chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Monday, February 22,  in the evening,  I started feeling lightheaded, then more debilitating dizzy, worsening, nauseas . Went home from work that evening around 9:30 p.m. I Vomited as soon as I got home.  Felt better but still lightheaded, dizzy, not as bad.  No fever. Couldn't sleep. Tuesday, February 23 felt pretty weak, tired some lingering lightheadedness. Stayed home from work.  Next day, Wednesday, my right arm around the injection site was pretty sore. Hard to sleep  last night. Took Tylenol for arm. Still somewhat sore today,  Thursday.
Later in day after administration on 5/9/07 child started vomiting, fever 102 and next say vaccine site very swollen and red 8cm in length.
PATIENT REPORTED TROUBLE SWALLOWING, MILD COUGH. BENADRYL 25MG PO GIVEN. PATIENT WAS ON OBSERVATION FOR 1 HOUR, REPORTED THE SYMPTOMS DISSAPEARED, NOT TROUBLE SWALLOWING, NO COUGH. VITAL SIGNS STABLE. PATIENT WAS PICKED UP BY A FAMILY MEMBER. FURTHER INSTRUCTIONS GIVEN TO VISIT HER PCP AND REPORT THE EVENT. ADVISED TO CALL 911 IF ANY COMPLICATIONS NOTED, PATIENT VERBALIZED UNDERSTANDING.
pt recvd vax; exp fever 102;fatigue,HA,chest pain & blurred vision on 8aug95;reporter felt that exp related to vax;was examined & exam w/in nl limits;
He had a high fever of 103. Pain in his arm and in legs.  He cried for many hours in pain. We went to the ER. They thought reaction to the vaccine and sent him home. Two days later, he had cellulitis near his vaccine site on the arm. It kept getting longer and wider on his arm. He was in so much pain, crying high fever of 105. The doctor determined it was cellulitis. His white blood count went from 10,000 to 24,000 within three days. He was very sick and in a lot of pain. As a result of the infection, doctor put him on an antibiotic which caused cdiff. He has now has had cdiff since June which he was hospitalized for. He is currently on medication to get rid of cdiff.
Swelling in and under the armpit the size of a baseball , swelling behind the shoulder blade the size of a marvel . Swelling is red and hot and sensitive but can not feel lymph node swelling goes from very part of lower armpit into pectoral region the size of a baseball
Suspected Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 67 year old  male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cardiac problems. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected immunological vaccination failure. On an unspecified date, Laboratory data included: Antibody test (NR: not provided) with result negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from suspected immunological vaccine failure.  This report was serious (Other Medically Important Condition). The report is associated with Product quality complaint.; Sender's Comments: V0: 20211006505-COVID-19 VACCINE -suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
itching  at site of jab on 7th day, evening (Sunday, 3/7/21) ;  next morning redness, red "bumps", spreading...pressure sensitive.  Outcome as yet unknown!  (see below)
Information has been received from an RN concerning a 51 year old female pt with multiple allergies, a connective tissue disorder and osteoporosis who on 10/22/01 was vaccinated with a dose (lot 636849/0944K) of pneumococcal vaccine 23 polyvalent. Concomitant therapy included risedronate sodium (Actonel), hydroxychloroquine sulfate (Plaquenil) and bethanechol chloride (Myocholine). Subsequently, the pt reported to the physician's office that she developed localized erythema at the injection site and that it was getting worse. Unspecified medical attention was sought. The physician requested a lot check because 2 other pt's (WAES 01104569 and 01112683) also had adverse experiences with the same bottle. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Injection site red, warm area of swelling 2.5 inches in diameter, itchy.
Pt was shaking and screaming at 5AM day after injection. Lasted 5 min. A second episode happened. Went to ER. Blood work done. T 101.5 and rash before going to ER.
Pt received vaccine 7/10/12 & came in 7/12/12 with redness around injection site (a few inches in diameter). Area was also swollen & hot to touch. Recommended she go to urgent care to rule out cellulitis. Pt received antibiotic - followed up with her 7/18 & her arm was clearing up.
I began to have pain along my right thorax and then began to have a vesicular rash about 3 days later. I took OTC ibuprofen and received treatment with valacyclovir & gabapentin. After about a week, all symptoms subsided.
I developed diarrhea 4 days after the vaccine, which was Friday, January 8. I took over the counter anti-diarrheal medication because I was told the vaccine could cause GI upset. The diarrhea continued for another 2 weeks with increasing severity that turned into hematochezia and watery stool on January 22, whereby I reached out to my PCP and a stool culture was obtained along with a prescription of antibiotics. Although the lab result came back negative for shiga toxin and could not be tested for other pathogens, my symptoms gradually improved after I began taking oral antibiotics.
Pain, discomfort and weakness in my left arm. When I informed the nurse about the symptoms she recommended that I apply a cold pack of ice to the left arm. She instructed me to apply the ice pack 10 minutes near the injection then take the ice pack off for 10 minutes. I followed the directions exactly as given by the nurse.
?Moderna COVID- 19 Vaccine EUA? Flu vaccine allergy discussed at length with patient prior to Moderna vaccine. Patient's arm became red and very swollen on two separate occasions after receiving flu vaccine but patient did NOT experience difficulty breathing, respiratory distress, throat swelling, shortness of breath, or anaphylaxis. Approximately 11 minutes after receiving Moderna vaccine, patient complained of warmth and redness at injection site. Immediately after this complaint, patient began to faint and complain of difficulty breathing and pain when breathing. Rapid response was called. Patient continued to complain of painful inspirations and difficulty breathing. EpiPen, albuterol inhaler, and diphenhydramine IM were administered. Patient improved and was transported to emergency room for further monitoring. Patient improved in emergency room and was discharged sooner after.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 4:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 4:26 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 9 AM, 10 AM, 11 AM, 2 PM, 3 PM temperature was 32, 32, 32, 35, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 21-Mar-2021, Excursion time was 9 AM,10 AM,11 AM temperature was 34, 32, 34 total doses given for the day was 94, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vials were sent to clinic. Vaccine BUD date was 15-Arp-2021.  On 21-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM: 34, 10 AM: 32, 11 AM: 34, 12 AM: 43, 1PM: 40, 2 PM: 40, 3 PM: 41, 4 PM: 41 and 5 PM:41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a raceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Only received liquid portion; Accidentally received the liquid portion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA911A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only received liquid portion) and inappropriate dose of vaccine administered (Verbatim: Accidentally received the liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: The reporter was a clinical pharmacy manager. The reporter reported that the patient accidentally received the liquid portion of Menveo. Adverse event information was collected but reporter did not had all the details at the time of reporting. The reporter gave by error Menveo liquid portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The reporter did consent to follow up.
After the shot soon after started having some itching in my right hand and thought I was developing a cyst.  By the time I went to my dermatologist who I see yearly she told me that  I was developing  dupuytren's contracture and it was not a cyst and wandered how it had developed so quickly as there was nothing there last year.  Since then I have been to an orthopaedic urgent care and regular visit  who confirmed it, and began to have itching also in my feet . I have been to several doctors who were taken aback of the suddenness of these developments as now I have dupuytren's contracture, and ledderhose disease in my feet.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt was 89 years of age with a PMH significant for CAD, T2DM, hyperlipidemia, HTN. No cause of death listed. Per note 4/25 PT was having difficulty breathing "last couple of weeks." No other recent illness noted.
Approximately 2 days after my 2nd booster shot I experienced the following symptoms: Excruciating headache, chills, body aches, muscle aches, extreme fatigue, nausea, vomiting, rapid and irregular heart rate. I went to the Emergency room and they said I have Atrial Fibrillation and prescribed me with Eliquis and Metoprolol and a follow up to a cardiologist. The medications made me feel better. As of today 04/25/2022, I have fully recovered from my symptoms.
EXTREME shakes, scary I was shaking so much. Weak, couldnt sleep,  Extreme sweating. Very fatigued, arm very sore.
This case was reported by a nurse and described the occurrence of elevated bilirubin in a 2 day old female patient who had received hepatitis B vaccine recombinant for prophylaxis. On 2/20/04, the patient received a pediatric dose of Engerix B. According to the reporter, the hospital was uncertain whether the neonate had received an initial dose of Engerix B, and administered the dose on 2/20/04 due to this uncertainty. On the same day that the patient received Engerix B vaccination, she experienced elevated bilirubin and was hospitalized. The event was unresolved at the time of reporting. The nurse considered the event was possibly related to vaccination with Engerix B.
This spontaneous report was received from a pharmacist concerning to a 66 year old patient of unknown gender. Patient's pertinent medical history, drug allergies/reactions and concomitant medication were reported as none. On 31-JUL-2017, the patient was vaccinated with PNEUMOVAX23 lot # M043424 (expiry date: 06-JUL-2018, dose, route and frequency not reported). The patient complained of "flu like symptoms, swelling and redness at the injection site". On 02-AUG-2017, the patient visited their primary care physician and was diagnosed with cellulitis, prescribed an unspecified antibiotic. It was not known at this time if the patient had recovered. The outcome of cellulitis was unknown. No further information to provide. The causal relationship between the event and PNEUMOVAX23 was not reported. Product quality complaint (PQC) was not involved. Upon internal review, the event cellulitis was determined as medically significant. This is one of the two patients report received from the same reporter (linked case#1708USA003434).
Tingling and flushing of the face. Ears felt plugged. Some difficulty chewing. No treatment given. Lasted about 10 minutes. Resolved on its own.
17 year old who received the 1st dose of Moderna COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old who received the 1st dose of Moderna COVID-19) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old who received the 1st dose of Moderna COVID-19). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old who received the 1st dose of Moderna COVID-19) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD21-063529 (E2B Linked Report).; Sender's Comments:  MOD21-063529:crosslink
patient received 2 does of DTAP and Polio/no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on same date.  This case involves a 5 months old patient of unknown gender who received extra doses comprised with vaccines HEPATITIS B VACCINE (HEPATITIS B VACCINE), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (UI992AAA, left deltoid, 0.5 ml via intramuscular route) on 23-Sep-2019 for all vaccines. The patient received 2 does of DTAP and Polio.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  As concomitant therapy, patient received ROTAVIRUS VACCINE.   It was of actual medication error due to extra dose administered.  It was unknown whether adverse event was experienced or not. .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever up to 102.5, chills, aches, beginning 12 hrs after injection, lasting 1 day
woke up about 12 hrs after vaccine admin with severe pain in rt side of neck and  head.   thought it was just a stiff neck  went to massagetherapist  .  pain worse next day on both sides of neck and in side of head. took tylenol  500mg q6 hrs for pain eased it didnt take it away. cried with pain . saw NP on Jan 3  given myo relaxant tabs told me to call if not better in 24 hrs  no better  NPprescribed Predisone packet... which kept be awake all nite and raised b/p and pulse rate over 100.called Dr in am stopped Predisone and changed b/p med for 48 hrs. Back on regular B/ P med  Amlodipine now.Still have rapid pulse and pain in left side of head and neck... VERY FRUSTRATING THOUGHT I WAS DOING RT THING TO GET THE BIVAL BOOSTER!
suffered a rash on the right side of his lower back, wrapped around his right groin and down his buttocks and was diagnosed with shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about his medical history, concurrent conditions and concomitant therapies was provided. On or about 20-AUG-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a rash on the right side of his lower back, wrapped around his right groin and down his buttocks and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
I?m extremely tired.  Been in bed most of today.  My arm hurts slit.  My entire body muscles aches.  I?ve had a terrible headache. It?s been  almost 30 hours.  Worse than covid vac.
She has cancer and her readings are better; booster dose; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) from medical information team.  A 78 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Oct2021 (Lot number: FE3592) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "colon cancer" (unspecified if ongoing); "kidney cancer" (unspecified if ongoing); "four heart ablations" (unspecified if ongoing); "knee replacement" (unspecified if ongoing); "ectopic pregnancy" (unspecified if ongoing); "hemorrhoids" (unspecified if ongoing); "surgery for ganglion in her wrist." (unspecified if ongoing); "basal cell taken off her nose" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: given on 29Jan2021. Pfizer lot number is EL9264. , Expiry: unknown , location site: Left arm), administration date: 29Jan2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Second dose: given on 04Mar2021. Lot number: EN6198. , Expiry: unknown , location site: Left arm), administration date: 04Mar2021, when the patient was 78 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Oct2021, outcome "unknown", described as "booster dose"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "She has cancer and her readings are better".  Follow up (29Nov2021) This is a follow up spontaneous report from a contactable Physician. This Physician reported for a 78 year old female consumer (patient) that:  No follow-up attempts are possible. No further information is expected.  Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.
On 15NOV91 @ 5PM mom called & said pt slept longer than usual; fever unk; pt won't crawl or walk; lt arm limp-no grasp;
Patient is 12 years old yet received child, 5 to 11-year-old, dose. Should have received adult Pfizer vaccine dose.
Swelling at site, redness, right arm received call from parent. 04/30/2003
On May 19th, approximately 6:00pm, I collapsed while out walking with my husband.  He said I was unresponsive, my eyes rolled back in my head, my skin color turned gray and he could not detect a pulse or respiration.  He and a neighbor called 911 and started CPR on me.  I came to as the rescue unit arrived.  Transported to Hospital via rescue unit where they started and IV.
Legs and back pain. Little strength in my legs. Chills and slight temperature. Very tired, slept for several hours for two days. Upset stomach and vomiting.