chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BP (198/100)/BP is on peak; essentially weaken, she is going weaker; Diarrhea; temperature on and off; Lots of GI symptoms; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (BP (198/100)/BP is on peak), ASTHENIA (essentially weaken, she is going weaker), DIARRHOEA (Diarrhea), BODY TEMPERATURE FLUCTUATION (temperature on and off) and ABDOMINAL DISCOMFORT (Lots of GI symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HYPERTENSION (BP (198/100)/BP is on peak), ASTHENIA (essentially weaken, she is going weaker), DIARRHOEA (Diarrhea), BODY TEMPERATURE FLUCTUATION (temperature on and off) and ABDOMINAL DISCOMFORT (Lots of GI symptoms). At the time of the report, HYPERTENSION (BP (198/100)/BP is on peak) had not resolved and ASTHENIA (essentially weaken, she is going weaker), DIARRHOEA (Diarrhea), BODY TEMPERATURE FLUCTUATION (temperature on and off) and ABDOMINAL DISCOMFORT (Lots of GI symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: 198/100 (High) BP is on peak..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient has nerve pain from elbow down to wrist, can't hold  a pot, started ever since she got the vaccine.  She feels like a nerve got hit when she got the vaccine.  She returned for her second dose 4 weeks later and reported that the symptoms hadn't gotten any better and she was still having pain at that time.
8:20 am  BP=164/90- 71 hr, O2 sat=97%.  Initial complaint of lightheadedness.  Was able to eat some snacks and water to compensate.  BP lowered at time of release to home to 150/88.  Encouraged to eat and drink throught the day and to result.
Patient described pain at injection site (deltoid) that radiated down the arm to the hand, 10 out 10 pain.
Pt stated that two hours after vaccine was administer she developed a sore throat, lethargy, increased temperature 99-100 degrees f  & difficulty concentrating for approximately 18 hours
Information has been received from a health professional concerning a 12 month old female who on 5/10/05 was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. It was reported that on 5/23/05 the patient was seen in the office for diaper rash. The patient came back to the office on 5/26/05 because the rash did not go away. The rash was cultured and found to have staph and yeast. The reporter noticed that a varicella type rash had spread to the right inner thigh, back, torso, and left lower leg. The doctor described the case as moderate breakthrough. The patient was given an IM injection of ceftriaxone sodium in the office. She was then prescribed oral cephalexin and fluconazole. It was noted that the doctor felt that the diaper area infection caused the varicella breakthrough. NO product quality complaint was involved. The reporter felt that diaper rash and varicella type rash were other important medical events (OMIC). Additional information has been requested.
POSSIBLE PERMANENT EYE DAMAGE; This spontaneous report received from a consumer via social media (twitter) concerned a patient of unspecified age and sex, unspecified race and ethnicity. Initial information was processed along with the additional information received from consumer on 26-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, the patients were hospitalized' (date unspecified). It also reported that the patient might have permanent eye damage' The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible permanent eye damage was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210861653.; Sender's Comments: V0: 20210850188- Covid-19 vaccine ad26.cov2.s- Possible permanent eye damage. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt stated 30May that 7 days post vax became weak @ work, had to be taken home & c/o muscle/joint aching; severe pain-could not walk; 28MAAY-29 c/o h/a, back, neck pain; 29MAY c/o swollen, painful glands w/anxiety-denied feve
Dose 1 on 1/21/21 - very sore upper left arm  Dose 2 on 2/18/21 - arm not as sore. Developed 3 small pimples on lip edges: 2 on edge of upper lip, and 1 on edge of lower lip. This is very unusual, I have very clear skin and no problems with pimples or acne. No new or different skin products or makeup was used. No new/different soap or cleansers used. I just thought this was a weird reaction. The pimples went away after about 5 days.
This spontaneous report was received from a nurse practitioner regarding an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medication were not reported. The reporter stated that, some of the nurses at her facility were properly reconstituting M-M-R II by using entire volume of sterile water diluent supplied which was about 0.7 ml. However, they are improperly withdrawing and administering only 0.5 ml of the total reconstituted dose subcutaneously which resulted in patients' receiving partial doses of M-M-R II. No adverse events were reported. No product quality complaint was involved. Additional information is not expected as consent to contact was not provided.
pt recv ax 20APR98 & approx 2wk later on 4MAY98 pt devel elevated liver function tests, malaise, dark urine & nausea;relevant lab data include SGOT 1300, SGPT 970, total bilirubin 1.78;pt not hosp;
Vaccine given in error; No adverse reaction to vaccine; This non-serious case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2307076-1. The original narrative from the sender is the following:  Vaccine given in error. Order was for Varicella (Varivax) which was misread and Dtap IPV HIb HepB (Vaxelis) administered. Pt had no adverse reaction to vaccine and will receive correct vaccine during 15 month well child check.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Vaccine given in error".  No further information is expected.
This spontaneous report was received from a licensed practical nurse regarding to 2 patients of unknown age and gender. There was no information about patient's concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, Lot # L013546, expiration date 17-JUL-2016, (dose and strength were not reported). No concomitant medication was reported. No adverse event was reported. No PQC involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient has redness on the chest and shoulder on the left side. refers to itching in the reddened area.
I have never had Gout before and two days after getting my COVID-19 vaccine I started to have swelling in my foot. My shot was on a Thursday and Saturday is when this started. On Monday I called my doctor and was able to get in the next day. They did a Uric Acid test since I had started having excruciating pain and the swelling did not get better. It was so painful that even my bed sheet hurt to touch my foot and at this point it looked like a marshmallow. Not only was my foot swollen and hurting but joints were as well. The test came back above 8 which is indicative of Gout. I was put onto a medication that helped with the joint pain and swelling but not the swelling and pain in my foot. I was then put on a steroid and that helped. At this point I am not recovered but it is much better. I do have a follow up with my health care provider to check again coming up in the future as well.
When patient was called 8-6 at 404pm she just had woken up from a nap and had chills. Called pt 8/7 750 am was had sore arm. Called again at 350 pm pat was fatigued. Called pt 8-8 at 8 am and patient was fatigued. Called at 4 pm pt was feeling better. Called pt 8-9 pt was feeling much better.
Rash at vaccination site appeared one week after 1st dose on 4/5. Patient took antihistamine Zyrtec for 2 days, but rash increased in size, then patient came in for visit with doctor. Doctor prescribed one week course of ciprofloxacin 750mg twice per day.
Patient had her vaccine at 1:45pm. By 2:12 patient noted lightheadedness and brain fog and fatigue. Patient requested to go to the bathroom. She was taken by a staff member. Patient reports hx of epilepsy, hx of covid with hospitalization, and kidney disease. 2:22 her bp was 104/63. Her HR was 80 and RR 20 and oxygen 95%. Still reported feeling lightheaded and sensation of head floating similiar to when she had seizures. We gave the patient orange juice and crackers. 2:32 bp was 110/72 with HR of 82 oxygen 99%. States feeling better but still slightly foggy in the head. 2:42 bp 118/76 hr 78 and oxygen 98% feels better and is more talkative. She asked to rest with her eyes closed for a few more minutes.
Pt received 0.5 ml intradermally, when it should have been 0.1 ml
Pt received 2nd dose early per his request. He needs to travel on 4/4/22 and is required to have had both vaccines at least 2 weeks prior. Pt was not due for his 2nd shot until 3/28/22. We did review with the patient we could do the 2nd shot up to 4 days early for it to still be considered valid but for his situation, the airline said he needs to have the 2nd dose completed today 3/21/22.  He is aware 2nd shot today is considered invalid. Patient is aware that it is recommended he repeat the 2nd dose after 8 weeks per the CDC COVID Vaccine Administration Errors and Deviation form. Pt still requests his 2nd shot be given early today.
Three patients age 17 years old received first dose of Moderna vaccine; Pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three patients age 17 years old received first dose of Moderna vaccine) and PAIN (Pain) in a  patient of an unknown age and 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 (Three patients age 17 years old received first dose of Moderna vaccine) and PAIN (Pain). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three patients age 17 years old received first dose of Moderna vaccine) had resolved and PAIN (Pain) outcome was unknown. 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 concomitant medications provided. No treatment details reported.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received on 08-JUN-2021.Added new event very painful.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Fever of 102 degrees, macular papular rash over face, trunk, arms and legs. Symptoms lasted 4 days, treated with Palgic 4mg qd, Cortane B lotion and Tylenol. Full recovery noted.
Palpitations, chest tightness, anxiety, nausea, elevated heart rate - symptoms worsened after vaccine number 3.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: Patient fainted a few minutes after receiving vaccine. She regained consciousness quickly and was given water. She said this was not an unusual reaction for her to have after a shot. She was nauseous and vomited a small amount. 911 was called and she was assisted by EMS. Patient was conscious, alert, and responsive. Left with EMS, outcome unknown.
Severe endometriosis flare up on right ovary. Lasted several hours pain radiated down right thigh.
Information has been received from a registered nurse concerning a patient who was vaccinated subcutaneous with a 0.5 ml second dose of VARIVAX (Merck). Subsequently the patient experienced injection site reactions after the second dose of VARIVAX (Merck). The symptoms included redness, bumps and heat at the injection site. Within 3 - 4 days, the reaction was gone. The nurse also reported the same events for other patients (refer to WAES# 0806USA00992). Additional information has been requested.
Dizziness, Migraine, no visual disturbance.  First Migraine accured on 05/12/2021 lasting 24 hours, Second migraine on 05/19/2021, lasting 24 hours
No adverse effect at this time - adult Pfizer vaccine given to pediatric patient. Patients mother reported Patient is okay with no issues at this time but advised to update if anything were to occur.
Minutes after the vaccination at 07:20 on 10/25/2021 I had swelling on the right side of my neck and left side on my arm, on Tuesday I had the expected symptoms on 10/26/2021 at 02:00PM ET, I had chills, fatigue, chest pain and fever of 102  and after 6PM my heartrate was high even at rest and I still had a fever at that time, 10/27/2021 I still had a high heart rate at resting, the fever went away but the pounding was extremely high, then I started having pain on my left side of my neck and on 10/28/2021 I had a Virtual appointment and I was advised to take Tylenol around the cock and If I didn't feel any better by Saturday 10/30/2021 to go to the ER. I wasn't feeling better and I was concerned about my heart rate and 10/29/2021 I saw my Cardiologist and he evaluated me he said to go to the ER right away and that when I went to Hospital and while I was there I was given IV and a relaxer for my pain and they took X-ray and blood work. they gave me a 50MG injection ketorolac and sodium Chloride 0.9 Bolus dose given 1000ML per hour one time.  Then they released me and advised me to see my PCP and to continue taking Ibuprofen as needed. 10/30/2021 I had another virtual visit and they told me again to go back to the ER if the chest pain was still the same and also 10/30/2021 I received a call from Hospital to let me know that my ESR was elevated and to follow up with my doctors and to let them know that my ESR was elevated and on Sunday 10/31/2021 I went to the hospital again because I vomit that morning and I started having pain on left side of my temple left side of my chest and I was fatigue and the left side of my Ribcage was painful. after that I continue with the same pounding on my chest and I don't know but my menstrual came earlier and I'm regular. The only thing I feel is the swelling and the ponding on my heart but I still get sharp pain and the left side of my temple is still there. Sometimes I feel pain on my left side of my elbow joint.
Patient was given the 5-11 yo COVID vaccine dose instead of 12+yo dose.
11/16/21-11/17/21 Fever up to 102; myalgia, arthralgia, dizziness 11/18/21-11/19/21 Asymptomatic 11/20/21 Experienced acute severe vertigo with retching; husband called EMS due to my inability to stand or walk without staggering. Went to ER where had CT of head, 12-lead EKG, labs and chest xray. Had IV Zofran and PO meclizine with slight improvement. D/C'd home with presumed diagnosis of vertigo. Vertigo continued despite Meclizine until  6pm 11/22/21
Burning sensation in lungs that got progressively worse. Similar feeling that I had when I had my anaphylactic reaction to shellfish.
Mother reported that patient c/o "swollen hands and feet" and "couldn't walk" on his feet. Seen in the ER mid-morning, basically normal exam. No treatment given (but instructions to give Benadryl if Sx's worsen or return).
Patient received second dose exactly 14 days from the first dose. Patient did not have any adverse reaction.
Heart attack; Dizzy; Blood pressure up; Weak and tired; Left arm in pain; Weak and tired; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 59267-1000-02), via an unspecified route of administration, administered in Arm Right on 12Aug2021 11:00 (at the age of 70-years-old) as dose 1, single for covid-19 immunization. Medical history included chronic pain, Covid-19 and IV contrast from an unknown date and unknown if ongoing. The patient received unspecified concomitant medications. The patient previously took tramadol and experienced allergy. The patient did not receive any other vaccines within 4 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. On12Aug2021 12:00, the patient experienced first day headache second to present dizzy, nausea, blood pressure up, weak and tired. She thought she was having heart attack as she had left arm in pain and went to emergency room. This took place on 6 day of receiving vaccine had been in touch with her doctor since Monday. The adverse event resulted in emergency room/department or urgent care. The patient received treatment in result of adverse events was blood work and X-RAY of chest. The patient underwent lab tests and procedures which included blood test: unknown results, chest x-ray: unknown results on an unspecified date. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Immediately became constipated after vaccination, uncontrollable bowel movements, unable to walk, fatigue, heart palpitations, loss of balance.  11/28 - began to suffer from seizures.
The patient presented in the ED on 3/11/2021 with abdominal pain. She reported having diarrhea and increased number of bowel movements compared to her normal. Reason for admission: suspected acute diverticulitis at distal sigmoid.
sick (malaise); fever; weakness; chills; Shingles/pain from Shingles rash on back/spots on back/skin crawling/itching/dry heaves; This spontaneous report was received from a 63-year-old female patient via Glaxosmithkline GlaxoSmithKline, reporting on herself. Medical history included that she was diagnosed with shingles 13 years ago. Information regarding concurrent conditions and concomitant medication was not provided.  In approximately 2008, when the rash went away, she received zoster vaccine live (ZOSTAVAX) for prophylaxis (dosage information, route, lot number and expiration date not reported). On an unknown date, the patient was vaccinated with varicella zoster vaccine rge (cho) (SHINGRIX) 0.5 (unk) (dosage information, route, lot number and expiration date not reported).      The patient referred that on an unknown date, when she had her first dose of varicella zoster vaccine rge (cho) (SHINGRIX), she was sick (malaise), fever and chills and couldn't get out of bed (weakness) and it lasted 2 days. These events resolved on an unknown date.   On 20-SEP-2021, she received the second dose of varicella zoster vaccine rge (cho) (SHINGRIX). Starting hours after the second dose, she had fever, chills, and she had been sicked all week, nausea, dry heaves and on Tuesday night when she took off the bra, on her back below the neck there was the first spot, kind of dime size. She went back to primary care on Wednesday (22-SEP-2021), started itching, the whole body, felt like her skin was crawling, and the spot on her back had turned into a rash. She was told to take some diphenhydramine (BENADRYL) and put cortisone cream on it, diphenhydramine (BENADRYL) did not help, cortisone cream made it worse, Wednesday was horrible, Thursday the rash was worse, she went back to the doctor and was diagnosed with shingles. The doctor told her to take pregabalin (LYRICA) for the pain from the shingles rash, but she did not take it. Fever, chills, nausea, and dry heaves are resolved. Itching, shingles rash, shingles rash pain, and skin crawling were not resolved. The outcome of shingles was unknown. The patient would like for it to be recorded that she is furious that varicella zoster vaccine rge (cho) (SHINGRIX) caused her shingles outbreak. The causality assessment between zoster vaccine live (ZOSTAVAX) and the events was not provided.
My son Fell out at work after shot was given. He had a seizure, he lay unresponse on floor until medics were called. He noe has a blood clot in brain & has had 3 more seizures.Patient drives a fork lift & drives a truck he is nolonger able to do either.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2007 the patient was vaccinated with dose 1 GARDASIL (lot # not reported), dose and route not reported. On an unknown date in 2007 the patient was vaccinated with dose 2 GARDASIL (lot # not reported), dose and route not reported. No concomitant medications were reported. The nurse stated that patient was in the office on 25-SEP-2012 to receive the third dose of GARDASIL (lot # not reported), dose and route not reported. No adverse event reported. No other information to report. Additional information is not expected.
Fever of 99.3 taken 1 hour after administration of APAP; fatigue; sore muscles, diahrrea, headache, sore joints, burning eyes, hyperalgesia, decreased appetite
Starting Day #2 - Nerve or joint pain in the hip, lower back, leg, and ankle.  Shingle outbreak on Upper left thigh at day #3. A small rash developed in about an inch area and it doubled in size and number of bumps until they turned into blisters. The pain has dissipated and focused on the thigh outbreak area.  On Day #8 - the blisters have not been broken - but an island of discolored skin (whiteish and red-tinged) with a little extra fluid retention has grown around the outbreak.
Extreme bruising, swelling, heat on day 1.  Swelling, numbness, itching, bruising continued for days. Day 11 arms is red, itchy, swollen.
pt recvd vax 11NOV93 & 19NOV93 devel a febrile sz & was adm to hosp for 1 day; lab eval revealed nl CBC, differential & CSF; pt recovered; no further details were provided;
Burning pain upon injection turned into dull ache within approximately 20 minutes. 3 months later still experiencing aching pain that intensifies with use of the muscle.
9/13/2011 12:22:13 PM > received shots on Friday, 9/9:  was noted to have a small temp over the weekend (99) & has been having diarrhea since; stooling at least 10; medium - large watery stools noted.  Voiding well, no vomiting noted, no blood or mucus noted in stools.  Eating well (BFing - 5 oz q 4 hrs)
Patient had sore/painful arm immediately after injection, pain became worse and was radiating down arm. Pain persists to this day (3/27/19) and has only mildly subsided. Patient reports he cannot sleep on side of injection and pain limits his activity (putting away groceries after shopping) - so I will indicate there is currently some disability.