chrisvoncsefalvay/vaers-outcomes huggingface dataset:
debilitating pain in left arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the left arm on 15Jan2021 (at the age of 66-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 66-year-old); both as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, high blood pressure and allergy to sulfa. 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 COVID vaccine. Concomitant medications were not reported. The patient previously took bee pollen (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On an unknown date in Jan2021, the patient experienced debilitating pain in her left arm and wanted to get booster but was concerned about it making the pain worse. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event debilitating pain in left arm was not resolved at the time of this report.
After Covid vaccine dose two I started experiencing insomnia. I could not fall asleep. I tossed and turned all night and would get only an hour or two of actual sleep for two weeks. I had incredibly vivid dreams that woke me up constantly. I started taking trazadone for about a month which helped me sleep for a bit. I was also taking 20 mg of melatonin just to get to bed. I eventually weened off of the trazadone and was just taking melatonin. Soon I stopped taking the melatonin too. I was able to fall asleep now, but I could not stay asleep. I would wake up every few hours and still sometimes have a hard time going back to sleep. I still am having this issue now a year later. Before the Covid vaccine, I had not trouble sleeping for 8 hours straight every night.
Doses too far apart/ first Moderna vaccine on 4May2021/ second vaccine was on 31Aug2021; Pressure behind nose; Head being squeezed; Fever blisters around lips; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses too far apart/ first Moderna vaccine on 4May2021/ second vaccine was on 31Aug2021), PARANASAL SINUS DISCOMFORT (Pressure behind nose), HEAD DISCOMFORT (Head being squeezed), ORAL HERPES (Fever blisters around lips) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 002C21A) for COVID-19 vaccination.     The patient's past medical history included Shingles (the exact pain in the exact spot on her right side.). Previously administered products included for an unreported indication: SHINGRIX.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses too far apart/ first Moderna vaccine on 4May2021/ second vaccine was on 31Aug2021), PARANASAL SINUS DISCOMFORT (Pressure behind nose), HEAD DISCOMFORT (Head being squeezed), ORAL HERPES (Fever blisters around lips) and HEADACHE (Headache). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses too far apart/ first Moderna vaccine on 4May2021/ second vaccine was on 31Aug2021) had resolved and PARANASAL SINUS DISCOMFORT (Pressure behind nose), HEAD DISCOMFORT (Head being squeezed), ORAL HERPES (Fever blisters around lips) and HEADACHE (Headache) outcome was unknown.            Patient started having a headache not really like a throbbing headache but a pressure in head and nose area like her head was being squeezed. It hurt mostly when she would lean down.  Concomitant medications were not reported. Treatment details were not provided.
makes you hurt your arm; Strange sore in my mouth; Not like a blister, just a peculiar little white bump; This spontaneous case was reported by an other health care professional and describes the occurrence of ORAL PAIN (Strange sore in my mouth), ORAL DISORDER (Not like a blister, just a peculiar little white bump) and VACCINATION SITE PAIN (makes you hurt your arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced ORAL PAIN (Strange sore in my mouth) and ORAL DISORDER (Not like a blister, just a peculiar little white bump). On 03-Aug-2021, the patient experienced VACCINATION SITE PAIN (makes you hurt your arm). On 05-Aug-2021, VACCINATION SITE PAIN (makes you hurt your arm) was resolving. At the time of the report, ORAL PAIN (Strange sore in my mouth) and ORAL DISORDER (Not like a blister, just a peculiar little white bump) had not 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.   Concomitant medications was not provided by the reporter. No treatment medication was reported. Second dose scheduled for 30Aug2021.
she has a lot of fatigue did not take temp but is colder than usual and wearing sweater which she says she normally doesn't, and if she takes a deep breath it is tight and hurts her chest and does have an occasional cough   Contact with and (suspected) exposure to covid-19
Site of injection in upper arm got very warm and itchy and developed a bumpy welted up red rash 2 days after getting Moderna Vaccination.
Hello, I am a licensed physician who had taken my first of two total COVID vaccination doses on 5/21/21. Since that time, (roughly 20 months) I have experienced both debilitating fatigue and depression. The symptoms started immediately after the vaccine and have persisted. My relevant laboratory data has been normal and there is no other explanation for my symptoms. I know that I am not alone with such manifestations from the vaccine and why I'm reporting it.
This initial spontaneous report was received from a female patient of unspecified age referring to herself. The patient did not wish to provide information regarding her medical history, concurrent conditions, drug allergies/reactions, or concomitant medications. On 14-SEP-2018, the patient was given ZOSTAVAX 0.65 ml once (route and lot # not provided). On an unspecified date since receiving the vaccine (reported as "since then"), she developed vision problems, dizziness and she is "all broke out on [her] face and body and [her] face looks a mess. The patient saw a physician for the events. Causality assessment was not provided. The patient asked if there were treatment recommendations for the events (based on this, the outcome of the events were considered not resolved). When she was directed to her doctor, she mentioned that she may contact a lawyer. Additional information has been requested.
Fever 99.5-101.5. Seizure. Lethargy, decreased appetite x 1-3 days.
Day 1: Sore arm, back pain, headache  Day 2:  Sore arm, back pain, headache, neck pain, pain in both calves, increased joint pain, low grade fever
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cervical dystonia" (unspecified if ongoing). There were no concomitant medications. No other medication in 2 weeks. There was no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Adverse event: 1-very bad med taste that does not go away. 2-I am on my 3rd day and should be feeling better, yet I am not better and have new symptoms. Paxlovid was taken as treatment for COVID-19, treatment started on 18Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
hypersensitivity reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of   in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.  Very limited information regarding the event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding the event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
abnormal mentrual cycle: Heavy bleeding lasting 6 weeks post vaccination which has never happened before.
Same day post vax, the pt developed a fever, redness, and swelling at injection site. He was unable to walk on leg. Physician told mother he shouldn't have anymore Typhoid vaccines.
Immediate swelling at injection site.  Down in 2 days.  Hard to raise arm.  One day after vaccination, inside front of arm, bicep area, started getting very red and hot to touch.
Pt. c/o nausea @ 1:35pm evaluated by EMS on site.  Pt. reported of feeling better and was released.  Pt. has no history of medical problems.  Vitals 128/88,   104,  R 6, 100%
Thrombocytopenia Purpura developed 48 hours after influenza vaccine.  Ecchymosis developed in mouth, purpura on legs. Platelets initially found to be 2.  Initial moderate response to corticosteroids, but short lived duration.  Platelets dropped back to 1-2 for 10 days and did not improve with IVIG.   Patient elected for splenectomy and platelets have increased to 135 post operatively (still on Prednisone and NPlate)
On my third booster of Pfizer, I got sharp, stabbing chest pain that radiated to my right shoulder blade. I was diagnosed with costochondritis and put on an anti inflammatory. About 4 days after my shot I have been being short of breath with activity and mild dull stabbing chest pain. I have also had a slight chest kind of cough, dry cough.
chills; body ache; Neck pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration over the left arm on 17Mar2021 at 12:00 (at the age of 40 -year- old) as a single dose of COVID-19 immunisation. Medical history included hypertension and eosinophilic esophagitis. The patient had previously received her first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number: unknown) via unspecified route of administration over the left arm on 24Feb2021 at 14:30 for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient had received other medications(unspecified) within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 13:00, the patient had experienced the chills, body ache, neck pain and fatigue. The patient did not receive treatment for the reported events. The clinical outcome of the events chills, body ache, neck pain and fatigue was not resolved.   No follow-up attempts are possible; information about lot number cannot be obtained.
Return to clinic 8/5/2010 Rt. leg red and swollen started on BENADRYL every 6 hours and AUGMENTIN 600/5 1 3/4 tsp BID x10days warm compresses, monitor and return to clinic 8/6/2010 if increase in size. She did return 8/6/10 area slight larger continue AUGMENTIN warm compresses BENADRYL every 4 hours. Checked with mom 8/9/2010, reports child doing better.
fatigue, soreness, headache occurred the night after receiving vaccine ( approx. 8 hours later) lasting into the following day. I did not take any medications for this .
The patient's arm immediately swelled and bleed more than usual.  The patient started feeling dizziness and weakness.  He also had a stomachache and nausea.  He did not feel well at all. He had us call 911 to get checked out.  When EMS arrived, they checked his vitals.  vitals were good.  Patient was still feeling bad, so he called a family member to take him home.  He came into the pharmacy on the 27th.  He was feeling better at that time.  The only symptom he had at that time was a sore arm.
Approximately 15 min after vaccine, child started with pain and inflammation in right arm. Child complained of not being able to move arm. Child came back to office on 06/15/2004. Meds given: Keflex, Orapred, Tylenol and codeine. Pt to be seen in 2 days.
Days 1-3 headachy; tired/Days 4-9 fatigue; loss of appetite; hives/By end of day 10, hives have moved up and down body, particularly arms and legs. Day 11 hives spread to fully cover arms and legs, down to feet/toes and hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 13:15 as dose 4 (booster), single (Lot number: GH9697) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Previous dose details, Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=331308A,, Prev dose lot unknown=False,, Prev dose administration date=08Dec2021,, Prev dose dose number=3,, Prev dose vaccine location=Left arm), administration date: 08Dec2021, when the patient was 41-year-old, for COVID-19 immunization, reaction(s): "tired (same as prev 3 doses)"; BNT162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False, Prev dose lot number=EW0172, Prev dose lot unknown=False,, Prev dose administration date=26Apr2021,, Prev dose dose number=2,, Prev dose vaccine location=Left arm,), administration date: 26Apr2021, when the patient was 41-year-old, for COVID-19 immunization, reaction(s): "tired (same as prev 3 doses)"; Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False, Prev dose lot number=EW0172, Prev dose lot unknown=False,, Prev dose dose number=1,, Prev dose vaccine location=Left arm), for COVID-19 immunization, reaction(s): "tired (same as prev 3 doses)". The following information was reported: HEADACHE (non-serious) with onset Oct2022, outcome "recovering", described as "Days 1-3 headachy"; URTICARIA (non-serious) with onset Oct2022, outcome "recovering", described as "hives/By end of day 10, hives have moved up and down body, particularly arms and legs. Day 11 hives spread to fully cover arms and legs, down to feet/toes and hands"; DECREASED APPETITE (non-serious) with onset Oct2022, outcome "recovering", described as "loss of appetite"; FATIGUE (non-serious) with onset Oct2022, outcome "recovering", described as "tired/Days 4-9 fatigue". The events "days 1-3 headachy", "tired/days 4-9 fatigue", "loss of appetite" and "hives/by end of day 10, hives have moved up and down body, particularly arms and legs. day 11 hives spread to fully cover arms and legs, down to feet/toes and hands" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, fatigue, decreased appetite, urticaria.
Breakthrough case admission after 3 vaccines Moderna 3/13/21 Lot# 002B21A;  Moderna 4/0/21 Lot# 025B21A;  Moderna 10/27/21 Lot# 032F21A
First Day complaint of aching arms, light head ache. on the 19th second day she said she did not feel very well, tired, by the evening noticed she was a little disoriented, by 10pm she was in bed my sister checked on her as she got worst called ambulance and she had a stroke right before paramedics got there.
pt recvd vax & Theophylline level was 16.1 5OCT93; on 8OCT93 pt was adm to hosp; Theophylline level was 25.6 & pt had nausea & vomiting beginning on the day prior to vax & cont; EEG suggested sinus tachycardia;
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form once a week. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and event onset date was not provided. Patient received 3 doses of mRNA-1273 vaccine on unknown dates. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. On unknown date, patient received Adalimumab which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and event onset date was not provided. Patient received 3 doses of mRNA-1273 vaccine on unknown dates. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. On unknown date, patient received Adalimumab which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I developed a ringing in my ears 2 days after receiving the first dose. It's a loud pitch constant ring but it's not that loud.
Swollen lymph nodes on the left armpit  appeared few days after 1st vaccine and disappeared after few weeks. Ear ringing ( Tinnitus)  appeared after 2nd dose. I never had ear ringing before getting Covid vaccine. Strongly suspect the ear ringing is related with Pfizer vaccine. Ear ringing disappeared after few weeks but it reappear whenever I feel tired.
maculopapular rash that began on abd & spread to entire body 2 days p/vax;
Varicella breakthrough. Had 2 doses of VARIVAX (3/21/05 & 8/28/09). Seen in our office with > 50 vesicles. Diagnosed with Varicella on 8/23/10.
During monitoring period post Pfizer COVID-19 vaccine #2 , pt experienced lightheadedness, dizziness, sweating, blurry vision. Assessment: 94, 108/64, 98% oxygen saturation. Patient legs elevated. Patient given orange juice. Patient alert  X 3, no signs of allergic reaction noted. Patient states "feeling better, no more blurred vision. Patient was left ambulatory to home
Vaccination administration error occured - no adverse event at this time.  Pfizer Bivalent Booster vaccine 12yr+ was given to  5yr. Office setting unaware of seperate vial for ages 5-11yr for Bivalent booster.
Tested positive for COVID 4/29/21. Had exposure to a friend who tested positive 4/24. Remains asymptomatic. Completed COVID vaccine series 3/30/21. Also COVID positive 10/28/20 and had positive antibody testing 1/20/21.
Pain all over my body, especially in spine and head. Slept for 21 hours. Only got up to eat small amounts. Was nauseous with little appetite.
Pediarix vaccine trasported to clinic in portable cooler. A vaccine excursion occurred with the portable cooler. The temperature on the portable cooler went out of range based on GlaxoSmithkline manufacturer recommendations. The portable cooler reconditioned and Pediarix vaccine admistered to patient. Manufacturer conatcted by representative. Per the Health Department they were advised by GlaxoSmithKline that the Pediaxrix vaccine was not viable and the patient needed to be revaccinated.
1st wk p/inject c/o constant pain rt shoulder both w/ & w/o movement; pain woke pt up @ noc; 2nd wk pain worse; pain radiated down to wrist area; 1DEC92 c/o soreness in muscle, joint & forearm w/movement;
Information has been received from a licensed practical nurse concerning a 9 year old white female who on 25-Aug-2004 was vaccinated SQ with VARIVAX (Oka/Merck) (lot# 64854/0195P), MMR II (MSD), subcutaneous, (Lot# 646886/0949N) and DTAP (Unspecified) IM "reported as manufacturer by Merck" (lot #U272DB). The nurse reported that on 08-Jun-2008 the patient experienced red papules-arms, legs and trunk, less than 50, which was reported by the patient's mother. On 11-Jun-2008 the patient recovered. Additional information is expected.
Generalized red measle like rash over entire body appeared 10 days after receiving vaccines.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that a patient was administered the first dose in GARDASIL (dose, lot #, expiration date and route for all doses not reported) series on an unspecified date in September 2012, the second dose in series on an unspecified date in November 2012 and was in the provider's office on 10-DEC-2013 for administration of the third dose in series. No adverse events were reported. Additional information has been requested.
Rash (patchy, about 6-10 raised sores, looks like acne but is not, resembles rash reported with active covid infection though I have not been infected in the past), itching and warm to touch