chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe migraine; severe joint and flank pain; severe joint and flank pain; severe dizziness/vertigo; severe dizziness/vertigo; electric shock sensations throughout body; nausea; Vomiting; tachycardia; elevated BP; Angry; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 28Jan2021 14:30 as dose 1, single for COVID-19 immunization (at the age of 39-years-old). The most recent COVID-19 vaccine was administered at Workplace clinic. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. There were no known allergies. Historical vaccine included flu vaccine and shingles vaccine and never had any reaction. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Jan2021, the patient experienced severe migraine, severe joint and flank pain, severe dizziness/vertigo, electric shock sensations throughout body, nausea, vomiting, tachychardia, elevated BP, and she was angry and will not get a second dose. Fix that. The media should be talking more about this because it was happening to a lot of people, but they were not because vaccines. Patient also stated that stop trying to normalize these effects, she got the flu vaccine every goddamn year and had never had any reaction, not even to her Shingles vaccine, that was poison. Events were assessed as non-serious as per reporter. Events resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 29Jan2021. Treatment included Advil, Oxycodone, Zofran, Phenergan (rectal), bena. The clinical outcome for the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
A sudden red and itchy rash appeared on site of injection 8 days after it was given, it?s been lasting for three days and is getting bigger in size. Ice packs used for redness.
hives onset 4 days after Pfizer covid19 vaccine #1 on 21 SEP 2021, these resolved within 2 wks, then patient had recurrent of hives on 20 OCT 2021, which was about 1 week after receiving Pfizer covid19 #2 (patient also received flu vaccine on 18 OCT 2021 / Influenza, injectable, quadrivalent, preservative GlaxoSmithKline)
SVT, heart rate at rest was over 200bpm, I laid down for 30 mins and couldn't get it under 180.  Felt pressure in head and not very stable. Concerned, sweating,  Bp was very high at that point. Don't have the exact number. Called for ambulance, paramedics ruled out WPW and gave me iv drug that brought rate down to 120 fairly quickly, Over the next hours resting rate slowly normalized to around 80 (normal for me is 72).  For 2-3 days afterwards had some high resting pulses up to 118 but never as bad and normalized in a few days.
SIGNIFICANT IRREGULARITY IN MENSURAL CYCLES AND IRREGULAR VISCOUS BLEEDING; ALTERED MENSTRUAL CYCLE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: birth control. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced significant irregularity in mensural cycles and irregular viscous bleeding. On APR-2021, the patient experienced altered menstrual cycle. The action taken with covid-19 vaccine was not applicable. The outcome of the significant irregularity in mensural cycles and irregular viscous bleeding and altered menstrual cycle was not reported. This report was non-serious.
erythema over inj site rt deltoid area 3" x 3" w/mild swelling of same area;non tender;
Patient was dizzy after the vaccine was given and 1 1/2 hours later vomited. She had continued vomiting throughout 5/15/21 and 5/16/21. She also had 3 episodes of watery diarrhea. She felt tightness in her chest.
3 to 4 inch, red, swollen patch over injection site. Area is tender to the touch, warm to the touch and itchy. Symptoms have not improved  nor have they gotten worse over the 2 day period since it began.. Treating the area with ice packs and soaking in a bath of Epsom salts once a day.  I did not have this reaction to the first dose  given at the same location 4 weeks ago.
07/19/2011 Fever - increased to 101.8 degrees later that evening.  07/20/2011 fever rose to 102.8 degrees up to midnight that night.
devel sever lt arm swelling, warmth, pain & redness;pt reports this was arm recv vax;w/in 24hr ice, elevation & DPH;sx resolved in 7 days;
Vaccine was stored in the refrigerator for more than 30 days; No adverse event; Dose was given one day after 30 days beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No allergies to medication, food and other products. It was unknown whether patient had ever diagnosed or tested positive for COVID-19.     On 15-Sep-2022 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose was given one day after 30 days beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event) to be not related.    No concomitant medications were provided by the reporter.  Patient's site of application was right leg.  It was reported that the date they removed the vial from the freezer on 16-Aug-2022. They administered the vaccine to 2 kids on day 31 of its storage in refrigerator. It was reported that the reporter had slight confusion as the day the reporter reported the incident the reporter was informed by 2 people that the vaccine was not considered expired based on date it was received and placed in refrigerator. Per their calculation expiry would be 15-Sep-2022 but reporter wanted to know if it was now considered the vaccine was expired on 14-Sep-2022.  Patient had no adverse events, patient was fine. The event had not caused patient to seek medical care. The patient had not experienced a similar event in the past.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-647008 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647008:Case for C-D(second pt)
Later, in evening, felt "itching" @ left arm, noticed a "hive" on left thigh, felt "foggy".  Took a Benadryl, went to bed, no further symptoms in the morning.  Upon inspection 4/19, 9AM, no signs of inflammation at injection site Left Deltoid area, no hives.
her right hand started twitching shaking uncontrollably; her right hand started twitching and shaking uncontrollably; Her temperature also started rising but did not reach above 100*F; This is a spontaneous report from a contactable consumer (Parent). This consumer (patients mother) reported for a 16-year-old female patient (daughter).  A 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration in left arm on 19Apr2021 (at the age of 16-year-old) for SINGLE DOSE for COVID-19 immunization. She received Pfizer vaccine on 19Apr2021 in left arm and within 2 minutes of receiving it left arm, her right hand started twitching and shaking uncontrollably on an unspecified date. The nurse and the fire department were with her and monitored her for 45 minutes until they suggested her to contact her primary care provider and go to the hospital. In those 45 minutes her right arm started twitching with her hand twitching more. It started going up and down with a flopping motion. Her temperature also started rising but did not reach above 100*F on an unspecified date. She was observed by several doctors in the hospital and was given Adavan (Ativan) for her symptoms which did not subside. She was dismissed from the hospital and was given Adavan (Ativan) again in the hopes that her symptoms would subside in the morning. This morning, only her right hand was still twitching. She is right-handed and could not use her right hand at all as she could not hold a pencil at all, which caused her to be absent from school today. She mentioned that her daughter was healthy, athletic, and had no underlying conditions. Her twin sister also had the vaccine yesterday and experienced nothing but nausea last night with some of the listed side effects. She is asking if there has been reports of this. Waiting to hear from hospital she may need to see a neurologist. Outcome of the event reported as recovering.   Response: Referenced PI Section 6 and Section 18 LAB-1457-7.0 Revised: 06 April 2021  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Extreme swelling entire arm and fever in arm. Treated with ice/TYLENOL.
pfizer vaccine was in fridge beyond 30 days at time of administration. pharmacist did not know of this until after administration. discussed with pt. pt stated body aches, tiredness. advised to repeat vaccination.
Patient indicates that they had been vaccinated with Pfizer and arrived at the center for their second dose. When the vaccination card is asked to write down the second dose, they indicated the vaccination card has been damaged and they want a duplicate. They are asked to verify that they have a photo on their phone and when it shows we realize that your first dose was Moderna not Pfizer, as verified at the beginning.
Had pain before getting the vaccine but it's now getting worst; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old elderly male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date at Single dose for COVID-19 immunization. The patient's Medical history included arthritis. She reported that her husband has stopped taking medications since 4 days now. They stopped taking a couple of mediations such as blood thinners, muscle relaxant and etc. The patient's concomitant medications were not reported. The patient was taking muscle relaxant to help with his pain related to arthritis. He also had pain before getting the vaccine but it's now getting worst because he hasn't taken his medication for a while. The outcome for the events was Unknown. Caller states that the pain her husband is experienced is not related to the vaccine. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Large swelling and redness, approximately 2.5 x 4? in size, hot to the touch, states it?s painful
aches, lackof appetite, fatigue--after a week waspositive for  covid and died 2 weeks later
No adverse effects reported; received improperly stored doses of VAQTA; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient' s concurrent conditions, medical history and concomitant medications were not reported. On 10-APR-2019, the patient received improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R025518, expiration date: 15-NOV-2019, for prophylaxis (exact dose, frequency and route of administration were not provided). The vaccine underwent temperature excursion of the lowest temperature of 36 degrees Fahrenheit/ 2 degrees Celsius (34F) for 1 hour and 17 minutes and the highest temperature of 47 degrees Fahrenheit/ 9 degrees Celsius (50F) for 30 minutes. There was no previous temperature excursion. The digital data logger was not involved in recording excursion details. No adverse effects were reported.; Sender's Comments:  US-009507513-1904USA005752:
Patient reports flu-like symptoms: body aches, low grade fever, sweats - starting the evening the vaccine was given and fully resolved by the next morning.
moderate aching/burning sensation in knees and hips started about 7pm- resolved when awoke in morning at 6am.
became light headed, then had to go to bathroom   Hand, arms and legs began to itch     I could barely get him up to walk to bathroom     had to lay him on floor - he was staring off into space and not really reacting to me.    Called 911 due to his extreme reaction.    by time ambulance got there, had gotten him up and to toilet, and back into a chair.       he went on to hospital  and was released several hours later
Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 28-Nov-2021 The patient died on 28-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Company Comment - This case concerns a 73 year old male patient with no relevant medical history, who experienced the serious unexpected event of death. The event occurred 9 months after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  No concomitant medications were provided. Treatment for the event was not provided.; Sender's Comments: This case concerns a 73 year old male patient with no relevant medical history, who experienced the serious unexpected event of death. The event occurred 9 months after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Pt was given Hep A vaccine in (R) thigh and developed hives around injection site within 5 minutes. Hives started going down before 5 ml of BENADRYL was given.
Approximately 2 days after receiving vaccine patient experienced localized swelling, redness , blotchy, heat (discomfort). This has continued to be red/puffy for a few days.
"Covid Arm" No reaction at all until around 3/10/21.  I noticed itching at the injection site and my upper arm.  The puncture area had gotten red, raw looking and noticeable which however previously for days after the shot I could not  see where the shot had even been given.    Last night, 3/12/21,  I noticed a large red area on my upper arm that felt hot and appeared slightly swollen.  I got online to research the symptoms last night and discovered it looked like "Covid Arm" and the information said it was not serious.  This morning the redness is still there but slightly less.  I am concerned about getting my second dose because as I understand it, the second dose can cause a worse reaction.
Per vaccinator, while administering vaccine she attempted to push the dose , the needle separated from the syringe leaving the needle in the patient's arm  and vaccine sprayed out. Vaccinator removed needle and hub from patient's arm. A replacement dose was administered as the patient did not receive any of the dose.  Syringe and needle was Haiou brand.
Firm, red, swollen area around vaccination site 11 days after vaccination. Some individual bumps.
Injection site - about .5 inch circle, red, itchy, painful to touch; Fatigue
Pt vaccinated /w DTP slept through day, wimpering throughout. Mom had to awake to feed. Fell back to sleep.
On 12/15/2016, the patient's mother came to report that since the flu vaccine, the patient has been having severe pain in her upper arm/shoulder and cannot lift her arm above a 90 degree angle. The patient is out of the country for several months. RPh recommended she go to a clinic where she is for evaluation.
pt recv vax 18JUN97 & had severe hives on the face, neck, thighs, back, trunk, arms;ER or MD visit was required to treat the events;both events were treated w/oral DPH;
Fever, severe headache, neck pain, swelling of eyelids and lips (and fingertips).
This spontaneous report has been received on 21-NOV-2014 from the primary reporter, a medical assistant. The medical assistant reproted that 2 unspecified patients (gender and age not reported) were administered VARIVAX (Merck) that was stored improperly. No dates of vaccinations provided. No adverse effects reported. No further information was provided. Additional information has been requested.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported
Patient admitted after fall and trauma, EtoH involved, apparently had shock from blood loss with epistaxis and anticoagulation, was persistently hypotensive in hospital, treated for Etoh withdrawal. Discharged with holding PTA BP/diuretics medications and Xarelto. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Pain in administration area(left arm); weakness; Pain and inflammation of the administration area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 14:00 (Lot number: EP7534) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 21Mar2018 (ongoing), notes: continuous medicines (prescribed drugs). Concomitant medication(s) included: MONTELUKAST taken for asthma, start date: 21Mar2018 (ongoing); CETIRIZINE [CETIRIZINE HYDROCHLORIDE] taken for asthma, start date: 21Mar2018 (ongoing); DYMISTA taken for asthma, start date: 21Mar2018 (ongoing); BREO ELLIPTA taken for asthma, start date: 21Mar2018 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Pain in administration area(left arm)"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered", described as "weakness"; VACCINATION SITE INFLAMMATION (non-serious) with onset Mar2021, outcome "recovered", described as "Pain and inflammation of the administration area". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported, the patient received dose 2 intramuscular on 04Apr2021 14:00 (Lot number: EP6955) and dose 3 intramuscularly on 18Dec2021 15:00 (Lot: 33025BD). Reportedly, the patient had side effect described as follow. 1st dose: Pain and inflammation of the administration area (left arm) and weakness. The effects disappeared after 2 days.  Follow-up attempts are completed. No further information is expected.
positive for COVID with symptoms; This is a spontaneous report from a Pfizer sponsored program contactable consumer or other non hcp. A 16-year-old female patient received bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EW0198)), dose 1 via an unspecified route of administration on 27Jul2021 (age at the time of vaccination was 16-year-old) as dose 1, single for COVID-19 immunisation.The patient's medical history and concomitant medications were not reported. On 01Aug2021, the patient experienced positive for COVID-19 with symptoms. The reported stated that her both daughters got COVID shot and they both tested positive for COVID; unfortunately, they actually took COVID test yesterday and they tested positive dates for her 2 daughters, they were 14 and 16 years old and unfortunately after taking the first dose they experience side effects. The patient had the first day that she got it that night she threw up. She was little nauseated, she threw up she also had, she had body ache. She had not lot of temperature like, she was gone up to maybe 98 point something but that is or 99 but that is it and she has, she said she is been getting to like middle cough and she just doesn't feel good, but my, because they have not felt good. I took them, they got their shot the vaccine on the 27. The reporter think it was the Tuesday or Wednesday of last week and yesterday I took them to get COVID shot and they both tested positive for COVID. So, my question is what I from here on I mean do they tested positive for COVID. The reporter will not be able to, and I need to get some information and that was what I need to do. Otherwise, I would I am sorry about that. Reporter was informed that the Pfizer Medical Information department is the concerned department. Reporter was unwilling to complete the report hence further probing could not be done. Hence, limited information was available over the call. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on 01Aug2021. The outcome of the event was unknown.