chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a shipment of FLUZONE HD QIV was delivered too late and caller had already spoken. However, 3 of the vaccines in the shipment were administered to patients, no AE; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via Agency inbound (reference number- 00792822) and transmitted to Sanofi on 30-Sep-2021.  This case involves INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] whose shipment was delivered too late, However, the vaccines in the shipment was administered to an 86 year old female patient (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On 29-Sep-2021, the patient received a dose (0.7ml) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ763AC; expiry date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was case of actual medication error due to incorrect product storage (latency: unknown).  It was reported "Pharmacist states a shipment of FLUZONE HD QIV was delivered too late and caller had already spoken. However, 3 of the vaccines in the shipment were administered to patients."  Also, the reporter mentioned that the shipment had been in transit for a few days. It was supposed to have been returned but it was not.  No adverse events were reported at the time of this report.  At the time of this report, the outcome of the event was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
24 hrs after injection cellulitis like edema noted of upper right arm extending from deltoid region to right wrist. No complaints of pain. Hospitalized for 48hrs on IV vanco and UNASYN and BENADRYL.
This spontaneous report was received from a registered nurse and refers to a 15 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-JAN-2017. On 07-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M038860 with expiration date of 13-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 21 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the unspecified patients was vaccinated with doses of improperly stored VAQTA (lot # L018499, expiration date 25-FEB-2017) (dosage, strength and route were not reported). 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.
swelling & itching in eyes/nose;difficulty in breathing;some flushing of skin;inject site=swollen & red X right /p of injection lasting X 10 mins;0.3 cc sub-cu epinephrine=Rx;oxygen given also;pt recovered & nl /p RX
Patient experienced nausea and vomiting hours after receiving vaccine. Patient also went out to eat after vaccine so it is difficult to determine cause of nausea and vomiting.
Death after 2 1/2 weeks.  Received 2nd shot on 6/21/21 and died on July 9, 2021.
Vertigo; This is a spontaneous report from a contactable consumer. This 61-year-old, non-pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number: EN6208) dose 2 via an unspecified route of administration on 02Apr2021 (at the age of 61-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history included hypertension, high cholesterol, diabetes. The patient past drug therapy included BNT162B2 (Lot number: EN6198, dose number 1) for Covid-19 immunisation start and stop date on 11Mar2021. The patient had no known allergies. The patient concomitant medications included progesterone, citalopram, valsartan, omeprazole for unknown indication on an unspecified date. The patient experienced vertigo on 21May2021. The patient received treatment with meds and IV fluids for adverse event. The patient underwent lab tests and procedures which included CT Scan and MRI with unknown result. The outcome of the event was not recovered.
Extreme headache, chills, pain in shoulders, lymph nodes under jaw slightly swollen, feeling overall very ill and very tired. Headache and chills lasted20 hours and brain fog and dizziness lasting total of 3 days.
7:00 pm that night, my arm started to hurt very intensely and then the next day when I woke up and it hurt - felt like it broke my arm. It hurt really bad - couldn't left it or move it. I took Tylenol once or twice that day with six hours in between. I was a little bit drowsy and headache and a little bit nauseous.  So I slept that day. I felt like my arm got hit by truck. 10th - I felt better that day. By Monday, the 11th, I was totally fine. Pregnancy: I'm due May 29, 2021; I have had a miscarriage before so it's my second pregnancy. So far everything has been normal.
Pt given FluMist as ordered in clinic order form. Child had no adverse affects. Parents vomited 1/2 hr.
She developed a slight fever on 9/18 and extreme fatigue.  Her fever went down on Monday but she developed a wet cough on Monday night.  On Tuesday, her fever returned and her cough persisted as well as abdominal pain.  We went to the doctor on 9/21.  As of 9/22 her fever is gone but still a slight cough and a little abdominal pain.
On 08/21/2008 A.M., mother noticed child's right upper arm over the deltoid area was swollen about the size of a baseball.  It was also red and warm to touch.  No drainage was noted.  Mom states child was also running fever but mother never checked it with a thermometer, she just gave the child Motrin and it still currently giving Motrin stating child still running fever today on 08/22/2008.  Mother brought child to MD and was seen by Nurse Practitioner and Pediapred was ordered by mouth along with topical hydrocortisone cream.  Nurse Practitioner instructed mother to give Benadryl next time child is to receive immunizations.  MD's office called our clinic after MD was back in clinic but hadn't given further instructions regarding administering future immunizations.  Requested order from MD regarding permission to give further immunizations.  On 08/26/2008, spoke with mother and she stated child stopped running fever as of 08/22/2008 and swelling in right arm resolved after 2 days.  Reminded mother of need for permission to give future immunizations.
Patient received Hep A (#1) and Varivax on 11/7/06. The next evening patient had visual hallucinations while awake.
Patient was given these immunizations on 05/11/2022 but he had already received 4 yr old vaccines. No symptoms were presented.
Fever, Erythema Multiform and injection site pain, erythema, and mild fever 102.7 F. ACETAMINOPHEN 325-600 MG QID.
Got sick as a dog; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received a dose on an unknown date and got sick as a dog, refer case US2021AMR198022).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingle shots and got sick as a dog.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198022:Same reporter
Brain Fog, persistent difficulty concentrating/focusing even after sleep within 16 hours of vaccination. Dizziness, Lasting fatigue, burning/dry eyes, strange seemingly random body cramps even with high fluid intake and rest.
This spontaneous report was received from a physician refers to unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. On 07-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX batch/lot number: R013565, expiration date: 13-MAY-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis, which was reconstituted with properly stored sterile water diluent. The administered doses of vaccines experienced the temperature excursion of -9 to 8 degrees Celsius for 13 hours 59 minutes and -9 to 8 degrees Celsius for l hour 43 minutes. There was not previous temperature excursion. Data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA007011.
Started to have more and more soreness at injection site after administration. Then soreness turned into muscle and joint pain. After about 6-7 hrs from injection time started to feel really bad. I took an Advil before trying to lay down. Was unable to sleep, started getting chills and headache. I took my temperature and it was 102.4. I then took some Tylenol and put some wet clothes on. Temp stayed at 102.4 for a few hours and then finally broke. My temperature went down to 101.4 and stayed there for awhile and now is 99.2.  Feeling better than I was, still have severe  headache and  soreness in body.
patient received 0.5ml dose instead of 0.25ml of the 6 months through 11 years moderna covid vaccine
Excessive swelling, redness, warm to the touch, itching. All at the injection site. Treatments tried: OTC hydrocortisone 1% cream with no relief.
(L) deltoid about 6 1/2 x 8 cm red. About 6 1/2 x 5 hard cm area. Red, swollen & warm to touch.
Information has been received from a physician concerning an 18 month old female child with pertinent medical history and drug reactions/allergies reported as none on 8/2/06 was vaccinated with Hep B + Hib vaccine. Concomitant medication was reported as none. On 9/10/06, the pt developed reactive arthritis shortly after completing the series of Hep B + Hib conj vaccine. A titer on the pt was 1000 for hepatitis which the physician considered to be very high. The pt was said to have a disability because the arthritis was in both knees. The physician reported that the Hep B + Hib conj vaccine was given at another practice and no specifics were known. The pts reactive arthritis persisted and was considered to be disabling. Additional information has been requested. As of 10-Sep-06 reactive arthritis persists and was considered to be disabling.
the patient was administered improperly stored PROQUAD; Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 11-AUG-2020, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T001187, expiration date 11-JUL-2021; dose, strength and route were unknown), which was reconstituted with properly stored Merck sterile diluent. The vaccine was exposed to multiple temperature excursions between minus 15 to 8 degrees Celsius (minus 6.1 degrees Celsius) (product storage error). There was no previous temperature excursion. The call was due to digital data logger.
Diarrhea for 24 hours. Approximately 4 loose non-bloody stools. Minimal cramping.
I felt extremely fatigued for about 24 hours starting around 6 p.m. the day of the injectin and lasting until around 6 p.m. the following day.   I also started having vertigo occuring intermittently for up to 15 mintues at a time.  As of today, 10/1/2021, I have experienced the vertigo every day since I received the injectin on 9/19/2021.
HCP called to report an infant who vomited after receiving a full dose of ROTATEQ. Patient received their first dose of ROTATEQ on 01NOV2023 and "vomited a few seconds later." No additional AE/PQC.; This spontaneous report was received from a nurse and refers to an 8-week-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2023, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, administered orally for immunisation (strength, lot #, and expiry date were not provided).  On 01-NOV-2023, the patient experienced HCP called to report an infant who vomited after receiving a full dose of ROTATEQ (a few seconds after). On 01-NOV-2023, the patient recovered from the event.   The causal relationship between adverse event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Swollen & red with deep muscle aches at injection site on right arm (where pneumonia vaccine was given.) Fatigue, chills, muscle aches over entire body. Slight fever.
Patient in postobservation area compliant of "face feeling numbed and agitated". BP 130/68, SOB and swollen tongue was noted. Pulse 135 BPM. No rash or skin changes. 911 Called, Epinephrine .5 ml administered to R area, Albuterol puff x 2 via mouth. Client comforted to stop crying and depleting self of air.  EMT transported client to ER. Client released on 8/11/21 at 10 pm. Contacted client on 8/12/21 to follow up. State was given IV fluids and released feeling well. Client denies any other problems at this time.
12 hours after vaccine injection I had a sore arm. The next morning I was fine.  36 hours (approximately) after vaccine injection I began to feel very sore. I got chills, my breasts became extremely painful (I am breastfeeding my three week old baby). I was unable to fall asleep despite being exhausted. My chills were so bad my teeth were chattering and I could not get warm, even though I slept with a heat pad on it's highest setting. I became very thirsty and had waves of nausea. I got a bad headache that pulsed with spasming pain on the back of my head. I got up to get water and was very dizzy. Checked my temperature and it was 101.7 Fahrenheit. In the morning my fever had dropped to 100.1 and my chills were not so bad. Nausea was gone, but I still had a bad headache and was completely exhausted. That day I could not do anything, and was barely able to feed my three year old.
Initial report was received from another manufacturer on 06 January 2012 (Manufacturer Report Number 2011286944/ US-PFIZER INC-2012286944). A nine-month-old female patient had received an injection of PENTACEL, sanofi pasteur Ltd. (lot number, route and site of administration not reported), PREVNAR, Pfizer (lot number, route and site of administration not reported), an influenza vaccination (manufacturer, lot number, route and site of administration not reported) and a hepatitis B vaccination (manufacturer, lot number, route and site of administration not reported) on 17 November 2011. An unspecified amount of time later on 17 November 2011, the patient experienced several seizures and was taken to the emergency room. The relevant therapeutic measure taken in response of the event and relevant laboratory data of the patient were unknown. It was unknown if the patient took any concomitant medications or had any relevant past medical history. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
NVAF; Two weeks after getting third vaccine I developed blood clot in my leg; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (NVAF) and THROMBOSIS (Two weeks after getting third vaccine I developed blood clot in my leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic fatigue (She had chronic fatigue probably all her life and had to always sleep for 10-12 hours a day. This started to become a problem in 2020.). Concomitant products included APIXABAN (ELIQUIS) from 03-Jan-2021 to an unknown date for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (Two weeks after getting third vaccine I developed blood clot in my leg) (seriousness criterion medically significant). On an unknown date, the patient experienced ATRIAL FIBRILLATION (NVAF) (seriousness criterion medically significant). The patient was treated with Surgery (Two different surgeries to remove blood clot) for Thrombosis. At the time of the report, ATRIAL FIBRILLATION (NVAF) and THROMBOSIS (Two weeks after getting third vaccine I developed blood clot in my leg) outcome was unknown.            Concomitant medication was not provided. Patient reported that, Eliquis was working great to her and she did not know what her life would be if she did not had it.  Company comment: This is a spontaneous case regarding a female patient of an unknown age in treatment with Apixaban for an unknown indication, who experienced unexpected and medically significant event of Thrombosis leg (AESI) 2 weeks after receiving third dose of mRNA-1273 vaccine. In addition, on an unknown date, patient experienced unexpected and medically significant event of atrial fibrillation (AESI). Treatment included two different surgeries to remove blood clot. At the time of the report, outcome was unknown.  No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Apixaban remains a confounding factor.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Large localized swelling and erythema >15cm in diameter on upper arm in vicinity of pneumovax.
Complaining on aching neck, shoulder, upper R arm where shot administered 4 days after getting H1N1 injection 4 wks ago.
One hour after administration of vaccine, patient had a massive bloody stool. He was directed to the ER where he was found to have intussusception that was reduced with air contrast enema. He was kept overnight for observation and released the next day without complication.
I gave 1ml of the vaccine instead of just 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (I gave 1ml of the vaccine instead of just 0.5ml) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 immunization.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 06-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (I gave 1ml of the vaccine instead of just 0.5ml). On 06-Mar-2021, ACCIDENTAL OVERDOSE (I gave 1ml of the vaccine instead of just 0.5ml) had resolved.        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 relevant concomitant medications were reported. No treatment information was provided.   This case was linked to INC.-MOD-2021-035775 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-035775:
During the week prior to my vaccination, a coworker came to work coughing continuously. My other coworkers encouraged him to go home and he didn't come back the rest of week. On Thursday, I was vaccinated. Afterwards, I began to experience progressively symptoms that lead me to believe I may have COVID-19. My job required me to do a home test before returning from the holiday weekend. So, on July 4th, I did a home test and it came back positive. I wasn't certain of the accuracy of that test. I found a clinic and requested a test to be conducted there. By midnight, July 5th, I received confirmation that I was positive for COVID-19. I had to take another day off work to quarantine. I don't feel great. On Friday, after my vaccination, I felt what seemed to be normal swelling under my left armpit at the site where I was injected with the vaccine. I went to work that Friday. By the end of Friday, I was beginning to feel tired, but I thought that was just from the work day. Saturday, I still felt tired and also began to experience muscle aches. They were mild. Sunday, the muscle aches and swelling continued, but they was joined by swollen glands in my throat. The tiredness increased. I was zonked out on Sunday and didn't do much of anything that day. By the end of Sunday, my throat started to hurt. On Monday, July 4th, I was dealing with the swelling, muscle aches, swelling in throat, the pain in my throat, the tiredness, and my nose was running with a post nasal drip. That caused me to have a cough. The symptoms continued to progress.
Reportedly, the subject stated he had his 3rd Anthrax vaccine on 02 May 07 and is currently working in California.  On May 12, 2007, the subject developed a red (pimple-like) rash over his whole body.
Information has been received from a registered nurse concerning an approximately 80 or 90 year old immunocompromised male who was in the same room where the other residents of the retirement community where vaccinated with a dose of Zostavax (Oka/Merck). It was reported that the patient had spouse or contact (s) who lived in the independent residence within the community and who were vaccinated with a dose of Zostavax (MSD). The patient was not vaccinated with the vaccine. On 16-OCT-2007 the patient developed shingles. At the time of report the patient had not recovered. The patient's experience was considered to be an other important medical event and disabling by the reporter. Additional information has been requested. This is one of several reports received from the same source.