chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; Patient was administered expired VAQTA; This spontaneous report has been received from a consumer referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 17-JAN-2023, the patient has vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) intramuscular Injection (lot #W007382 had been verified to be a valid number; expiration date 16-JAN-2023, and upon internal validation established as the same date) for prophylaxis (dose, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported) (expired product administered). No additional adverse events were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA006915:
Severe swelling, heat - treated with ice, BENADRYL, and CLARITIN.
administered on 6-4-07 Client to clinic on 6-7-07 with site of vaccine with red area about the size of a 50c piece. First noticed reaction on 6-5-07. It was itching and red. itches now alone. Clients Temperature 97.6 deg
She is having like a swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68-year-old female patient received bnt162b2 (BNT162B2), administration date 13Aug2021 (Lot number: FC3181) at the age of 68 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Aug2021, outcome "unknown", described as "She is having like a swollen lymph nodes".  Additional information: Reporter seriousness for She is having like a swollen lymph node was reported as Unspecified. Reporter stated, "Okay, well basically it's not for me, my roommate she got Pfizer got last Friday and reporter got the Pfizer shot on Tuesday okay she had hers (Unclear) now for almost like 6 days was that normal, was it normal?" (As reported).  Follow-up attempts are completed. No further information is expected.
Began experiencing redness, swelling of upper arm, chills & fever, at night. 10/8, Continued w/pain & swelling, advised to see MD. Saw MD 10/8 & given injection of antibiotic & Rx for same & told to keep arm in sling & elevated.
Vivid red itchy rash  both legs; Vivid red itchy rash  both legs; fevers; chills; This is a spontaneous report received from a contactable consumer or other non hcp.A elderly 83 years old female patient received bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 21Feb2021 09:00,at the age of 83 years old, as Dose number unknown,single for covid-19 immunization.Medical history included atrial fibrillation and hypertension from an unknown date and unknown if ongoing.Concomitant medication(s) included atenolol,diltiazem and irbesartan taken for an unspecified indication,start and stop date were not reported.The patient experienced vivid red itchy rash both legs, fever and chills on 02Mar202118:00. Therapeutic measures were taken as a result of vivid red itchy rash both legs,fever and chills.Treatment received for adverse event was Prednisone 20mg 1 pill per day 7days.The patient was not diagnosed with covid prior vaccination and not tested for covid post vaccination.The patient reported no allergies.The patient had not received any other vaccine within 4 weeks.The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Flu shot painful but blamed on need used.Within one hr of shot, swelling in back of throat and tongue.Within 6 hrs, face poofy (all wrinkles gone), tongue and throat swollen, difficult to talk. At 8pm onward, chills set in including goose bumps; couldn't get warm. 5 hrs post shot, ate oatmeal to be sure she could swallow although not hungry. Drank green tea with honey. Went to bed at 9pm, slept until 8:30am. She generally awakens at 6:30am.
I got the vaccine on Friday, and was feeling great. No sickness, had the next day planned. Woke up on Saturday with sweats, chills, body aches, muscle aches, and fever. Took my temp, and it was 101.7. My right arm was still sore, and my right lymph nodes were swollen. I had diarrhea, headache, cough, fever, nausea, almost puked a few times, lack of appetite. This morning, I noticed a rash on my legs. I called the pharmacy right away and told them about it. Took some Benadryl to help with the itching. I?m still recuperating from the vaccine.
There were 4-5 individuals at the local clinic on 1/19/23 that received the 6 months to 5 years monovalent formulation due to a preparation error. Clinic is unable determine which 4-5 individuals out of 14 actually received the monovalent formulation instead of the intended bivalent product.  Moderna monovalent Lot number was AS1414B with manufacturer expiration date of 2/13/23.  No adverse reactions
I noticed some rash on my abdomen and arms; Itching; Lichen Planus autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received  (BNT162B2), on 17Mar2021 at 15:00 as dose 1, single (Lot number: EP7534) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure after Covid" (unspecified if ongoing), notes: Other medical history: High blood pressure after COVID; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications.  The following information was reported: RASH (non-serious) with onset 18Mar2021 at 08:00, outcome "not recovered", described as "I noticed some rash on my abdomen and arms"; PRURITUS (non-serious) with onset 18Mar2021 at 08:00, outcome "not recovered", described as "Itching"; LICHEN PLANUS (non-serious) with onset 18Mar2021 at 08:00, outcome "not recovered", described as "Lichen Planus autoimmune disease". The events "i noticed some rash on my abdomen and arms", "itching" and "lichen planus autoimmune disease" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus, lichen planus.  Additional information: On 18Mar2021 the patient noticed some rash on abdomen and arms. Thought it was mosquito bites and within 5 days it got worse. Went to physician for consult and then dermatologist and infectious disease doctor. The patient submitted to of blood work to file out diseases like syphilis, DM, hepatitis and HIV. All test results were back normal. Took doses and doses of cortisone to help with itching and recently got diagnosed with Lichen Planus autoimmune disease.  Doctor believe it is a reaction of Covid vaccine and now I have no hope. The patient was a healthy women and never had skin issues until she got vaccinated. Her body is all covered with scars and few treatments options including light therapy which is not cover by my insurance. The patient had all test results including biopsy and pictures. Treatment received for the adverse event included Cortisone pills and steroids cream. The patient had past drug history included unspecified drug Reaction: Allergy.
1JUN98 devel pimply pink rash back, neck & chest;no fever or other sx;4JUN98 f/u pt had rash 2 days & it subsided;
This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot# L99262, Exp date Feb2017, NDC 00005197102, UPC 300051971022), intramuscular, on 16Feb2016, at 0.5 ml single. No other medication was administered to the patient on the same day. Relevant medical history included high blood pressure/hypertension. Concomitant medications were not reported. The patient experienced swelling arm on an unspecified date with outcome of recovering. The reporting pharmacist did not know if the swelling of arm was related to PREVNAR 13. Follow-up (27APR2016): Follow-up attempts are completed. No further information is expected.
Headaches and inability to focus. I sought a professional opinion when they increased in pain and occurrence. Ruled out dehydration, alignment, and vision problems. Symptoms unchanged by medications.
Info has been received from a physician concerning her oldest child (child has 4 younger siblings) who, at the age of 3, was vaccinated, SC with a 0.5ml dose of varicella virus vaccine live. In February or March, 2005, the pt broke out with chickenpox during a school outbreak, developing about 40 lesions but no other symptoms. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the pt's 2 siblings also developed chickenpox (WAES0509USA02318 and WAES0509USA02319). Additional info has been requested.
Gave patient a high dose flu shot instead of regular dose indicated for 58 year old patient. Patient aware of mix-up and counseled about potential for increased side effects.
Severe localized lt deltoid pain, denies rash, fevers, or numbness, took ibuprofen 800mg po and her pain subsided.
Patient had no symptoms or adverse effects from administration of vaccine.; patient received two doses of VAQTA at less than minimum interval; This spontaneous report was received from a nurse and refers to a 15-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 14-MAR-2022, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) first dose (strength, dose, lot #, expiration date, and route of administration were not provided) for prophylaxis. On 11-APR-2022, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) second dose, 0.5 milliliter, lot #U012007, expiration date: 18-JAN-2023 (strength, and route of administration were not provided) for prophylaxis (Inappropriate schedule of product administration). No adverse events were reported (No adverse event).
fever, vomiting, pale, limp intermittent lethargy;occasional leg jerking few seconds;eyes losing focus, diarrhea x 1;
Pt recvd vax & had feeling of nausea nothing given that time; eyes watery; unable to eat stomach turning; trembling, cold, crying; head hurting; throat felt tight;
Mom stated she noticed pt's L arm starting to get red and swollen on 7/31/02. Pt felt warm to touch, but no temp. taken. When pt came for skin test recording on 8/1/02, pt's upper L arm was red, swollen, and hot to touch. Appt. was offered have to get evaluated by MD, but pt has assigned PMO.
COUGH; LIGHT HEADEDNESS / DIZZY; CHILLS; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0428218, expiry: not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 07-APR-2021, the subject experienced cough. On 07-APR-2021, the subject experienced light headedness / dizzy. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fatigue on APR-2021, was recovering from fever, and light headedness / dizzy, and had not recovered from cough. This report was non-serious.
Employee states that the muscle in her arm became sore the evening after receiving her vaccine on 12/18/18. She states that the pain continues and is intermittent, described as feeling like a "charlie horse" in her muscle. There are no complaints of redness, pain or swelling at the site, no fever, no numbness. Employee states that the pain comes and goes, and is "deep" in the muscle, just not improving with time or use of Tylenol or Ibuprofen. I consulted with the hospital's pharmacist and epidemiologist. The employee was encouraged to follow-up with her physician.
Itching started on my belly. It goes deep into the muscles. It spread to my entire abdomen and has been HORRIBLE for 60 HOURS now!!! After 36 hours of itching, I developed a fine pink rash on my abdomen! WISH I'D NEVER RECEIVED THE STUPID VACCINES!!!
I received the Moderna Bivalent booster and a flu shot on 10/19/2022. On 12/15/2022, I developed fatigue. On 12/16/2022, the fatigue was even worse. At about 5:30PM, I took a home antigen test and got a positive result. I then went to bed and made sure to isolate from my husband. I couldn't really eat and lost about 10-12 lbs., because I couldn't smell or taste anything. I also had diarrhea and vomiting, so I couldn't keep anything down. Whenever I vomited, it was often just a yellow liquid, because I hadn't eaten anything. I also developed a sore throat and cough on 12/16/2022. I also had a low-grade fever of 100.1 on 12/16/2022 and 12/17/2022. I lost my senses of smell and taste completely; when my husband brought me cinnamon, I couldn't even smell or taste it. The smell and taste did not return for about 2 1/2 weeks. I treated my diarrhea with IMODIUM, and it helped. By the time 12/19/2022 rolled around, much of the vomiting, nausea, and diarrhea has subsided. On 12/19/2022, I went to an urgent care clinic. The doctor examined me and said that my lungs were clear. My symptoms had started to subside for the most part, and I had no fever, so she told me that I didn't need an antiviral. I continued to test positive until 12/30/2022, which was when I finally tested negative for the first time.
Pt reported temp of 38 Celsius without using a thermometer, fatigue, headache and generalized body aches. Seen by student health MD who recommended Tylenol and rest.
19-apr-94 mom states had low grade temp & the whole lt deltoid was swollen, red, hard, & hot to touch; states area is still swollen & warm to touch-area still hard;
On 7/26/2022 and 7/27/2022, I was serving. On the night of 7/27/2022, I received an email notifying me that the trainer had tested positive for COVID-19. On 7/28/2022, I had a slightly sore throat when I woke up. I decided to stay at home and took a home antigen test, which yielded a negative result. I started to feel tired and to have a headache. On 7/29/2022, I woke up with a significantly sore throat, slight headache, and a slight fever. I tested negative again. Throughout the day, the symptoms worsened. By the morning of 7/30/2022, I had a high fever, significantly sore throat, a headache, and extreme fatigue. I stayed in bed for maybe two or three days afterwards. I didn't feel well enough to do anything, though I did try my best to drink plenty of water. Starting on 7/29/2022, I tested positive every day on the home antigen tests. On about the fifth day, I developed a persistent, unproductive cough. My lungs felt heavy, and I had a little shortness of breath. I thought that if it got any worse, I would have to contact a doctor. Fortunately, though, it didn't get worse, and I didn't have to see a doctor. During my illness, I took two Aleve to treat my fever, and they helped. About two days after the cough started, I had burning, watery eyes and runny nose, and this lasted for about three days. I finally tested negative on about 8/7/2022. I stayed at home for another three days to be on the safe side. When I finally went out, I felt extremely tired, a little heavy in the chest, and like I had brain fog. I kept waiting for the symptoms to improve, but they have gotten worse. Since then, I have had memory loss. I'm the sort of person who puts items in the same place every time I use them, but one day, I couldn't find my car keys. I then went out to my car, and the car was running. I couldn't even remember putting the keys in the ignition! Whenever I'm tired or under a lot of stress, it gets worse. I have progressed from having memory loss to actually having no short-term memory in recent time.  In around November 2022, I developed a condition in both eyes in which I see what seems to be an aura of light. I can still see everything, but it's kind of fuzzy. I don't know what is causing it, and I am due to see a doctor in the near future to find out what the issue is.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX. Concomitant products included EFFEXOR. On 27th April 2018 09:30, the patient received the 1st dose of SHINGRIX. On 27th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 27th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 27th April 2018 19:00, the patient experienced generalized joint pain and generalized muscle aches. The patient was treated with TYLENOL. On 28th April 2018, the outcome of the generalized joint pain and generalized muscle aches were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm, generalized joint pain and generalized muscle aches to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's spouse. On 27th April 2018 19:00, 09:30 hours after receiving SHINGRIX, the patient experienced generalized joint pain and generalized muscle aches. The patient developed muscle and joint pain all over her body about 7 or 8 PM. The patient took a TYLENOL and felt fine the next day. She went to sleep around 5:30 AM.
Pt is a 24 y/o. He has been in good health throughout his life until February 2000 when after receiving his 2nd anthrax vaccination he began having severe recurrent headaches. Since that time he has persistent and worsening headache after subsequent doses of the anthrax vaccine. He received his first shot ; the 2nd and 3rd. His symptoms immediately following his anthrax injections are listed below. Anthrax #4 headache occurred three days after injection, increased in intensity. Rx with compazine and Percocet, helped for short period, but headaches returned. Reports he is having a difficult time at work due to either to his headaches or the effect of the medication he is taking. His work schedule (on 2 days, off two days and on three days)-also makes it hard for him to recover from his recurrent headaches. He is currently taking Motrin for mild headache and lying down in a darken room for mild headaches; for the more severe ones he has taken Percocet-up to 3/day. Has been treated in ER 6 times during last month where he has received Dilaudid and phenergan IV. Seeing neurologist MD who wants him to begin a trial medical regime on Maxalt 10mg at onset of headache; repeat in 2 hrs prn limit 3 tablets/24 hrs or 8/week. If no relief Zomig 5mg, repeat in 2 hrs prn limit 2 tabs/24 hrs or 8 tabs/week. If no relief Axert 12/5mg at onset, repeat in 2 hrs prn limit 2/24 hrs or 8 tabs/ week. His symptoms have hindered his ability to exercise. Previously he would exercise 4 times a week running at 2 miles and doing some weight-lifting. He is currently unable to run. He has a profile that does not allow him to "arm up" or to drive when on pain medication.
PATIENT STATED THAT THE SITE OF INJECTION WAS RED AND IRRITATED AND IT SEEMED LOWER THAN USUAL.  COUPLE OF MONTHS LATER SHE WENT TO A DERMATOLOGIST AND VOLUNTEERED TO HAVE A "SURVEY" AS BIOPSY PROCEDURE AT THE SITE AND AFTER THAT IT GOT WORST AND STILL RED AS OF TODAY
8cm diameter area of erythema, increased warmth, and tenderness at site of injection.
Fever; arm soreness; swelling andpain at injection site; swelling andpain at injection site; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old patient of an unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Sep2021 at 15:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, irritable bowel syndrome (IBS) and severe allergies. The patient had a history of allergic to kiwi and to all furry animals. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 23Sep2021 at 18:00, the patient experienced fever, arm soreness, swelling and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, arm soreness, swelling and pain at injection site was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
hard area around injection site; Chills; Fatigue; Muscle pain; Headache; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard area around injection site), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068F21A, 047B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced VACCINATION SITE INDURATION (hard area around injection site), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, VACCINATION SITE INDURATION (hard area around injection site), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Child's arm was swollen, red and warm to the touch. Mom was told to treat with Hydrocortisone cream, Benadryl, and Ibuprofen  as needed.
THREE DAYS AFTER RECEIVING VACCINE i AWOKE WITH A RED, RAISED, DIFFUSE RASH COVERING BOTH ARMS AND UPPER CHEST--RASH WAS WORSE ON UPPER ARMS AND UPPER CHEST THAN ON LOWER ARMS  RASH WAS NOT PAINFUL, NOT REALLY ITCHY.  THREE DAYS AFTER RASH APPEARED (1/23 OR 24) SKIN STARTED FLAKING/PEELING OFF BOTH ARMS AND CHEST.
mom states pt had high shrill cry for several hrs, lt leg became swollen & devel fever (exact temp unk) 103 per MD chart; notified personal MD-did not notify clinic until 1SEP94;
Painful 4.5 cm X 4.5 cm Red Raised area Right arm deltoid area noted 8/11/09 12:30 PM - Ibuprofen as needed for pain - Cool compresses as needed - Continue to monitor - Return child to office if worse
Three inch area below site of vax. Warm to touch. Complained of discomfort at site. Area was measured and mom was instructed to call back tomorrow to inform us if symptoms worsen. Advised Benadryl tonight. Call back tomorrow if onset of fever.
rash both arms & neck;itchy little bumps;feels pale, wiped out, cough more;
PATIENT BEGAN TO PASS OUT AND IT IS AMBIGUOUS IF HE PASSED OUT OR HAD A MINOR SEIZURE.