chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received AFLURIA (Lot # T59406) in her left upper arm on the morning of 10/2/14 (both the patient and the vaccinator were standing). She was in her normal state of health at the time. The patient is left hand dominant. The patient immediately noted "that something felt different" in that the vaccination site "hurt more than normal". She noted a "stinging/burning" pain (6/10) in her left upper arm while waiting in the clinic during the 15 minute period of observation. The patient took 800mg MOTRIN in later in the day without improvement. Over the next 72 hours the patient noted intermittent "soreness" (6/10) of her left upper and left shoulder. This pain increased with writing, driving and was worse in the am and at night while sleeping with some improvement during the course of the day. The patient denied having numbness, tingling of the shoulder/arm/hands/fingers, decreased ROM or weakness of her left upper extremity. The patient was seen on 10/7/14 by her PCM for a history (over 10 month) of right shoulder pain with radiculopathy. An MRI of the cervical spine (done 1/13/14) should: multilevel degenerative disc disease, worse at C5/C6 with mild/moderate bilateral neural foraminal narrowing. The right shoulder pain was treated with Gabapentin tid, neck pillow and PT. At that time the patient continued to have intermittent pain in her left upper arm/shoulder which was worse when writing, driving and sleeping but she did not mention this at the appointment. On 11/12/14 the patient was seen by her PCM for complaints of left shoulder and left upper arm pain, decreased strength and decreased ROM (the patient stated that she had pain and difficulty with lifting her arm above her head; washing her hair and internal rotation--hooking her bra). The patient denies a history of trauma to her left shoulder or neck. Labs were drawn for CRP, CK (both normal) and ESR (slightly elevated at 28). The patient was prescribed LIDODERM patches which did improve the pain. Physical therapy was ordered at this appointment but was not started until 1/9/15. Prior to her first PT appointment the patient had noted improvement in her ROM (she was able to reach above her head). At the time of her appointment the patient reports much improvement (pain 0-1/10 and that she can drive and wash/comb her hair without left arm/shoulder pain; she is experiencing minimal discomfort with writing and that she is able to hook/unhook her bra with some discomfort).
fell asleep; tired; Didn't roll over or even move; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Lot number: ET7534) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EN6208, When I initially got your vaccine 1st shot I did not feel anything, my arm did not hurt, nothing hurt I felt great.), administration date: 29Mar2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 19Apr2021, outcome "recovered" (Apr2021), described as "fell asleep"; FATIGUE (non-serious) with onset 19Apr2021, outcome "recovered" (Apr2021), described as "tired"; HYPOKINESIA (non-serious) with onset 19Apr2021, outcome "recovered" (20Apr2021), described as "Didn't roll over or even move". Additional information: Reporter had received two doses of the Pfizer COVID vaccine and she reported that, it was almost a benefit, after her 2nd dose she slept through the night and then she slept for about 12 hours and that is unusual for her. The caller had a good night sleep which is unusual for her. She also mentioned her friend who is immunocompromised and a female had received two doses of the Pfizer COVID vaccine and ended up getting COVID. Reporter was clarifies and says that she actually does usually sleep good she had slept through the night which was the perfect scenario for her. She usually goes to sleep around 11:00 PM and usually wake up to her alarm around 7:00 AM to 7:30 AM. She was tired around 9:00 that night that she had her COVID vaccine and when her head hit the pillow she didn't roll over or even move until 9:30 AM. She guesses that if this would of been in the daytime her side effect would of been tiredness. When she woke up that morning her husband was installing windows and she helped him with that that morning and actually for her with the timeframe for the tiredness it was a terrific night's sleep. Now, if her tiredness had been at 9:00 AM then maybe she would of slept the whole day away. Her only side effect was being tired and then she slept. If that would of happened at a different timeframe then maybe she would of slept the day away but it happened through the night. She says she was usually not good at surveys. Her 2nd dose was 19Apr2021 and so this would of been on the night of 19Apr2021 and it was only for that one night. Caller declined to complete a report on her friend, she says she will just leave it with the information that she provided. All of it is a little personal and she will just leave the report he way it is. Follow-up attempts are completed. No further information is expected.
3 mild reactions to report.  1 - A little over 24 hours after vaccine, my ankles were extremely swollen.  I elevated over the next 24 hours frequently an swelling went away.  2 - On Friday, March 26, swollen glands under my left armpit (shot received in left arm), swelling is completely gone as of 3/29.  3 - the evening of 3/28/21 I became itchy on my scalp, arms and back.  I have showered and applied lotion and have not introduced anything new to my routine which is why I believe it may be shot related and worth mentioning.  The intensity is mild but if it persists or worsens I will contact my doctor.
My extremities were numb and tingling and I could not stand without falling over.; I was unable to shower or work; I lost balance to the point of feeling like vertigo for 9 days; I lost balance to the point of feeling like vertigo for 9 days; My extremities were numb and tingling and I could not stand without falling over.; My extremities were numb and tingling and I could not stand without falling over.; scared; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received first dose of bnt162B2(PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302) via unspecified route of administration on Left arm on May2021 (at 52-years of age) as Dose 1, single for COVID-19 immunization. Medical history included allergies to tomatoes, allergies to many antibiotics (unspecified) and Possibly Covid in autumn of 2020, hair fell out in chunks & had a skin rash, had a terrible time sleeping because of nervousness. She didn't have respiratory issues but in hindsight think it may have been Covid. The patient has not received any other vaccine in four weeks. The patient has not received other medications in two weeks. Device timestamp was reported as 06Jul2021. Concomitant medications were not reported. Known allergies included many antibiotics, tomatoes. No Covid prior vaccination nor post vaccination reported. No other vaccine administered in four weeks and other medications in two weeks. It was reported that "I lost balance to the point of feeling like vertigo for 9 days. My extremities were numb and tingling and I could not stand without falling over. This was after the 1st dose and I am too scared to take the 2nd dose. I was unable to shower or work and want to know what to do about a 2nd vaccination". No treatment received for AE's. Outcome of the event was recovered on 2021.  Information about lot/batch number has been requested.
She woke up with a rash all over her face yesterday; it looks like her face has been burnt and it's very uncomfortable; This is a spontaneous report from Pfizer Sponsored Program. A contactable female consumer(patient) received first dose of (PFIZER COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient reported, she received her first dose 3 days ago. She woke up with a rash all over her face yesterday. It is even more intense today. It looks like her face has been burnt and its very uncomfortable. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
upper right quadrant pain; prominent immature granulocytes; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 23Apr2021 at 17:45 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and penicillin allergy. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 26Apr2021 the patient experienced upper right quadrant pain. The patient had to go to the ER because of a upper right quadrant pain. Some studies were conducted which included (Blood, XRAY, CT Scan) and told that the patient had prominent immature granulocytes and some markings on my lungs which the patient had never before. The patient needed to know if this can be a consequence of the vaccine as it was the only thing different that she had done and  had never been mentioned any of this condition before this vaccine. The event resulted in emergency room/department or urgent care.  On 26Apr2021, the patient underwent blood test, CT scan and XRAY and the results were prominent immature granulocytes and some markings on her lungs which the patient never had before. On 11May2021, the patient underwent nasal swab and the result was negative. Therapeutic measures were unknown whether taken as a result of the event. The clinical outcome of the events upper right quadrant pain was not recovered at the time of this report.
Patient broke out in hives on 11/21/15 after MMR and Varicella given on 11/18/15. Influenza PF also given on 11/18/15. (12 months).
9/3/2022 I woke up nauseous and dizzy. I had to crawl to the bathroom. I was so dizzy I could not hold myself up right. The nausea continued throughout the day. We called a healthcare service and had a nurse come to our house. I was given meclizine and ondansetron for the nausea and dizziness. I was also prescribed an antibiotic, can't remember the name. This did not go away. The next evening, I went to the emergency room. The diagnosis at first was a middle ear infection. The doctor on duty could not see a sign of a middle ear infection. I was admitted to the hospital for five days. I was diagnosed with Labyrinthitis. It had damaged, permanently, some nerves in my inner ear that connect to my brain stem. After I was discharged, I saw my doctor and she referred me to an ENT doctor. My PCP told me to not have another COVID 19 or Flu vaccine for several weeks. After I went to the ENT doctor, he said I did have Labyrinthitis, probably caused by a virus rather than bacteria. I had some permanent hearing loss as well. I have been in vestibular rehab therapy helping me learn to retrain part of the brain. It affects my balance and my vision.
Symptoms: Headache, Fever, Nausea, Body Aches, Fatigue, Cold Chills, Soreness in arm and injection site
Significant swelling, redness, erythema, pain of left upper arm to elbow - lasting 6 days.  After resolution, depression remains in muscle of upper left arm.  Symptomatic treatment, only.
When the patient came to the pharmacy today, the patient had a 3-4 inch in diameter red spot, circular in shape, slightly sore, and not itchy. The patient wasn't experiencing any other reactions.
Me to / Thought I was well protected. Wrong!!!!!/ Suspected Vaccination Failure; Me to / Thought I was well protected. Wrong!!!!!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles and thought was well protected after receiving vaccine but was wrong. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case has been linked with the case US2021AMR063266, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063266:Same reporter.
potentially fatigue/fever; potentially fatigue/fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "motion sickness, hurt ankle (see previous AER for this), unsure if wears contact lenses" (unspecified if ongoing), notes: Known allergies: Unsure; "motion sickness, hurt ankle (see previous AER for this), unsure if wears contact lenses" (unspecified if ongoing), notes: Known allergies: Unsure. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "potentially fatigue/fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.In the attached report, you stated that you aware of (patient initial) first dose adverse event before you started at Pfizer. Per clarification email from colleagues, if the reporter was not a Pfizer colleague at the onset of the event, they would clarify the date of their first Pfizer awareness, Pfizer awareness date should be this reporter's  training completion date. Hence for the first dose adverse event, the awareness date should be the date you firstly completed training. Could you help to confirm when you firstly completed  training.The patient receive any other vaccines within four weeks prior to the vaccination was unknown reported. List of any other medications the patient received within 2 weeks of vaccination: unsure - potentially birth control but cannot confirm for sure  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient fainted/fell off the chair after getting the vaccination. He gained consciousness right after. Pharmacist called EMT, then stayed with patient. She also checked his blood pressure and gave him water. EMT came a few minutes later and brought him to the hospital.
This serious case was received on 26 March 2009 from another manufacturer. The initial reporter was the consumer's spouse. A male patient received a Tetanus vaccine (manufacturer and lot number not reported) on an unspecified date. Post vaccination the patient experienced anaphylactic shock. The reporter was not able to provide any other information. List of Documents held by Sender: None.
About 5 hours after the flu shot, my eyelids and the bridge of my nose started to swell. I suspect the vaccine caused a flare up of IGg4 related disease but it could just be a coincidence.
This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 17-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Pt reports arm was sore the day after injection- about 2 weeks later soreness worsened. Went to Urgent Care who Rx'd an anti-inflammatory. Not much help-saw her PCP at home- ordered Prednisone and an x-ray of Left arm-results were normal. Arm pain continued and on 12/6/21 she woke up with arm numbness. Her home PCP ordered an MRI that she will have done in 1-2 weeks.
Mixed series. PT received a dose of Moderna on 4/22/2021 and a dose of Pfizer 5/20/2021
About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned  - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg  - twice a day
Body chills; Body aches; Blindness; Septic shock due to serratia infection (not sure how the infection came to be); Septic shock due to serratia infection (not sure how the infection came to be); Kidney failure; This is a spontaneous report from a non-contactable consumer.    A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 (Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included type 2 diabetes, stage 4 kidney disease, high blood pressure. Concomitant medications included unspecified drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. On 14Feb2021, the patient experienced body chills, body aches, blindness, septic shock due to serratia infection (not sure how the infection came to be), kidney failure. The events required a visit to the emergency room. No treatment required. The patient was hospitalized due to the events for 18 days and condition was life threatening. The final outcome was fatal. The patient died on 06Mar2021. An autopsy was not performed. Cause of death was septic shock.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Septic shock
pt recv vax 7NOV96 & 18MAR97 pt indicated failed to seroconvert;varicella zoster IgG level was 0.55;
This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the fifth of eight reports. A patient of unspecified age, ethnicity and gender received TRUMENBA via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
Fever; Headache; Nausea; Chills; Cold sweats; Body ache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 03Apr2021 at 04:00, the patient experienced fever, headache, nausea, chills, cold sweats, body ache and diarrhea. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, headache, nausea, chills, cold sweats, body ache and diarrhea was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Swollen and painful axillary lymph nodes- swollen to size of a quarter. Muscle weakness and loss of mobility in vaccinated arm. Joint pain. Shooting pain. Spinal pain.
Pt recv vax on 12/14/98; on same day pt exp fever(103.2), swelling at vax site; tx=Tylenol
Expired vaccine was administered.   Contacted Moderna. Waiting for Lot analysis from Moderna.
After vaccination I got sore left arm and pain in right breast. Pain in arm stopped after few days. Pain in breast didn't go away, Started around nipple and now all right chest. Intensity is 3 on the scale 1-10
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211014509, 20211015239, 20211015303 and 20211014279.
Breakthrough case admission after 5 vaccines Moderna 3/23/21 Lot# 045A21A;  Moderna 4/20/21 LOt# 016B21A;  Moderna 11/16/21 Lot# FH8028;  Moderna 4/21/22 Lot# 083J21A;  MOderna 10/24/22 Lot# 060F22A