chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate reaction was the headache at the time of the vaccine, and has had headaches on and off but nothing like the initial one.   Started to get dizzy and felt weird on the ride home from the vaccine.  The headache lasted a fairly long time and got tired by the evening and the next morning.  The headache has still continued a  little off and on until now, 2/17/21.  The dizziness has gone away, the feeling "out of it" feeling has gone away, does not feel well about the concentration.  The tiredness and fatigue started the day after the vaccine and has gotten worse, has to drag herself through the day and by 1:00 PM is done through the day due to the fatigue.  Some days can go to 4:00 but most days only lasts until 1:00.  She gets up at 7:30 and today at 10:37 has the feeling of tiredness.  The gland under her arm a couple of weeks ago was swollen, which is still sensitive but not as bad as it was.  The fatigue is the main thing that continues to bother her.  She has not taken anything for these reactions.   She has seen her doctor, and is supposed to get some blood tests today, 2/17/21.
Hives, Benadryl 25 mg given, itching has decreased, but is moving from original area.
Patient presented to the COVID vaccination clinic to receive COVID vaccination. Patient was advised that he wanted to receive Johnson & Johnson vaccine and patient agreed. Patient was screened for allergies and for prior vaccines in the last 14 days, patient stated no. Upon administering Johnson & Johnson vaccine to patient he informed staff that he had already received the 2-step vaccine of Pfizer. Upon searching in patients EHR, it was verified that patient had received 2-step Pfizer vaccine on January 16th, 2021 and February 10th, 2021. Patient was monitored for 15 minutes after administration and was given vaccine face sheet. Patient was advised on adverse reactions and to follow up should reaction occur.
I was going thru menopause but almost immediately after both vaccine shots I got a very heavy period twice in a month.
This spontaneous case, initially received on 13-Mar-2018, reported by a physician, and concerns a 26-year-old adult female patient. The patient's current conditions included urticaria, attention deficit/hyperactivity disorder (ADHD), headache and allergies (since age 4-5 years). The patient was allergic to many foods (unspecified) and environmental things. The patient's concomitant medications were reported as none. On 16-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, expiry date: not reported). On the same day, after the administration of vaccine, the patient developed 1.5-1.75 cm wide rash, which was raised with bubbles. The patient also experienced pain, induration for 2 weeks and depigmentation at the injection site. 4 weeks after vaccination, the skin at the injection site was white and was no longer red. The patient was treated with Ibuprofen. The symptoms completely resolved by 4 weeks after vaccination. It was reported that, eventually the patient's skin peeled off (as reported) and at the time of the 4th week, the patient's skin had come off (as reported). The patient had recovered from the events.
While sitting in waiting room, patient stated she felt a little lightheaded. Patient stated the lightheadedness is not completely abnormal. Vitals checked: B/P: 120/58 Right arm, Heart Rate: 58 bpm, SpO2: 98% Room air
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain, tiredness and feeling abnormal. On an unknown date, the outcome of the muscle pain, tiredness and feeling abnormal were recovered/resolved. It was unknown if the reporter considered the muscle pain, tiredness and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter asked if he experienced the side effects of the SHINGRIX shot, was there any concern about being around his grandchildren or pregnant daughter who did not have chicken pox. The patient reported that his side effects were not any different then what was listed on GlaxoSmithKline's website. The patient experienced muscle pain, tired and just not real ambitious feeling. The patient did not receive the second shot till the of reporting. The patient agreed to be contacted to their physician for follow up and provided the contact details for the same.
I got lightheaded on the drive home. Since I got home I had cramps, gas and diarrhea. I've recovered some but not 100%. Ate no dinner last night.  Its been 5 days with these symptoms.
This case was reported by a physician via sales rep and described the occurrence of fever in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received SHINGRIX. On 21st July 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On 22nd July 2018, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional information was reported as follows: The physician stated that, one of their patients was vaccinated with a shot of SHINGRIX from the office on the past Friday, before the date of reporting. On Saturday, the patient experienced fever (body temperature: 103 degree F) for a day. The patient did not call or came in, so they did not see him. The reporter did not agree to be followed up.
Sibling with chickenpox wks prior. Twin sibling with chickenpox also, simultaneously. Note: lesions appeared on both children after sib with chickenpox.
In 2/21 I started to have abdominal pain that I thought was maybe an ulcer.  I was getting an upset stomach when I would eat.  This gradually got worse over the next couple of months where I would get nauseous and sometimes vomit.  On Sunday I got whole body tension/headache and threw up.  At this time the pain had moved over to the upper right quadrant of my abdomen.  After that I decided to go to my PCP.  She ordered an ultrasound of my upper right quadrant.  Everything looked normal except a kidney stone.  A HIDA scan was ordered.  This showed a low functioning gallbladder.  With my other symptoms, it appeared this was the issue and I had a cholecystectomy on May 10.   After surgery I continued to not be able to eat, only things got worse.  I could barely eat and had trouble with bowels.  At the end of July I started to develop ankle pain and swelling.  At this time my PCP ordered bloodwork showing I had high inflammatory markers.  She prescribed Prednisone which helped and also referred me to a gastroenterologist.  On August 19 I had a colonoscopy and EGD.  They showed high bile acid with inflammation and ulcers.  The biopsies came back showing no sign of IBD.  Due to my inability to eat, weight loss, trouble with bowels, inability to eat, uveitis, and inflammation -  Prometheus blood work was ordered and came back positive for Crohns Disease.  This all started less than one month after my second dose of Moderna.   Most recently on 11/1/21 I received my flu vaccine.  I have been experiencing joint roaming joint pain only on my left side for over a week.  I never previously had any reaction to the flu shot.   Whether this is all related or not, I am not sure, but everything is way too coincidental to not be.  I have done research on increased inflammatory responses after the COVID vaccine and feel that now I have a diagnosis, I need to report.
I immediately began to get dizzy and needed to walk it off before leaving the facility, I was totally disoriented like with alcohol or drugs and I fear of fainting.
Cellulitis of thigh around injection site swelling, redness, induration. Treated prophylactically with antibiotic, Keflex.
On 09JAN2023 they removed the upper right lobe in my lung. It tested as adenocarcinoma , I was told its growth was very quick.
This case was reported by a other health professional and described the occurrence of injection site discomfort in a male patient who received FLUARIX QUADRIVALENT (batch number 2RG54, expiry date 30th June 2017). In October 2016, the patient received FLUARIX QUADRIVALENT. In November 2016, 21 days after receiving FLUARIX QUADRIVALENT, the patient experienced general body pain and sweating. On an unknown date, the patient experienced injection site discomfort, muscle pain and fever. On an unknown date, the outcome of the injection site discomfort and muscle pain were recovered/resolved and the outcome of the fever, general body pain and sweating were not recovered/not resolved. It was unknown if the reporter considered the injection site discomfort, muscle pain, fever, general body pain and sweating to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The GlaxoSmithKline had not been previously contacted about any adverse event for this patient. The permission to contact reporter was granted. The age at vaccination was not reported. The patient experienced initially discomfort at the injection site, muscle ache, and a low grade fever, after receiving FLUARIX QUADRIVALENT 3 weeks ago, which went away. At the time of reporting (now), approximately 3 weeks after vaccination, the patient was experiencing fever (102 degree F), body aches, and sweats.
last night had a violent bout of chills; slight headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 85; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. Medical history included sars-coV-2 virus. The patient's concomitant medications were not reported. Reporter wanted to know if her side effects are normal. Vaccine received at a community center. Patient had been infected with the sars-coV-2 virus several months ago, this past Saturday (Jan2021) she got the first dose of the COVID vaccine series at about 10 AM and last night (Jan2021) had a violent bout of chills which was 6-8 hours after the shot. Also reported a slight headache for which she took 2 ibuprofen, 3 hours later, it struck her like a ton of bricks. She wanted to know if the timeframe for which her side effects appeared is a long time or not. She wanted to know if she should get the second dose of the covid vaccine. She stated "I'm not docking your product, I'm thankful that we have it." She would like to know if her history of being positve for covid infection reacted with her first dose of Covid vaccine. The outcome of the events was unknown.    Information on the batch/lot number has been requested.
Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Monday, 9/13- fever began around 10am. severe back aches. fatigue. 1000 mg of Acetaminophen taken every 6 hours. Highest fever 101.5. No fever at night.  Tues, 9/14- woke up not fatigued. No fever. No symptoms. Did not take Acetaminophen in afternoon. Returned to work. That night had fever of 102.7 for over 2 hours with intense chills and back ache. 1000 mg of Tylenol taken with cold rags applied to body to cool down.  Wed, 9/15- Fever ranging from 100.3-101.5 all day. Alternated Tylenol and Motrin throughout the day to keep fever in check. No chills. Small back ache. Sore throat. Swelling of tonsils. Thurs, 9/16- No fever. Fatigue. Sore throat has gotten worse. Swelling of tonsils continues. Throat very dry.
Started as swelling, a lump.   Progressed over next several days to increased swelling, pain, warmth and redness
No adverse event; 2 doses of Moderna bivalent vaccine was administered ; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered ) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered ).    No concomitant medications were provided. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-726446 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726446:Patient 1
BURNING SENSATION TO THE LEFT OF THE GROIN AREA AND LEGS; INFLAMED GROIN AREA AND LEGS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received COVID-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 13:00 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the patient experienced burning sensation to the left of the groin area and legs. On 27-MAR-2021, the patient experienced inflamed groin area and legs. The action taken with COVID-19 vaccine was not applicable. The patient had not recovered from burning sensation to the left of the groin area and legs and inflamed groin area and legs. This report was non-serious.
Within about 10 min of receiving the vaccine, pt reported not feeling well and had syncopal episode while seated.  BP elevated to 230's/100's and pt reported severe headache unlike any she had ever had before. Pt recovered and vital signs normalized. About 10 min later, pt had second syncopal episode. Upon awaking, pt reported severe headache and tingling to extremities.  EMS called due to multiple syncopal episodes. EMS assessed and did not feel that transport to ED was necessary and left. Approximately 7 min after they left, pt had two more syncopal episodes, each accompanied by BP >200 systolic, severe headache and tingling to extremeties. EMS called again and pt transported to ED. Pt was observed in ED. Pt reports to ED provider total of 6 syncopal episodes.  Per ED notes, no further syncopal episodes in ED and pt returned to baseline. ED physician did not feel that this was anaphylactic reaction to vaccine. Pt discharged to home.
In the observation area, shortly after receiving her 2nd dose of COVID-19 vaccine, she felt nauseous and went to the restroom where she vomited.  Another patron reported to staff that someone was sick.  A staff member caught patient exiting the restroom and escorted her back to the observation area.  She reported chest tightness, nausea, felt clammy, foggy/lightheaded.  Vitals were monitored for 45 minutes. 0856 BP 124/76 P 98 O2 94, 0900 BP 103/71 P 93 O2 95, 0904 BP 83/55 P 92  O2 95, 0908  BP 93/59 P 94 O2 94, 0911  BP 94/68 P 98 O2 96, 0917  BP 102/72 P 93 O2 97, 0923 BP 102/68 P 89  O2 97, 0933 BP 118/70 P 86  O2 96, 0935. Patient escorted out, reported feeling much better, her husband was transporting her.  She was instructed to seek help if symptoms returned or worsened.
Full body aches and pains and pain at injection site on arm; unable to sit or lay down for long periods of time.
Elevated high blood pressure when I always had low blood pressure. I would wake up with a pressure reading of 140/90. Before the vaccine I was in a competitive cycling team. Now I'm out of breath for no reason. Felt off balance, foggy. I couldn't drive for weeks or exercise at all. I had to take off work for weeks. I used to belong on a competitive cycling team but now because I don't feel confident with my balance, I can't ride a bike anymore. I can't weight train anymore and my walks are limited bc I feel fatigued. It took me a while to feel confident to stay by myself bc I wasn't sure if and when my pressure would shoot up. I drive, but am not driving on the highway. My life has changed significantly since getting the vaccine. I am a single mom and have only one income coming in. I am only working PT where I was working FT prior.
I started feel like my ears, feel like, it just starts off the plane; Throat sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR DISCOMFORT (non-serious) with onset 22Mar2021, outcome "unknown", described as "I started feel like my ears, feel like, it just starts off the plane"; OROPHARYNGEAL PAIN (non-serious) with onset 22Mar2021, outcome "unknown", described as "Throat sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received dose from vial refrigerated more than 30 days; This spontaneous case was reported by an other health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Additional information received and Patient demographics were updated
administered expired doses of DAPTACEL, with no reported adverse event; Initial information received 22-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old male patient got administered expired doses of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine and hib vaccine (HIB) for Prophylactic vaccination.  On 18-Aug-2023, the patient received 0.5ml (TOTAL) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot C5893AA and expiration date- 21-Jun-2023) via intramuscular route in the left thigh (strength: not provided) for Immunization (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vomiting; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 25Feb2021, outcome "recovered", described as "Vomiting"; MYALGIA (non-serious) with onset 25Feb2021, outcome "recovered", described as "muscle aches". Therapeutic measures were taken as a result of vomiting, myalgia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Ibuprofen was received as treatment for the events. Events did not result to physician office visit and emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient became bradycardic, diaphoretic,  hypotensive and had a decreased level of consciousness 10 minutes post vaccination. BP 67/34 mm/Hg, HR 39-44 BPM, O2 96%, improved when he was supine.
Blood clot in lower left leg; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the left arm, at age 58 years, first dose on 23Jan2021 14:00 at single dose for COVID-19 vaccination. Medical history was reported as none. Patient had no known allergies. The patient is not pregnant. There were no concomitant medications. There were no other vaccines administered in four weeks and no other medications taken in two weeks. On 30Jan2021, patient experienced blood clot in lower left leg. ER doc indicated that patient had no reason to have formed a clot given the medical history, health, weight, age, diet, no surgeries, no prior injury, etc. Facility type vaccine was administered at a Public Health Clinic/Veterans Administration facility. Event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event includes rivaroxaban (XARELTO) as blood thinner. The outcome of the event was not recovered.   Information about lot/batch number has been requested.