chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 2nd dose 10 days after receiving 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 10 days after receiving 1st dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 10 days after receiving 1st dose). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 10 days after receiving 1st dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment products information  provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 022M20A) with no associated AEs.
Patient felt light headed after administration of vaccine Patient felt jittery and felt her heart was racing. Epipen ws administered.
Pt noticed itching, redness & swelling at Rt arm injection site. Area was tight & hard the next day.
Breakthrough case admission after three vaccines: Moderna 1/18/21 Lot# 012L20A;  Moderna 2/11/21 Lot# 007M20A;  Moderna 10/31/21 Lot# 9399903011822.
3/15/21: began feeling short of breath with any exertion as well as having tachycardia. Went to get covid tested and was negative, vitals were heart rate 169 at  and they sent me to an ER to be evaluated for possible . While at Hospital my heart rate continued to be 150-160 while resting and elevated with movement. D dimer was elevated at 1.67. CT angiogram of Pulmonary arteries was negative. Troponin was negative x3. Wbc were 3.08. EKG showed sinus  tachycardia with possible left atrial enlargement. Tested again for covid and was negative. Hospitalized for 1 night for observation. Discharged 3/16/21 with a 1 month heart monitor.  Had follow up visit with PCP on 3/19/21. Heart rate in office was 120s. EKG was performed, lying down my heart rate dropped to 70s. Orthostatic vitals were obtained. Heart rate increased with sitting and standing and blood pressure continued to decrease. Magnesium level and echocardiogram were then obtained and both came back normal. I had to be off of work for over a month due to heart rate and symptoms with it. 3/28/21: covid test performed, negative for 3rd time. 4/1/21: tilt table exam performed. Heart rate laying was 100, tilted up went well over 170 with almost passing out and shaking uncontrollably in the first 7 minutes of the test. Cardiologist ruled it as inappropriate sinus tachycardia.  4/20/21: office visit with cardiologist. Cardiologist notes, "Impression inappropriate sinus tachycardia with hypersensitivity of sinus node.  Post viral syndrome without evidence of flu or Covid with negative testing.  History of being previously vaccinated." Cardiologist stated to me it was most likely vaccination related since he has seen cases like this recently. Had to be put on beta blocker atenolol 12.5 mg and still taking it to this day. Heart rate still occasionally increases to 140s while on medication but is overall controlled.
Information has been received from a physician concerning a female patient, who in approximately July 2008, was vaccinated with the third dose of GARDASIL. Recently, the patient experienced GUILLAIN-BARRE SYNDROME and was hospitalized. The patient sought medical attention via ER visit. Additional information has been requested.  2/18/09 Received hospital medical records of 9/22-9/27/2008. FINAL DX: cardiogenic syncope & migraines Records reveal patient experienced tingling of bilateral LEs & 1 arm that progressed to face/throat lasting approx 15 min while in school, with dizziness, lightheadedness when standing from sitting, visual disturbance & difficulty walking x 3 days.  Had been seen in ER on 9/22, w/u WNL & released  Eval by PCP & sent to hospital as direct admit.   Neuro & cardio consults.  Exam revealed decreased DTRs.  LP done. This is in follow-up to report9s) previously submitted on 11/14/2008.  Follow-up information was received that the patient with no pertinent medical history and no known drug allergies on 10-JUL-2007 was vaccinated with the first dose of GARDASIL (lot # 657621/0387U), and on 08-OCT-2007 she received the second dose of GARDASIL (lot # 658558/1061U).  On 16-MAY-2008, the patient was vaccinated with the third dose of GARDASIL (LOT # 660391/0063X) IM into her left arm.  There was not concomitant medications given with the third dose.  On 15-SEP-2008, the patient experienced guillain-barre syndrome.  The patient was seen in the office on 22-SEP-2008.  During confinement, the patient had a normal EKG and normal blood work;  the patient also had a "successful" lumbar puncture on 25-SEP-2008 (no result provided).  The patient was discharged on 26-SEP-2008 on FLORINEF prescribed by neurologist.  The patient was seen in the office on 30-SEP-2008 and she stated that she had back pain from the lumbar puncture.  As of 03-OCT-2008 the patient was recovering.  Additional information has been requested.
Pain in the side of my leg and it is like a sharp shooting pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) 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, Lot/batch number: Unknown), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Pain in the side of my leg and it is like a sharp shooting pain".  Additional information: Patient stated, "I have a question regarding a possible side effect after the second shot. So, I got my second shot yesterday at 11 O' Clock and around 4 O' Clock yesterday started having pain in the side of my leg and it is like a sharp shooting pain and it happens like in every 2-3 minutes. Was that a possible side effect? Should I be concerned? Have you heard of this?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Member developed a satellite pustule near vaccine site.  Area appeared to have a generalized cellulitis around site.  Member sent to ER and was treated and released.  Member was given BACTROBAN 20% to use on a questionable pustule on side of his nose.  No other medications or treatment given.
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient was vaccinated with VARIVAX subcutaneous (SC) on 19-OCT-2012 (lot not reported) instead of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The pharmacist discovered the mistake right after administration of the (Merck) VARIVAX. No adverse effect was reported. Additional information has been requested.
has had contact with multiple family members positive for COVID-19, last on 12/30/21.  The patient is vaccinated for SARS-CoV-2, but not boosted.  He tested negative for COVID-19 on 12/30.   Repeat testing for COVID was performed on 1/4/2022 and was positive, and thus chemotherapy plans were delayed.
passed away of COVID19; passed away of COVID19; This is a spontaneous report from a contactable consumer (patient's son). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included a little overweight but she was not big. The patient's concomitant medications were not reported. The patient had the COVID vaccine and she recently passed away of COVID19. Patient got tested for Covid-19 on 25Jul2021 and was negative at that time. But then 3 days to 4 days later (Jul2021) she was sick and he had to call the ambulance, that was on a Monday going into Tuesday morning, 27Jul2021 or so and she was admitted to the hospital with COVID. Then 3 days later patient stopped texting and answering and she passed away on 18Aug2021. Covid-19 tested positive in Jul2021. Reporter seriousness for COVID-19 was death. The outcome of the events was fatal. The patient died on 18Aug2021.  It was not reported if an autopsy was performed.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away of COVID19; passed away of COVID19
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 30-OCT-2014, the patient was vaccinated with improperly stored PNEUMOVAX 23, (single dose vial), 0.5 ml, intramuscularly, exposed to 66 Fahrenheit (F) for 15 hours. No concomitants were reported. No adverse effect was reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
In the early morning of Monday, January 11th the patient developed a significant headache with neck pain.  She also reported parathesia and tingling in bilateral upper extremities with weakness of the right upper extremity.  She reported feeling very anxious and "wound up".  Patient presented to the Emergency Department 3 hours later.  CT of the head/brain, EKG, CBC,CMP, Magnesium and Cardiac profile were performed with no significant findings.  Ativan 0.5mg was administered orally.  Patient was admitted to the facility for observation.  Symptoms gradually resolved with no additional treatment.
Child developed shingles like rash at site of H1N1 vaccine spread to dermatome on same side of trunk.
Severe joint pain, especially in knees that woudlnt go away, Amenorrhea or loss of period after first shot
Patient returned to clinic at 12N reporting chest tightness, light headedness, nausea, transient shortness of breath, pain from injection site L deltoid to L fingertips, "heavy band" around L arm. Vitals stable 97.9 - 76 - 20, 140/96 - elevated. Speaking calmly. To ER.
Approximately 3 minutes after receiving his vaccine, started to not feel very well. He was feeling warm and was visibly clammy/sweating. He got very pale and the lost consciousness. He is in a wheelchair so we got him out of the chair and laying flat on the ground where he regained consciousness fairly quickly. 911 was called and they did take him in ambulance for follow-up in the emergency room. Vitals were taken while waiting for ambulance to arrive, but those were given to the EMTs.
Reported to military sick call two hours after vaccination with headache and dizziness. Examined by a health care provider. Advised to increase fluid intake and not to participate in physical activity until recovered.
Symptoms- Rash, Chills, fevers, Treatment - Glut injection Kenalog 40 with 5mL of Dexamethasone Sodium Phosphate
Pt developed allergic reaction, numbness in lips, itching nose within an hour after administration of Moderna.  She administered Epi-pen in ours presence and we contacted 911. Ambulance took her to  hospital where she was treated and discharged home with prednisone.
Patient tells me 2 days prior to vaccine  on 3/3 (Pfizer) she had mild hives?not unusual for her in the spring.  They typically occur along with seasonal allergies and she thinks the hives are unrelated to current rash. She went ahead and had the 1st Pfizer  vaccine on 3/3.  She developed a new circular rash at the injection site on the left arm and  new rash over the left side of her back described as ?on fire?.  she was seen for a telemedicine clinic visit diagnosed with possible shingles and was prescribed treatment. Did not improve significantly.  She went ahead and had the second Pfizer jab on 3/24. She  developed extreme tenderness at injection site. the rash that was on her back got much worse and spread. The rash occurs any place she scratches, has blood drawn or gets a band-aid placement.  After that second shot she also noticed  that her hip joints feel ?weak and unhinged". . Has also had similar symptoms of weakness in bilateral shoulders.  Feels like her leg muscles are weak (points specifically to quadriceps). She has trouble repositioning herself and doing normal activities that she had been doing without difficulty just a few weeks ago. Her RN notes that she can get out of bed and walk to bathroom but is unsteady and shuffles.   Has also noticed facial and periorbital  swelling with purple discoloration and darkness around eyes. Had a faint pink rash extending from eyelids up over brows  that has now decreased. Feels her legs are puffy and swollen.
Patient was found unresponsive, EMS brought to ER in full cardiopulmonary arrest.  CPR was given and patient intubated and sent to hospital.
I fainted the following evening after my vaccination. I felt fine all day and after dinner started to feel flush, vision became blurry and had trouble hearing. Within 3 minutes I fainted. Felt fine after coming to, and have felt fine so far the next day.
This is a spontaneous report from a contactable consumer or other non-health care professional. A 47-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On unspecified date 2021, The patient experienced, after the first dose of the Pfizer COVID-19 vaccine 3 weeks ago and was due to get his second shot today but he had been "deathly ill", so bad that it was like flu like symptoms, she checked his temp every day, he had no energy/fatigue, kept a bucket next to him to throw up in, he was eating fine until 3 days ago, his breathing sounds was good. His temperature was 98. but yesterday it went to 100.1, she was not sure if he were dehydrated or not. She wanted to know what to do for him and if he should get the second shot or not today. These symptoms started one and a half weeks after getting the vaccine. My fiance had his shot. Three weeks ago and he started developing the flu like symptoms and that was a like symptoms because I was taking his temperature every hour and he was stayed at 98 all week so, I knew. It's side effect from the shot. I mean throwing up, fatigue but he also have no energy at all. It's hard for him to get up and go to bathroom. I am not finish. I know that, There are some side effects, That few people get but yesterday. He often loss his appetite and he losses appetite from three days and he haven't appetite. All week during all this because, I was eating three or four times a day and he was not eating and he was drinking lot of water and all sudden, Had already started again and now his temperature, It went from 98 to 100.1 and now he is due for his 2nd shot today and I am scared to taking with. I don't know, What to do about it. He doesn't have a doctor. He doesn't have a servant. I don't know, What to do." The patient underwent lab tests and procedures which included body temperature: 98 on 2021, body temperature: 100.1 on 2021. The outcome of events was unknown. Follow up attempt completed. No further information is expected.
Received DTaP and IPV in R deltoid.  Patient had tactile fever and pain on day of vaccine (10/2/07) and then had 1 1/2 day history of redness, warmth below injection site.  No fever.Pt had 11 x 11 cm red warm non-tender area below injection site.  Injection site not warm, not tender, not red and not swollen.  Pt treated with cephalexin 400 mg bid x 7 days.
A fatigue that lasted from 04/26/2021 to 05/02/2021. Low energy, very tired.   I had to miss work on all scheduled days within that time frame. Quarantine at home. No irregular temperatures, no nausea.   On 4/28/2021 to 05/01/2021, I did take one dose of Coricidin a day. I also took Airborne tablets. I eat chicken soup everyday. Lots of rest & naps.
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 27Nov2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of JNJ-78436735 ( COVID-19 VACCINE; Lot number: 202A21A) via an unspecified route of administration in the left arm on 04May2021 as a single dose for COVID-19 immunisation. On 27Nov2021 at 17:00, the patient had experienced injection site soreness so far and wasn't any pain for the first couple of hours or so and then got worse. It was reported that it was still sore more than 24 hours later. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site soreness was not resolved at the time of this report.
Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC   1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains
My son has splotchy welts on the left side of his arm, same arm shot was administered.  He also has had a headache and felt nauseous all day
Systemic: Vomiting-Mild, Additional Details: Vomited water according to daughter in law. Gave pt water and let them stay extra 15 minutes more. She was fine when she left.
48 y/o M presented to receive first dose of Pfizer vaccine. Pt received vaccine at 0915 to LD, pt presented with symptoms shortly after vaccine at 0918.  Symptoms  included pallor, weakness,  nausea, and diaphoresis. RN attended to patient immediately- ice pack applied to back of neck, pt asked to take off mask to allow increased tissue perfusion, ice water offered and pt only able to take a few sips due to nausea. Vital signs were obtained (while patient was sitting up in chair) as the following 76/49 BP, HR 53, SpO2 at 97% at 0923.  Vital signs were repeated at 0930  while patient was laying on gurney. Vital signs recorded as the following 101/54 BP, 53 HR, 94% SpO2.  RN stat called at 0925, staff arrived to assist patient. Pt taken to treatment room for further observation. Upon arrival to treatment room, vital signs obtained and recorded as the following at 0935 BP 102/70, HR 61, SpO2 96%, RR 20. Pt stated symptoms has improved significantly.
This spontaneous report was received from a pharmacist and refers to a 21-year-old male patient. No information regarding the patient's pertinent medical history and drug reactions or allergies and concomitant therapies was provided. On 19-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # M040412, expiration date: 30-JUN-2019; exact dose and route of administration were not reported). On 26-MAY-2017, the patient was inadvertently vaccinated with another dose of GARDASIL 9 injection (lot # M040412, expiration date: 30-JUN-2019; exact dose and route of administration were not reported). The pharmacist was not aware about the fact that the patient had already received the first dose. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Developed a severe chronic hive outbreak following flu vaccine.  No known allergy to eggs or chicken.  No history of hives prior to receiving the 2009 flu shot.  In 2009 hives developed several days after receiving the flu shot.  Medication was prescribed and the condition could be controlled by the medicine.  Several days after receiving the 2010 flu shot, the condition has returned with a vengeance and cannot be controlled even with medication.  I suspect that the flu shot has created a chronic hive condition that will not be easily resolved.
REDNESS, ITCH, HOT AT INJECTION SITE  FOR 5 DAYS AND COUNTING  USED CORTISONE OINTMENT FOR ITCH WITH EFFECT
She has a fever of 101.5 chills shakes eyes sensitive to light severe headache body and muscles ache weak fatigue mild neasua
Shingles on left side of body - healthy 34 year old- not under any stress - started about 6-8 weeks after vaccine- symptoms was tingling sensation and pain on left side of body from shoulder to foot for about a week then the shingles rash- I?m on week 3.5 of having active shingles with the rash about a week after rash diagnosed with neuralgia
3/2 I got my first moderna shot yesterday. Last night I started developing chills, a couple degree fever, overall body aches much like the flu and persistent slight nausea. Did not throw up but was uncomfortable for sure. Slept in 2 to 2.5 hour shifts then up to pee and back to bed. Finally this morning I lslept from 10 am to 2 pm. 4 wonderful hours of blissful unconsciousness. My O2 this morning was 98/74 BP 135/81/69. I just took my bp 315 pm and it was running 141 high end. O2 was good at 97 but heartrate was 99 and temp was 99.7 to 99.1.
Fever of 103  - all day and only returned to normal with aspirin.  Chills -  most of the day Headache - All day.  Dedicated slightly with aspirin  Body and joint ache - All day
Within 20 minutes, wave of nausea. Vomited on way home, very intense wave of fatigue, could barely stand/walk - unbalanced, dizziness, spinning - like terrible, sudden vertigo. Had to sleep off about 4-5 hours and feel better now.
Onset redness, bruising (R) arm 24 hour after injection. Rx CLARITIN & CORTAID.
10/02/14 Received a call from patient's mother, that patient had received her flu vaccine on 9/20/14 and on Wednesday evening she had a 4 inch welt on her arm that was warm to touch, swollen, and painful to the touch and she had itchy eyes. Mom says they had applied warm compress's to her arm and the swelling has gone down, still some redness. She is wondering if this should be documented as a reaction, and maybe get FLUMIST in the future. She will have her continue to do warm compresses's and she is picking up BENADRYL for her as well. Any other recommendations, please advise, thanks.
pt recv vax & devel inj site rxn characterized by blotchy redness, warmth & burning pain;pt recovered p/2 days;reporter indicated that lot# 4978149 was administered to pt & MD @ this sam facility w/o adverse exp;
Significant swelling and pain at the sight developed causing patient to seek help at the Urgent Care Center. Antibiotics were prescribed and a safety report was submitted.