chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intestinal stuff; felt like he was going to die; sweats; vomiting; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (intestinal stuff), DEPRESSION (felt like he was going to die), HYPERHIDROSIS (sweats), VOMITING (vomiting) and NAUSEA (nausea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (intestinal stuff), DEPRESSION (felt like he was going to die), HYPERHIDROSIS (sweats), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, DIARRHOEA (intestinal stuff), DEPRESSION (felt like he was going to die), HYPERHIDROSIS (sweats), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
This case two involves an unknown age and gender patient were inadvertently given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] 2020-2021 instead of the 2021-2022, the vaccine expired on 6/2021 (expired product administered). Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7002BA and expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered). It was reported "The patients have been contacted by our office an made aware of the error. Since the vaccine expired on 6/2021 are there any medical concerns, we should be aware of so we can inform the patients". This case was an actual medication error due to expired vaccine used (latency: same day). At the time of reporting, 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 the directive 2001/83/EC and Module Regulatory Authority. 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.
polychondritis; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced polychondritis on an unspecified date with outcome of unknown. A patient reported symptoms "many months after their dose".  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event Polychondritis  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Hep A vaccination was given on 02/13/2023.      Vaccine had expired on 02/06/2023.  Parent of child was notified.
Dermatographia and urticaria from pressure with generalized skin hypersensitivity. Itching started on scalp and back of neck and progressed to entire body, worst on neck, shoulders, scalp, inside of knees and back. Any scratching would result in hives. Improved with cetirizine. Still ongoing, but only need to take cetirizine about once per week. Urticaria is less inflamed, dermatographia is still present but less inflamed.
Information has been received from a woman in a physician's office concerning a 12 month old white female who on 19-FEB-2002 was vaccinated IM in the right leg with a first dose of Varivax (lot # 640153/0823L). On 13-OCT-2006, the patient started to develop chickenpox lesions. No medical attention as sought. The disease was noted to be in progress and the patient had not yet recovered. Additional information has been requested.
began feeling hazy; difficulty breathing; light headedness; lost his appetite; Depression/ looks sad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (began feeling hazy), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness), DECREASED APPETITE (lost his appetite) and DEPRESSION (Depression/ looks sad) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (began feeling hazy), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness) and DECREASED APPETITE (lost his appetite). 27-Mar-2021, the patient experienced DEPRESSION (Depression/ looks sad). At the time of the report, FEELING ABNORMAL (began feeling hazy), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness), DECREASED APPETITE (lost his appetite) and DEPRESSION (Depression/ looks sad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Weight: lost (Low) Lost.         Patient went to his HCP where he was given an oral anti-histamine.   Patient went to the HCP again, and was told that he might have depression.  An anti-depressive medication was started.  No concomitant medications were mentioned. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
HEAVY CHEST; ANXIOUS; STRESSED; CHILLS; HEADACHE; MUSCLE PAIN; TIRED; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A,and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle pain. On 08-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced stressed. On 13-APR-2021, the subject experienced heavy chest. On 13-APR-2021, the subject experienced anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stressed on 13-APR-2021, chills, and muscle pain on 09-APR-2021, and headache on 11-APR-2021, and had not recovered from tired, heavy chest, and anxious. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that this case confirmed with cellulitis, but the events were resolved spontaneously. The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. This is one of the 13 cases reported by same reporter.
Acute urticarial reaction in skin overlying L deltoid injection site of 10-12 cm. Subsequently lymphadenopathy and pain in axilla and L chest wall over 6 weeks.
Immediately following administration of shots got up from exam table and had syncopal episode with collapse for seconds, developed pallor + emesis after. No airway compromise, vital signs normal. Follow-up Information 06-NOV-2007: 14 year old female presents with c/o pain for 3 weeks bilateral knee pain, achiness all the time worse with activity, Advil about one time per day for the last 1 week. Points to lateral aspect of both knees where tendon inserts. Denies: direct trauma, fall. Denies any redness, swelling or other joint pain. Had gardisil vaccine 10/16/07 and family concerned that the joint pain may be related. Also play club soccer with practices 2-3 times per week and games on the weekend. Discussed at length with patient and parents. History and exam c/w tendonitis likely from overuse. Rec advil 400 mg 3 times per day for one week, rest when possible, ice or heat prn. Does not have a break from soccer until the holidays. Also rec doing Jump exercises for adolescent girls they will talk to trainer at school and look on Internet. Could be related to vaccine with small percentage of girls in studies having arthralgias but would expect it to be getting better. Gave Parents phone number for Merck to call and further discuss vaccine with them. Doubt autoimmune with no family history and no other signs or symptoms but if no improvement over the next 1-2 months especially after 1-2 week rest from soccer would consider doing blood work. arthralgia
feels dizzy and has trouble breathing; feels dizzy and has trouble breathing; had nosebleed by morning; has pain in forehead and nose; This is a spontaneous report from a non-contactable consumer, reported for co-worker via Pfizer colleague. A 27-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date, dose 2, single for COVID-19 immunisation. No patient medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported), via unspecified route of administrated on an unspecified date, as dose 1, single for COVID-19 immunisation and had no reaction on previous exposure to drug. On an unspecified date after second dose, the patient had nosebleed by morning, had pain in forehead and nose, feels dizzy and has trouble breathing. Reporter wanted to know what to do and stated that after the vaccination, the patient drank 3 beers, and he wants to know if this had any consequence. The reporter wanted to know if there was a problem consuming alcohol after administration of Pfizer COVID-19 vaccine. Reporter commented that Pfizer was playing with their lives because vaccine was not approved by FDA. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
TWO WEEKS OF GENERALIZED WEAKNESS AS WELL AS DARK AND ODOROUS URINE
Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from April 1996 through October 1997. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Vaccination history: A second and third dose of hep B vaccine were given on 5/6/96 (1198B) and on 1/1/97 (615998/06420) IM. A first dose of hep B virus vaccine was given on 4/6/96, a route and manufac. unknown. A dose of Haemophilus B conjugate of diphtheria toxoid (+) poliovirus vaccine inactivated (+) tetanus toxoid (6M711EV) in the left thigh on 10/15/96. Two doses of diphtheria toxoid (+) Haemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid were given in the left thigh on 6/11/96 and 8/20/96. Three doses of poliovirus vaccine (Orimune) was given orally on 6/11/96 (07397) and 8/10/96 (0746A) and on 10/15/97 (0760F). A dose of MMR II was given on 7/15/97 SC (D013E/0185). A dose of Haemophilus B conjugate vaccine (HibTiter) (M271AA) was given in the right thigh on 10/24/96. A dose of varicella virus vaccine live was given in the left thigh on 4/17/97. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). Upon request complete medical records wil be provided. No further info is available.
UrticariaPruritus Severe bilateral otalgia, Narrative:  Severe bilateral otalgia improved after ~ 1 hour. then recurred 24 hours later on one side, followed by persistent unilateral hearing loss. Also had mild diffuse skin itching.
Her vulva swollen up. It happened about 2-3 hours after getting vaccine. Her grandmother on fathers side was in emergency when we got there and had swelling in arm from vaccine. Swelling still exits - 2nd day.
10 days after the second dose of the vaccine, a rash started on my right arm where I got the vaccine. Initially I wasn't sure if it was related to the vaccine, and I thought it was just a rash. But it started to worsen and went up to my shoulder, my back, my arms, torso, legs, and ankles. Very itchy and I still have it to this day. I had a regular check up on 8/22 with my PCP. I addressed it there and the PCP couldn't tell what it was either. There was blood work done, there was a raised level in eosinophils - eosinophilia. Referred me to a dermatology and hematologist. I went to derm 9/23 was not able to say what it was? Gave me cortisone and antihistamine, I did that and haven't had good results. Doctor did a skin biopsy and report was that it was being caused by an internal antigen. Asked if it was possible by the vaccine and they said they didn't know so they said to ask PCP. No one knew but they said sometimes rashes may be a symptom. So I don't really know what started it.
Left arm swelling. Admitted to the hospital for severe allergy reaction, finger like rash on the site of injection, high fever 102.7.
Patient's first 2 doses were Moderna.  Patient did not have vaccination card and system to verify was down.  Patient reported Pfizer first 2 doses.
As per mother - states that son had fever of 98.8 - 100 degrees F. At  4:30 am 12/18/08. States he passed out x2. Had previous complaint of dizziness. Vaccine administered 12/16/08 approximately 6:00pm. Patient seen by pediatrician , he recommended he see a cardiologist to rule out heart disease. EMS called responded with vitals check and no hospital required.
Localized discomfort on both arms, extreme pain, solid lump, immobilization on left side. Sore neck extending down to breast and waist on left side and over to collarbone and shoulder blade, fever and chills, severe headache with didn't respond to 600mg dose of ibuprofen, lethargy, extreme tire-ness and sleeping thru first 3 days, unable to lift left arm yet on 4th day. Finally by 6th day post vaccinations, could return to work with normal motility, but still localized lump. Patient called concerned about possible cellulitis, a previous condition, but didn't follow that course. Tried ice on first day, no response. Most severe symptoms came on later on the second day (less than 24 hours from immunization).
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe
No additional adverse events reported; One unspecified patient received a dose of PNEUMOVAX 23 that was improperly stored; Information has been received from a pharmacist regarding a 75-year-old female patient. Her current conditions included high blood pressure, high cholesterol, and estrogen replacement therapy. Concomitant therapies included gabapentin, diclofenac, losartan potassium (manufacturer unknown), amlodipine besylate (NORVASC) and paroxetine. The patient's medical history, drug allergies and reactions were not reported.  On 25-SEP-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered intramuscularly in the left deltoid as prophylaxis (lot number T009744 has been verified to be valid, expiration date reported and validated as 28-JAN-2022) (dose, dose number, and frequency scheme were not reported). Additionally, he received a dose of influenza virus split virion 4v vaccine inactivated (FLUZONE HD).  It was reported that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced a temperature excursion at a temperature range of 49.1 degrees Fahrenheit (F) for the time frame of 12 hours. There was no previous temperature excursion and the call was because of a data logger. No additional adverse effects reported.  It was reported that the patient was considered fully recovered from any adverse event. The vaccine was purchased with private funds.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA011084:
POTS, Tachycardia, Diverticulitis, Migraines
hallucinations; High fever; headaches; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12May2021 11:45 (Lot Number: Eu0173) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient previously had BNT162B2 (lot number: Er8736) 1st dose on 20Apr2021 10:45 AM in the left arm at 36 years old for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced hallucinations, high fever and headaches on 13May2021 02:00. The facility where the most recent COVID-19 vaccine was administered was in the School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of events was recovering.
Rashes appeared on both legs, front and back, one week after vaccine. Symptoms lasted for about 3 days. My husband had the same reaction to his vaccine, one week earlier. Itching responded well to antihistamine treatment.
20-25 MIN AFTER VACCINE GIVEN, CLIENT BEGAN TO FEEL FLUSHED, BODY TINGLING, ITCHY, AND THROAT "TICKLING".  VITALS WERE MONITORED  FOR 30 MIN AND BENEDRYL GIVEN AT 11:22 AM.  CLIENT BEGAN TO FEEL BETTER AND LEFT THE HEALTH DEPT AT 1145 WITH DAUGHTER.  CLIENT WAS GOING HOME AND DAUGHTER WOULD BE WITH HER AT HOME TODAY.
First dose was given on Jan2020 and second dose on Oct2020.; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 1st January 2020).   On 1st October 2020, the patient received the 2nd dose of Shingrix. On 1st October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The patient called for information regarding another dose or not of Shingrix for this situation. The patient disconnected before they could be transferred to GRC or more data could be collected. The reporter did not consent to follow up.
Severe Headache,  Chills, and Body Aches for 4 days
PT'S VISION BEGAN NARROWING AND THINGS LOOKED 'GRAY'. PT WAS INSTRUCTED TO LIE DOWN WITH HIS FEET ELEVATED. BP AT 10:25 WAS 117/74 HR: 52. PT WAS GIVEN SOME WATER. PT BEGAN FEELING BETTER AND WAS INSTRUCTED TO SIT UP. BP WAS 108/71 HR: 79 AT 10:33. PT WAS GIVEN CRACKERS AND SOME FRUIT SNACKS. AT 10:43 BP WAS 123/78 HR: 47. PT WAS FEELING MUCH BETTER. PT STOOD AND WAS FINE.. MOM/ PT WAS INSTRUCTED TO MONITOR HIS SYMPTOMS, TAKE IT EASY AND LIE DOWN IF NEEDED. PT LEFT THE OFFICE WITHOUT ANY COMPLICATIONS , LPN, 01/28/2021 10:47:45 AM >
Vaccine 3/9, 3/30. Admit 5/3. Admit for COVID PNA, DKA. Treated w/ abx, steroids, remdesivir, zinc. CXR shows bilat opacities. Elevated WBC and procalcitonin. He was found to be COVID-19 positive and pulmonology was consulted. Required increasing amounts O2, tfer to PCU. Some clinical improvement but none for worsening confusion. Family opted for DNR and hospice. DC to IP hospice.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown ages and genders. On an unknown date unknown number of patients were vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot number, expiration date, dose, frequency, route were not reported). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
1 day after my vaccination all of the redness at the site was gone but a week later in the same place I developed a 3 by 4 red welp that was hot and tender. Within 24 hours it has started to get better.  I also have this delayed reaction if I?ve been stung by a bee or wasp.