chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Minor headache with accompanying fatigue of equal intensity. Very minor muscle soreness in the area directly below the injection site, not the site itself.  Headache and fatigue began roughly three hours after injection. These subsided with one over the counter headache pill and an hour nap. They returned a short time later, but we slightly less intense.  As of 6 hours after the injection, no other side effects have been noted.
Site: Itching at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild
I have been diagnosed IBS D (Irritable bowel syndrome with diarrhea). Symptoms are correlated with stress pain, bloating in abdomen, frequent diarrhea; extra pressure in my bladder; gut cramps that make me feel fatigued and uncomfortable. They did a Xifaxin (2 week course - 550 mg 3 times a day for two weeks) - for gut biome to be reset - that did relieve a lot of symptoms for a time;  But this week, I'm starting to get symptoms back but I am a little more stressed again because I'm planning a move. Bentil - Antihistamine - that helps mitigate the symptoms - so I have been taking that.
migraine; This is a spontaneous report from a Pfizer Sponsored Program, received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had vaccine first dose this afternoon (26Feb2021) and wanted to know if she can take migraine medication The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
"flu-like"  started 03/20/21 in the afternoon.  Has had nausea, tiredness, headache, bodyaches that continue through 03/22/21. Called his own PCP who told him to call the Health Department.
I currently have numerous cold sores (herpes labialis) on my upper lip - started as tingling. I typically get a single cold sore when I am on the verge of having a cold or flu, but not three at once. I also experienced pain in my left armpit (assuming lymph nodes) for two days post-vaccine.
04/08/21 - Pain at injection site, Fever (100.4*F), Fatigue 04/09/21 - Pain at injection site and arm, Fever (100.0*F), EXTREME Fatigue, Joint Pain, Body Aches, Dizziness  (Did not go to work) 04/10/21 - Dizziness, No fever, Fatigue, Joint Pain, Nausea 04/11/21 - Large Joint Pain, Fatigue, Pain in Left Shoulder near injection site 04/12/21 - Large Joint Pain, Fatigue, Pain in Left Shoulder near injection site
FLU LIKE FEELING; PAIN IN RIGHT BREAST UNDER ARM; This spontaneous report received from a patient concerned a 52 year old female. 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced flu like feeling. On 12-APR-2021, the subject experienced pain in right breast under arm. Laboratory data included: Body temperature (NR: not provided) 103.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like feeling, and pain in right breast under arm. This report was non-serious.
Upper back pain, swollen glad under left armpit, large circular rash on top of left arm.     The upper back pain started on 4/16 and lasted three days, the armpit was swollen on 4/18 and lasted four days and the red circular rash started on 4/26  I have not received the second dose yet.
Liquid diarrhea after any food/beverage intake.    Only minimal relief from OTC Loperamide & PeptoBismal
Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number 3 . Pfizer Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 15:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 at 17:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 20Mar2021 at 16:45 as dose 2, single (Lot number: FF2590), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Mar2022 at 15:00 as dose 3 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna Dose Number 3 . Pfizer Dose Number: 4". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shingles after the first dose of Shingrix; patient received the first dose of Shingrix 1 year ago, and did not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported a patient received the first dose of Shingrix 1 year ago, and did not received the second dose yet, which led to incomplete course of vaccination.  Also, the patient developed Shingles 5 months ago. The HCP asked how to proceed with the second shot. HCP provided consent to be contacted for the follow-up of this case.
Initial unsolicited report received from a health care professional (Infectious Disease Specialist) on 28 October 2015. This case involves a 40 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number, dose, dose number and site were not reported) via intramuscular route on 2 October 2015. Patient's medical history includes allergies to antibiotics: Penicillin, erythromycin and concomitant medications was not reported. It was reported that, on 2 October 2015 (same day after vaccination in evening) patient developed severe pain in her arm, shoulder, and neck and also progressed to include headache, myalgia, low grade temp, sinusitis. It was reported that the patient required ER/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events pain in arm, shoulder, neck, headache, myalgia, low grade temp and sinusitis were recovering at the time of this report. List of documents held by sender: none.
Fever, stomach ache, chills, nausea, headache, aches, weakness
8/8/06 started itching, pink, swelling at site right deltoid, low grade temp. and pain.  Has taken ibuprofen and put ice on right deltoid.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/08/21pfizer,Lot#EL3248 2nd dose: 01/29/21Pfizer,Lot# EN5318 Diagnosed covid positive:04/23/21 Exposure:Home Exposure Symptoms:Fever, sore throat,fatigue,chills,muscle aches,runny nose,loss of smell/taste,HA
1 of 4 pts vaxed from the same Tetramune lot exp fever 102-103, irritability (crying) w/in 1 hr p/vax & inject site react described as swelling & redness; pt also recvd Orimune; pt recovered;
tingling on left pinky warmth hot sensations moving up towards the cheek cheek and lips went numb
Arm felt like a rock; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Arm felt like a rock), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy, Allergy to chemicals (Formaldehyde) and Sulfonamide allergy (All sulfa drugs). Concomitant products included SERTRALINE for Anxiety, OMEPRAZOLE for Hiatal hernia.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Arm felt like a rock), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE INDURATION (Arm felt like a rock), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-084745 (E2B Linked Report). This case was linked to MOD-2021-019243 (Patient Link).; Sender's Comments:  MOD-2021-084745:crosslinked, Husband of MOD-2021-019243
Upset stomach; Headache; Swollen glands; Breast pain on left side - where shot was given; Dose number 3; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Dec2021 (Lot number: FJ1620) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8731, Route of administration: Unspecified), administration date: 14Apr2021, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0176, Route of administration: Unspecified), administration date: 05May2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "Dose number 3"; ABDOMINAL DISCOMFORT (non-serious) with onset 14Dec2021, outcome "recovering", described as "Upset stomach"; HEADACHE (non-serious) with onset 14Dec2021, outcome "recovering", described as "Headache"; LYMPHADENOPATHY (non-serious) with onset 14Dec2021, outcome "recovering", described as "Swollen glands", BREAST PAIN (non-serious) with onset 14Dec2021, outcome "recovering", described as "Breast pain on left side - where shot was given". Therapeutic measures were not taken as a result of abdominal discomfort, headache, lymphadenopathy and breast pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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.
Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, chills.
A few days after receiving my vaccine, I began having heart palpitations. I turned so red that it concerned my coworkers and my boss. I'm not sure what happened, but it was some sort of heart episode. I felt like I had lost my breath and I knew my heart wasn't beating right. I called my doctor the following morning and she referred me to a cardiologist. The cardiologist did a stress test and other tests, but they never found anything. My doctor did tell me at the time that the vaccine probably created a mild case of inflammation around my heart and that it will clear itself up. I haven't had any more problems and I continue to receive vaccines.
no adverse outcome- patient had already received two pfizer and this was not caught in database prior to administration- investigation ongoing as to why this was not found
This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX QUADRIVALENT (batch number FS575, expiry date 30th June 2014). On 23rd October 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 18 pts were involved and investigation still ongoing. Called did not have pt info. Maladministration caught on 10/23/14.
Around 4PM on the day of the vaccine I started feeling severe joint pain and my hip were hurting really bad that I could barely walk. I also had nausea and headache (felt like a migraine). With my 1st dose I ended up at the ER so they had recommended me to take a Prednisone after the second dose. I took it and next morning I was much better. I still felt achy and my legs felt weak but that lasted only 48 hours and then I as fine.
Pfizer 5/13/21 and 6/3/21. Positive on 1/10/22
He woke up in the middle of the night vomiting. He vomited nonstop. I reached the doctor at around 10 am the day after because I was worried about dehydration, so he threw up about 15-20 times. The doctor called a prescription for Zofran for us and gave that to him and it helped a little bit. He slept for a bit and he was okay after that. He did say he had a headache before the vomiting started and during the vomiting as well.
I was given on May 27, 2016 a dose of PNUcn13 (Prevnar 13)(Pneumococcal conjugate, 13 valent and on June 27, 2016 I was given another dose of PNUps (Pneumococcal polysaccharide, pneumonial. I believe it was to soon to be given those similar vaccine. As soon as my secound dose was given I felt pain in my right arm that plain started spreding all the way to my back close to my neck. I could not move or elevate my arm. My arm got so swollen. I felt really thirsty. I did not felt right. I call the advise nurse. They told me to take Tylenol. The pain was so intense I felt like my arm was dislocated. I could not sleep. So I call in the morning to schedule appt to see my doctor. She diagnose that it was a local reaction to the injection. I still feel pain in my right arm. I was given Nabumetone.
I was in the hospital for a DVT and I started having symptoms on January 22. I didn't really feel that bad but my daughter told me after I got home from the hospital I was coughing a lot at night. I began to feel extremely fatigued and weak but never had a lot of other symptoms. I didn't get any treatment for the COVID19 because I was on a blood thinner. I took a home test for COVID19 on January 26th. At that point my two daughters were symptomatic and had tested positive for COVID19 so they tested me as well. As far as I know I have recovered but I have developed a lot of restless legs and feet at night and it makes it difficult for me to sleep. I did have it occasionally previously but since the hospital stay and COVID19 it is almost nightly.
Patient contracted COVID after being fully vaccinated Headache, Fatigue, Diarrhea
Fatigue, Fever, Chills, Muscle pain for 24 hours.  Ibuprofen and bedrest. Resolved by next morning.  Site pain persisted 2 more days.
Feverish the next day with intense body pains and my mensural cycle was messed up for 2 months following the shot.
Sleepy; tired/feeling fatigued; itching on left arm; She is pushing her self and she feels sluggish.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EL9269, expiration date was not reported) via an unspecified route of administration in the left arm on 13Feb2021 between 2-4pm (at the age of 65-years-old) at single dose for covid-19 immunisation. Medical history and concomitant medications were reported as none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no additional vaccines administered on same date of the Pfizer Suspect. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EL3248, expiration date was not reported) via an unspecified route of administration in the left arm on 23Jan2021 (at the age of 65-years-old) at single dose for covid-19 immunisation and no adverse effect. The patient received the second dose on 23Jan2021 between 2-4pm and was having a reaction. The patient stated that she told them at her job that she had been tired since getting the vaccine. They jokingly told her she was getting old. The patient was a strong person. On her 2 days off from work she was resting and sleeping. She was pushing herself and she felt sluggish in 2021. On 14Feb2021, the day after she received the second dose she was sleepy, she was tired and her left arm was itching. Since, the patient had been feeling fatigued, and sleepy even though she got 7 hours of sleep. There were no relevant tests. The patient stated that she mentioned to a doctor that she was feeling tired, and the doctor suggested that she should take vitamins, B-12 to help with energy and wait another month since the doctor was aware that the Pfizer Covid vaccine can cause tiredness. The treatment received for event tired/feeling fatigued was vitamins, B-12. Events sleepy, itching on left arm and felt sluggish did not require a visit to emergency room nor physician office. The outcome of events sleepy and tired/feeling fatigued was not recovered. The outcome of event itching on left arm was recovered on 15Feb2021. The outcome of event felt sluggish was unknown.
MODERNA VACCINE - 2 DODES  WHEN EAR BLOCKED DUE TO SWIMMING UNDERWATER TRIED BUT DID NOT SUCCEED WITH  EAR SOLUTIONS
Bivalent vaccine was administered with dose of 0.25ml instead of 0.5ml.
Infant Dx /w infantile spasms 1 month following vaccination.Infant normal prior to vaccine being given.
On 9/29/2021  Patient received the Pfizer booster shot at pharmacy On 10/18/2021 Patient said "I feel funny". She had very low energy and a mild fever. On 11/1/2021 Patient saw a doctor for her problem. Diagnosis fluid on the lungs. Sent to ER. See Attached hospital record. Patient is a 77 yo F with h/o atrial fibrillation/flutter, status post cardioversion, stroke, vertigo, admitted with complaints of shortness of breath, found to have large pleural and pericardial effusion, status post pericardiocentesis, pericardial window with opening of both pleura with bilateral chest tubes, developed acute kidney injury and hyponatremia in the ICU, transfer to the floor on 11/9 Patient found to have large left pleural and pericardial effusion with dyspnea on exertion and orthopnea.  Bedside pericardiocentesis on 11/3 followed by the subxiphoid pericardial window on 11/5.  Patient also had drainage of bilateral pleural effusions with chest tube placement and pericardial drain which was removed.  Started on colchicine daily for pericarditis.  Pericardial fluid AFB, fungal cultures, cytology negative.  Pericardial biopsy positive for SSB, seen by rheumatology team and concern for MCTD, recommend Plaquenil for a year, cardiology referral as alternative with steroids, due to interaction of Plaquenil with flecainide.  Plan for trial of prednisone with taper over the the next 3 to 4 weeks, started on 11/13. Patient has a history of A. fib with RVR, had been on flecainide, history of prior cardioversion.  Eliquis has been on hold with all those procedures in the hospital, now Eliquis resumed, flecainide discontinued per  EP team, as okay with CT surgery to resume. Patient was found to have fevers, mild leukocytosis, blood and urine cultures have been negative, chest x-ray unremarkable, ID team thinks that it's likely related to MCTD. Patient found to have acute kidney injury and hyponatremia with metabolic acidosis and urinary retention on admission, AKI resolved, initially was given albumin, diuresis was held.  Seen by nephrology team.  Patient had Foley catheter placed which was removed. Patient developed diarrhea, no abdominal pain, diarrhea resolved.  PT and OT recommended SNF, patient wanted to go home and home therapy was ordered, she will go home with her husband.
Extreme headache, nausea, vomiting diarrhea, loss of balance, dizziness, blurred vision, muscle spasms, muscle weakness, fatigue, joint pain. Lasting until 2/10. Have been to emergency room, neurologist, CT scan, MRI, EEG, given over 8 medications, seen multiple doctors. Most symptoms have subsided except for constant headache. Neurologist and internal medicine specialist both indicate extreme symptoms caused by virus. Was tested for cancer, polythycemia, MS, lupus, RA and a host of other diseases. I have been sick for almost 6 months and missed almost three weeks of work (thankfully I work in the school system and we have a lot of natural breaks).
she was sick/ Sick; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was sick/ Sick) and RHINORRHOEA (Running nose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. In January 2022, the patient experienced ILLNESS (she was sick/ Sick) and RHINORRHOEA (Running nose). In 2022, ILLNESS (she was sick/ Sick) had resolved. At the time of the report, RHINORRHOEA (Running nose) had not resolved.            Relevant concomitant medications were not reported.  In Jan-2022, she was sick with a running nose and it got resolved in 2022.  Treatment medication was not provided.  Company's opinion was that the causality with HUMIRA and the event of sick is not assessable.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620239 (Patient Link).