chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Grade 3, swelling at injection site, arm pain after injection on Friday and today, Saturday after second dose with LVN. The nurse LVN may not have injected it correctly. I struggled to do dishes after dinner. My arm pain kept me awake last night. I didn't have any arm pain or swelling at injection site with the first Pfizer dose with nurse. No Pain or side effects whatsoever with the first Pfizer vaccine.  Vaccine may be fine.  It might be the way the nurse injected it.
Left arm started becoming sore and got increasingly worse until my left arm was barely usable. This took about 3 weeks to subside.
Patient received MCV4 vaccine #2 dose around 11:15am on June 8, 2021 while sitting on corner of exam table.  About 11:20am, patient suddenly fell forward from exam table and hit the floor face down while MA and mom present in room and assisted him further. Vitals were taken and stable. Patient remained alert and oriented. Patient was able to arise from floor and sit up on exam table and was further examined by Dr. and FNP. Patient started to experience chest pain within a few minutes and 911 was dispatched at 1136am. Patient has remained alert and oriented through exam and upon arrival of EMS/Fire Dept around 11:45am and vitals remained stable. Ambulance with paramedics arrived around 11:55am and vitals remained stable. After the EMS/Fire Dept  and Paramedics discussed mom the different options of going to ER by ambulance or Private vehicle, mother chose Private vehicle. Patient walked out of Dr office around 12:09 pm to private vehicle while being escorted by mom and Fire EMS personnel. Mom was going to take patient to Local ER for further evaluation.
Stroke; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Facility type vaccine was Nursing Home/Senior Living Facility. The patient medical history was not reported. No Covid prior vaccination. Concomitant medications included unspecified other medications received in two weeks. The patient experienced stroke on 13Jan2021. AE resulted in ''Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization''. The patient was hospitalized from Jan2021 to Jan2021 for 2 days for stroke. Patient not received other vaccine in four weeks. Patient was not pregnant. Therapeutic measures were taken as a result of stroke. The outcome of event was recovering.  Information on the lot/batch number has been requested.
Injection site pain, no treatment. A discomfort when I move my arm up my head.
Had two friends got their first dose got sore arm, second dose knocked them down for 4 or 5 days; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Had two friends got their first dose got sore arm, second dose knocked them down for 4 or 5 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3rd dose 06sep2022; 1st dose 26Apr2022, 2nd 06Jun2022; This case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number kl472, expiry date 30th September 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 6th September 2022, the patient received the 3rd dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. On 6th June 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 6th June 2022, not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device and unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 6th September 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received the 2nd dose of Bexsero later than the recommended interval, which led to lengthening of vaccine schedule. The patient received an extra dose of Bexsero, which led to extra dose administered.
Patient received Hepatitis B vaccine on 11/20/2018: Left Deltoid IM. States she broke to in Rash present on Chest/Forehead, woke up to itchy Chest w/ rash on 11/25/2018, when she first noticed Rash. No other Sx. Patient came back to office on 11/26/2018 for MMRR#1, patient didn't disclosed that she was having a rash break out at time of visit. MMR#1 was administered, with no complications or new symptoms. Patient states she has very sensitive skin, not sure if food, dairy, or contact.
Injection site reaction. Injection site swelled and was pus-like. No signs of bleeding. Occurred immediately after vaccination.
no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from medical assistant and refers to a 1 year-old female patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W003819, expiration date: 24-FEB-2022, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008720: US-009507513-2209USA008838: US-009507513-2209USA008836: US-009507513-2209USA008837: US-009507513-2209USA008835:
HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.; Sender Comments: US-009507513-2306USA011972:
This spontaneous report as received from a medical assistant concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported) oral route. Co-suspect and concomitant therapies were not reported. The medical assistant reported that unspecified patients received improperly stored ROTATEQ exposed to 49F for 35 minutes, on an unknown date. No adverse effects were reported. This is one (1) of four (4) reports from the same source (MARRS 1408USA016198. 1409USA006389, 1409USA00638 and 1409USA006390).  Additional information has been requested.
Left arm was sore, swollen with hot to the touch, redness extended approx 65 x 50mm. Mother stated child had no temp. Instructed mother to apply cold compress to left arm site, Prn. Instructed to give child Tylenol for fever and pain (per bottle instr.) prn. Instructed to buy OTC Benadryl for s/s. Instructed to call back if s/s persisted and become worse for RN assistance to see MD in local family care clinic or go to local ER. Mother verbalized and understood all instructions given. TC with Mother, ask how child was doing. Mother stated child was fine and that the redness was gone and the arm was hard about 1/2" around injection site.
Mother reported one event of seizure activity 24-25 hrs post vaccination. Event reported as stiffness/rigidity of muscles, eyes rolled back and unresponsive x 1 min duration. Taken by mother To ER for evaluation.
sore; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore) and INJECTION SITE PAIN (injection site pain) in a 65-year-old male patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (sore) and INJECTION SITE PAIN (injection site pain). At the time of the report, PAIN (sore) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were provided.
CLIENT STATED HER ADVERSE REACTIONS BEGAN 24 HOURS AFTER HER INJECTION. SHE EXPERIENCED HEADACHE, SORE THROAT, STIFF NECK, DIZZINESS, NIGHT SWEATS, AND INSOMNIA. AS OF TODAY, SHE STILL COMPLAINS OF INSOMNIA AND DIZZINESS. PRIMARY PHYSICIAN ENCOURAGED HER TO REPORT HER ADVERSE REACTIONS.
Pt recvd measles vax 28DEC90 & five days following vax pt felt funny & was hospitalized w/fever; no further details were provided;
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Bad pain left leg on 5/12, 5/13, 5/14 treating with BIOFREEZE. 5/14 in evening noticed that shingles broke out on left buttocks so put cortisone 5/15 went to urgent care and diagnosed with shingles. Given VALTREX (generic), CIPRO 500 mg for bladder, phenazopyridine 200 mg. Bladder infection did not clear up after 2 days as usual. Husband also broke up in shingles. Went to doctor on 5/18 doctor confirmed it was shingles and changed bladder medication to doxy-cycl-hycl 100 mg. As of today bladder improving but not a lot. For the shingles had pain on various parts of body and it looks like they are clearing down.
Information has been received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX with lot # M036293 and expiration date of 17-AUG-2018 (route of administration, dose and anatomical location were unknown) for prophylaxis; reconstitued with sterile diluent (lot # and expiration date were not provided). The vaccine was exposed to a temperature excursion of  6°F to 14°F with a time frame of 45 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. There was not product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012630:
Patient had a very sore arm for 2 or 3 days after injection. It is now three months later and patient still has a sore arm. Has trouble sleeping on that side. Hurts when he sneezes. Hurts to push himself out of bed with that arm. Has tried Heat and cold therapy and has taken ibuprofen for 5-6 days, with little relief.
Patient states she started to feel poorly within 1/2 hour. Presented to clinic on 7/2/18 with fever 101.5 after Tylenol. nerve pain and blister on left hand. General Malaise and muscle soreness. She was diagnosed with Shingles on this date.
Narrative: COVID infection following COVID vaccine series 01/19, Moderna, dose #1 02/16, Moderna, dose #2 09/07 COVID swab, result: detected 08/24 pt cc: chills, cough, diarrhea, fatigue, fever, rhinorrhea, dyspnea, exposure: unknown 08/27 COVID swab, result: detected 08/27 SARS-COV-2 Variant Sequencing result: pending 08/28 pt admit to ED cc: cough & SOB, dx: LOS: 1 day 08/28 CXR impression: Similar radiographic appearance of the chest, as detailed above. 09/09 clinically rlesolved
Drank 4oz of milk out of bottle. Became limp, unresponsive, eyes rolled. Stopped breathing 45 sce -60secs. Mom called 911. Did Heimlich and stimulated him. Began crying.
Received tetanus shot on Sat. 5/19/07 within minutes of receiving the shot I got a bad headache and became nauseated. I took benadryl and antibiotic when I got home. I continued to feel bad. I took antibiotic and benadryl everyday and was having infrequent extreme anxiety. Tuesday was the last day I took benadryl for itching and Wednesday I started feeling extreme anxiety, nausea and headaches, by the afternoon my chest was hurting and my left arm too. I felt very confused and very bad. I called the Dr's office and was advised to discontinue the antibiotic they thought I was having an allergic reaction to and to take 2 benadryl.  The benadryl eased the heart pain I felt and headache eventually subsided. Everday since Sat. 5/19/07 I have had bad headache, nausea, neck tension and just generally not feeling good. Also, infrequently my chest hurts and I am not thinking clearly.  I was having none of these symptoms before I came into the office and had this shot.  I went in for itching and a bug bite that became infected and now I'm so nauseated I can not eat right and have lost 6 pounds in a week and having wicked headaches.
Chest, joints, and back pain, abnormal heart palpitations, painful headaches, dificulty to remember, chronic sinus pain.
Shots doesn't prevent you from getting shingles / got them in Oct & still have them /Suspected vaccination failure; Shingles / got them in Oct & still have them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2020, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles and till the time of reporting, the patient still had them. The patient stated that shots did not prevent you from getting shingles, but it reduces chances and severity if you get them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
I started a lot of the pain in my right arm where I received the vaccine. The pain was so severe, I couldn't sleep. I went to an urgent care and gave me morphine. The pain left after the morphine was given. Experienced a lot of nausea and  diarrhea
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-OCT-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # N020016 and expiry date 17-JUL-2019) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. There was involvement of Digital data logger was involved. There was no involvement of Product quality complaint (PQC).
Swelling in right side of neck, daily headache, peroid off and on.  We seen patient on 11-04-2021 an d patient still had a 1.2 cm mass on right side of neck. Patient sees OB GYN for her other stuff.
Headache, Myalgia, NauseaVomiting, Chills Narrative:  No further details
Patient recieved PPD placement ansd then received typhoid in left arm. Patient then stated he didn't feel well and went unconscious.  Patient fell back on an exam table and sustained zero injuries.  Patient began to grunt and became very tense.  Overhead Code Blue was initiated.  0.3ml Epi Auto Injector was administered Immediately into Left medial lateral thigh and held in place for 10 seconds.  Patient woke up 10-15 seconds after auto injector was given.  Patient stated he did not remember anything.  Patient was placed on NRB at 15lpm.  Initial vitals where taken and recorded.  Patient was assessed by Dr.
Severe headache; lightheadedness; extreme fatigue; soreness at injection site; slight fever; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative.  A 59-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No underlying conditions, I felt fine prior to vaccination. On an unspecified date, The patient experienced severe headache, light headedness, extreme fatigue, soreness at injection site, slight fever. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot been obtained.
While sitting in infant swing-threw arms up in air over head, stiffened up w/red face, eyes widened;
Tasting metal; Headaches; General side effects; A spontaneous report was received from a consumer concerning of an unknown age,female patient, who received Moderna's COVID-19 vaccine and experienced tasting metal, headache and other general side effects.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced a metallic taste, along with having headaches and other unspecified side effects. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, tasting metal, headache and other general side effects was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Twitching 24 hrs following which lasted a few days; t100-101 w/APAP;
Patient experienced tenderness and pain the next day. Two days later she reported a rash around the injection area about 2 inches in diameter.
Entire upper arm developed a rash that was hot to touch a couple days after the injection was given was when it was noticed. It was there for at least one week.