chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ which had lot # L03545, expiry date: 30-MAY-2017 (route, dose and anatomical place of vaccination were not provided)This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates after 24-MAR-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # K009105 with an expiry date 21-JAN-2016, doses, frequencies and route were not reported). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested. The vaccines were exposed to temperature of 74 degree Fahrenheit for 10 hours. The temperature excursion was detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Two days after the shot I had a large bruise on my right leg. I don't remember bumping my leg.; This is a spontaneous report from a contactable consumer (patient).   A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Feb2021 10:00 (Lot Number: EL9266) (at the age of 50) as single dose for covid-19 immunisation. Medical history included high blood pressure. No known allergies. Concomitant medications included amlodipine, boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken. No other vaccine in four weeks. The patient experienced two days after the shot 'i had a large bruise on my right leg. i don't remember bumping my leg' on 17Feb2021 07:45. No treatment received. No covid prior vaccination. No covid tested post vaccination. The event outcome was unknown.    No follow-up attempts are possible. No further information is expected.
Myalgias, fatigue, left sided chest pain syndrome. Patient admitted to civilian hospital; thought to have myocarditis. Co-existing left upper lobe pneumonia. Follow Up: Arm tender at site x 2-3 days. 2 days after receiving vaccinations, awoke with fever, chills, bad occipital headache on the right side, chest pain, and SOB. He did not see medical eval until about 7 days later. At that time. He was hospitalized and diagnosed with pneumonia and myocarditis. 60 day Follow Up: Pt is undergoing additional workup at Medical Center. Results of workup pending.
Redness under the injection site; Tingling in the arm; This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On 3rd January 2020, the patient received the 2nd dose of Shingrix. On 3rd January 2020, less than a day after receiving Shingrix, the patient experienced localized erythema. In January 2020, the patient experienced tingling of extremity. On an unknown date, the outcome of the localized erythema and tingling of extremity were unknown.   It was unknown if the reporter considered the localized erythema and tingling of extremity to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient after vaccination experienced redness under the injection site and then tingling in the arm. The reported batch number KX526, was updated to KX52G, as per sales data sheet. The reporter consented to follow up.
Developed rash 3 days ago, continues to break out with pink bumps then scabs over. Some lesions with blister head.
Mild rash on face, trunk and thorax, itchy, some oval macular and some pustular. No fever. Feels well. Dx'd mild vaccinia received in 48 hours.
mom describes high pitched constant cry since left ofc; lt leg stiff swollen afeb 230PM;
Head ache, irritated sinuses, fatigue, sore muscles, pain at injection site, for 3 days. Treated with acetaminophen on 3rd day.
Headache, treated with Tylenol, went away but came back as medicine wore off. Lasted about 30 hrs after vaccination. Trouble sleeping the first night. No treatment. Some arm pain at vaccination area. To be expected, no treatment. Slowly went away over the next 48 hours.
I received the Covid 19 booster shot (my first and only booster) on 12/7/21 and on 12/9/21 my lymph nodes were swollen in my armpit. After a couple weeks I went to see my PCP and she suggested warm compresses and Advil or something similar. My lymph nodes were not sticking out, but it is what we called "full" basically just swollen. A few weeks and nothing worked so she sent me for tests.
The day after injection she had a migraine all day; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Aug2021 at 15:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included bad cholesterol and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Aug2021 at 00:00, the day after the injection, the patient experienced migraine all day and injection site pain. Therapeutic measures were not taken as a result of the events. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the events migraine all day and injection site pain were recovered on an unknown date in Aug2021.
A non-serious spontaneous report of arthralgia has been received from a health care worker concerning a 10 year-old female, subsequent to receiving FLUMIST.  The patient's past history includes experiencing right arm pain one month after her 2007 FLUMIST dose.  No concomitant medications were reported.  The patient received FLUMIST on 18-Oct-2008, nasally for influenza prevention.  On 19-Nov-2008, the patient came to her physician's office unable to walk complaining of severe right ankle pain.  The patient was referred to an Infectious Disease (ID) specialist, due to the similar event that occurred the previous year.  The ID specialist diagnosed the event as arthralgia and was unable to determine the etiology of the event.  The event was treated with ADVIL.  The ankle pain resolved on 28-Nov-2008 at which time the patient's mother stated the patient was without fever and pain;  she was doing well and walking fine.  The site indicated they will discontinue dosing the child with FLUMIST.  The patient experienced a similar adverse reaction in 2007 one month after receiving FLUMIST.  Follow up was received on 08-Jan-2009 and incorporated into the above narrative.  Diagnosis obtained and date of resolution.
Patient received vaccines on 8/21/03. MMR in (Lt) thigh; DTaP and IPV on (Rt) thigh. She developed 2cm erythema on (Lt) thigh and 8cm erythema (Rt) thigh.
PATIENT RECEIVED 2ND SHINGRIX DOSE ON 11/8/18  AT APPROXIMATELY 10 AM. AT 12 AM ON 11/9/18, PATIENT REPORTS HE WOKE UP IN A DEEP SWEAT ON THE FLOOR OF HIS BEDROOM, PANTING HEAVILY "LIKE A DOG" AND EXPERIENCED LOSS OF BLADDER CONTROL. THESE SYMPTOMS CONTINUED FOR APPROXIMATELY AN HOUR WHILE THE PATIENT LIED ON BEDROOM FLOOR IN FRONT OF A FAN, THEN MOVING BACK TO HIS BED WHERE HE EXPERIENCED CHILLS AND SEVERE SHIVERING UNTIL HE FELL ASLEEP A SHORT TIME LATER. PATIENT REPORTS HE THEN WOKE UP APPROXIMATELY 7 HOURS LATER WITHOUT PREVIOUS SYMPTOMS, EXCEPT FOR INJECTION SITE TENDERNESS AND ARM SORENESS.
Fever 102-105 for 10 days 7 days after shot  In the hospital with high temp Pneumonia
This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (route, frequency, batch/lot number, expiration date were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Initial medication error report received on 09-OCT-2013 from a nurse. A 8-year-old patients whose gender, medical history and concomitant medications were not reported, received dose of FLUZONE (lot number, route and site of vaccinations was not reported) on an unspecified date. Pharmacist reported that patient took FLUMIST instead of FLUZONE. List of documents held by sender: none.
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 13-FEB-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Hospital Course:  Cough 1 mo sob 2 days likley old covid inf per id doesn t qualify for paxlovid no risk factors for progression rec to cont doxy at dc total 5d for CAP htn bp elevated but pt very anxious; will send Vn to help fu op bp advised to self monitor and go see pcp 7d for fu Ibs, mctd, stable
This case was reported via a legal complaint, and described the occurrence of autism in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline) and hepatitis vaccine not otherwise specified (Hepatitis vaccine). A physician or other health care professional has not verified this report. Previous and/or concurrent vaccination included hepatitis B vaccine recombinant (Merck; unknown) given on 13 October 2000 and 25 April 2001; tetanus and diphtheria toxoids adsorbed (Aventis Pasteur; unknown) given on 20 December 2000; seasonal influenza vaccine (non-GSK, Aventis Pasteur; unknown) given on 29 October 2003. On 20 December 2000 the subject received unspecified dose of Hepatitis vaccine (unknown), manufactured by Merck or GlaxoSmithKline that reportedly "contained thimerosal, mercury poisoning". On 02 November 2004 the 4-year old subject received unspecified dose of INFANRIX (unknown) manufactured by GlaxoSmithKline that reportedly "contained thimerosal, mercury poisoning". In 2004, less than one year after vaccination with INFANRIX and approximately four years after vaccination with Hepatitis vaccine, the subject was diagnosed with autism and/or Asperger's syndrome. The complaint alleged that from "11/2 to 2 years of age", the subject did not talk. The reporter further indicated that the subject "suffered neurological damage caused by defendants' vaccines made with the preservative thimerosal, which contains toxic substance mercury". The complaint alleged that thimerosal caused the subject "to develop and sustain autism", and that "autism is a novel form of mercury poisoning". The subject also experienced "pain and suffering, and permanent disability". At the time of reporting the outcome of the events was unspecified.
approx 4yr p/vax pt was dx w/chickenpox. pt will recover. was dx on day of the breakout
Patient said she has had pain in her arm where she received the vaccine since she has received it. This was about 6 weeks ago. She has taken ibuprofen which seems to help but it doesn't completely go away. I advised her to try warm compress and ALEVE along with an antihistamine in case it is some type of allergic reaction. I told her if the pain continues. She needs to be seen by a doctor.
I had severe veritgo with nausea and vomiting out of nowhere. I couldn't even stand up because of it. I  should have gone to the hospital but i couldn't  even sit up to get the phone or see/focus to use it. I live alone.
Loud tinnitus, all day headache, dizziness, memory loss, insomnia
From what I have read it is sometimes referred to as "Popeye's elbow", a swelling of the elbow (the spot that would rest on a desk or counter) to the size of a golf ball. I described it as feeling like a small water balloon. No redness, no pain.
Increased inflammation, with nerve sensitivity, with numbness in right extremities. Initial treatments included chiropractic care three weeks, followed by physical therapy for three weeks.  No change in conditions. Currently pursuing treatment with primary care physician, including MRI and EMG studies.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for Obesity, Essential Hypertension, sleep apnea, parkinson's disease, t2dm. Received both Covid Pfizer vaccines at outside entity. Patient was placed in Home Care in April due to wound on coccyx and wound vac. Per note 5/12, patient was admitted to outside entity hospital, and had aspiration pneumonia and infection from wound on the coccyx. Was placed into hospice on 5/13.
TOOK SECOND AND FOURTH DOSE OF VIVOTIF A DAY LATE; This spontaneous case report (PVX2019-2024) was received from a pharmacist on 05-Aug-2019 and additional information received on 20-Aug-2019. It described a male consumer who "took second and fourth dose of Vivotif a day late" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took the second and the fourth dose of Vivotif a day late. He completed his course in 8 days.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took second and fourth dose of Vivotif a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the fourth dose a day late" was considered as not applicable.
she does have anaphylaxis to eggs, soy, Aspirin, and MMR vaccine; has gut issues; This spontaneous report was received from a consumer, referring to herself a female patient of unknown age. The patient's historical conditions included anaphylactic reaction. Her historical drugs included aspirin. The patient's concurrent conditions included anaphylactic reactions, food allergies and pharyngeal swelling. Her concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported) as prophylaxis.   On an unspecified date, the patient experienced anaphylaxis to measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (anaphylactic reaction). As treatment she had "six shots or something", she doesn't recall the reaction as it was too many years ago when she was a child. Also, the patient mentioned that she has gut issues (gastrointestinal disorder).   The outcome of the event anaphylactic reaction was not reported, and the gastrointestinal disorder was not resolved by the reporting time. The reporter considered the event anaphylactic reaction to be related to measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II). The causality assessment for the event gastrointestinal disorder and the suspect therapy was not provided.   Upon internal review, the event anaphylactic reaction was determined to be medically significant.
I woke feeling groggy, fuzzy, fatigued with a slight headache.  As the day progressed I developed a migraine and pain/weakness all over my body.  I had difficulty walking, moving, lifting, etc.  By afternoon I was in so much pain I was crying and even laying still I hurt in every cell of my body. Once home I was administered epson salt soaks for my feet x3 and bath, a variety of homeopathic remedies, herbal detox tea, herbal cream/tinctures for pain and lots of water.
no adverse reaction. Gave patient dose IM instead of SQ. Manufacturer said it was okay and not to repeat dose. Patient is aware
Pain in right shoulder injection site, joint & muscle pain including lower abdomen/pelvic area, buttocks, down back & front/sides of legs - from about 11/10/11 thru today 3/24/12 - filled out by patient. Acupuncture treatments pain clinic appointment.
Fever of 103 the night of. Several days later developed hives all over body and a low fever that lasted 3 days and itchiness another day.
The main adverse event, depressive episode, lasting 8 weeks post vaccination.  The other side effects I had: chills (lasted 3 days), hot flashes (lasted 2-3 days), fever (lasted 3 days), nausea (lasted for 5 days), vomiting, brain fog (lasted 3 weeks), body aches (lasted for 5 days), headaches (lasted 5 days), left sore arm (lasted 3 days).  I consulted with my psychiatrist about my symptoms.  As of today I am still recovering from the depressive episodes. .
Within 8 hrs, chills that lasted for 4 hrs. -this was reported via daily text message.  About 6 days later, I started to experience dizziness and that has continued.  I am 12 days post vaccine at this time.
anaphylaxis; seizure; hives; Covid test date=19Jan2022, Covid test result=Positive; Covid test date=19Jan2022, Covid test result=Positive; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Jan2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: Polycystic ovarian syndrome ("PCOS") (unspecified if ongoing); Gastrooesophageal reflux disease ("GERD") (unspecified if ongoing); "known allergies: shellfish" (unspecified if ongoing); "known allergies: nuts" (unspecified if ongoing),; "known allergies: figs" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing), all notes: known allergies: shellfish, nuts, figs, pollen, eggs. Concomitant medications included: OMEPRAZOLE; METFORMIN. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant, life threatening) with onset 20Jan2021, outcome "recovered with sequelae", described as "anaphylaxis"; SEIZURE (hospitalization, medically significant, life threatening) with onset 20Jan2021, outcome "recovered with sequelae", described as "seizure"; URTICARIA (hospitalization, life threatening) with onset 20Jan2021, outcome "recovered with sequelae", described as "hives"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Covid test date=19Jan2022, Covid test result=Positive". The events "anaphylaxis", "seizure" and "hives" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Nasal Swab: (19Jan2022) positive. Therapeutic measures were taken as a result of anaphylactic reaction, seizure, urticaria, which included epinephrine (EPIPEN). Clinical course: Facility type vaccine: Hospital. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Right Hand (thumb, middle finger and index-no pain just swollen) left hand index and thumb. I saw a Doctor who diagnosed my on 08/15/2021- he diagnosis me with tendinitis I did a follow up on 09/03/2021at medical facility - doctor diagnosed me- Rheumatoid Arthritis. I went to another doctor because I wasn't getting any relief-11/03/2021-doctor diagnosed me with - Carpal tunnel syndrome and the doctor referred me to a hand doctor. The Hand doctor also diagnosed me with Carpal tunnel syndrome.
Vasovagal response treated with first aid, rest, ice, lowering extremities. Neurological assessment. Vital signs and fluids.
Minutes after his vaccinations he became lethargic, pale in color and bluish hue to lips. Needing RN to enter room to evaluate. No wheezing, retractions, grunting, lip swelling, tongue swelling or rashes. Remained pale, bluish lips and falling asleep for 2-3 minutes. Stimulation/chest rubbing to stay awake. After this he recovered to his normal self and left the clinic without further intervention.
pt recv vax & 3 days post vax pt reportedly exp a probable afeb sz;
This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (face was tingly), HYPOAESTHESIA (face was numb) and HYPOAESTHESIA ORAL (nose and mouth as well) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included High cholesterol and Thyroid disorder. Concurrent medical conditions included Allergy (Allergic to Bactrim). On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PARAESTHESIA (face was tingly) and HYPOAESTHESIA (face was numb). 23-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (nose and mouth as well). At the time of the report, PARAESTHESIA (face was tingly), HYPOAESTHESIA (face was numb) and HYPOAESTHESIA ORAL (nose and mouth as well) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe period cramps which I haven't had in months since I've gotten COVID-19 back on Jan 29th. I believe I got it then bc I wrote on Feb 14 exactly 2 weeks after seeing our factory partners. My head felt shaken like astigmatism in my brain. So haven't had a real period for a year and then after the vaccine worst cramps in my life. Then I have stomach hurting and GI issues every hour or so. Lastly my eyes have been red at night a lot and I would keep getting headaches from time to time for no reason and I'm not a headache person.