chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.    Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not have patient details at the time of call.  The reporter did not know dates of administration. The reporter consent to follow up. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This was one of the 7 cases reported by the same reporter; Sender's Comments:  US-GSK-US2022AMR136348:Same reporter. US-GSK-US2022AMR136361:Same reporter. US-GSK-US2022AMR136362:Same reporter. US-GSK-US2022AMR136363:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136365:Same reporter.
Balance disorder; Weakness generalised; Pain; Back pain; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness), BALANCE DISORDER (Balance disorder), ASTHENIA (Weakness generalised) and BACK PAIN (Back pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness) and BACK PAIN (Back pain). On 04-Oct-2021, the patient experienced PAIN (Pain). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder) and ASTHENIA (Weakness generalised). On 05-Oct-2021, PAIN (Pain) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (Tiredness), BALANCE DISORDER (Balance disorder), ASTHENIA (Weakness generalised) and BACK PAIN (Back pain) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the events of Back pain, Tiredness, Balance disorder, Weakness generalized and pain was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.  Reporter did not allow further contact  Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Significant follow up contains New event PAIN, updated Moderna vaccine administration date and updated event causality with Moderna vaccine.
1 WEEK AFTER 1ST SHOT I STATED TO GET RED RASH THAT IS WARM ABOUT THE SIZE OF A SOFTBALL AND AT 1ST IT WAS AROUND SHOT AREA AND NOW 2 WEEKS AFTER SHOT IT SEEM TO BE ABOUT AN INCH LOWER.
pain, swelling & inflammation @ site of inj rt deltoid, w/in 72hr of vax;
hiccups; fever; body pain; tiredness; sleepiness; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Jun2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced hiccups, fever, body pain, tiredness and sleepiness. Consumer calls in requesting information about symptoms management related to second dose administration of Pfizer's COVID-19 vaccine. Consumer reports that her 21-year-old son received first dose on Sunday 20Jun2021 and presented hiccups, fever and body pain. Consumer reports that after first dose her son only had tiredness and sleepiness. The outcome of the events was unknow.  Information about Lot/Batch number requested.
Approximately 10 minutes after receiving vaccine, patient felt light headed. Patient drank juice and felt better. Approximately 20 minutes after vaccine administration, patient began to complain of tongue tingling. Patient received Benadryl 50 mg IVP. Rash developed on her chest. Patient given Solumedrol 125 mg IVP, Famotodine 20 mg IVP and NS wide open. Epi pen 0.3 mg IM was administered and patient became tachycardic. At that point, patient was transferred to the ED.
Patient died in crib 48-hours after receiving the series of vaccines identified in Box 13 below. Coroner listed the cause of death as SIDS.
I have been allergy free for 10 years... I received my first flu vaccine 3 years ago and immediately I had to go back on Chlorpheniramine Maleate due to constant sneezing & runny nose....every year after that I received the flu vaccine and I had to increase the dose of my medication because the symptoms got worse after each flu vaccine...I am an RN and I believe the flu vaccine exacerbates allergies and you need to consider that as a side effect of the flu vaccine, as I continue to get worse every year I have taken it....
Sore arm then developed acute heart palpitations . The palpitations picked up over a few days in intensity and frequency to the point where they were constant. My lungs weren?t functioning well and I was winded.   I started to have  pain in my chest and upper back as well as pain running down the inside of my left arm to my elbow. The pain would increase especially at night when trying to sleep. It started to feel like I was having a heart attack. Like my heart and chest were being ripped open. After 3-four nights of  no sleep and intense attacks I went to the ER.  An EKGand CT were done. I left with a heart monitor after hours of testing.    It took 1.5  weeks to get into the cardiologist and then took another month and a half to complete the heart testing due to no available spots.
Symptoms: Dizziness and tingling in the arm Outcome: monitor her until her symptoms resolved
This medically confirmed spontaneous report (initial receipt: 27-Jul-2012) concerns a female patient, who had a medical history of rare autoimmune disorder in which her stomach did not make enough acid. She was allergic to eggs, sulfamethoxazole; trimethoprim combination and 'the flu shot'. Five or eight years ago the patient received flu vaccine (brand, manufacturer and batch number were not provided) and suffered a stroke. The event outcome was not reported.
This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a 7 months old female patient and was vaccinated with LIQUID PEDVAXHIB in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA003615: US-009507513-1706USA009007: US-009507513-1706USA009001: US-009507513-1706USA009003: US-009507513-1706USA009006: US-009507513-1706USA009005: US-009507513-1706USA009004:
On 11/15/13 this client received an influenza vaccine at 9:35 am. At 10 am she called the clinic and reported that after she left the clinic and got into her car as a passenger she started to feel "weird". Several minutes later she lost consciousness for about 10 seconds or so and her body jerked according to the client's boyfriend who was driving the car at the time. This episode happened about five minutes after she had received the influenza vaccine. After regaining consciousness, she reported that her head didn't "feel right" and she had chills and felt weak. She denied any hives, rash or trouble breathing,
Follow up information received 10/14/02 from physician contained dates of Prevnar immunization and complete vaccination record of patient. A physician reported that a 2 year old male child received a 4th dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 1st dose of Varivax, 3rd dose of Polio vaccine on 3/19/01, when he was 12 months old. On 8/23/02, the child's blood culture was positive for Streptotoccal pneumoniae. He was treated with IM ceftriaxone sodium and high doses of amoxicillin. The organism was penicillin sensitive. A serotype is pending. The patient's experience was considered to be life-threatening. On 12/3/01, the patient also had positive blood cultures for Streptococcal pneumoniae. See case HQ4203613SEP2002. No additional information was available as of the date of this report. Follow-up information received 04Mar2003 from physician stated that serotyping was not done following child's first episode of invasive pneumococcal disease. Serotyping performed by CDC following second episode of invasive pneumococcal disease identified serotype 23B (not a Prevnar serotype. Follow-up received 02Dec2002 contained quality control results (satisfactory) for Prevnar lot numbers. Follow-up information received 14Oct2002 from physician contained dates of Prevnar immunization and complete vaccine record of patient.
Narrative: Patient received the COVID 19 Moderna vaccine in Mar/April 2021. The patient tested positive on 23 October 2021 and was hospitalized on 24 October 2021 with COVID pneumonia. The patient was treated and discharged on 31 October 2021.
Pain started in bilateral shoulders 36 hours after vaccines were given. Pain is worse in L shoulder.  Treatment is to take Acetaminophen 1000mg every 8 hours along with ibuprofen 800mg every 8 hours. Provider evaluated that vaccines were placed too high in the arm.
Patient not 12 at time of vaccine. The doctor contacted the family and advised to monitor. No adverse symptoms noted
within 2 days of 1st vaccine I experienced INCHY PALMS , FEET, AND RIGHT EAR LASTED UNTIL 2ND VACCINE.... With second vaccine experienced ICHY HANDS, FEET, THROAT, EAR,
REDDENED AREA AROUND SHOT SITES APPROX BASEBALL SIZE-RT THIGH.
On 12/10/19 I saw my family doctor for a check-up.  She strongly suggested I have the pneumonia vaccine.   I was administered PNEUMOCOCCAL CONJUGATE 13-VALENT at this visit.  The following evening, I went to get up from a desk chair and could not bear weight on my right leg.  I also could not weight bear much on my left leg.  The pain was excruciating.  Over the course of the next few days, I continued to have difficulty ambulating.   Just when I thought the symptoms were subsiding, they would flare.  I contacted my health provider several weeks after the injection to inform her what  happened..  Although it has been over a month since this injection, I continue with some strange symptoms I did not have prior to the injection to include a continual buzzing type sound in my ears.
02/10/22 presents to EC ED for "right neck and arm swelling for over a month" "incidentally positive for COVID" "no significant PMH"
Initial report was received from a health care professional on 10 September 2012. A 16-year-old female patient developed Bell's Palsy on 08 September 2012, 18 hours after receiving a intramuscular injection in the left deltoid of MENACTRA, lot number U4341AA on 07 September 2012. The patient had no past medical history and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
Patient is fully vaccinated and boosted on 12/6/2021.  Hospitalized on 12/21/2021.An 88-year-old female, was in assisted living, was admitted due to low blood pressure and COVID-19 positive.  Positive on admission for weakness, tiredness, difficult to breathe.    Has history of tremors.  No fever or chills at present. The patient's creatinine is 1.13, today is 1.66.  CRP is 150.  White count is increased to 17,000 from 15,000. D-dimer is more than 10,000. Admission dx:  acute deep vein thrombosis, altered menal status and COVID 19.  Heparin for DVT, no steroids, no remdesivir, IV fluids. HG (10.1 low) d-dimer > 10,000.  Discharged with home health care services.
It is now 2 weeks after I've gotten the second shingles shot and my left arm still aches, the way it did right after the shot. I don't want anyone to touch or hug me, it hurts that bad. By the end of the day, it throbs and at night, I can't find a comfortable sleeping position. I knew it would hurt for a few days, but I don't think this isn't normal. I see other people report having this ache permanently, and even needing surgery to alleviate the pain. I'm afraid that might be my case. I already have nerve damage in that arm due to a blood draw I had in my left forearm decades ago, with a faulty needle probably slicing a nerve. My arm and hand have tingled every since, like when your arm falls asleep. Now this.
Patient received 1st dose of PCV20 vaccine at our center on 05/15/2023. Patient roomate called in on 5/19/2023 to report patient had pain, redness and swelling to  left arm under the site of injection after vaccine.  patient denies hives, rash, other redness/sweeling.  patient state symptoms improved but continues to be erythematous and swelling.  Advised patient use tylenol, Icing. call back to center if condition not improved.
At 11:45 ct. developed rash on arms, neck and inside of mouth near back of throat. Went to school nurse who told her to wash up and return to class.  Rash described as itching badly, red raised spots with white bump in middle.  Hot flashes no fever.  Ct's mother called writer at 3:40 PM and described SX. Writer advised her to take Benydryl (ct. states itching was somewhat relieved and rash improved) and take ct. to ED and if any breathing difficulties call 911.  Ct. saw pediatrician who examined her and sent home.  At 11:00 PM ct. developed severe headache and severe nausea. Pediatrician sent to local ED.   Itching relieved w/ Benydryl 25 mg.  at home 4:00 PM.  Emergency Dept. - Ultraset for HA, Phenegren for nausea and more Benydryl. 11/2, 10:00 AM - rash resolved, slight HA, slight nausea, resting comfortably.
solid red rash on rt of body, chest area & under area of rt arm;recovering, rash has dissipated to spots, swelling decreasing;some itching;no pain;no resp distress;
This spontaneous prospective pregnancy report as received from a licensed practical nurse refers to a 31 year old female patient. The patient's concurrent conditions were not provided. The patient had no drug reactions or allergies. Concomitant therapies included unspecified prenatal vitamins. On 10-JAN-2016, the patient received her first dose of M-M-R II, lot # L027431 with expiration date on 27-JUL-2017 (dose and route of administration were not reported), which was reconstituted with sterile diluent (lot # and expiration date were unknown). On an unknown date in 2017, after administration of M-M-R II, the patient became pregnant. At the time of this report (reported as "currently"), the patient was still pregnant. The pregnancy outcome was pending. The fetal outcome was unknown. The last menstrual period (LMP) date was on an unknown date in 2017 (estimated based on the fact that the patient was still pregnant). The estimated due date (EDD) was unknown. On an unknown date, after unspecified laboratory work was performed, it was discovered that the patient failed to seroconvert after administration of M-M-R II. On 17-APR-2017, a rubella titer test was performed and the result was indeterminate. In July 2017, the patient's immunoglobin G (IgG) was less than 0.90 (units not provided). No treatment was given for the event. The outcome of the event "failed to seroconvert" was not reported. The relatedness between the event "failed to seroconvert" and M-M-R II was not assessed by the reporter.
Death J98.4 - Cavitary lesion of lung R50.9 - Fever, unspecified fever cause
pt recv vax;local rxn, wheel & surrounding erythema approx 2 cm above site of inject;given dph; observed at clinic for 1 hr; resolved; no resp involvement
Fever (103F), chills, encephalopathy (somnolence, large change in mental status compared to baseline). Onset 3 days after immunization. Persisted for 2 more days until spontaneous recovery
A non-serious spontaneous report of asthma attack was received from a Allergist's office concerning a child subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient has a history of asthma. No concomitant medications were reported for this patient. The patient received FLUMIST for the first time. Twenty-four to forty-eight hours after receiving FLUMIST< the patient was seen in the emergency room for an asthma related event. The child was treated, stabilized and released from the emergency room. The final outcome of the adverse event was not reported. Additional dosing with FLUMIST was not reported. The causality for asthma attack to FLUMIST was not reported.
Asthma Attack; Rash on her arm and back; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma Attack) and RASH (Rash on her arm and back) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SAZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma Attack) and RASH (Rash on her arm and back). At the time of the report, ASTHMA (Asthma Attack) and RASH (Rash on her arm and back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received on 03-AUG-2021 and contains non-significant information.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 09-DEC-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Chills, body aches, nausea, fatigue, headache Treated with Advil and rest
This patient was given and adult dose of the Pfizer vaccine 0.3ml. The patient was 10 years old at time of administration. The on duty Nurse missed verifying the age of the child 'patient" before she administered. The child's dose should have been 0.2ml. The Nurse is no longer employed at this facility.  This event has been reported to our safety team, the mother was contacted and the child was ok and did not have any adverse effect from this vaccine dose. She has since received second dose and was also fine after this administration. Officially I am reporting that the incorrect dose was given to a child without any adverse reaction.
Diffuse urticaria covering most of upper body with patches on lower extremities.   Intense pruritis. Starting about a week after the bivalent vaccine.
I got my vaccine on February 27th, and about a week later I noticed that the muscles in my calf were twitching, which has never happened to me. I went to my primary care and he referred me to a neurologists. She said it was benign calf fasciculations. She prescribed Coq10, B complex, and magnesium. That seemed to help with the feeling of the spasms, but the spasms still continued. And that has continued to this day, and was almost constant.