIN; VIT D3; VITAMIN C [ASCORBIC ACID]; FLUTICASONE; BREO ELLIPTA. Past drug history included: Cephalosporins, reaction(s): "known allergies: Cephalosporins"; Gentamicin, reaction(s): "known allergies: Gentamicin"; Erythromycin, reaction(s): "known allergies: Erythromycin"; Floroquinolones, reaction(s): "known allergies: Floroquinolones"; Asparagus, reaction(s): "known allergies: Asparagus". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Rash on both hands". The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (non-serious) all with onset 06Apr2021, outcome "unknown" and all described as "Pfizer-administration date 06Apr2021, dose number 2; Moderna vaccine same date vaccine date 06Apr2021"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "covid test date 30Dec2021 covid test result Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, covid-19, off label use and product use issue with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Information has been received from a Registered Nurse (R.N) concerning a 23 year old male patient who on 21-OCT-1986 and on 15-JUL-1991 was vaccinated with the first and second doses of MMR II. It was reported that the patient had had a rubella titer which indicated no immunity. The doses were given at another facility. At the time of the report no symptoms have been reported. Additional information has been requested.
swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were tender; Body ache; Had low grade temp fever 99-99.5; Terrible headache; Fatigue/ tiredness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 29Dec2020 12:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication included levothyroxine sodium (SYNTHROID). On 30Dec2020, approximately 12 hour started with body ache; from 18 hours to 30 hours, patient had low grade temp fever 99-99.5 (I usually run 97.50), body ache, terrible headache, fatigue, tiredness- slept all but 3 hours throughout day, sore arm at injection site with warmth, swelling and redness. On day 3-4, the patient had swollen lymph nodes in right armpit  that were tender. By day 5, the patient felt back to baseline. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
Incredible Dizziness; Vertigo; This is a spontaneous report from a contactable consumer reported for self. A patient with unspecified age and gender received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Batch/lot number: unknown, Expiration date: Unknown), via an unspecified route in the left arm on Monday, 24May2021 at 16:15 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 30May2021 today at 13:00, patient experienced various side effects which included incredible dizziness and patient can barely keep eyes open. When paraphrased the concern, patient stated vertigo. It's been 7 days since patient had the first vaccine. Patient wanted to know if it can be a late side effect. It was unknown if the patient received any treatment for the events. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She was out from work for 1.5 days) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age 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 OROPHARYNGEAL PAIN (Sore throat), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She was out from work for 1.5 days) and PAIN IN EXTREMITY (Sore arm). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She was out from work for 1.5 days) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant medication was not provided.  Reporter's daughter had a drastic reaction after vaccination.  Treatment information was not provided.
Mom notes that in February he started to complain about random headaches and had never had headaches before. In March 2023 he had a high fever and HA of unknown cause. Sx resolved. In May 2023 he had high fever and HA of unknown cause that then progressed to seizures and a working diagnosis of autoimmune encephalitis.  He has had seizures, personality changes, auditory and visual hallucinations. Mom feels like symptoms began after the covid vaccination series, severe sx didn't start until about 5 months following the vaccination
Began with headache, aching in arm, across upper chest, dizziness, weakness; within 3 hours, very weak, very hot and feverish yet cold with chills, shaking, very tired.  Slept for 2 hours layered in clothing and blankets.  Chills subsided by 9:00 pm. Sweat profusely overnight. Felt okay next morning.
STARTED AT 1AM 1/8/2021 WITH CHILLS, STRONG HEADACHE, MODERATE GENERALIZED MUSCLE PAIN, PAIN LEFT ARM WITH ABDUCTION. LOWER BACK PAIN, MALAISE AND FATIGUE
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Mild, Additional Details: numbess and tingling of the right arm
Information has been received from a physician concerning a 7 month old patient who on 11-APR-2007 was vaccinated with the first oral dose of rotavirus vaccine (human-bovine). On 16-APR-2007 the patient developed loose stools and a decrease in appetite. Since 16-APR-2007, the patient alternates between loose multiple stools and constipation. Prior to the vaccination, the patient was eating 6 ounces of formula every 4 hours and at the time of the report was eating 4 ounces every 6 to 8 hours. The patient was examined by the physician on 23-APR-2007 and was noted to be alert and playful. The physical examination was benign. Additional information has been requested.
Fever 102; (lasted only 24h) chills, headache, pt has been taking APAP.
High fever; Swollen lymph node; This is a spontaneous report from a contactable nurse, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 14:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, legs restless, anxiety, depression, hypertension and COVID-19. Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), semaglutide (OZEMPIC), propranolol (MANUFACTURER UNKNOWN), pramipexole dihydrochloride monohydrate (MIRAPEX) and citalopram (MANUFACTURER UNKNOWN) all are for an unknown indication and started from an unspecified date. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 19:00, the patient experienced high fever and swollen lymph node. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events high fever and swollen lymph node was recovering, at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reported vomiting two times, approximately one and two hours after vaccine was administered.  Recommended rest and for patient to see physician.  Patient was monitored for worsening symptoms.
Bleeding anywhere from 3-7 days every 3 weeks. Started exactly at the 2 week mark of my second shot (at which time I'm considered fully vaccinated), and was not experiencing bleeding at all since I was prescribed Nexplanon in September of 2020 up until May of 2021. Am also experiencing incredible abdominal pain that's becoming increasingly worse each time I experience bleeding.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date in March 2017, the patients were administered improperly stored doses of GARDASIL 9 lot # M041212, expiration date 21-JUN-2019 for prophylaxis. The doses were stored at temperatures in the range of 32 degrees Fahrenheit to 35 degrees Fahrenheit (34 Fahrenheit) for a time frame of 4 hours; 36 degrees Fahrenheit to 46 degrees Fahrenheit (35.8 Fahrenheit) for a time frame of 12 hours. There were no previous temperature excursions. The call was not because of a data logger. No adverse effects were reported. No further information was provided. This is one of the several reports from the same reporter. Follow up information was received from nurse on 25-AUG-2017. The nurse stated that it was determined that they did not have a temperature excursion and the state was looking at wrong records. Sender's Comments: US-009507513-1707USA002699.