chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 2 minutes after receiving the vaccine, patient reported feeling chest tightness and back discomfort.  Patient was given a bottle of water and asked to remain seated for 15 minutes.  Her symptoms resolved and patient was able to leave the premises.
Several hours after receiving Td became very sore (from elbow to neck). had several episodes of shaking chills. Did not have a thermometer to take temp. Called family MD instructed by nurse to apply hot/cold compresses and to call if not better. All pcn sulfa codiene. Also instructed to take Motrin for pain.
administer powder portion with an unknow liquid; administer powder portion with an unknow liquid; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA653A, expiry date 28th February 2023) for prophylaxis.   In July 2022, the patient received Menveo. In July 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The nurse reported that two patients received early second dose with unknown details, while only one patient had an incorrectly reconstituted dose administered. The reporter reported that they had one vial of the liquid component of Menveo left, so there was a patient who received an incomplete dose (they administered the powder portion with an unknown liquid). 3 patients were vaccinated with the same lot so the reporter was asking what happened if a patient receive two complete doses of Menveo .  All patients were vaccinated on July 2022. The reporter consented to follow up. The case is for 1 of 3 linked patients, reported by same reporter. Additional supportive information: The patient was administered the powder portion of Menveo with an unknown liquid, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022AMR112790:Same reporter US-GSK-US2022AMR112789:Same reporter
I started bleeding even though I was not due for my period for another 3 weeks. I also had a massive migraine headache 24 hours later and have had a headache ever day since. I never get headaches and my periods are typically very short and light .
Information has been received from a physician concerning a 12 week female with down's syndrome and no drug reactions or allergies who on 27-MAY-2011 was vaccinated orally with a dose of ROTATEQ (lot # and dose not reported). There was no concomitant medication. On 09-JUN-2011, the patient experienced hematochezia after receiving the ROTATEQ. The patient's parent called to seek medical attention. No treatment was given for the event. No lab diagnostics studies were performed. At the time of the report, the patient had recovered. Follow-up information was received from a registered nurse indicating that on 27-MAY-2011, the patient received the first dose of ROTATEQ (Lot # 669523/1556Z) and concomitantly received the second dose of hepatitis B virus vaccine (Lot # 669597/0294AA, thimerosal free), and the patient received the first dose of PREVNAR and the first dose of PENTACEL. On 09-JUN-2011, the patient's mother called the physician to report that the patient had "a lot of blood in her stools". The patient was seen by the physician and was referred to a General Surgeon. The patient was taken to a Medical Center. The patient had a short-term admission, overnight for observation. The patient tested positive for blood in her stools. The patient had a KUB with an air enema. There was no report of intussusception. The patient's labs were normal. ROTATEQ was not discontinued. On 05-AUG-2011, the patient received the second dose of ROTATEQ (Lot # 669764/0776AA). The patient had no adverse reaction. On 06-SEP-2011, the patient received the third dose of ROTATEQ (Lot # 669476/1529Z). On 17-SEP-2011, the patient had three diapers with blood in her stools. The patient was admitted to Medical Center. The patient had a three view Abdominal x-ray which revealed normal bowel gas patterns. The patient was discharged from the hospital. The patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
a pear shaped red sport at the injection; a little bit of soreness at the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (a little bit of soreness at the injection) and VACCINATION SITE ERYTHEMA (a pear shaped red sport at the injection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (a little bit of soreness at the injection). On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (a pear shaped red sport at the injection). On 17-Jan-2021, VACCINATION SITE PAIN (a little bit of soreness at the injection) had resolved. On 30-Jan-2021, VACCINATION SITE ERYTHEMA (a pear shaped red sport at the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
pt recvd vax; rash; T 106.3 by ear thermomether
FLU-LIKE SYMPTOMS (BODY ACHES, FEVERISH, NAUSEA) FOR 48 HOURS POST VACCINATION.
Immediately after vaccine administration, I had significant pain in my arm, shoulder, neck, and into my head reaching my C1-- all on my left side. I was not able to process/understand what others were saying to me, described as "brain fog." I was unable to stand for periods of time. Symptoms improved after approximately 24 hours. On day 6 post administration, I had a pain begin in the left side of my neck that radiated outward at approximately 1:00 PM. There was a pain, tingling sensation, and weakness that then began to travel down my left arm into my middle fingers and down my left leg. I then began to feel the left side of my mouth droop downward. My significant other witnessed this, and he immediately took me to the hospital to receive care.
Day after injection patient had an episode of emesis and one of diarrhea. Lt arm became beet red and even had blistering on yesterday. Today not as red and non tender. Warm 12.7cm x 12.7cm. Mom gave a dose of ibuprofen yesterday and cool cloth placed on arm. Having mom give ibuprofen every 6 hours for next 48 hr along with cold compressed.
mom described pt as being limp & pale & sleeping alot over 48hr p/vax;on direct questioning pt was responsive & cont to feed during the same period;highest temp reported by mom during above was 100.3a;
15 year old patient was administered with Flublok, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA305218 (same reporter).  This case involves a 15 years old female patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1936, expiry date: 30-Jun-2020 via unknown route in the left arm on 17-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
HYPOTENSION 4/20/2022 & 7/31/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Inflammatory response to vaccine caused asthma exacerbation; Inflammatory response to vaccine caused asthma exacerbation; I felt tight; woke up from sleep having coughing; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Oct2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: had an attack in years. Concomitant medication(s) included: XYZAL; SINGULAIR. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 22Feb2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 08Feb2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: INFLAMMATION (non-serious), ASTHMA (non-serious) all with onset 11Oct2021, outcome "recovering" and all described as "Inflammatory response to vaccine caused asthma exacerbation"; CHEST DISCOMFORT (non-serious) with onset 11Oct2021, outcome "recovering", described as "I felt tight"; COUGH (non-serious) with onset 11Oct2021, outcome "recovered" (11Oct2021), described as "woke up from sleep having coughing". The events "inflammatory response to vaccine caused asthma exacerbation", "inflammatory response to vaccine caused asthma exacerbation", "i felt tight" and "woke up from sleep having coughing" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation, asthma, chest discomfort, cough.  Additional information: AE treatment was breathing treatment, steroids. Inflammatory response to vaccine caused asthma exacerbation, which began day after vaccine. Patient had very mild asthma and had not had an attack in years. The next day he felt tight and woke up from sleep having coughing that lasted 30 minutes. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive other vaccine in four weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Possible administration of a menomune dose past the expiration date with no reported adverse event; Initial information received on 09-May-2023 (with live follow up received on 10-May-2023) regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age female patient who had possible administration of a Meningococcal A-C-Y-W135 vaccine [Menomune] dose past the expiration date with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In 2021, the patient had possible administration of a Meningococcal A-C-Y-W135 vaccine Powder and solvent for solution for injection (lot number, expiry date, strength, dosage- not reported) via unknown route in unknown administration site for Prophylactic Vaccination, past the expiration date with no reported adverse event (expired product administered) (latency- same day)   Reportedly, Physician stated that in 2021 a student received the Menomune vaccine, a meningococcal vaccine, that was discontinued in 2017. The physician stated that he needed to know whether this was acceptable or not or if student needs to sign a waver, or go get another vaccine. He has no record of the lot number or expiration date of the product that was administered. His question is whether it is at all possible that vaccine was in-date when administered in 2021? In other words, was the shelf-life such that if Menomune was received as late as 2017, that it could have been in-date during 2021?  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
He already got the first dose but he is under 18. He is 17; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He already got the first dose but he is under 18. He is 17) in a 17-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He already got the first dose but he is under 18. He is 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He already got the first dose but he is under 18. He is 17) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non significant follow up received on 19-MAY-2021, no new information
Redness; Pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) and PAIN (Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness) and PAIN (Pain). At the time of the report, ERYTHEMA (Redness) and PAIN (Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Patient administered FLUARIX and ADACEL IM. Patient collapsed upon arising shortly after vaccine administration, did not loose consciousness. Complained of "feeling it move through his shoulder and heart".
Heavy period with large amounts of blood clots; Shingles; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number FA7485), via an unspecified route of administration, in the left arm, on 27Aug2021, at 01:15 PM, at single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included shingles from an unspecified date. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included fluoxetine from an unspecified date (within 2 weeks of vaccination), at an unknown dose, for an unspecified indication. On 28Aug2021, at 12:00 AM, the patient experienced heavy period with large amounts of blood clots and shingles. The patient was treated for shingles with Valtrex. Clinical outcome of the adverse events was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
dehydrated; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), fist dose at the age of 57-years-old via an unspecified route of administration, administered in arm left on 04Mar2021 (Batch/Lot Number: EN6205) as 1st dose, single for covid-19 immunisation.  Medical history included cholesterol from an unknown date and unknown if ongoing. Concomitant medication included simvastatin taken for cholesterol, start and stop date were not reported.  The patient reported that he had lingering effects from all week long mostly fatigue and dizziness and so just to rule it out, he had a covid test on 11Mar2021 and it came back; he found out today, 13Mar2021 that it came back positive. He further reported that he was a little bit of tired before the vaccine but didn't really had the dizziness and fatigue. The patient underwent lab tests and procedures which included blood iron: unknown results, blood test for sugar: unknown results, urine test: unknown results (was dehydrated); all on 12Mar2021, sars-cov-2 test: positive on 11Mar2021. The patient was recovering from COVID-19 while the outcome of dehydrated was unknown.
Red, swollen, pox blister developed-blister broke-call MD-Dr. = primary care MD - she wanted pt to call to be seen by her.
SORE THROAT; HEADACHE; RUNNY NOSE; BODY ACHES; FATIGUE; A spontaneous report has been received from a consumer. The report concerns a female patient (age 12 years, height 62 in, weight 108 lb).    The patient's past and current medical history included viral asthma (dates not reported). The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received FluMist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, for flu vaccine on 01-OCT-2021.     A Health Professional administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On 03-OCT-2021, the patient experienced sore throat (preferred term: Oropharyngeal pain), headache (preferred term: Headache), runny nose (preferred term: Rhinorrhoea), body aches (preferred term: Pain) and fatigue (preferred term: Fatigue).     Action taken with FluMist Quadrivalent was not applicable.    The patient recovered from the event(s) of sore throat, headache, runny nose, body aches and fatigue after 2 days on 04-OCT-2021.     The events were considered non-serious.     The reporter considered that there was a reasonable possibility of a causal relationship between FluMist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): fatigue, runny nose, body aches, sore throat and headache.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Bilateral high pitch ringing in ears with aural fullness. Ringing started one day after I received the 2nd dose of the Covid vaccine.  Once it stated it has not stopped or even diminished.  I did not previously have any ringing in my ears.  The duration has now been over 2.5 months.
Sore arm, flu like symptoms, headache, period started 3 days after vaccine (patient thought she was already in menopause)
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Redness and swelling in injection site.; Redness and swelling in injection site.; This is a spontaneous report received from a contactable consumer (Pfizer colleague). A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 45-year-old) as a single dose for COVID-19 immunization. Medical history included covid-19 (Prior to vaccination the patient diagnosed) and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if any other medications the patient received within 2 weeks of vaccination. On 08Apr2021, the patient experienced redness and swelling in injection site. The patient did not receive any treatment for the events. The outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt reports that on 06/17/21 he had one episode of trouble breathing & shortness of breath at rest that resolved. Pt reports he experienced this again on 06/23/21 when he woke up, with improvement throughout the day.
2/13/21 Patient had covid like symptoms 2/15/21 Patient admitted to Hospital with covid like sx and decreased O2 sat; tested positive for Covid on 2/15/21; treated with Remdesivir and convalesent Plasma. Sx worsened and patient died 2/26/21..
Information has been received from a 25 year old female with no allergies or medical history, who on 29-MAY-2007 was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  On 29-MAY-2007 a couple hours post vaccination, the patient felt sick, tired and experienced a fever.  On 08-FEB-2008, the patient was vaccinated with a second dose of GARDASIL.  On 08-FEB-2008 the patient felt tired, sick and developed a fever.  Unspecified medical attention was sought.  No diagnostic studies were performed.  The next day after experiencing the events, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Skin rash on torso, beginning within 12 hours, lasting 3-4 days.
I took her to the doctor at the end of April due to her complaining of sore throat, a headache and stomach pains. They did a strep test which came back negative. We went back a week following due to her complaining of the same symptoms as well as pale color and ear pain. She had an ear infection, and her doctor ordered a blood test on 05/01/2023 due to her skin paleness. Her iron levels were significantly so we were advised to return some weeks following after giving iron supplements to see if they would rise. We went in for a follow-up appointment on 06/14/2023 for complete blood count test and Celiac disease panel test. She was still anemic even after a month of taking supplements and the Celiac test came back positive for PTG. She had a pediatrician appointment yesterday where we were suggested to visit a gastroenterologist for a biopsy appointment, but in the meantime, she was suggested to begin a gluten-free diet until then.
Information has been received from a certified medical assistant (C.M.A.) referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L008578, expiration date 14-DEC-2016; dose was not reported) orally. No adverse effects were reported. It was reported that the vaccines had been exhausted and there was no previous temperature excursion. The reporter called because of the data logger. Temperature/time frame was reported as: 10-DEC-2015: 25.7 (unit not provided), 9 hours, 37 minutes; 15-DEC-2015: 30.0 (unit not provided), 2 hours, 52 minutes. This is one of two reports received from the same reporter. Additional information has been requested.