chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an 85 year old female with no pertinent medical history who on 13JAN2004 was vaccinated wit a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. On 13JAN2004 the patient developed "swelling, itching and hot around injection site". The patient was told to put ice on the affected area. The outcome is unknown at this time. Unspecified medical attention was sought. There was no product quality complaint. No laboratory diagnostic studies were performed. The reporter also indicated that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Fullness in ears, pain in ears, palpitations, dizziness. Going for CAT scan next month and allergy test, all started with first jab, then went away until after I got the third shot, the booster.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (hospitalization), DRUG INEFFECTIVE (hospitalization), outcome "unknown" and all described as "COVID-19". The patient was hospitalized for covid-19, drug ineffective (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ALLERGIC REACTION; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, breast cancer, hypothyroid, atrial fibrillation, morphine allergy, penicillin allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, clopidogrel bisulfate, and salbutamol. On an unspecified date, the subject experienced allergic reaction. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566.
Vertigo, dizziness, balance impairment which caused me to be unable to work, lightheadedness, nausea, fatigue, headache, sinus congestion. At doctor appointment on 03/26/2021 I was given Augmentin for possible sinus infection (which was ineffective and was replaced with Levoquin on 04/01/2021) , Meclizine for dizziness/vertigo, Ondansetron for nausea. My symptoms started as sinus pain/pressure, vertigo/dizziness/balance issues on 3/25, went to doctor 3/26, symptoms worsened 3/27, 3/28, 3/29. Symptoms of vertigo/dizziness/ balance issues were up and down after that while the nausea improved, and the sinus pain/pressure remained.
painful arm for 1 to 2 days and after 3 days paitent both eyes were red (blood shot) and and the left eye has redness and bottom of eyelid  is brown to red spot.
became completely paralyzed/couldn't move or talk, just tears flow through eyes; Began a horrible pain in patient's arm; Began a horrible pain in patient's arm and immediately went through patient's whole body; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left, on 01Apr2021 13:45 (at the age of 60-year-old, not pregnant) as single dose, for covid-19 immunisation. Medical history included lupus, asthma, lupus anticoagulant, stroke, allergies to sulfa and iodine. Patient did not have COVID prior vaccination. Concomitant medications included alprazolam (XANAX); valsartan; apixaban (ELIQUIS); vitamin D nos (VIT D); and magnesium probiotics. No other vaccine in four weeks. The patient previously took morphine, codeine, hydromorphone hydrochloride (DILAUDID) and oxycodone hydrochloride;paracetamol (PERCOCET), all experienced allergies. On 01Apr2021 22:00, the adverse events began at time for sleep. Began a horrible pain in patient's arm and immediately went through patient's whole body and patient became completely paralyzed. Patient couldn't move or talk, just tears flow through eyes. It lasted about 24 hrs and the slowly it took 2 day for the pain to leave. Events resulted in life threatening illness (immediate risk of death from the event. The patient underwent lab tests and procedures which included Sars-Cov-2 test (Nasal Swab) was negative on 07Aug2021. Therapeutic measures were taken as a result of events included muscle relaxants and paracetamol (TYLENOL). The outcome of events was recovered in 2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events paralysis, pain in extremity, and pain the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Spots noticed on 3-21-04- came to our office 3-24-04 with papular pustules and oral lesions. No fever.
Approximately 5 minutes after the immunization, patient felt light-headed and weak and fell to the ground. Patent was aided to sit down on a chair and a pharmacy staff offered a bottle of water and patient rested for about 10 minutes and walked away voluntarily without any further problem. We informed patient of any further adverse reactions in the future.
The patient developed erythemaous, pruritic rash over face, neck and upper chest, 5 mins after injection Treated with Diphenhydramine 50 mg IM. Syntoms disappeared after 15 mins of itratment Diphenhydramine 50 mg tabs.: 1 tab PO q. 6 hrs prescribed
FATIGUE, BODY ACHES, FEVER, FACIAL SWELLING, CHILLS/FEVER/SWEATS, NAUSEA, SORE THROAT
This case was reported by a other health professional via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. Concomitant products included Pneumococcal vaccine and FLUAD. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell, feels awful, inability to work and diarrhea. On an unknown date, the outcome of the feeling unwell and inability to work were recovered/resolved and the outcome of the feels awful and diarrhea were unknown. It was unknown if the reporter considered the feeling unwell, feels awful, inability to work and diarrhea to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The physician assistant reported that vaccinated patient was sick for 5 days and missed work for 3 days. The patient felt terrible along with diarrhea. The reporter did not agree to follow up from GlaxoSmithKline but gave permission to follow up preferably with the affected patient.
Approx. 3 hrs after shot pt. had throat swelling, eyes & face swelling, fluid retention in face, hands and gas type pain.
Information has been received through the pregnancy registry through a 23 year old female consumer who on 12-OCT-2007 was vaccinated with her first dose of Gardasil.  There was no concomitant medication.  On 20-OCT-2007, the patient had a pregnancy test which was positive (LMP approximately 25-SEP-2007).  The patient reports visiting the emergency room after finding out she was pregnant because she was experiencing some bleeding and spotting.  The patient had a "HCT Quantitative test" (not further specified).  She was not admitted to the hospital.  The patient reports having an "x-ray of hip while pregnant" (not further specified).  Additional information has been requested.
I got my second Pfizer COVID-19 shot on 4-15. I began noticing a swooshing noise in my ear, like I can hear a gear moving or blood pumping in my right ear, or tinnitus, during the day and when I was trying to fall asleep on 4-21. It has been almost consistent daily since then - most commonly at night as I try to go to sleep, but sometimes occasionally during the day. I often spend times during the day in silence while working and do not hear it. I have been playing white-noise to drown it out to go to sleep.
pt devel immed urticaria;seen by MD given DPH w/good results monitored for next hr;
slept all day after the second dose; feeling bad; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept all day after the second dose), FEELING ABNORMAL (feeling bad), PYREXIA (fever) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (chemotherapy for a blood disorder.).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-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 HYPERSOMNIA (slept all day after the second dose), FEELING ABNORMAL (feeling bad), PYREXIA (fever) and CHILLS (chills). At the time of the report, HYPERSOMNIA (slept all day after the second dose), FEELING ABNORMAL (feeling bad), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-285683 (Patient Link).
Patient received a total of 6 COVID-19 vaccines. Patient received first two doses of Pfizer on 02/08/2021 and 03/01/2021 per hospital medical records. Patient received Pfizer booster on 08/07/2021. Patient received second set of Moderna vaccines on 09/04/2021 and 10/02/2021. He also received a Pfizer booster on 01/11/2022.
INJECTION SITE REACTION (had 2 vaccines Thursday, left IM site red and swollen and 6/10 pain on palpation, right side slight red) and HEADACHE. HPI: Patient is a 14 Y male with a h/o VSD and AP window repair who presents c/o Redness, swelling, pain over his left deltoid, patient received a vaccine there yesterday. Patient also has fever today, and some streaking towards his armpit.  Endorses nausea, no vomiting. Denies abdominal pain, diarrhea. No URI symptoms. No chest pain or shortness of breath. Patient also notes that his veins are darker colored on the left.
At time of event in 2006, 26 y/o M who received his primary smallpox and anthrax vaccines on 24 APR 2006. Around 3 MAY, he developed a prodromal syndrome with chills, headache, and body aches. On 6 MAY 2006, he awoke with mild pain (2/10) over his left nipple area. As the day progressed, his chest pain spread to the entire left side of his chest, and increased in pain intensity to 5-6/10. His pain was described as nonradiating. nonexertional, dull "pressure around heart". There was no change in his chest pain with changes in position or deep breaths. He denied any shortness of breath, but reported his chest felt "tight". No accompanying symptoms were reported in his records. Patient was initially evaluated at the ER where he had ECG changes and elevated cardiac enzymes. He was admitted to hospital x 1 day before being transferred to another hospital. He was placed on limited duty, and was prescribed lisinopril 5 mg daily. Patient continued Cardiology follow up at hospital, until he was discharged from employment. He denies any recurrence of chest pain since initial episode.
Information has been received from a nurse practitioner concerning an 18 year old female who was vaccinated on 01-JUN-2007 with a third dose of Gardasil. Subsequently on 05-JUN-2007, the patient experienced abnormal bleeding and spotting. Unspecified medical attention was sought. The patient's abnormal bleeding and spotting persisted.
On third day had extreme pain in abdomen (felt like huge air bubble) for 24 hours; Saw acupuncturist, which helped relieve it; then for 4 weeks was extremely fatigued....I am healthy and exercise regularly and I could not do anything like shop, cook, except briefly....less than 2 hours and then would  need to lay down to recoup.....no energy at all...the stress and not knowing what was happening increased my blood pressure and my anxiety greatly.  After 4 weeks, energy began to come back gradually over the next two weeks. Am now fine.
Pt complained of n/v and severe chest pain, we monitored him 15 minutes more. GCS: 13, alert and responsive.  He appeared dehydrated, we provided water for him. EMS evaluated him, vital signs appeared normal, EKG was normal sinus rhythm, MD examined him, stated no pulmonary or cardiac abnormalities. Pt requested for further hospital evaluation.  Ambulance accompanied him to hospital.
Initially, I had redness and soreness at the injection site (back of right arm) which eventually covered the entire back side of my right arm from shoulder to elbow.  Approximately, 24 hours after receiving the injection, I had facial flushing, hot feeling on the face and ears, and elevated blood pressure.  On December 17, 2012, my blood pressure was elevated to the point of requiring emergency room treatment.  My body temperature dropped to 92.5, my face was flushed, and my face and ears were hot. On December 20, 2012, I began to have symptoms of a cold and upper respiratory infection; these symptoms lasted until January 2, 2013. On December 31, 2012, January 5, 2013, January 7th, 2013, January 9th, 2013, and February 5, 2013, I had to go to the ER because of elevated blood pressures around 220/115 and elevated heart rate (140). Around the end of March, 2013, my symptoms started to subside, with the exception of elevated heart rate, which persists until today. My doctors determined I had a reaction to the shingles vaccination which affected my autonomic nervous system.  For 90+ days, I did not perspire, I had very low body temperature, extreme fluctuations in blood pressure, rapid heart rate, loss of sense of smell, severe flushing, feeling hot on face and ears.
pt recvd vax & 2 wk later mom noticed sz; described as eye roll to back of head then followed by shaking, then sleeps for 3 or more hrs;
HCP said that 606 doses were given after expiration date.; Product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.) and PRODUCT STORAGE ERROR (Product storage error) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (Product storage error). On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were reported. Vials were placed in refrigerator on 28-Dec-2021 No temperature excursion was reported.
Within 2 days post vax, pt developed a quarter sized demarcated lesion with tiny blisters surrounding a large center blister at the injection site.  The physician indicated that it appeared as ringworm in appearance.
Small knots all over the body; Very itchy knots; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Small knots all over the body) and PRURITUS (Very itchy knots) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced NODULE (Small knots all over the body) and PRURITUS (Very itchy knots). At the time of the report, NODULE (Small knots all over the body) and PRURITUS (Very itchy knots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included diphenhydramine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Cough  ? Generalized Body Aches  ? Nasal Congestion   LMP 06/27/2021/EDD 04/03/2022 25 y.o. G1P1001 IUP, 6w0d, Estimated Date of Delivery: 4/3/22.
A report has been received from a health professional via medical representative concerning a 9 year old female patient. The patient's relevant history, concomitant medications and concurrent diseases not reported. The patient received nasal FLUMIST Quadrivalent on 13-JAN-2015. The patient came back to the office on 23-JAN-2015 with flu-like symptoms. She also developed fever. Patient tested Influenza A. She was prescribed TAMIFLU on 23-JAN-2015. The patient's temperature was 102.7F on 23-JAN-2015. The nurse also stated the patient received FLUMIST several times in the past without problems. Action taken with FLUMIST Quadrivalent was unknown. The outcome of the event of influenza A and fever was unknown. The reporter assessed the event of influenza A to be non-serious. The company physician captured the event of fever from source document and assessed it as non-serious.
On the day of the vaccination, 02/19/2021 my arm was sore and I had a fever. The next day I was very very tired and the arm had a large, red swollen area (4 inches) around the injection site. The next day I went to urgent care, they were going to give me antibiotic and they decided to wait 1 more day and it went down the next day on its own. The provider that was at the urgent site thought it might have been a poorly applied injection. The very next week, I have psoriasis, It's an autoimmune condition, but overnight it appeared very aggressively. It never comes on that fast. I went to dermatology, they treated it with a steroid shot, Kenalog and it took care of it. I have Alopecia and it suddenly got worse fast. It became noticeable in May. The doctor gave me the same steroid shot and asked me to use Rogaine. Till this day, there is no hair coming back and there is still some hair loss. The adverse event, I'm still working on, is I'm having irregular blood pressure. I have never been aware of having irregular blood pressure and I am currently working with my doctor on it. My blood pressure seems to drop when I stand or bend over.
Severe Headache with Nausea, Vomiting and Dizziness for several days. Had to go to ER due to dehydration and symptoms from vaccine etc. Even with hydration continued to be ill and in hsp for 2 days. Able to home and improved rapidly on Thurs.
Dizziness, Arthralgia, Fever, Diarrhea chills, weakness, thirst, Narrative:
Swelling in ankles; Strange Red Slotching in  lower legs; Bruising a lot more in odd places; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Swelling in ankles), RASH MACULAR (Strange Red Slotching in  lower legs) and CONFUSIONAL STATE (Bruising a lot more in odd places) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CONTUSION (Swelling in ankles), RASH MACULAR (Strange Red Slotching in  lower legs) and CONFUSIONAL STATE (Bruising a lot more in odd places). At the time of the report, CONTUSION (Swelling in ankles), RASH MACULAR (Strange Red Slotching in  lower legs) and CONFUSIONAL STATE (Bruising a lot more in odd places) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment information was not provided by the reporter.
Pateint was given her 3rd injection in the Hep B series in her left deltoid. After the injection was given, another employee came and informed the nurse, that patient was feeling "woozy". The nurse, went to check on patient and patient stated that she felt nauseated and was seeing spots. Patient had red blotches on her neck, chest, and behind her left ear. Patient denied any swelling of her throat or tongue. 911 was called and they came to the center and spoke with patient. She was asked if she wanted to go and get checked out and she replied that she did. At hopsital, she was given 2 shots. 1 was Benadryl and the other was a steroid. She was also sent home with a prescription for a Medrol pak.
Patient. Received second dose of COVID-19 vaccine Pediatric Pfizer (LOT#: FK5618) exp: 2/21/22 on 12/26/21 and first dose COVID-19 Pediatric Pfizer was given on 12/07/21. Patient came in with siblings and mother. Mother brought children two days early from second dose due date. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID second dose Pediatric Pfizer. Per Dr., approval to proceed with COVID second dose Pediatric Pfizer vaccine was obtained from medical consult team via text message from RN, Vaccine Operations Lead. Client received COVID vaccine Pediatric Pfizer 2 days before due date. The patient did not report any symptoms during the 15 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. Patient left vaccination site with her mom and siblings at 1545 unassisted and with a steady gait.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 52-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA6780), at the age of 52, on Jul 22, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient felt fatigue, and vaccination site pain/tenderness at the injection site, onset Jul 2021, with outcome of unknown. No follow-up attempts possible. No further information expected.
Incorrect dosing of booster was administered. Patient received a 0.5 ml dose instead of 0.25 ml dose
Sore arm at site of injection. 1st dose.  Lasted at least 18 Hours.