chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness; This is a spontaneous report from a non-contactable other healthcare professional (HCP; "Pharmacy tech").  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name unspecified, lot number: not provided), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced arm soreness on an unspecified date, after use of product. Outcome of the event was unknown. The reporter mentioned that arm soreness is a common occurrence when administering pneumococcal pneumonia vaccines. She did not mention which vaccine or any other details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No adverse event; Pharmacist calling to report patient received a vaccine pass 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report patient received a vaccine pass 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     It was unknown if patient had any diseases and had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 08-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report patient received a vaccine pass 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report patient received a vaccine pass 12 hours post puncture) 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 (Pharmacist calling to report patient received a vaccine pass 12 hours post puncture).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. It was reported that the vaccine was punctured around 12:15 pm yesterday (07-May-2023) and was administered to 2 patients at 9:58 am and 10:02 am the following day (08-May-2023). This case is reported for patient 2 out of 2 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723413:Patient 1
Severe shoulder pain first 48 hours, topical ice applied (3/29/21)  6 MONTHS later, shoulder pain,  throbbing 24-7, disrupting sleep  Person giving the shot remarked "you're so relaxed" after stabbing me deeply in what seems to be in the  wrong place, missing the deltoid muscle proper.  This was the second dose and the code EP7533 appears after it.
Headache, Fatigue and  Fever - for 36 Hours.  IMPORTANT NOTE: After the Fever and headache  left, I had (And continue to have) swelling in my lymph node under the left arm - where I had the shot. At first it was painful but after several days, the pain subsided but I can feel a little pain ehen I touch the area.
Pt received her 2nd ROTATEQ vaccine on 1/21/16. Approx 8 hrs after vaccine, the pt had 1 episode of diarrhea with mucus and streaks of blood. Pt was not fussy and had a normal BM later.
A non-serious spontaneous report of runny nose and fever has been received from a consumer concerning a 39-month-old female patient, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a dose of FLUMIST on 19-Nov-2010. On 21-Nov-2010, the patient began running a fever (102F) and had a runny nose two days after receiving FLUMIST. The patient was taken to emergency care and was given oseltamivir phosphate. The outcome of the event was unknown.
NOT FEELING WELL; TRYING NOT TO VOMIT; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 48.2 kilograms, and height was not reported. The patient's concurrent conditions included secondary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) and dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: macitentan (oral, batch number: ZE019B0101 expiry: 31-JUL-2024, form of admin was not reported) 10 mg, 1 time every 1 day, therapy dates were not reported for pulmonary hypertension secondary. Concomitant medications included sildenafil citrate. On MAR-2021, the subject experienced not feeling well. On MAR-2021, the subject experienced trying not to vomit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with macitentan was not reported. The outcome of the not feeling well and trying not to vomit was not reported. This report was non-serious.
Rash on the arm the shot was administered and lasted a day. I also got rashes on my legs. A day after the shot, I got stomach aches and cramping. The cramping comes and goes occasionally. I also have had rapid heartbeats after the shot.
Patient received their vaccine higher up on the arm which lead to stiffness and soreness in the arm. Patient described as unable to work for 7 days.
On 01/29/2021 around 5 PM, my left arm was sore and my lymph node on my left arm pit started to swell up and continued swelling up for the next 3-5 days. I went to see my Doctor around 02/12/2021 . My Doctor told me it was normal. They did not prescribe me any medications and no tests were done.  A week after I seen the doctor around 02/19/2021  it did start to get better.
Around 08/2021, when I would blink I would see a dark, black dot, in my left eye. The ophthalmologist said I had a blood vessel that burst that caused a pool of blood which was the black spot I was seeing. They did outpatient laser surgery and cauterized it. I have already gone to one follow up appointment and my eye was good, the bleeding stopped and no other blood vessels were bleeding. I have a follow up appointment on 11/05/2021.
starting at the base of head/shoulder pain goes up head, throbbing can not lift head. Taking Tylenol, applied heat pad to back of neck and head
Pain left arm injection site numbness, tingle, burning in left arm can not lift arm above shoulder may need to seek more medical treatment.
Flublok was administerd to patient below age 18, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA309972 (same reporter).  This case involves two patient (below the age of 18) who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported via unknown route in unknown administration site), on an unknown date.  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 reporting the patient had no adverse event.  The physician stated that the standard packaging for both the Flublok Quad and the Fluzone Quad look the same.  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.  Information on batch number is requested.
Fever started at 12:30pm on 3/8 and finally subsided at around 12:30pm on 3/9. The fever went up to 101° at times in the middle of the night. Excruciating pain in joints that started around 3pm on 3/8 and finally subsided on 3/9 at around 12:30pm. Extreme fatigue and getting winded doing menial tasks like showering all day on 3/9. Pain at the injection site.
Client should have received Pfizer Monovalent 1st Dose in primary series.  Client was incorrectly given Pfizer Bivalent instead
Shortness of breath both times the evening of the injection given that lasts about 2 hours. Patient just reported to us on 8/2/17 - the day 3rd injection was going to be given.
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Upon internal review on 24-May-2021, age was corrected to unknown.   Reporter did not allow further contact
High heart rate, dizziness, exhaustion, nausea, vomiting, pain, mild fever
Within 1-2 hours of both shots headache, fatigue, nausea, fever, 100-101.3 degrees F. Headache, fatigue, fever laster approx 36-48 hours.  Between the two shots not sure what day, noticed  intermittent tingling and numbness in the left arm. The tingling and numbness have not gone away. Tingling/numbness seems permanent, at least has lasted 9 months.
I got vaccinated /and got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital and described the occurrence of suspected vaccination failure in a 55-year-old 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 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.  Additional case details were reported as follows: The patient reported case for himself or herself. The patient got vaccinated for shingles and got shingles when he or she was 55. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 22-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
About a week after receiving my first booster, I noticed three lumps located above my elbow, below my elbow and one close to my wrist on my left arm. It was diagnosed as lymphoedema. I was seeing Dr. because I may have needed radiation after my lumpectomy. I had a lumpectomy performed on my right breast in January 2022. During the surgery they removed 14 lymph nodes under my right arm. In April 2022, I had a surgery because of a bowel blockage and hernia. The small intestine was put back in the proper place and they repaired the hernia with Mesh.
Contracted Covid; Contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247) and on 25Mar2021 as dose 2, single (Lot number: EL3247) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "recovering" and all described as "Contracted Covid". The event "contracted covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Unknown results, notes: Since the vaccination, has the patient been tested for COVID-19:Yes. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Device Date : 16Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
did not have full anaphylaxis; a sense of her throat swelling; hives; This is a spontaneous report from a contactable physician. A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced "a sense of her throat swelling" and hives 1 hour after the vaccination occurred. The patient received 1 dose of Benadryl and Tylenol and "felt ok." The physician commented that the patient did not have full anaphylaxis and was asking if it would be safe for the patient to receive the second dose of the vaccine at the time of report. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Stroke; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged, medically significant and life threatening). The patient was hospitalized on 16-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        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.
received only the liquid portion; received only the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva764a, expiry date 31st December 2023) for prophylaxis.   On 30th January 2023, the patient received the 1st dose of Menveo. On 30th January 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and incorrect dose administered. On an unknown date, the outcome of the inappropriate preparation of medication and incorrect dose administered were unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The patient had accidentally received only the liquid portion of Menveo on 30th January 2023. They gave the vaccine details, patients detail and requested information about how to proceed.  She accepted follow-up and provided her e-mail address so that the medical information could be sent. The Vaccine Administration Facility was the same as Primary Reporter. The reporter mentioned it was incredibly difficult to make out what she was saying as there seemed to be a lot of background noise on the reporter's end.  She moved location without having to be asked to.  During the initial part of the call, she only mentioned that she was inquiring for a patient, but after that she mentioned another patient.  She also gave information for that other patient. Additional Supportive Information: The patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023015039:Same reporter.
Patient developed a generalized, vesicular rash about 10 days after vaccination, on 6/29. Rash worsened, and patient developed secondary skin infection, impetigo (diagnosed as staph infection). Vesicular fluid was collected for VZV-PCR and VZV Viral Culture on 7/14 (two weeks after onset), no VZV detected. Patient's rash improved after receiving a prescription cream for impetigo, is now resolved. No secondary varicella cases reported among contacts, no VZV exposure prior to illness identified.
No additional AE or PQC reported; VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022 and was administered to the patient on 16-JUN-2022; This spontaneous report was received from a medical technologist lab manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported by the reporter.  Varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W002599, expiration date: 24-JAN-2024) was delivered on 07-JUN-2022 after the receive by date of 06-JUN-2022 (temperature and time frame were unknown) (Product storage error) and was administered to the patient on 16-JUN-2022 for prophylaxis (formulation, strength, dose and route of administration were not provided). There was no previous temperature excursion. No additional adverse event (AE) or product quality complaints (PQC) reported (No adverse event).
Patient describes the injection site as being hard and red right where the injection was given.  It has been 2 days since and the area that is swollen has increased to about 4 inches in diameter and the area itches and is warm to the touch.  She says she was feverish last night.
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).    No concomitant medication was reported.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No treatment medication was reported.  This case contains information for the 25th of 190 patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335: MASTER CASE
Vomiting; Weakness; Muscle soreness; Sweating; Headache; Nausea; Tiredness; Soreness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 14Apr2021 at 13:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included Charcot Marie tooth disease, bilateral foot drop, hip dysplasia, manic bipolar depression and anxiety. The patient had known allergies to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cariprazine hydrochloride (VRAYLAR), levetiracetam (KEPPRA), clonazepam (KLONOPIN), codeine phosphate, paracetamol (TYLENOL WITH CODEINE) and citalopram hydrobromide (CELEXA); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced immediate reaction at the pharmacy which included sweating, headache and nausea. The patient left the pharmacy, went home and got really tired and soreness at the injection site. On 15Apr2021, the patient woke up the next morning after vaccination and still felt very fatigued, headache, vomiting, muscle soreness, weakness and continued soreness at the injection site. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sweating, headache, nausea, soreness at injection site, fatigue, vomiting, muscle soreness and weakness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.