chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight headache and aches; Slight headache and aches; This is a spontaneous report from a contactable consumer (patient).  This 65-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 19Dec2020 at 14:30 at single dose for COVID-19 immunisation. Vaccination facility type was workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included allergy to latex. Concomitant medication included levothyroxine sodium (SYNTHROID). On an unspecified date, the patient experienced slight headache and aches. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The outcome of the events was unknown.  The information on the lot/batch number has been requested.
SUSPECTED COVID-19 INFECTION; FATIGUE; This spontaneous report received from a consumer concerned an 8 decade old male. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced suspected covid-19 infection, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210620153.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Moderna 1st booster administered, no adverse reactions. Health Department requested to be reported due to Monovalent given instead of Bivalent
Hospitalized;  COVID-19 vaccine positive;  fully vaccinated; Admission Date: 10/11/2021 Discharge Date: 10/13/2021; PRESENTING PROBLEM:Urinary tract infection with hematuria, site unspecified [N39.0, R31.9]Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC) [A41.9]Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01]Pneumonia due to COVID-19 virus [U07.1, J12.82]HOSPITAL COURSE: 73 y.o. male who presented with fatigue and found to have Sepsis secondary to UTI with COVID-19 viral pneumonia with 5 days of symptoms prior to admission. The patient has a pmh copd, htn, osa, htn , obesity.  He is fully vaccinated with x2 moderna dosing. The patient was treated with remdesivir x 2 days and decadron while hospitalized. Will discharge home on decadron to complete the 10 day steroid coarse. The patient was also given a prescription for mucinex and metformin due to steroid induced hyperglycemia. An A1C is pending. Recommend outpatient follow-up with PCP for BG monitoring. Acute hypoxic respiratory failure resolved, he had a home oxygen evaluation completed and no oxygen is required. The patient is eager to return home. The patient received 2 days of ceftriaxone and will be transitioned home on keflex to complete the antibiotic course. The urine culture is pending upon discharge. Recommend post-hospitalization follow-up with PCP in 1-week. CT abdomen pelvis recommend outpatient follow-up with dedicated kidney imaging with IV contrast is suggested to exclude presence of mass. Due to finding suggestive of bilateral multilobulated kidneys with presence of cortical thickening overlying the left kidney superior pole and the right kidney middle pole probably representing hypertrophied column.
experienced chills and fever from about 10:30am which took advil and after 4 hours tylenol and drank water and reseted.
Redness and swelling over injection site with generalized rash per emergency room report did not see patient.
Information has been received from a physician referring to a 26 year old female patient. There was no pertinent medical history or drug reaction/allergy reported. On 11-MAY-2016, while the patient was pregnant, she was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, Lot# and expiration date were not reported) (Medication Error and Vaccine Exposure during Pregnancy). Concomitant therapies included prenatal vitamins. The gestational age was 30 weeks and 4 days as of 11-MAY-2016. The last menstrual period (LMP) date was approximately 09-OCT-2015 and the estimated date of delivery (EDD) was approximately 15-JUL-2016 (calculated from the gestational age). The patient was in the office to seek medical attention. No treatment was given for the events. No lab diagnostics study was performed. At the time of reporting, the outcome of pregnancy was pending. Fetal outcome was unknown. Additional information has been requested.
This case was reported by a physician via a sales representative and described the occurrence of hives in a 22-year-old female subject who was vaccinated with HAVRIX and influenza virus vaccine for prophylaxis. On 24 October 2008 the subject received 2nd dose of HAVRIX in the left arm and a dose of Flu vaccine (unknown manufacturer). Either that same day or the next day (25 October 2008) the subject developed hives. She presented to the office. The treating physician implied that the hives resolved, but the reporting sales representative was not certain, thus the resolution was reported as unknown. The physician was not certain whether the hives were caused by the HAVRIX or the concomitant flu vaccine given on the same date. The physician considered the event was possibly related to vaccination with HAVRIX and FLU vaccine. Follow-up information received on 19 December 2008 indicated that hives began on 24 October 2008. They resolved on an unknown date and were considered to be possibly related to treatment with HAVRIX.
Patient received IM Pneumovax and a baseball size swelling occurred at the injection site and the inflammation continued down the entire arm. It did not progress to any other part of the body, and the patient saw his PCP 3 days after and was not given any further treatment. Patient came back to the pharmacy and reported the event on 12/21/2019 and his arm was getting better. He said the swelling peaked around the 16th of December.
Pt. arm was very sore about 3 or 4 hours after receiving the vaccine. She could not lift her arm for 3-4 days after that. As of 8/18/2016 Pt. states she still can not lift her arm up enough to put on her own shirt.
gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021)) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Treatment information was not reported.   The patients had gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation for the 2nd dose.
TINGLING AND BURNING SENSATION IN FEET; WEAK IN THE BODY; TIRED IN THE BODY; FEELING NUMB IN THE HANDS; This spontaneous report received from a patient concerned a 61 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feeling numb in the hands. On 05-APR-2021, the subject experienced tired in the body. On 08-APR-2021, the subject experienced tingling and burning sensation in feet. On 08-APR-2021, the subject experienced weak in the body. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired in the body, and feeling numb in the hands, and had not recovered from tingling and burning sensation in feet, and weak in the body. This report was non-serious.
24 hours post vax, the pt developed a low grade fever. Two days post vax, the pt's fever was 103.8. He responded to Tylenol and Motrin.
walks on toes-nl neuro exam;nl MRI;fever 104 beginning day p/vax & cont to present 13JUL98;p/1wk @ hosp still febrile;
Swollen, red skin size 6"x7" at spot of injections. Some itching, lasting over a week. Patient applied hydrocortisone cream (1%).
Member stated he felt alittle itchy and developed hives systemically. Patient states that he never developed any shortness or difficulty breathing.
pt recv vax;rt deltoid area very swollen; arm red & feels warm to touch;Dad said pt had been crying w/ pain;to clinic; apap, dph & erythromycin given;
I am angry and it is effecting my sleep, it's effecting my job and my sleep; I am angry and it is effecting my sleep, it's effecting my job and my sleep; Could not sleep last night/ It is effecting my sleep; It felt like someone socked me in the head/ Feel bad; Neck pain/ right side of my neck is painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head/ Strained Neck, Neck Pain; Headaches/ it is like a crown headache; Nauseated; Flu-like symptoms; Kidney Stones 2-3 weeks after Vaccine; This is a spontaneous report from a contactable consumer (patient).  A 66-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 28Feb2021 (Batch/Lot Number: EN6203) at the age of 66-year-old, as single dose for covid-19 immunisation.  The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Feb2021 (Batch/Lot Number: EL9264).  Medical history included, nephrolithiasis from Dec2020 to Dec2020, ongoing sleep disorder, pain from an unknown date and unknown if ongoing. Concomitant medication included eszopiclone (LUNESTA) taken for sleep disorder from an unspecified start date and ongoing; tamsulosin hydrochloride (FLOMAX RELIEF) taken for nephrolithiasis from Dec2020 to an unspecified stop date; hydrocodone bitartrate, paracetamol (NORCO) taken for pain, sleep disorder from Dec2020 and ongoing.   The patient reported that he received his 2nd Pfizer vaccine dose on 28Feb2021 and after 10 - 12 hours it felt like someone socked me in the head. The patient has had neck pain and headaches ever since the 2nd dose on 28Feb21. He stated: 'I am angry, and it is effecting my sleep, it's effecting my job and my sleep. Somedays the neck pain may go away a little, but never completely and the headaches are terrible. I have tried applying ice and applying heat, I have been to the chiropractor to treatments.'  Patient is a self-employed and this was affecting his ability to work. He stated that the left side ok and the right side of my neck was painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head.  It is like a crown headache. I have never had problems with headaches before this vaccine.  The reported adverse events were: kidney stones 2-3 weeks after vaccine (nephrolithiasis) on 2021 with outcome of unknown , neck pain on 28Feb2021 with outcome of not recovered, headache on 28Feb2021 with outcome of not recovered , nausea on 28Feb2021 with outcome of recovered, flu-like symptoms on 28Feb2021 with outcome of recovered, insomnia on 02May2021 with outcome of unknown, feeling abnormal on 28Feb2021 21:00 with outcome of unknown, anger on an unspecified date with outcome of unknown , and impaired work ability on an unspecified date with outcome of unknown.   Therapeutic measures were taken as a result of neck pain and headache.  Information on Lot/Batch number was available. Additional information has been requested.
Approximately 3 weeks after Moderna Covid-19 vaccine administration, patient began to experience dizziness, transferred to Hospital, diagnosed with ischemic stroke, discharged, returned within days with worsening, diagnosed with new ischemic stroke (contralateral side), transferred to Medical Center, patient's condition worsened, presumably additional new ischemic stroke, patient ultimately died on 3/5/2021.  Diagnosis was acute infarction of the brainstem/pons as well as acute bilateral cerebellar/occipital infarctions.
This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot#, expiry not reported). No adverse effects reported. The nurse stated that the vaccine was exposed to warmer temperatures. However, she had to research to determine if the vaccines were administered. This is 1 of several reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare worker referring to multiple, unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of M-M-R II lot # K011188, expiration date 12-AUG-2016 (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
After receiving 4 mos. vaccines child developed hives - Mom gave 1/2 tsp BENADRYL x 1 dose hives disappeared came in for office visit on 8/12/09
Migraine started on 3/23. Struck with Bells Palsey on 3/25.
starting  day after  covid  booster she  developed excruciating headaches  at the base of her skull going gorward over her head to the frontal area as  weell as an  upset stomach with abdominal pressure and  some what upset bowels  with looser stool than normal  fatigue  she would get a sensation of being very cold and   shakey inside although not objectivity like she would be out in the cold weather  this recurred about  every  15 minutes or so   she had become increased in nocturia  3 to 4 times  per night  in the past  3 days  she had had bowel movements about  3 times per night   she developed cramps in her feet and after e days  this has progressed to also having  cramps in her  calves  these have been quite severe
Subsequent to receiving vax, the pt experienced dizziness. The most recent information received reports the outcome of the event as resolved.
sensorineural hearing loss requiring; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 22-OCT-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered sensorineural hearing loss requiring use of hearing aids. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX), patient's symptoms resulted in physical limitations not present prior to using Company's product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The outcome of the events was unknown.  Upon internal review, the event of deafness neurosensory was considered to be medically significant.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY-2014 the patients were vaccinated with Oral, ROTATEQ. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and Oral, ROTATEQ was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of Oral, ROTATEQ was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality compliant was involved. This is one of several reports received from the same reporter. Additional information has been requested.
After receiving the second Moderna vaccine, I (the patient), began light spotting/menstruating for 7 days before beginning my period, then bled (my period) for 5 more days.  After 4 weeks, I started lightly bleeding again for 11 days, then began my period. I?ve bled 29/55 days. This is extremely unlike my body which usually bleeds 4-5 days/month, about 32 days apart.
Patient received COVID vaccines 1/29/2021 and 1/8/2021.  On 5/2/2021 developed body aches, cough, headache, rhinorrhea, sore throat.  Tested positive for COVID.
pt recv vax 345PM 12SEP96 & 545AM 13SEP96 pt awoke c/o tickles scratching, side, abd, legs & arms;mom noticed dark red blotches;no SOB;no diff swallowing;no edema;pt cont to itch 7AM MD called for appt;
Lymph nodes under the left armpit swollen and very sore; Lymph nodes under the left armpit swollen and very sore; The area around  injection site was sore; A fever; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 08:15 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. On 05May2021 at 05:00, at the morning following the second vaccine, the patient woke up to lymph nodes under the left armpit swollen and very sore as well as the area around injection site was sore. Later that day, the patient developed a fever and body aches that lasted for 5 hours. The swollen lymph nodes in her armpit area lasted 4 days and was very sore event after using heating pads. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event lymph nodes very sore that included treatment using heating pads.  Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events fever and body aches was resolved on an unknown date in May2021, after the duration of five hours and lymph nodes under the left armpit swollen was resolved on 09May2021, after the duration of 4 days while that of the events lymph nodes very sore and the area around injection site was sore was resolved on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed shingles starting around Sunday April 4, 2021.  Being treated by Dr (2019748949).  Medication given for shingles treatment include: Valacyclovir 1gm (1x daily), Betamethasone Dipropionate Cream (2x daily), Gabapentin 300mg (2x daily), Ibupropin 600mg (2x or 3x daily as needed).
Cold, tingling in lower legs & feet - felt constantly for 3 days, now intermittent at night. dull intermittent pain in left ankle, left foot, knee & calf, right foot & ankle tingling, lower arms tightness & dull pain in muscles, floating feeling, tinnitus - louder in left ear.
Developed rash; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of rash in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included MENQUADFI for prophylaxis.   On an unknown date, the patient received Boostrix and MENQUADFI. On an unknown date, an unknown time after receiving Boostrix, the patient experienced rash (Verbatim: Developed rash).The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Boostrix.  It was unknown if the company considered the rash to be related to Boostrix.   Additional Information: GSK Receipt Date:05-OCT-2023 The initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involved a patient of an unknown age and gender who experienced rash after receiving vaccines Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) and Meningococcal A-C- Y- W 135 (T conj) Vaccine (Menquadfi).  The patient's past medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received an unknown dose of suspects Meningococcal A-C-Y-W 135 (T Conj)vaccine solution for injection and Boostrix (formulation: unknown) not produced by Sanofi Pasteur both with unknown strength, expiry date and lot number via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed rash (unknown latency).  The information on the batch number was requested. It was not reported if patient received corrective treatment. At the time of reporting, the outcome was recovered/resolved on an unknown date for an event. It was unknown if reporter considered rash to be related to Menquadfi. This case was linked to case 2023SA265313.
Nurse Mgr/APRN discovered that the above mentioned Pfizer vaccine was not properly removed from the regular freezer (-25°c to -15°c) on 10/13/2021. The Pfizer vaccine was moved from ultra cold freezer to regular freezer on 09/28/21 and should have been removed from the regular freezer the end of the day on 10/13/21 and placed in the refrigerator for 31 days. The vaccine was not removed on the day from the freezer. The vaccine  is still in the freezer today 10/15/21. It was investigated and found that the vaccine was use in clinic Monday 10/18 through 10/23. NP called Pfizer and spoke with an attendant, walked her through the scenario and she made NP aware that vaccine could note be used past day 17 after being in the regular freezer, voice that the vaccine stability could not be determined and that vaccine should not have been used past the 3 day grace or day 17 and should have been moved to the refrigerator on day 14 after removal from regular freezer. Patient was notified of the incident.