chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Vaccine underdose; While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.; While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine underdose), DEVICE CONNECTION ISSUE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.), PRODUCT LEAKAGE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.) and NO ADVERSE EVENT (No adverse event) in a 39-year-old 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 22-Sep-2022, 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 22-Sep-2022, the patient experienced UNDERDOSE (Vaccine underdose), DEVICE CONNECTION ISSUE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.) and PRODUCT LEAKAGE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose), DEVICE CONNECTION ISSUE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.), PRODUCT LEAKAGE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.) 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 assessments were provided for UNDERDOSE (Vaccine underdose), DEVICE CONNECTION ISSUE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.) and PRODUCT LEAKAGE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.).    No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
SWEATING, WEAK, NAUSEA, SINUS DRAINAGE, COUGH  6 DAYS AFTER VACCINE
This solicited report was received from a friend of the patient's mother (also reported as patient's mother), as part of a marketing research program and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL injection (route and site of administration, dose, lot number and expiration date were not reported). On an unknown date, after getting the third dose of GARDASIL, the patient passed out. The outcome of the event was unknown. The relatedness between the event and the vaccination with GARDASIL was not reported. Additional information is not expected as no consent for further contact was given.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), on 05May2021 as dose 2, single (Batch/Lot number: unknown) and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Lobster allergy" (unspecified if ongoing); "Bees allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications and other medications the patient received in 2 weeks were unknown. The following information was reported: VACCINATION FAILURE (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: (2022) Positive, notes: I have tested positive for COVID; (2022) Negative, notes: I tested negative twice; (2022) Negative, notes: I tested negative twice. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 24May2022 to 29May2022. The patient tested negative twice after taking 5 days after completing Paxlovid. Now, 8 days later, the patient had tested positive for COVID. She now had a cough as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Vaccination failure and BNT162B2 is considered possible.
A couple of hours after receiving his vaccines, my sons eyelids began to swell up. This lasted for about 3 days. We treated with Benadryl.
Severe left arm pain with no strength to hold any weight, like a bottle of liquid, in my hand.  Still soreness at injection sight of needle
Frozen shoulder 3 hours after injection. Iced , PROM, no change. Left chest wall with pain also.
patient reported swelling and redness at injection site which started almost immediately..she also reported headache and fatigue for the first 3 days. She no longer has the headache or fatigue (today the day she reported) but continues to have the redness and swelling which she called to confirm was normal to still be experiencing.
The patient came in to get his COVID vaccine. The vaccine was administered with no abnormalities. The patient went to sit in the waiting area and fell off his chair. Pharmacy staff rushed to him to find him on the floor conscious and speaking stating he was okay. The patient was assisted to stand and get on a chair. At that point Orange Juice and Water were provided to the patient and the pharmacist sat next to him for ten minutes. Next, the patient was instructed to stay for five more minutes to make sure he was okay. The patient stated this happens to him every time he gets a vaccine and it isn't out of the ordinary at all. Patient also stated he did not eat or drink much all day besides a bag of chips and on top of that was doing strenuous work in the heat all day and this could have contributed to his collapse.
This case was reported by a consumer and described the occurrence of sickness in a female patient who received BEXSERO for prophylaxis. In October 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced sickness and illness. On an unknown date, the outcome of the sickness and illness were unknown. It was unknown if the reporter considered the sickness and illness to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. It was reported that was there any timeframe that the 2nd dose of BEXSERO could no longer be received as the patient got her 1st dose of BEXSERO in October and was very sick and did not end up getting 2nd injections due to illness. The reporter asked if she could receive the 2nd dose and get it covered or had to restart the injections and what was the last possible date to get an injection and it if it would still counted as part of the series. This case has been linked to the case US2019GSK005612 (first daughter), reported by same reporter.
Patient noticed rash, pain, swelling, and heat at injection site radiating down towards elbow.  Sought treatment at ER.  Was diagnosed with cellulitis.  Was given cephalexin 500mg QID for 7 days and discharged.  Infection responded to treatment and has completely resolved.
12 year old female received Flublok Quadrivalent, NO AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA285086 same reporter.  This case involves a 12 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1917, expiry date-30-06-2020 via intramuscular route in the left deltoid on 09-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report 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 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.
Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; The vaccine was administered to about 9 to 10 patients before the excursion error was discovered; vaccine expired by 1 day/Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day/Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day/Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day/Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were provided by the reporter.
Injection site became red, hot, slightly edematous, Vaccine given on Fri. On Sunday, the area under right eye along with the check and jaw red edematous, hot to touch Taken to PMD on Monday. He felt it was reaction from vaccine. Outpatient on antibiotics and warm/cool compresses and sent to the HD. (Mother is also to see dentist and has appointment for 04/29/2002 but will go today.)
a rather large patch of redness and itchiness at the vaccination site, which appeared about a week after the injection was given
Fever inj site pain, fever, chills, fatigue x3 days Narrative:
Shingles break out. Had previously had within the past year and a half the two dose shingrix vaccine.
Blistering hives on entire torso. Took Benadryl and continues having them so I went tot he ER. They put me on two antihistamines and a steroid for 5 days and prescribed me an Epipen. I?ve still had flare ups of hives. They have not stopped. I?m being referred to an allergist.
Erythema and edema localized at injection site. slightly raised irregular borders approx. 2-3 in in diameter. Symptoms appeared 24 hours after immunization was given. Pt reported to medical 24 hours after symptoms appeared. Pt was given benadryl and cold compresses and instructed to f/u in 24 hours
Patient received 1st dose Moderna Vaccination at 1405, went to sit in observation area and began to feel lightheaded and faint within first few minutes. Escorted to cot to lie down  at 1412. 1415 VSS: BP 140/82 HR: 98 steady, RR:18 98% on RA with no visual rash, or difficulty breathing. Pt. reported that she was rushing in to clinic to get the vaccination and was often hot, face flushed at this time though pt reported that this was her baseline. Reported that she continued to feel faint, ABC all within normal limits. VSS continued to be stable with no signs of trouble breathing. Pt remained A&Ox5. 1425: pt reported tingling in hands bilaterally. VSS remained stable, tingling grew stronger in left FA dissipated in the R FA. Pt reported that she continued to feel as if she was unable to sit up, that this would cause her to pass out and that this sensation came in waves. Pt. was monitored for 20 minutes prior to receiving 50mg IM Benadryl in LUA and Code Green was called. Patient taken to ED for further observation.
There was a lot of pain at injection site for the first couple of days, then that subsided. On day 8 I woke up and the injection sight was raised, warm to the touch, and very itchy.  So far it hadn?t gone away, but gets a bit better with Benadryl.  No other issues at this point.
she has had covid; she has had covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has had covid".  Clinical course: Patient wanted to know if she got the second booster if they will check it to see if the Covid was present or not. She mentioned she has had covid. While checking for the information the call got disconnected. She refused to provide any of her information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
For first two days following shot I had redness (2-3 in diameter circle) surrounding injection site, as reported in v-safe. Then was clear until day 8 following shot, redness reappeared along with mild itching. Redness is again 2-3 in diameter circle surrounding injection site. Redness still present today, day 9.
Patient was seen in the ED on 10/15-10/16 due to lethargy, fever, confusion. he was diagnosed with viral syndrome after having a Lumbar puncture, CT scan of head, labs, and chest xray. patient is new and did not mention he had flu vaccine on 10/14. he speaks different language.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 1" (unspecified if ongoing); "undifferentiated connective tissue disease" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 26Sep2023 to 30Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Drug ineffective and COVID 19 cannot be ruled out.    ,Linked Report(s) : US-PFIZER INC-202300320787 same patient, different event/ drug;
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) at the pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causality was related.
Very large red  raised bump about 3?X2?  that did not go away for 3-4 days .  Did not go away with Benadryl. Not itchy or painful but hard to touch and warm.
I gave patient FLUARIX, TDAP and PNEUMOVAX shots this morning around 10 AM. I gave all shots on the left deltoid 1 inch apart and put a latex free Curad bandage on the injection site. He looked fine after the shots and was released from the pharmacy right after. Patient came back around 5:30 pm with a swollen arm which was tender and felt warm to touch. He mentioned that swelling and pain started shortly after leaving the pharmacy and it has gotten worse. I gave him a bottle of TYLEOL and a tube of CORTIZONE to help with the inflammation for free and I hope to reach out to him to see how he is doing. I have reached out to patient 3 times after the incident including today 10/15/17 and he said everything is fine and the swelling and pain has gone away.
Dose administered after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.
Woke up overnight with a black eye, a pretty good shiner. No trauma to the eye area. I feel great. Face was slightly puffy in the AM.
Patient recieved TDAP vaccine on January 19, 2010. Mother called January 22, 2010 report severe swelling and inflammation in Right arm, patient was seen the same day as a sick visit.
Headache, Myalgia, LUMP AT INJECTION SITE, CHILLS Narrative:
Systemic rash - pruritic. Body aches. Fever greater than 102.
Report 2001029402-1 describes back pain in a female (age not specified) who received hep B vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no adverse experiences following receipt of her first injection of Engerix B. On 12/6/01, the pt received her second injection of Engerix B. An unspecified time post-vaccination, she experienced back pain, abnormal cramping, weakness, sweating, chills, and nausea. The pt was seen by a physician. The outcomes of the events were unknown.
venous sinus thrombosis of the superior sagital sinus, based on imaging likely occurred 1-2 weeks prior to presentation, ~ 1-3 weeks after vaccination no other clear reason for hypercoag state, no prior thromboembolic events, no h/o malignancy or rheumatological disease.
Client reports left arm swelling up, getting red and a lot of pain.  Went to urgent care two days after getting the shot, they told him he had staph infection and gave him amoxicillin.  Came in five days after shot to let health department know about reaction, no signs of redness or swelling noted at this time. Client only reported sore elbow.
Beginning the 17th increased numbness. By the 20th total left side facial paralysis (Bell's Palsy).
Sore arm 3 days after 1st shot. Menstrual cycle started 8 days after 1st vaccine and has not stopped yet (6 weeks and counting). After 2nd shot, I had a sore arm for 4 days and 99.5 degree fever within 12 hours after the shot along with a swollen left supraclavicular lymph node. Treated sore arm and fever with Tylenol and Motrin every 3 hours for about 24 hours.  Scheduled a telehealth visit with my physician the following Tuesday. MD ordered a CBC and an ultrasound of my lymph node.