chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 4/26/2022, patient received his first MODERNA vaccination (0.5mL, Part 1). Two days after, patient reported swelling of his upper right lips and itchiness in his throat. Patient took Benadryl, which helped with patient's swelling and itchiness. Patient denies having issues with breathing during the event, which might be partially due to patient ingesting Benadryl during the event. Patient reported and showed that swelling of lips has subsided for patient to where the lips has mostly returned to regular size. Patient reports today (5/4/2022) that currently there is still itchiness in his upper right lip region, his lips still feel tender. Crusting(?) in upper lip region was observed among the patient's moustache hairs. Patient denies any follow up reactions similar to initial adverse event. Patient denies having any previous vaccinations prior to his first MODERNA vaccine and reports that this is not only his first MODERNA vaccination, but also his first ever vaccine in his life.
Patient reported that she felt like her throat was closing few hours after receiving her vaccine. She reported that she took Benadryl and she felt better. She reported that the next day the roof of her mouth and her lips started swelling and again took Benadryl and the swelling did not go away then she started taking prednisone 20mg along with Benadryl and she felt better.
PAIN, TENDERNESS, AND SWELLING AT THE INJECTION SITE AND 8 INCHES AROUND THE INJECTION SITE.
Shortness of breath; Felt like a sinus infection; right eyelid is twitching; sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes; can't raise his left arm sometimes; Achy; the Injection site was aching; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection), BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes) and MOBILITY DECREASED (can't raise his left arm sometimes) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Retinal hole (Patient has hole in the retina in his left eye so he sees eye doctor for that, was diagnosed three years ago.). Concomitant products included APIXABAN (ELIQUIS) and CLONIDINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection), BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes), MOBILITY DECREASED (can't raise his left arm sometimes), MYALGIA (Achy) and INJECTION SITE PAIN (the Injection site was aching). At the time of the report, DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection) and MYALGIA (Achy) had resolved and BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes), MOBILITY DECREASED (can't raise his left arm sometimes) and INJECTION SITE PAIN (the Injection site was aching) had not resolved.            No treatment medicine was provided.   This case was linked to MOD-2021-285694 (Patient Link).
Parent took child to phyisican with noting left arm swollen and "purple looking".  Child complained of left arm "pain, heavy feeling."  Per mom Dr. sent child home to put warm water on it, no meds given and mom says Dr. said not to get HAV shot again.
Got shingles on my right chest and back.  Started feeling something on my right chest around Monday December 6th.  It changed to stinging pain on my surface of my skin later the week. On Thursday December 9th, I noticed the rash is appearing and the next day recognizable rash is on my right chest. On Saturday December 11th, I went to urgent care. The doctor there diagnosed it as shingles and prescribed Valtrex.
MISCARRAIGE AT 11 WEEKS OF PREGNANCY.  First sign of blood on 11/15 late afternoon, then major cramping on 11/16 around 8 a.m, followed by major blood discharge on 11/16 around noon. 12/07/09 ER records received for DOS 11/18/09. Pt. presented with vaginal bleeding, abdominal pain, onset three days ago. G2 P1, EDD: 06/04/10. Seen by Ob MD in office, US in office showed miscarriage, pt  told to follow up if symptoms worse. DC DX: spontaneous miscarriage-complete 12/08/09 Medical records received for DOS 11/16/09, 11/30/09. Pt. presented on 11/16/09 with h/o vaginal bleeding, which had stopped by time of exam.
Received 2nd shot last week. 1st  shot 3 weeks before. Baby stopped growing last week at 9 weeks. Also after 2nd shot last week my left arm was so sore, I couldn?t lift it up. Lasted overnight and went away.
Mild itchiness of the face and neck and ears severely red.  Took half of a Benadryl and it resolved after a short time.    I still have periodic itchiness of  face and neck.  I take claritin everyday.
6 days after shot, my arm became really itchy and hot. It began to feel hard around my deltoid muscle below the injection site. That night I was not able to sleep on that side. The site continues to be itchy, red and hard. It is rectangular in shape and approximately 2x4?.  I?ve taken ibu, Zyrtec, and used triamcinolone cream on it.
the day following vax pt devel a rash & less than 50 skin lesions. addl info requested
Swollen lymph nodes near right elbow crease.; Sore, achy muscles; Light green urine; Swelled up/a little swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Light green urine), SWELLING (Swelled up/a little swelling), LYMPHADENOPATHY (Swollen lymph nodes near right elbow crease.) and MYALGIA (Sore, achy muscles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), OMEPRAZOLE, TOPIRAMATE, ALBUTEROL [SALBUTAMOL] and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced SWELLING (Swelled up/a little swelling). On 15-Apr-2021, the patient experienced CHROMATURIA (Light green urine). On 16-Apr-2021, the patient experienced MYALGIA (Sore, achy muscles). On 23-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes near right elbow crease.). On 17-Apr-2021, MYALGIA (Sore, achy muscles) had resolved. At the time of the report, CHROMATURIA (Light green urine) and SWELLING (Swelled up/a little swelling) had resolved and LYMPHADENOPATHY (Swollen lymph nodes near right elbow crease.) had not resolved.            No treatment details were reported.   This case was linked to MOD-2021-410354 (Patient Link).   Reporter did not allow further contact
approx 6 days p/vax pt exp neck pain progressing to lt shoulder, chest & back pain w/extreme fatigue.  pain progressed to involve entire body; worst w/3rd vax; rheumatology eval; dx fibromyalgia; sx present currently
COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, COVID-19 (COVID-19) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication provided. No treatment information mentioned.  Patient experienced COVID. Took first dose in April and second dose in July.  The reporters causality for event with Rinvoq was no reasonable possibility.  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
INTENSE itching, at site, swelling down to near elbow, hot to touch, itching eyes, ears, genital area, gradually lessening over three days.  Took Ibuprofen. Applied topical anti-itch cream. Did not want to take Benadryl as it would make me sleep. Stayed awake all night Friday as I have experienced Anaphylaxis following fire ant sting and wanted to be sure no swelling began in face, etc.
pt has fear of needles and passed out 5 mins after vaccine- pt was  in and out for about 5 mins. then came to, paramedics were called and pt left on his own after about 45 mins
Day 1-3: pain, redness at injection site.  1/30/21  3x3 fire red, raised and bumpy, painful circle around injection site; additional red circle appeared outside initial circle 2/3/21  2nd circle with same characteristics appeared below initial rash site
difficulty in breathing; fatigue; pain at the site of injection; Weakness; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced asthenia (weakness), dysponea (difficulty in breathing), fatigue and vaccination site pain ( pain at the site of injection).  The patient's medical history was not provided. No Concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 0NJ20A) via unknown route for prophylaxis of COVID-19 infection and On 9 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced weakness, difficulty in breathing, pain at the site of injection and fatigue.  Treatment details was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
I woke up in the middle of the night feeling like a truck had rolled over me.  Every muscle in my body was in pain from my neck to my toes.  I normally have some muscle pain each day but this was unbearable.  I had to stay in bed for 4 days because of the pain.  During that time I took Ibuprofen which did not work.  On the 5th day my Dr. told me to take a pain pill so I started taking Tramadol.  That made the pain go away but also put me into a fog.  On the 7th day I went to see my Dr.  She then put me on Prednisone for 4 days.  I am still hurting on this the 8th day.  My chest and rib muscles are hurting, my middle and lower back along with my hips, thighs, calves and ankles.  I also have swollen ankles and my orthostatic hypotension has gotten worse.
allergy reaction to Moderna Covid-19 vaccine, causing rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (allergy reaction to Moderna Covid-19 vaccine, causing rash) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (allergy reaction to Moderna Covid-19 vaccine, causing rash). At the time of the report, RASH (allergy reaction to Moderna Covid-19 vaccine, causing rash) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided.
Patient received the Pfizer-BioNTech COVID-19 Vaccine at 1000. Reported onset of symptoms at 1040 with tingling in upper body, headache, flash heat, and  flash nausea. Given Benadryl 25mg PO and kept for additional observation.
patient administered dose on 2Oct2021 from vial that was beyond 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered dose on 2Oct2021 from vial that was beyond 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered dose on 2Oct2021 from vial that was beyond 30 day use by date). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient administered dose on 2Oct2021 from vial that was beyond 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 30-Aug-2021 at 8:45 pm, the vial was initially stored in the refrigerator and had 30 day use by date expiration of 29-Sep-2021.  As per reporter vial punctured on 2-Oct-2021 approximately around 3:35pm and Reporter declined that patient experienced any side effects that he was aware of.  No relevant concomitant medication was reported. Treatment information were not provided.      Reporter did not allow further contact
Intussusception requiring surgical reduction.  12/10/2009 Received ED records for 6/16-6/18/2009, DC DX Intussusception which was successively reduced. ICD-9 560.0   patient with c/o's nausea/vomiting, fever, lethargy, progressive sx x 3 days. Blood per rectum,  Tx: IVF, IV ABX, Telemetry. Air enema partially reduced IS & patient transfered to higher level of care.  Repeat air enema done.
reaction was stronger than after 1st dose muscle pain, neck pain, fever, HEADACHE, all symptoms still here on 3rd day except fever extremely sore, hot and red injection site, with more swelling than after 1st dose
Covid-19 positive, Headache, sore throat, chills, congestion; Covid-19 positive, Headache, sore throat, chills, congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3 (booster), single, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 01Mar2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Feb2022, outcome "unknown" and all described as "Covid-19 positive, Headache, sore throat, chills, congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vertigo; raised alt liver numbers; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4244517-00 (AbbVie).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154341) for psoriatic arthropathy, uveitis. The patient's relevant medical history was not reported. Concomitant medication(s) included: REPATHA. Vaccination history included: Bnt162b2 (Dose 2, Route of administration: Intramuscular), administration date: 23Aug2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Vertigo", "Raised alt liver numbers"; Bnt162b2 (Dose 1, Route of administration: Intramuscular), administration date: 02Aug2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "Vertigo", "Raised alt liver numbers". The following information was reported: VERTIGO (hospitalization) with onset Dec2021, outcome "unknown", described as "Vertigo"; ALANINE AMINOTRANSFERASE INCREASED (non-serious), outcome "unknown", described as "raised alt liver numbers". The patient was hospitalized for vertigo (start date: Dec2021). The event "vertigo" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: alanine aminotransferase: raised, notes: increasing. The action taken for adalimumab was unknown.  The reporters causality for the events vertigo and raised ALT liver numbers with BNT162B2 was not reported. The reporters causality for the events vertigo and raised ALT liver numbers with Humira (Adalimumab) was reasonable possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. The vials were placed in refrigerator on 6-Dec-2021.  It was reported that patient took booster dose.
Patient presented to the hospital in respiratory arrest.  Patient's household had tested positive for Covid-19.  Patient had a hx of Lung Ca.  In ED CXR showed left lung interstitial infiltrate's.  Patient was placed on mechanical ventilation.  Patient's COVID test was positive.  D dimer was more than 20, CRP of 75.90.  Patient was admitted to ICU.  Nephrology was consulted for severe acute kidney injury, cardiology followed for elevated troponins.  Patient was on steroids, antibiotic therapy for PNA, patient deteriorated requiring low dose levophed.  He continued to deteriorate and had 3 episodes of cardiopulmonary arrest.  Patients family wanted to withdraw care.  He expired on 01/18/2022.
Patient who was 15 years old was given Johnson and Johnson instead of Pfizer. Pfizer is currently the only approved covid vaccine for those under 18 years of age.
auto immune disorder; both wrist started swelling\Swollen Knee/swollen ankle; Swollen hands\swollen feet; muscle pain every night\Pain became persistent and wont go away.; Joint (and muscle ) pain; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (auto immune disorder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included QUINAPRIL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (auto immune disorder) (seriousness criterion medically significant), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle) and MYALGIA (muscle pain every night\Pain became persistent and wont go away.). an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain). At the time of the report, AUTOIMMUNE DISORDER (auto immune disorder), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle), PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain) outcome was unknown and MYALGIA (muscle pain every night\Pain became persistent and wont go away.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: high (High) extremely high but no visible sign of infection..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included steroids.  It was reported that, side effects from both doses were alike and started on the night of vaccination. Two weeks after 2nd dose of vaccine, both wrists started swelling followed by the joint and muscle pain every night. Pain became persistent and won't go away. Pain only subsided 5-6 hours after taking steroids. It's been 6-8 weeks of extended inflammation. The laboratory exams performed to further understand the event included number of drug test and results pointed to an auto immune disorder.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.