chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Half dose administered.; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 8-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 5277A, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received the 1st dose of Fluarix Quadrivalent 2021-2022 season .25 ml and Fluarix Tetra Pre-Filled Syringe Device. On 11th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose was 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 provided as follows: The reporter was a clinical supervisor. The reporter stated that, half dose (0.25 ml) was administered to infant patient, which led to underdose. The reporter consented to follow up. Note: Event outcome date was reported as 26th October 2021 however was not captured considering the nature of event (medication error).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222783:same reporter
Began with feeling achy and tired around 12:00. This feeling accelerated in the next two hours whereupon I went home from work.  By 4:00, I was having uncontrollable chills and a fever of 101.9. I felt extremely achy all over and feverish.  My fever broke at 10:00 PM and the worst was then over, dropped to 100.1.  I had a rather pronounced headache the next morning, with my temperature by then at 97.2.   The headache was episodic with changing my head position.  This gradually faded over subsequent days. I had no significant bowel movements for the next six days. Then, on 1/17/2010, I had an episode of severe painful constipation which required Dulcolax to relieve.  This has never happened to me before.
Patient is having "nerve pain" on medial aspect of the left arm that extends from the elbow to the wrist.
severe kidney pain; she had her third dose of the Pfizer COVID-19 shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 08:20 (Lot number: FH8020) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose; Lot Number / Expiry Date: EW0162/ Unknown; Anatomical Location:  Left arm), administration date: 07Apr2021, when the patient was 47 years old, for COVID-19 Immunization; Bnt162b2 (Second dose ; Lot Number / Expiry Date: EW0179/ Unknown; Anatomical Location: Right arm), administration date: 29Apr2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "Numbness"; Bnt162b2 (Second dose; Lot Number / Expiry Date: EW0179/ Unknown; Anatomical Location: Right arm), administration date: 29Apr2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "Tingling". The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "she had her third dose of the Pfizer COVID-19 shot"; RENAL PAIN (non-serious) with onset 09Dec2021 04:00, outcome "recovering", described as "severe kidney pain". Therapeutic measures were taken as a result of renal pain. Additional information: She woke up at 4 am that morning and had to take ADVIL because it (severe kidney pain) was so painful. The pain was currently dull. She would probably go to the doctor today or tomorrow depending on how the pain feels after the medicine (ADVIL) wears off.  No follow-up attempts are possible. No further information is expected.
A few days later I noticed numbness and tingling in my pinky finger and the tip of my ring finger on my left arm. It hasn?t worsened or improved
8 days after receiving the vaccine I started to experience extremely sensitive skin all along my right arm (which received the vaccine) and hand as well as my left arm and upper back. There is some sensitivity in my legs as well. The sensitivity/pain started on the 14th around 4:30pm , worsened overnight, was consistently present all day on the 15th, and is still present today on the 16th as I report this information. I have also felt more lethargic than normal.
Unsure if shot was administered intramuscularly in the deltoid; Muscles on the whole right side of her body are flaring up and tensing up; The big gland in her axillary area are really big; Scapula and shoulder blade area was very tense and balling up; Arm was sore; A regulatory authority report was received from a healthcare professional concerning a 37-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced unsure if shot was administered intramuscularly in the deltoid, muscles on the whole right side of her body are flaring up and tensing up, arm was sore, the big gland in her axillary area are really big and her scapula and shoulder blade area was very tense and balling up.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 15 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot 025L20A) intramuscularly in the right, dominant arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient received first shot in right, dominant arm at the peak of shoulder, between the clavicle and humerus and is unsure if shot was administered intramuscularly in the deltoid. She reported the muscles on the whole right side of her body flared and tensed up, arm was sore, the big gland in her axillary area was really big and her scapula and shoulder blade area was very tense and balling up. Treatment for the event included paracetamol, diphenhydramine citrate, and ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The event, unsure if shot was administered intramuscularly in the deltoid, was considered resolved on 15 Jan 2021. The outcomes of the events, muscles on the whole right side of her body are flaring up and tensing up, arm was sore, the big gland in her axillary area are really big and her scapula and shoulder blade area was very tense and balling up, were unknown.; Reporter's Comments: This report refers to a 37 Y/O female who had NS event Product administered at inappropriate site with NS unexpected Muscle tightness, Musculoskeletal stiffness, and NS expected Injection site lymphadenopathy, Injection site pain. Event onset the same day as first dose mRNA-1273. Treated with paracetamol, diphenhydramine, ibuprofen. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt vaccinated with DTP developed fever 102 & high-pitched screaming for hours.
I have had worsening PVCs and chest pain since I received my vaccine. My cardiologist ruled-out other factors and causes. I have no history of this. I am healthy and have never experienced this before. It feels like my heart is struggling to beat. The PVCs are constant and often trigemini.
Site of vaccination is red, itchy, and warmer and harder than surrounding tissue.  This is currently still the case, 15 days after vaccination.  Itchiness is not severe.  No treatment/medications have been deemed necessary.
Severe headache 101 temp Nausea Intense pain at injection site Intense body pains
Information has been received from a physician assistant concerning a 38 year old female with an allergy to an unspecified cardiac medication who on 06/14/2001 was vaccinated with a first dose of hep b vaccine recombinant. On 06/14/2001 the pt reported that injection site arm bothered her. On 06/15/2001 the pt developed redness, soreness, swelling from her shoulder to her hand on injection site arm and a fever. On 06/16/2001 the pt developed a swollen node in axillary area the size of a golf ball. Subsequently, the next day the node was the size of a pea and the other symptoms had resolved. Unspecified medical attention was sought. As of 06/22/2001 the pt felt fine. Additional info has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates, these unspecified patients were vaccinated with LIQUID PEDVAXHIB, (injection, lot#, dose, route and frequency were not provided) that were improperly stored outside the recommended storage temperatures in the product insert. No adverse effects reported. No product quality complaint (PQC). The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
progressively had more anxiety; depression symptoms; Any kind of exercise...panic attack and anxiety all day long; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (progressively had more anxiety), DEPRESSION (depression symptoms) and PANIC ATTACK (Any kind of exercise...panic attack and anxiety all day long) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 023B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced ANXIETY (progressively had more anxiety), DEPRESSION (depression symptoms) and PANIC ATTACK (Any kind of exercise...panic attack and anxiety all day long). At the time of the report, ANXIETY (progressively had more anxiety) had not resolved and DEPRESSION (depression symptoms) and PANIC ATTACK (Any kind of exercise..panic attack and anxiety all day long) outcome was unknown.            Treatment details were not provided.   This case was linked to MOD-2021-234381 (Patient Link).
I actually blacked out./But the blackout was scary; trouble sleeping; fevered; sick feeling; don't remember much from Friday morning at all; threw up the tylenol; scratches; could not form coherent sentences; This is a spontaneous report from a contactable consumer (patient). This 33-year-old  non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 16:15 (Batch/Lot Number: EW0169) as DOSE 2, SINGLE (at the age of 33 years) for covid-19 immunisation.  Historical vaccine included BNT162B2 for Covid-19 immunization as DOSE 1 SINGLE (at the age of 33 years) on 01Apr2021 16:30 in the right arm Brand: Pfizer Lot number: ER8732 and experienced insomnia.  The patient had no other vaccine other than BNT162B2 in four weeks. The patient medical history was not reported. The patient reported she did not have any known allergies.  The patient did not have Covid prior vaccination.  Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.  The patient experienced "I actually blacked out./but the blackout was scary " on 23Apr2021 04:00 with outcome of recovered, trouble sleeping on 23Apr2021 04:00 with outcome of recovered , got up at 4am running a fever on 23Apr2021 04:00 with outcome of recovered, sick feeling on 23Apr2021 04:00 with outcome of recovered, threw up the Tylenol on 23Apr2021 with outcome of recovered, scratches on 23Apr2021 with outcome of recovered, could not form coherent sentences on 23Apr2021 with outcome of recovered, "don't remember much from Friday morning at all" on 23Apr2021 with outcome of recovered, "The next thing I remember is my dog waking me up by licking my face about 20 mins later. I was laying face down in the hallway between the bathroom and the bedroom. Other than some scratches, I didn't get hurt. I also could not form coherent sentences while trying to call my husband to tell him to come home from work. I don't remember much from Friday morning at all. It is all a fog. But the blackout was scary. I was fevered and sick feeling for 24 hours and then was fine again."   The patient underwent lab tests and procedures which included body temperature: fever on 23Apr2021.  Therapeutic measures were taken as a result of fevered (Tylenol).  Fever and sick feeling resolved on 24Apr2021.  All other events recovered in 2021. The patient did not have a Covid test-post-vaccination.    No follow-up attempts are required. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021458876 same reporter/patient, different vaccine dose and event
Client was given Pfizer vaccination after receiving Janssen vaccine.  Client had reported on his information that he had never received a COVID vaccination even though he had received a COVID vaccine with Janssen product (lot # 043A21A) on /07/2021 by another provider.  Client reported that he was aware that he had received Janssen vaccine but wanted a Pfizer vaccine because it was more effective.  Client reported NO adverse effects after receiving Pfizer vaccine.  No follow-up treatment needed.  Client was informed he would not be receiving a second Pfizer vaccination.
Client passed out falling off the exam table to the floor, striking his forehead on the floor.  He was rolled over onto his back, his mother cradled his head in her lap.   Ice pack was placed on his head, he was given a juice box to drink.  Client stayed on the floor for 15 minutes until he felt good enough to sit up.  He then sat in a chair for 5 minutes before he left with his mother.
Acute Infarction of the Posterior Left Frontal Lobe, left sided weakness, left sided facial droop, low grade fever, nonverbal- Not a candidate for TPN due to current medical conditions.  Hospitalized on 10/1/22 progress notes reveal gradual improvement to speech and swallowing on 10/2/22 and 10/3/22.  Using verbal one word answers, white dry erase board to communicate and other communicative devices (pictures). Resident has returned to baseline BLE and ULE. Plan is for resident to return to nursing facility upon discharge from acute setting.
I was diagnosed with Bells Palsy on Jul 31st. Had to take two rounds of steroids, currently going through physical therapy and had a panic attack that got me to the ER as a result of first round of meds
pt first had a positive COVID test 12/2021; was admitted to hospital on 3/12/22 for septic shock due to HCAP and CAUTI; IV fluids and ABX given; no COVID symptoms and no treatment needed; hypernatremia; poor prognosis; transitioned to comfort measures; pt passed away in the hospital
After receiving my shot on 3/4/21, I visited my doctor for routine  blood test on 3/17/21. I discovered that I now have low sodium, low chloride and elevated cholesterol levels. My blood test were perfect for years before taking this vaccine. My habits or exercise routines did not change. Moderna is  the only variable here. I need Moderna to do follow up testing on me to see what is happening...VERY UPSET... Thank you
Urticaria, pruritus and injection site itching, pain, redness, and swelling. Diphenhydramine 25 mg PRN, ibuprofen 600 mg prn.
Breakthrough case admission after 4 vaccines  Pfizer 1/12/21 lot# EL0142;  Pfizer 1/30/21 lot# EL9265;  Pfizer 9/2/21 lot# 30130BA;  Pfizer 9/15/22 lot# GJ5342
Pt here with concerns of numbness and tingling of his body since his COVID vaccine. He had it on 2/3 in his R deltoid. He notes started to feel bad on 2/6. He went to urgent care and was told that he probably had TIA. He came into clinic that next week and I ordered an MRI of his brain.  MRI brain showed senescent changes and mastoid congestion, but no evidence of stroke/acute event.        His symptoms started with R hand numbness (R thumb and R index finger), then progressed to R leg and arm numbness, R facial numbness with trouble speaking, which he describes as feeling like he had a lidocaine shot at the dentist. He denies any acute illness at that time, but did sleep alot more.         Currently the only symptom he has left is R index and thumb numbness as well as feeling like the R side of his face feels different than the L.
Approximately 20 hours after receiving my 2nd COVID vaccination, I became aware of a painful area in my upper arm distinct from the pain in my shoulder at/around the injection site.  Upon investigating, I found that a red, hot, painful, and slightly puffy rash had developed about 1.5 inches below the injection site.  The rash covers an area of about 2 inches wide and 4 inches long, running diagonally from below my shoulder muscle to about the middle of my bicep.  The lower portion of the rash is most painful and irritated part of it.   Around the time of onset, I also began to develop a dull headache.  The rash is still present, but beginning to diminish in severity.  Please see the related report, VAERS e-report temporary No. 449921, for details about a similar but less severe reaction following my 1st COVID vaccination.
Internal shaking; Chest pain; Chest pain that made her out of breath; Anxiety; Lack of sleep; Headache; Fatigue; Muscle pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8735, Expiry Date: Unknown) via an unspecified route of administration in right arm (reported as injection to upper right arm) on 26Apr2021 at 08:00 (at the age of 53 years-old) as dose 1, single for COVID-19 immunization. Patient medical history reported as none. The concomitant medications (other products) were not reported. The vaccine was not administered at (Privacy) facility. No Family medical history relevant to adverse events was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. No additional administered vaccines and prior vaccinations (within 4 weeks) reported. Adverse events following prior vaccinations once, it was the flu shot, her arm got the flu, if that, it sounds weird, her arm became feverish, swollen, she became somewhat sick, tired, it was a really nasty reaction to that shot, the injection area. Flu shot, lot, expiry unknown. On Apr2021 patient experienced headache, fatigue, muscle pain, chest pain that made her out of breath, these side effects causing her anxiety and lack of sleep and shivering of internal muscle (it is outside the norm, she is having kind of, she does not know how to describe it, it was like cold and shiver, it is kind of an internal shaking and is still having that) on 26Apr2021. Internal shaking was started the same day as the vaccine, but later that night, it is not going away. Patient first shot symptoms were more noticeable. Patient didn't visited emergency room and physician office. The relevant tests and  investigation assessment were not reported. The outcome of internal shaking was not recovered (ongoing) while that of remaining was unknown.   No follow-up attempts are needed. No further information is expected.
seeing floaters in right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 14:00 (Lot number: EN607) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid cancer", start date: 2008 (unspecified if ongoing); "full thyroidectomy", start date: 2008 (unspecified if ongoing). Concomitant medication(s) included: CALCIUM/VITAMIN D [CALCIUM;ERGOCALCIFEROL]; SYNTHROID. Vaccination history included: Bnt162b2 (Lot number: EN608, in left arm at 13:00 as dose 1, single), administration date: 17Mar2021, when the patient was 47 years old, for COVID-19 immunisation, reaction(s): "Intense eye pain in both eyes". The following information was reported: VITREOUS FLOATERS (non-serious) with onset Apr2021, outcome "not recovered", described as "seeing floaters in right eye". The event "seeing floaters in right eye" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of vitreous floaters.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
No additional AEs reported; She stated that a consumer made her aware that a vial of PROQUAD was found missing the lot and expiration.; She stated that a consumer made her aware that a vial of PROQUAD was found missing the lot and expiration.; an AE is being filed since a PQC product was administered to a patient; This spontaneous report has been received from a registered nurse via a company representative concerning to a 4-year old male patient. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 15-FEB-2022 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD)  0.5 milliliter, (lot number U019289, expiration date: 15-DEC-2022) (strength, route of administration, were not provided) for prophylaxis. However, the patient made the reporter aware that the vial of the vaccines had missing the lot and expiration numbers in the carton (product lot number issue,  product expiration date issue) but the carton did not present any damage. The label was intact, there were no other printing issues, the label did not look like was exposed to moisture or increased humidity. Nevertheless, the missing information the vial appeared normal. It was reported that, the vaccine was administered after the missing information was discovered (poor quality product administered). Additionally, the carton appeared normal and was not damaged, the other vials in the carton appeared normal and had the lot and expiration date printed on the vials.
Pt received 5 travel vaccines plus seasonal influenza from RN on 9/26/2016. Pt stated that later that night he started feeling sick and went to the ED and was diagnosed with kidney failure and hospitalized for a week.