chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Worst headache; bad bodyaches; fever; puffy face; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 23Mar2021 at 18:15 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to the vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medication included thyroid (ARMOUR THYROID) for unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. On 24Mar2021, the patient experienced worst headache, bad body aches, fever and puffy face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event worst headache, bad body aches, fever and puffy face were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Regurgitation & vomited x 2 awaken out of sound sleep; muscle stiffness, neck-back; h/a, fever, chills, sweats, ears sensitive to noise; tx ASA for h/a;
PT IS A BREAKTHROUGH CASE OF COVID-19. PT EXPIRED ON 8/24/2021.
hives, rash, urticaria, no treatment needed, will speak to provider to determine if a second dose should be provided
In the first three hours there was pain in injection site, which disseminated to the hole upper left arm. The pain limited movement and worsened at night. After three days the pain was gone
I woke up on Friday, April 2nd with severe Vertigo issues (side spins), couldn't get out of bed without the help of my husband. I have been dealing with Vertigo issues ever since and today is May 31st. I have been seeing a physical therapist as well as one visit to my regular doctor and one to a nurse practitioner. I have been given a week long series of steroids and that hasn't helped yet. Since receiving the  vaccine  I have had maybe 3-4 days where I felt somewhat like how I felt before getting the second dose of the vaccine. Up until getting the 2nd dose of the vaccine I NEVER had any symptoms of Vertigo before.  A lot of my issues are on the right side of my body which is the same side I received my 2nd dose ( right arm).
Pt states she developed redness and swelling 4 days after injection. Pt did seek care at PCP office but no treatment was given.
On this date two immunizations were given.  There was no reaction from the Influenza in the left arm.  The reaction came in the right arm from the Pneumococcal vaccine.  The area around the injection site (on the right arm) became very swollen, very red and very hot and extremely painful to touch.   Patient had mild fever.  By 10/06 the area had formed a very large blister (size of a dime) and had many smaller blisters around it.  This lasted for almost two weeks, although redness, pain and swelling went down within a week and a half.  By 10/18/2013 the blisters had resolved, scabbed and the scab had fallen off.
p/vax pt lt arm @ inj site became hot, red & swollen;pt was seen in ER on 5/19/99 & told has an abscess;tx w/ATB by MD;adm to hosp dx cellulitis;pt missed a month of work;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "breast cancer diagnosis Feb2022, stage 1a", start date: Feb2022 (unspecified if ongoing), notes: breast cancer diagnosis Feb2022, stage 1a. The patient's concomitant medications were not reported. Past drug history included: Statins, reaction(s): "Known allergies: statins", notes: Known allergies: statins. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 28Apr2022, outcome "not recovered" and all described as "tested positive for Covid on 28Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive, notes: tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. I developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022; (09May2022) Negative, notes: tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. I developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022; (14May2022) Positive, notes: tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. I developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022; (16May2022) Positive, notes: tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. I developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022. Therapeutic measures were taken as a result of drug ineffective, Covid-19. It was unknown whether patient received other medication in two weeks. Vaccine lot number were also not available. Patient tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. Patient developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
p/recv vax on 10/9/98 pt inadvertently recv another inj on 10/22/98 of Pnu-Imune-23 & on 10/23 devel inj site rxn of redness 7 sl swelling
Itchy rash started over waist spreading downward then up trunk. Resolved w/ Benadryl 25mg IM and PO Benadryl.
swelling of lower lip and other parts of face; swelling of lower lip and other parts of face; This is a spontaneous report received from a contactable consumer or other non hcp. A 81-years-old  non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration in Arm Left on 19Jan2021 10:00 (Batch/Lot Number: ELI283) as single dose for covid-19 immunisation. The patient medical history included hypertension, arthritis, vertigo from an unknown date and unknown if ongoing. The patient had allergies to medications, food, or other products with Codeine, Z-pak, some Sulfa drugs. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and, zithromax z-pack and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swelling of lower lip and, swelling of face on 20Jan2021 03:00 primarily noticeable to me and others who know me. Otherwise, not particularly noticeable .The patient visited  Emergency room/department or urgent care for the event.Outcome of the event unknown.   Follow-up attempts completed. No further information expected.
ARM STILL HURTING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced arm still hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still hurting. This report was non-serious.
pain at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in roughly 1949 patient who received HBV (Engerix B 10 mcg) for prophylaxis.  On an unknown date, the patient received Engerix B 10 mcg 10 mg. On an unknown date, less than a year after receiving Engerix B 10 mcg, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Engerix B 10 mcg.  Additional details were provided as follows: The age at vaccination was not applicable. reported. The nurse reported that during the last year the patient had pain at injection site. The reporter did not agree to follow up.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K020215 with expiration date 15-MAY-2016, dose, dose# and route unknown). No symptoms reported. The vaccines were stored under 9 C for 1 hour and 15 minutes without previous temperature excursion. No doses were administered past labeled expiry. This is one of several reports received from the same source. Additional information has been requested.
Pt phoned Saturday afternoon said they had received a pneumonia vaccine on 10/14/05. Area where vaccine was given red and sore mildly inflamed. Told pt to use ice and either Tylenol or Ibuprofen. If inflammation becomes worse or developed other symptoms contact doctor.
I was feeling fatigued, I had a very powerful headache, sensitivity to light, sound, I had a low-grade fever of 101F for a couple of days, I had flu type symptoms, chills. Three days of feeling like blah, but functional. I did take a home COVID-19 test that came back positive, I called my doctor, to have a telehealth visit. I was not given the antiviral medication. I was able to get over this within six or seven days. I do feel that since getting over this I have lingering fatigue.
note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was worrisome in case of side effects.  dizzy first day, chills, fast heart. Everyday so far feel off and on tired, dry mouth off and on, dehydrated?  Felt tired within an hour of injection on Tuesday.  I don't remember if my stomach was growling on the first night on the day I got injected and I just went to bed.  The next morning I woke up really thirsty/hungry and tired. I slowly made myself breakfast. Sat down to eat on a stool and felt dizzy. My heart raced for 30 sec as I carefully made my way to the flow to be safe. I had the chills, a bit shaky for a short period. I called my doc who told me to stay hydrated. The clinic where I got injected DID NOT inform me about dehydration. As of today, I still have off and on a dry mouth, feel more of an empty stomach at meal time, tired off and on, and maybe dehydrated. I work from home so I am not pushing myself. I have not felt dizzy again and am decent at taking in water now.
Patient presented with redness, warmness and itching at injection site. Noted 2 blisters also present, not directly on but around injection site swelling. Tx included BENADRYL for itching and ice at least 3x daily. F/u if no improvement.
Fatigue, headache, body/joint pain that lasted three weeks and one day. Managed pain with Tylenol 500x2 twice a day.  Tested positive for COVID on 12/11 with mild symptoms that lasted few days. By day 14, I was negative.
Within 30 minutes client developed rash on chest and upper arms. Client treated self with Benadryl and symptoms resolved during monitoring period.
Shortness of Breath for few days after vaccine #1; after vaccine #2 shortness of breath increased along 10 day period, so I contacted PCP. Clinical exam, chest xray, blood work resulted D-Dimer level increase, so CT scan ordered. Result was lungs full of PE. Placed on Eliquis and referred to hematologist. Hematologist ordered deeper dive in blood work as well as echocardiogram, which displayed a widening in aortic root and ascending aorta, but no ventricular or valve damage. Dr. will continue to monitor and refer me to cardiologist. Other symptoms include unprovoked fatigue, some shortness of breath, a strange smell of burning plastic and cramping of the upper part of my feet, only at night. Never tested posit  positive for COVID with wife and son both had "undocumented" COVID in January and March 2020. They both have antibodies (confirmed with blood testing) and I did not have antibodies. Our physician would not authorize a test for COVID at the time of their symptoms as tests were so coveted and not authorized widely at the times of their illnesses. I really want someone to come forward and confirm the causation and correlation of my symptoms to the vaccine, because I am otherwise an extremely health and active 64 year old with no preexisting or predisposed conditions to widespread PE...not just a clot or two...it is wide spread throughout all lobes of my lungs!
Felt lethargic (aprox. 1 hour after shot) went home fell asleep for about 2 hours and woke up severe pain in chest and tightening of chest and airway and could only get about half at most of a full breath of air every breath. Could only get sufficient O2 it seemed when lying on back and laying down on my side. Was every bit of all my energy to just take a shower and nearly blacked out with heart racing as I tried to breath in the shower but steam in air was too much to breathe.  Lasted for 4 days that way.  I still feel like I am constantly winded and I as of today have only regained about half the lung capacity I had prior to incident, and that is just over 1 month mark. I also now have been getting these bad facial breakouts particularly on and around my nose and forehead /;eyes area. I never ever had any acne issues to speak of prior, even as a teen and during puberty. Never had any acne ever and now its bad breakouts some appear to may even leave ling term scarring in certain spots. My day to day diet and normal habits have not been added to or altered in any way either. My heart feels like it beats twice as fast and twice as hard now and I am always short of breath now too. I do not have a family doctor to go and see and I was afraid to call for an e.m.t. or go to the e.r. at the early onset of it all. I truly hought I was a gonner a couple of times though throughout the first 4 days.
on post vaccine day #9 pt developed light bruising r antecubital [vaccine was l deltoid] and knots. she has had ongoing mild nontraumatic bruising here and sq nodular lesions ? clot. pt also has had generalized malaise and some mild shortness of breath with this and has generally felt sick.
Painful and shingle-like reaction. Throbbing pain down the neck and left shoulder. Symptoms persist almost 14 days after vaccine completion.
Pt to ED on 9/14 and dx'd with DVT  Pt. discharged home on Xarelto
Headache, Myalgia, Fever and fatigue Narrative:  Other Relevant History:
Chronic digestive issues including constipation and diarrhea; feces black; all occurred for 4 weeks. Menstrual cycle was halted for 2 months from the first dose on 5/12. Elevated skin bump on middle of chest akin to a mole appeared five days after second dose (6/8) where there was nothing previously; it was frozen/removed by a dermatologist.
Patient is a 54 y.o. female who is a patient of MD with significant medical history of GERD, migraines, anxiety and depression, now presented with shortness of breath.   Community-acquired bacterial pneumonia Sepsis POA? RR 25, leukocytosis 18 K Suggested by chest imaging, negative COVID-19 testing, and white blood cell count with left shift.  Started on Rocephin, azithromycin on admission, continued Follow Blood cultures, pneumonia urine antigens neg IV fluid resuscitation Discharge on Azithromycin to complete 5 days, Omnicef to complete 7 days   Acute kidney injury, resolved Creatinine 1.2 on admission Likely related to above Creatinine normalized with IV fluid resuscitation   Hypokalemia Replaced Monitor and continue to replace as needed   Migraine disorder Continue home as needed Imitrex. Patient had been on Topamax in the past, but was taken off of it by her doctors remotely.   GERD History of peptic ulcer disease Continue home omeprazole.   Anxiety and depression Continue home Wellbutrin, Abilify, Prozac and as needed Xanax.   Tobacco abuse Cessation strongly encouraged and advised NRT while inpatient
Arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid 19 with an associated reaction of pain in extremity.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR094579   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had arm hurt both times much worse and longer than the Covid shots. Additional Supportive Information: For the tolerance of 2nd dose, refer linked case US2022AMR094579.  The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094579:Same reporter
Second dose of shingles vaccine for both my wife and me. First dose was on March 19, 2019. Both my wife and I are experiencing aching muscles everywhere, tired, fatigued, headaches and fevers. Feels like we were run over by a truck. My wife also had jabs of pain in her joints. She normally gets out of bed at 5am but didn't do so this morning until noon. We have been lying around doing nothing all day. Neither of us would be able to work or go anywhere, though luckily its Saturday and we can just rest at home. Though we did get both written and verbal notice of these sorts of side effects, they are WAY more severe than we were led to believe.
Dizzy, no balance, could not hold down any food, starting 2 hrs after shot, lasting 4 days, ears still ring.
Pt recvd vax & on the same day as the vax pt exp abdo cramps, h/a, nausea, vomiting, & diarrhea; sx persisted for 2 days; No further details were provided;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: Pt had anxiety about 30 minutes after dose. said \"he just needs some air\". EKG taken by EMT was normal. Did ortho stats and he was tilting and dehydrated. he takes HCTZ and does not like urinating often so does not drink much. HR was in 130s but after giving two glasses of water patient was fine and HR was down in 90s. He is diabetic and BS 236. Had just eaten.
Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift
PT began feeling tingling in left arm around 5min after injection. she complains of numbness. pt was given Benadryl 50mg
Had cough, runny nose, congestion, low grade fever about 6 hours after flu shot on 01-09-2013.
information has been received from a physician concerning an approximately 67 year old male who was vaccinated with a 0.65 ml dose of ZOSTAVAX. It was reported that about 2 weeks after vaccination, the patient developed a rash as a two spots on the inner thigh. The physician suspected it as shingles but was not sure. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Shortness of breath, migraine, nausea, dizziness, severe pain in arm that got flu shot.
Dose # 3 given, pt discharged, came back and reported tongue swelling, scratchy throat, voice changes, tight throat and difficulty swallowing, sent to ER, and treated for anaphylaxis.
Information has been received concerning a pt who was vaccinated on 12/31/96 with varicella vaccine. On 06/20/00 the pt experienced a good case of chickenpox with lots of lesions. Unspecified medical attention was sought. It was noted that the pt was afebrile.