chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hands had been stiffer; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Hands had been stiffer) 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) tablet, extended release for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   In January 2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 mg once a day. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 MUSCULOSKELETAL STIFFNESS (Hands had been stiffer). At the time of the report, MUSCULOSKELETAL STIFFNESS (Hands had been stiffer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, SARS-CoV-2 antibody test: negative No Covid-19 antibodies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.  The patient was not advised of possible need to pause Rinvoq prior to receiving the Covid-19 vaccine doses, therefore, she regularly took the medication. The patient stopped Rinvoq due to the negative Covid-19 antibodies. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Significant FU added- New event added
Received 2nd booster Pfizer vaccine at 12pm.  Skin turned red, flushed, temperature rise. Called 911 at 12:50.  Patient received 1 Epi-pen  at 12:50 on left upper leg. Fire department came 1:03 and left with patient.
Intussusception.  11/02/07 Reviewed medical records from 2nd ER of 10/19/07 which reveal patient experienced pulling up of legs, vomiting & apparent abdominal pain.  Seen in outlying ER & admitted overnight.  Tx w/IVF & serial abdominal exams.  D/c to home & had continued gagging, reduced oral intake, irritability, decreased sleep & uncomfortable abdomen.  BE reduced IS & admitted overnight for observation s/p reduction. FINAL DX: Intussusception, enema reduced. Records faxed to CDC. 11/13/07 Reviewed hospital medical records which reveal patient experienced vomiting, fever & abdominal pain.  Admitted 10/18-10/19/2007. Abdomen was diffusely tender.  Tx w/IVF, antipyretic & antinausea meds.  Improved & d/c to home. ER Diagnosis: dehydration, vomiting & abdominal pain. Seen at outlying hospital for persistent vomiting where IS was dx & reduced by BE.  Admitted overnight for observation & d/c to home.   Continued to run fever & had diarrhea & returned to ER.  Temp 103 in ER.  Tx w/antipyretic & d/c to home. Final ER dx: fever secondary to vaccines. Records faxed to CDC. 11/16/07 Received vax record from pcp which confirms RO dose & lot as reported.  Record faxed to CDC.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 71 year old female of unknown ethnic origin. Initial information was processed with additional information received from complaint vigilance on 10-AUG-2021.   The patient's weight was 190 pounds, and height was 67 inches. The patient's concurrent conditions included: blood pressure, sulfa drug allergy, non smoker, non alcohol user, and thyroid, and other pre-existing medical conditions included: Patient was on Blood thinners. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: Unknown) frequency one total, dose was not reported, administered at left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  Six weeks later after vaccination patient reported negative for antibody test. On MAY-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: Antibody test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188999.; Sender's Comments: V0: 20210817330-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
PT CAREGIVER  EXPLAINED 6 HRS AFTER RECIEVING SHOT HAD FEVER, FEVER AROUND 101.1 THEN INCREASED ON WED. ON SATURDAY EVENING SPIKED TO 103.7  AND THEN PT WAS ADMITTED TO HOSPITAL ON  1/7/22. PT IS BEING TRANSFERED TO ANOTHER HOSPITAL 1/8/22 TO SEE INFECTIOUS DISEASE DOCTOR
I experienced COVID on 08/12/2021 and tested positive in the evening.  I talked to my doctor on 08/13/2022 and she advised against Paxlovid because there were rebound cases.  I did sleep for ten days straight. For three weeks I felt awful.  I can not say I had a cough or had a fever, I just remember feeling terrible for three weeks.  i can say I have recovered from my symptoms.
Fever, chills, headache, body aches, sore throat and occasional cough. Takes Tylenol.
Localized redness and swelling with 2-3 in diameter.  Patient didn't feel or notice until seen in mirror days later.
Pt. given DTAP/HIB vaccine. Pt (per mom) had "large" red area at site of injection and diffuse urticaria within 30 minutes of vaccine. Resolved. No resp. distress. (This was a repeat vaccination due to concerns that our vaccines may have been as effective secondary to refrigerator storage issue). We followed recommendations of the state and the CDC. Rx: Decadron and Benadryl.
Patient reported receiving vaccine in the day or morning and experiencing a hard red spot @ injection site.  The redness spread down the arm (2-3 inches?). Patient repors the skin being irritated by clothes and warm to touch
6 hours after vaccine administered patient began suffering from high fever, headaches, severe chills, severe body aches...all of which continued for the next 12 hours at least
Patient complained of inflammation, swelling at injection site and tenderness 24 hours after injection.  Complained of general malaise, achiness 48 hours after injection.  All symptoms resolved within 72 hours after injection.
Severe headache, 36 hours after shot.  Body aches 36 hours after shot.  Flu-like symptoms 36 hours after shot.  Redness, swelling in area of shot.  Serpiginous red line originating from vaccine site.
This spontaneous report was received from a pharmacist regarding a male patient who was in his mid fifties. Patient's pertinent medical history was not reported. The patient had no drug reactions or allergies. On 08-DEC-2015 the patient was vaccinated with ZOSTAVAX lot # L032397, expiry date: 26-NOV-2016, 0.65 ml, subcutaneously. Concomitant medications were not provided. On an unknown date in December 2015, approximately, the patient experienced redness and warmth at injection site. The patient sought medical attention by visiting the pharmacy. No treatment was provided for the events. No laboratory diagnostics tests were performed. The outcome of redness and warmth at injection site was unknown. Causality assessment was not provided. Product quality complaint was not filed. This is one of the two reports from the same source. Additional information has been requested.
Pt recvd 3 doses of Engerix-B on 25JAN91, 22FEB91 & 19AUG91; did not seroconvert;
starting 2APR98 pox appeared-approx 2-3 dozen-all crusted over by 8APR98;had an ear infect during this same time period;no exposure to chickenpox;
Shoulder injury due to how the vaccine was administered. Sadly the pain did not go away for several years.
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.  An 84-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 83 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: ancef antibodies, reaction(s): "Known allergies: Ancef antibodies". 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: (unspecified date) Positive, notes: Treatment of COVID-19; (Dec2022) Negative, notes: Tested negative for 3 days after Plaxovid treatment ended; (Dec2022) Negative, notes: Tested negative for 3 days after Plaxovid treatment ended; (Dec2022) Negative, notes: Tested negative for 3 days after Plaxovid treatment ended. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment was reported as yes. Reporter type patient, if vaccine received was reported as yes. Patient received Paxlovid treatment from 14Dec2022 to 18Dec2022 for Covid-19.  The lot number for [BNT162b2, BNT162b2 omi ba.4-5], was not provided and will be requested during follow up.
5" circumferance erythema, edema, tenderness, fever x 1 day; APAP & cold compresses to site;
25 min after shot on my left arm Tingling in my mouth through and face  swollen feelings. They gave me two Benadryl?s and 4 Pepcid  Waited for a hour in a half Symptoms subsided.  Around 9 pm I had horrible pain under my arm pit and top of my breast. And fast heartbeat  I took two Tylenol and the pain subsided but I am also getting pain in my two lymph nodes on the left side all the time
pt recvd flu vax & exp arm pain the the same arm as vax was given; pt has recovered;
congestion; Hot flashes; Dizziness; Tingling in nose and throat; Trouble breathing because of rapid heart beat; Blood pressure was elevated; felt lethargic and weak; nauseated; Soreness in muscle; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Soreness in muscle), NASAL CONGESTION (congestion), NAUSEA (nauseated) and HOT FLUSH (Hot flashes) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Soreness in muscle). On 16-Mar-2021, the patient experienced NASAL CONGESTION (congestion), NAUSEA (nauseated), HOT FLUSH (Hot flashes), DIZZINESS (Dizziness), PARAESTHESIA (Tingling in nose and throat), HEART RATE INCREASED (Trouble breathing because of rapid heart beat), BLOOD PRESSURE MEASUREMENT (Blood pressure) and LETHARGY (felt lethargic and weak). The patient was treated with CETIRIZINE HYDROCHLORIDE (oral) on 16-Mar-2021 at an unspecified dose and frequency. On 11-Mar-2021, HEADACHE (Headache) and MYALGIA (Soreness in muscle) had resolved. On 16-Mar-2021, NASAL CONGESTION (congestion), NAUSEA (nauseated), HOT FLUSH (Hot flashes), DIZZINESS (Dizziness), PARAESTHESIA (Tingling in nose and throat), HEART RATE INCREASED (Trouble breathing because of rapid heart beat), BLOOD PRESSURE MEASUREMENT (Blood pressure) and LETHARGY (felt lethargic and weak) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
a fewhours later he began to have abdominal pain; a fewhours later he began to have loose stools; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (a fewhours later he began to have abdominal pain) and DIARRHOEA (a fewhours later he began to have loose stools) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.        No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced ABDOMINAL PAIN (a fewhours later he began to have abdominal pain) and DIARRHOEA (a fewhours later he began to have loose stools). At the time of the report, ABDOMINAL PAIN (a fewhours later he began to have abdominal pain) and DIARRHOEA (a fewhours later he began to have loose stools) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
This spontaneous report was received from the mother of a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In approximately 2017 (reported as "about two years ago"), the patient received a PNEUMOVAX 23 injection in the arm "to help her fight sinus infections" (lot number, dosage and specific route of injection not provided). There were no adverse reactions reported. No additional information was provided. This is one of three cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1903USA007431: US-009507513-1903USA007433.
Expired daptacel was given to a patient/ no AE; Initial information was received on 01-Jul-2021 regarding an unsolicited valid non-serious case received from a Consumer via Medical Information (Reference number- 00665216) and transmitted to Sanofi on 01-Jul-2021.  This case involves a one-year-old female patient while receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] reported that expired DAPTACEL was given to a patient with no adverse event (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) for prophylactic vaccination and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 30-Jun-2021, the patient received 0.5 ml (total) dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5624AA, expiry date 10-Jun-2021] via intramuscular route in right thigh for prophylactic vaccination.  It was reported, "A Medical Assistant reporting on behalf of a consumer on Daptacel having a medication error described as the Daptacel dose being expired on the day of administration. Caller stated that expired DAPTACEL was given to a patient on yesterday. Caller would like to know what to do next regarding matter. Product used: Used. Still using product: No.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse 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 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.
Patient presented with injection site reaction of redness, swelling, and itching.  Advised patient to take Benadryl and if it doesn't improve see physician.
Itchy red rash at injection site. It started 1 week after receiving the shot.
Same day post vax, the child developed a fever of 105. He was sick for 2 days. She called her physician and questioned whether or not it was caused by the vax. No treatment given.
It started as a mosquito bite on the left knee and left and right thigh, with a lot of itching, as the days went by more came out, located on the knees and thighs, both left and right, but the left side was the most affected side and later it presented with hives that indicated an allergic reaction.
pt reported significant left axillary swelling that was initially evaluated on 2/22/21 and treated as adenopathy with Claritin or Zyrtec.  I saw patient on 3/24/21 after 2nd dose (given to right arm on 3/18/21), and at that time he was complaining of right axillary swelling with some redness as well as persisting left axillary swelling.  Patient had also had other symptoms (fevers, aches, chest discomfort/cough) in the few days after the vaccines that had resolved.  I consulted with our ID specialist, who saw the pt on 4/16/21, and at that time only left axillary fullness was noted.
This spontaneous report as received from a 11 year old female patient concerning herself. On approximately 01-AUG-2013 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly. On 31-AUG-2013, 30 days after onset of therapy the patient experienced headache. The outcome of headache was unknown. Additional information has been requested.
Narrative: Patient received Moderna vaccine 2/13/21 and 3/13/21. Per 11/12/21 primary care note, patient developed "heart symptoms" within a month of the vaccine, and patient reported his cardiologist said this was an adverse reaction to the vaccine.
Post-menopausal staining starting 3 weeks after the vaccine, duration  5 days
Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information  was not provided  by the reporter.  Treatment medication information  was not provided  by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: The follow up document received on 12-JUL-2021 contains NO NEW information.
RECEIVED A SHOT IN MY LEFT ARM, NEXT DAY I STARTED FEELING NAUSEAS, DIZZINESS,WAS NOT ABLE TO LIFT ARM, PAIN IN SHOULDER, LOSS OF APPETITE, HEADACHE, WHOLE LEFT SIDE GOES NUMB FROM PART OF MY LIPS TO MY FOOT THEN TINGLING, LOSS OF TASTE AND SMELL. BALANCE IS OFF,
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-SEP-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 120, and 144 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
SORE THROAT; RUNNY NOSE; HEADACHE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and allergic to sulpha based drugs. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-NOV-2021as a booster for prophylactic vaccination into right arm. No concomitant medications were reported.  On unspecified date in NOV-2021, the patient experienced symptoms (sore throat, runny nose, headache) after receiving the Janssen Covid-19 vaccine booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, runny nose, and headache. This report was non-serious.
threw up 3 times @ 3AM, fever, hot, t100-very, very thristy; threw up again 330AM;
2 day after flu shot I had sore eyes. 3 day coughing. 4 day coughing, hoarseness. Cold like for days.
Loss of menstrual cycle for 100 days, Migraines with most severe  migraine ( lasting  4 days) at 3 weeks  post vaccine. Left side neck and shoulder pain
Redness and warm, swelling and pain in the left arm, firm induration about a quarter sized and this is tender around the injection site, Warm compresses 15-20 minutes at a time Monitor. If worsening or new symptoms let me know!