chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My husband tested positive for Covid 30Aug2021; My husband tested positive for Covid 30Aug2021; This is a spontaneous report from a non-contactable consumer. This consumer reported for a patient. A 37-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955, Expiration date: unknown) intramuscular, administered in left arm on 22Mar2021 (age at vaccination was 37 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication the patient received within 2 weeks of vaccination included pantoprazole taken for an unspecified indication. 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. On 30Aug2021, the patient tested positive for COVID-19 (drug ineffective). The patient was not hospitalized for the event. The patient underwent lab test which included COVID test (Sars-cov-2 test), positive on 30Aug2021. No treatment was received for the adverse event. The case was reported as non-serious. The outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
pt recv vax 17OCT96 & 25OCT96 pt devel a  gen classic varicella rash of less than 50 lesions, mild malaise & low grade fever for only a couple of days;
Initial report was received from a consumer on 21 February 2013. A 4-year-old female patient received her third dose of an injection of DAPTACEL, lot number C4154AA, in the left deltoid on 19 February 2013 (route of administration not reported). Two days later, on 21 February 2013, the patient experienced the onset of adverse events. At night, the patient felt "punky" and had a fever of 101 degrees fahrenheit (38 degrees Celsius). The next day the fever dropped to 99 degrees fahrenheit (37 degrees Celsius). The patient had an ascending rash around her ankles and calves up the thigh, also on the wrist and hand, that was red, slightly raised, and not itchy. The patient had a clear papule at the injection site. The patient also had armpit pain and brachial plexus pain, only on the left side. There was concern "about vasculitis but not sure." The patient took TYLENOL at night for fever. The patient had positive ketones in the urine. The patient's outcome was not recovered. Documents held by sender: None.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 11:01 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 04-Nov-2021 at 11:01 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Nov-2021 at 11:01 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, upon delivery of each vaccine order (021B21A: 02/2021 and 021B21A: 03/2021). The vaccines was placed into the freezer the same day they were delivered. The vial was removed from the freezer and put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patient did not appear for their vaccine. The vial was not kept in the refrigerator for more than a week, since all unused vials were utilized for the following patient.   On 04-NOV-2021 at 11:01 am, the patient received the expired additional dose of vaccine. The patient previously received the 2 doses of vaccine (name unspecified).  No concomitant medications were reported.   No treatment information was reported.   This case was linked to MOD-2021-399960 (Patient Link).
This spontaneous report was received from a Licensed Practical Nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The Licensed Practical Nurse informed that on 03-APR-2015, the patient received a dose of GARDASIL (dosage, route, lot# and expiration date were not reported) and on 20-APR-2015 received a second dose of GARDASIL, (dosage, route, lot# and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/6/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
About 10 hours after my vaccine my arm was extremely sore, I vomited several times, and have the chills.
She was sore in the area where she got the injection, on her arm, after the first vaccine; This is a spontaneous report from a contactable consumer (patient). This female consumer of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Apr2021, in the arm, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after the first vaccine, the patient was sore in the area where she got the injection, in her arm. Event outcome was unknown. The second vaccine was scheduled on 17May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
feels really sick; got covid19 vaccine #2 at 1300 on 1/23/2021.  Pt today has head pounding; chills; feels cold; stomach cramping; legs cramping. Subjective fever. Started with chills and headache 2am on 1/24/2021. around 0500 much worse. Fatigue. No vomiting no diarrhea. Advised pt likely a vaccine reaction
NAUSEA; MIGRAINE/HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 22 year old male. 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: 0431A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced migraine/headache. On 05-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 05-APR-2021, and had not recovered from nausea, and migraine/headache. This report was non-serious.
Patient received expired vaccine for her first Moderna Covid-19 booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her first Moderna Covid-19 booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A, 044A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her first Moderna Covid-19 booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her first Moderna Covid-19 booster dose) outcome was unknown.            No concomitants were reported. Expiration date was 22 NOV 2021. The patient reported no adverse reactions or side effects to her first and second vaccine. No Treatments were reported.   This case was linked to MOD-2022-544178, MOD-2022-543577 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2022: Follow-up received updated No New Information.
HIVES ON EAR AND HEAD; FEVER; This spontaneous report received from a consumer concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and heart problems, and concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced hives on ear and head. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on ear and head on 28-MAR-2021, and fever on 27-MAR-2021. This report was non-serious.
GENERALIZED SORENESS, WEAKNESS, STIFFNESS NUMBNESS AND TINGLING IN TOES AND FINGERS THAT IS GRADUALLY MOVING UP SOME DIFFICULTY BREATHING AT TIMES NOT ASSOCIATED WITH URI SEVERE WEAKNESS IN LEGS, FALLING PAIN IN NECK, STIFFNESS I WENT TO OCCUPATIONAL HEALTH CLINIC ON 10/27/2017 AND NP ADVISED ME TO GO SEE MY PCP BECAUSE IT WAS DUE TO MY "THYROID", TO HAVE MY TSH CHECKED AGAIN.
the patient was administered improperly stored PROQUAD; This spontaneous report has been received from a medical assistant referring to a 4 years old male patient. Information about pertinent medical history or drug reactions/allergies was not provided.  On 28-AUG-2020, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were not reported; lot # S021620 and expiration date 09-JAN-2021) for prophylaxis (product storage error). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  The administered doses of the vaccines experienced a temperature in the range -14 degree Celsius to -10 degree Celsius (-13.04 degree Celsius) for 45 minutes recorded by a data logger. There was no previous temperature excursion.
Pt fainted 3-5 seconds after injection. Pt was seated at the time, became very pale then fainted. He slouched in chair. I guided him to floor as he was sliding out of chair. I cleared the area & he woke up within about 5 sec. from the time he fainted. We moved him to a chair & gave him water & crackers and pt was fine.
bumps around the place of the vaccine, like mosquito bites; warm to the touch; was itchy - ongoing; it hurt if she moved or touched it; The site of injection got swollen; chills; a little bit of a headache; general discomfort in the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (general discomfort in the area), RASH PAPULAR (bumps around the place of the vaccine, like mosquito bites), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (was itchy - ongoing) and VACCINATION SITE PAIN (it hurt if she moved or touched it) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE DISCOMFORT (general discomfort in the area), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (was itchy - ongoing), VACCINATION SITE PAIN (it hurt if she moved or touched it), VACCINATION SITE SWELLING (The site of injection got swollen), CHILLS (chills) and HEADACHE (a little bit of a headache). On 12-Sep-2021, the patient experienced RASH PAPULAR (bumps around the place of the vaccine, like mosquito bites). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at a dose of Cream. On 11-Sep-2021, HEADACHE (a little bit of a headache) had resolved. On 14-Sep-2021, CHILLS (chills) outcome was unknown. At the time of the report, VACCINATION SITE DISCOMFORT (general discomfort in the area), RASH PAPULAR (bumps around the place of the vaccine, like mosquito bites), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (was itchy - ongoing), VACCINATION SITE PAIN (it hurt if she moved or touched it) and VACCINATION SITE SWELLING (The site of injection got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Heart burn medications
Client received nasal mist and then later developed hives on his shoulders.  Mother applied Benadryl Cream to hives and gave Zyrtec.  Within 1-2 hrs. after her treatment the hives were gone.
Stuffy Nose, headache, Fever, Soreness and Swelling at injection site, limitation of arm movement, muscle pain and tingling/numbness.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. There was an excursion from the freezer on 01-Oct-2021 and the vaccine was administered to the patient on 01-Nov-2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021 contains Patient demographics, Vaccine start date and Dose number of the vaccine.
Severe VomitiNg, dizzy (unable to stand or have eyes open due to room spinning) Pain in abdomine
Information has been received from an unspecified reporter referring to an 10 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Swelling, redness, and tingling in extremities and in face.  Itching due to swelling.
PATIENT RECEIVED DOSE 2 OF PFIZER INSTEAD OF MODERNA. PATIENT HAS HAD NO ILL SIDE EFFECTS.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown multiple dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot #K022285, expiry date: 12-NOV-2016, dose and route were not reported). The doses were stored under temperature of 60 F for 3 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna Covid-19 vaccine was given to a patient from a vial that had been left out at room temperature for 18 hrs. post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given to a patient from a vial that had been left out at room temperature for 18 hrs. post puncture) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 18-Mar-2022, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 18-Mar-2022 at 8:15 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given to a patient from a vial that had been left out at room temperature for 18 hrs. post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given to a patient from a vial that had been left out at room temperature for 18 hrs. post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Heptatitis A and Varicella were given on October 14th in patient's right arm. Varicella was in LA. On 10/15 mother called stating patients left arm was swollen and red but no fever. Cool compresses advised. 10/16 mother called Right arm swollen and hot and size of $.50 piece and "feels like a needle is in arm." Patient seen in office 10/16 with possible cellulits and reaction to Varicella. Placed on Omnicef and warm compresses. To be rechecked on 10/18 in the office.
dull pain" at the injection site "shortly after administration; Inappropriate route of vaccination; This spontaneous report has been received from a pharmacist referring to a 52 years old patient of unknown gender. The patient's concurrent condition, medical history and drug allergies information was not provided. Concomitant therapies included water, sterile (DILUENT FOR INTRON A).    On 06-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N020924, expiration date 01-AUG-2019) (strength, dose and frequency were not reported) intramuscularly for vaccination against measles, mumps, and rubella.    The patient experienced dull pain at the injection site shortly after administration, that lingered for a little bit but then resolved. Pharmacist recommended patient apply ice to the area and take acetaminophen (TYLENOL) if necessary for treatment but did not know if patient did either. No lab/diagnostic tests were performed.  The causality between the dull pain at the injection site and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
This spontaneous report as received from a physician via company representative refers to a currently 24 year old female patient (age at onset of AE calculated to be approximately 21 years). The patient's medical history included tonsil removal, no drug allergies. Patient received 3 doses of GARDASIL intramuscular (dose strength was not reported), doses were administered in time frame of 2006 and 2007 when the patient was 17 years old. Lot number was not reported. In 2011, the patient experienced hair loss, weight loss and reported that her thyroid was being attacked by antibodies. Antibodies levels were normal at times while elevated levels were also reported to the physician. The patient had breast surgery to remove a benign fibroid tumour (medically significant). No treatment was provided to the patient at this time for autoimmune symptoms. The patient had sought medical attention. The outcome of event benign fibroid tumor and breast surgery to remove a benign fibroid tumor was unknown. The outcome of the rest of the events was reported as not recovered. Physician informed the company representative that these symptoms have been reported to the VAERS. Upon internal review, the event breast surgery was determined to be medically significant. Additional information has been requested.
Varicella injection on 5/20/08. Muscle swelled with pain; "pimple" noted at injection site during exam on 5/22/08.
c/o mild numbness to the throat and anxiety. Denies chest pain, SOB, swollen tongue, or difficulty swallowing.  Vital signs : BP: 140/98 HR: 77 Sp02: 98% room air  Refusal form signed for ER transfer. Patient states symptom is mild. advised to go to ER if symptom worsen, verbalized understanding seen and cleared by EMS
mildly pruritic erythematous macular morbilliform eruption on the lower back; mild subjective fevers; headache; injection site soreness in the deltoid region; This is a literature report.  Herein, the authors report the development of a morbilliform rash on the trunk of a patient two days following vaccination, a hitherto unreported event. A 30-year-old male healthcare worker with no past medical history presented for vaccination with the SARS-CoV2, the Pfizer-BioNTech COVID-19 vaccine. The day after vaccination the patient experienced mild subjective fevers, headache, and injection site soreness in the deltoid region without overlying skin changes. Forty-eight hours after administration of the vaccine, the patient developed a mildly pruritic erythematous macular morbilliform eruption on the lower back (Figure 1). Over the course of the following 24 hours, the patient's rash resolved without intervention. Twenty-one days following the initial vaccine, the patient received the second dose of the PfizerBioNTech COVID-19 vaccine, after which he experienced chills, fatigue and myalgias. Forty-eight hours after administration of the second dose, the patient developed a recurrent morbilliform eruption most prominent on the bilateral flanks and flesh colored papules on the right flank with significantly increased pruritus and body surface area involvement. Notably, areas which were previously spared by the first rash including the flanks, proximal extremities and upper back were involved (Figure 2). Of note, regions affected in the first rash (lower back) were similarly affected in the recurrent rash. This rash similarly resolved over the following 24 hours without treatment. Herein, the authors report a case of morbilliform rash secondary to the Pfizer-BioNTech COVID-19 vaccine, like that seen in COVID-19 infection. Figure 1. A) Morbilliform, erythematous macular patches on the lower back of the patient. B) Closer view of morbilliform eruption, revealing erythematous macules with confluence and intervening areas of unaffected skin. Figure 2. Recurrent morbilliform eruption on the right flank with flesh-colored papules on the posterior right flank. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event  rash morbilliform 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021226966 Same author, patient, drug/ different event.
after 2nd dose, very sore arm, chills, very fatigued. tylenol has helped
Arm at site of injection  swelled, sore, broke out in hives  and itches       Had strawberries and blueberries  2 hours before reaction