chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the Shingrix vaccines, developed shingles/ suspected vaccination failure; shingles; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The patient was healthy. She received the Shingrix vaccine both doses correctly about 2 years ago and developed shingles last month. The patient asked if she/he need to repeat the vaccine series because the first series did not work. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not provided.
34 days after developed post-menopausal bleeding.  Bleeding  lasted 7 days.  Last menstrual period was when I was 52 years old.  Also had minor acne breakouts.  Had a second episode of bleeding that began  Jan 2 or 3 and lasted 6 or 7 days. - The bleeding was heavier this time and I had minor cramping and minor acne breakouts.
This spontaneous report as received from a healthcare worker and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX 23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates. No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 04-MAR-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX 23 (Lot number: J010654, Expiry date: 17-OCT-2014). This is one of several reports from the same reporter. Additional information has been requested.
MY MOUTH IS SORE; GUMS, TONGUE, ROOF OF MOUTH. IT IS DIFFICULT FOR ME TO EAT AND DRINK ANYTHING BUT WATER.  I HAD TO DRINK COFFEE WITH A STRAW DIRECTED TO MY THROAT. I RINSED MY MOUTH WITH HYDROGEN PEROXIDE /WATER. I STARTED THIS LAST NIGHT .
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 83-year-old female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, blurred vision, diplopia and lazy eye. In November 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the blurred vision and lazy eye were unknown and the outcome of the diplopia was not recovered/not resolved. The reporter considered the influenza-like symptoms, blurred vision, diplopia and lazy eye to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter's sister. About 4 days ago from the day of reporting, the patient received 2nd dose of SHINGRIX. The day after the vaccine, the patient had moderately severe flu like symptoms. While watching the television (TV) that day she noticed the captions were blurry. The next day she felt better and did not have any problems. The third day after the vaccine she started experiencing diplopia while driving. The patient had seen her ophthalmologist who said one muscle was weaker than the other causing an effect like lazy eye. A carotid exam, computerised tomogram (CT) or nuclear magnetic resonance imaging (MRI) did not show any problems. They still tried to determine what was the cause of the diplopia, but the reporter thought there was a relationship with the vaccine. Lab Comments: In November 2018, the patient underwent carotid exam which did not show any problems.
This spontaneous report was received from a pharmacist and refers to a 66 year old female patient with unspecified chronic pain and allergy to drugs such as MOTRIN and heparin. On 23-SEP-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # K008927, expiration date: 17-MAR-2016) 0.5 ml, intramuscularly in the right arm. The pharmacist did not know if the patient had ever received PNEUMOVAX 23 previously. Concomitant therapies included SOMA and hydrocodone. On 24-SEP-2015, the patient experienced back pain, hip pain and stiff shoulder, she was treated with unspecified muscle relaxer and pain medications. On 25-SEP-2015, the patient sought medical attention to the pharmacy in order to refill her treatment medications, when the pharmacist observed the patient's injection site had slight local redness and some swelling. The outcome of the events was reported as not recovered. The reporter did not assess the causality of the events with PNEUMOVAX 23. Additional information has been requested.
TTOX given 7FEB91 w/in 24 hrs dev lg area of erythema & discomfort in rt upper arm. Packed area in ice;Returned to office 11FEB91; Given Ibuprofen to comfort. 21FEB91, arm doing fine except very small nodularity @ inject site.
The morning after my injection I woke up to a swollen lymph node in my right armpit.  I had read that this was a known an expected side effect, but to contact your doctor if does not go away after 10-14 days.  I messaged my doctor on the online portal on 4/12 (14 days after vaccination) telling her I observed this swollen lymph node after receiving my vaccine and that it was firm and about 1 inch in diameter.  The nurses requested that I come into the clinic that week.  I went in for my appointment on 4/14 and my doctor measured the lymph node to be 2.5 cm.  She told me to come back if it does not go away after 4-6 weeks after my 2nd dose and she would then follow-up with an ultrasound.
Burning, itching, splotchy red rash on the backs of both hands (from the first knuckle of the thumbs around the back of the hands to the tops of both index fingers to the nail) and the insides of both forearms from the wrist almost to the elbow; Burning, itching, splotchy red rash on the backs of both hands (from the first knuckle of the thumbs around the back of the hands to the tops of both index fingers to the nail) and the insides of both forearms from the wrist almost to the elbow; Burning, itching, splotchy red rash on the backs of both hands (from the first knuckle of the thumbs around the back of the hands to the tops of both index fingers to the nail) and the insides of both forearms from the wrist almost to the elbow; Burning, itching, splotchy red rash on the backs of both hands (from the first knuckle of the thumbs around the back of the hands to the tops of both index fingers to the nail) and the insides of both forearms from the wrist almost to the elbow; Burning, itching, splotchy red rash on the backs of both hands (from the first knuckle of the thumbs around the back of the hands to the tops of both index fingers to the nail) and the insides of both forearms from the wrist almost to the elbow; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 30Mar2021 at 17:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. Concomitant medications included CLARITIN and BABY ASPIRIN both started on unknown date for unknown indication and unknown if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 09:00, the patient experienced burning, itching, splotchy red rash on the backs of both hands (from the first knuckle of the thumbs around the back of the hands to the tops of both index fingers to the nail) and the insides of both forearms from the wrist almost to the elbow. The rash on forearms only lasted for the evening but the rash on hands was still there. Therapeutic measures were not not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event rash over arms was recovered on 15Apr2021. The clinical outcome of the event burning, itching, splotchy red rash on the backs of both hands (from the first knuckle of the thumbs around the back of the hands to the tops of both index fingers to the nail) and the insides of both forearms from the wrist almost to the elbow was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Awakened at 4AM by increased heart rate. 100 bpm. Lasted about one hour. Palpitations  Repeated every night for 5 days in a row, then went away. Each time it lasted about 1 hour.
started 17NOV93 w/rash & fever; today having trouble walking on lt leg;
Flu; This case involves a patient with unknown demography who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication 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 expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  The patient reported that he/she have not had the flu since he/she quit getting the flu shot 5 years ago.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
hives/urticarial w/in 15 minutes ER within 1 hr throat weird sensation tongue thick AL Alavert 10 mg 3 Epinephrine Rx Medrol dose pk IV fluids IV steroid Pepcid
Pt was given the wrong vaccine his first dose was a pfizer his second one he received a moderna
Swelling and red bullseye mark at injection site. Very hot to the touch. Painful arm.
2/22/23 I had a sinus issue a week prior. I began coughing a lot.  I went to the Emergency Room because I could not stop coughing. I was taking Sudafed for my sinuses prior to the emergency room. I was diagnosed with Bronchitis. I was given a breathing treatment and sent home with medications: Mucinex, Albuterol, Afrin Nasal spray, Prednisone and Tusculum pearls.  I took several at home COVID tests and all were negative. I had a COVID test at the Emergency room which was negative.
she cannot get over the anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "she cannot get over the anxiety".  Additional information: Patient spoked with someone the other day and they were not really giving her information at all. She statet it "was super frustrating" and is requesting to speak with someone else at this time. She said she had a "useless conversation" with someone in medical information who was a pharmacist. Caller states she is "Trying to figure out what is going on and is this vaccine dangerous enquired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HYPOTENSION 3/25/2023 BPH W LOWER URINARY TRACT SYMPTOMS ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/25/2023 BPH W LOWER URINARY TRACT SYMPTOMS HYPOXIA 3/21/2023 BPH W LOWER URINARY TRACT SYMPTOMS HYPOTENSION 3/25/2023 INTESTINAL PERFORATION ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/25/2023 INTESTINAL PERFORATION HYPOXIA 3/21/2023 INTESTINAL PERFORATION HYPOTENSION 3/25/2023 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/25/2023 NONTRAUMATIC ACUTE KIDNEY INJURY HYPOXIA 3/21/2023 NONTRAUMATIC ACUTE KIDNEY INJURY
hives all over my body that I have had since July 20th- prescription drugs have not helped
Tongue swelling, throat swelling and soreness, hot flashes and itchy throat 10-15min after dose. EMT administered 2 benadryls and epipen injection on left leg. Was then taken by ambulance to ER and monitored for about 4 hours due to hypertension and tachycardia
Patient reports: dizziness, SOB and palpitations.  Patient has a history of anxiety.  Serial vital signs for 20-30 minutes.
received a Tenivac immunization that was later noted to have already expired with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 70 years old female patient who experienced received a tenivac immunization that was later noted to have already expired with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 09-Jun-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, once ( lot: U6669AA ; Expiry date: 15-May-2022)  via intramuscular route in the right deltoid for immunization.  Medical assistant reported that the patient  received a Tenivac immunization that was later noted to have already expired with no reported adverse event (expired product administered) (onset date: 09-Jun-2022; latency: same day)  Action taken : not applicable.  Outcome: unknown   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 guidelines. 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.
Patient is 9 years old but received the 0.5ml dose for 12+ years instead of the 0.25ml dose for 6mo-11yr
ended up with serious complications; Initial information received on 27-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) who ended up with serious complications (vaccination complication) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination  On an unknown date the patient ended up with serious complications (vaccination complication, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were laboratory data/results available.  It was reported "So much advertising! Folks need to discuss this and any other medicine with their doctor before taking it! I agree that Flu vax helps to prevent fatal pneumonia. I just disagree with the incessant advertising and push to vax. By the way, a friend of mine who followed advertisement's advice ended up with serious complications from flu vax. People, do it after you have evaluated risks and benefits with your physician."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Shortness of breath, arrhythmia 1. Predominantly sinus rhythm (rates 51-171; avg 74 bpm). 2. Frequent PVCs (24% burden) with rare NSVT up to 5 beats. Rare PACs. 3. Two episodes of shortness of breath occur during sinus with isolated PVCs. Recommend increasing beta blocker and follow up in Cardiology
right nostril had a little blood in it, it would come out and then stop; She stayed in bed; Did not eat or drink; Slight headache; Fatigue; Joint pain; Muscle pain; Vomiting a little bit; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (COMIRNATY), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: EPISTAXIS (non-serious) with onset 2021, outcome "not recovered", described as "right nostril had a little blood in it, it would come out and then stop"; BEDRIDDEN (non-serious) with onset 2021, outcome "unknown", described as "She stayed in bed"; EATING DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Did not eat or drink"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Slight headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Joint pain"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "Vomiting a little bit"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills". Additional information: patient states 27Oct2021 will be 8 months since her second Pfizer Covid vaccine injection. After second dose of the Pfizer Covid vaccine she experienced slight headache, fatigue, joint pain, muscle pain, vomiting a little bit, chills muscle aches. She stayed in bed and did not eat or drink. Also said her right nostril had a little blood in it, it would come out and then stop. Next day I was fine then every other week my right nostril would bleed a little bit, and that has happened every two to three weeks with the last time being last week, for the last 8 month, patient also states her daughter had some of the same symptoms but declined to provide demographic information. Her daughter took the Moderna booster. Caller stated her granddaughter did not have the same side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Throat tingling, flushed, diaphoresis, increased blood pressure to 160's,
This case was reported by a other health professional via call center representative and described the occurrence of expectoration in a 2-month-old female patient who received ROTARIX (batch number A41FB470A, expiry date 4th February 2016). On 28th January 2015 12:15, the patient received the 1st dose of ROTARIX (oral) 1 ml. On 28th January 2015, immediately after receiving ROTARIX, the patient experienced expectoration and underdose. On an unknown date, the outcome of the expectoration was recovered/resolved and the outcome of the underdose was unknown. It was unknown if the reporter considered the expectoration to be related to ROTARIX. Additional information: A portion of the vaccine was given to patient; she swallowed that portion without incident. Then patient received remainder of vaccine but spit it out. She spit out medication along with milk. Milk was given shortly after ROTARIX.
Fever 101 degrees, headache, muscle ache, nausea, lethargy, mildly off balance, slight disorientation, sore arm, slightly out of breath, stuffy nose. Fever for 24 hours, nausea 48 hrs  and ongoing, tired 48 hours and ongoing, headache resolved 24 hrs, feeling "out of it" 48 is now improving.
18 hours after vaccine: body aches, joint pain, headache, fever. Lasted approx 12 hours.
Red swelling, sore, muscle aches, weakness, headache, dizzy, fever.
Patient received scheduled childhood izs @ 1100 9/6/23. Had allergic reaction @ 150 9/6/23; presented to my office with left thigh site reaction, diffuse rash with hives (head to toe), facial swelling, and wheezing. No strider or airway compromise, VS WNL. Tx with 25mg IM Benadryl, 5mg PO Dexamethasone, and 0.5ml 2.25/ racepinephrine neb. Monitored & DC home with Rx for prednisone taper, epipen jr, & OTC Benadryl.
Received Hep B (2 shot) around 2 pm. At 5 pm began experiencing pains in shoulder and neck worsened over next 20 hrs.
I started with headaches then congestion, cough on Friday. Then on Saturday afternoon I lost taste and smell. I took tylenol every 6 or 8 hrs. I took some robitussin Friday night.
Caller states that she was in hospital for 3 days and "couldn't walk"; Also had episodes of "throwing up."; Caller states that she is "off balance" on a daily basis since receiving the vaccine; after the 2nd Pfizer Covid19 vaccine her vertigo worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 Immunization, reaction(s): "Affected her balance and vision", "Vertigo", "Affected her balance and vision". The following information was reported: GAIT DISTURBANCE (hospitalization), outcome "unknown", described as "Caller states that she was in hospital for 3 days and "couldn't walk""; VOMITING (non-serious), outcome "unknown", described as "Also had episodes of "throwing up.""; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Caller states that she is "off balance" on a daily basis since receiving the vaccine"; VERTIGO (non-serious), outcome "not recovered", described as "after the 2nd Pfizer Covid19 vaccine her vertigo worsened". The patient was hospitalized for gait disturbance (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of gait disturbance. Clinical course: Patient got the Pfizer COVID-19 vaccine in Feb2021 and has had side effects from it for over a year now. Caller states she has been experiencing vertigo which has affected her balance and vision since having the 1st dose of the vaccine and after the 2nd Pfizer COVID-19 Vaccine her vertigo worsened. Caller states that she was in hospital for 3 days and "couldn't walk" and had to go through Physical Therapy and also had episodes of throwing up. Patient states that she was off balance on a daily basis since receiving the vaccine. Patient was asking are there any other reports of vertigo after getting the Pfizer COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.