chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm sore at injection site; Headache; Tiredness; feeling ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 10:15 (Lot number: EN6203) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "perimenopause" (unspecified if ongoing); "depression" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: PROGESTERONE; ARMOUR THYROID; PROZAC; CETRIZINE. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot unknown: False, Administration date/time: 03Mar2021 10:00 AM, Anatomical Location : Arm Left, Dose Number:1), administration date: 03Mar2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "arm sore at injection site"; HEADACHE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Tiredness"; ILLNESS (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "feeling ill". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue, illness.  Additional information: The patient was administered COVID-19 vaccine in clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination was Progesterone; Armor Thyroid; Prozac; OTC certirizi. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No any allergies to medications, food, or other products. The response received for the query that aware of feeling ill on the 25Mar2021. The next day, on the 26Mar2021, felt better, returned to work & submitted the noted report.  No follow-up attempts are possible. No further information is expected.
945AM rash on arms, hands & fingers then itching; wheezing for short time- 15 mins (like as if had exercised & got out of breath); rest & fluids; mom to call MD & check on DPH;This report was compiled @ 1115AM; mom was told 1015 to call MD;
17 minutes after injection, .  Moved to a clinical room.  BP initially elevated and tachycardic.  Respiratory rate and pulse ox normal.  Patient given oral Benadryl, IM epi and IV Solu-medrol.  HR slowed and patient became hypotensive.  IV fluids initiated.  Patient observed for a couple of hours and discharged home.  Patient called her allergist who initiated steroids and continuous histamine blockers.
platelets are still below 4K; Bruising; This case was reported by a physician via sales rep and described the occurrence of contusion in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   On 23rd May 2019, the patient received Shingrix and Hepatitis A vaccine. On 23rd August 2019, 92 days after receiving Shingrix and Hepatitis A vaccine, the patient experienced contusion. On 24th August 2019, the patient experienced platelets decreased. The patient was treated with rituximab (Rituxan). On an unknown date, the outcome of the contusion and platelets decreased were unknown.   It was unknown if the reporter considered the contusion and platelets decreased to be related to Shingrix and Hepatitis A vaccine.  Additional details were provided as follows: The age at vaccination was not reported applicable for this report. The patient received Shingrix and went to dentist and developed bruising. The patient had intravenous immunoglobulin and steroids therapy. The off treatment down. The patient had platelet booster and rituximab (Rituxan) and still platelet was still below 4k.
After receiving flu vaccine (Aventis) shortly after, nose, mouth, cheek, became red, itching: after work, arm was very red, swollen 2x2" : also had angio edema to right side of face. Had had flu vaccine in past  6 years.
Approximately a week after getting the shot I started to experience tinnitus (pulsatile) in both ears.
Dose administered to 10 patients after more than 30 days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30 days of storage in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter who was an HCP stated that they found there were 4 vials form Moderna COVID-19 vaccine that were stored on the fridge for more than 30 days prior to first use. Vials were stored in the fridge since 22-Dec-2021. It was reported that the HCP didn't know if any of the patient experienced any symptoms.  It was also reported that the reporter did not know if the patient was under any concomitant or regular medication and had no information about the clinical history of the patient.  The expiration date of vaccine reported was 25-Mar-2022.  No treatment information was provided.
Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Consumer reported developing 5-8 lesions following VARlVAX administration.; This spontaneous report was received from a nurse practitioner, referring to a 7-year-old female patient. The patient had no pertinent medical history, previous drug reactions, allergies, or concomitant medications.   On 28-JAN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliter (ml) by subcutaneous route (lot number T022315 which has been verified to be valid, expiration date reported as 30-JAN-2022, but upon internal validation established as 30-JUN-2022) (vaccination scheme and anatomical site of injection were not reported) as immunisation. Sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) was reported, however, no information was given regarding the use of it.   On 28-JAN-2021, following the administration of varicella virus vaccine live (Oka/Merck) (VARIVAX), the patient developed 5-8 lesions (ill-defined disorder). The patient sought medical attention, however, no treatment was given for the event. In addition, no laboratory diagnostic studies were performed.   The outcome of the event ill-defined disorder was unknown by the reporter. The causality assessment between the aforementioned event and therapy with varicella virus vaccine live (Oka/Merck) (VARIVAX), was not provided.
tested as follow up to known exposure from roommate, asymptomatic, tested positive on Abbott ID Now molecular test has had 3 doses of pfizer, due for bivalent booster
Initial report from a healthcare professional on 20/Jun/2006.  An 18-month-old male  baby developed a hardened lump at the injection site with 24 hours of receiving the subcutaneous injection of the fourth dose of Tripedia, lot number U1400DB (expiry date 24/May/2007) in the left thigh on 01/Jun/2006.  Per reporter the patient had no illness at the time of vaccination.  No diagnostic tests or laboratory work was performed.  Reporter stated that the injection was given subcutaneously instead of the recommended route of intramuscular.  At the time of this report the patient had not recovered.
TOOK ONLY ONE DOSE; This spontaneous case (PVX2019-765) was received from a pharmacist on 29-Mar-2019. It describes a female consumer who "took only one dose", while being on Vivotif for an unknown indication.   Case report: The consumer only took the first dose of Vivotif and missed the other 3 doses.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took only one dose" was unknown.  Company's Comment: The causality of the event "took only one dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose" was considered as not applicable.
GOT VERY SICK; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. 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 (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced got very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got very sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220236638 and 20220236731.
6 year old patient was administered a COVID-19 vaccine 6 months to 4 years.
Area of swelling approximately 3 inches in diameter around injection site with significant pain, redness and hot to the touch. Area increased in severity on day two. On day three area remains the same but swelling has progressed to neck, face and eye on left side, same side as shot was received.
3 hours after taking the HPV vaccine (1st dose), my son started feeling a heavy headache. The next day, he kept feeling the headache but not too heavy. On Saturday night, 9/11/21 at 9:00pm he felt a heavy headache again and at 11:30 he had a seizure. Paramedics came to take care of him and they took him to Emergency.
Fever & Diarrhea Narrative: onset of diarrhea and chills at about 36 hours post
Systemic: Seizure-Severe, Systemic: Weakness-Severe, Additional Details: Janssen vaccine given at 05:44pm. patient reported that she felt faint about 1 minute later. provider went over to patient to attempt to help her to exam table. patient's head went back, eye rolled back, arms and legs became rigid. provider placed her hand behind patient's head to avoid injury and yelled for nurse. What looked to be a seizure lasted approximately 20 seconds. Nurse entered room. Patient became alert but was confused and incoherent. 5:52EMS called.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported. On 29-MAR-2019, the patient was vaccinated with one dose of improperly stored VARIVAX (lot # R018780, expiry date: 01-JUL-2020) for prophylaxis (dosing details, dose number, route not reported) (product storage error). The vaccine underwent temperature excursion from -14 degree Celsius to -10 degree Celsius (- 12.5 degree Celsius) for a time frame of 2 hours 15 minutes. There was a previous temperature excursion which was between - 9 degree Celsius to 8 degree Celsius (- 5.1 degree Celsius) for 1 hour 15 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) identified. This is one of several reports received from the same reporter.
Pt w/an episode of SVT 2-3 hrs p/DPT; subsequently devel cerebellar ataxia - 3 days from DPT; evaluation is underway currently;
mom called reporting fever 102 p/giving APAP; pt was taken to ER 20AAPR93 PM w/fever 103.7 x-rays were clear; ENT examined - fine; was sent home to cont APAP;
Redness measuring 5 cm x 2 cm left arm warmth, itching at site.
On Thursday 6/9/2022 patient was seen at the office  for ADHD and 1st booster COVID-19 vaccine dose. The provider examined and saw the patient and ordered the COVID-19 Pfizer vaccine for 12 and over to be administer to the patient. The medical assistant failed to verify the doctor's order or the patient's age and prepare and administered the patient 10mcg/ 0.2ml dose for 5-11 years of age at 02:18pm. The medical assistant realize the error when she began to document the vaccine in the medical record,  she immediately went ahead and notify the physician, the manager and the director of the vaccines. The patient did not suffer any adverse effects for the administration of the COVID-19 Pfizer vaccine for 5-11 years old.
At 6 pm I started feeling tingling/prickly sensations around my body in different areas lasting about 1 sec each time.
Local RXN left arm.  Pt said initially itchy and did scratch.  Noted more redness yest and 2 blisters today.  14 X 17 cm area of cellulitis with 2 vesicles to post lat left arm.
Shot given in left arm on Thursday. By Friday very sore to move. On Saturday extremely sore and red blotches (hives?), raised, swollen and hot to touch. Symptoms lasted almost 1 week.
My daughter had serious problems with her period had to be put on birth control, and now she is in the hospital with depression at 14 years old she never had this problem until after she had this shot, I wish I had never let her get this shot, and now she will have to take medicine for depression and anxiety for we don't know how long I just know that she never had this problem until after she had this shot.
A nurse reported the occurrence of possible seizures in a 4 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history, concurrent conditions, or concurrent medications. The subject had experienced no adverse events following previous immunizations. On 12/9/02, the subject received his first injection of Infanrix (574A2). On the same date, he received an injection of Haemophilus influenzae type B conjugate vaccine (manuf unk). Approximately one hour later, the subject experienced a possible seizure. He was taken to the local ER. The reuslts of two electroencephalograms were reported as normal. As of 1/29/03, the event had resolved. The reporting physician considered the event to be possibly related to Infanrix administration. The Infanrix immunization series was discontinued. The reporting physician considered the event to be non-serious; however, seizure is considered medically serious (OMIC).
Mother states that the patient developed fever 100.3 F and a generalized, erythematous rash, cephalocaudal spread, some conjunctival erythema and nasal congestion.
BELLS PALSY; SORE THROAT PAIN; DENTAL PAIN; CANKER SORE; This spontaneous report received from a patient concerned a 56 year old female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperlipidemia, and penicillin allergy, and patient was allergic to wycampin. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, isoniazid, and atorvastatin calcium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: 05-AUG-2021) dose was not reported, 1 total administered on left arm on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the patient experienced sharp ear pain, sore throat pain, dental pain, canker sore, taste issue, drooping left eye, and left side of head pain for which patient visited physician office and emergency room. On 21-JUN-2021, the patient was diagnosed with Bells palsy. Patient had been in contact with the health care professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bells palsy, sore throat pain, dental pain and canker sore was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210664608-covid-19 vaccine ad26.cov2.s -Bell's palsy . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On March 4th , I developed a skin rash and hives at about 0530PM in the evening. I immediately took Benadryl 25mg because It hoguth it was some sort of allergic reaction. I ended up taking it through the evening. I called the doc's office on March 7th because I could barely lift my shoulders off the bed. They were so weak. I was able to get in March 10th. Blood was drawn at that time. They tested me for an egg allergy but that was ruled out. They don't know what caused it but she was very concerned with a couple of the lab results. Because the thyroid blood lever was high, she wanted me to start on Synthroid. The other elevations were elevated were Fed rate and rheumatoid factor. She wanted me to see a rheumatologist.  I needed up going and everything was fine. On March 25th, it was noted that I had an abrupt onset of high blood pressure. So, I had to go through a battery of tests. Ultrasound, CT Scan, and I had to see a cardiologist. At that time, she wanted me to stop taking the Synthroid. Down the road, I had the thyroid level retested and there was no thyroid issue. From there, I saw a cardiologist. She put me on blood pressure medication but she still wanted me to see a cardiologist. I ended up on 4 medications total. I had to see an endocrinologist on May 10th. The only other thing she asked me to do, during an April 25th visit, my oenophiles were elevated. She referred me to a hematologist that I say on June 1st. Everything came out OK there. I'm not taking Lisinopril, Chlorthaledone 25mg 1xday, Amlodipine 5mg 2xday, Spironal Lactone 25mg 1xday.
covid vaccine breakthrough event  all Moderna dose 1   3/1/21 010A21A dose 2   3/29/21 018B21A dose 3   11/9/21 049C21A dose 4   4/18/22 065K21A
Itchy, hot rash broke out the night of the vaccination on elbows, moving the buttocks and then ankles.  Feet sweating profusely.  Lasted about 3 weeks.  After another week, jaw, shoulders and back starting aching.  Then right toes started tingling.  Muscle twitches and spasms occurred primarily in back at first, now all over.  The tingling progressed to both feet and some in the hands.  MRI of brain and spinal cord showed nothing but age related degeneration.  Blood tests all negative except ANA slightly elevated (133).  Neurologist put me on prednisone and Gabapentin.  Seemed to have little effect on pain and tingling.  Tingling has progressed to groin, back and stomach at times.  Pain persists in back, upper shoulders and neck.  Tingling especially in toes and exacerbated upon exercise and hot bath.  Neurologist just upped the dose of Gabapentin to see if it would alleviate the symptoms.  Another blood test for ANA will be done.
Arm (L) upper - Red, swollen, painful, hot to touch, itching. Temp 99.0, malaise. Prednisone burst 20mg x 3days x3; 3 days x2 3days x1 Hydroxyzine 25mg one every 8 hours.
Within minutes of being injected with my second dose I experienced ear ringing to what I know to be called Tinnitus. It hasn't stoped.
arm on the injection site got hot; arm on the injection site got red; arm on the injection site got swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm on the injection site got hot), VACCINATION SITE ERYTHEMA (arm on the injection site got red) and VACCINATION SITE SWELLING (arm on the injection site got swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm on the injection site got hot), VACCINATION SITE ERYTHEMA (arm on the injection site got red) and VACCINATION SITE SWELLING (arm on the injection site got swollen). At the time of the report, VACCINATION SITE WARMTH (arm on the injection site got hot), VACCINATION SITE ERYTHEMA (arm on the injection site got red) and VACCINATION SITE SWELLING (arm on the injection site got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information reported. No relevant concomitant medications were reported.   Reporter did not allow further contact
seizure activity occurred after patient left the office.  When vaccines were administered, patient did stay in the office for 15 minutes to monitor.  Parents call the office to notify provider of seizure.  Patient has seizure disorder.
8 days after injection I was diagnosed with Local Cellulitis/skin infection due to swelling, extreme pain and redness at the injection site. My muscle area is swollen and I was given cefuroxime axetil 500 mg tablets to take twice a day to fight the infection.
Clt. was administered Varicella vaccine to left arm subcutaneous on 7/28/2009, without adverse event. Clt returned to facility on 7/29/2009 with onset of hardened, red area that measured approximately 2.5 by 2.5 inches. Area warm to touch denied pain to area and states symptoms started morning of 7/29/2009. Clt denied swelling or trouble breathing. No treatment taken. Clt and gaurdian educated that if worsens and swelling and trouble breathing occur to go to E.R, clt. and guardian verbalizes understanding.
Pt recv vax on 12/8/98; pt exp SIDS 12/30/98
hands and feet are ice cold; This case was reported by a consumer via interactive digital media and described the occurrence of cold hands & feet in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2021, the patient received Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced cold hands & feet. On an unknown date, the outcome of the cold hands & feet was unknown.   It was unknown if the reporter considered the cold hands & feet to be related to Shingrix.  Additional information was provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not provided. The patient received Shingrix shot and developed ice cold hands and feet. The reporter did not consent to follow up.
Approximately 5 weeks post vax, left thumb began to "pop" when bending at middle joint. Approximately 1 week later the sensation of swelling was felt (not at site) in thumb and fingers. This sensation is mild during the morning, but worsens as the day progresses. Within several days, the pt began experiencing aches in left elbow with shoulder joint 2 days later. Pt has experienced pain in right foot, mainly in joints of 1st two toes beginning with big toe. All symptoms remain today. No treatment received.
C/O arm tingling and hurts as well as headache. Monitored for approx 45 min-TC to mom. Notified of sx. Mom stated child could return to class. She would watch and have eval. if sxs persist/worsen.