chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vaccine leaked on her hand; the vaccine leaked on her hand; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a adult female patient who received Herpes zoster (Shingrix) (batch number zm749, expiry date 22-AUG-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: the vaccine leaked on her hand), exposure via skin contact (Verbatim: the vaccine leaked on her hand) and pharmaceutical product complaint (Verbatim: Product Complaint).  The outcome of the occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt date: 21-SEP-2023 HCP reported she was a difficult time withdrawing Shingrix after reconstitution and the vaccine leaked on her hand (solution-0010-vial leaking) All operations were performed appropriately before defect was discovered. The defect was discovered during preparation. The mixing/shaking performed after reconstitution, gently the vial held upside-down when the vaccine was being withdrawn. The product was not administered. The HCP preparing/administering vaccine is a experienced user. The reconstituted product was impacted, adjuvant had been injected into antigen vial. The customer inject air from the syringe into the vial during preparation at the step of reconstitution small amount of air injected. The leak coming from the stopper at the neck of the vial. The customer remove only the plastic flip-off of the vial before handling. There was no evidence of leakage in package or carton. The stopper pierced in the circular area dedicated to perforation. Small amount of air injected into the vial. The vaccine leaked on her hand which led to occupational exposure while preparing product for administration and Exposure via skin contact. The reporter Consented to follow up.
Rash on the arm where the vaccine was administered. It apparently persisted over a week.  No treatment advice was requested from our office. The patient's wife reported that he did not treat himself or seek attention elsewhere.
Reported right hand tingling.  Stated he was fine wanted to leave after 15 minutes.  No signs or symptomes of distress.
NUMBNESS IN INJECTION SITE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced numbness in injection site arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness in injection site arm was not reported. This report was non-serious.
Client described swelling and blistering developing at injection site, a day later the blisters popped.  Went to Urgent care and was treated with antibiotics and steroid. Site is improving, no further swelling.
Extreme swelling and pain. Hard, hot to touch. Muscle impacted by pain. Runny nose, cough, weak muscles. Fever.
felt horrible; couldnt get out of bed; threw up once; couldent eat or drink; diarrhoea; nauseous; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt horrible), BED REST (couldnt get out of bed), FEELING ABNORMAL (threw up once) and EATING DISORDER (couldent eat or drink) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first 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) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Feb-2021, the patient experienced FEELING ABNORMAL (felt horrible), BED REST (couldnt get out of bed), FEELING ABNORMAL (threw up once), EATING DISORDER (couldent eat or drink), DIARRHOEA (diarrhoea) and NAUSEA (nauseous). On 12-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 13-Feb-2021, EATING DISORDER (couldent eat or drink) had resolved. On 15-Feb-2021, FEELING ABNORMAL (felt horrible), BED REST (couldnt get out of bed), FEELING ABNORMAL (threw up once), DIARRHOEA (diarrhoea) and NAUSEA (nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication included.  No treatment medication included.
Mother states child had sore throat, off and on, after first Hep-B vax in March, 2000 and after the 2nd the sore throat was even worse. Child had sore throat before Hep-B #2 on 6/12/00. Mother is concerned about "Immune system damage".
About 3-4 minutes after Td, and Hep A vaccines, pt has upper body stiffening, his right arm flew up and eyes glazed per mom. Episode ? ? and to lie down, given juice and O2. Recovered fully.
Vaccinated 37 people with Moderna vaccine which had passed 31 days in the refrigerator; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated 37 people with Moderna vaccine which had passed 31 days in the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated 37 people with Moderna vaccine which had passed 31 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated 37 people with Moderna vaccine which had passed 31 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information provided by the reporter .
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for Covid-19 immunisation; Janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 17Mar2020 at 12:00 as dose 1, single (Lot number: 042A21A), in left arm for Covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 02Apr2022 at 12:00 as dose 2, single (Lot number: 048L21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: Wellbutrin; Zoloft; Synthroid. 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: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with anti-viral Brand: Paxlovid. Treatment start date with 21Jun2022 and stopped on 25Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had mild runny nose and baseline intermittent "growing pain" achy pain in legs and lower back prior to vaccination. Received HPV in the morning 9/11. Played volleyball game that evening. Some leg cramps and spasms later that night. Woke up tired and achy 9/12. Played volleyball that night and was exhausted that night. Woke up several times the night of 9/12 with significant leg pain, muscles "locking up," different from usual achy growing pains 9/14 AM with legs "really tight" and pain with walking, tactile fevers. Unclear if symptoms related to vaccine or concurrent viral syndrome.
Patient had a reddened area on her left arm (about 1/3 of the area of her upper left arm). Patient reports that this red area has gone down slightly since receiving the vaccine  3 days ago. The area was not raised and patient reports that it has not gotten bigger. Patient reports that the red area is slightly below the area of the injection site.
The phone call from Pt's mother stating Pt has little red bumps/rash on chest and both arms. Instructed mother to take her to MD for diagnosis. Mother stated she would probably just wait for them to go away.
Seven days after receiving the second dose of the Pfizer/BioNTech COVID-19 vaccine, I began to experience ringing in my ears, and the ringing has continued ever since.
LIGHTHEADED NOSE NUMB/TINGLING CAME ON QUICKLY WITHIN 5 MINUTES OF INJECTION, AND FADED SLOWLY, MOSTLY GONE WITHIN ANOTHER 10 MINUTES NO SIGNS/SYMPTOMS AT 2 HOURS POST VACCINATION
Came on gradually.  I felt like it was an additional symptom of Covid 19 about once every hour.  Started with headache, then a neck ache.  Then my eye balls felt swollen and hot in the back .  Next was total body aching and fatigue. The fever started and within about 1.5 hours it was up to 102.6. after about 103 I had chills really bad.  Of course in that time I took Tylenol.I laid under 3 blankets until morning.  By the next morning the fever broke.  And little by little the symptoms started to go away  Today is the third day and I don't feel symptomatic any more.  But I feel like I'm coming down with a terrible head cold and cough.  And the injection sit itches something awful
Medication Error:  Incorrectly given to a 57 year old.  No treatment, symptoms from patient currently.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/22/21, pfizer,Lot#EL9262 2nd dose: 02/12/21Pfizer,Lot# EM9810 Diagnosed covid positive:07/29/21 Symptom onset:07/26/21 Exposure:Home exposure Symptoms:cough, fatigue,muscle aches, fever, chills, diarrhea
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021. the patient got an antibody test which was negative. On 09-APR-2021, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422747-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
pt recvd vax & 24 hrs later exp a red rash & hives which resolved in 2 days;
When I went to urinate, I noticed blood in my urine.  Contacted the on-call nurse at the VA.
she has a weak heart muscle; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMYOPATHY (she has a weak heart muscle) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Head injury in February 2021.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced CARDIOMYOPATHY (she has a weak heart muscle) (seriousness criterion medically significant). At the time of the report, CARDIOMYOPATHY (she has a weak heart muscle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Electrocardiogram: abnormal (abnormal) Abnormal. On an unknown date, Electrocardiogram: normal (normal) Normal.         No treatment information was provided. No relevant concomitant medications were reported.  Husband (retired is calling to report that his 55-year-old wife fell and bumped her head the first week of FEB2021 about 2 weeks before she received the first vaccine. While she was in the Hospital, they did an EKG and it was normal. Her heart was healthy prior to vaccination. He reports that his 55-year-old wife received the first dose of Moderna COVID-19 vaccine on 25FEB2021 (Lot# 001A21A & Exp. Date:  Unknown) and received the second Moderna COVID-19 vaccine on 25MAR2021  (Lot# 003A21A  &   Exp. Date: 14AUG2021). Sometime at the end of AUG2021 she went for routine check up and they did an EKG.  The EKG was abnormal. Wife was told that she has a weak heart muscle.  Company Comment: This case concerns 65 year old female who experienced cardiomyopathy after approximately 5 months after the second dose of the vaccine. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns 65 year old female who experienced cardiomyopathy after approximately 5 months after the second dose of the vaccine. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report.
the second dose; I have headache; I noticed the gums are swollen but not as big as the first time.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included High Blood Pressure. Concomitant medication included amlodipine for High Blood Pressure. The patient previously took first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization and experienced "gum on my right face was swollen". It was reported that patient received the second dose and when she woke up, she had headache and then noticed the gums were swollen but not as big as the first time in Jan2021. No treatment received for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt yesterday had nausea and some diarrhea, some redness to face and hot to touch, no lip swelling, no swollen tongue, no fever, no redness to other areas. Pt has slight red bump to lt shoulder that is painful 2/10 pain, skin is hot to touch to injection site.
Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something.  hands tingling fingers both hands.  NOT hyperventilating.  Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions were provided. On 27-MAR-2014, the patient was vaccinated with M-M-R II inj (dose, route and lot number not provided). No co-suspect or concomitant therapies were provided. On 27-MAR-2014, the patient was administered a dose of M-M-R II that was improperly stored. No adverse effect was reported. Additional information has been requested.
SORE RT SHOULDER AND TINGLING THAT START APPROX. 1 WEEK AFTER THE VACCINATION.  I REQUESTED PATIENT TO SEE A DOCTOR AND SHE HAS NOT, BUT SAID THE SORENESS HAS GONE AWAY.  SHE STILL HAS A TINGLING IN THE RT SHOULDER AREA.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (Batch number-K004431, expiry date-26-JAN-2016, dosing regimen unknown) following multiple excursions, that started on an unspecified date in February 2014 and have persisted until an unspecified date during the last month. It was reported that the excursions were recently discovered during an audit and that no specified dates of administration was currently available. No doses were administered after their expiration dates. PNEUMOVAX 23 and MMR II (K014833, exp: 14-SEP-2016) had appeared on the product list as temperature stability questions were asked about these products, but no doses of these products were administered to any patients. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
had at least 3 nosebleeds in the last month out of nowhere; rash on the upper neck and around her chest and around her blossom; head aches; fever; muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (had at least 3 nosebleeds in the last month out of nowhere), RASH (rash on the upper neck and around her chest and around her blossom), HEADACHE (head aches), PYREXIA (fever) and MYALGIA (muscle aches) in a 37-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.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 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 experienced EPISTAXIS (had at least 3 nosebleeds in the last month out of nowhere), RASH (rash on the upper neck and around her chest and around her blossom), HEADACHE (head aches), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL HEADACHE & MIGRAINE) for Pain head, at a dose of 1 dosage form. At the time of the report, EPISTAXIS (had at least 3 nosebleeds in the last month out of nowhere), RASH (rash on the upper neck and around her chest and around her blossom), HEADACHE (head aches), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: decreased (Low) white blood cells have taken a big decline.         No concomitant medications were reported.  Treatment medication included Steroid cream for the rash.   Reporter did not allow further contact
Pt presented to pharmacy on 10/19 after receiving FLUZONE HD flu shot on 10/17; showed a very large, red, inflamed, warm area over her entire left deltoid; stated not painful but "tender".
This spontaneous report was received from a healthcare worker referring to a 7 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Started having headaches, body aches, persistent coughing, runny nose, tightness in the chest, elevated heart rate.  This lasted for approximately 2 weeks. Went to get a COVID -19 test on June 2nd,  results came back negative. Went to my PMC doctor on June 3rd, my bp was 170/100, I had irregular heartbeat, I did an EKG which came back abnormal. I?ve been having heart palpitations and been seeing a cardiologist since.
Reported severe aching, nausea, dizziness, denies fever, weakness; T. consultation w/MD only; decided no need for MD visit unless temp becomes elevated;
Patient has a red rash in a line from his shoulder to his wrist. It is itchy and red.
Had to go the hospital the day after I received my second dose. There was tightness in my chest and I had trouble breathing.
pt recvd vax & had elevated serum alkaline phosphatase 161; pt neg for anti hbs;
Patient was administered an extra dose of the Pfizer 5-11 monovalent COVID-19 vaccine instead of the intended Pfizer 5-11 Bivalent Booster COVID-19 vaccine on 12/4/22 at 10:10am.   I called and informed patient's mother, on 12/5/22 and she reported that patient is doing well except for some mild expected post-vaccination symptoms.
Within 1 hr after vaccine administration developed red splotchy areas all over, sores around mouth & pouring sweats. Given OTC antihistamine with relief.
1st shingles shot 2 years ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (1st dose received 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 19-JAN-2023 Reporter comment: The reporter stated that, was it too late to get her/his 2nd dose now. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.