chrisvoncsefalvay/vaers-outcomes huggingface dataset:
side effect (Does the vaccine affect the nervous system in any way?); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect (Does the vaccine affect the nervous system in any way?)) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect (Does the vaccine affect the nervous system in any way?)). At the time of the report, VACCINATION COMPLICATION (side effect (Does the vaccine affect the nervous system in any way?)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Sore arm, tired, fever, headache, chills, vomiting, and at 1 am I got up to vomit and passed out on the floor.
had the flu; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who had the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient got flu 3 times and each time it was after flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Vaccine on 9-8-2022 and wanted to know if there are any effects of waiting this long to receive the second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 8th September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Vaccine on 9-8-2022 and wanted to know if there are any effects of waiting this long to receive the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUN-2023 The patient received her Shingrix Vaccine and wanted to know if there were any effects of waiting this long to receive the second dose.  Patient information was given to the Healthcare professional. PQC was unrelated to health safety information. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient's husband reported patient had bruising, hard swollen warm area of appoximately 8 inch on upper arm area starting day after administration. Vaccine was administered in correct location. Patient reported after vaccine administration that she had gotten previous pneumonia vaccine.
Recieved Covid 19 Booster on 10/31/21 and within 3 hours developed total body arthralgias including jaw pain.  Pain progressed overtime to include neck, jaw, scalp, forehead, back and hip pain and continues to get progressively worse. On January 28th, had a temporary episode of Amaurosis Fugax (temporary blindness to left eye.) and immediately went to the Emergency Department and was admitted and ultimately diagnosed with Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica.
Paresthesia - 2/22/10 - numbness right hand (mild), right foot (mild), left hand (mild) and left foot (mild) & tongue. Mild difficulty walking.
I took COVID-19 vaccination and the influenza vaccination in the same left arm. The shot site for the Covid vaccination was approximately 1 inch higher than the site of the flu injection vaccination. I have recovered completely, however, there is a persisting nagging cough that continues.
NUMBNESS IN LEFT LEG; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced numbness in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in left leg on 02-MAY-2021. This report was non-serious.
Est date of delivery 07/23/2021 I had inner thigh pain in my right leg; which became swollen could not walk. I had to used crutches. After pain went away I began having pain same spot on the left leg.
sore left arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm after first dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Yearly IM Flu vaccine Fall 2021). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Penicillin allergy and Blood pressure high (No change reported. Patient took unspecified medication for high blood pressure.).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left arm after first dose). At the time of the report, VACCINATION SITE PAIN (sore left arm after first dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  No treatment drug details was reported. Patient experienced similar event in the past.   This case was linked to MOD-2022-547050, MOD-2022-547040, MOD-2022-547048 (Patient Link).
37 y/o female with past medical history of Anxiety who presents with palpitations 10-15 mins post vaccination. Patient states that she received the Johnson vaccination. Patient states that the vaccination was placed to the left arm. Patient denies previous reaction to vaccinations in the past. Patient denies pregnancy. Patient denies sore throat, shortness of breath and/or difficulty breathing. Patient states that she is an anxious person. Patient initial vitals with noted Hypertension, 166/91 BP and Tachycardic 110, all other vitals within normal limits. Patient monitored for 15 mins with resolution of palpitations. Patient vitals reassessed and patient normotensive, 138/81 BP, all other vitals normal and patient discharged in stable condition.
I started feeling restless and then achy overnight. My arm (injection site) was very sore. This was within 12 hours of the injection. Within 16 hours of the injection, symptoms increased - I felt achy all over, similar to the flu, and I ran a low grade fever (100-101). Tylenol brought the fever down to barely under 100. I was listless and had no energy or appetite. I was sleepier than normal also.  I was occasionally nauseous, but that feeling was minor compared to the other symptoms. The full range of symptoms lasted for a full 3 days. It took another 2-3 days to regain normal energy and activity levels.
TOOK THE FIRST DOSE OF VIVOTIF IMMEDIATELY AFTER EATING; A spontaneous case report was received from a caregiver on 19-Feb-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201902-000134 (PVX2019-457; husband) and PVX201902-000135 (PVX2019-458, daughter) were created and cross-linked in the database.  The report describes a 46-year-old male consumer who "took the first dose of Vivotif immediately after eating". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   It was reported that the consumer took the first dose of Vivotif immediately after eating on 19-Feb-2019.  The action taken with Vivotif with respect to the event "took the first dose of Vivotif immediately after eating" was not applicable.  The clinical outcome of the event "took the first dose of Vivotif immediately after eating" was unknown.  Company's Comment: The causality of the event "took the first dose of Vivotif immediately after eating" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the first dose of Vivotif immediately after eating" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000135:
I was fine immediately after. On 2/22/2022, my hands got itchy, red and swollen. This passed in about an hour. Thursday night, 2/24/2022, my entire body broke-out in hives. This has not stopped since. I've taken Claritin, Benadryl and calamine lotion. The itching does not stop. I have very obvious welts all over my body with itching. Now this is beginning on my face. I am concerned that this issue does not stop.
Some lightheadedness upon vaccine given.  Lightheadedness constant with body aches, body chills, headache, nausea and fever.  These symptoms have been constant for going on 6 days.  I can't smell or taste as of 4/8/2021, but I do not know if that is from seasonal allergies or vaccine.  As of 4/9/2021, still have headache, body aches and weakness.
approx 5 days p/vax pt c/o dec vision in lt eye;saw ophthalmologist who referred to neurologist;dx w/optic neuritis & is receiving IV steroids x 14 days as outpatient;
Redness swelling itching at injection site on arm Noticed on March 25 2021
Injection site shows a swollen lump 1 1/2" in diameter tender, itchy. Arm is weak, child fatigued.
I have not had any issues with a bechet's/crohn's flareup since diagnosed many years ago.  I received my first covid vaccine on 12/29/21.  On 1/6/21 I was admitted for small bowel obstruction due to major inflammatory attack.  I was admitted for 2 days and placed on high dose steroids.  I went home on 1/8/21 but was unable to progress past liquid diet due to the inflammation/scarring from this event so was admitted hospital on 1/21/21 and had small bowel resection.  I was discharged from there on 1/27/21.   My concern is that the vaccine could have triggered this major inflammatory response in my body as I was doing so well prior to that vaccine.
Jaw pain under left ear. One week after vaccination.   The jaw pain comes and goes. The joint is tender to the touch. Hard to open moth wide and can be hard to chew
After the second shot, the next day I felt pain in my arm and feverish. After shot I had body aches and pains. I had headaches that were pretty bad. I did not have to go to the doctor. In August of 2021 I contracted COVID 19. I felt like I had a sinus infection. I had body aches and a really bad headaches. I took monoclonal antibodies after about a week of feeling sick. My symptoms lasted about a week, I started feeling better shortly after receiving the antibodies.
Narrative: 58 yo female with PMH of HLD, fibromyalgia, OSA, allergic rhinitis, panic disorder, depression, PTSD reported having swollen and itchy lips 2 hours post vaccine, event lasted for 30 minutes. It happened again the following day. No other symptoms reported. It was not mentioned in the record if patient took anything to treat it. Record did not mention if patient sought medical care (except for the note regarding patient's ADR). Pt also has hx of swelling of throat to kiwi, avocadoes, melons.
COVID-19; Acute hypoxemic respiratory failure due to COVID-19; Confusion caused by a drug
Patient given Pfizer-NioNTech Bvialent as second dose vaccine rather than Pfizer-NioNTech Monovalent series that was to be completed, no reactions/side effects noted after immunization.
VACCINE GIVEN AT 0915 LD IM WAITED 20 MIN IN THE LOBBY WITHOUT REACTIONS.  LEFT AND WENT BACK TO SCHOOL AT 1120 SHE COMPLAINED OF LEFT ARM PAIN AND DIZZINESS MOTHER WAS NOTIFIED TO PICK UP DAUGHTER AT SCHOOL.  PATIENT ARRIVED AT 1215 AT OUR CLINIC VITALS T 98.0, BP 118/72, P 105 R 20, PATIENT STATES SHE FEELS DIZZY.  PATIENT SEEN BY DR. AT 1300 VITALS T 97.5, P 82 BP 114/80 R 20 MOTHER STATES PATIENT IS FEELING BETTER.  NO OTHER COMPLAINTS VOICED.
Back Pain; Stomach Ache; Head Ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain) and ABDOMINAL PAIN UPPER (Stomach Ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BACK PAIN (Back Pain) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Stomach Ache) (seriousness criterion hospitalization) and HEADACHE (Head Ache). At the time of the report, BACK PAIN (Back Pain), ABDOMINAL PAIN UPPER (Stomach Ache) and HEADACHE (Head Ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  Patient was hospitalized after receiving the Moderna COVID-19 vaccine.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. However, the Company believes the hospitalization in Unlikely related to the product as it occurred over two (2) months after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04-JUN2021 was added the new event which was serious.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. However, the Company believes the hospitalization in Unlikely related to the product as it occurred over two (2) months after vaccination.
Increase in heart rate, blood pressure, fluttering/butterflies in chest, over past 3 months. One instance BP shot up to 220/110 with accelerated heart rate.  EKG, blood work, chest xray normal.
Patient's arm became swollen, red and warm to the touch.  This reaction occurred at the injection site and went up to the top of the arm and down to just before the elbow.
pt recv vax 3SEP97 & c/o rash starting on legs;7SEP had sl fever, rhinitis for 3 days starting 9SEP97 came to hlth ctr 17SEP because rash spreading worse on legs, but faint on chest, back;advised DPH, Kenalog;
experiencing pain in the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "experiencing pain in the injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
WORSENING ASTHMA SYMPTOMS; FELT LITTLE WEIRD; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) 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 subject experienced worsening asthma symptoms, felt little weird, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101, and MRI (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, worsening asthma symptoms and felt little weird was not reported. This report was non-serious.
Information has been received from a physician concerning an 18 year old female who on 21-NOV-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) IM. On 21-NOV-2007 the patient became dizzy and felt faint after receiving the first dose. Subsequently, the patient recovered from being dizzy and feeling faint. The patient sought unspecified medical attention. Additional information has been requested.
Arm hurt more than after the first shot, then shoulder pain (cause me to awake at night), ignored it but then realized was having decreased Range of motion in left shoulder and left arm external rotation, saw primary doctor and she prescribed PT for possible bursitis or tendonitis. Started PT in June 2021 2x per week with little improvement. Finally saw orthopedist who prescribed a steroid shot for shoulder. Left shoulder injection on 9/10/2021 (Kenalog) and will continue with PT.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX at a medical center (considered a hospital) as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2013, the patient was treated at the same medical center (not specified whether admitted; therefore, considered an Emergency Room visit until follow-up is received) for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
The day after the shot the area with the shot was tender and felt painful to the touch. It was also difficult to raise my arm past 45 degrees without some pain. Around 24 hours after the shot was administered, I started to feel more immense pain and swelling around the area of the shot and now felt pain even when my arm was resting, with the sensation sometimes traveling to my fingers. Taking two tylenol helped reduce the swelling and the pain significantly after about 20-35 minutes.
Information has been received from a Certified Medical Assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. ROTATEQ (lot # L027719 with expiration date 28-APR-2017) was actually exposed to the following temperature excursions on the following dates: 46.01 Fahrenheit degree (F) for 20 minutes on 01-FEB-2016, 47.62 F for 8 hours 45 minutes on 12-FEB-2016; 47.78 F for 15 hours 24 minutes on 26-FEB-2016 and 46.73 F for 15 hours on 15-MAR-2016. Then (at an unspecified time later in the days) on 15-MAR-2016, after all of the above temperature excursions had occurred, the patient was inadvertently vaccinated with an improperly stored dose of ROTATEQ listed above (dose unspecified) orally. No known adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
get COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (get COVID) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (get COVID). At the time of the report, COVID-19 (get COVID) outcome was unknown.            Patient received unknown concomitant drug.   No treatment medications were reported.
Patient received Smallpox vaccine on 06Sep08 and was seen at the emergency room on 14Sep08 for tachycardia, fever, shortness of breath and pressure in chest.  12/8/08 ER record received for DOS 9/14/08 with DX: Adverse effect to smallpox vaccine. Pt presented with tachycardia, fever, shortness of breath and chest pressure 8 days s/p smallpox vaccination. PE (+) for tachycardia, anxiety and ulceration at the smallpox vaccination site on the LUE.  Tx with Toradol and Indocin.
painful arm; difficulty moving the arm that was used for immunization; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old male patient received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the arm in 2017 (at the age of 65-years-old) as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received pneumococcal vaccine polysacch 23V (PNEUMOVAX 23) for immunization in 2010.  In 2017, after the vaccination, the patient experienced painful arm and difficulty moving the arm that was used for immunization. The clinical outcomes of painful arm and difficulty moving the arm that was used for immunization was unknown.     No follow-up attempts are possible; information about lot number cannot be obtained.
4/15/21 - right outer ear pain. 4/19/21 - saw Dr. on demand - prescribed Amox-Clav 875-125 mg 2X a day.  4/20/21 - right facial swelling - went to urgent care. Dr. said to stay on prescription given to fight bacteria infection. 4/27/21 - saw Dr. - prescribe Azithromycin 250 mg 2 tablet a day and Ciproflox-dexamerh ear drop. Again - diagnose as bacteria ear infection. 4/29/21 -right face paralysis-extreme pain. 4/30/21 - went to urgent care - extreme pain - Dr. directed to go to Hospital Emergency Room for CT scan and blood work.  Diagnosed from Hospital ER is 1. Otitis external of right ear. 2. Facial nerve palsy 3. Ramsay Hunt Syndrome - auricular. Prescription-Acyclovir 400MG tablet 5x per day for 7 days. Prednisone 50 mg daily for 7 days. Hydrocodine-acetaminophen 5-325 mg as needed. Ask to follow up with ENT specialist on paralysis. Appointment made for 05/10/21 afternoon. Pain and swelling persisted throughout ordeal.