chrisvoncsefalvay/vaers-outcomes huggingface dataset:
took vaccination at the dose of 60 years with no reported adverse event; Initial information was received on 05-Jan-2022 regarding an unsolicited valid non-serious case received from a health professional via call center.  This case involves a 60 years old male patient who took vaccination at the dose of 60 years with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength and formulation: unknown) at the dose of 0.7ml via unknown route (batch number and expiry date: unknown) in unknown administered site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "took vaccination at the dose of 60 years with no reported adverse event" (product administered to patient of inappropriate age) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event took vaccination at the dose of 60 years with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt receiving seasonal vaccine stated having a sharp pain immediately after injection. Pt described radiating numbness and tingling, radiating from face to hand on side of injection. Pt denies any airway, breathing , or circulation issues.
Pt presents with red inflamed site around injection, 4"x3" oval, hot to touch.  Pt had pneumonia, congested heart and fluid in lungs accompanied with headaches and sore throat.
Breakthrough infection with sore throat, runny nose and general malaise, called my doctor and was prescribed Paxlovid, symptoms disappeared by fourth day.
A nurse reported that a pt received an injection of Pnu-Imune-23 on 1/31/2001. The following day, the pt developed a fever of 102F and an injection site reaction characterized by redness and soreness. The pt was hospitalized and treated with unspecified antibiotics and steroids. As of the date of this report, the pt's symptoms were improving. Follow-up info received from the physician on 3/7/01, indicated that the pt was a 54 year old female. She recovered.
Pfizer 3/23/21, 4/13/21, 9/16/21. Positive on 2/20/22
Shoulder in injection sore but 2 days after shot Left elbow was causing heavy pain within the week right wrist  and shoulder pain in most joints of upper body . 10 days still having issues.
"Weight when breathing, tingling throat" that she/we worried might be the start of an anaphylactiv reaction. She has many allergies, and so was immediately concerned that this was another reaction. She took 25mg diphenhydramine immediately at my recommendation, but did not want to use her or our Epipen yet (while waiting to see if reaction materialized). We called EMS, who took her blood pressure and calmed the patient down. After 15-20 minutes of joking around, we all concluded that this was not an anaphylactic reaction. She refused transport to the ED. She left with her husband, both walking, talking, and laughing. Phone follow up at 2 hours and 6 hours showed she was still fine - "back to normal."
Given Menactra vaccine Today instead of the intended HPV #2.  Had Menactra vaccine previously 5/23/07 at MD's office.  No adverse effects known at this time.
Pt relays after the vaccination she began to feel dizzy. Pt relays symptoms started about 5 minutes after receiving the vaccine. Pt also c/o tingling in her mouth, lips, tongue and throat. Dr. contacted and instructed Pt and personnel to administer Benadryl and Pepcid. Dr. instructed personnel to monitor Pt for 30 minutes. Pt given 25 MG benadryl and 20 MG Pepcid. Vitals were obtained three times and Pt monitored for 30 minutes. After 30 Minutes Pt relays she is feeling better and feels she can go home.
Less than 2 weeks after 2shot extreme right flank  pain consistent with  passing of kidney stones/UTI.   Trouble breathing, consistent with Sarcoidosis flare.  Previous (May/2021) full work up by Pulmonologist  PFT and Chest xray showed normal, no disease activity, stable.   Urinologist ordered Ct Scan for Kidney/bladder stones; incidental findings, lower bibasilar GGO in lungs on 10/4/2021.  Follow up Thoracic CT on 11/11/21 found GGOs have cleared but left with very small scarring consistent of previous inflammation or some kind of viral infection.   Timing of symptoms and subsequent imaging, suggests TO ME that the vaccine triggered interstitial lung disease inflammatory reaction.
Constipation after both dose 1 and 2 for about a week. Resulting in hard bloody stool
At 48 hours, significant Local Reaction - Site erythematous, warm to touch - Softball size area.
Pt received Pfizer x2.  Pt tested COVID + on 8/9/21 and admitted to hospital for COVID on 8/10/2021. Pt received remdesivir and dexamethasone. Deceased on 9/4/2021
Fever: Appetite Change; Arthralgia, Malaise,myalgia, Lymphadenopathy, asthenia, fatigue, -- Information has been received from a health care professional concerning a 22 year old caucasian female patient who on 22 May 2000 was vaccinated SC with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #0300B - invalid).  There was no concomitant medication or past medical history.  On 24 May 2000 the patient experienced fever, fatigue, general malaise, decreased appetite, joint aches and muscle aches and bilateral swollen maxillary glands.  On an unspecified date the patient recovered.  Additional information has been requested.
Information has been received from a health professional concerning a 12 year old male with no allergies who on 21-JUN-2007 was vaccinated SC on left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657404/0592U). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Lot # U2331AA). There was no illness at the time of vaccination. It was reported that after vaccination the patient had the left arm swollen with quarter size ring-red around the injection site that was itchy. No medical attention was sought. At the time of report the patient had recovered. Additional information has been requested. This is one of several reports received from the same source.
A report was received from a health care professional on 11/19/03 concerning a 50 year old female vaccinee who experienced a localized red wheal at the injection site which was raised, itchy and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, 4x4 inches in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Allergic reaction; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24May2021 at single dose (lot: EW0191) for COVID-19 immunization. Medical history included blood pressure abnormal, she had blood pressure medicine (medical condition was not clarified further). Concomitant medications included carvedilol and hydrochlorothiazide for blood pressure.  Patient stated she had an allergic reaction on 27May2021 and she thought she was still having reaction, she was at the hospital, ER for two days really. She was in the emergency room. Treatment included paracetamol (TYLENOL), 500 mg tablet. The outcome of event was not recovered.
Patient woke this morning with left sided facial swelling and  rash under her arms and groin area.
Information has been received from a registered nurse concerning a child who recently, in approximately April 2006, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  In approximately April 2006, the patient experienced a fever equal to or greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released.  Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:46, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
child recieved dtap on 7\2\2009 was seen in office 7/3/2009 for site that was red, warm to touch, swollen, and painful.
Patient recieved a Fluzone quad vaccine. Injection was administered at approx 9:30am. Employee presented 2.5 hours later with redness on arms, legs, ear and nose. Also reported itchy hands. No respiratory distress.  BP was 128/90, P 76. IM Benadryl was administered at 12:05pm. 12:15pm BP was 122/90 p 72. 12:35pm BP was 140/90 p 74. 12:55pm BP 136/90. At 12:45pm, patient was oriented x2, sleepiness from Benadryl, rash continued to subside.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcoholic (The 4 glasses of wine per week (weekends only). and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced swelling of tongue when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 11-MAR-2021 18:44 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021 she had performed antibody test at Doctor's office that was negative. she Had second antibody test on April 15th which was negative as well, which was considered a Confirmed immunological vaccine failure . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210456470-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
hard to get a breath; anxious; my heart began to race; felt the urge to use the bathroom; This is a spontaneous report from a contactable consumer. A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in arm right on 25feb2021 at 16:15 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. No Known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 25Feb2021 16:15 after about 1 minute she began to fill anxious, her heart began to race, and she noticed it was hard to get a breath. She also immediately felt the urge to use the bathroom. She raised her mask up slightly and was able to take deep breaths and she tried to calmly read the vaccine pamphlet as she thought maybe she was just nervous as she have never had a reaction before. No treatment received. The events outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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 2015, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance and for the long-term 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. Later in 2015, the patient was treated by a physician for the onset of a severe vesicular rash which was diagnosed as 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 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.
Information has been received from a health professional concerning an 8 year old female whose twin sister was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot#626409/0666H) on 21-Oct-1998. It was reported, that "currently," in 2007, the patient had one questionable lesion with no other symptoms. No other information was provided. The patient's twin sister experienced a varicella rash and a fever following vaccination with varicella virus vaccine live (Oka/Merck) (WAES# 0705USA00066). Additional information has been requested.
Sharp pain in top of shoulder. Hard to move arm.. this is 4 days after quad flu vaccine.
Patient received Pneumovax23 on 6/28/22, she states that her arm became swollen, red, and hot starting on the morning of 6/29/22 (the next day).  On 6/30/22 she saw her doctor and was prescribed Sulfamethoxazole/trimethoprim to treat the symptoms, which she picked up and is currently taking.
Severe dizziness and nausea. Body aches, headaches. No fever. Achiness improved but lasted for 2 days.
Fainting spells, local site rash with inflammation and pain. MD prescribed antibiotic for possible infection and pain medication.
This spontaneous report as received from a consumer refers to a 66 year old female patient. The patient had no pertinent medical history and no known drug reactions or allergies. In approximately 2013, about a year ago also reported as at least a year ago, the patient was vaccinated with a dose of ZOSTAVAX, intramuscular (lot # and expiration date were not provided). There was no concomitant medication. About two weeks ago, on approximately 20-OCT-2014, the patient experienced mild pain to the shoulder blade with no blisters. The patient's doctor prescribed anti-itch cream. There were no laboratory diagnostics studies performed. The patient sought medical attention. The outcome of mild pain to the shoulder blade with no blisters was unknown. Additional information has been requested.
Had Tdap 12/23 RD. No signs or sx until 12/28 (R) upper arm and sh pn with ? swelling. MD treated with doxycycline as precaution. Possible cellulitis.
Several things happened to me - within the first 24 hours my digestive track started to make unusual sounds then within 48 hours I had severe diarrhea that lasted for days.  However, the reason that I'm submitting this report is that I noticed on day 13 that I had a cluster of about 6 or 7 burst blood vessels on the outside of my left leg.  The next day I noticed another one on the inside of my left leg near my knee.  An then I noticed another one on the back of my right hand. I was very concerned at this point.  Luckily I did not get any additional burst blood vessels and they have since healed.  This all happened with my first innoculation.
Myalgias, h/a, sore throat, cough, fever to 100 beginning 20NOV91 lasting approx 1 wk;
Dizziness, Myalgia, Arthralgia, fatigue, night sweats Narrative:
Information has been received from a registered nurse concerning a 12 month old male who on 6/16/04 was vaccinated with a dose of varicella virus vaccine live (lot # 646141/0540N). Two weeks after vaccination on approximately 6/30/04, the patient experienced an injection site reaction. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also indicated that two other patients (WAES0409USA02212 and 0409USA02213) had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
PATIENT STATES PAIN AND NUMBNESS ON HER HAND. PATIENT REPORTED ON 10/9/14. CONTINUED PAIN, NUMB FEELING. NOT SURE IF RELATED TO VACCINE. PATIENT HAD SURGERY ON OPPOSITE HAND AND GETTING PHYSICAL THERAPY.
The symptoms lasted about 4 days. At first I was more tired more than usual, then blowing my nose a lot, then scratchy throat and loosing my voice. I got a antihistamine nasal and within the same day I started healing. Friday I was ok and Monday I went back to work. So total was a week.
Patient has bone/deep muscle pain at left shoulder since time of injection. This was temp. treated with MOTRIN 404 mg tid.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, RASH, VACCINATION SITE PRURITUS, VACCINATION SITE RASH, and VACCINATION SITE ERYTHEMA in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH, RASH, VACCINATION SITE PRURITUS, VACCINATION SITE RASH, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE WARMTH, RASH, VACCINATION SITE PRURITUS, VACCINATION SITE RASH, and VACCINATION SITE ERYTHEMA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 31-Mar-2021, the patient received their first dose of Moderna vaccine. Since 07-Apr-2021, the patient noticed a rash at injection site which started as itching and later felt very hot and red in color. The patient reported that the rash was moving rapidly and getting bigger and bigger.   The patient received prescription for Prednisone medication to take for 4 days for the symptom but didn't start yet.  No Concomitant product use was reported.  Treatment medication prescribed to the patient was Prednisone, but the patient didn't start yet.
Ever since I got my second dose Nov 2021 I have had inconsistant chest pains thats not a heart attack related no high blood pressure. Also Ever since I got the vaccine my menstrual cycle has not been the same and have not had my menstrual cycle since  I got the moderna and there is no chance of pregnancy just took a test and its a negative. I have had weird sharp pains where my ovaries would be  and the pain always starts a week after I was supposed to be on my menstrual cycle
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
brutal shot, couldn't use arm for 4 days; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injected limb mobility decreased (1st dose recevied on an unknown date and could not use that arm, refer case US2021AMR224142).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injected limb mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the brutal Shingles shot and patient could not use that arm for 4 days. As per the patient, worth the shot though. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224142:Same patient, same reporter, differnet dose (1st dose)
This spontaneous report as received from a pharmacy technician (reported also as: healthcare worker) refers to an unspecified patient of unknown age and demographics. Information regarding medical history and drug reactions or allergies was not reported. On 20-OCT-2014 an unspecified patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, anatomical location, route of administration not reported) after being exposed to a supported temperature excursion. No adverse effect had been observed or reported. Concomitant medications were not reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Systemic: Other- paralysis. Stroke ruled out at Emergency room.  symptoms lasted 2 days and began morning after immunization
The patient was exposed to chicken pox at school. The patient now has a few scattered chicken pox lesions on her face, stomach, back, arms and legs.
I started getting insanely tired, then every joint and my muscle started hurting, I got really cold and have a migraine headache. It all started going really downhill around 4 pm the day of. It is now 9:30 am the following morning and everthing from my teeth and hair to my toes hurts.