chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of gait disturbance (he couldn't walk after the vaccine) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced gait disturbance (he couldn't walk after the vaccine). At the time of the report, gait disturbance (he couldn't walk after the vaccine) outcome:  unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-233364 (patient link).
A non-serious spontaneous report of motor tic one day following FLUMIST vaccination has been received from a physician concerning a ten-year-old male, subsequent to FLUMIST. The past medical history includes similar reaction in earlier years when he received other vaccines. No concomitant medication was reported for this patient. On 02-Dec-2010, the patient received FLUMIST. On 03-Dec-2010, the patient experienced a motor tic and was referred to a neurology consult. The outcome of the event motor tic one day following FLUMIST vaccination was unknown.
Pt recvd measles vax on 2MAY91 then on 16MAY91 pt exp unspecified psychotic sx; 22MAY91 pt psychotic episodes were resolving; No further details were provided;
Patient came in on 03/29/2021 to get a COVID vaccination. We were giving Pfizer on that day. Patient filled out COVID vaccine administration and consent form.  We were giving this patient their first shot. On the consent she answered "NO" to the question, Have you ever received a COVID vaccine. I then gave the shot.  On 04/21/2021 this patient came back in to get her second shot. I asked for the CDC  record card. She gave me a card from another location with Moderna listed and the shot date of 02/11/2021. I called supervisor to ask what to do. He called back and said the two shots completed the series even though they were different. I did not give the third shot. I informed the patient by phone.
Day of injection patient had pain at site, next AM developed chills and as day progressed pt had fever (max of 104.0 F) and neck pain.  Sent from school to ER by ambulance who reported shortness of breath, HR 100-130 as well as fever. Treatement in ER was IV fluids, IV Rocephin and acetaminophen.  Recommended spinal tap to r/o meningitis, parents declined. Discharged home in stable condition with recommendation to f/u if worsening sx and to treat with acetaminophen and cool compress to site.
Reaction to meningitis B on the left arm (localized swelling, mild tenderness). Pt states of body aches and lower back pain.
I had rashes all over my body. It started just only at night then it keep getting worst. I went my doctor because it was not getting any better. He prescribed me medicine to take for it. It is getting a little better now.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04May2021 (Lot number: EW0167) at the age of 64 years as dose 1, single and administered in arm left, administration date 25May2021 09:00 (Lot number: EW0185) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Sore arm".  Additional Information: Patient was not taken any other vaccination in four weeks. Patient had not tested for COVID-19 before and after vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.
Extreme whole body itching with no rash; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 22Feb2021 08:15 (at an age of 79-years-old) as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medications included metformin (MANUFACTURER UNKNOWN), via an unspecified route of administration from an unspecified date at 500 mg unknown frequency for unknown indication; doxycycline (MANUFACTURER UNKNOWN), via an unspecified route of administration from an unspecified date at 20 mg unknown frequency for unknown indication. The patient previously took bnt162b2 (Product=COVID 19, brand=Pfizer, lot number=EL9265, lot unknown=False, administration date=31Jan2021, administration time=08:00 AM, vaccine location=Left arm, dose number=1). On 22Feb2021 17:00, the patient experienced extreme whole body itching with no rash. The patient did not receive any treatment for the events. The clinical outcome for the extreme whole body itching with no rash was recovering.
Itching, more joint pain, lasted days, needed prednisone. Next dose was the same (3/30), also with syncope 2 days later. Resolved over a few weeks.
sore spot at site for two days,  about 6hrs after shot got very fatigued and had to go to bed. the next night in bed had fever and chills.
Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.
Stiff Neck, raging headache, bone-shaking chills, all over body aches, nausea
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 010a21a) for COVID-19 vaccination.     Concurrent medical conditions included Stevens-Johnson syndrome. Concomitant products included OLMESARTAN, ZINC, PROBIOTICS NOS;VITAMINS NOS, MELATONIN, GABAPENTIN, SERTRALINE and CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment Information was not provided Patient stated that she has over active immune system
Information has been received from a infectious disease control nurse concerning a grade school age child who was vaccinated between 1999 and 2000 with a dose of varicella virus vaccine live.  In approximately November 2005 (through December 2005), the patient developed varicella.  It was unknown if medical attention was sought.  No outcome was reported.  No product quality complaints were involved.  This is one of several reports from the same source.  It was reported that there was an outbreak of varicella in a school.  Additional information has been requested.
But the third is really unusual, I am sicker. I am on my 6th day and I am still sick; My heart, my blood pressure went out of control; My heart, my blood pressure went out of control; I still have infection; it is the third one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FE3594) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Note: was sick on the first one for two days), when the patient was 60 years old, for COVID-19 immunization, reaction(s): "sick"; Bnt162b2 (Dose: 2, Note: was sicker on the second one for 3 days), when the patient was 60 years old, for COVID-19 immunization, reaction(s): "sicker". The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "it is the third one"; ILLNESS (hospitalization), outcome "not recovered", described as "But the third is really unusual, I am sicker. I am on my 6th day and I am still sick"; BLOOD PRESSURE ABNORMAL (non-serious), HEART RATE ABNORMAL (non-serious), outcome "unknown" and all described as "My heart, my blood pressure went out of control"; INFECTION (non-serious), outcome "not recovered", described as "I still have infection". The event "my heart, my blood pressure went out of control" and "my heart, my blood pressure went out of control" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: went out of control, notes: my blood pressure went out of control; sars-cov-2 test: negative, notes: Have I gotten Covid? I was negative I did not get Covid and so; heart rate: went out of control.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient did not experience temperature excursion previously. On 26-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
Narrative:  died 9/23; caregiver stated that on night if the 23rd, patient began to "breath funny" with very heavy breathing. She planned to send him to the hospital, but before ambulance could arrive he had already passed away.
Severe swelling at the site, lump, hives forming, tender to the touch, aches, chills, extreme fatigue
kind of feeling low, not good; kind of feeling low, not good; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 12Mar2021 14:00 (Lot number: EN6204, Expiration Date: 31Jul2021) at the age of 48 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious), DEPRESSED MOOD (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "kind of feeling low, not good". The event "kind of feeling low, not good" and "kind of feeling low, not good" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). Patient stated that he had never been vaccinated before (only as a kid) and had no adverse reactions. Clinical course: he got the shot 5 days ago and he is still kind of feeling low and not good.  No follow-up attempts are possible. No further information is expected.
Started with warmth and swelling the evening of the immunization. Redness the following day when she came in for assessment. Was not able to get arm over head the night of the injection, but improved the following day. Area is red, warm and slightly indurated on day two. Advised to continue icing, tylenol and motrin.
Patient stated having nausea, vomiting, difficulty breathing, chest pain, lethargy. Pt was given epinephrine shot 0.3 ml SC and sent to ER via ambulance. Pt now Ok. ER nurse stated patient is ok. To be seen by MD and d/c'ed home.
Fever which passed after a day or two, but over the next few months my son completely stopped speaking, stopped playing with toys typically, stopped interacting with myself or others as he had done before the vaccination. And he stopped reaching typical developmental milestones according to his physician, myself, and others observations.
Left ear felt like it was clogged - sensation of water being in her ear; This is spontaneous report from a non-contactable healthcare professional (patient). A 38-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left arm, on 28Dec2020 14:00, at a single dose, COVID-19 immunization. The patient's medical history included allergies to sulfa. The patient's concomitant medication included lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 at 17:00, the patient's left ear felt like it was clogged - sensation of water being in her ear. This lasted a couple of days after receiving the vaccine. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event in Dec2020.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
several hours aft vax pt ex fever of 40.7 C and irritability.  infant examined in office, given tylenol and was consolable. fever decreased to 39.4 C.
Insufficient dose administered; RN was not familar with syringe; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Insufficient dose administered) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (RN was not familar with syringe) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Insufficient dose administered) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (RN was not familar with syringe). On 05-Jan-2021, INCORRECT DOSE ADMINISTERED (Insufficient dose administered) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (RN was not familar with syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) (batch no. 41L20A) on her right arm.  Concomitant product use was not provided. Treatment information was not provided.
Arm started feeling sore, tender, and warm to the touch, itchy, and a hard lump formed at the vaccination site about 8-9 hours after vaccination. Started having headache, body aches, stuffy nose, and fatigue around the same time. Headache, body aches, stuffy nose, and fatigue lasted roughly 24 hours and improved slightly with Tylenol, Ibuprofen, and rest. Injection site swelling and pain were made better by an ice pack, but symptoms are still present 48 hours after vaccination.
Begin with rapid elevation of blood pressure which he went to see his dr. He was put on Lisinopril 5mg
Second dose of the moderna covid vaccine was given too early for the dosing interval recommended by the FDA.  Records indicate first dose was given on February 2nd 2021, and the second given on February 25th 2021.
Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Patient passed out within 5 minutes of receiving the shot. He had some convulsions and 911 was called. BP was 106/70. Pt stated he felt weird, his arm hurt, everything went white, and he felt numb before passing out and had a headache. Pt has history of passing out when giving blood and did not disclose that information. Pt was taken care of by paramedics that sent him home.
This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy was not provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came to pharmacy to inform that the shot that was provided on 9/13/2016 on the Right Arm is still sore after almost a year from the PNEUMOVAX Vaccination. When rotating arm, or arm movement there is still soreness that occurred and still lingering from that vaccination date of 9/13/2016.
27mm circle of erythema, warm to touch at injection site. Being treated as cellulitis. Follow-up in 3 days.
Same day started with right arm burning, hot, down to finger tips, swollen and red to elbow, elbow not even visible .Took Tylenol PM to help sleep, still restless all night with pain.  Next day having chills, couldn't take temp,  swelling continued into elbow, no longer effecting fingertips.  Took Tylenol & Advil in the morning, then felt worse around 4pm, took 2 Tylenol, arm still swollen. Called pharmacy, advised to take 2 Benedryl, then instead of Tylenol take Advil for next dose.
very sore arm; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 50-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 50-years), administered in arm left on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced very sore arm. It was further stated that the vaccine recipient was my landlord she told me today at 9.17 AM via text message that she received the Pfizer vaccine yesterday and that she had a very sore arm and other then the sore arm no other side effect. The treatment was not received for the event. The clinical outcome of the event very sore arm was reported as not recovered.  No follow-up attempts are possible; information on lot/batch number cannot be obtained.
patient that received the incorrect diluent; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA172536, same reporter.  This case involves a 2 months old male patient who received the incorrect diluent, while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant was received.   On 21-Jun-2019, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI973AA, expiry date 04-Apr-2020 via intramuscular route in the left arm.  It was an actual medication error due to Wrong solution used in drug reconstitution.  It was reported that patient that received the incorrect diluent.  It was unknown whether patient experienced any adverse reaction after the injection.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Headache; Fever (100.4); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2022 at 19:00 as dose 3, (booster), single (Lot number: FP4554) at the age of 13 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma (Mild intermittent)" (unspecified if ongoing), notes: Other medical history: Asthma (Mild intermittent). There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose dose number: 1, Time: 03:30 Pm, Lot number: EP6955, Route: Intramuscular, vaccine location: Right arm), administration date: 27May2021, when the patient was 12-year-old, for COVID-19 immunization; BNT162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose dose number: 2, Time: 03:30 Pm, Lot number: EP6955, Route: Intramuscular, vaccine location: Right arm), administration date: 17Jun2021, when the patient was 12-year-old, for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 22Jul2022 at 08:00, outcome "recovered" (Jul2022), described as "Fever (100.4)"; HEADACHE (non-serious) with onset 22Jul2022 at 08:00, outcome "recovered" (Jul2022). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia.  Additional information: Patient has no known allergies. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. the patient was diagnosed with COVID-19 prior to vaccination. the patient has been tested for COVID-19 since the vaccination.
Rapid onset of atrial fibrillation while weightlifting, following usual dose of caffeine preworkout. Onset was two weeks after Moderna booster shot. Symptoms included pounding sensation and mild chest discomfort, no lightheadedness/dizziness. Presented to emergency room two hours after onset. Magnesium and K found to be mildly low, 0.64 mmol/L and 3.3 mEq/L. Did not convert to NSR following electrolyte and fluid replacement. Was subsequently cardioverted successfully.
Numbness & weakness 1 day p/inject; 7-9 days p/gradual numbness of legs; on day 21 problems walking & was adm to hosp; Numbness in eyes p/29 days; Electromylograms=nl dx probable mild GBS
Dry mouth, anxiety, tongue swelling, flushing/sweating. BP 160/84, pulse 111. Took Benadryl 50 mg PO.