chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 2 year old female patient. The patient's pertinent medical history, drug  reactions, allergies, or concomitant medication were unknown by the reporter. On an unknown date and during her 15 month old check-up, the patient was vaccinated with LIQUID PEDVAXHIB for meningitis (dosage information, route and lot number were not informed). On an unknown date, the patient developed "hives and swelling on unspecified parts of the body". The patient was treated with BENYDRYL and unspecified steroids "at an unspecified Hospital Emergency Room and on an unknown date, was "discharged to home in good condition". The patient subsequently "recovered 3-4 days after receiving treatment." The outcome of urticaria and swelling was reported as recovered on an unknown date. The causality assessment between urticaria and swelling and therapy with LIQUID PEDVAXHIB was not provided.
The pt developed a fever of 103F, cough, runny nose and a rash.
No other adverse effects were reported in the patient.; a patient received an improerly stored dose of PROQUAD; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 05-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: S012472, expiration date: 20-OCT-2020; strength, frequency, route and dose details were unknown) for prophylaxis (product storage error).         The vaccine was stored between 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.9 degrees Fahrenheit) (-14 degrees Celsius to -10 degrees Celsius) for 20 minutes. There was previous temperature excursion included between 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.2 degrees Fahrenheit) (-14 degrees Celsius to -10 degrees Celsius) for 40 minutes. The digital data logger was involved. No other adverse effects were reported to the patient.
rash; metallic taste in my mouth; urinated frequently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH (non-serious), outcome "unknown"; DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste in my mouth"; POLLAKIURIA (non-serious), outcome "unknown", described as "urinated frequently". Additional information: the patient was in excellent health before taking the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Two days after injection patient reported redness, swelling, and itching at the injection site about 2 inches in diameter. She said it got a little worse but then got better.
12 weeks pregnant at time of vaccination. I have hives on both arms, neck and chest.  I did not change or start using any new soaps, perfumes, detergents. Did not eat anything new or start any new medications that could cause a reaction. No other family members have similar symptoms.
24JUL96 pt recv vax & 31JUL96 devel t102, rash;seen office 2AUG96 w/red macular papular rash head, chest, abd, extremities, t101-102 tired/fatigued;
Legs are weak; confused; dizzy; Both legs feel like "jello"; "Out of body feeling"; Mild headache; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULAR WEAKNESS (Legs are weak), CONFUSIONAL STATE (confused), DIZZINESS (dizzy), MUSCULAR WEAKNESS (Both legs feel like "jello") and MYALGIA ("Out of body feeling") in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (Autoimmune disease). Concomitant products included CHLORPHENIRAMINE MALEATE, FAMOTIDINE, VITAMIN B12 NOS, GABAPENTIN, ATENOLOL, SPIRONOLACTONE, CITALOPRAM and OMEPRAZOLE for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Both legs feel like "jello"), MYALGIA ("Out of body feeling") and HEADACHE (Mild headache). On 11-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Legs are weak), CONFUSIONAL STATE (confused) and DIZZINESS (dizzy). At the time of the report, MUSCULAR WEAKNESS (Legs are weak), CONFUSIONAL STATE (confused), DIZZINESS (dizzy), MUSCULAR WEAKNESS (Both legs feel like "jello"), MYALGIA ("Out of body feeling") and HEADACHE (Mild headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information in response to events was not provided.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 29Dec2021, outcome "unknown", described as "she is not well at all"; GAIT DISTURBANCE (non-serious) with onset 29Dec2021, outcome "unknown", described as "barely walk"; DYSPNOEA (non-serious) with onset 29Dec2021, outcome "unknown", described as "keeps getting out of breath"; ASTHENIA (non-serious) with onset 29Dec2021, outcome "unknown", described as "weak"; PANIC REACTION (non-serious) with onset 29Dec2021, outcome "unknown", described as "little bit alarmed"; WEIGHT DECREASED (non-serious) with onset 29Dec2021, outcome "unknown", described as "loosing weight"; FEELING ABNORMAL (non-serious) with onset 29Dec2021, outcome "unknown", described as "feel strange"; BEDRIDDEN (non-serious) with onset 29Dec2021, outcome "unknown", described as "has not been out of bed since it happened". The events "she is not well at all", "barely walk", "keeps getting out of breath", "weak", "little bit alarmed", "loosing weight", "feel strange" and "has not been out of bed since it happened" were evaluated at the emergency room visit. Additional information: The Patient stated she is not well at all. She can barely walk and keeps getting out of breath. She is no good for work or for her kids, she cannot do nothing, has not been out of bed since it happened. She stated on Monday she came to work and got there for 5 minutes and could not do it. She couldn't on Tuesday or Wednesday. She is there now again and cannot work like this. She wanted to know how long this is supposed to last because it has been a week. The paper they gave her only said a couple days. She reported she was not feeling well at all. She can barely walk. She was loosing weight, and she did not like, it feels 'strange'. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Presented with 28 YO male, seated in a chair S/P receiving the Johnson and Johnson COVID-19 vaccine. PT states he was feeling dizzy with shortness of breath. PT was given a bottle of water by RN for hydration. PT skin color starting to change from normal to a pale and PT started to become diaphoretic. Ambulance notified for transport to the closest facility. PT pulse 70 and strong and regular, BP 100/60 and respirations 20 strong and regular. PT denies any medical history or allergies at this time. No other interventions performed with PT due to ambulance arrival and PT care relinquished to EMS with full report, PT care relinquished without incident or injury.
11/24/2021 - In ER for hypoxia. Covid + on admit following primary care home visit to check O2 level. O2 at home  sat 88% on rm air. In ER - O2 92% on 3L NC, afebrile, WBC normal, RR 20, HR 65. Patient feels fine. Chest XR shows diffuse bilateral infiltrate. D dimer elevated at 714. Admit to inpatient acute hypoxic respiratory failure secondary to bilateral Covid pneumonia.  Started on Ceftriaxone, Doxy, Decadron, Baricitinib. Remdesivir held for abn kidney function GFR- 37. 11/29 - Covid pneumonia improved. Hyponatremia developed Na 128 - started sodium intake with fluid restriction. 11/30- On room air saturating in the high 90s. IV Doxy D/C. Oral Baricitinib, Decadron changed to oral. Continued Ceftriaxone. 12/1- Poor caloric intake. Albumin 2.7, total protein 5.1, Na 126 treatment continued. 12/8 - Covid pneum resolved. Na 131.  12/9- Hemoglobin trending down 8.9, baseline 12,with elevated BUN 47. Na currently 131. Continued fluid restriction and sodium chloride. Off NC on room air.  12/11- Transfuse RBC x1 - GI consult for possible upper GI bleed. Continue with protonix 12/13 - RBC transfused x1 more, Hem - 7.5. Hem up 8.9 following transfusion 12/16 - Covid pneumonia resolved. Tolerating diet well. Vitals/H&H remain stable and on room air. Discharged to a Rehab facility.
patient felt dizzy and nauseous a few hours after the injection. later felt hot and sweaty, increased dizziness, leg weakness, tingling in thighs
Patient received COVID-19 vaccine from other practice on 11/15/21. On 11/17/21, patient presented w/fever for 1 day at 101F; defervesce w/ antipyretics. Assoc w/ chest pain and sore throat; worsening chest pain. Referred patient to ER.   Patient went to ER on 11/18/21, completed EKG, X-ray, blood work, and urine test - results were normal. ER dotor referred patient to cardiologist. On 11/19/21, patient was well; denied of chest pain, difficulty breathing or discomfort.  On 11/21/21, patient's fever and chest pain have been improved.
I had a stroke after the vaccination. I have left sided weakness. I went to the ER and had MRI and determined I had a stroke. I take medications and go to therapy.
Tested for COVID on 3/7, Pt got johnson and johnson vaccine later that day on 3/7. Developed COVID syptoms that night. Developed RUE and RLE weakness on 3/12. Admitted to hospital for COVID PNA, found to have acute lacunar stroke x 2 on MRI.
Extreme tiredness, injection site pain, right arm soreness, high fever, body aches, chills
Pt states 9JAN lt arm becam swollen difficult to move, 9PM 9JAN increased temp 101- lt arm red w/chills. Seen by MD given Motrin for pain lt arm. Dx small local reaction.
felt nausea, vomited, then hypertensive with diastolic 110. HR remained stable at 74.
Expiration date for lot # had been extended and vaccine had remained in the freezer until date of administration but was administered 2 days past expiration date.  Moderna consulted and deemed the vaccine viable so revaccination was not necessary.  No adverse side effects were reported by the patient.
Kinrix administered to a 2 year-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 17-Nov-2022. Reporter's Comment: The medical assistant stated that Kinrix was administered to a 2 year-old patient.  The reporter asked for further instructions for patient's vaccination. Additional supportive Information: Two year old patient received Kinrix which led to inappropriate age at vaccine administration. The reporter gave consent to follow up.
Low grade fever, chills, headache, aches on left side of body (neck, arm, back, leg) began around 9:30p, increasing in intensity over the next several hours. Took recommended dose of Tylenol around 2:30am. Chills had disappeared by 8am the next day.  Took another dose of Tylenol around 9am the next day to treat residual headache and body aches. Fever disappeared by 3p.  Headache and mild aches in arm and leg have continued this submission.
102PM pt recv vax; 105PM posterior aspect rt arm red, swollen, warm; 110PM exam by MD; 115PM Diphenhydramine elixir 10ml PO;
Chills, bruising, redness, itching, tenderness around vaccination site. Treatment included CBD oil. No change in symptoms.
swelling to the base of the neck and left side of face. Patient states she does have a little burning at the site of the swelling just above her clavicle. Patient also reports some mild swelling to the left side of the face. Patient denies any pain, redness, or swelling at the injection site. Patient states that she is taking Tylenol and Aleve to treat the discomfort and has provided minimal benefit. Patient denies any is swallowing or fever. She denies any other symptoms.
Client reported feeling not well/onset nausea first couple of minutes after vaccines administered; rested supine x 15 minutes; reported feeling better after approx. 5 minutes of lying supine; BP/HR stable/unchanged from baseline Q 5 minutes while supine; nausea subsided after 1 or 2 minutes with no vomiting; after 15 minutes able to sit up then stand without return of symptoms; ambulatory feeling well with return to baseline; left clinic in good condition.
woke up with pain under arm and some minor swelling...pain continued and on Wednesday, injection site itches, is red and hard to the touch. itching continues and pain under arm has not subsided.
induration of area around inj site approx 4" x 6" erythema;no heat;
She got her vaccines, the arm was a little sore on site.  She woke up Friday and she had a 3" shape from front to back of extreme sunburn redness, and it itched.  She didn't scratch it but it itched.  By Friday night it started going down her arm.  Saturday it got to her elbow.  She put Cortisone cream as even with a washcloth over that section, and as much as it itched if she wiped it in the shower it hurt to touch.  She did not go to an UC or ER.  The redness is not red on site, it's below where the shots were given.  She continues to have the redness and the itching.  She has not notified her doctor, called us first to report it.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was inadvertently vaccinated with a fourth dose of GARDASIL 9 (strength, dose, frequency, lot number and expiration date were unknown), intramuscularly. No adverse effects were reported. Additional information has been requested. Follow-up information was received on 05-OCT-2016 (initial information was 04-OCT-2016) from the medical assistant who reported the patient received the first dose of GARDASIL 9 (Lot number L014415, expiration date 25-JUL-2017) on 24-SEP-2016. The patient received the second dose of GARDASIL 9 (Lot number L024993, expiration date 17-OCT-2017) on 20-MAR-2016. The patient received the third dose of GARDASIL 9 (unspecified Lot number/unspecified expiration date) administered to patient on an unspecified date. The patient received a fourth dose of GARDASIL 9 (Lot number M011840, expiration date 01-FEB-2018) on 03-OCT-2016. The medical assistant explained that their "system shows patient received a total of four doses of GARDASIL)." No adverse effects were reported. No further information was provided. Additional information has been requested.
Patient started to cough and had trouble breathing within 30 seconds after administration.  Epi-Pen 0.3 was administered to left lateral leg with good response and 911 initiated
Client 11 years old, lied and reported being 12. Accidentally give dose while ineligible.
Awoke with chills, headache, goose bumps and fever at 2:00 AM. Took Advil. Slept some after that then awoke with chills and hives. Temp of 100.6 F. Tired and no energy. Took daily Zyrtec. Next day felt better but still with 2 hives. Hives all gone by 8/1/2016. Is on daily Zyrtec for allergies.
Tingling/numbness in left wrist, sharp pain in neck (as if getting a stiff neck) followed by facial numbness on left side (same side as shot was administered), followed by dry mouth. Tingling/numbness in wrist resolved within 10 minutes, pain in neck resolved within 20 minutes, facial numbness and excessive thirst began subsiding in about 7 hours.
Narrative:  73 year old male admitted on June 4 2022 with from long-term care after testing COVID positive on surveillance screening. He had a fever fo 101F and was transferred to intensive care without evidence of respiratory failure. He had received Moderna vaccine x 3 on December 28, 2020, January 26 2021, October 27 2021. He was treated with remdesivir 200 mg IV x 1 then 100 mg daily x 4 days and dexamethasone 6 mg IV daily x 5 days. He clinically improved and returned to long-term care on June 25 2022 after completing quarantine.
severe abdominal pain experience 2 days post vaccination of dose 1 of 2. Diagnoses with early acute appendicitis on Friday December 18th and had a laproscopic appendectomy on Saturday December 19th.
Nausea; Vomiting; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Psoriatic arthritis, Hypertension and Diabetic neuropathy. Concomitant products included GLIMEPIRIDE, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN & HCTZ), DULAGLUTIDE, METFORMIN, SULFASALAZINE, HYDROCHLOROTHIAZIDE, GABAPENTIN, TAMSULOSIN, ROSUVASTATIN, PRAMIPEXOLE and TRAMADOL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and MYALGIA (Body aches). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-103698, US-MODERNATX, INC.-MOD-2021-103698 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04-MAY-2021 contains non-significant information follow up for Dose 1. New information applies to Dose 2 case. Right arm  for Dose 2 and many AEs after dose 2. On 05-Jun-2021: Action taken and Dechallenge Results updated to not applicable.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103698: US-MODERNATX, INC.-MOD-2021-103698:
Initial report received from a consumer on 11 November 2010. A male patient (age not specified), with a medical history of migraine headaches, blunt head trauma, fracture left side of skull and dengue fever, received on 11 November 2010 a left arm injection (route not reported) of FLUZONE, lot number unknown. The patient stated he takes prescription medications but can not legally filled. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of the flu vaccine. On 11 November 2010, following the vaccination, the patient felt as though his neck, brain, and sinuses were being engorged with a strong salt. By the afternoon of the 11 November 2010, the patient was having bleeding: nosebleeds and out of the corner of his left eye (previous condition, but stated it was "clearly exacerbated or made phasic with the vaccine as environmental stressor"). The patient treated himself with CAFERGOT and "PRN" medications. He stated he did not seek medical treatment from a health care professional. The patient stated that the bleeding lasted 2 days. He had no other symptoms or problems now. The patient did not have a health care professional and stated he travels a lot. The outcome was reported as recovered. Documents held by sender: None.
Patient  had red, itchy rash at site of injection starting 1/13/22.  On 1/14/22 rash had spread to both arms and upper body.
Throat was burning; Edges of mouth are swollen; Edges of mouth are numb; Edges of mouth are irritated; Taste the chemicals in mouth; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 16:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received naproxen (MANUFACTURER UNKNOWN) and diclofenac sodium (VOLTAREN) gel; on an unknown date for an unknown indication and experienced drug allergy. On 05May2021 at 17:00, after the shot was given, the patient started to taste the chemicals in her mouth. On 06May2021, next morning her throat was burning and the edges of her mouth were swollen, numb and irritated. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events taste the chemicals in mouth, throat was burning, edges of mouth were swollen, numb and irritated was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I went to the hospital for chest pain on Jan 21st 2021, Had a high heart rate. When I stand up my heart rate spikes.