chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The adverse event was that she was given 0.3 ml of J &J vaccine and will not have as much immunity coverage if she had received 0.5 ml of J&J. She came into receive 4th dose of Pfizer (2nd booster), erroneously given J& J vaccine, Because I thought I had picked up the Pfizer vaccine vial, 0.3 ml was given. Patient notified.
Information has been received from a physician via agency concerning a patient who was enrolled in a study. This report was part of a post-marketing surveillance program. On an unspecified date, (Eighteen week after vaccination) the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient experienced immunization/vaccine reaction (Tox grade 2 and 3). The reporting physician felt that immunization/vaccine reaction was related to PNEUMOVAX 23. Immunization/vaccine reaction was considered to be an other important medical event. Additional information has been requested.
My COVID-19 infection symptoms started on 12/31/2022 in the afternoon. I felt chilled and I had muscle aches.  I wasn't  feeling well so I might have taken Tylenol and  I also  did a COVID-19 home test which was negative.  On 01/01/2023  I did a home COVID-19 test which was positive. I waited till Monday  to go to the Urgent care because I wasn't sure if the urgent care were open. I felt  a little under the weather that day. In the urgent care they  did COVID-19 test which was also positive on 01/02/2023. They  prescribe me with Paxlovid for 5 days which I started taking it the same day.
Swollen lymph nodes hard to swallow; Swollen lymph nodes hard to swallow; This is a spontaneous report from a non-contactable consumer (patient).  A 23-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date, at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient was not diagnosed with COVID-19 and was not tested for COVID-19 Prior to vaccination. The patient experienced Swollen lymph nodes and hard to swallow on an unspecified date. The outcome of events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient said arm was really red and also back and chest area. Itching very bad. Told patient to continue taking BENADRYL, could use some hydrocortisone, AVEENO oatmeal bath or baking soda bath to soothe. Patient said they might use calamine lotion too. Told him he may need to go to dr for prednisone taper if gets worse.
side effects with the 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (1st dose received on unknown date, refer case US2020136706).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The reporter is the patient's wife reported on behalf of husband. The age at vaccination was not reported. The patient had some side effects with the 2nd shot. However she provided no additional information. The reporter became irritated because GlaxoSmithKline could not advise her if her husband would ever need to be vaccinated again.
Pain; Stiffness; Wearing off effect; SORE ARM WHEN TOOK COVID 19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), MUSCULOSKELETAL STIFFNESS (Stiffness), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and VACCINATION SITE PAIN (SORE ARM WHEN TOOK COVID 19 VACCINE) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM WHEN TOOK COVID 19 VACCINE). In September 2021, the patient experienced PAIN (Pain), MUSCULOSKELETAL STIFFNESS (Stiffness) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). In 2021, VACCINATION SITE PAIN (SORE ARM WHEN TOOK COVID 19 VACCINE) had resolved. At the time of the report, PAIN (Pain), MUSCULOSKELETAL STIFFNESS (Stiffness) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) had not resolved.            Concomitant medication was not reported.  Treatment details not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.  Company comment-This spontaneous case concerns a female patient aged 59 years with relevant medical history of PSORIATIC ARTHRITIS on Humira reported, who experienced the non-serious unexpected event Therapeutic response shortened, that occurred on an unknown date (Sep 2021) in the context of mRNA-1273 vaccination. Patient also had non serious events of Musculoskeletal stiffness and Pain. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient aged 59 years with relevant medical history of PSORIATIC ARTHRITIS on Humira reported, who experienced the non-serious unexpected event Therapeutic response shortened, that occurred on an unknown date (Sep 2021) in the context of mRNA-1273 vaccination. Patient also had non serious events of Musculoskeletal stiffness and Pain. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Extensive swelling in entire upper left arm, hot to touch, very tender within an hour. Rash and bruising of entire upper left arm emerged within two hours. Swelling, rash and bruising  began to subside after four days. Bruising and rash continued for another five days. All symptoms gone after 14 days.
Patient with history of COVID-19 vaccination admitted to hospital with COVID detected test. Per provider discharge note, "Reason for Admission:  Patient is a 93 yo female, lives alone, with PmHx notable for hypertension, hyperlipidemia presents with son due to weakness. Patient reports feeling overall weak. Only associated symptoms include 1x day history of diarrhea.    Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  See below note for details re: this hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   Acute kidney injury due to Acute Rhabdomyolysis and hypovolemia Increased GAP acidosis from suspected starvation ketosis -held home Lasix, naproxen. -this was her initial issue at admission.   COVID-19 Pneumonia with acute resp failure and Sepsis. -developed SOB, hypoxia, on her 2nd -3rd hospital day. -became disoriented and imaging showed bilateral lung infiltrates. -tested positive for COVID-19. -Decadron, Remdesivir, antibiotics started  -Lasix given to keep negative fluid balance. -baseline ECHO appears OK. -bilateral leg US for DVT (portable). No DVT. -transferred to CCU as she became more and more hypoxic. She was on HFNC while on the medical floor. -Pulmonology consulted.   Acute metabolic encephalopathy - likely from above- No intracranial abnormality noted on CT.   Hypertension: normotensive  Transaminitis: monitor, repeat CMP in AM   Initially remained a full code. As she continued to do poorly, she and her family decided to transition to comfort care measures only. Was transferred to the medical floor  the evening of 9/10/2023. Hospice service evaluated 9/11/23 AM. She was deemed in patient Hospice appropriate. Was transitioned to GIP status on 9/11/2023 for end of life care."
Printed label used to put on form was mis-marked as bivalent, It was actually monovalent.  Bivalent should have been given
HPV 9 given 10 mins later, LOC, urine incontinence, and convulsion x 10-20 seconds. Patient came to, brought to exam room, A and O X3, given juice. Evaluated by MD BP 103/68, CV normal. Laid down x 15+ minutes, able to leave department- ambulatory on own.
A non-serious spontaneous report of accidental exposure and swelling of her knees had been received from a immunization coordinator concerning an adult female subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient is a nurse who administered H1N1, Intranasal to patients starting on 01-Oct-2009. The patient did not receive the vaccine. Within the past three weeks in October 2009, the patient has experienced swelling of her knees. The outcome of the event was not reported.
Sudden Chills and Dizziness lasted for 15 minutes. Symptoms went away after drinking some warm water and rested.
I was immunized for yellow fever, polio, typhoid fever, and hepatitis A on 4/29 at 3:15 PM. Around 3:15 the next day I began to get sleepy. I went outside at 4PM and became very drowsy and slightly nauseous. By 5PM I was so exhausted I had to sleep, but I was having heart palpitations. I slept for almost 2 hours, and still woke up drowsy. I got a fever with chills and sweats for another hour or two, which was relieved by Advil. My upper abdomen (hypogastric region) started burning on 4/30 and is still burning today on 5/2- it is very uncomfortable and makes me feel slightly weak.
Received the vaccine beyond the use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the vaccine beyond the use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the vaccine beyond the use date). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received the vaccine beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.  The reporter asked if the patients may need another vaccine booster.   This case was linked to MOD-2021-348962 (Patient Link).
fluid overloaded; passed away; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Feb2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 24Feb2023, outcome "fatal", described as "passed away"; HYPERVOLAEMIA (hospitalization, medically significant), outcome "unknown", described as "fluid overloaded". The patient date of death was 24Feb2023. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Additional information: Nurse administered PCV20 on 16Feb2023 to patient. On 17Feb2023, patient went to the hospital and on 24Feb2023 the patient passed away. They didn't report because based on doctor it didn't feel it was related to Prevnar 20 and instead on fluid overloaded however the nurse felt suspicion that it was due to her giving PCV20 which is why she asked me what the mortality rate of PCV20 is.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The limited information in this report precludes a full assessment of the case.  The patient's death on fluid overloaded which occurred one day after the vaccination more likely is associated with underlying medical condition.  However, follow-up information such medical history, concurrent diseases, concomitant medications and event term details especially death cause and autopsy results are needed for meaningful evaluation.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: passed away
pt awoke from nap 3PM w/ red spots, ear were red, mom called clinic & was referred to PMD or ER;took to ER face began swelling on way to ER was given med & sent home;
Fainted after injection and fell hitting face against floor, cutting lip. Had not eaten since 11:00 AM. Neuro exam normal.
This spontaneous report was received from a Registered nurse regarding a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Vasovagal presyncope -Patient was given the HPV injection first dose. Patient was starting to hold breath before receiving injection. Patient was told to relax and take a deep breath and relax the arm. Within a few seconds of the injection she started to complain of trouble breathing, numbness in the arm and hands, and ears ringing. I was then called into the room to re-evaluate the patient. Vitals remained excellent with HR 70-80, normal breath sounds, no evidence of angioedema, O2 sats at 100%. She did vomit once. Patient was reclined on the exam table, given cold water and a bag of ice. She felt back to normal within 10 minutes. She did not lose consciousness. during this entire episode.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed red, tender and scabby areas on his abdomen radiating around right side to mid right back. One lesion exists on the pts wrist. The pt was afebrile. Pt was seen in the physician's office on 11/17/99 and dx'd with shingles and treated with amoxicillin and acyclovir.
injection site turned red; Slight amount of swelling; tender to the touch; confluent rash; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site turned red), VACCINATION SITE SWELLING (Slight amount of swelling), VACCINATION SITE PAIN (tender to the touch) and VACCINATION SITE RASH (confluent rash) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, RANOLAZINE (RANEXA), CARBIDOPA, LEVODOPA (SINEMET), DONEPEZIL HYDROCHLORIDE (ARICEPT), ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D NOS, MULTIVITAMINS;MINERALS, METFORMIN and METOPROLOL for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site turned red), VACCINATION SITE SWELLING (Slight amount of swelling), VACCINATION SITE PAIN (tender to the touch) and VACCINATION SITE RASH (confluent rash). At the time of the report, VACCINATION SITE ERYTHEMA (injection site turned red), VACCINATION SITE SWELLING (Slight amount of swelling), VACCINATION SITE PAIN (tender to the touch) and VACCINATION SITE RASH (confluent rash) outcome was unknown.        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 treatment information was provided.
Child was vaccinated on Monday, March 6th. Parent works and child was in a licensed home daycare (with 3 other small children) the remainder of the week. When the parent was playing with the child on the weekend (5th day following vaccination) it was noted the infant did not bear weight on or extend his right leg. Parent contacted the infant's pediatrician and was seen in the office. The pediatrician referred the infant for Xrays of right leg (hip and knee included)and bloodwork to rule out deep tissue infection. All results were unremarkable. Infant was referred for physical therapy and has had one session with the physical therapist to date. Parent reports the infant still will not use or straighten his right leg and elicits a pain response when parent attempts to straighten leg. Parent feels the infant displayed changes in his right leg all week, but they went unnoticed until parent spent more time playing with the infant over the weekend.
Symptoms consistent with subjective tinnitus.  Ringing sound in ears, high frequency, long duration (over 4 weeks), still experiencing sounds even now (June 14, 2021)
Patient was ordered Pfizer Bivalent Booster vaccine before going to a residential facility.  Patient was inadvertently administered the Monovalent Vaccine which is for Primary Immunization only.  Both Vials look very similar, they are separated and labeled for primary vaccination only.  Case Management informed to contact residential facility of error, so patient can be scheduled to get the bivalent vaccine in 2 months.  VAERS report also to be filed for error.  This formulation is no longer approved for booster vaccinations.  Discovered when viewing data
After drinking, awoke feeling dehydrated and with leg pain.  Called 911 after having a syncopal episode.  Taken to hospital with likely pulmonary thromboembolus treated with aggressive resuscitation including tPA. Died a few hours after admission.  Went to tissue donation, small pulmonary thrombus and lymphocytic aggregates in heart at autopsy.
fever to 101 & fussiness; cried only 45 minutes interludes of sleep;
Over a four day period the PTs symptoms consisted of: fever ranging from 103.6-104.1, body aches, chills, and headache.
Flu like symptoms; light headedness; whole body weakness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, light headedness and weakness generalized. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the light headedness and weakness generalized were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, light headedness and weakness generalized to be related to Shingrix.  Additional details were provided as follows: On 11th March 2020, about 12 to 18 hours after he received the vaccine he experienced flu like symptoms that lasted 36 hours. He also had light headedness and weakness that started about the same time, but those continue today (27th March 2020). He noted the weakness was whole body weakness. He was encouraged to speak with his physician about the continued issues.  Consented to follow up.
None Stated. 200 Dec 10 WTW Gave 200 H1N1 FLU SHOT. PT APPARENTLY FAINTED/SEIZED WITHIN 30 SECONDS AND REVIVED WITHIN ANOTHER 30 SECONDS. MOM SAID PT HAD EGG ALLERGY AS BABY, BUT HAS OUTGROWN IT AND HAS HAD SEASONAL FLU SHOT. MOM ALSO SAID PT BUMPED HEAD TWO WEEKS PRIOR. PARAMEDCS SUSPECTED VASO-VAGAL REACTION. PT ROUGHT TO EMERGENCY DEPT FOR CHECK-UP. ASSISTANT MANAGER, TOOK PT NAME AND PHONE NUMBER FOR FOLLOW-UP AND INCIDENT REPORT
Headache in the forehead area and it is dull and constant; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache in the forehead area and it is dull and constant) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Headache in the forehead area and it is dull and constant). At the time of the report, HEADACHE (Headache in the forehead area and it is dull and constant) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment medications included Ibuprofen for headache and cetirizine for allergies.  Action taken with mRNA-1273 in response to the events was not Applicable  Company comment:Based on he current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on he current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
DTaP no. 4/ Influenza given at 10:45 am. Hives noted on face then diffuse on chest and back. Benadryl 50mg 1/4cc IM given 10:42am 028A5 98%. HR 130-140s.  RR40s. Transferred to hospital ER department. Check paramedic/ fire department left in stable condition requiring no treatment at 11AM.
Patient started having behavioral changes. Patient was more irritable and violent and difficult to control.  Since that time, she has good days and bad days.  Her mother definitely noticed a change in her behavior after receiving her influenza booster.
A few hours after vaccines - pt felt a lump in back of throat, lips swollen took Benadryl - felt better after a few hours.
Temperature of 99 degrees started around 6 pm after getting vaccine at 9:30 am, temperature rose to 102 degrees by 12 am, temp was brought down to 100 degrees using both ibuprofen and acetaminophen. Following day a rash broke out on the legs and the whole body is itchy.
Headache, nausea, vomiting, low grade fever on PVD 4.  Persisted on and off but pt. was able to work.  On 05/30/03 (PVD 28) ataxia, R sided weakness, R lower face droop, dropping objects.  Had consultation with neurologist, performed an MRI of brain multiple small ring-enhancing lesions
Dizziness, nausea, fatique, injection site pain  ; 48 hours