chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed a white raised hive 12mm in diameter with erythema surrounding the area on the left thigh where the varicella vaccine had been administered SC.  The area of erythema was approximately 90mm in diameter.  The area of erythema was warm and slightly hardened to the touch.  2.5mL of diphenhydramine was administered PO at 1650.  At 1700, hive was no longer white (became pink) and began to diminish in height. Erythema began to diminish.
3min p/vax pt was diaphoretic & pale;faint & feeble;face pink;BP 60/0;R30 labored;
Sore shoulder; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) and FATIGUE (Feeling tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder) and FATIGUE (Feeling tired). At the time of the report, ARTHRALGIA (Sore shoulder) and FATIGUE (Feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood glucose: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient was diabetic, and her blood sugar had been really kind of high and not at all stable as they usually were. It started a day or two after the first injection.  The patient did not receive any treatment
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Additional Details: Patient stated that she noticed the bruise around injection site on that night she received a vaccine. She stated that she didn't notice any change in the size of bruise. Patient stated that she will follow up with the doctor on following Monday if symptom is not improving.
Patients administered Moderna vaccine while temperature excursion assessment was ongoing; Patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
PAIN THROUGHOUT MY BODY/ESPECIALLY IN MY SHOULDERS, BACK, GROIN, HIPS, LEGS AND UPPER ARMS. LETHARGIC, LOWER BODY/HIP WEAKNESS. PAIN IN ELBOWS/SHOULDERS WHEN TRYING TO GET OUT OF CHAIRS, TO NAME BUT A FEW.POSSIBLE SHINGLES ISSUES ARE MENTIONED PER NOTES IN , JAN 2019, JULY 2019, JUNE 2019  AND I COMPLAINED ABOUT THE SIDE EFFECTS I WAS HAVING FROM APRIL 2019 TO THE PRESENT DAY.
Cerebral vein sinus thrombosis - patient developed headache 4-5 days following the vaccine, then presented on 10/16 with worsening aphasia found to have ICH with CVST - required thrombectomy - subsequently developed HIT (presentation not consistent with reported cases of VITT) - discharged on apixaban and stable
Myalgia and fever 103 F. 2 cm X 3 cm erythematous macule right arm.
Approximately 10 minutes after injections, she returned to nurse.  She was having jerking movements in arms, head, and had unsteady gait. Epinephrine given, 911 called, was taken to the hospital.  After receiving immunizations, boyfriend verbalized that she had been drinking and had taken 2 pain pills earlier.
This spontaneous report as received from a nurse refers to a 14 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 17-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
bloating and feels swollen; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. It was reported that the caller received second shot and was experienced bloating and feels swollen. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
throat swelling up to her ears w/ post nasal drip.  HX of autoimmune dx.   Takes Zyrtec / Benadryl daily.  Shot #1 had smiliar reaction resolved w/ benadryl.   pt. speaking and swallowing secretions.  w/o difficulty.  pt. refused transport.. will call EMS is needed.
ACUTE RESPIRATORY FAILURE 12/18/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  ACUTE ON CHRONIC RESPIRATORY FAILURE 2/14/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  ACUTE RESPIRATORY FAILURE 12/18/2021 ACUTE ON CHRONIC RESPIRATORY FAILURE  ACUTE ON CHRONIC RESPIRATORY FAILURE 2/14/2022 ACUTE ON CHRONIC RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 12/18/2021 ATRIAL FIBRILLATION, UNSPECIFIED   ACUTE ON CHRONIC RESPIRATORY FAILURE 2/14/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Dose I received made me feel sick; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 25Jan2021 (12:00) at a single dose on the right deltoid, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included scoliosis; diabetes; mitral valve prolapse (MVP); gastroesophageal reflux disease (GERD); and torticollis. The patient's concomitant medications were not reported. The patient previously took codeine, and had drug allergy. On 26Jan2021 (04:00), the dose of vaccination that the patient received made him feel sick. The patient went to urgent care as a result of the event, and had received an unspecified treatment for the event. The outcome of the event, 'feel sick', was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  Information on lot number/batch number was requested.
injection site sore/painful, itchy, swollen, hot, pink   area 2 inches by 3 inches
Slight headache and fatigue by 7:30 that got increasingly worse. Muscle aches throughout whole body, especially around injection site. Extreme fatigue, muscle soreness and headache through the night and into next day. Woke up feeling like a terrible hangover. Took ibuprofen at 8am. Slept all day. By 4, soreness and headache was better. Slightly fatigued for 3 days after, sore arm for 4 days after.
I had trouble breathing for two days and had a sore arm within 5 minutes of having the injection. And pain in my left leg is still ongoing.
RECEIVED A HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received  with covid-19 vaccine ad26. cov2..s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 1) for prophylactic vaccination The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 1822809 ,211A21A expiry: UNKNOWN) 0.25 ml, 1 in total, administered on 28-NOV-2021 for prophylactic vaccination. (dose number in series: 2) No concomitant medications were reported.  On 28-NOV-2021, the patient experienced received a half dose for their booster dose (coded as Vaccine under dose) On 28-NOV-2021, the patient experienced off label use (both events dose number in series: 2). The reporter stated that something was printed and was disseminated which said to administer 0.25ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211202193, 20211201082, 20211200752, 20211200994, 20211201450, 20211201351, 20211201046, 20211202469, 20211202515, 20211200675, 20211201168, 20211201179, 20211201228, 20211201304 20211201392, 20211201443, 20211201963, 20211202161, 20211202199, 20211200717, 20211200723, 20211200769 20211201362, 20211202207, 20211202246, 20211202371 and 20211202379.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 31 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Unspecified laceration of eye; Sore eye; Wound infection; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), EYE INJURY (Unspecified laceration of eye), EYE PAIN (Sore eye) and WOUND INFECTION (Wound infection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced EYE INJURY (Unspecified laceration of eye), EYE PAIN (Sore eye) and WOUND INFECTION (Wound infection). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and EYE PAIN (Sore eye) had not resolved and EYE INJURY (Unspecified laceration of eye) and WOUND INFECTION (Wound infection) outcome was unknown.            No concomitant medicine were reported. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  For HUMIRA, the reporter causality for the events of Vaccination site pain, Eye injury, Eye pain and Wound infection was not provided. 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. No treatment medicine were reported.   Reporter did not allow further contact
Severe pain and swelling of lymph nodes in left armpit 11 hours after injection. Severe pain (7 out of 10) lasted about two hours and subsided to a 3 out of 10, but lymph modes have remained swollen and painful at the time of this writing (36 hours and counting). Fever and fatigue began 12 hours after injection and lasted 18 hrs.
No additional adverse effect; patient was administered GARDASIL 9 on 8/6/2018, 10/9/2018, 6/7/2019 and 6/30/2020; patient was administered GARDASIL 9 on 8/6/2018, 10/9/2018, 6/7/2019 and 6/30/2020; This spontaneous was report as received from a nurse via a field representative and refers to a 18-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 06-AUG-2018, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On 09-OCT-2018, the patient was vaccinated with the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On 07-JUN-2019, the patient was vaccinated with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On 30-JUN-2020, the patient was vaccinated with the fourth dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). No additional adverse effect reported.
Severe pain causing to wake from sleep and unable to lift arm at all for several hours and unable to fall back asleep due to pain
Onset of headache, lethargy, dizziness ~6 hrs post vaccination.  Sx's continued with few episodes of vomiting x24-36 hrs with 2 episodes of night terror ~48 hrs. post vaccination.  Sx's gradually resolved over 3 days with obvious residual.
This initial spontaneous case, was received from nurse on 06-Nov-2017, concerning a patient of unspecified age and gender. On an unspecified date, the patient was administered with AFLURIA (expiry date: Jun-2017, dose, route of administration, anatomical location and batch number: not reported) (explicitly coded as expired vaccine used). The reporter assessed the case as non-serious.
Severe arm pain with swollen axilla Lymph node x 3 days. Headache x 2 days.
Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial was initially stored in refrigerator on 04-PAR-2022. The vial did not undergo any temperature excursion. The pharmacist says that pharmacist thought that the vaccine expired in June 2022 however the vaccine expired on 01-APR-2022. No treatment details were provided.
Cellulitis from his right leg to the bottom; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 04May2021 the case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional (patient). This other health professional reported 2 cases for different patients. This is one of the 2 reports. A 64-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 14Apr2021, as single dose, for COVID-19 immunisation. Medical history included dizziness (subsided) from Oct2020. Concomitant medications were not reported. The patient previously took warfarin for blood clotting disorder; rabies vaccine in Jul2020 for immunisation and experienced arms and legs were weak (subsided), hypersensitivity with eczema psoriasis, allergic reaction, stroke and brain bleeding and the patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on an unspecified date for COVID-19 immunisation.  The patient underwent lab tests and procedures which included international normalized ratio: 3.5 on an unspecified date still threw a clot. The patient was in the emergency room in May2021 in the night because of cellulitis from his right leg to the bottom. Therapeutic measures were taken as a result of the event and included treatment with antibiotics.  The information on the lot/batch number has been requested.; Sender's Comments: Due to implausible temporal association, the event of Cellulitis is assessed as unrelated to the Vaccine BNT162B2.  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.
Information has been received from a physician, via a company representative, concerning a patient of age between five and seven years old and of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. Approximately in 2017 (reported as: administered within the last two weeks), the patient was vaccinated with M-M-R II (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On an unspecified date in 2017, the patient experienced mumps outbreak. The patient visited the doctor on an unspecified date and was treated with an unspecified antibiotic. In reference to the mumps outbreak, the patient also visited a Hospital. The reporter stated that the mumps outbreak was related to M-M-R II administration. The patient's outcome was reported as recovered. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006841.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 05-JUL-2016, the patient received an expired dose of VARIVAX (injection, lot # K00798 with expiration date of 03-JUN-2016) (exact dose and route of administration were not reported). No concomitant therapy was reported. The reporter stated that the VARIVAX did not have any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Pt came in this am with a 3 cm lesion on (L) upper arm round in shape red in color, arrangement isolated and localized distribution, status is stable, pt had varicella # 2 in (L) upper arm yesterday reaction to site per Dr.
AFTER 5 MINS, PATIENT EXPERIENCED LOW BLOOD PRESSUE, WEAKNESS, & PERSPIRATION. ONE OF MY TECH IMEDIATELY CALL 911. HIS BP & PULSE WAS MEASURED & TAKEN TO THE HOSPITAL
Varicella vaccine given 11/25/1996. Pt developed varicella with over 100 pox 7/3/01.
Received shots on 10/9. On the arm of Friday 10/11, patient woke with severe neck pain "like she slept on it funny." Then on Saturday she became dizziness and felt like her ears were plugged. On Sunday she noticed facial drooping on right side of face. Went to clinic on 10/13 and received 6 days valacyclovir and drops for dryness in eyes.