chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). An adult female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Apr2021 as dose 1, single for covid-19 immunisation. Medical history included, prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date in Jan2021. The patient's concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. The patient stated, on 13Apr2021, tuesday after the monday vaccination she was having a fever and body aches. On an unspecified date in 2021, outcome of the events were recovered .    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt had sz & admitted to hosp on 13NOV91 appr 24hrs p/DTP; pt is fully recovered; mom reports admitting MD said pt had allergic rxn to pertussis;
We sent out an email to store associates over 18 years of old to have prefilled out VAR for an offsite clinic. Pt showed up to get vaccine, consent form signed, was screened down the list and the vaccine was administered. Staff  returned to bill the vaccine on 4/9/21 and our system on  halted it due to pt age. I was made aware of the error on 4/12/21 when I returned from the weekend. We then looked deeper into the VAR to find it had been signed by the father for consent to give the vaccine to his daughter.
pt recv vax 6JAN98 & pt exp sl redness @ the inj site;
HEADACHE, CHILLS, FEVER, GENERALIZED MUSCLE PAIN, TIREDNESS
Redness and hard at the site.  Fever of 103.3.. Tylenol given last night with no further fever.
Information has been received from a licensed practical nurse concerning a 10 year old male who on 02-FEB-1997 was vaccinated with the first dose of VARIVAX (Merck) 0.5 ml, subcutaneously. On 10-APR-2007, the patient received the second dose of VARIVAX (Merck) (lot # 656289/1510F) 0.5ml, subcutaneously. The nurse reported that "recently", the patient developed a breakthrough of chickenpox. His outbreak was on his legs and abdomen and was considered to be moderate with no fever. He was on vacation at the time of the outbreak. The patient recovered within 7 days of the onset date. The patient sought unspecified medical attention. This is one of two reports received from the same source. Follow up information has been received from a licensed practical nurse that reported that they did not keep track of these incidents and they did not have the names any longer so she cannot pull up the information requested. The only information that she had is that 2 siblings received 2 vaccines for VARIVAX (Merck) and were diagnosed with chicken pox while vacationing out of state. Additional information is not expected.
Starting having Chest Pain and SOB on 2/5/21. Had oxygen saturation of 85%. Went to ICC and then ER on 2/8/21 for these symptoms.
RED RASH AT INJECTION SITE (1330). STATES HE FEELS FINE. HAD SOME REACTION AT 1ST SHOOOT. GIVEN 50MG BENADRYL AND WENT HOME. ADVISED TO FOLLOW UP WITH PCP OR ER
Left arm swelled up, turned red, and got hot to touch. After 3-4 days swelling went away. Fever lasted 24 hours, and went away with TYLENOL.
Immediately after the shot, I started to feel my pulse race slightly. After half an hour this progressed to a flushing heat in my neck and ears. This was an anticipated histamine type reaction to the vaccine that I have gotten to a number of triggers this year. The second day after the shot, I developed a 1-2 degree fever, which stayed with me for the past week, and still has not resolved. My pulse has stopped racing after about the third day, however, and I don't feel so dizzy. I have taken extra strength Tylenol to control the fever and reactions for the first 4 days around the clock to avoid my pulse spiking, and the last 2 days I took one dose of Tylenol each day when the fever rose again.
Dry mouth; occasionally experienced interesting vivid dreams; Swollen glands after first moderna covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), ABNORMAL DREAMS (occasionally experienced interesting vivid dreams) and LYMPHADENOPATHY (Swollen glands after first moderna covid vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TASIMELTEON (HETLIOZ) capsule for Non-24-hour sleep-wake disorder.    Concurrent medical conditions included Food allergy (Fish containing products), Allergy to plants (Poison oak), Allergy to antibiotic (Bactrim DS), Blindness (Blindness Right category 5, Left category 5) and Panniculitis (Panniculitis affecting regions of neck and back). Concomitant products included HYDROCHLOROTHIAZIDE, SIMVASTATIN, ENALAPRIL MALEATE, CENTRUM SILVER WOMEN 50+ and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN ES) for an unknown indication.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TASIMELTEON (HETLIOZ) (Oral) 20 milligram once an hour. On an unknown date, the patient experienced DRY MOUTH (Dry mouth), ABNORMAL DREAMS (occasionally experienced interesting vivid dreams) and LYMPHADENOPATHY (Swollen glands after first moderna covid vaccine). At the time of the report, DRY MOUTH (Dry mouth), ABNORMAL DREAMS (occasionally experienced interesting vivid dreams) and LYMPHADENOPATHY (Swollen glands after first moderna covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's age was late 60s when at the time of report.  It was reported that patient might accidentally ingest the Hetlioz packets or may thought someone had tampered with the medication.  It was reported that the event dry mouth was result of Hetlioz. The reporter did not provide causality between events of swollen glands and vivid dreams.  Information regarding the patient's dry mouth or dietary intake was not provided. However, in agreement with the reporter, until additional information was obtained, the causal relationship between Hetlioz and Dry mouth was assessed as possible. Due to the knowledge of the product the causal relationship between Hetlioz and Abnormal dreams was assessed as possible. The patient's Lymphadenopathy per the report, was fater COVID vaccine, therefore the causal relationship between Hetlioz and Lymphadenopathy was assessed as not related.  No treatment medications were provided by the reporter.
The pt received Flu shot in the left arm at work on 11/16/01. On 11/23/01, the pt had weakness of LUE and could not lift arm above shoulder. He had occasional pain in left shoulder. Will refer to neurologist. Pt was evaluated for ? nerve problems.
Pt fainted in waiting room breaking her tooth and bite her tongue. We took pt to dental then the ambulance came to pick pt up.
Days-1&2 mild diarrhea (resolved) + days 3&4 contineous mild pain in the right eye (now visual impairment or blury vision, resolved on 08/08/2021) + severy joint pain in the right carpometacapal joint and two interphalangeal jints of the third finger. Pain radiates to other fingers and palm, but none of the other joints are painful in passive flextion and extention. Pain is so sever that doesn;t allow proper grip or fine movements such as typing. No intense physical activity was done in the past few days since the vaccination, no exposure to cold and no sign of redness, swelling, blunt traumma etc. the pain started while sitting watching the mobile screen.  Will update again if it progresses or additional symptoms manifest.
After the vaccine, I was just tired and a little soreness in arm but not much. Shingles - painful soreness in my upper buttocks/hip area and I felt a bit of bruising when I did  my walk - when I looked at it - it looked like a belt and was red. It had a mild case of shingles because I had a Shingles vaccine in May  6th. I took a phone of the shingles and sent it to my doctor and she prescribed an anti-viral medication, Acyclovir and I took that through yesterday. That helped to resolve it. It's just now a kind of a dry patchy area.
Elevated temperature - 99-100 degrees, muscle aches especially at vaccination site, fatigue, slight nausea.  Treated with OTC pain reliever and rest.  Symptoms weakened after 24 hours, and mostly diminished after 48 hours except slight pain at injection site
patient has 7.5 x 6 cm erythematous patch on mid-arm, area is blanchable, warm, below deltoid (in my opinion it is lower that an appropriate IM vaccination location, unknown if this was vaccination site or coincidence)
Headaches, body aches, joint aches, fever to 100.0F, injection site pain, and diarrhea
Started having headaches, dizziness, off balance, word finding issues for 2 months;  started 2 weeks after 1st vaccine.  symptoms gradually improving
Information has been received from a Licensed nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female with a history of gastric bypass surgery who on 10-JUL-2009 had a pregnancy test showing negative after 3 minutes and then was vaccinated with the first dose of GARDASIL (0.5 ml, lot number 662404/0312Y). After 5 minutes the negative pregnancy test result turned into positive. The nurse reported they will complete the GARDASIL after completion of pregnancy. The patient had sought unspecified medical attention by nurse. Follow-up information was received from a licensed nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female with a history of gastric bypass and no previous pregnancies who on 10-JUL-2009 was vaccinated with the first dose of GARDASIL (lot number 662404/0312Y). The patient was confirmed pregnancy at the vaccination time. Ultrasound was performed on 22-JUL-2009, the result showed she was 5 weeks + 4 days pregnancy but the LMP was not sure. Another ultrasound was performed 05-AUG-2009, the result showed she was 7 weeks 1 day pregnancy and the EDC would be on 23-MAR-2010. Follow-up information was received from a licensed nurse practitioner. The nurse stated "Everything was fine." The patient had no complications with her pregnancy and the baby was born full-term, vaginally, and was healthy. She also reported that the mother did have "one complication unrelated to the vaccine." The mother had a history of cardiomyopathy and a history of gastric bypass surgery. The nurse stated the patient had an exacerbation of the cardiomyopathy during her pregnancy, but everything has resolved. The patient had a follow-up EKG postpartum and it was normal. She had no further information to add as the chart was not with her. Additional information is not expected.
12/12/21-approximately 6:00am noticedmy left ear was red/itchy. 1:30pm noticed my right side had a rash type itchy/ache. 12/15/21 woke up @ 6:30 am left side of face burning/itchy.
Significant reduction in breast milk production following COVID-19 vaccine. Began the same day I received the shot and continued for at least three weeks. At the time of my second shot production is still not where it was before the vaccine but was coming back with work. I got my second shot this morning and my pumping session this afternoon was very low again.
Itchy welts on chest and abdomen 6 days after 2nd Rabies injection-subsided spontaneously-same event occurred after 3rd Rabies injection, 7 days after-Both times started upper body and moved down to feet-lasted 2 days. Used Hydrocortisone cream with some help, no fever.
Severe Immune Response.  Fever, Rash, Itching, High Heart rate, Weakness, Shortness of breath. Treated at Emergency room May 09, 2021  Follow up office visit with Dr  May 10, 2021 May 12, 2021  May 17, 2021 and June 03, 2021
Patient developed idiopathic thrombocytopenia purpura with 1st symptoms noted 10/28/02. Platelet count 9,000 10/29/02. Symptoms: bruising and petechiae. Treated 10/29/02 with Winnho IV. Per 60 day follow up: pt has recovered. His recovery was rapid but treatment was costly. An annual follow-up report received 11/24/2003 adds: (Pt recovered). I never received a follow-up from VAERS with an opinion as to whether this reaction was from the flu vaccine.
legs are achy and sore as well as muscles; can't lift left arm; severe muscle aches/sore muscle; Joint tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs are achy and sore as well as muscles), HYPOKINESIA (can't lift left arm), MYALGIA (severe muscle aches/sore muscle) and ARTHRALGIA (Joint tenderness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04152A, 043B21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Hypertension.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (legs are achy and sore as well as muscles), HYPOKINESIA (can't lift left arm), MYALGIA (severe muscle aches/sore muscle) and ARTHRALGIA (Joint tenderness). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (legs are achy and sore as well as muscles), HYPOKINESIA (can't lift left arm), MYALGIA (severe muscle aches/sore muscle) and ARTHRALGIA (Joint tenderness) had not resolved.            It was reported that patient took Cholesterol medication and Blood pressure medication.
Softball size swelling/pain & redness at site of vaccine injection. Treatment: Insains, alteration of extremity.
At 11:50 am Patient C/O being sweaty and clammy. patient stated she didn't eat breakfast in on a Keto diet. Vital sign's were monitored temp. 98.8, BP 160/97, Pulse 73, R 20 at 11:55 am. Water was giving and patient rested another 15 minutes. Vitals were retaken. temp 98.5, BP 138/87, pulse 68 and R 18. Patient stated that she was better. No additional complaints noted.
Approximately 10-12 hours after receiving the vaccine. I started having tightness in my chest; chest pain.; short of breath and difficulty taking deep breaths.; DOSE 1: 22May2021; DOSE 2: 05Aug2021; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 05Aug2021 at 12:15 (Lot number: FA6780)at the age of 51 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Premature menopause" (unspecified if ongoing); "Thyroid function decreased" (unspecified if ongoing), notes: low thyroid and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0187, Route of administration: Unspecified, Administration Time:10:45, Anatomical location: Left arm), administration date: 22May2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Aug2021 at 12:15, outcome "unknown", described as "DOSE 1: 22May2021; DOSE 2: 05Aug2021"; CHEST DISCOMFORT (non-serious) with onset 06Aug2021 at 01:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Approximately 10-12 hours after receiving the vaccine. I started having tightness in my chest"; CHEST PAIN (non-serious) with onset 06Aug2021 at 01:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "chest pain"; DYSPNOEA (non-serious) with onset 06Aug2021 at 01:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "short of breath and difficulty taking deep breaths". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Tachycardia and palpitations started when I laid down the bed to sleep for the night.
Information has been received from a certified medical assistant and physician concerning a 66 year old female with diabetes and hypertension who on 12, Feb 2007 was vaccinated with a 0.5 ml dose of zoster vaccine live (oka/Merck) (lot #652965/0622F). On 05, Mar 2007, the patient experienced shingles in the mouth which was diagnosed by a dentist. A sample of the lesions was unable to be obtained.  The patient had hives (date of onset not reported).  No laboratory tests were performed. There was no product quality complaint involved.  The final outcome was not reported.  No additional information is expected.
Fever 99.5 F start after 24hours High fever 101.3F start after 31hours Recovered from fever after 43 hours
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unspecified date the patient was vaccinated with live ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, while on live ZOSTAVAX, the patient had an unspecified anaphylactic reaction. She was admitted to an unspecified emergency room on an unspecified date for an unspecified length of time. Patient was given EPIPEN injection for treatment. The status of the patient was unknown at the time of reporting. Additional information has been requested.
Broken out in a rash on her arm and thighs; reddish blotchy looking; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 07:45 (Batch/Lot Number: EL9267) as dose, 1 single (at the age of 42-year) for covid-19 immunisation. Medical history included ongoing Blood pressure high, Autoimmune disease, sensitive skin. There were no concomitant medications. Historical vaccine of flu for immunization and had bumps, rash. She mentioned she does get the Flu Vaccine and it's possible the same thing happens, gets the bumps and rashes. However, they occur within a few hours and goes away. The patient got the vaccine, first dose, at 7:45 AM this morning. Right afterwards, physically she felt fine. However, she has Broken out in a rash on her arm and thighs. It was reddish blotchy looking. The rash was not itchy. She feels fine, but just wanted to know if she should report this and if this was something she should be worried about. The events occurred on 17Feb2021. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
States that several hours after receiving MMR injection she 6/1/07 she developed "itchy welts" on arm and continued to develop new welts on both her arms and her leg.  Continued to develop new welts until 6/15/07.  Took Benadryl 50 mg once daily until 6/15/07.  Denied SOB, difficulty swallowing or any swelling or fever.
Information has been received from a physician concerning a 68 year old male with gastroesophageal reflux disease, a history of glaucoma and no allergies who on 25-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included omeprazole (MSD), timolol, LUMIGAN, aspirin. It was reported that the patient was treated in mid June 2007 for a bilateral rash on the patient's buttocks, between the cheeks. The patient was prescribed KETAZONE for the rash. On 03-JUL-2007 the patient's rash worsened after vaccination. It was reported that the rash was not elevated, but reddened. It was reported that the patient experienced burning pain. A wound culture test was undertaken which was reported to be negative for bacteria. At the time of report the patient was not recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Additional information has been received from the physician who stated that the patient developed rash on buttock and in August 2007 the patient recovered. No further information is expected.
Received 2nd Dose of Heplisav-B on day 22 of The Series; Initial report received on 21-Sep-2023  A pharmacist reported that a patient (age, gender, race, and ethnicity not available) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the second dose of HEPLISAV-B 22 days later.   Medical history, allergies, and concomitant medications at the time of vaccination were not available.   On 30-Aug-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not available).  On 21-Sep-2023, 22 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not available).   No additional information was available.  Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Anaphylaxis with in 45 minutes of administration of vaccine pt developed lip swelling, wheezing, sob, pt went to ER and received epinephrine and advised to take Benadryl for 24 hours.
Patient got sick after first shot and was admitted in the hospital; Patient missed second dose and its been more than 42 days already; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient got sick after first shot and was admitted in the hospital) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient got sick after first shot and was admitted in the hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose and its been more than 42 days already). At the time of the report, ILLNESS (Patient got sick after first shot and was admitted in the hospital) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose and its been more than 42 days already) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment was provided. The patient was on several medications and did not want to go about listing all of them. she wants to know whether she should go ahead and get the second shot or not. She consents to follow up.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
ACUTE HYPOXEMIC RESPIRATORY FAILURE PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED HYPOXIA ANGIOEDEMA, INIT