chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOST LITTLE BIT WEIGHT; NIGHT SWEATS REALLY BAD; DID NOT HAVE SAME ENERGY (LOW ENERGY EACH DAY); CHILLS; TEMPERATURE WENT UP EVERY NIGHT CLOSE TO 100F (FEVER); FELT LIKE HAD FLU WITHOUT VOMITING; HARD TIME SLEEPING; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included copd (chronic obstructive pulmonary disease), hypertension, diabetes (undiagnosed), skin issues, and allergic to pneumonia vaccine (bad reaction from second dose).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 2038218, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced felt like had flu without vomiting. On 26-MAY-2021, the subject experienced hard time sleeping. On 26-MAY-2021, the subject experienced night sweats really bad. On 26-MAY-2021, the subject experienced did not have same energy (low energy each day). On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced temperature went up every night close to 100f (fever). Laboratory data included: Body temperature (NR: not provided) 100 F. On 02-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 97.4 F. On an unspecified date, the subject experienced lost little bit weight. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from felt like had flu without vomiting, night sweats really bad, hard time sleeping, did not have same energy (low energy each day), lost little bit weight, temperature went up every night close to 100f (fever), and chills. This report was non-serious.
AS SOON AS WE COMPLETED VACCINE , HE START FELLING HOT AND NAUSE  AND HE SAID HE  FEEL LIKES HE WILL PASSOUT , WE GAVE HIM  1 TABLET  OF BENADRYL 25 MG AND CALL 911 ,AFTER 5 MINUTES HE START FEELING GOOD AND EMS ARRIVED IN 10 TO 15 MINUTES CHECCK  HIS BLOOD PRESSURE AND PULSE AND HE FELT  GOOD  AFTER 15 MINUTES AND WALKED TO HIS CAR.
Moderate to severe axillary lymphadenopathy requiring missing work and inability to perform his functions as a first responder/wear protective gear
patient lied on vars form and to staff saying it was his third covid shot when in actuality it was his 4th.
Patient states that the next day after vaccine administration she became fatigued. This resolved over a few days however several weeks later she had neck swelling which another MD diagnosed her with parotiditis and Rx antibiotics and Decadron.  At the end of December she devleoped deep throat muscle pain and neck swelling. Strep throat swab negative.  She was given another antibiotic.  She then saw another MD who questioned MONO but she had had no fevers.  He checked a CBC and WC was elevated and he prescribed another antibiotic.  She then developed muscle and joint stiffness in her knees and shoulders and hips.  An ENT MD saw her and a CBC was repeated with elevated white count and he saw lymphadenopathy.  EBV blood test was positive.  HE gave Decadron.  She then received her second Gardasil vaccine on 1/10/2010.  She then began having trouble sleeping along with her joint stiffness.  She was prescribed Lortab.  She then went to another MD who ordered arthritis labs (ANA, RF, ESR, TSH - all negative).  White count normalized.  He prescribed NSAID.  She then started having numbness and tingling in her fingers and pain in her feet.  No swelling, fevers, rash on exam.  She did not get the third Gardasil vaccine.
No adverse effects reported; The patient was administered only half to three quarters of a dose of PROQUAD due to the needle leaking; The patient was administered only half to three quarters of a dose of PROQUAD due to the needle leaking; some of the vaccine may have gotten on the patient's leg; some of the vaccine may have gotten on the patient's leg; This spontaneous report was received from a medical assistant referring to a 4 year old patient of an unknown gender. Information regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies were not reported.  On 25-JUL-2019, the patient was administered only half to three quarters of a dose (underdose) of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot number R008203 and expiration date on 16-SEP-2019; and the sterile diluent for the reconstitution with lot number N008379 and expiration date on 14-NOV-2019, both administered subcutaneously in the left thigh, for prophylaxis (dose and dose number were not reported, due to the needle leaking (needle issue). Also was reported, that some of the vaccine may have gotten on the patient's leg (exposure via skin contact and accidental exposure to product). No adverse effects were reported.  At the time of the report, the outcome of the event and the causality assessment between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and sterile diluent with the needle issue were not reported.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 72nd of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
100.0 fever; Chills; Extreme muscle fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills and muscle fatigue. On an unknown date, the outcome of the fever, chills and muscle fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and muscle fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-MAY-2022 Reporter's Comments:  The case was reported via interactive digital media. At the time of reporting the patient experiencing fever(100), chill and extreme muscle fatigue after receiving shingles vaccine. No other information was provided.
A few minutes after receiving the vaccine, while sitting in the monitoring area, patient expressed feeling dizziness and appeared pale. Patient escorted to recliner chair by RN and lower extremities elevated. BP 102/78, SpO2 98%, HR 61. Patient remained seated for 15 minutes while drinking water and Gatorade after which the patient expressed feeling "better".  Upon re-check BP 112/82, SpO2 97%, HR 64.
Patient tested positive for covid 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for covid 19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for covid 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive for covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Stevens Johnson syndrome; Sunburn-like rash; This spontaneous case was reported by a physician and describes the occurrence of STEVENS-JOHNSON SYNDROME (Stevens Johnson syndrome) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced STEVENS-JOHNSON SYNDROME (Stevens Johnson syndrome) (seriousness criterion medically significant) and RASH ERYTHEMATOUS (Sunburn-like rash). At the time of the report, STEVENS-JOHNSON SYNDROME (Stevens Johnson syndrome) and RASH ERYTHEMATOUS (Sunburn-like rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  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.
Dizziness. Nausea, confusion, inability to turn head while walking or any movement without severe dizziness and nausea, unable to drive or be in any busy situation, severe headache and light sensitivity in mornings. Severe headache after looking at computer for more than 10 minutes.Can't look down while walking so causes a tripping hazard. Unable to look at paperwork and back up without severe nausea and dizziness
administered ACT-HIB that expired on 26-OCT-2022 with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 months old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that expired on 26-oct-2022 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine for prophylactic vaccination; and pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for prophylactic vaccination.  On 20-Dec-2022, the patient was administered 0.5 mL of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (1X; batch/lot number: UJ594AAA; strength, dose: unknown) via intramuscular route in the left deltoid for immunization that expired on 26-oct-2022 (expired product administered) (latency: same day).   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.; Sender's Comments:  01481406: 01481498: 01481505: 01481508:
Swelling in her lymph nodes/30 minutes after receiving the 1st dose she experienced lymph node swelling; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in her lymph nodes/30 minutes after receiving the 1st dose she experienced lymph node swelling) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LYMPHADENOPATHY (Swelling in her lymph nodes/30 minutes after receiving the 1st dose she experienced lymph node swelling) and PRODUCT DOSE OMISSION ISSUE (Missed dose). On 06-Mar-2021, LYMPHADENOPATHY (Swelling in her lymph nodes/30 minutes after receiving the 1st dose she experienced lymph node swelling) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported. Patient stated that she has experienced similar symptom of swelling of lymph nodes in the past in reaction to certain medications.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received  contains significant information. updated and added reporter information, updated patient age to 39, updated dose start date and lot number, updated event outcome to recovered, start date of the drug updated.
LEG PAIN DIAGNOSED AS BLOOD CLOT; HEADACHE; MILD FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: unknown) dose was not reported, 1 in total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, in APR-2021, the patient experienced mild fever (99 degrees fahrenheit), headache and leg pain diagnosed as blood clot (leg pain) on 21-APR-2021. On an unspecified date in APR-2021, laboratory data included: Body temperature (NR: not provided) 99 F, and Diagnostic ultrasound (NR: not provided) unknown.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg pain diagnosed as blood clot, headache and mild fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:2021045225-covid-19 vaccine ad26.cov2.s-Leg pain diagnosed as blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
2nd Day: -Fatigue -Chills -Queasy 5 Days: Sore arm
Patient received Pfizer vaccine on 2/11/21. Came in to clinic today and received the Janssen vaccine. Did not annotate in regards to previous vaccines and administering pharmacist clearly stated that the vaccine was Janssen and it's a one dose vaccine.
pt devel erythema & warmth @ inj site-consistent w/cellulitis & low grade temp 99.3 by mouth;
Information regarding Prevnar was received from a healthcare professional regarding a patient who received dose of Prevnar that was exposed to out of temperature range on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. On an unspecified date, the patient received a dose of PREVNAR that was exposed to out of temperature range due to a power outage. No adverse event was reported. The reporter was unable to specify the number of patients who received this vaccine. No additional information was available at the time of this report.
No additional adverse events reported; VARlVAX that was administered after improperly stored; This spontaneous report was received from a certified medical assistant regarding a patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not provided.  On 04-OCT-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL (route of administration was not reported) lot# T027303, expiration date 12-AUG-2022, given as prophylaxis (Product storage error).  The improperly stored dose underwent a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (average temperature: 8.5 °F) for 0 hours, 18 minutes and 0 seconds; and of 6°F to 14°F (average temperature: 11.9°F) for 1 hour, 0 minutes and 0 seconds. The cumulative timeframe was 1 hour and 18 minutes, with no previous temperature excursion. No further information given, and no additional adverse event was reported (no adverse event).
20mins post vaccination, pt reported headache and dizziness. Vitals: 101/53, 76, 12, 100% Pt stable and released from the vaccination site.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454 expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
I was having shortness of breath when exercising or running up stairs to catch subway.   This was new onset.  Continued for a month and seemed to be getting worse - sought care in February.  March 25, Echo showed EF 40% preliminary diagnosis myocarditis (post infectious) vs. atherosclerotic hear dz (cath ordered). Placed on beta blocker and Calcium Channel Blocker.  Cardiac cath on 4/8/22 was significant for minimal luminal irregularities in all 3 coronary vessels. LVEF on LV gram was 50%.  MR on May 9, 2022 showed Left ventricular global systolic function is normal. The LV ejection fraction improved to 56  %.   Symptoms were also improved by that time.  Of note - there was a few days of headache and burning in......... chest like going outside in -15 degree weather and taking deep breath, but no fever or other symptoms.  Omicron was spreading in NYC at the time but went to PA for the holiday week and could not get tested - later asked PMD for COVID nucleocapsid antibody test which was negative (February 16, 2022).    Although timing is on far end of timing for potential vaccine associated myocarditis, I felt important to enters in lieu of an alternate cause.
Mother reported via message to PCP staff the day after the injection, that patient had developed facial swelling and redness limited to around her right eye. A picture was provided. The cheek and right upper lip were also slightly swollen without erythema. She had developed a cough and nasal congestion overnight as well. She states that patient still had the ability to wink, wrinkle her forehead, and smile.
Our patient received a Pfizer monovalent COVID vaccine on 9/6 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Multiple pustules with erythematous base over upper back that began 2 days prior to visit. No symptoms associated with presentation. No treatment given. Diagnosis: acute folliculitis vs vaccinia reaction.
3/31/11 child had 4-5 episodes of seizure-like activity: mouth open/head shaking/unresponsive to voice/falling to ground/rigid body with interspersed periods of motor hyperactivity. Some perioral cyanosis. All over 15-20 minutes. Parents called 911.
Itching followed by what resembles a shingles rash that began as patches on right arm and then continued spreading in strips down right arm, left arm, areas on torso especially back and continues spreading to this day.   All rash areas continue to itch and have not healed.  Yesterday PA prescribed Prednisone and Hydroxyzine HCL, which has somewhat helped with the itching.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 84-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805415 was crossed linked to original cases 201804863 due to same reporter.
Information has been received from a physician concerning a male who was vaccinated with MMR II. The patient developed erythema after getting MMR II and VARIVAX (MSD) on the same day. Lot number was not provided. It was reported that the patient recovered from the event (date unspecified by reporter). Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: 911 called pt never lost consciousness recovered in store after emt vistit to store
05/05/04 @ 10AM: Vaccine given; 05/06/04 @ 02:00: Complained of shortness of breath, cough and chest pain, non-radiating; 05/06/04L 10AM: Dr. appointment;