chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A rash developed on arms, chest and next within a week of the second vaccine and got much worse after the booster shot (3rd).  Took predisone oral steroids in Mar2022 but it still will not go away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EW0164) at the age of 45 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 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: ER8737, prev dose lot unknown: False, prev dose administration date: 31Mar2021 , prev dose number: 1, prev dose vaccine location: Left arm), administration date: 31Mar2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "A rash developed on arms, chest and next within a week of the second vaccine and got much worse after the booster shot (3rd).  Took predisone oral steroids in Mar2022 but it still will not go away.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks: none. Adverse event treatment: Oral Steriods and steroid crème. No covid prior vaccination. Patient was covid tested post vaccination. Covid test type post vaccination was nasal swab. Covid test date: Sep2021. Covid test result: Negative. Known allergies: none. Other medical history: none.  Follow-up attempts are completed. No further information is expected.
Patient fainted in the waiting room about 5 minutes after receiving Gardasil injection.  Patient slid to floor from a chair, sustaining an abrasion to the temple.  Patient regained consciousness immediately and was able to walk supported to an exam table to recover.  Patient's abrasion was treated and bandaged.
Patient developed a sore throat, was unable to taste and smell normally and had a dry mouth; Patient developed a sore throat, was unable to taste and smell normally and had a dry mouth; Patient developed a sore throat, was unable to taste and smell normally and had a dry mouth; Patient developed a sore throat, was unable to taste and smell normally and had a dry mouth; Information has been received from a medical assistant, concerning a 69-years-old female patient. The patient's concurrent conditions included liver sclerosis, osteoporosis, thrombocytopenia, hypertension, osteoarthritis and electrocardiography abnormalities. The patient was allergic to depomedrol, penicillin, cortisone, levofloxacin (LEVAQUIN), red dye and sulfa. Patient's concomitant medications included calcium (+) vitamin D supplement, alprazolam (XANAX), desmopressin, escitalopram oxalate (LEXAPRO), lansoprazole (PREVACID), loperamide hydrochloride (IMODIUM), multivitamin, tramadol hydrochloride and ursodiol (ACTIGALL).  On 21-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in her right arm to prevent pneumonia (lot number: R033342 with expiration date: 03-AUG-2020) (strength and dose was not provided).  On the same date later than night, the patient experienced a sore throat (oropharyngeal pain), was unable to taste (ageusia), and smell normally (parosmia) and had a dry mouth. The patient sought for medical attention and there was no lab diagnostics or studies performed. There was no treatment given for the adverse events.  It was unknown if the abovementioned adverse events were resolved at the time of this report.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the abovementioned adverse events were not provided.
Soreness/cramping in arm/ arm pain; Couldn't lift her arm laterally; Sleep disturbance; Fatigue; Headache; Joint soreness; Muscle pain; Chills; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Soreness/cramping in arm/ arm pain), LIMB DISCOMFORT (Couldn't lift her arm laterally), SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 039K20A and 027620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Soreness/cramping in arm/ arm pain), LIMB DISCOMFORT (Couldn't lift her arm laterally), SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint soreness), MYALGIA (Muscle pain) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness/cramping in arm/ arm pain) had not resolved and LIMB DISCOMFORT (Couldn't lift her arm laterally), SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint soreness), MYALGIA (Muscle pain) and CHILLS (Chills) was resolving.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) and product storage error (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026A21A) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) and product storage error (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen). At the time of the report, administered expired product (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) and product storage error (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
The area of injection became very hard.  It was stinging, burning, itching, hot, and turned red. It swelled quite a bit and was painful to the touch.  Fatigue was also brought on by the vaccine.
Within 12 hrs of this patient's vaccination, she developed high fevers then proceeded in the next 24 hrs to developed Kawasaki Syndrome including eye changes, generalized rash and oral changes - confirmed by Dr. Treated with IV gammaglobulin.  5/11/07 Received medical records from initial hospital which reveal patient seen in ER on 4/20/07 for fever, decreased appetite, runny nose, agitation & excessive crying since receiveing vax on 4/19. Dx: vaccine related fever.  Treated w/antipyretic & d/c to home. Returned to ER on 4/21 w/persistent fever, nasal stuffiness, cough, conjunctivitis, eye swelling & fussy.  Admitted 4/21/-4/22/07 to r/o sepsis.  Tx w/IV antibiotics.  Developed gen erythematous maculopapular rash.  Antibiotics d/cd.  Rash worsened & continued w/high fever & developed heart murmur.  Transferred to higher level of care to r/o Kawasaki syndrome.  ID consult done 4/23 revealed nasal congestion, bilateral conjunctivitis, dry & cracked lips, strawberry tongue, tachycardia, diffuse macular rash all over her body.  No bacterial focus for persistent fever.  Echocardiogram revealed small pleural effusion & coronary arteries were WNL.  Antibiotics were d/c & she was treated w/ASA & IVIG. Patient returned to ER at initial hospital on 4/27/07 w/complaints of intractable crying s/p hospital d/c for Kawaski disease.  Released from ER to see PCP in AM.  PCP rechecked patient on 4/27.  Exam neg except for known dermatitis/seborrhea on scalp & eczema on ears. 6/6/07 Received D/C Summary from higher level hospital which CDC had requested & faxed to VAERS.  Reveals patient admitted 4/22-4/26/07 after experienced 3 days of fever, emesis & 1 day of rash.  Seen at outlying ER w/fever, nasal stuffiness, cough, conjunctivitis, yellow eye discharge, slightly increased work of breathing & red dots on neck.  Admitted to outlying hospital for possible sepsis & started on antibiotics.  Rash spread to entire body s/p antibiotics & was then transferred for higher level of care.  Peds ID consult obtained & dx w/atypical Kawasakis disease.  Treated w/IVIG & ASA.  Rash & fever improved prior to d/c home on continued high dose ASA. FINAL DX: atypical Kawasaki disease.  Remainder of hospital records will be mailed. 6/8/07 Received vax record from PCP which confirms RO lot & dose #.  6/12/07 Received medical records from higher level hospital via fax from CDC which reveal patient experienced fever x 3 days, rash x 1 day, conjunctivitis & respiratory distress.  Admitted 4/22-4/26/07 after transfer from outlying hospital. ID consult obtained who made dx/atypical Kawasaki disease.  Treated w/high dose ASA & IVIG.  Fever, rash, strawbery tongue & conjunctivitis resolved by d/c to home.  To continue on high dose ASA for 3 more days then low dose ASA for 2 mo.  Close f/u w/PCP & f/u w/ID. FINAL DX: Kawaskis Disease, atypical.
Red, painful itchy site and arm. Infection treated by PCP. Says still red and painful "10 days later".
This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 66 year old female consumer who on an unspecified date was vaccinated with ZOSTAVAX (Oka/Merck). Subsequently, the patient developed shingles four months after the vaccine was given. Medical attention was sought, the patient spoke to the physician. It was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source. Follow-up information has been received from this 66 year old female patient with no pertinent medical history or drug reactions, who reported that she received the vaccination sometime in November 2007. Concomitant therapy included LIPITOR. Subsequently, the patient broke out with shingles "about 6 months later, around 01-APR-2008". the patient reported she developed shingles on her left groin, and her whole left hip became numb. The patient also reported that she had a lot of pain from the shingles. Medical attention was sought. The patient stated that once she saw the shingles she went to her physician right way. There were no lab studies performed. At the time of the report the patient was recovered. The patient reported that the pain only lasted about three weeks and that the shingles have gone away at this point in time. Additional information has been requested. This is one of several reports from the same source.
STORAGE IN REFRIGERATOR (2 grade C - 8 grade C) UP TO 30 DAYS,  (VACCINE USED AFTER 10/16/2021)
This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Left knee started to feel tight), CONDITION AGGRAVATED (Worsening the next day until I could barely walk), JOINT SWELLING (Left knee started to feel swallon), GAIT DISTURBANCE (He could barely walk) and ARTHRALGIA (Pain started to switch from my left to my right) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced JOINT STIFFNESS (Left knee started to feel tight) and JOINT SWELLING (Left knee started to feel swallon). On 26-Apr-2021, the patient experienced CONDITION AGGRAVATED (Worsening the next day until I could barely walk) and GAIT DISTURBANCE (He could barely walk). On 29-Apr-2021, the patient experienced ARTHRALGIA (Pain started to switch from my left to my right). On an unknown date, the patient experienced HEADACHE (Headaches) and PRODUCT DOSE OMISSION ISSUE (Second dose or a booster dose as he has not received those yet). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 02-May-2021, JOINT STIFFNESS (Left knee started to feel tight), CONDITION AGGRAVATED (Worsening the next day until I could barely walk), JOINT SWELLING (Left knee started to feel swallon), GAIT DISTURBANCE (He could barely walk) and ARTHRALGIA (Pain started to switch from my left to my right) had resolved. At the time of the report, HEADACHE (Headaches) and PRODUCT DOSE OMISSION ISSUE (Second dose or a booster dose as he has not received those yet) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that recent lab data included antibody  test showed a count of 313. He had not received  the second dose. Relevant concomitant medications were not provided by the reporter.
About 30 min later, I started to swell from my neck to your chin. It went numb and was red. My husband immediately took me to the hospital. I was given Pepcid, Benadryl and an Epi. I was released after a few hours and I went home and slept for two days. The guy that gave me the shot must have hit a bone and I was in pain for weeks. I am still experiencing some issues from it. My doctor has me stretching every morning due to my shoulder feeling tight. She says it could be a nerve issue.
UPSET STOMACH; SOME LOOSE STOOLS; ARM ACHED; CHILLS; HEADACHE BECAME AGONIZING AND POUNDING; TROUBLE BREATHING; TROUBLE FALLING ASLEEP; FACE FELT SWOLLEN; FELT DISORIENTED; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 09-APR-2021, the subject experienced trouble breathing. On 09-APR-2021, the subject experienced trouble falling asleep. On 09-APR-2021, the subject experienced face felt swollen. On 09-APR-2021, the subject experienced felt disoriented. On 09-APR-2021, the subject experienced arm ached. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache became agonizing and pounding. On 10-APR-2021, the subject experienced upset stomach. On 10-APR-2021, the subject experienced some loose stools. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm ached, and headache became agonizing and pounding, and the outcome of chills, trouble falling asleep, face felt swollen, trouble breathing, upset stomach, some loose stools and felt disoriented was not reported. This report was non-serious.; Sender's Comments: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
High dose was given inadvertently to patient who is under 65. She states at about 7 or 8pm she started to feel worse and felt a tightness in her chest that she felt right under her breasts and up. She received her shot in her right arm but states she felt pain in her left arm that hurt worse than the right. She states she otherwise felt like she has before "Flu-like" side effects. She felt the chest tightness through the next day but did not seek treatment. She also noted a significant headache.  About 48 hours after her shot most of her side effects had resolved.
Besides sore arm, started with dizziness, upset stomach, 99? fever, chills, headache and vomiting that would not stop  abusing dehydration.
elevated spots of itching and swelling on his body. He said the elevated spots didn't change color/elevated spots on his thighs and part of his back; elevated spots of itching and swelling on his body. He said the elevated spots didn't change color; swelling on his body; he doesn't know if the spots would be considered hives; Reported 1 day after getting his second COVID-19 Vaccine dose, his muscles were tight; he felt lazy when starting off, until his muscles loosened up, and then he felt better; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9810), via an unspecified route of administration, administered in left arm on 09Feb2021 at 10:25 am as single dose for COVID-19 immunization. The second dose of the vaccine was given at a hospital. The patient's medical history was not reported. No family medical history. No additional vaccines administered on the same day. No prior vaccinations within 4 weeks other than the first dose of BNT162B2 (lot number: EL3247), on 16Jan2021, intramuscularly on the left arm for COVID-19 immunization and experienced itching around his waist, spider bite, the spot on his waist looked like shingles, spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle. There were no concomitant medications. On 10Feb2021, 1 day after getting his second COVID-19 vaccine dose, his muscles were tight. He said he felt lazy when starting off, until his muscles loosened up, and then he felt better. The patient took a dose of Tylenol 325 mg caplet that night and said when he woke up the next day on 11Feb2021, he felt good. On 12Feb2021 at 03:00, the patient experienced elevated spots of itching and swelling on his body, he said the elevated spots didn't change color, elevated spots on his thighs and part of his back. He doesn't know if the spots would be considered hives. The patient reported he put rubbing alcohol and anti-itch lotion on the itchy, elevated spots on his thighs and part of his back. He said the rubbing alcohol soothed the spots for a second. He said he then he put the anti-itch cream on the elevated spots. The events did not require physician's office or emergency room visit. The outcome of the event muscles were tight and felt lazy was recovered on 11Feb2021 while for the rest of the events was recovered on 12Feb2021. Reported he had blood work done for his urologist between his first and second COVID-19 vaccine doses. He said everything was OK with his blood work, and there was nothing negative.
First I got diarrhea for a day then along with that I ran a temperature which I still have today
Petechia, thrombocytopenia (severe) anemia. Admitted to hospital and transfused.  11/30/06 Received medical records from hospital which reveal patient admitted 5/17/06 with red rash, cough & runny nose.  Had otitis media approx 1 mo prior which resolved only after 3 rounds of antibiotics.  ER notes indicate Heme & Endocrine consults were requested.  Exam revealed petechia over legs, abdomen, arms & trunk, mild jaundice & cervical lymphadenopathy & patient was admitted to Heme service w/dx ITP, thrombocytopenia, petechia & anemia approx 5 days s/p vax.  Continued usual meds & also steroids.  Became febrile, developed hematuria & emesis.  Continued to improve with treatment & was d/c to home 5/19/06  Patient seen 5/22/06 for labs & plts were 83, H/H 6.8/17.  Received Epo & started on iron.  Patient was readmitted to hospital on 5/24 with severe fatigue, severe hemolytic anemia, emesis increased jaundice & continued hematuria.  Again, became febrile & antibiotics were started.  Patient continued to improve w/stable labs & afebrile.  D/C to home 5/26/06.  Patient seen on 5/30 for labs & plts were 122, H/H 9.2/26.9, WBC 7.9.  Retic count remained high at 26.4.
muscle soreness; This is a spontaneous report from a contactable consumer (patient). This male patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 16Feb2021 around 11 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced a bit of muscle soreness nothing real serious on unspecified date after second shot, and inquired if can take Tylenol to ease the pain. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Information has been received from a registered nurse concerning a 72 year old female patient with multiple allergies who on 10/10/02 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (lot # 643249/0358M). Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the patient developed redness, swelling of her left arm, swelling of her cheeks and swelling of her eyes. On 10/12/02 the swelling increased and the patient developed shortness of breath. The patient was treated with a methylprednisolone sodium succinate benzyl alcohol pack and diphenhydramine HCl. Upon internal review, shortness of breath was determined to be an other important medical event. Additional information has been requested. The follow up states on 10/28/02 the pt had a follow-up visit and the physician documented that "she had recovered from her reaction to the pneumococcal vaccine 23 polyvalent." Additional info is not expected.
Rash on left arm,   139/78   Blood pressure Pulse    64 temp     99.9
Vaccine exposure via breastmilk; irritable; difficulty sleeping; fever; This is a spontaneous report from a contactable Nurse and other health professional. This Nurse reported information for herself and a female patient (baby). This is the baby report   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via trans mammary on an unspecified date as an unspecified dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The nurse (mother) reported that the baby was taking vitamin d drops. The nurse (mother) also reported that currently she was exclusively breastfeeding and after both the first and second vaccine her daughter became irritable and had difficulty sleeping. After the second vaccine her daughter had a low-grade fever on 22Apr2021 at 14:00. The patient did not receive any treatment for the reported event. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021467100 same reporter/drug, different patient and event.