chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden cough, wheezing and shortness of breath daily one time during 24 hours for 20-40mins. Red acne on arm stayed for 10 days.
crying inconsolably >4hr;mom reported inc fussiness w/1st vax but no other rxn;mom called MD who felt rxn was enough to warrant no pertussis;
This spontaneous report as received from a healthcare worker who refers to a group of six patients of unknown age and gender. Patients' medical histories were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (doses, frequencies, indications, routes of administrations and lot numbers were not provided). No concomitant medication and no adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning her father with blood clots in his lungs and a medical history of transient ischaemic attack (TIA) who on 16-DEC-2011 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included COUMADIN. The daughter of the patient reported that after her father got the ZOSTAVAX (Merck), "it brought on some sort of immune disorder with nose bleeds and throwing up blood." The patient had sought unspecified medical attention. Lab diagnostics studies included "blood work". At the time of the report, the patient had not recovered. The patient's some sort of immune disorder with nose bleeds and throwing up blood were considered to be disabling and immediately life-threatening. Additional information has been requested.
This spontaneous report was received from a female patient of unknown age, who was referring to herself. The patient had not medical history, concurrent conditions or concomitant medications. On 09-DEC-2020 at 4:00 pm, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 injection, once or as needed (site and route of administration, lot# and expiration date were not reported) for prevention of pneumococcal disease. On 11-DEC-2020, 26 hours after getting the vaccination, the patient woke up in the morning with chills and flu-like symptoms. She had no fever, fatigue and headache. The patient wanted to know if that was attributable to PNEUMOVAX23. No treatment was given for the event. No lab diagnostic tests were performed. The patient sought medical attention. The outcome of the event was not recovered. The relatedness between the event and PNEUMOVAX23 was
not feeling; Patient was found deceased; Stiffness in neck; Extreme fatigue; A Spontaneous report  was received from a consumer concerning a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stiffness in neck/ musculoskeletal stiffness, extreme fatigue and patient was found deceased/Death.  The patient's current condition included obesity and diabetes. Concomitant medication was not reported.  On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 14 Mar 2021, prior to the event, the patient received his second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Mar 2021, after receiving the second dose of the vaccination the patient began to complain of not Feeling. On 16 Mar 2021, the patient began to complain of stiffness in neck and extreme fatigue. On Wednesday 17 Mar 2021, the patient was found deceased in their home. The event deceased was reported as serious. The family member states they would hate to link the Moderna vaccination to their uncle's death but the vaccination was the only alteration of the patient normal diet and medications. Treatment medication was not reported. The patient died on 17 Mar 2021. It was unknown if autopsy was performed.  Action taken with the drug in response to the events was not applicable.  The outcome of the event patient was found deceased was fatal whereas outcome of other events stiffness in neck, extreme fatigue was unknown.; Reporter's Comments: This is a case of sudden death in a 65-year-old male subject with a hx of obesity and diabetes  who died 3 days after receiving the second dose of vaccine. Very limited information has been provided at this time." Further information is requested.; Reported Cause(s) of Death: Death
Injection site became red and swollen. Pt reported to MD, was prescribed antibiotic as MD determined that an infection had occurred.
Approximately a week after my 2nd dose vaccination, I experienced the following symptom/s: Migraine, Loss of vision (Partial), Tinnitus, Dizziness  - I went to the doctor because it was really concerning and was prescribed with Ubrelvy and had a Aimovig shot. -These medications didn't really help improve my situation and up to this day 03/22/2022 I am still experiencing the same symptoms.
pt. with history of anaphylaxis, c/o sudden onset of nausea, and "feeling throat tight", epi given
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 51-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
This spontaneous report as received from a nurse refers to a 67 year old female patient with diabetes mellitus. No drug allergies or reactions were reported. On 27-APR-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (subcutaneous, dose, anatomical location was unknown, lot# L003217, expiration date: April 2016 (reported as 31-APR-2016). Concomitant therapies included lisinopril (manufacturer unknown) metformin, aspirin and hydrochlorothiazide (reported as HCTZ baby aspirin). On 29-APR-2015, the patient experienced redness and swelling at injection site. On 29-APR-2015, the patient consulted the physician and was prescribed with antibiotics as treatment fo5r the events. No Lab diagnostics or studies were performed. The outcome of the events was reported as recovered/resolved on treatment (reported as on therapy). The causal relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
BAD CASE OF THE FLU; GOT REALLY SICK; HAD TO TAKE OFF WORK; This spontaneous report received from a patient via a company representative concerned a 34 year old male. 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: Unk) 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 20-MAY-2021, the subject experienced got really sick. On 20-MAY-2021, the subject experienced had to take off work. On an unspecified date, the subject experienced bad case of the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad case of the flu, got really sick and had to take off work was not reported. This report was non-serious. This case, from the same reporter is linked to 20210544577.
Itching, bruising at injection site. Pain at injection site - resolved but took longer than previous injections.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 14May2022, outcome "unknown", COVID-19 (medically significant) with onset 14May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive, notes: Paxlovid started 16May2022 (2 days after symptoms and testing positive); (25May2022) Positive, notes: Tested positive day 5 after completing treatment; (31May2022) Positive, notes: 11days after final dose-still testing positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient started paxlovid two days after the symptoms and testing positive. The patient completed medications on 20May2022. The symptoms subsided by day 3 of treatment. Four days after completion of treatment symptoms returned. The patient tested positive on day 5 after completing treatment. 11 days after final dose, the patient was still testing positive. The patient still had head congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
approx 10 min p/receiving vax c/o back pain, very pale, lethargic, diaphoretic & cyanotic around mouth; pt laid down w/feet elevated, pulse 110, BP 90/60; MD administered 0.3 Epi & DPH; pt was given 02;
pt recv vax 31MAY96 & 4JUN96 pt devel a swollen face & cracking of the skin around lips;to ER;tx w/DPH & sent home;swelling did not resolve & pt returned to ER w/inc facial swelling;lt eye almost swollen shut;
Pt recvd Hep B vax on 15MAY92 & 12 hrs p/vax arm was red & warm; pt t102, nausea, arthralgia, malaise,chills, body aching;
lower back hurt; Feeling flu-like symptoms; felt icky; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 8th November 2022, several hours after receiving Shingrix, the patient experienced influenza-like symptoms and feeling unwell. On 13th November 2022, the patient experienced low back pain. On an unknown date, the outcome of the influenza-like symptoms, feeling unwell and low back pain were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, feeling unwell and low back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's Comment: The case was self reported by the patient. The patient received dose of Shingrix into right arm and few hours later, the patient began feeling flu like symptoms and just felt icky. The patient reported that she was feeling much better today but still not completely resolved. The patient also reported that 5 days after vaccination her lower back hurt starting Sunday. The patient reported that she did not know if it was related to the Shingrix vaccine, but it was better today but not resolved. The reporter did not consent to follow up. The reporter does not give permission to contact HCP.
Sore arm; Aches; Fatigue; This spontaneous case was received on 28-Sep-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-02897) and concerned a female patient of an unreported age. At the time of this report, the patient was 67-year-old.  The patient's medical history was not reported. The patient's concomitant medication included Metoprolol (metoprolol tartrate) used for an unreported indication.  On an unspecified date in 2019, two years ago as reported, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, anatomical location and route of administration: not reported) for prevention of seasonal influenza. The batch number was not reported.  On an unspecified date in 2019, unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced sore arm, mild aches and fatigue.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  Company comment: A female patient, of an unreported age was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced sore arm, mild aches and fatigue. Causal role of the suspect vaccine is unassessabe for all events, due to unclear temporal relationship.; Sender's Comments: A female patient, of an unreported age was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced sore arm, mild aches and fatigue. Causal role of the suspect vaccine is unassessabe for all events, due to unclear temporal relationship.
ActHib was mixed with sterile water and given to a patient; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown demography who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and reported that Act-Hib was mixed with sterile water and given to a patient (product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if the patient had any 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.  Information on the batch number was requested.
dizzy; her arm where she got the injection, was a little red about a half inch and it has continued to get bigger; her arm where she got the injection, was a little red about a half inch and it has continued to get bigger; it is swollen, red and holding heat; it is swollen, red and holding heat; This is a spontaneous report from a contactable consumer.  A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On Mar2021 the patient experienced dizzy, her arm where she got the injection, was a little red about a half inch and it has continued to get bigger, her arm where she got the injection, was a little red about a half inch and it has continued to get bigger, it is swollen, red and holding heat, it is swollen, red and holding heat.  The outcome of the events were unknown.  No follow up attempts are possible; Information about Lot/batch number cannot be obtained.
15Jan98 Pt recv 1dose vax. 21Jan98 Pt devel vesicular rash on abdomen,back & proximal extremities.
Day after vaccine, large red area bigger 24 hours has 50 cent piece, painful. Next day, 48 hours later was swollen to knee, hot to touch and cried continually. Lasted about one week.
Swelling, pain, hardness, redness spreading. Treated with Cephalexin 500 MG. Infection is going away.
Big red splotch on arm right below injection site.  It takes up about 1/3 of my upper arm. At first it was slight itching, and then before I went into work that evening for 3, my arm was sore and I looked and the large red splotch had appeared. It was bright red, painful and hot to the touch. At this point it didn't itch. Today, it's still red but not as red, and there is minimal pain, but extreme itching. Today at my gynecologist she informed me this is what I'd being called "covid arm".
Reccurent Vertigo episodes starting 09/12/21. First episode required ER visit. Second Pfizer COVID19 vaccine on 01/12/2021. Lot # EL3249.
Nausea with vomiting and uncontrolled hyperglycemia leading to volume depletion, dehydration and admission the next day in hyperosmolar state and presumed diabetic ketoacidosis.
R09.02 HYPOXIA 4/20/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION
Injection site reaction--mild bleeding and then a 1-inch diameter raised/bruised welt.
Patient received an incorrect vaccine on 10/10/2018 at 5:00pm. The patient has no known side effects or symptoms at this time.
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (about 20 years in right arm, before the date of reporting). On 15th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 21 days after receiving SHINGRIX, the patient experienced shoulder pain, pain in arm and discomfort. On an unknown date, the outcome of the shoulder pain and pain in arm were not recovered/not resolved and the outcome of the discomfort was unknown. It was unknown if the reporter considered the shoulder pain, pain in arm and discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a PhD, but was not a healthcare professional. The patient received SHINGRIX in the right arm. Three to four weeks after receiving SHINGRIX, the patient experienced an annoying dull pain in his right arm, which went down from the shoulder to the elbow. It was not bad, he did not need to take drugs to treat it, but it did make it difficult to get comfortable sleep at night. The patient had not lost any function in his arm. The reporter consented to follow up.
Patient with a moderate vasovagal episode and full syncope. The patient improved rapidly with hydration and repositioning and was returned home with a driver at baseline.
The day after the vaccine, my upper arm, the injection site, was really sore. I felt it and there were red bumps. The bumps were about 1/4 inch wide and were in the area from the injection site to almost my elbow. It took a few days for them to go away. In addition, when I went to run on my treadmill (day 2 - 5) I could not, because my arm hurt from the motion, the jumping. In addition, when I did any lifting with my left arm (the injected arm), pain radiated down to my finger tips. It then spread to my back and felt like it was going down my spine. The pain went away within 5 minutes. It is now 9 days after the vaccine and my upper arm is still slightly sore. I am able to exercise now. It is now 9 days after the vaccine and I have been having stomach issues since having the injection.  It isn't diarrhea, but very soft stools, very smelly and my stomach is bloated.
Developed large erthema area around vaccination.  Area about 5 inches in diameter.  States was probably aggravated by Tegaderm covering used.  Had some lymph node swelling axilla area.  Missed one day of work due to not feeling well.