chrisvoncsefalvay/vaers-outcomes huggingface dataset:
L arm has hives approximately 3"x1". Donor stated after shot given is allergic to alcohol. No mention of allergies on donor record. Site cleaned with alcohol wipe. Reaction clearing within 30 minutes with ice. No medication given. No distress on donor part.
Pharmacist thought patient was 5 years of age. Patient was 4 years of age. No known adverse events.
flu like symptoms; Her arm is still a bit sore; she reported experiencing fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (Her arm is still a bit sore) and FATIGUE (she reported experiencing fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A24A) for COVID-19 vaccination.     Concurrent medical conditions included UTI (she takes antibiotics for a suspected UTI).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (Her arm is still a bit sore) and FATIGUE (she reported experiencing fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (Her arm is still a bit sore) and FATIGUE (she reported experiencing fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Chills and fever within 5 hours of vaccine.  Each day after chills, fever, headache, body aches
3RD PARTY NURSE ADMINISTERED VACCINE TO MINOR. MONITORED FOR 20 MINUTES WITH NO SIGNS OF ADVERSE REACTION.
Pt recv #3 vax on 4/2/97; on 4/13/97 pt exp pain in big toe then pain in left foot w/ stiffness;in '98 pt exp joint sx, fatigue, cool extremities dx=rheumatoid arthritis,tensosynovitis Raynaud's syndrome, antinuclear antibody, hiatal hernia
Little fever of 100.7; feeling lazy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.  Concomitant products included VITAMIN D3, ALLIUM SATIVUM (GARLIC NATURAL), ATORVASTATIN and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy). At the time of the report, PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Pyrexia: 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included two capsules of Tylenol. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.  Concomitant products included VITAMIN D3, ALLIUM SATIVUM (GARLIC NATURAL), ATORVASTATIN and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy). At the time of the report, PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Pyrexia: 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included two capsules of Tylenol.
Initial unsolicited pregnancy report received from a nurse on 26 August 2016. This case involves a 31-year-old female patient who was vaccinated with a first dose of ADACEL (batch number U5458DA, expiration date 28 September 2018, dose, site of administration was not reported) intramuscularly on 26 August 2016 while she was pregnant. Pregnancy information of last menstrual period (LMP) and estimated delivery date was not reported. At the time of vaccination, patient was in third trimester of pregnancy, gestation period- 33 weeks. The patient health during pregnancy and specify risk factors (e.g.: alcohol, tobacco or recreational drugs) and concomitant medication was not reported. On unspecified date, following the vaccination, the patient experienced unknown adverse event. Lab data and corrective treatment was not reported. The outcome of events was not reported. Documents held by sender: none.
1/24/21 7:00 p.m.  Mild gas  1/25/21 mild to moderate gas pain throughout the day. Later in evening  occasional severe gas with bloating and abdominal rumbling - 10:00 pm diarrhea continuing throughout the night 1/26/21 1:00a.m. explosive diarrhea 10-12 times - saw blood spotting on TP / chills / no fever / tremors / felt nausous 1/27/21 fatigued - even sitting my neck feels too weak to hold my head up / after diarrhea stopped felt better but exhausted
Painful lump in my underarm , moving but painful lympnode , not under the skin.No abcess no redness on the surface.
On Oct. 27, noticed a few small blisters on right hand after potentially coming in contact with poison ivy. Later that morning, received the Covid booster. Did not have any reactions with the first 2. Later in day, blisters developing rapidly over hand and forearm. oral Bendaryl and Bendaryl topical applied with only slowing reaction. Continued with oatmeal baths, cortisone cream, and oral Bendaryl but blisters and hives on upper arm and shoulder. Provider ordered prednisone 40mg x 5 days. During course of treatment, cont. Benadryl and topicals but rash spread rapidly. On day 5 of prednisone (Nov. 2), rash developed with plaques on entire right arm, right hand and forearm severely edematous, raised rash w/plaques and hives across chest on lower left arm, and small blisters starting on neck and torso. Went back to provider who represcribed prednisone 40mg and referral to dermatology.  Rash cont. to spread with increasing edema and extreme itching on Day 6 after vaccine.
Extreme Redness, swelling and Pain at site also with heart palpatations for four days following shot. Dr.'s office visit said site was infected and antibiotic is being taken for 10 days.
Pt vax 27APR98, pt telephoned Dr. to complain of injection site swelling, redness and pain which radiated to the breast. She was instructed to apply cold packs. Pt telephoned Dr. 29APR98 to report swelling and pain and greatly decreased.
I had some dry blood in my nose in the morning before vaccination as well, but 3 hrs after vaccination, my nose started bleeding; I had some dry blood in my nose in the morning before vaccination as well, but 3 hrs after vaccination, my nose started bleeding; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 24Apr2021 at 01:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included some dry blood in nose in the morning before vaccination. The patient had no known allergies. 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 COVID-19 vaccine. The patient did not receive any concomitant medications. On 24Apr2021 at 04:30, 3 hours after vaccination, the patient's nose started bleeding. The patient had some dry blood in nose in the morning before vaccination as well. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had some dry blood in nose in the morning before vaccination as well, but 3 hours after vaccination, nose started bleeding was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Mouth and eyes started to itch, then left eye became swollen.  Nose was stuffy but no breathing problems. Advised to go to ER. Did not go. Placed warm compress on left eye.
noticing joints are usually uncomfortable and painful at times/both shoulders have pain/left knee sometimes is so painful to walk but might go away/feels like his joints hurts sometimes; muscles are usually uncomfortable and painful at times/hamstring on the right side painful since month and half; Left knee inflamed, old maniscuse injury flaired up; Left knee inflamed, old maniscuse injury flaired up; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021. The most recent information was received on 28-Jul-2021 and was forwarded to Moderna on 28-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Left knee inflamed, old maniscuse injury flaired up), CHONDRITIS (Left knee inflamed, old maniscuse injury flaired up), ARTHRALGIA (noticing joints are usually uncomfortable and painful at times/both shoulders have pain/left knee sometimes is so painful to walk but might go away/feels like his joints hurts sometimes) and MYALGIA (muscles are usually uncomfortable and painful at times/hamstring on the right side painful since month and half) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013L20A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN from 01-Jan-2018 to an unknown date for Cholesterol.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced JOINT SWELLING (Left knee inflamed, old maniscuse injury flaired up). On an unknown date, the patient experienced CHONDRITIS (Left knee inflamed, old maniscuse injury flaired up), ARTHRALGIA (noticing joints are usually uncomfortable and painful at times/both shoulders have pain/left knee sometimes is so painful to walk but might go away/feels like his joints hurts sometimes) and MYALGIA (muscles are usually uncomfortable and painful at times/hamstring on the right side painful since month and half). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, JOINT SWELLING (Left knee inflamed, old maniscuse injury flaired up), CHONDRITIS (Left knee inflamed, old maniscuse injury flaired up), ARTHRALGIA (noticing joints are usually uncomfortable and painful at times/both shoulders have pain/left knee sometimes is so painful to walk but might go away/feels like his joints hurts sometimes) and MYALGIA (muscles are usually uncomfortable and painful at times/hamstring on the right side painful since month and half) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant FU-event onset date Batch number provided
Tightness in chest which grew into severe asthma never before experienced in my life.  Became impossible for me to take a full breath.  Went from daily exercise to no physical exertion possible. On oral prednisone for 7 weeks.  Had to nebulize albuterol every 3 hours for weeks in addition to the oral prednisone.  Also nebulized budesonide.  Eventually Dr. added Trelegy. 6 months later, I am still having to nebulize albuterol twice a day, use the Trelegy, and nebulize budesonide.  In addition I have to use my rescue inhaler if I exercise.  (Previous to the 2nd Pfizer vaccination my asthma had been under complete control for many years.  I took Advair 250 mg once a day and rarely needed the rescue inhaler.)
dizziness; some eye ache; focus issues.; Lethargy; This is a spontaneous report from contactable consumer (patient).  A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Sep2021 10:30 (Batch/Lot Number: FF2588) age at vaccination of 75-years-old, as single dose, for covid-19 immunisation. Medical history included granulomatosis with polyangiitis from an unknown date and unknown if ongoing Wegener's GPA. The patient previously took tamiflu and experienced hypersensitivity, antibiotics and experienced hypersensitivity.  The patient previously BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Sep2021 10:30 (Batch/Lot Number: FF2588) age at vaccination of 75-years-old, as single dose, for covid-19 immunisation. Concomitant medications included prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Beginning one day after second shot on 23Sep2021 at 01:45 AM (and continuing into third day after second shot) the patient experienced dizziness, he also experienced while walking or standing, when sitting he had some eye ache and focus issues. The patient also experienced lethargy on 23Sep2021 at 01:45 AM. No treatments were administered. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not recovered from the events.
Information has been received from a physician concerning a 6 year old male with no past medical history and no allergies who on 01/08/1999 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 03/12/2002 the pt developed a mild rash, vesicles over the back, a few scattered on the arms and legs. There was no other systemic symptoms. The pt sought unspecified medical attention. Additional info has been requested.
After a few minutes the patient stated she felt a  dizzy. She had felt dizzy the previous covid immunization she received as well. We watched her for about 40 minutes. I took her blood pressure and it was 150/95 with a pulse of 88. I gave her a refrigerated pack for her wrists and neck. After 40 minutes she stated that although still a little dizzy she had improved. She stated she would walk over to management since she is an employee here and see if she could get out of work early. I stated she should not drive herself and she agreed she would ask her son to pick her up.
FEEL HORRIBLE; FEEL WORSE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-AUG-2021, the patient experienced feel horrible. On 06-AUG-2021, the patient experienced feel worse. On 06-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, feel horrible, and feel worse. This report was non-serious.
redness at injection site going towards her shoulder and elbow; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2019, the patient received Shingrix. On 30th December 2019, less than a day after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient has redness at injection site going towards her shoulder and elbow from Shingrix injection.  The reporter consented to follow up.
Breathing problem.  Couldn't get air in.  Had fever of 103, headache, chills.  Arm pain as expected, swelling red and raised hot area.  table salt for breathing p roblem and it helped me breathe.  I was not well for over 2 days.  3rd day I began to feel better but 100% day 4.  Please note  I would never have made it to the hospital alive, not being able to breathe.  I did not get the 2nd shot!!
Patient reported to Clinic for appointment on 8/3/2021 with PCP. Patient returned to Clinic and stated "I worked up the nerve to get my COVID vaccine." Nurse discussed at length the vaccine, side effects and date to return for 2nd Covid vaccine. Patient denied getting any injections in the last 28 days. Covid vaccine was given and patient did not have any further concerns. Patient was informed to wait in the waiting room for 30 minutes as she did have an epi pen for bee stings. When RN went to check on patient 20 minutes later patient had left the office. Patient was coincidentally seen  walking down the street visually in no distress.
Onset of blistering to arms a few days after receipt of vaccination, did not realize it was related until the same occured after receiving 2nd dose.
Vaccinated with Varivax on 12/01/99. Reported with dx of chickenpox on 02/21/03.
took the shingles shot,but it did not help/ Suspected vaccination failure; have had them several times; They are painful; itchy red rash.; Itchy red rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the shingles shot,but it did not help/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: have had them several times), pain (Verbatim: They are painful), itchy rash (Verbatim: itchy red rash.) and red rash (Verbatim: Itchy red rash). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain, itchy rash and red rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain, itchy rash and red rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, itchy rash and red rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she had them several times, they were terrible, they were painful, itchy red rash. The reporter reported that he or she took the Shingles shot, but it did not help. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.
A consumer report has been received from the mother of a 35 year old male patient. Medical history and concomitant medication were not reported. The patient received FLUMIST (intranasal) in Nov-2013. A month later, in Dec-2013 he developed inflammation of the lungs. He has been to various doctors. CT scan revealed lung image of ground glass opacity and hypersensitivity. He has been in and out of hospital and is on high dose of prednisone. He was diagnosed with Erdheim-Chester disease. [Erdheim-Chester disease is a rare form of non-Langerhans cell histiocytosis.] At the time of reporting, the inflammation of the lungs was ongoing, and the outcome of Erdheim-Chester disease was unknown. Inflammation of the lungs was reported as a serious event, based on hospitalization. Erdheim Chester disease has been identified by the company physician from the source document and added as an important medical event.
Developed painful nodule 1x2cm at (L) deltoid injection site. Treated with NSAIDS & warm compresses. Sx continued 3wks after injection.
Janssen COVID-19 Vaccine EUA. Joint and muscle soreness for approximately six hours.
after the 2nd shot wound up losing his hearing; had a terrible tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP, patient's friend) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "after the 2nd shot wound up losing his hearing "; TINNITUS (non-serious), outcome "unknown", described as "had a terrible tinnitus".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Tested positive for Sars-CoV-2; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Sars-CoV-2) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Sars-CoV-2) (seriousness criterion medically significant). The patient was treated with BAMLANIVIMAB for COVID-19, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Sars-CoV-2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     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 relevant concomitant medications were reported.   The patient was scheduled to receive his 2nd dose of vaccine on 16 Feb 2021.  Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 positive test and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 positive test and mRNA-1273 is assessed as not applicable.