chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was considered medically important. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a published literature article for childhood invasive pneumococcal disease in the era of conjugate vaccine. The article reported that a 6 month old participant in an independent study, received a third dose of Prevnar on an unspecified date. At 23 months of age, the participant developed cellulitis and pneumococcal bacteremia. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. A literature article, citing an independent study that reviewed cases of invasive pneumococcal disease, reported that at 6 months of age a study participant received a third dose of Prevnar. At 23 months of age, the participant developed cellulitis with bacteremia after a blood culture performed on an unspecified date revealed Streptococcus pneumoniae, serotype 19A. The author concluded from all study cases assessed that universal administration of Prevnar to children younger than 2 years of age and selective administration to children 2 to 5 years of age has resulted in a significant decline in invasive pneumococcal disease. Children younger than one year of age, African American and Hispanic children and those with recognized comorbid illnesses (malignancy, human immunodeficiency virus, immune deficiency, nephrotic syndrome, etc.) continue to remain at risk for invasive pneumococcal disease. See attached literature article for additional information. The investigator considered cellulitis streptococcal, pneumococcal bacteraemia and drug ineffective to be possibly related to the study product. Blood culture was done on an unspecified date.
Chills and fever for 3 days. Chronic Fatigue and headache starting on 12/25 until today (12/27)
Initial report received on 22 December 2006 from a healthcare professional. A male patient received on 22 November 2006 Fluzone (lot number not provided). 2 days later, on 24 November 2006, the patient experienced flu like symptoms. 21 days post vaccination, on 13 December 2006, the patient was admitted to the hospital and diagnosed with encephalitis. Patient's outcome was not reported. No other information was provided.
received 1st dose during active episode of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number J7J4X, expiry date 31st January 2023) for prophylaxis.   Concurrent medical conditions included shingles (active episode of shingles). Concomitant products included acyclovir.   On 23rd September 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The health care professional provided limited information concerning date of birth and intials. The registered pharmacist reported that a patient received 1st dose of Shingrix during an active episode of shingles, which led to off label use. The pharmacist reported that patient told the health care professional that she was having an episodes of shingles once she received the whole dose of Shingrix. At the time of reporting, the patient was taking acyclovir. The reporter consented for follow up.
Replace two discs in neck; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4194031-00 (Agency).  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single and intramuscular, administration date 10Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERVERTEBRAL DISC OPERATION (medically significant) with onset 2021, outcome "unknown", described as "Replace two discs in neck". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of intervertebral disc operation.  Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 18Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer Biontech. On 10Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer.   Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of 'Replace Two discs in neck was not provided. Agency's opinion is that there is no reasonable possibility that the event of Replace two discs in neck is related to Humira (Adalimumab).  The reporter's assessment of the causal relationship of the events with the suspect product HUMIRA was not reported. The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was reported as possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event of Intervertebral disc operation is assessed as not related to BNT162B2, and more likely due to underlying medical condition of Rheumatoid arthritis as patient was on Co suspect HUMIRA.
pt came in for Hep B and received Hep A and Hep B TWINRIX provider was notified and provider stated that they would notify patient.
24 Hours after injection, I had a high fever and headache for the next 24 hours. Over the next week, extreme itching all over my body. A week later, my rosacea flared. The autoimmune response set off an inflammation of my face in the locations where my rosacea is commonly triggered. I recovered from the fever but the skin itching and face swelling has not calmed down - I need to take doxycycline and Alleve to lower the rosacea swelling and redness.
Approximately 25 minutes after the shot, patient came back saying that she feels like her throat is closing, cheeks felt like swelling , he mouth tastes funny.
This case was reported by a consumer and described the occurrence of weakness in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (refer case US2018GSK233407 for tolerance of 1st dose).  On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On 27th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness, sleepiness and leg pain. On an unknown date, the patient experienced spinal disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the weakness, sleepiness, leg pain and spinal disorder were unknown.  It was unknown if the reporter considered the weakness, sleepiness, leg pain and spinal disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did laboratory test X-ray and MRI to eliminate spinal issue. The patient experienced that he was feeling weak, sleepy and very sore legs. after receiving 2nd dose of SHINGRIX.
This case was reported by a physician and described the occurrence of not responsive in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included cough and sneezing. On 1 May 2012 at 15:30 the subject received 1st dose of PEDIARIX (.5 ml, unknown, left thigh). On 1 May 2012, 30 minutes after vaccination with PEDIARIX, the subject experienced not responsive, sweating, could not breathe, possible seizure, stiffened up and immunization reaction. The physician stated that the subject had a little cough and sneezing but that his rectal temperature was 100.3 and within normal range. So he administered the vaccination to the subject. About 15 minutes after the baby left his office the parents called to report the subject was unresponsive, sweating and not breathing right. The subject had also stiffened up at one point. The subject went to the hospital emergency room, the emergency room physician diagnosis was possible seizure verses reaction to immunization. A chest x-ray, urine analysis and complete blood count were all normal except an elevated platelet count was observed. The calcium was elevated to 10.7, creatinine was low at less than 0.03 and potassium was a little high at 5.5. All other parameters of his metabolic profile were normal. The subject was transferred by ambulance to another hospital for further observation. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the not responsive, sweating, could not breathe, possible seizure, stiffened up and immunization reaction were unspecified. The physician considered the events were possibly related to vaccination with PEDIARIX.
mild symptoms of a low grade fever; mild general discomfort; Last night my daughter (10) tested positive for covid.; Last night my daughter (10) tested positive for covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2 (tris), single and administration date Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Mar2022, outcome "unknown" and all described as "Last night my daughter (10) tested positive for covid."; PYREXIA (non-serious), outcome "unknown", described as "mild symptoms of a low grade fever"; DISCOMFORT (non-serious), outcome "unknown", described as "mild general discomfort". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Mar2021) positive. Clinical Course was reported as, Last night on 10MAR2022 reporter daughter (10) tested positive for covid. She was vaccinated with both shots of Pfizer vaccine in Dec2021. She was experiencing mild symptoms of a low grade fever and mild general discomfort. It was believed that she was exposed at school where other kids also reported testing positive. Because of privacy policies at school, Reporter did not know which kids tested positive or if they were vaccinated. No one else in his home tested positive or has any symptoms. His wife, other daughter (7) and he were all also vaccinated with Pfizer vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient states she had a circular, blistering, itchy rash at the injection site. She states it came on 2 days after the injection and lasted for about 2 days.
Gave pt undiluted pediatric dose of pfizer bivalent instead of adult version. still gave 0.3 ml undiluted
Localized redness, pain generalized joint pain, aches, headache, low grade fever (99 degrees).
High fever of 103.4 Had heat flashes blood pressure low 90's but was in 120 when doctor took it took Ibprofen took a ice bath next day fever was 100 , then in the next few hours i was fine.
Received shot Monday. Complained of pain in left after DTaP and IPV immediately, leg swollen Monday night--almost 2 times size of other from below knee to hip. By Tuesday, red, indurated approximately 6" diameter--migratory--erythema and warmth resolved Friday. Swelling gone after 7 days. Pain resolved after 3-4 days.
Red, hot firm to touch. Painful only if touched. Full use of arm. Symptoms started 03/26/04 AM. Grandmother report size 4". Grandmother using ibuprofen and cool cloths to area. Afebrile.
Visual disconnect, dizziness, ringing in ears, anxiety, depression, hard to get a deep breath, fatigue, shaking, heart racing, face and ear discomfort, brain fog  The only thing that has helped is going to an  medicine dr for  therapy and lots of natural supplements. I am a healthy, vibrant and athletic women who plays competitive tennis, hikes, helps run a family business. This has completely changed my life in the negative. I have not been able to do any of my usual activities. Felt suicidal at times. I HAVE NEVER FELT THIS WAY!
Erythema, edema, pain to injection site of posterior upper left arm that was non-responsive to analgesics within 24 hours and ice so client went to ER for further evaluation/care related to what the ER physician described to her as "allergic reaction" and advised her to not receive vaccination again.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced rash. The patient received a dose of an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On an unspecified date, the patient experienced rash. The outcome was unknown. See related case (s): US WYE H15128310 (adverse event, non expedited) and US WYE H15204410 (adverse event, non expedited). No additional information was available at the time of this report.
Wednesday, March 31, 2021 Moderna vaccine, 2nd shot at 4:00pm. Arm began to feel sore about 10pm. Blood pressure and oximeter reading remained normal throughout.  Thursday, April 1, 2021 Insufficient sleep, sudden increase in sinus congestion, muscle soreness and increasingly sore arm upon arising. Fatigue, Imbalance and Brain Fog rapidly increased. Urinary incontinence 3 times - once upon awakening and twice in the afternoon. Temperature began rising and reached 100.2°F by 3:00pm (normal temp 97.5°F). Resting pulse rate 74 at 10pm (normal 54). Headache and weakness in the evening.  Friday, April 2, 2021 Insufficient sleep, sore arm, sinus congestion, sneezing, moderate headache, moderate imbalance, muscle soreness, weak, moderate brain fog. Resting pulse rate 64 (normal 54). Temp at 7:30am 99.4°F (normal 97.5°F). NEW today: joint pain in both hips and Tinnitus suddenly spiking high. 10:00pm noticed mood began to change, feelings of irritation then anger for no apparent reason.  *Saturday, April 3, 2021 Insufficient sleep. Temperature at 12:30pm 98.1°F then continued to fall until it reached normal range (97.7°F) at 10:00pm. Resting pulse rate 68 (normal 54). Increasingly painful hip joints, sinus congestion still high, sneezing, mild headache, canker sores, tinnitus spiking, brain fog, increased imbalance. *NEW today: 7:30am-10:00am mental confusion, hallucinations, auditory, increased imbalance. Afterwards, feelings of fear, anger and paranoia that persisted through Sunday. Evening: increasing blurred vision and diplopia (both chronic conditions but usually very mild). Injection site suddenly red and more swollen, itching. Still feeling uncharacteristically emotional at bedtime.  Sunday, April 4, 2021 Insomnia. Volatile emotions - anger, agitation, crying - kept me awake Saturday night; slept 2:30am-8:30am Sunday morning. Brain fog, imbalance, sinus congestion, sneezing, right arm itching, hip joint pain, canker sores on tongue, spiking tinnitus continue. Temperature normal all day; resting pulse rate still high 64 (normal 54).  Monday April 5 through Thursday April 15: Most symptoms continued to gradually subside over the next ten days. Spiking tinnitus, canker sores and injection site itching were the most persistent and lasted until April 15. Imbalance subsided on April 12. NEW Symptoms: Anxiety dreaming began on April 6th. Most nights had insufficient sleep. Concern about the cause of the episode of delirium on April 3rd continues. Good news, no COVID-Arm like I had with the 1st vaccination.  General observations: It seems as though my body's response to the 2nd vaccination was to temporarily trigger some of the symptoms of my chronic health conditions like MCAS, Dysautonomia and Diplopia, without causing an actual flareup of those conditions. This was quite unexpected and disconcerting. The episode of delirium was something I've never experienced and hope to never experience again.
Shingrix Vaccine for Shingles administer at Pharmacy. It caused severe Uveitis in left eye. Also severe headaches and swelling on gums  on the left side. Required an MRI on the brain to rule out other factors. Effects began the next day and have gotten worse. I am nearly blind in my left eye. I have an appointment with a Retina Specialist on Feb 28. I had very good vision with or without glassed. Now I have to use the computer magnifier to see letters and I cannot read a paper or a book.
Patient received his second dose of Moderna Covid-19 vaccine on 5/25/21 in the morning. That afternoon he had a headache and took a Goody's powder. He later vomited severely and vomited up blood. He went to the hospital and was hospitalized for 5 days. They did have to give him replacement blood in the hospital. No further information provided.
After vaccines he started to just fall down without cause. On 10-19-04 he had a seizure in the morning. Blood work and EEG done, all results negative. No further events after seizure until vaccines given on 4/6/06.
Heart felt like it was being squeezed for 7 days (beginning 11/14 in evening) Chest Pain (centered in heart area) for 9 days  (beginning 11/14) Pain in left shoulder blade for 9 days (still happening) (beginning 11/14) Tightness in chest to the point I couldn't breathe 9 days  (beginning 11/17 at 4am) Additional Headache for 8 days (still happening) (beginning 11/15) Sinus Pressure began 11/22  Treatment: I nebulize each day now. I take my inhaler each day.  Take Ibuprofen (800 mg) from the Doctor for the next 2 weeks to help with inflammation  Heating Pad on Chest and Back areas  Rest and no stress   Outcome:  Tight Chest, but heart doesn't feel like it's being squeezed anymore  Feel Cold Symptoms coming (tight chest--with the asthma acting up, sinus pressure, excess mucus in throat, sore throat)
Errytyematiis, edematis warm to touch 3 inches diameter area surrounding injection site on left upper arm.
PATIENT CALLED STORE ON 5/25/23 TO ASK ABOUT PAIN IN HIS ARM AFTER GETTING TDAP SHOT ON 5/17/23. HE COMPLAINED ABOUT PAIN THAT WOULD NOT LET HIM RISE HIS ARM ABOVE HIS HEAD AND NEEDED TO KEEP HIS ARM IMMOBILE. AT THAT TIME HE HAD TRIED TYLENOL WITH NO IMPROVEMENT AND PER PATIENT PAIN WAS WORSENING
Arm soreness continuing on now for 6 weeks. Strong pain when lifting arm or certain motions. Soreness around vaccine spot
arm sore; felt awful for a couple of days; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer (Patient).  This case involves a patient of unknown demography who's arm was sore (Pain in extremity) and felt awful for a couple of days (Feeling abnormal), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient received INFLUENZA VACCINE and experienced arm sore (Pain in extremity) and felt awful for a couple of days (Feeling abnormal).  This was the third year patient had received flu shot it made his/her arm sore.   No relevant laboratory details were provided.  It was not reported if the patient received any corrective treatment.  Outcome of the events was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that his doctor's wife experienced pain in her arm after receiving the SHINGRIX injection. The reporter stated that his doctor just mentioned this to him and he did not have any additional information regarding this event.
PATIENT HAS LARGE RASH ON LEFT ARM FROM SITE OF INJECTION AND FEW INCHES DOWN AND LEFT AND RIGHT. AREA IS RED, WARM TO TOUCH. SAW URGENT CARE MD WHO PRESCRIBED CEPHALEXIN AND TRIAMCINOLONE TO CALM REACTION WITH FOLLOW UP IN TWO DAYS.
A few minutes after administering the vaccine the patient complained of light headedness, vision became spotty, and she felt like she was going to pass out.  She also felt tingly fingers and nausea. After a few minutes her blood pressure was checked and it was normal. The light headedness and nausea subsided. The tingly fingers continued for several minutes but later became normal. She drank some water and we provided a fan to help cool her down.
Went into A Fib; Went into A Fib; thirsty; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) at the age of 79-years-old, via an unspecified route of administration in left arm on 19Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included allergies to penicillin, arthritis, and episodic atrial fibrillation (AFib) in which she had 3 episodes in the last two years. The patient has no COVID prior to vaccination. Concomitant medications included apixaban (ELIQUIS), diltiazem, colecalciferol (VITAMIN D), and bifidobacterium lactis (PROBIOTIC). The patient has no other vaccine in four weeks. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 79-years-old, via an unspecified route of administration in left arm on 22Feb2021 at 11:00 at single dose for COVID-19 immunization. The facility the vaccine was administered was public health clinic/veterans administration facility. The patient went into AFib on 19Mar2021 at 23:45, 12 hours after receiving the dose (as reported). She was told to drink plenty of liquids following the shot, which she did because she was so thirsty. The patient was in AFib for about 18 hours until it resolved into sinus rhythm. She wondered if there was any association with the vaccine and heart rhythm. The patient did not receive any treatment for the event "went into A Fib". She was not tested with COVID post vaccination. The outcome of the event "went into A Fib" was recovered on 20Mar2021 at 17:45 and unknown for the other event.