chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000939: US-009507513-1906USA011674:
Pain, erythema and edema at injection site. Afebrile event 48 hrs post vaccination. Given Clindamycin and Advil.
Patient presented to the ED and was subsequently hospitalized for NSTEMI within 6 weeks of receiving covid vaccination.
Swollen lymph under the armpit; Swelling in the armpit; Pain is all around the butt and on the knees and all the area/all the area down; Pain is all around the butt and on the knees and all the area/all the area down; Pain is all around the butt and on the knees and all the area/all the area down; Back pain; pain in the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 No. 1), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph under the armpit; Swelling in the armpit"; ARTHRALGIA (non-serious), MUSCULOSKELETAL PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Pain is all around the butt and on the knees and all the area/all the area down"; BACK PAIN (non-serious), outcome "unknown", described as "Back pain"; NECK PAIN (non-serious), outcome "unknown", described as "pain in the neck".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I am a healthy individual with no pre-existing conditions. I had Covid-19 in August of 2020. I was in bed for 5 weeks with most of the symptoms and regularly had fever exceeding 104. When I was allowed to return to work, the Dr. gave me light duty orders to not exceed 5 hours worked per day for 2 months.  After receiving the first vaccination dose, my arm became incredibly sore. These symptoms lasted for almost 2 weeks.   The morning following vaccination, my body began to ache and hurt on touch to the point where the cover woke me up in pain. These symptoms lasted nearly three days during both day and night.   I became nauseous about 24 hours following the vaccination. These symptoms lasted almost 4, 24 hour days.   I became dizzy, periodically, about 24 hours after receiving the vaccination.  These symptoms lasted for almost 7 days.   I had low grade fever on three occasions that I knew about, I treated with Tylenol.  These symptoms lasted 3 days after vaccination.   I had a horrible headache (I never have had headaches before) I could not open my eyes or expose them to light. Most of the pain was concentrated on the left side of my head. These headaches started 3 days after receiving the vaccination and lasted 5 days later until day 8. I used Tylenol, which seemed to have little effect and slept all day.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 4:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 4:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.16   Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM,10 AM,11 AM, 2 PM and 3 PM temp was 32, 32, 32, 35, 35, total doses given for the day was 162, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vial was moved to clinic. Vaccine BUD date was 10-Mar-2021.  Vial was stored on cooler 2, on 14-Feb-2021, Excursion duration At 9 AM: 32, 10 AM: 32, 11 AM: 32, 12 AM: 39, 1PM : 37, 2 PM : 35, 3 PM: 35, 4 PM: 36.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Headache, chills, extreme fatigue, muscle aches, nausea, dizziness
Swelling in upper arm with redness and soreness.   Progressed to include itchiness. Lasted about 14 days.
Immunized 1/30/01, on 2/1/01 and 02/02/01 slept a lot and had a fever of 102F on 02/02/01 with decrease feeds. Admitted to hospital to rule out sepsis. Dx'd with influenza B. In hospital from 2/1/01 to 2/4/01 and went into shock by the time she was admitted to the hospital.
Headache, Myalgia, CHILLS, THROAT FEELS "HOT" Narrative:
Approximately 45 minutes after admin isteration of the vaccine to the left upper arm I started to experience loud ringing in my ear I tinnitus. I've had tinnitus in the past probably for a couple of years recently was relieved by chiropractic care. Approximately two days after on Saturday May the 22nd at 9:00 a.m. upon waking noticed left side of neck very stiff. Cannot move head to the right.
nurse gave a Tdap to an 18 month old instead of a Dtap with no reported adverse event; Initial information received on 03-May-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 18 months old of an unknown gender patient who was administered a tdap instead of a dtap with no reported adverse event, while receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  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 Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection lot number not reported at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date ,it was reported that nurse gave a tdap to an 18 month old instead of a dtap with no reported adverse event (wrong product administered) (latency: Same day) . No problems were stated as of yet.   Action taken :not applicable  At time of reporting, the outcome was Unknown for the event nurse gave a tdap to an 18 month old instead of a dtap 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 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.
8 Weeks Pregnant and Received Heplisav-B; Initial Report Received on 19-Oct-2022  This is a spontaneous report, received from a pregnant female patient, who received HEPLISAV-B for hepatitis B immunization.  There was no medical history reported.  Concomitant medications were not reported.  On 11-Oct-2022, dose 1 of HEPLISAV B (Lot #938793, expiration date 07-Oct2023, NDC # unknown), route not specified, was administered in the left deltoid for hepatitis B immunization.  The patient was 8 weeks pregnant with an estimated date of delivery 27-May-2023.   She did not experience any adverse reactions.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This spontaneous report was received from a registered nurse refers to a 19 year old male patient. On 07-JUL-2011, the patient was intramuscularly vaccinated with first dose of GARDASIL (lot number, expiry date was not reported). On 12-MAR-2013, the patient was intramuscularly vaccinated with second dose of GARDASIL (lot number, expiry date was not reported). No adverse effect was reported. Additional information has been requested.
delayed (7 days) induration 4x6cm distal to injection site Narrative:  Delayed onset of puritic mildly painful induration 4x6cm , distal to inj site. no other symptoms
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Tested negative after the tablets were taken; positive, notes: Got sick again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated that he was heavily exposed to covid so took Paxlovid and it quickly controlled the disease. Tested negative after the tablets were taken. Got sick again and tested positive. Then sick for several days. Anti-viral details for COVID 19 Treatment included PAXLOVID (lot number: unknown), treatment start date was on 19Jul2022 and treatment stop date was on 23Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events.
Injection was administered under deltoid, mid upper left arm.  Patient started to experience   warmth, and redness around injection site  this next morning.    Patient has taken Ibuprofen and applying an ice pack to the area.  Borders around redness marked.
Golf ball size of lump right upper arm that for a week as of today 11/16/2013 I continue to red area size of dime that is sensitive to touch and itches when touched, I was physically ill for several days after shot with muscle weakness and generalized fatigue for the week following the shot.
Pt recv vax on 8/12/97; on 8/13/97 pt exp rash w/ eruptions.  On 12/17/97 f/u visit pt imp.
Pt tolerated vaccine well. About five mins after injection, pt reported slight nausea and mild dizziness. I reported findings to FNP, he informed me to provide cold water and to observe patient. Rechecked vitals@ 1303 hrs: 02: 99 pulse: 71.At 1322 hours pt stated that she no longer felt any dizziness or nausea. Denied any SOB, CP, difficulty breathing, swelling of the throat/lips/tongue. Pt is aox4, speaks in clear and complete sentences. Per FNP pt able to be discharged if no longer feeling symptomatic. Patient denied UC services. Strict 911/ED given if sxs were to worsen or new symptoms were to arise. Patient verbalized understanding and agreed with plan. RN
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend who was a GlaxoSmithKline employee. The age at vaccination was not reported but, it could be 65 or 66 years. The patient received SHINGRIX in the left deltoid. The patient experienced soreness, redness and warm to touch from the injection site at the deltoid to her elbow. The patient planned to follow-up with her physician on an unknown date. The reporter provided limited information.
Pt did not convert p/a series of five doses of Hep vax; The 1st 3 doses of Hep vax were unspecified brand, but not Engerix-B were administered in buttock; the fourth & fifth doses were Engerix-B vax;
I though I was having bad allergic reaction to seasonal allergies, I took a covid home test and results came back positive had telehealth visit I was instructed to quarantine 11/3 to 11/10.  And wear mask for week.
Patient was supposed to receive Infanrix (DTaP) vaccine, was given Pediarix  (DTaP-Hep B-IPV) by mistake
MYALGIA/CHILLS AFTER VACCINATION WITH BOTH ANTHRAX AND SMALLPOX VACCINE--TX WITH DIPHENHYDRAMINE AND IBUPROFEN
No pain until 24 hours after, then mild soreness.  That night the pain woke me several times.  In the morning, the 2nd day after injection, there was severe, aching pain and my arm was very sore.  It was difficult to use.  I took aspirin and used a warm compress throughout the day (I took a sick day at work.)  I felt okay to return to work on Thursday, but by noon I began having severe pain,which seemed to spread to the upper shoulder muscle,and nausea.  I took aspirin and within an hour I began to feel better.  I was able to finish the day at work.  The soreness and pain continued through Sunday (the 6th day after injection)but each day was less severe.
Pain in left arm from 1/5 at 8am to 1/6 at 1pm. Ibuprofen did not help and it was hard to be able to move arm or it be touched. Fever, body aches, joint pain, and chills on 1/5 for about 7 hours. Tylenol and Ibuprofen did not break fever or body aches. 1/6 no body aches, fever, chills but very slight pain in left arm.
AFTER 1ST DOSE OF ENGERIX-B, PT EXPER FATIGUE, ATYPICAL LYMPHOCYTOSIS, PHARYNGITIS, AND ELEVATED LIVER ENZYMES. STILL HAS SYMPTOMS. HE WILL BE TESTED FOR EPSTEIN-BARR VIRUS. NO SUBSEQUENT DOSES GIVEN YET.
Nausea, hadache,low fever (100.9) deep fatigue - Slept 16 hours of last 25 hours.  Still have slight fever -99.8
Patient was vaccinated at 1606, then sat down to be observed. Staff observed patient fall to floor from his chair and another patient came to help the patient. Staff came over to assess patient and saw that patient?s legs were shaking and he was trying to get up. Staff observed patient?s eyes roll to the back of his head and drool was present. When trying to get patient?s attention while he was trying to get up, he did not respond and seemed unaware of his actions. 911 was called, while calling patient was alert and oriented. Paramedics arrived on scene, vital signs- SpO2:99, HR:74, BG:77, BP 150/90, 12 lead sinus rhythm. Patient explained he felt very nervous and anxious about getting his vaccine because he is afraid od needles. Paramedics think he had an anxiety episode. Paramedics and clinic staff advised patient to get checked out at ER due to potential head injury. Patient described throbbing pain at forehead and paramedics observed swollen spot on his forehead. Staff offered ice pack for head. Advised to discuss what happened with his doctor. Patient left with his wife and decided against medical advice to go to the ER. He appeared stable as he left.
On 02/22/2023, I was leaving town, and I felt weird and didn't have an appetite. I left town and decided to test myself for COVID-19 when I got to a hotel. When I returned home the next day, I decided to get an appointment since I have lung issues. I never had more than cold like symptoms. I saw my doctor who prescribed Paxlovid. My symptoms began to improve after that. I did develop a head cold shortly after that though.
Approx 15-20 min after receiving influenza vaccine pt had sharp pains upside of neck (L) which is the deltoid flu shot was pain in. Then started feeling foggy and thought she was going to pass out. The feeling came and went 3 times, whole episode lasting 5-10 min.
Patient received both flu and pneumonia shot in her left arm around 2 finger width apart and developed what appeared to be an injection site reaction with swelling, redness, and hot to touch. She followed up with her doctor 2 days later who diagnosed her with cellulitis post the vaccinations and is being treated with keflex.
Case number PHEH2014US014051 is an initial spontaneous report from the nurse on 11 Jul 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that on an unknown date she inadvertently received an intramuscular dose of Men A lyophilized conjugate of MENVEO (batch number: not reported) reconstituted with sterile diluent from Merck instead of MenCYW-135 liquid component. No adverse events were reported following the maladministration.
This vaccine gave my son shingles all over his body! From his eyes all the way down to his toes! This happen with in 48 hours of vaccination!
11 years old male patient / has received Infanrix; Did not receive the full dose as they realized / the wrong vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 5th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and incomplete dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete 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 details were reported as follows: The 11 years old patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration. The nurse also reported that patient did not receive the full dose as they realized that it was the wrong vaccine which led to incomplete dose administered. The reporter consented to follow up.
This spontaneous report as received from a medical assistant refers to a 20-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9, in the right deltoid, lot # N017833, expiration date 16-NOV-2019 (dose and route of administration were not reported) for prophylaxis. On an unknown date, the vaccine had been incorrectly stored at temperature of 32 Fahrenheit degrees up to 35 Fahrenheit degrees (0 Celsius degrees to 1 Celsius degrees) for a total time of approximately 11 hours. The temperature excursion had not occurred as a result of a reading from a Digital Data logger. No adverse effects were reported. There was no prescription drug treatment for the experience required. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA012500: US-009507513-1803USA012501:US-009507513-1802USA003340.
erythematous thigh w/swelling of thigh;crying x >3hrs p/vax; tx w/APAP, Motrin & hosp x 1 day
I had a fever for a couple of days with achiness. I could not sleep, with an associated cough. I also experienced brain fog for a while.