chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my first COVID dose on March 31, 2021, exactly 40 days ago. The evening of this first dose, my arm became very sore, particularly the muscle exactly where the injection was given (left arm). No redness or rash or any visible issue. I know a sore arm could be expected for a couple or few days, but this has continued to linger; the muscle has continued to ache every day since, specifically when I exert it such as lifting an object like a book or water bottle, or extending my arm straight out away from my body. It feels like somebody has punched me in the arm there or a pulled muscle of sorts. (My second injection April 22 was same arm.) There is no pain when my arm is at rest, but even a slight exertion causes discomfort, and lifting anything more than a few ounces or stretching it far from my body causes pain, as does trying to do a single push up. My arm was 100 percent prior to the injection and I could do 50 pushups no problem; now my left arm doing a single push up.
29MAY92 t/c from pt states on 25MAY92 devel sharp pain behind lt shoulder; 26MAY92 red rash devel on lt shoulder blade & around the front of chest; seen by MD 28MAY92; dx shingles;
5 1/2 days post vaccine, 12/25/2021- he had fatigue, lack of appetite, chills, vomiting, nausea. When I would give him the Tylenol for the fever of 101.6, he could not keep any of it down. He laid in his bed from mid afternoon to the next day. These symptoms lasted 24 hours, and the next day he was back normal. He was still tired. He did not have any fever, or any chills, and he was eating. 12/31/2022-he developed COVID toes red spots that were flat throughout all of his toes, he also had white dots that looked like they had whiteheads, and that is all he had at the time. The redness did leave, but I noticed he has like dry,  bubble skin separation. This week, 01/31/2022, he said he was itchy and developed a rash on his bottom, like 10 dots, and arms, around his elbow, legs, upper thighs and back and stomach, and his jaw, like 3 dots. I am treating it with a prescription topical cream that the dermatologist prescribed. He has not recovered from the rash. He has an appointment on 02/17/2022 with the dermatologist. Note: 10/06/2021- he tested positive for COVID-19. All he had for symptoms was a fever for 2 days and a little bit of  cough and a little nasal congestion.
Severe and widespread itching in every inch of my body, initially on my head/scalp and my pelvis and then expanded all over. Duration a good amount of time, maybe 10-15 minutes and then it went away. Same event the day after.  The third day I woke up with a more severe itching mixed to a strong and painful stomach pain, very similar to an acid reflux/heartburn type of pain, where I could barely swallow my saliva. I spent a mostly sleepless night fighting against this chest pain/burning feeling. The third day I needed to go to the Urgent Care. The itching kept migrating all over my body and showing severely, mostly in the morning after my awakening and in the evening before sleeping. At times I would wake up with red and swollen eyes, herpes on my lips and tonsillitis. Stomach pain very painful for a week before improving slightly with medications.      Antihistamine 2 times a day for eczema and Omeprazole 40mg once a day for 8 weeks for stomach heartburn/reflux.  I started my therapy  4 weeks ago and I'm slowly improving. The most difficult to deal with pain, is my stomach!  Useful to know that for my eczema I'm following a histamine free diet where I try to limit the consumption of food which contains or produce too much histamine.
Had red circle around injection site warm to the touch. Has been gone a day then back the next for two weeks still after shot arm still sore
New onset vertigo started 5/15 and continued through her office visit on 5/18.  Had covid vaccine two days prior two symptom onset and started spironolactone (new medication for her prescribed by dermatologist for acne) one day prior to symptom onset.
rash; breakout of vaginal herpes; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (10 years before the reporting date). Concurrent medical conditions included herpes simplex (herpes simplex 2). On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash and genital herpes. On an unknown date, the outcome of the rash and genital herpes were recovered/resolved. It was unknown if the reporter considered the rash and genital herpes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Field representative was told by a medical assistant or nurse at an HCP office that a patient experienced an adverse event after getting SHINGRIX. The field representative then went to the pharmacy where it was administered and spoke with the pharmacist there. After vaccination she had a little rash and an breakout of vaginal herpes. The representative did not know if the "little rash" was the vaginal herpes rash, or if it was a rash somewhere else on the patient's body. She took a couple days of therapy and the symptoms resolved.
awakening of dormant viruses in body, vaginal ulcers potentially Herpes virus after never having symptoms, never testing positive
This spontaneous report as received from a licensed nurse practitioner refers to a male patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB dose 3 (dose, frequency, route and therapy type not provided). No concomitant medications were reported. On an unknown date the patient's titres showed less than 3. Patient sought medical attention (office visit). Patient was not hospitalized. There was no significant disability and there was no medical or surgical intervention required. No product quality complaint was involved. The outcome of the event was unknown. The report is lined to 1401USA011517 (same reporter link). Additional information has been requested.
Severe body aches, fever, Severe nausea, diarrhea , Pain, swelling,hot on arm, Severe fatigue. was unable to do anything the first week following injection Most lasting for approv 3 weeks. except the arm pain and soreness. Did not go back for second dose.
In addition to the listed adverse events of chills, arm soreness, swelling at the injection site, fatigue, muscle ache, headache, and depressed appetite I had one additional symptoms that I don't believe was listed on the paperwork included with the injection.  The chills included severe trembling which lasted about 3 hours (started at 12:12 AM on Saturday, May 22nd and ended at 3:38 on Saturday, May 22nd).  I also had a body temperature drop to 97.0 degrees at around 5 PM on Saturday, May 22nd.  I never had a detectable fever at any time during the 24 hours after having the vaccine, but I was taking  Advil to help with the headache and muscle ache which may be why I never developed a fever.  My body temperate ranged from 97.7 to 97.0 through the 24 hour period after the vaccine.  Advil was started 12:30 AM.
Cough, sore throat, difficulty breathing, watery eyes, achiness, feverish, tired.
The pain is present in the right arm. This is a new problem. The current episode started yesterday. There has been no history of extremity trauma. The problem occurs constantly. The problem has been gradually worsening. The quality of the pain is described as aching. The pain is at a severity of 9/10. The pain is severe. Pertinent negatives include no fever or itching. She has tried nothing for the symptoms. The treatment provided no relief.
chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (batch no. 023C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included BUPROPION and MULTI VIT for an unknown indication.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and SUMATRIPTAN for Headache, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and HEADACHE (headache) outcome was unknown.
SHARP PAIN WHEN VACCINE WAS ADMINISTERED AND A WEEK LATER ARM AND LEG NUMBNESS AND WEAKNESS. ALSO A RASH AND BLISTERS OCCURRED A WEEK OR LONGER AS WELL.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a male pt who experienced fever and sore throat.  The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (IN).  Concomitant medications were not reported.  The pt experienced fever (pyrexia) and sore throat (pharyngolaryngeal pain).  No additional information was available at the time of this report.
@841 client walked 10 feet to ask a question and suddenly felt dizzy.  Assisted to sit down in chair. Vitals obtained @0842: 90, 110/69, 99% on RA. Head-to-toe assessment completed. Patient noted to be anxious and hyperventalating. Instructed to take slow, deep breaths.  Given reassurance and water to sip. Client refused to have EMS called to check here out and reported feeling better after a few minutes. Monitored for an additional 15 minutes. Client assisted to stand and walked without issues. Denied dizziness. Client walked to door and left with husband ambulating, AAOx4. NAD.
This spontaneous case was reported by a nurse and describes the occurrence of POLYMYALGIA RHEUMATICA (acute polymyalgia rheumatica) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced POLYMYALGIA RHEUMATICA (acute polymyalgia rheumatica) (seriousness criterion medically significant), MOBILITY DECREASED (couldn't reach her arms out,thighs would not move), MYALGIA (couldn't get out of bed from pain) and ARTHRALGIA (pain in her shoulders,pain in her hip area). The patient was treated with PREDNISONE for Polymyalgia rheumatica, at a dose of 40 milligram; PREDNISONE for Polymyalgia rheumatica, at a dose of 20 milligram and PREDNISONE for Polymyalgia rheumatica, at a dose of 10 milligram. At the time of the report, POLYMYALGIA RHEUMATICA (acute polymyalgia rheumatica), MOBILITY DECREASED (couldn't reach her arms out,thighs would not move), MYALGIA (couldn't get out of bed from pain) and ARTHRALGIA (pain in her shoulders,pain in her hip area) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Patient's physician started her with Prednisone 40 mg, then down to 20mg and then 10mg, but the polymyaligia came back so she had to increase the prednisone. Patient reports that she felt better, and the 20 mg seem to be working. The patient did not had this type of complication in the past. Patient's physician stated to take therapy for 6 weeks and then to run more tests. Antinuclear antibody (ANA) titer was high, indicating Lupus. EFR (as reported) high at 27, White blood cell (WBC) was 12.8 but did not had any symptoms of cold or flu. Mean Corpuscular Haemoglobin (MCH) was 41.3 and Liposides were 3.5.  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. However, medical history and concomitant medication details are required for further assessment.; Sender's Comments: 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. However, medical history and concomitant medication details are required for further assessment.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 and has since received second dose on 04/09/21
pt recv vax;pt would not take cereal & had some emesis of the cereal;apap given;breast fed but poorly;in am, woke crying & felt warm but was breast fed well;devel fever 103 R;high pitched cry 15-20 mins;noted pt was lethargic,ate poorly
Hospitalization for COPD with acute exacerbation and pneumonia from COVID-19 on dates 2/12/2023- 2/14/2023. Treated with dexamethasone.
Nurse administered 2nd dose series of Pfizer five days early. Client & Epic record confirmed that 1st dose was received on 04/28/21. No adverse reaction noted.
Right olecranon process swelling; Right axillary Lymphadenopathy; Right abdominal Lymphadenopathy; Right toe swelling; Swelling and lymphadenopathy on theright side of the body; Swelling and lymphadenopathy on the right side of the body; This is a spontaneous report from a contactable physician. A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via intramuscular route of administration in the right arm on 21May2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via unknown route of administration on 30Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 21May2021, the patient experienced right olecranon process swelling, right axillary lymphadenopathy, right abdominal lymphadenopathy, right toe swelling and swelling and lymphadenopathy on the right side of the body. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were 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 right olecranon process swelling, right axillary lymphadenopathy, right abdominal lymphadenopathy, right toe swelling and swelling and lymphadenopathy on the right side of the body was unknown at the time of this report.
ARM SORE AND HURTING; This spontaneous report received from a patient concerned a 41-year-old female patient of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood clotting disorder (Factor 5 leiden). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration was not reported, and batch number: 043A21A, expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, (dose number in series 1), the patient experienced sore arm, nausea and fatigue.  The patient recovered from sore arm. The outcome for nausea and fatigue was not reported.  The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on 14-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient had sore vaccinated arm which was hurting (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore and hurting. This report was non-serious. This case, involving the same patient is linked to 20211212291.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported
large amount of swelling at injection site lasting 1 day. persistent "achey" pain from elbow to wrist on arm of injection continuing through last 2 days to now.
First injection large red dot left arm, arm pain, unable to move arm for 3 days   Second injection - 3 days of blurred vision, constant eye twitch in right eye that has lessened but still happening to this day as of 11/11, severe headaches that began day after second shot and have not subsided. This is a new daily norm.  Arm expanded /swollen almost double in size for 6 days and was hot to the touch, lethargic and mostly slept for 4 days, fever and chills day 2 and 3 after shot.
Severe pain at injection site, shivering, nauseous, and right arm where injected still very sore.
Seizure/focal approximately 10 minutes after injection lasted 1-1.5 minutes....
This spontaneous report was received from a registered nurse. It was reported that (Merck) VARIVAX had been administered to an unspecified number of patients between 13-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1209USA002392 1210USA000958 1210USA000959 1210USA000960 1210USA000961. Additional information has been requested.
band, 3 inches in width, of little bumps on her left arm that were itchy; pain on her left arm; could not lift her arm without having pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2022, the patient received the 1st dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced mobility decreased. On 20th June 2022, the patient experienced pain in arm. On 23rd June 2022, the patient experienced itchy rash. On an unknown date, the outcome of the pain in arm and itchy rash were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased and itchy rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JUN-2022  Reporter's Comments: The patient received Shingrix and experienced pain on left arm on the day she received vaccine. The patient could not lift her arm without having pain for the next three days.  The pharmacist reported that three days after patient noticed a band, three inches in width, of little bumps on left arm that were itchy.  The pharmacist would like to know if the patient should get the second dose.  The reporter provided medical disclaimer and referred to health care professional.  The pharmacist did not want to provide any patient contact or demographic information.
CHIEF COMPLAINT:  Weakness, shortness of breath, and a cough of several days' duration.   HISTORY OF PRESENT ILLNESS:  The patient is an 84-year-old with history of paroxysmal atrial fibrillation, on Warfarin, chronic kidney disease, diabetes mellitus, coronary artery disease status post stents, hypothyroidism, and osteoarthritis, who tested positive on 08/20/2021.  Wife was also positive.  He has been at home, but has had gotten increasingly weak with very poor oral intake.  He has had several falls at home and refused to come in.  Today, he had another fall and wife convinced him to have a rescue squad was called in and he was then brought to the ER.  When they presented, he had a rhonchorous cough and was also hypoxic and quite deconditioned.  Currently, patient is not providing much history.  He admits to the cough.  He states he usually gets around with a walker or a cane.  Other questions asked like loss of smell or taste, the patient is unable to provide.  He is selective with some of his answers.  In the ER, found to be hypoxic, requiring 4-6 liters of oxygen and we were asked to admit the patient.  The patient did get his COVID vaccination.  Wife was taking care of him at home, but she states she is unable to cope, which is why she brought him to the hospital.  The patient is hypoglycemic with a blood sugar of 45. Wife had stated to the ER that though he had poor oral intake she still gave him   his Insulin because he had previously had some hyperglycemia.  ASSESSMENT AND PLAN: 1.  COVID infection, his creatinine clearance  is about 30, which is borderline so will hold remdesivir We will put him on steroids at this time.  Continue oxygen supplementation.  He is already on Warfarin.  We will continue this for anticoagulation. 2.  Some acute encephalopathy.  I am not sure whether he is just weak and involves an effort to answer questions or just some lethargy.  He has had this history of falls and he is on Coumadin.  We will get a CT of his head. 3.  Acute hypoxic respiratory failure, likely from COVID pneumonia.  CXR findings  is not classic at this time.  We will repeat a chest x-ray in the morning.  Continue to monitor patient, wean the oxygen as needed.  We will get a baseline ABG  Due to  lethargy to ascertain if he has hypercapnia.   He may need BiPAP.  Contains critical data CORONAVIRUS (COVID 19) PCR Order: 274006261 Status:  Final result Specimen Information: NASOPHARYNGEAL SWAB    0 Result Notes  Ref Range & Units 8/8/21 2010 CORONAVIRUS SARS COV 2 PCR (RESP) NEGATIVE POSITIVEPanic   PATIENT STILL HOSPITALIZED AS OF 8/20/2021
7pm started with nausea, chills and shaking, vomited, then total body aches, headache, and temperature for about 36 hours even while on Tylenol.  If didn't take Tylenol temperature 102. By 48 hours just weak and sore at site of injection.
2 yr old male with no pmhx presented with increasing LUE+LLE swelling and erythema 5 days following administration of HIB to left arm, PCV right arm; Hep A, MMR and Dtap on LLE. Admitted with diffuse cellulitis.  MRI showed multiloculated abscesses of the humeral shaft, osteomyelitis of the distal humerus and osteomyelitis of proximal radius and ulna. Patient required surgical intervention by orthopedics. There is concern that vaccine lot may be contaminated and patient was seeded with bacteria. Blood culture are growing back gram + cocci in clusters. Please evaluate and take appropriate measures. Would appreciate cultures to be taken from vaccine lot.