chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache after getting the 1st dose on 02Aug2021. The patient would like to know if Tylenol would lessen the effectiveness of the Pfizer-BioNTech COVID-19 vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The pediatric dose was drawn up and administered without dilution resulting in a higher than expected dose.  No other information regarding reaction is available at this time as it happened this same day.
tested positive for COVID19; Exposed to many family members with Positive COVID19 virus; This spontaneous case was reported by a physician and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to many family members with Positive COVID19 virus) and COVID-19 (tested positive for COVID19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to many family members with Positive COVID19 virus). On an unknown date, the patient experienced COVID-19 (tested positive for COVID19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to many family members with Positive COVID19 virus) and COVID-19 (tested positive for COVID19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: positive positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was reported.
Primary Care Physician at Discharge: Doctor Hematologist/Oncologist: Doctor Admission Date: 6/6/2022 Discharge Date: 06/10/2022 Patient's Discharge Disposition:  Home in stable condition.  PRESENTING PROBLEM: Shock Hypotension, unspecified hypotension type COVID-19 UTI (urinary tract infection)   Hospital Course:   This is a 70 y.o. year old patient who was admitted on 6/6/2022 with PMH of IgG kappa multiple myeloma, HTN, hyperthyroidism, and type II DM.  She was admitted with severe hypotension requiring ICU and pressors.  Her hypovolemic shock was thought secondary to volume depletion which responded to fluid resuscitation, and patient was able to come off pressors on 6/7.  She was treated with stress dose steroids in setting of shock but was weaned off steroids on 6/8 without any recurrence of low blood pressure. Blood cultures were positive for corynebacterium aurimucosum, however this was likely a contaminant.  She was also incidentally found to be COVID positive, however she continued on room air and CXR/CTA chest did not show any acute pulmonary process. Her urinalysis showed moderate leukocytes, however her urine culture was negative.  Given negative urine culture, she was taken off antibiotics on 6/9 without any recurrence of symptoms or worsening ROS.  She was treated with Remdesivir on 6/8 and 6/9 but did not need to complete entire course given overall improvement and stability. Patient deemed stable for discharge on 6/10.   Prior to discharge today, patient is feeling well. She is on room air without SOB.  Patient eating/drinking/voiding well and ambulating as tolerated.  Patient will plan to follow up in our office with the NP on 6/14.  She is due for her next cycle of daratumumab on 6/20/22.  She was encouraged to follow-up with her PCP for blood pressure and diabetes management given her elevated A1C and that blood pressure medications were stopped with hypotension.  Patient's discharge medications and instructions were discussed as per below and new prescriptions were sent to patient's requested pharmacy prior to discharge.  All questions answered.  Patient is aware to call our office should further questions or concerns arise following this discharge.
Did not leave my house or see anybody 3 days before vaccine shot on Friday. Nor left my house the day of or the Saturday + Sunday after shot. COVID-19 symptoms started Sunday, 2 days after shot. COVID-19 tested positive on Monday.
Patient stated that the day after the shot (11/27/18) her arm was sore to move and her range of motion was limited when she raised her arm at the shoulder. She stated the injection site was a bit swollen and the swelling increased to her shoulder area. Today(11/29/18)the area was getting better and she was able to move her shoulder more. She wanted to know if it would just take time. Suggested calling her physician also.
Pt c/o of shortness of breath and feeling like throat swelling.  Lungs clear bilat, w/o wheezing on auscultation but diminished.. no stridor noted over upper airway on auscultation, air movement heard however. No swelling noted to throat or tongue.  Pt voice is real hoarse and difficulty to understand.  Dry cough noted. No hives noted but pt did complain of feeling like her legs were itching.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (dose, route and lot number were not provided). On an unkonwn date, the nurse reported that since unspecified date, improperly stored VARIVAX (Merck) (lot # J014228, expiry date: 08-NOV-2015) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
awakened the following morning w/a swollen upper lip & serous nasal congestion; sx clearing rapidly when examined a few hr later;
I woke up to severe pain in left shoulder from the shot which was left arm right below the shoulder. Pain persists today in waves on and off. This is over a month later. Sometimes I cannot move my left arm for the amount of pain. I got the free flu shot at pharmacy, not totally sure of the time but my Medicare record should show all the information, and who gave me the shot.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5 ml Single-Dose Vial (SDV) (lot # L019297, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Over a week later still have fever, chills, loss of appetite, fatigue and severe headache
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox with greater than 15 lesions characterized by itching and fever of 101F.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11Jan2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.  This case contains information for the 71st of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
breathlessness; racing heart rate; shaking disease; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 27Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Dec2020, the patient had an immediate reaction which included breathlessness, racing heart rate, and "shaking disease." She said that the reactions happened a minute after getting the vaccine. She was observed for an hour and said she still had the breathlessness, but was improving. She wanted to know if she should still take the second dose of the vaccine. Outcome of the event breathlessness was recovering, while for the other events was unknown.  Information about the lot/batch number has been requested.
Case number PHEH2014US013297 is an initial spontaneous report received from the medical assistant on 02 Jul 2014. This report refers to 18 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: X130558) intramuscularly on 17 Jun 2014. It was reported that he was erroneously received a dose of Men A lyophilized conjugate reconstituted with sterile diluent instead of MenCYW-135 liquid conjugate. No adverse event reported after the maladministration.
Employee developed severe diarrhea and possible colitis following admin of 2nd COVID vaccine along with suspected side effects
Information has been received from a registered nurse referring to a 4 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M015698, expiry date: 26-SEP-2017; dose and route were not provided). The vaccine was improperly stored at a temperature of 11 degree Fahrenheit for 12 hours 35 minutes. No adverse effects were reported. This is one of two reports received from the same source. Additional information is not reported as no further information is available.
2/4/2021-Extreme rapid heart race  11:30pm  until 4:00am  .  Skipping beats.  Extreme heat sensation last all day.  Shaking (not a chill feeling, body shaking so bad.  Felt like Gallbadder  inflamed and an Ovary had pain.   No fever 2/5/2021_ Heart skipping.  Extreme Heat/ Body Shaky (no chills)  No Fever 2-6-2021- Heart racing.  Extreme heat inside of body.  Red blood dots on arms, chest and back. (not like rashes)  Flat to feel.  Extreme heat then shaking insides felt like it was being sucked out of body.  Heart flutter.  Muscle jumps.   No Fever 2-7-2021- Body on fire again and shaking real bad all night.  Feeling like insides were being sucked out.  Heat fluttering.   No fever. 2-8-2021- Heart Fluttering . Heat sensation.  Went to doctor.  EKG was performed.  Doctor advised not to get the second dose. 2-9-2021 - Brain fog .  Heart Flutter. I did not feel like myself until 3 weeks later.  Kinda felt like my body was off or shutting down.
Narrative: Pharmacy had discovered pt had received expired per beyond use  preparation date of covid vaccine booster dose . Pharmacy called patient to provide clinical disclosure that the COVID dose she received was expired. Per Moderna, the dose is still effective and does not need to be repoeated, but there is higher risk for infection when administering a preservative-free dose after the recommended beyond use date. Patient reports redness and irritation at the site following administration that has improved but is now itchy. Pharmacy recommended that she seek medical evvaluation.
This spontaneous report was received from a 57 year old female patient (who was also a healthcare worker). Patient had no pertinent medical history and was allergic to sulfa. On 15-JUL-2016 the patient was vaccinated with PNEUMOVAX 23 intramuscularly as her doctor recommended it, since she was antibody deficient. On 26-AUG-2016, 'blood work' was performed to see if the vaccine worked and the results showed that the patient did not have a good response to the vaccine (no therapeutic response). There was no further clarifying information on this. The patient then received, on 16-SEP-2016, a second dose of PNEUMOVAX 23 and on an unspecified date after this dose (approximately 2016), she developed inflammation of the lymph nodes in her armpits. The patient did not see her doctor since the second dose of vaccination. No treatment was given. The patient stated that her lymph nodes were still inflamed at the time of the report and hence outcome was considered to be not recovered/resolved. Outcome of 'no therapeutic response' was unknown. Causality assessment was not provided. Additional information is not expected since the patient's physician could not be contacted for further information.
Fever all the way up to 103.9.; Vomiting; My head hurt uncontrolled like it's excruciating pain in my head; Chills; Severe body aches; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient reported she got the vaccine shot on Monday (unspecified date) and since Thursday night she had severe body aches. She have had the fever all the way up to 103.9. She have had fever for three days straight now (at reporting time). She had body aches, had been vomiting, head hurt uncontrolled like it's excruciating pain in head. She have chills. As treatment, the patient had taken Tylenol 500 mg, Ibuprofen is 200, NyQuil, Theraflu. The reporter stated, "I am a 'line person' (not clarified), I am a first responder." The patient wanted to know if for these symptoms it was recommended going to the doctor. Fever had not resolved, while outcome of other events was unknown.  Information on the Lot/Batch number has been requested.
LOW GRADE FEVER FOR 3 DAYS, HANDS AND ANKLES SWOLLEN FOR 1 WEEK, RASH ON FOREARMS
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 64.17 years.  No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 1, on 03-Apr-2021, excursion time at 8 am 38, at 9 am 34, at 10 am 38, at 11 am 42, at 12 pm 41, at 1 pm 41, at 2 pm 41, at 3 pm 40, at 4 pm 40 and at 5pm 41.   On 03-Apr-2021, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021.  Vials only punctured right before administration.  No treatment information was provided.
Triggered a severe gout attack left foot..toe area and ankle top area both sides. 6 days and counting, never had a gout attack this long...usually 3days total.. Had second shot on a Sunday, Monday morning about 5am gout happened...  Was walking with no issues before.  Treatment was colchicine and prednisone   Informed my doctor, who said to report it.
During the administration of the vaccine the needle detached from the syrenge. Leaving the patient with most of the vaccine still admistered,
This spontaneous report was received from a certified medical assistant concerning to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. Between 02-JUL-2015 and 04-AUG-2015, the patients were vaccinated with ROTATEQ lot # K007828 with expiration date of: 02-MAR-2017, (strength, dose and route of administration were unknown). That was improperly stored at a temperature of 32F during 6 hours. No adverse events of product quality complaints were reported. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 11-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
2 minutes after shot patient was sitting and fell to the floor. Woke up in 30 seconds and refused for an ambulance. Pt parents picked him up and he went home.
APPENDICITIS; This spontaneous report received from a patient via social media of unspecified age, race, ethnicity and sex. 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 administered on 15-NOV-2021 for prophylactic vaccination (dose series 1). 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 experienced appendicitis and stated "just had to have it removed" on 06-DEC-2021, three weeks post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of appendicitis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210408818.; Sender's Comments: V0: 20211218018-covid-19 vaccine ad26.cov2.-Appendicitis. 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).
Eyes and lips swollen and red. BENADRYL did not help. ATARAX around the clock x 2 days. Follow-up on 10-19-10.
This spontaneous prospective pregnancy report as received from a 35 year old female consumer regarding on herself with sulfa allergy. The patient became pregnant with Last Menstrual Period on 07-FEB-2014, Estimated date of Conception 21-FEB-2014 and Estimated Date of Delivery of 14-NOV-2014. On 19-AUG-2014, the patient was vaccinated with GARDASIL 1 single shot, intramuscular (dose, strength frequency and lot number were not reported) at her 28 weeks of pregnancy. Secondary and concomitant therapies were not reported. Patient reported that at her 28 week checkup (on 19-AUG-2014), she was schedule to receive DTAP vaccine but the nurse accidentally gave her GARDASIL. The patient reported that she feels fine aside from her arm that was feeling a little sore. The outcome of arm feeling a little sore was reported as recovered/resolved (in an unknown date of 2014). At the time of the report the patient was 30 weeks of gestation. It was reported that the patient sought unspecified medical attention. No treatment was given for the adverse events. No labs diagnostics were performed. Additional information has been requested.