chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of lack of coordination in a male patient who received FLULAVAL QUADRIVALENT (batch number 972F3, expiry date 13th June 2019) for prophylaxis. Concomitant products included ZOLOFT. On 6th September 2018, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 7th September 2018, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced lack of coordination, personality change, feeling abnormal, anxiety and irritability. On an unknown date, the outcome of the lack of coordination, personality change, feeling abnormal, anxiety and irritability were not recovered/not resolved. It was unknown if the reporter considered the lack of coordination, personality change, feeling abnormal, anxiety and irritability to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at the vaccination was not reported. The patient developed lack of focus, anxiety, crankiness, out of sorts feeling, and a personality shift the day after receiving the vaccine. The patient was not feeling better. Both health care professional and coworker were taking ZOLOFT and health care professional was concerned about potential drug interaction between ZOLOFT and the FLULAVAL. This was one of the 3 cases reported by the same reporter.
Pt states on 1/20/23 he received covid booster shot here at clinic.  Started to have itching, rash and urticaria same day,  Hot water showers helped, has taken 5 showers per day for past few days  Did not eat anything new, no new detergents, soaps. No food allergies, no medication changes 4 days after event, started taking OTC diphenhydramine, taking 50mg q4 hours. Urticaria has resolved, itching improved, rash resolved.
I had an odd menstrual cycle - the byproduct was a lot more clumpy and clotty than usual. I have typically been having regular cycles for the last few years (28 days), but this one occurred 14 days after the last ended (March 1), and 15 days before the next started (April 5). It lasted a typical amount of time (3 days). I have been feeling more tired than usual. Could be other factors.
area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep; area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep; area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep; area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case is linked to case 2022SA431439(CLUSTER).  This case involves a 76 years old female patient who developed an area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included prior to the vaccination she had got over the virus which was not Covid and that virus caused her not have a voice (Aphonia) (viral infection) in 2022 . She was 3 days post feeling better from the virus when she got the flu vaccine. It was also reported that always reported being tender at the injection site with getting her vaccinations such as flu vaccine in the past and also received Fluzone high dose Quadrivalent and had tenderness to the arm, the reaction was noted next night after the injection and the reaction had down. The patient's past medical treatment(s) and family history were not provided.    On 12-Oct-2022, the patient received a  dose of 0.7 ml once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , injection, with an unknown strength , (lot number and expiry date:  not reported) via intramuscular route in the left arm for immunization. Information regarding batch number has been requested  On the same day,  the patient developed a non-serious events of area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep (vaccination site erythema), (vaccination site swelling), (vaccination site pain), (vaccination site warmth), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.. The patient wanted to know  if it was a common side effect for the soreness to travel along the arm like that  since she received the shot in her upper arm , around the shoulder. The patient never had this reaction other than tenderness to the arm . These events lasted for 2 days.    Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Negative  Action taken : not applicable for all the events.  Corrective treatment: not reported for all the events  Outcome:  Recovered / Resolved on 14-Oct-2022 for all the events
I felt like I had a bad cold after receiving the vaccine and a sore arm for 24 hours. I started having symptoms of congestion, headache and sore throat. I tested positive for COVID-19 in 08/2022. I contacted my doctor, and I received an infusion to help with my symptoms. As of today, I have an ongoing cough, but I do feel better.
dizziness lightheaded after 5 minutes of the vaccine.drank water and felt better. 126/84, 74, 100% RA
Unable to move my arm higher than midway.  Shoulder/arm pain especially at night.  Tylenol doesn't work,  advil doesn't work.  Bio freeze eases the pain, tens unit eases the pain. I have had physical therapy...that temporarily eases the pa8n. But it has not went away.
Injection given @ 9:00 a.m. on 11/18/09. Pt called at 11:21 a.m. to say she had rash on arms. Red and blotchy. Chest, face, and belly itching. No breathing difficulties . Instructed to take BENADRYL 2 tabs Q 6-8 hrs (50mg). 11/19/09 9:05 a.m., rash gone, congested, sore throat. Continue BENADRYL, lots of water, warm salt water gargles.
The arm where I had the vaccine still feels sore at that place after all this time. While doing simple stretching my right arm feels normal while the left's muscles hurt and can't extend as usual.
Received 3rd Anthrax injection 26 Sep 08, right deltoid.  Next day injection site extremely red, inflamed, hot to touch, and painful with large raised knot.  In the evening of the next day, several small blisters appeared around injection site.  The second day several more blisters appeared all 1-3cm in size with increasing pain.
p/vax pt devel a fever & an inj site rxn characterized by redness & swelling approx 48hr post vax;
Dizziness & Myalgia Narrative: Dizziness on 11/1 and 11/2/21
I started getting a red dry itchy patch on my right side about a week and a half after my first shot, that's the only shot I ended up getting. I then got like more spots and began to have extremely breasts. I also got itchy spots under my arms and into my arm pits and onto my back. I was extremely itchy it woke me up in the middle of the night with the itchy red spots. I had a DRs appointment at the Clinic and my dermatologist said that it was very similar to what she was seeing on her other patients post vaccination. She put me on a strong round of Prednisone on 4/26/2021 as well as a steroid cream. She did biopsy of the rash. The prednisone helped the rash go away it worked very well, I was hoping that would be it then the rash came back with a vengeance. It was mostly around my breasts, under arms and on my back. It also sprung up on my feet as well at that point. I saw an Immunologist and he said he did not know if it was a COVID rash. They sent my biopsy all over the place to get thorough analysis. They said it was an allergic reaction of some kind. I did use a low allergen wash and detergent for my clothes. Another Dermatologist called me and brought me in, they decided it was very likely that it was psoriasis rosacea and likely from the COVID vaccine but could not track how long it takes to go away. I was advised against getting the second vaccine due to my reaction.
11-6-11 Fever/chills, myalgias, neck pain, H/A went to ED on 11-8-11 for evaluation, UTI, increased creat. prerenal (viral syndrome) 11-10-11 admitted to hospital after returned to the ED with acute renal failure/Flu vaccine stimulus for symptoms was indicated, Rx IVP, plasmapheresis, discharged 11-17-11.
Approx 10 minutes after receiving flu shot into left deltoid, began c/o strange sensations in left underarm and left breast. No resp Sx, no egg allergy. Denies pain. Likens sensation to engorgement with increased sensation of warmth.
At night on the day of vaccination, there was swelling, redness and pain at the site of injection, which continued for 10 days. On August 10, 2018 morning, when I woke up, I had a fever of 102.5 F which continued for 7 days. I took 2 tablets of Acetaminophen, 500 mg twice a day to control fever.  On December 1, 2018, while on a trip, I developed dry cough, fever and shortness of breath. I was given Acetaminophen to control fever, as needed, Azithromycin 500 mg for 5 days. On December 9, 2018, I was admitted to Emergency ward in the Hospital, with 73% oxygen saturation, fatigue, shortness of breath. X-ray showed severe damage to lungs and I was shifted to ICU where I was put on CPAP with 10 liters/minute oxygen. No bacterial infection or H1N1 flu were detected. However, I was given multiple antibiotics to treat for bacterial pneumonia and tamiflu to treat for pneumonia due to flu. None of these medicines improved my condition. Tests for malarial antigen, scrub typhus, leptospira, acid fast bacilli (tuberculosis), Pneumocystis carinii were negative. X-rays and CT scan taken during hospital stay showed sever damage to the lungs with fibrosis. A number of medicines were given with no benefit. I was started on 40 mg i/v methylprednisolone on December 13, 2018, increased to 1 g of methylprednisolone on December 17, 2018 for 3 days and bringing to 40 mg from December 20, 2018. Prednisolone continued until December 2019, when it was tapered down. On January 14, 2019, I was started with Azathioprine, 50 mg twice a day, which is still continuing. On February 1, 2019, I was discharged from the hospital with 24 hrs oxygen from a oxygen generator and taking prednisolone, 24 mg and Azathioprine 50 mg twice a day. On February 5, 2019, I cam back, was at the Hospital, on February 7, 2019 for 2 days due to shortness of breath. I consulted with a number of pulmonologists, including Dr who is currently treating me and pulmonologist.  I was diagnosed with Acute interstitial pneumonia leading to pulmonary fibrosis and type 1 respiratory failure at the hospital and Interstitial lung disease by the hospital, caused by a severe auto-immune reaction. I was enrolled for total lung transplant by the Hospital to which I refused due to personal reasons. I also consulted Rhematologist and Immunologist to rule out general autoimmune disease. None of the typical autoimmune factors came positive (ANA, dsDNA/ANCA all Negative). I believe that MPL and QS21 adjuvants present in Shingrix, produced high level of lipid A antibodies in my body after taking Shingrix Vaccine on August 9, 2018. MPL has been known to elicit antibodies against lipid A and presence of strong adjuvant QS 21 helped MPL to elicit very high levels of lipid A antibodies. There are a number of publications in 1990s that lipid A antibodies cross react with human muscles. These lipid A antibodies elicited a very strong inflammatory immune reactions in December 2018, about 4 months after taking the Shingrix vaccine and destroyed my lungs.  Due to the severe reactions, I did not take 2nd dose of Shingrix vaccine.
Extreme irritability & unusual crying & squealing night of vaccination & next day. Following day hives across entire body that would fade & come back. Next day, hives spreading to face & other new areas.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 85-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 20th August 2018). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient got their 1st dose of SHINGRIX and did not have a headache with the first dose. The pharmacist stated that a patient got their 2nd dose of Shingrix and had a severe headache since receiving SHINGRIX that was still ongoing at the time of reporting. The patient went to emergency room (ER) and they did a CAT Scan which was normal. The healthcare professional (HCP) did not know if the patient was given any medication to treat her. The severe headache started after the 2nd dose of SHINGRIX. The reporter consented to follow up.
This reaction started 4 days ago. Localized reaction to the R thigh. Raised, red, swollen area 80x110cm. It is warm to the touch and pruritic.
Developed firm lumps at all injection sites, then redness/eyrthema developed on left thigh. "Favoring" leg and irritable. Examination on 02/18/05, induration/lump approximately 2.5 cm with approximately 1cm of overlaying erythema and some tenderness. Treated with Keflex.
The pt experienced inconsolable crying from 9:00 am to 3:30 pm, and erythema at the injection site on left thigh.
R sided facial numbness approx 30 mins after vaccine. R lip felt swole/big then R lower face. I took 1/2 Benadryl after.
She developed inflammation at site of the ZOSTAVAX injection. Initially, it was the size of a half-dollar. On 9-22-13, when she called me it was only quarter-sized. She reported throbbing pain in her right arm. She also had headache, nausea, and a feeling of lightheadedness.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 30-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, subcutaneous, 0.5ml). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
very sick; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she has been feeling very sick since the first vaccine dose. The patient wanted to know if she needs to take the second dose of the vaccine since she is having reaction from the first. The event outcome was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 29SEP97 12:30PM & @ 930PM 30SEP97 pt noticed cheeks were red;then noticed rash on arms & legs;p/undressing pt noticed rash was all over body;no fever, nausea, or other sx;
Patient was given vaccine noted to have warm/hot flashes at 1405. Noted at 15 minutes post injection feeling warmer and noted elevated blood pressure. CRNP came to evaluate and orders given for 650mg po. Given at 1420. Patient monitored for 30 minutes post Tylenol. Patient advised to see Primary care for elevated blood pressure. Noted at time she left no longer feeing warm and no more perspirations noted. Team will follow up tomorrow with condition update.   - Per RN
Itching, hives, severe discomfort.  Dermographia as hives subsided. Sever swelling bilateral wrusts and the forearm for days. Esophageal/pharynx? spasm like heartburn/something blocking swallowing , hiccups(especially at night)..
It was itchy like hives but looked like measles; broke out in a rash on trunk that quickly spread from chin to toes that evening; It was itchy like hives but looked like measles.; It was itchy like hives but looked like measles.; left eye swelled shut and was itchy and red; left eye swelled shut and was itchy and red; left eye swelled shut and was itchy and red; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 43-year-old female patient (no Pregnancy at time of Vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 at the age of 43 years old (Lot Number: ER8730) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient never had allergic reaction before. On 08Apr2021 (day 9 post vaccine), the patient's left eye swelled shut and was itchy and red. She assumed she had pink eye and was treated accordingly. It did not go away. On 15Apr2021 (Day 16), she broke out in a rash on trunk that quickly spread from chin to toes that evening. It was itchy like hives but looked like measles. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Eye drops and steroid creams and antihistamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
Case number PHHY2011US25117, is an initial spontaneous report from a consumer received on 25 Mar 2011. This report refers to a 67-year-old female patient. She was vaccinated with FLUVIRIN (seasonal influenza virus vaccine, batch number 89973) on an unspecified date in 2008. Approximately eight weeks after vaccination, she was diagnosed with the worst case of Gullain Barre Syndrome variant, a type of Miller Fisher, the university had ever seen. Every organ in her body shut down. Her autonomic nervous system was involved as well as she had serious cardiac complications. As corrective treatment, intravenous immunoglobulin (IVIG) was started. She suffered from two strokes at fifth day since starting of IVIG. Two years later, she had been completely paralyzed and wheel chair/bed bound. She was legally blind and could not stand, sit up, feed herself, toilet herself. The patient needed 24 hour care and had no life. Final event outcome was not reported.
Entire body is sensitive to movement in a negative way. Like extreme dehydration. Yet I drank over 1 gallon of water yesterday. No energy, not able to get comfortable in any position. Tylenol helps a little.
Moderna given to patient (14 yo) not indicated for <18. Discovered upon arrival for 2nd shot on 1/7/2022. Pfizer given for second dose.
Presented with increasing sob .  Patient was recently d/c from the inpatient service after being admitted for COVID. Was d/c on on steroids, abx and elliquis. Had gone home on O2 but had been increasing it herself. Her breathing continued to get worse so she came to the ER. She is having a hard time ambulating without worsening breathing. She is also having fevers. ID was consulted in the ER and concern for cytokine storm as inflammatory markers going up. Out of window for remdesevir.
High fever AM/PM that night also (6m later high fever); high pitched cry in sleep PM and AM; restless; hyperactive, severe ADHD; Staring spells; not smiling; rash; paleness; weakness; anemia; auditory processing disorder; visual processing disorder; allergies; developmental delays; dyslexia; stuttering.
12 hours after vaccination pt began woke from a fitful sleep.  Pt was unconsolable.  Child was running a fever of 101 rectally.  Next day child was running fever of 103 and was very destraught.  I called the Dr's office, hours later did not get a call back.  Called again at 5 pm and explained that child was running high fever and was unusualy cranky.  Was adviced to go to after hours clinic.  Child was seen my Dr at after hour clinic.  Dr stated ear, and throat were clear.  There was some clear nasal discharge.  Pt had 101.1 fever at that time, axillary.  Advised to monitor child closely and get a CBC done the next day.  Took child for blood draw and called the doctor later in the day to see if a cbc had been done on the date of the vaccinations.  Doctor called back and spoke to my husband.  He was not sure if she said that a cbc was taken at the office or not.  Doctor advised she would try to get the results of the cbc done today.  She did not call back.  At 5 pm I called the office, they had just closed.  At 5:01 I paged the Dr.  The doctor called back.  I advised her that pt was still out of sorts and running a fever of 101 despite tylenol and motrin given alternatively every 6 hours.  She said office was closed and I would have to call back tomorrow, Thursday to get the results of the blood work.  Vaccines were given to the child at 3:30 on Monday 12-8.
arm extremely sore day after shot. could not hardly move my arm for 5 days. on the 6th day pain subsided some but extremely painful to move it certain ways. muscle also weak.
Patient received the flu shot on 10/13/2020 in his right arm deltoid muscle, and reported feeling pain in his shoulder that started on 10/22/2020 in the afternoon.  He stated the pain radiates from the lower bicep of the right arm, up into the shoulder blade on his right side.  He has tried heat, ice, ibuprofen to try to relieve the pain without avail.  He spoke to his physician's office, and is going to make an appointment with them for 10/26/20.
One day post vax the pt developed a fever of 101F and swelling at the injection site which extended to the wrist and was described as pitting. The left arm was 1.5 times it usual size. The fever resolved within two days.
Report received from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four (4) patients experienced flu-like symptoms (nasal congestion, chest tightness, general muscle aches, and malaise). One (1) out of the four (4) experienced chest congestion (see case 200914610). All four (4) patients received the AFLURIA dose on approximately 29-Oct-2008 and experienced the adverse effects three (3) days later (01-Nov-2008). As of 05-Nov-2008, all symptoms are milder for all patients. No patient went to the emergency room. (See cases 200914608, 200914609, and 200914610). Several attempts have been made to the reporter to confirm and verify the number of patients involved. To date, reporter has not provided a response. Patient outcome is unknown. No further information is expected. The manufacturer considered causality possible in relation to the administration of AFLURIA. Information derived from this ADR report does not change the current safety profile of the product.
"Covid arm". Mid- morning 4/13 arm started to hurt/ slightly itch. After work (~3pm) noticed arm had 3inch diameter red spot, hard lump and hot to the touch.  4/14- less painful, but affected area is nearly double in size.
6 days p/vax pt had stiffness, eyes fixed & staring to side, irritable cry; adm to hosp pt had shaken baby synd w/retinal hemorrhages; altered consciousness for 1 more day; began seizing;
The pt experienced flu-like symptoms, sore, swollen left arm, redness and a fever of 101 with chills.
October 2: woke up with headache and body pain, mainly back pain  October 3: pain in right shoulder and collar bone area, lump in collar bone area, surrounding area hurts at touch too