chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Intense muscle pain in right arm, unable to lift more than half way up; Temperature reached a maximum of 101.8 degrees F; Headache; Swollen lymph nodes under right arm; Bruising at inject site; Tenderness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 23Apr2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The medical history included reactive airways disease, allergies to certain trees, weeds, grasses, molds, rodents and cats. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 31Mar2021 at 15:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 20:00, the patient experienced body aches, intense muscle pain in right arm, unable to lift more than half way up, temperature reached a maximum of 101.8 degrees F, headache, swollen lymph nodes under right arm, bruising at inject site and tenderness at injection site. On the same day, the patient underwent body temperature test and the result was 101.8 degrees fahrenheit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events which included treatment with acetaminophen (MANUFACTURER UNKNOWN) according to the direction given. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, intense muscle pain in right arm, unable to lift more than half way up, temperature reached a maximum of 101.8 degrees F, headache, swollen lymph nodes under right arm, bruising and tenderness at injection site were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Multiple red vesicular lesions on arms, back, legs and chin. Very itchy, beginning 2 days after IMZ administration. Returned to clinic on 8/12/15 for treatment, given instructions for Calamine/Caladryl OTC lotions.
My husband had a Shingrix vaccination on 1/24/2020 and got very sick with fever headache and extreme fatigue 1/25/20. He is still very sick today 1/26/20. He is the third person I know who has had very severe reactions to the Shingrix vaccination.
Severe left shoulder pain,  awakened from sleep at approximately 1:45 AM, 9 hours post injection.  Unable to return to sleep secondary to pain.
prostate cancer; This case was reported by a other health professional via call center representative and described the occurrence of prostate cancer in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received the 1st dose of Shingrix. In May 2020, between 1 and 3 months after receiving Shingrix, the patient experienced prostate cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the prostate cancer was not recovered/not resolved.   It was unknown if the reporter considered the prostate cancer to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported but it could be 71 or 72 years. The patient reported that a patient got 1st dose of Shingrix and was diagnosed with prostate cancer in May 2020. As a measure, the patient received chemotherapy. This condition was ongoing.  The patient's 2nd dose was planned for 12th September 2020, but the patient was on chemo treatment until last week. His oncology suggested to not get Shingrix and wait for 4-6 weeks after last day of treatment.  The patient would receive his 2nd dose would be then on 10th October 2020. He did not receive the 2nd dose within the recommended 2-6 month period.  No other information was provided. The reporter consented to follow up.
Patient was given pediatric bivalent booster 5-11 years instead of adult bivalent booster 12+ years. He received too small of a dose.
Patient passed away unrelated to covid vaccination Narrative: The patient had COPD and history of prostate cancer. Patient was placed on hospice care. Patient received his first dose Moderna on 2/9. Patient passed away on 2/16. Cause of death not documented. No indication that death was related to COVID 19 vaccination.
Headache, chills, fever of 102, body aches, constant pain at vaccine site, constipation, neck twitch, lethargic, fatigue.
vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen on 29-Mar-2021 and Pfizer on 18-Dec-2021. Past adverse reactions to the above products included No adverse event with Janssen and Pfizer.    On 28-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022. No adverse events had been reported by patient at the time of the call. No treatment medications were reported.
Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also neck and arm pit. I also had headaches and body aches across my shoulder, neck and back.
a patient inadvertently received an expired dose of ActHIB, NO AE; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 2 years old male patient who was vaccinated with inadvertently an expired 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ActHIB] (lot number UI913AAA and expiration date 14-Nov-2019) via Intramusculary in the right vastus lateralis on 10-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX).  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
Pt was seen on 12/28/02 for 3rd Hep-B and noted to have some indentation in the center of deltoid where Hep-B was given and local discoloration 2" X 1".
Felt awful the night after vaccine;  terrible chills, nausea, ringing in ears, still lacks energy 4 days after vaccine.  Adverse event: I passed out the next morning and fell on floor;had small cut on head due to fall; was admitted to hospital after an emergency room examination; spent one night in hospital.
Patient speaks different language  and the following are  his own words. Clinic staff member helped him to translate. 11.19.2020 I got my flu shot at medical services. The following day, I was very dizzy and my head was spinning. I sat down and rest and the dizziness last for  10 min.  Since then I became dizzy every day and lightheaded.  On 2.13.2021. I was very dizzy again and it last for  5 min.  I was very dizzy , My doctor prescribed dizzy medicine for me  and it did not help  after i took it for longtime.  My doctor also ordered  EKG Brain ultrasound and f blood tests. Please contact my doctor for my  doctor for my  medical history and treatment. Because of that, it hurts  a lot  and I am afraid to get the COVid vaccine. If i do not take the covid vaccine. I would not travel to see my families there. I am alone and I asked for compensation of $50,000.
With Shingle shot, patient's shot site became red and swollen.  Patient also reported to her doctor itching, redness, swollen tongue and black spots.
Pt presents for evaluation concerning potential reaction following the flu vaccine. She had the flu vaccine on October 5 around 11:40. Approximately a couple hours afterward she developed pain at the site of the injection and the sensation she had to clear her throat. She stated her chest felt congested and she noticed that she was wheezing and short of breath. She felt mildly feverish at that time. No sweats. She was able to complete work at 6:00 and went home. When she arrived home, she described having intense pain as her muscles and bones were being ripped apart. It was diffuse. That night she reported being in significant agony. She was at decreased alertness and was noticed by her husband moaning and groaning. He took her temperature, it was 99.3. She felt hot but there was no sweating. She began to feel better around 12:30 that night. The next morning she felt exhausted, sore all over. She was able to resume her work. She noticed left arm was sensitive. She remained exhausted for the remainder of the day but then improved. Today she feels back to baseline. She reports a history of significant prior allergies. She described an anaphylactic type reaction with cats and prior skin testing where they had to stop and use steroids. She is required to have two EpiPens with her at all times. She sees an allergist on a regular basis. Her last food reaction was 12 years ago. Systemic reaction to flu vaccines. Unable to rule out anaphylaxis. Patient described fairly significant systematic response to the flu vaccines. The level of symptoms suggest mild anaphylaxis with an arthralgia picture. The symptoms resolved one or two days which is typical for the vaccine. She has a prior history of fairly robust response to allergens. At this time, we would recommend the patient be evaluated by her allergist to be determine whether she is truly allergic to the flu vaccines and, if so, then documentation will be obtained to exam different future flu vaccine. Patient will discuss this with doctor. Patient to set up a referral with her allergist.
TOOK SECOND DOSE A DAY LATE; This spontaneous case (PVX2019-1441) was received from a consumer on 04-Jun-2019. It describes a 14-year-old male consumer who "took second dose a day late". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 31-May-2019 and took the second dose on 03-Jun-2019 instead 02-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses 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 POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 61-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses 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.   No concomitant medications information was not reported.  The reporter stated that because their facility has not been able to download the digital data logger, they have 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, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.   Reporter stated that no adverse reactions were reported by any patients.
Hair falling out; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling out) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair falling out). At the time of the report, ALOPECIA (Hair falling out) outcome was unknown.            Concomitant medication was not provided Treatment information was not reported On an unspecified date, her hair started falling out. She states that she uses the same shampoo and has the same diet.   Reporter did not allow further contact
PRESENTING PROBLEM: Severe sepsis (HCC) [A41.9, R65.20] COVID-19 [U07.1]   HOSPITAL COURSE:   Patient is a 64 y.o. female who presented to the emergency department with complaints of headache and nausea.  Patient has a past medical history of tobacco abuse, chronic obstructive pulmonary disease, NSTEMI, hypertension, hyperlipidemia, GERD, depression, chronic neck and back pain, and anxiety. Patient states that the day of admission she got up from a couch, and walked toward a recliner where her  boyfriend was and felt dizzy, her legs gave out, and she fell to the floor.  She also endorsed a headache, nausea, diarrhea, shortness of breath increased from baseline, low appetite, and fatigue.  She denies fever and chills.  She presented to the emergency department for evaluation.  In the emergency department, patient was hypotensive, blood pressure was 62/36, tachycardic, and tachypneic.  She was afebrile and did not require supplemental oxygen.  She met criteria for severe sepsis with unknown source.  Complete blood count was unremarkable and CMP were remarkable for hypokalemia.  Lactic acid was 0.9.  Influenza a and B and RSV were negative.  COVID-19 was positive.  EKG shows normal sinus rhythm.  CT of the head showed no acute intracranial abnormality.  A chest x-ray was obtained which showed no acute cardiopulmonary disease.  Differentials for hypotension include dehydration, antihypertensive medications, or developing infection.  Despite 3 L of IV fluid resuscitation, patient's MAP remained under 65. A norepinephrine infusion was initiated in the emergency department.  Patient was admitted for further evaluation and management of severe sepsis of unknown etiology.   Patient was quickly able to be weaned off of Levophed.  Her blood pressures remain stable.  She was given 1 L of IV fluid bolus.  Blood pressure stable without any maintenance fluids.  Patient's blood cultures remained negative.  No etiology could be found for her shock.  Infective workup was negative.  Patient was asymptomatic.  Suspect hypovolemia leading to syncope.  Patient was discharged home in stable condition.
The severe throbbing of pain in complete arm continuously.  Never-ending pain in the upper shoulder and pain and stiffness in the neck on the left side.
Pain in lower rib cage, shortness of breath. Eyes bright red and sandy feeling. Upon arrival at ER- BP 179/92, HR 124. HR remained elevated for ~1 week, BP is still elevated (140/90).
About two hours after receiving vaccine #1, I had the feeling of being high--woozy, light-headed, a feeling of moving in slow motion and feet not quite touching the ground. I felt weak the following day, as if recovering from an illness, but the feeling in my head was gone. Only a slight soreness in my arm remained.
Case number PHEH2012US009829 is an initial spontaneous report received from a medical assistant on 08 May 2012: This report refers to an 11-year-old male patient. He was given only the CYW-15 liquid component of MENVEO (batch number: X10133) intramuscularly on 18 Apr 2012. No adverse event was reported following this administration error.
Information has been received from a physician concerning a 17 year old female who in approximately May 2007 was vaccinated with Gardasil. The physician reported that the patient was rushed to the hospital the day following vaccination with Gardasil. The patient was admitted to the intensive care unit and was still there as of 16-MAY-2007. The patient was diagnosed with cardiomyopathy and pneumonia, which required ICU management and intubation. The physician considered the cardiomyopathy and pneumonia to be life-threatening and other important medical events. Additional information has been requested. 6/27/07-records received from facility for DOS 5/9-5/17/07-DC DX: Acute respiratory syndrome. Disseminated intravascular coagulation. Diastolic dysfunction.  Seen in PCP office for shortness of breath and chest pain. Three days prior to admission began to experience tactile fevers and headaches. Became short of breath day she received Gardasil vaccine. Including midsternal chest pain and productive cough. Complaints on admission vomiting and palpitations. Temp 99.9. HR 117. Respirations 60.
DIZZINESS, THROUGHOUT THAT DAY AND FOLLOWING DAYS, ALTHOUGH SEVERITY WAS LESS EACH DAY.  ALSO INCREASED GASTRIC GAS OUTPUT.
11/5/09 c/o pain in legs 11/24/09. Observed aggressive behavior 11/10/09. q day -screaming - not seen by MD 1 day memory loss & regression - observed Dec 2, 09.
a new nurse at the practice administered vaccine had expired with no A/E; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received via an other health professional via consumer via phone call.  This case involves a 16-years old male patient who was administered with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] by a new nurse at the practice with no reported adverse event (expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6745AA and expiry date: 06-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Caller asking what they should do, is there a possibility that it is still good and when is it okay to administer another dose."  At the time of reporting, 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 the 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.
BLOOD CLOTS; This spontaneous report received from a parent via a company representative via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had blood clots. It was reported by parent that, "My daughter took J and J shot and got blood clot's" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220213352-COVID-19 VACCINE AD26.COV2.S-blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Patient received Pfizer on 4/15/21 and 5/6/21. She was admitted to the hospital on 6/8/21 for COVID-19.
Approx 16hrs post vax, while eating breakfast pt pitched over backwards off her chair to the floor, shaking, unconscious;