chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; upset GI; pain in the skin; This case was reported by a other health professional and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, gastrointestinal upset and skin pain. On an unknown date, the outcome of the fever, gastrointestinal upset and skin pain were unknown.   It was unknown if the reporter considered the fever, gastrointestinal upset and skin pain to be related to Shingrix.  Additional details were provided as follows: Th patient was born in 1963. The age at vaccination was not reported. After receiving Shingrix, the patient experienced fever, upset gastrointestinal and skin pain. The reporter checked with the label and it said1 out of 6 people can't work next day. The reporter did not agree to follow up from GlaxoSmithKline.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of M-M-R II injection, lot # reported as L037356 with expiration date 23-JUL-2017 (doses, routes of administration and therapy types were not reported). No adverse effects were reported. This is  one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Within days of injection developed a teeth sensitively to cold, with more sensitivity on left-side of mouth. Beginning January 22, 2022, one issue after another (all documented), including but not limited to right earache, ear popping/pressure issues, sinus issues, right heel burning sensation/pain, hip pain, headaches and shooting sensations into right breast.
Became extremely drowsy for hours post injection. Right arm feels like someone hit it with a baseball bat.
This is a spontaneous report from a non-contactable consumer. A male patient (age unknown) received a dose of PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date, the patient experienced a fever. Outcome was unknown at the time of report. No follow-up attempts possible. No further information expected.
11-10-15 patient called clinic after returning home, after receiving HepB vaccine in clinic this afternoon. Reported had vomiting three times, and prior to vomiting, friend reported she fainted for 3 seconds and had jerking movements. Advised to go to ER/notify MD. Called patient back on 11-13-15 to follow up. Reported recovered on 11-10-15 and did not seek medical attention.
The patient reported swelling of her upper lip that began on 7/28/2021. It was more pronounced this morning.
Patient believes she may have had an allergic reaction to the second dose of Shingrix. She had redness and bump around the injection site and then two days later she had a rash on both arms and around her neck/chest. No breathing problems. Recommended that she take a picture to make sure no spreading. Also, that she can take benadryl / apply cold compress to the area. Advised her to stop "patting" the area. Advised her to go to ER if there are any breathing issues.
I woke up during the night with severe chills that lasted about 2.5 hours.  I could not get warm nor could I stop the shaking or teeth chattering during this time.  Also, especially my neck, back and shoulders joints were very achySite of injection was painful for 4 days. I took Tylenol and finally fell asleep. Upon awaking in the morning, I was very warm and the shaking had finally stopped. The aches were still present.  I am ok now and not sick.  I am a radiographer at this hospital.  I have received the flu shot many times in the past and have never had this type of reaction.
Woke up dizzy; Pain; Bruise at injection site; Having flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain), VACCINATION SITE BRUISING (Bruise at injection site), INFLUENZA LIKE ILLNESS (Having flu like symptoms) and DIZZINESS (Woke up dizzy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW).   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced VACCINATION SITE PAIN (Pain), VACCINATION SITE BRUISING (Bruise at injection site) and INFLUENZA LIKE ILLNESS (Having flu like symptoms). On 28-May-2021, the patient experienced DIZZINESS (Woke up dizzy). At the time of the report, VACCINATION SITE PAIN (Pain), VACCINATION SITE BRUISING (Bruise at injection site), INFLUENZA LIKE ILLNESS (Having flu like symptoms) and DIZZINESS (Woke up dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
expired dose of Engerix-B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-year-old female patient who received HBV (Engerix B pediatric) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   On 7th July 2022, the patient received Engerix B pediatric. On 7th July 2022, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 28-JUL-2022 Reporter's comments: Pharmacy resident reporting expired dose of Engerix-B administered on 7th July 2022 which expired on 1st June 2022. The adverse event report contained all details provided by the health care professional (HCP). The health care professional (HCP) gave consent for safety team to follow up. Additional Supportive Information: The patient received Engerix B pediatric beyond expiry date, which led to expired vaccine used. This case has been linked to the case US2022112346 reported by the same reporter.; Sender's Comments:  US-GSK-US2022112346:Same reporter
Nausea and vomiting (not experienced with first dose or during Covid in January 2021) Muscle weakness Joint pain Headache
Case number PHHY2011US34417 is an initial spontaneous case received from a physician on 19 Apr 2011 with a follow up report received from a health care professional on 16 May 2011. This report concerns a 1-year-old girl. She was vaccinated with MENVEO (batch number: 029011) intramuscularly in to the left thigh on 19 Apr 2011. On the same day, she was also given an intramuscular dose of HAVRIX (batch number: unknown) and a subcutaneous dose of varicella vaccine (batch number: unknown). No adverse event was reported following this inappropriate schedule. Follow up information received from a health care professional on 16 May 2011: Updated information about patient demographics, site of application and concomitant medication.
6 days after shot I have a lot of pain, swelling, and heat in my arm at injection site. Feels like my whole muscle is a hard lump. Also itches. Not really red or rashly yet.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received the 2nd dose of SHINGRIX. On 1st March 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain and lightheadedness. On 2nd March 2019, the patient experienced injection site erythema. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the injection site pain and lightheadedness were not reported and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, light headedness and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received her second dose of SHINGRIX, on Friday, March 1st at a retail pharmacy. She reports pain at the injection site immediately. She also reported that she felt a bit lightheaded right after the injection as well. The patient reports that there was some redness and soreness the next day, which resolved. The reporter cousin of the patient stated that the flu like symptoms were not elaborated. The patient did not wish for physician to be contacted. The reporter did not consent to follow-up.
Fever started 2 days after receiving vaccination, bleeding a lot. Rash 3 days after receiving the vaccine's , started on her face now spreading to her body. Cough, runny nose for 1 day. pink macular papular rash on face, rash also at trunk. Slight nasal discharge.
Narrative:  83 yo M received booster COVID-19 vaccine dose (Moderna) 0.25 mL IM on 11/10/21. Within 24 hours, fever was detected (100.1F), pulse up to 153. Patient is admitted to a long-term care facility. On 11/11/21, pt was transported to an outside hospital. Received treatment with APAP, ceftriaxone x1 and then 2-3 days of PO cefpodoxime with improvement in temperature, WBC count, and heart rate. Pt admitted to this outside hospital for 4 days. Previous COVID-19 vaccine history: moderna dose #1 12/24/20, moderna dose #2 1/21/21.
Dilated Cardiomyopathy with mutated gene FLNC,; mutated gene FLNC; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: ER8730) at the age of 43 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: CONGESTIVE CARDIOMYOPATHY (hospitalization, medically significant) with onset 27Apr2022 at 13:15, outcome "not recovered", described as "Dilated Cardiomyopathy with mutated gene FLNC,"; GENE MUTATION (hospitalization) with onset 27Apr2022 at 13:15, outcome "not recovered", described as "mutated gene FLNC". The patient was hospitalized for congestive cardiomyopathy, gene mutation (hospitalization duration: 4 day(s)). The events "dilated cardiomyopathy with mutated gene flnc," and "mutated gene flnc" required emergency room visit. Therapeutic measures were taken as a result of congestive cardiomyopathy, gene mutation. Clinical information: Dilated Cardiomyopathy with mutated gene FLNC, the only thing that may of triggered the gene mutation how enlarged my heart is and the time frame sort of points to the vaccine because I really didn't have any other sickness, not totally saying it was the vaccine for sure but you also can't deny it wasn't. The adverse events treatment was Medication. Patient not received other vaccine in four weeks, other medications in not received in two weeks, no covid prior vaccination, no covid tested post vaccination. No history of known allergies.
Patient developed chicken pox on her shoulders, underarms, and scalp.  We noticed 15-20 pock marks.  I took her into our doctor and he told us it was chicken pox from the vaccine.  We are currently treating her with calmine lotion and a topical antibotic ointment.  Also, her twin brother devloped chicken pox a few days earlier but we only noticed five pock marks and thought they were bug bites.  Most of them have gone away.
suspected vaccination failure; had them 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles three times. The patient's doctor said, once you had them you could get them over and over, but the Shingles shot helped them not to be so bad. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Anaphylactic Reaction Standing Order Worksheet   Nursing Assessment Patient presents at 10:05 am  with the following symptoms: pruritus, flushing, dizziness, diaphoresis, headache, dyspnea/SOB, hoarseness and cough   Patient's weight 99.8kg per patient reports   Medical History Patient has hypersensitivity/allergy to: medication  Codeine High Anaphylaxis   Cyclinex [tetracycline] High Breathing Difficulty   Meloxicam High Edema,generalized   Sulfa Antibiotics High Cardiovascular arrest         Nurse Actions:  911 called: no, provider at chairside   Clinician informed: yes, Clinicians Name:    Suspected trigger removed: No   Epinephrine Epipen Adult IM held.  Benadryl 50mg PO 1012 Positioned patient Lying supine   Vitals obtained and documented 1006-1035  (enter in vitals section)   Narrative Code charting 1006 Patient coughing continuously, unable to say more than a word or two at a time.  Dr. assessed patient. SAO2 99% (RA), P 90, RR 30, B/P 127/82 1010 Continues to cough continuously SAO2 100% (RA), P 110, RR 30 1012 Benadryl 50mg PO 1017 Coughing less, flushed face resolved.  Dr. assessed patient. SAO2 98% (RA), P 107, RR 30 1020 Able to talk in full sentences, coughing less, RR 24 1025 Talking, drinking, very rare cough.  Dr. assessed patient. SAO2 100% (RA), P 85, RR 20 1030 Sitting up, RR 20 1035 Moved to chair, Dr. discussed d/c plan and left room. RR 20 1040 RN left room.   1052 Patient discharged       Oxygen Oxygen: Patient >94% O2 saturation at initial assessment (enter in vitals section)   Glucagon Held.     IV initiated per standing order no    Additional intervention for bronchospasms/wheezing.  Not applicable.   Response Respiratory rate decreased, coughing lessened. Patient able to talk   Disposition/Outcome  Disposition:  discharged from clinic with husband driving, Patient was given the following prior to leaving the clinic Patient Education take benadryl the next few days and Personal belongings with:  Patient   RN 2/17/2022, 10:58 AM
When younger when first got it I remember he use to bang his head, then he got older and more problems broke out now he has temper lobe seizures. How: He's had them and been tested.
Mother started noticing red areas on Pt from scalp to legs, red areas with little blister like areas in the middle. Pt with low grade (100) temp and increased fussiness. No new lotions, soaps.
Covid19 breakthrough.  1st vaccine received on 04/17/2021.  65 y/o PMH of TBI s/p MVA with post traumatic seizures presents to ED with c/o multiple syncopal episodes which began the day after pt received Covid booster vaccine.  Pt afebrile, room air sat 100% and CXR with pulm edema.  Pt admitted to r/o cardiac cause of syncope.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with improperly stored VAQTA(lot # M011116, expiry date 17-JUN-2017, dose, strength, dose number, vaccination site, route not provided). No adverse effects were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Achy joints; Fever; Sore muscles; Night sweats; Unable to move his arms; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2022, less than a month after receiving Shingrix, the patient experienced joint pain, fever, muscle soreness, night sweat and mobility decreased. On an unknown date, the outcome of the joint pain, fever, muscle soreness, night sweat and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, fever, muscle soreness, night sweat and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received Shingrix in an unknown arm. The patient began to experienced achy joints, fever, sore muscles, night sweats and was unable to move his arms within few days. The patient was seen in the emergency room for these symptoms since they had been present for nearly 1 month. The lot number or expiration date of the vaccine was not known. The patient's wife wanted to know long term effects of vaccine.  The reporter consented to follow up.
pain and 4 x 4 cm edema redness and swelling at injection site myalgia x 4 days headache x 3 days sweats x 3 days fatigue that prevented work x 3 days GI upset Loose bowel movements x 2 days  loss of appetite 5 lb weight loss in 6 days
horrible rash all over my back stomach neck arms hair; huge red area at the injection site; Reaction to preservatives; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2019, the patient received the 1st dose of Shingrix. On 27th November 2019, less than a day after receiving Shingrix, the patient experienced generalized rash, injection site erythema and reaction to preservatives. On an unknown date, the outcome of the generalized rash, injection site erythema and reaction to preservatives were unknown.   It was unknown if the reporter considered the generalized rash, injection site erythema and reaction to preservatives to be related to Shingrix.  Additional case details were reported as follows: The patient just got the Shingle shot. The patient got a horrible rash all over the back, stomach, neck, arms and hair. Also had a huge red area at the injection site. The patient was curious if the preservatives that are in the shot cuased this reaction.
an expired dose 27Jun2019 of Menactra was given to patient/ No AE; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who received expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5916AA, expiry date: 27-Jun-2019 via intramuscular route in the right deltoid on 11-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation on 11-Jul-2019.  It was a case of actual medication error due to expired vaccine used.  There were no side effects after the vaccine.  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.  Documents held by sender: none.
HIGH BLOOD PRESSURE/BLOOD PRESSURE OUT OF WHACK; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient not had any drug abuse / illicit drug use. the patient did not drink caffeine and had no high sodium. the patient had no change in his life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 165-180 (unit not reported), 140-165 (unit not reported). On MAR-2021, treatment medications included: metoprolol. On 24-MAR-2021, the subject experienced high blood pressure/blood pressure out of whack. On 15-JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 165-180 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure/blood pressure out of whack. This report was non-serious.
pt recv vax;lt leg swollen from hip to foot w/ red,warm area size of adults palm surrounding inject site;27jul95, swelling dec in leg but area around inject site "puffed out more like cellulitis bumping,red and hot;subsided 31jul95;
Case number PHEH2012US020068, is an initial spontaneous report received from a medical assistant on 04 Oct 2012. This report refers to 11 year old female patient. She was vaccinated only with the CWY-135 liquid component of MENVEO (batch number: X10130), intramuscular on 04 Oct 2012. No adverse event was reported following this administration error.
Extremely sore arm, swollen lymph nodes in arm, neck on side of shot and through out body, fever, chills, headache, pressure in face