chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles on 02-Oct-2020 after two doses of Shingrix on 19-Dec-2018 and 30-Apr-2019/ suspected vaccination failure; shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2018, the patient received the 1st dose of Shingrix. On 30th April 2019, the patient received the 2nd dose of Shingrix. On 2nd October 2020, 653 days after receiving Shingrix and 521 days after receiving 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 details were reported as follows: The age at vaccination was not reported. The physician reported that a patient experienced an episode of Shingles after two doses of Shingrix. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting.
This spontaneous report has been received from an office manager refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L007225, exp. date on 03-MAR-2017), (strength, route of administration and dose were not provided). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was a little nervous about the vaccine and received the vaccine around 4:40 PM. She was in observation area and after about 10 minutes, looked like she was about to pass out and was assisted to the floor. She started having seizures. Called 911. Seizures lasted about 2 minutes and patient became conscious. She was taken to the hospital by EMS
Information has been received on 11/10/03 from a registered nurse concerning a dialysis patient who on 10/20/03 was vaccinated IM with a first dose of hepatitis B virus vaccine (lot # 644028/1017M or 645647/0527N). Subsequently, the patient presented to the clinic with a fever, low blood pressure, and generally not feeling well. The patient had a positive blood culture for gram positive cocci. The patient was hospitalized for antibiotic therapy. Specific antibiotics were unknown. It was noted that the patient also had other issues such as catheters or other frequent needle sticks so causality of the infection had not been determined. The patient reportedly recovered. It was also reported that another dialysis patient had a positive blood culture for gram positive cocci, however this patient was not hospitalized. It was also noted that these were two of fifteen patients who were vaccinated on the same day at the same facility. Additional information has been requested.  Follow up on 12/16/03: "Subsequently, the pt presented to the clinic with a fever, low blood pressure and generally not feeling well.  The pt had a "positive blood culture for gram positive cocci."  The pt was hospitalized for antibiotic therapy.  Specific antibiotics were unknown.  It wa snoted that the pt also had other issues such as catheters or other frequent needle sticks so causality of the infection had not been determined.  The pt reportedly recovered.  Follow-up information received on 12/03/03 reported that the pt had a previous medical history of an infected vascular catheter, and the pt was again diagnosed with an infected vascular catheter this time, which needed to be replaced.  It was noted that the diagnosis was not caused by hepatitis B virus vaccine rHBsAg (yeast).  It was reported that these events were reported "prematurely and thought that the symptoms may have had something to do with the [hepatitis B virus vaccine rHBsAg {yeast}] vaccine that the pt's received, since the symptoms of fever and generally not feeling well began with in 48 hours of the vaccination.  It was also reported that another dialysis pt previously reported with a positive blood culture from gram positive cocci (WAES# 0311USA01213), who was not hospitalized, was diagnosed with pneumonia.  It was also noted that these were two of fifteen pt's who were vaccinated on the same day at the same facility.  No further information is expected."
Pt recvd MMR @ 15mos, & booster dose of MMR on 25OCT90; On 10NOV90 pt devel morbilliform rash & cold sx w/low grade fever, h/a, malaise; Approx 1 month later sx resolved completely w/out tx;
itching/burning sensation on skin, but not everywhere, lightheadedness, congested feeling in throat, shaking all over-  were worst ~50 minutes - 3 hours after injection systemic allergic reaction  Took 2 benedryl  at pharmacy, where I tried to get an epinephrine shot - I thought I would get faster treatment there than ER- was a mistake  Believe should have gone to ER; friend wanted to take me   I categorized as life threatening below - think I was just really fortunate  Did not have what I would consider significant reaction to first injection-- no allergic reaction; very minimal immune  response side effects -  felt a little like I might get sick
I began to have a sore throat 02/13/2022 and went to my primary physician and tested COVID positive on 02/18/2022. I had congestion, breathing and coughing up mucus. I wake-up and gasps for air. Vitamin C, Zinc, and Vitamin D.
Information has been received from a medical assistant referring to a 17 year old male patient with attention deficit/hyperactivity disorder. The patient had no drug reaction or allergies. On 16-MAR-2016 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L028082, expiration date 18-SEP-2017, intramuscular, dose unknown). Concomitant therapies included a dose of BEXSERO administered on the same day and VYVANSE. Later the same day the patient developed a fever of 100/9 Fahrenheit and a cough. On 17-MAR-2016 the patient's fever increased to 102 Fahrenheit. The patient visited urgent care clinic. On the same day the patient had a blood work drawn which showed his white blood cell count was decreased at 2.9 (unit unknown) and his haemoglobin was decreased 13.8 (unit unknown). Unspecified intravenous fluid bolus and ibuprofen were given as treatment. On unknown dates in March 2016 the patient recovered from the events (reported as resolved with two weeks). The patient intended to continue the GARDASIK 9 series. Additional information has been requested.
aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pollen allergy" (unspecified if ongoing). Concomitant medication(s) included: BENICAR; VIMPAT; CHLORTHALIDONE; AMLODIPINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 18Oct2023, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 18Oct2023, outcome "recovering". The events "aches" and "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, fatigue. Additional information: No COVID prior vaccination. No other vaccine in four weeks. The patient had experienced aches and fatigue. Now into the 8th day. Only usually 3 days.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Ten days after receiving the first dose of the Moderna Covid 19 Vaccine, I developed a rash on the arm that had the injection.  The rash lasted 4 days, it was hot to the touch and red.  I had no other side affects, no fever or body aches.  Interestingly enough I have blood type B, as does my Mother, who also received Moderna and got a rash.
multiple adverse events including chills, fever, rash on arm but the most severe were the joint inflammation and muscle pain which essentially affected every major joint in my body-shoulder, hands, hips, knees and ankles. and  immobilized me for weeks, Graduallly all but the knees got better The knee pain and swelling was getting worse so I went to the ortho doc and  needed steroid inections in both knees on April 21, 2021 which was the first available after the standard post vaccine waiting period.
delayed cutaneous hypersensitivity reaction Narrative:  area around injection site was swollen, red, itchy, and hard to the touch. Approximately 2-3 inches wide. Onset 3 days after injection and duration was 3 days.
Previously had long covid which went away the vaccine reignited this 2-3X. Side effects:  Brain Fog, Persistent headache, derealization, Tremors in hand, Internal Tremors throughout body at night, Cognitive issues, memory issues, loss of word recall, inability to sleep, post exertional malaise, extreme fatigue
systemic potentially allerg rxn to last vax;pt had rash & itchy trunk & face 17MAR98;
Redness 1 & 1/2 inch wide at site of injection. Warm and hard to touch - little swollen. Her PCP informed he'll contact a patient.
Information has been received from a licensed practical nurse concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours Previous temperature excursion: Yes, -9°C to +8°C for 5 hours Data logger involved: Yes This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 with expiration date 24-APR-2019 (reported as April 2019) has been verified to be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1708 USA000471: US-009507513-1708USA000472: US-009507513-1707USA004998: US-009507513-1708USA000473: US-009507513-1708USA000475:
Rash throughout, with redness, heat to the ears starting withing 30 min of vaccine administration, Employee given Benadryl 25mg po for relief of symptoms.
Cough, wheeze, increased HR, observed x 1 hour, albuterol 4 puffs with resolution.
Initial case received on 14 February 2011 from a healthcare professional via another manufacturer (reference number US-WYE-H17670610). A 3-month old male infant received an intramuscular first right leg injection of ACTHIB (lot number UH125AB) and an intramuscular first left leg injection of PREVNAR 13 (lot number E57642) on 04 August 2010. On 17 August 2010 he received an intramuscular first right leg injection of PEDIARIX (lot number AC21B249AA) and a first oral dose of ROTATEQ (lot number 0500Z). On 17 September 2010 the patient developed symptoms of an upper respiratory infection with fever. The following day his symptoms worsened, and included fussiness, pallor, and bulging fontanel; he was also diagnosed with otitis media. On 19 September 2010 the patient experienced a seizure, and was diagnosed with "strep pneumo meningitis". He was hospitalized for 14 days. Relevant testing included a CT of the head, lumbar puncture, biochemistry work-up, MRI of the brain, EEG, and BSAER; results of this testing were not provided. Medical history at the time of vaccination included hematochezia and a possible allergy to cow's milk. The patient was 8 pounds 7 ounces at birth, and was delivered via C-section at 40 weeks gestation due to fetal distress and failure to progress. At the time of the event, the patient weighed 7.4 kg. Per the reporter, the vaccines were administered by a health care professional and medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth were reported as normal. At the time of the report, the patient was recovering from the events with mild hearing loss. The other manufacturer also reported the event "drug ineffective" for the vaccine PREVNAR 13. Follow-up information has been requested by the manufacturer, and no further information was expected. Per the manufacturer's case comment, "Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13".
Patient reported extreme pain in the muscle of the arm over 24 hours after receiving the vaccine. she also had what looked like hives a few inches below the injection site. She said the reddened areas resembling hives were painful to the touch, not itchy at all. She said she had no fever.  She says she applied hydrocortisone, iced the area, and took some benadryl and now is feeling much better and it looks like the reaction is going away now.
Information was received from a lawyer on 19-APR-2019 regarding a case in litigation concerning a female (age and medical history not provided). In or around 30-SEP-2016 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles. Four days after receiving the vaccine the patient suffered from a painful rash on left arm and was diagnosed with herpes zoster. As a direct and proximate result of ZOSTAVAX the patient symptoms have resulted in physical imitations not present prior to using the vaccine. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of condition. The patient has suffered severe and permanent personal injuries and suffered serious progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient suffered and incurred damages including medical expenses, the loss of accumulations and other economic and other economic damages. Herpes zoster was considered to be disabling. Additional information has been requested.
Sore left arm; muscle aches in my upper arms; back spasms; numbness in both hands; tingling in both hands; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), MYALGIA (muscle aches in my upper arms), MUSCLE SPASMS (back spasms), HYPOAESTHESIA (numbness in both hands) and PARAESTHESIA (tingling in both hands) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included MGUS.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), MYALGIA (muscle aches in my upper arms), MUSCLE SPASMS (back spasms), HYPOAESTHESIA (numbness in both hands) and PARAESTHESIA (tingling in both hands). At the time of the report, PAIN IN EXTREMITY (Sore left arm), MYALGIA (muscle aches in my upper arms), MUSCLE SPASMS (back spasms), HYPOAESTHESIA (numbness in both hands) and PARAESTHESIA (tingling in both hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter
This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient got really sick after first dose of SHINGRIX and did not want to proceed with 2nd dose in series. No further information was available at the time of report.
104F temperature, non-responsive, vomiting, very low blood pressure, sepsis physiology (no infection found)
5/21: aches that worsened into the night 5/22: 11 am- feeling faint, extreme N/V, shivering, numb hands halfway up forewarm, abnormal HR; 5 pm - feeling resolved 5/23-24: "feeling off" w/out the above or new sxs  took 2 tab bayer 500 mg throughout ; stopped taking on Saturday
This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a female patient who received SHINGRIX for prophylaxis. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 1st September 2018, 86 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. On 7th June 2018, prior to leaving on a 2 month long vacation,  the patient was vaccinated with the 1st dose of SHINGRIX. When the patient returned back from the vacation, his local pharmacies were unable to provide him the 2nd dose of SHINGRIX and the patient experienced shingles in his eyes. The patient inquired how soon after experiencing shingles it was safe to get vaccinated with the second dose of SHINGRIX as the patient did not wanted to get shingles again.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe
Shortness of breath, tachycardia (HR 130), and redness all over body.
Date event was reported to the clinician:November 23, 2021 Date Adverse Event : middle of July 2021 Describe Event:Patient's wife said sprycel was discontinued due to development of pulmonary artery hypertension that was due to sprycel or covid 19 vaccine (Pfizer - 2nd vaccine given late April or early May 2021), she was not sure. Patient  had leg swelling and rash with undetermined etiology (by infectious disease doctor)  in middle of July 2021,  had trouble breathing and admitted to hospital for 5 days  in September, and on September 16th and November 1st had fluid pulled off of lungs and is currently taking furosemide.  Unknown if it is completely resolved.
Headache over right forehead started 1/28/21 for 24 then sudden runny nose on right nostril, then loss of taste in right side of tongue started 24 hours later and the other symptoms improved. Mild pain over right cheek and into ear have remained over the past 72 hours along with the loss of taste and funny feeling on right 1/2 of tongue. No facial muscle weakness noted. No change in hearing or vision.
Vomiting (24 hours) severe diarrhea (3 days) high fever (100-104 degrees, 3 days), swelling in thighs, unable to walk or stand (3 days), extremely lethargic (4 days), dehydration.
Heart started pounding so hard; I had my heart pounding, absolutely pounding; Elevated blood pressure; Heart rate was 135; Heart rate was faster than normal and I still could feel it; This is a spontaneous report from a contactable other health care professional (nurse practitioner) (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number 30145BA and expiry date not reported), via an unspecified route of administration, on 25Sep2021 14:30 (at the age of 74-year-old), as dose 2, single, for COVID-19 immunisation. Patient had no medical history. Concomitant medication included vitamins. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FC3183 and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as 19Aug around 14:00 (not clarified), as dose 1, single, for COVID-19 immunisation and flu shot on last year. On 25Sep2021 14:35, five minutes after vaccination, the patient heart rate was 135. On 26Sep2021, the patient went to church at 11:00 clock, and the patient could hardly get through it, so the patient went home to rest and suddenly, heart started pounding so hard and had elevated blood pressure. The patient lies down and put feet up against the wall to try to make it better and when it got better, the patient called the doctor. The patient was taken to emergency room with a pounding heart and elevated blood pressure. When the patient reached emergency room, the patient didn't have another pounding heart, but the blood pressure was elevated the whole time, heart rate was faster than normal, and the patient could feel it. The patient had increased heart rate and some palpitations and a little bit of pounding right before the patient was going to sleep on 26Sep2021 (reported as last night). It was reported that, the patient was not on any cardiac medication at all and did not have cardiac history, and did not have history of hypertension. It was reported that, they just said that probably the immune system was causing blood pressure elevation. The patient underwent lab tests and procedures which included EKG, Troponin, Chest X-Ray, Cardiac Enzymes, BMP, CBC, and Cardiac studies (not clarified further), and everything was normal. Covid test showed negative on 26Sep2021. The outcome for the events was unknown. The reporter stated that the events were related to vaccine.