chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Productive cough (white sputum), excess mucous; Non-productive cough; Sore throat; Throat irritation; This is a spontaneous report from a contactable nurse, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an intramuscular route of administration in the right arm on 04Aug2021 at 16:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 05Aug2021, the patient experienced sore throat and throat irritation. On 06Aug2021, the patient experienced non-productive cough. On 18Aug2021, the patient experienced productive cough with white sputum, excess mucous and on 26Aug2021, the patient experienced productive cough with green/yellow sputum, excess mucous. The events resulted in doctors or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab test which included chest X-ray on an unknown date in Aug2021 and the result was unknown. Therapeutic measures were taken as a result of events which included prednisone (MANUFACTURER UNKNOWN), tessalon perles (MANUFACTURER UNKNOWN) and azithromycin (MANUFACTURER UNKNOWN). The clinical outcome of the events sore throat, throat irritation, non-productive cough and productive cough with white sputum, excess mucous were not recovered at the time of the report.
Developed very bad taste in mouth 45 minutes after taking first dose of medicine and continues throughout the course of taking the medicine; developed nausea within first hour of taking medicine.; Also developed foul smelling flatulence; This is a spontaneous report received from contactable reporter nurse. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7534) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing); "T&A" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing); "appendectomy" (unspecified if ongoing); "tubal ligation" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE; PREVACID; RESTASIS; METOPROLOL; VITAMIN D 2000; CLARITIN ALLERGIC; VITAMIN B COMPLEX. Past drug history included: Tavist-d, reaction(s): "Allergy". The following information was reported: FLATULENCE (non-serious) with onset 19Mar2021, outcome "unknown", described as "Also developed foul smelling flatulence"; TASTE DISORDER (non-serious) with onset 19Mar2021, outcome "unknown", described as "Developed very bad taste in mouth 45 minutes after taking first dose of medicine and continues throughout the course of taking the medicine"; NAUSEA (non-serious) with onset 19Mar2021, outcome "unknown", described as "developed nausea within first hour of taking medicine.". Therapeutic measures were taken as a result of taste disorder.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On unknown date in 2006 (reported as: "8 years ago") the patient was vaccinated with first dose of GARDASIL (dose, route and lot # not reported) and on 06-NOV-2014 (reported as: "today") the patient received a second dose of GARDASIL (dose, route and lot # not reported). No adverse event was reported. Additional information has been requested.
received a 3rd dose of Shingrix; Swelling; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose was administered last year).   On 1st September 2020, the patient received the 3rd dose of Shingrix. On 1st September 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. In September 2020, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were recovered/resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the swelling and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, this led to extra dose administered. The batch number was updated from 24KZZ to 24KZ7, as per sales data sheet. Less than 2 week after vaccination, the patient experienced redness and swelling. The reporter consented to follow up. No further clarifications were reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020185498:same reporter
Information has been received from a nurse concerning a 13 week old patient who on 01-MAY-2008 was vaccinated with the first dose of ROTATEQ (lot# not reported). Subsequently the patient experienced no adverse symptoms. Additional information has been requested.
73-year-old male with a past medical history of AFib on AC, hypertension, CAD wiuth hx of VATS 2018 comes to the hospital today with complaints of weakness, decreased appetite for 4 days now with shortness of breath.   In the ER Patient was hypoxic 85% placed on 4 L nasal cannula. Fever 101.4. chest x-ray Findings suggest COPD with right lower lobe infiltrate consistent with pneumonia. Questionable small right pleural effusion. The patient had elevated markers including a D-dimer. Bumped troponin 0.07 likely due to demand ischemia. Due to this patient's sent for CTA of the chest to rule out a pulmonary embolism. CT resulted small left-sided PE despite patient being on anticoagulation.
COVID vaccine was administered after the 6 hour administration window from being mixed.              Lot # 030B21A    Vial Exp-9/30/2021
Nausea followed by crampy abdominal pain. Resolved after 36 hours.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, Swollen glands, Swelling at injection site Narrative:
Headache - lasted 24 hours Fever (100) - lasted 24 hours Swollen lymph node (under left arm) - lasted 12 hours Vomiting - lasted 2 hours
Tongue swelling; broke out in hives and Welts; Itchingvery bad itching across her hands, feet, and bottom; burning in body, hands, feet, and bottom; This case was reported by a consumer via call center representative and described the occurrence of swollen tongue in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced swollen tongue, hives, pruritus and burning sensation. The patient was treated with steroids nos (Oral Steroids), cortisone (non-proprietary) (Cortisone Cream) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the swollen tongue, hives, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the swollen tongue, hives, pruritus and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and had a bad reaction to the vaccine and had been experiencing side effects, which lasted a few months. The patient experienced tongue swelling, broke out in hives, welts, very bad itching, and burning in various areas of her body across her hands, feet, and bottom.  The patient stated that it lasted for a few months, but it subsided for a while. The patient stated that the symptoms had returned but were less severe. The patient received oral steroids, cortisone cream and Benadryl for treatment for her symptoms.  The patient was inquiring about how long these symptoms would occur and recommendations for treatment and management of symptoms. The reporter provided permission to contact healthcare professional. The reporter consented to follow-up. No additional details were provided.
Erythema, edema, tingling, pain left upper arm at site of vaccination.  Ice, Benadryl and Motrin recommended.
had very bad reaction for those two injection/had a very bad reaction; for three days they have swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling). At the time of the report, VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  It was reported that the patient had two shots of the Moderna COVID 19 vaccines and had very bad reaction for those two injection and wants to take the booster on the hip or somewhere else on that is not the arm, because they had a very bad reaction, for three days they had swelling and was very concern but it went away. Treatment information was not provided.   This case was linked to MOD-2022-528838 (Patient Link).
2 days after vaccination, patient experienced itchy rash at site of injection along with redness and swelling. Advised to contact MD and Claritin (patient allergic to Benadryl).
Throat tight, hard to swallow, extreme dry mouth, chills,  shaking, anxiety
This spontaneous report as received from a pharmacist refers to a 24 year old female patient. On 19-JUL-1990 the patient was vaccinated with the first dose of M-M-R II (route, lot number and expiration date not reported). On 31-AUG-1994 the patient was vaccinated with a second dose of M-M-R II (route, lot number and expiration date not reported). There was no concomitant medication reported. The pharmacist reported that an unspecified physician stated that the patient had titers drawn on 14-JUN-2013 as evidence of measles, mumps and rubella immunity. The outcome of the event was unknown Additional information has been requested.
Starting one day after the shot I experienced the following reactions which came and went intermittently for three weeks: -heart palpitations  -numbness in hands  -tingling and shakiness in arms and legs -severe pressure headaches -Difficulty focusing eyes, eye pain/strain -ear pain/pressure  -dizziness and confusion -tinnitis
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.   This case was linked to MOD-2021-402935 (Patient Link).
Severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; severe chills, headache, nausea, vomiting for approximately 1-1/2 hours; This is a spontaneous report from a contactable consumer (patient). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 16:30 (Lot Number: ew0186) at 14 years old as single dose for covid-19 immunisation.  Medical history was none. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 on 13May2021 16:30 (lot number: ew0186) at 14 years old in left arm for covid-19 immunisation. The patient experienced severe chills, headache, nausea, vomiting for approximately 1-1/2 hours on 09Jun2021 23:00. Treatment received for the adverse event was aleve pm. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovered. This case was reported as not serious.   No follow-up attempts are possible. No further information is expected.
Within 15-minutes of vaccination, the patient reported dizziness and a heartburn sensation in her chest. EMS noted orthostatic hypotension in the field, systolic was in the 130s when sitting with a rapid drop to the 70s upon standing. Patient was transported to emergency department. In the ED, the patient reported having a dry mouth and having not eaten breakfast. Patient was administered IV fluids and noted improvement. Labs were unremarkable. Diagnosed with orthostatic hypotension secondary to dehydration, vasovagal episode, and GERD.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. A 46-year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Mar2022, outcome "unknown" and all described as "family member tested positive 22Mar and then he tested positive 27Mar symptoms unknown". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Mar2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: It was unknown if the patient had symptoms. Facility type vaccine was workplace clinic. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to COVID vaccine. It was also unknown if Covid test type post vaccination. Post vaccination the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
SORE ARM; TIREDNESS; SHIVERING; MUSCLE ACHINESS; SHAKING; CYCLING BETWEEN FEELING VERY HOT AND VERY COLD; TINGLING; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 138 pounds, and height was 167 centimeters. The patient's concurrent conditions included non-alcoholic, non-smoker, asthma, and tmj, and other pre-existing medical conditions included patient have no known allergies and had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 13:00 for prophylactic vaccination. Concomitant medications included cyclobenzaprine for tmj, fish oil for tmj, lactobacillus reuteri for tmj, and vitamins nos for tmj.  On 06-APR-2021, the subject experienced inappropriate route of vaccination. On 06-APR-2021 22:00, the subject experienced shaking. On 06-APR-2021 22:00, the subject experienced cycling between feeling very hot and very cold. On 06-APR-2021 22:00, the subject experienced tingling. On 06-APR-2021 22:00, the subject experienced shivering. On 06-APR-2021 22:00, the subject experienced muscle achiness. Treatment medications included: paracetamol. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021 04:00, treatment medications included: paracetamol. On 07-APR-2021 10:00, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, cycling between feeling very hot and very cold, tingling, sore arm, shivering, muscle achiness, and tiredness on 08-APR-2021, and the outcome of inappropriate route of vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413992.   Additional information was received agency Follow Up on 09/Apr/2021.The following information was updated and incorporated into case narrative: Reporter details, Patient demographics, medical history, events (tingling and tiredness added),Event stop date added for all events, Event Outcome updated for all events, Concomitant products Cyclobenzaprine, multivitamin, fish oil,  probiotic. added, Product Lot number added.
Rainbow shaped hive like rash near injection sites.   Left arm was first Pfizer covid 19 vaccine and right arm got second dose of Pfizervaccine. I had a very mild bumps near injection site of left arm. So we avoided left arm and used right arm for 2nd Pfizer dose. Within 12 to 24 hours, bumps that were little and pale on left arm were then red and itchy. And then right arm had red itchty spots as well , in a rainbow shaped pattern above near injection sites
CVA; ischemic; suffered hemorrhagic bleed; Swelling; This is a spontaneous report from a contactable other health care professional. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single (at the age of 73-years-old) for COVID-19 immunization at public health clinic/veterans administration facility. The patient medical history included coronary artery disease (CAD), hypersensitivity lung disease (HLD). Concomitant medications within 2 weeks of vaccination included bisoprolol, ASA, clopidogrel bisulfate (PLAVIX); all taken for an unspecified indication, start and stop date were not reported. The patient does not have any known allergies. Prior to vaccination, patient did not receive any other vaccines within 4 weeks and had not been diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19 was unknown. On 22Jun2021, the patient experienced with cerebrovascular accident (CVA), ischemic, clot removed, then suffered hemorrhagic bleed; now swelling, on mannitol in ICU. Patient was hospitalized for 14days. Adverse events (AE) resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received for AEs was unknown. device timestamp 04Jul2021. The outcome of the events was reported as not recovered.  Information on Lot/Batch information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Cerebrovascular accident, Ischaemia, Haemorrhage, and Swelling and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Fever, Diarrhea, NauseaVomiting, CHILLS, FEVER 102F Narrative:
Information has been received from an 18 year old female patient with allergic to DURACEF and no pertinent medical history who in "March 2009" and "August 2009" was vaccinated IM with the first and second 0.5 ml doses of GARDASIL (lot # not reported). Concomitant therapy included prednisone. On approximately 26-NOV-2009 the patient developed mononucleosis after getting her second shot of GARDASIL. The patient sought unspecified medical attention. A bloodwork was performed but the outcome was not reported. At the time of the report, the patient was recovering. No further information is available.
An event of entire dosage of FLUMIST in the same nostril occurred in a 34-year-old patient: the report was received from a registered nurse. No medical history or drug history information has been reported for this employee. The patient received FLUMIST intranasally. The reporter indicated the patient was inadvertently administered the entire dosage of FLUMIST in the same nostril, this is not in accordance with FLUMIST dosage and administration requirements. No adverse events were reported. Outcome: the patient had no ill effects. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this drug administration error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable
Patient called and stated she became shaky, had the chills, had a low grade temp, passed out and hit her head on a wall.
VACCINE ADMINISTERED AFTER 31 DAY REFRIDGERATED DATE BUT BEFORE THE 45 BEYOND USE DATE.
c/o severe headache, abd pain, increased temperature 2 hours after vaccine T 99 deg administration
Dizziness, CoughWheeze, Diarrhea, NauseaVomiting, Chest tightness Narrative:
Contracted COVID despite having been boosted with the Moderna Bivalent Booster Oct 17, 2022 Lot# AS7140C