chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Psoriasis flare-up; Off label use in unapproved indication; General body pain/Pain; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up), OFF LABEL USE (Off label use in unapproved indication) and PAIN (General body pain/Pain) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis and Psoriatic arthritis.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up), OFF LABEL USE (Off label use in unapproved indication) and PAIN (General body pain/Pain). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved, OFF LABEL USE (Off label use in unapproved indication) outcome was unknown and PAIN (General body pain/Pain) had resolved.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  No concomitant medications were reported.  It was reported that, the patient had psoriasis, which was coming back, body aches following vaccination and off label use in unapproved indication.  The patient's arthritis was doing well. The patient also had body aches for a few weeks following vaccination.   The patient still had pain and psoriasis, RINVOQ stopped on 01-Feb-2022 and changed to another medicine.  It was unknown if she was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.  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.
Patient stated that she got her vaccine on 10/4/21, and started feeling armpit pain on 10/5/21. Patient believes she has swollen lymphnodes.
Nurse reported that she felt some drops expel from the needle/syringe connection. Amount unknown
pt revd vax 29OCT93 & devel fever on 7NOV93; fever lasted for 3 days; devel rash in the body in 10NOV93; rash small macular pink all over the body;
This case was reported by a healthcare professional (nurse) and described the occurrence of injection site pain in a male subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included FLUARIX; manufacturer unspecified; unknown; unknown given on 13 February 2012; meningococcal acwy vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 13 February 2012. On 13 February 2012 the subject received a dose of BOOSTRIX (unknown route, left arm). On 13 February 2012, immediately after vaccination with BOOSTRIX, the subject experienced injection site pain and facial hives. The subject was given BOOSTRIX and immediately after the vaccination he developed hives on his face and complained of pain at the injection site. The subject was treated with BENADRYL and after 30 minutes he was "fine". The lot number provided for the BOOSTRIX was not in the correct batch numbering system for BOOSTRIX, but attempts to clarify with the reporter were unsuccessful. The healthcare professional considered the events were clinically significant (or requiring intervention). At that time of reporting the facial hives were improved and the injection site pain was resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow up information received from the healthcare professional on 21 February 2012. The healthcare professional reported that the correct lot number for the BOOSTRIX is AC52B073CA. No further detail was provided.
February 9th noticed sore at injection site,  February 10th woke up with soreness and swelling at the injection site, warm to touch.
shingles; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. The patient's second dose is scheduled on 29Mar2021 however, they rescheduled the second dose on 05Apr2021 because she experienced shingles after the first dose. The outcome of event was unknown.  Information on the lot/batch number has been requested.
1/25/05 fever, bad dreams, partial complex seizures with aura, up to many times per day: child became flushed, trembling, disoriented, with some rigidity. 2/3/05 Ped neuro eval, 2/7/05 Trileptal started, 02/25/05 anticonvulsant tapered, no further episodes.
Developed a rash and bumps on my left torso above my hip extending below my waste in a narrow band. Rash was preceded by an intermittent sharp subcutaneous pain which continues. Surface pain where the rash is located. Also, a similar pain developed a few days later that extends into left groin area.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient had slight rash posterior base of neck to mid back.
Within 8 hours of the vaccine I was experiencing a right sided headache, sharp shooting; aches; fatigue and mucousy diarrhea. The right sided headache continued for days. On Saturday evening Jan 16th it became the worst headache of my life. Like a fool I didn't go to ER until Monday morning when I developed left handed weakness. I was visiting my son and presented to the Medical Center ER where I was diagnosed with an acute sub-dural brain bleed and airlifted to Specialized Hospital. Was admitted to the Neuro-Neurosurgery Unit.
Day 1 after: Shortness of breath, achiness. Day 2 after: Shortness of breath/palpitations. Patient went to ER on Day 2 after palpitations started.
pt reported numbness in the left arm at the injection site with little tingling within 1 minute of injection. progressed to whole arm tingling  within 5 minutes.  within 15 to 20min right hand started tingling, also reported feeling cold.  30 to 45 minutes small leg tremors. called 911. ambulance and emts took pt at about 1 hour after vaccine.
No additional adverse events reported; administration of expired VAQTA; This spontaneous report was received from a nurse via a company representative and refers to an identifiable patient of unknown age and gender. No information regarding the patient's medical history, drug reaction/allergies or concomitant therapies was provided.  On 16-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), lot # S037574, expiration date was not provided but upon internal review established as 10-APR-2021 (dose and route of administration were not provided) for prophylaxis. No additional adverse events were reported. The reporter was inquiring viability information. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity:devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
R thigh swelling red blotchy area hot to touch.  C/O pain with movement.  Dr did assess suggested to continue with BENADRYL.
PT CALLED SAYING HE HAS A MILD RASH ON HIS CHEECK/NECK AREA, LITTLE SWOLLEN AND SESITIVE TO TOUCH. HE DID NOT HAVE ANY DIFFICULY BREATHING OR ANY OTHER SYMPTOMS. ADVISED PATIENT TO SPEAK WITH MD AND SEEK EMERGENCY HELP ANY TIME SYMPTOMS WORSEN. FOLLOWED UP WITH PT AGAIN TODAY, HE SPOKE WITH MD AND MD ADVISED TO JUST WAIT, PT THINKS RASH IS GOING DOWN AND NOT SO MUCH SENSITIVE TO TOUCHING ANYMORE.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 08:00 as dose 1, single (Lot number: En6201), in left arm, on 04Mar2021 at 08:00 as dose 2, single (Lot number: En6198), in left arm and on 25Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FC3183) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart arrhythmias" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: Apr2018; TOPROL XL, start date: 01May2018; ROSUVASTATIN, start date: 30Nov2021; TAMBOCOR, start date: 01May2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive, notes: I started taking Paxlovid on the day after I 1st tested positive, which was 07Jun2022; (20Jun2022) Positive, notes: I still tested positive 13 days after taking my first dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: I still tested positive 13 days after taking my first dose of Paxlovid. started taking Paxlovid on the day after I 1st tested positive, which was 07Jun2022.
Received vaccine 12/29/2020 and site became raised, red and hot.  On 12/30/20 area is larger, raised, red, hot and painful.  When to ED on 12/31/2020 and had increased redness to the injection site. The site is painful nonpruritic.  Low grade fever (99.5), otherwise normal vs. patient with localized reaction from Covid vaccine, patient believes that she may not have received the vaccine in her muscle. She has pictures of the actual vaccination that show as the vaccine was placed into her arm that the needle was somewhat out of her arm and not fully engaged into her arm.  Patient will start a short steroid burst of 40 mg of prednisone daily, patient is an RN, is concerned she may have cellulitis potentially due to vaccine not being administered properly, will cover with keflex. Tryptase pending.
Pain; INJECTION SITE PAIN OF COVID VACCINE; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), VACCINATION SITE PAIN (INJECTION SITE PAIN OF COVID VACCINE) and FATIGUE (Fatigue) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    There was no reported medical history.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-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) Citrate Free Discontinued. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (INJECTION SITE PAIN OF COVID VACCINE) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had not resolved and VACCINATION SITE PAIN (INJECTION SITE PAIN OF COVID VACCINE) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported.
Information has been received from a consumer concerning his 9 year old daughter, who on an unspecified date, was vaccinated with MMR II (Lot number was not available). There was no concomitant medication. The reporter stated that his daughter was diagnosed with autism after receiving the MMR II. Unspecified autism tests were performed with unreported results. Reporter did not provide physician's information. At the time of the report, the patient had not recovered. The patient sought medical attention and was seen by a physician. Upon internal review, autism was determined to be an other important medical event. No further information is available.
This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Pharmacist felt it was anxiety and not anaphylaxis), THROAT TIGHTNESS (his throat closed for a few seconds and then it opened back up during booster shot) and INTENTIONAL UNDERDOSE (Pharmacist stopped administering the booster and only gave patient 0.1mL instead of .25mL) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .1 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced ANXIETY (Pharmacist felt it was anxiety and not anaphylaxis), THROAT TIGHTNESS (his throat closed for a few seconds and then it opened back up during booster shot) and INTENTIONAL UNDERDOSE (Pharmacist stopped administering the booster and only gave patient 0.1mL instead of .25mL). On 16-Nov-2021, THROAT TIGHTNESS (his throat closed for a few seconds and then it opened back up during booster shot) and INTENTIONAL UNDERDOSE (Pharmacist stopped administering the booster and only gave patient 0.1mL instead of .25mL) had resolved. At the time of the report, ANXIETY (Pharmacist felt it was anxiety and not anaphylaxis) outcome was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No relevant concomitant medications were reported.No treatment information was provided. This case was linked to MOD-2021-388934 (Patient Link).
Numbness beginning in feet the last week of March/first week of April.  Extended to knees by mid May, thigh level by mid June.  Now at hip level.  Gait unsteady.  Bladder urgency.  Diagnostic testing in progress.
Immediate numbness in right hand and right shoulder, followed by pain in hand and shoulder.  Facial pressure, fever, body aches, headache lasting 24 hours.
Information has been received from a pharmacist concerning a female who "one or two years ago" on unspecified dates was vaccinated with the first and second dose of PNEUMOVAX 23 (lot# not reported). The patient received the second dose approximately 6 months after receiving the first dose. Subsequently, after the second dose of vaccination, the patient developed paralysis of her arm. The patient sought unspecified medical attention and was no outcome provided. The paralysis of arm was considered to be an other important medical event. additional information has been requested.
Had MMR and chickenpox vaccine on Feb 20. On Feb 27 had PCV13 vaccine. Same evening had fever of 106. Used ibuprofen in combination with tylenol to lower temperature. Fever lasted 3 days. Would go down in the morning but would come back at night.
Tested positive for coronavirus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for coronavirus) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COVID-19 (Tested positive for coronavirus). At the time of the report, COVID-19 (Tested positive for coronavirus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment details were provided.
No additional AEs; HCP calling to report that MMR II and VARIVAX were reconstituted with sodium chloride and administered to same patient on 07/15/2022.; Inappropriate schedule of vaccine HCP calling to report that MMR II and VARIVAX were reconstituted with sodium chloride and administered to same patient on 07/15/2022. No adverse reactions reported at this time. No additional AEs, no PQCs reported.; This spontaneous report has been received from a registered nurse, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 15-JUL-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, 1 dose, and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live, 0.5 milliliter, 1 dose, (strengths, routes of administration, anatomical location, lot numbers and expiration dates were not provided) indicated as prophylaxis (inappropriate schedule of product administration), both vaccines were reconstituted with sodium chloride (product preparation error).  No additional adverse event were reported.
TEMPERATURE EXCURSION. vaccine was stored in freezer longer than manufactures recommendation. Patient did not have any adverse reaction to covid vaccine
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at 0.55 Celsius Degrees for 200 hours, -0.55 Celsius Degrees for 32 hours, 1.11 Celsius Degrees for 40 hours and 0 Celsius Degrees for 152 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
arm sore and swollen at injection site, fatigue, a little light headed, occasional chills, occasional nausea, elevated blood pressure day of shot
Severe migraine with photo sensitivity and sound sensitivity that lasted 6 days Severe fatigue that lasted >12hrs
Fluvirin was administered instead of Fluzone-"off label" use of vaccine by accident.  Clinic contacted manufacturer and Imm. program consultant, who talked with NIP.  Dose will count as 1st dose.  Fluzone to be given in 4 wks.  Talked with mother 1/24/07 and explained about vaccine. She stated that child is doing fine-just a little fussy; no fever.  Will return to clinic 02/20/07 for Fluzone.
Injection site still sore 10 days s/p vaccination Itchy, maculopapular rash diffusely on back, torso, upper and lower ext's.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Product Quality Group provided investigational results received. Conclusion: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Manufacturing facility concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients may have received improperly stored doses of GARDASIL injection (lot # K008931, expiration date 04-MAR-2017 or lot # K011325, expiration date 08-APR-2017, dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccine experienced the temperature excursion at 34 degrees Fahrenheit for 75 hours. Data logger was involved. There were no previous temperature excursions reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
I had been on a family outing on 07/04/2022 and 2 people that were there ended up contracting COVID-19. On the evening of 07/05/2022 I had a slightly elevated temperature of around 101 and I felt weak. The next morning, I felt extremely weak but I didn't seem to have a fever. For the next two days I was still flat on my back with weakness and could not eat anything. I only really got up to go to the bathroom. On the third day, I was feeling much better but still a little weak and felt a little spacey and wobbly. I tested myself for COVID-19 with an at home test on 07/07/2022 and the results were positive. My wife spoke with my doctor who is also my step son and he prescribed PAXLOVID. My energy and strength is only now returning back to normal today on 07/21/2022.
With regards to her incidental COVID-19 diagnosis, she remained asymptomatic and on room air so no COVID-directed therapies were started.
Pt states her arm (L) hurts. Pt favors left arm. Notable redness in upper left arm.
rapid heart beat, irregular heart beat. from 6:30 PM to present, 11:55 PM
On 1/7/03 at 15:30, pt came for IZ's. No reported allergies to food or medications. Reported a rash in the Philippines but non-specific. IZ's were given and an itching, hive-type of rash appeared within 5 minutes. No respiratory distress noted. Pt told to go to Urgent Care to be checked by MD. Pt went there but left before being seen.