chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt reports rash redness, swelling @ site beginning the evening of the inj; next day had h/a, upset stomach, sore muscles & joints, fever; called clinic 3 days p/inj stating all these side effects are quite severe; pt told to contact MD;
Fatigue, Muscle weakness, and soreness primarily in arms.  Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.
Approximately 10 minutes after immunization with her second dose of Janssen COVID-19 vaccine, patient reporting symptoms including heaviness and tightness in her chest, like "someone is squeezing my heart". She subsequently had difficulty taking a deep, full breath and felt like she was about to faint. I (pharmacist) gave her water and then called 911 as patient was beginning to panic and condition was not improving. Paramedics arrived shortly and took patient on a stretcher for further evaluation.
hair breakage; excessive hair loss; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that: A patient of an unspecified age and gender received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date, the patient experienced excessive hair loss and hair breakage. It was reported that consumer asked if anyone had reported excessive hair loss and hair breakage more than usual since she also experienced that with the Pfizer Biontech COVID19 vaccine. Consumer stated she called her local county in which one nurse mentioned that a patient mentioned having a similar experience but was unsure which covid vaccine, added that she had a friend who also expressed the same thing to her regarding the vaccine. All the events were considered as non-serious as per the reporter. Outcome of the events was unknown.  The lot number for the vaccine, [COMIRNATY] was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101595686 same reporter/drug/event, different pt;US-PFIZER INC-202101599236 same reporter/drug/event, different pt
My right eye started to have shooting lights and floaters.  The flashing lights were repeated over and over.  The floaters were off to the right of the eye where the flashers were.  I have gone to an ophthalmologist and have a follow up appointment next week.  The pressure in the effected eye is a bit higher that the other eye.  The vision is blurred now. It was not at blurred at first.  I also have been very very tired since the vaccine.   My heart feels racy  as if it is going way too fast.  My Blood pressure is very high which is NOT normal.
Ankylosing Spondylitis Flare; This is a solicited report based on the information received by Pfizer from a company (MFR Control No. # 21K-163-4057384-00). A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (Batch/Lot number was not reported), first dose intramuscular on 01Apr2021 at the age of 63-year-old as single dose, second dose intramuscular on 01May2021 at the age of 63-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at citrate free for ankylosing spondylitis. The patient's medical history and concomitant medications were not reported. The patient experienced ankylosing spondylitis flare in 2021, patient paused a week dose of humira to take covid-19 vaccine in 2021. Solicited report by a consumer of a 63 years old female with events of non-serious patient paused a week dose of Humira to take covid-19 vaccine and Ankylosing spondylitis flare with Humira (adalimumab). There was no reported Medical history. In 2021, the patient experienced patient paused a week dose of Humira to take Covid-19 vaccine and ankylosing spondylitis flare. Pfizer BioNTech covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 01Apr2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer/BioNTech. On 01May2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer/BioNTech. The action taken in response to the event for adalimumab was unknown. The outcome of event was unknown.  The reporter's causality for the events of patient paused a week dose of Humira to take covid-19 vaccine and Ankylosing spondylitis flare with adalimumab was not provided. Causality as per reporter (drug/vaccine) between bnt162b2 and events was possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event ankylosing spondylitis flare  and the suspect drug BNT162B2  cannot be ruled out. 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.
PT had a vesicular, moist, erythemic rash directly below the left nostril from nare to vermilian border complained of burning sensation.
My symptoms were relatively mild. A cough that got greater and greater, tiredness some congestion but  not very much primarily cough.
Unusual painful swelling of toes of left foot.  (NOT entire leg or entire foot.)  Pain like that after foot "falls asleep" then "wakes up." Symptoms started ~5 days after vaccination Took Ibuprophen for pain. Swelling faded after ~24 hours.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included C-section (Live, Full time birth) on 02-Dec-2018. Concurrent medical conditions included Drug allergy (Monistat) and Gestational diabetes.    On 25-Feb-2021 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 14-Jul-2020 and the estimated date of delivery was 16-Apr-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was provided. No concomitants were provided.
Could not move left arm (tetanus vaccine site) for three days after vaccine due to immense pain and my arm was swollen; my arm is still tender and slightly swollen at the vaccine site and it is now 4/11/2011. After the vaccine, I experienced neuropathy that has not gone away and occurs 24/7 (my fine motor skills in that hand have been impaired as a result). About an hour after the vaccine I also became extremely fatigued. I did not sleep that night, nor well for the next two weeks on account of hot and cold sweats. The day after the vaccine I also had what felt like the flu that lasted a week. The following week I went back to the doctor to have the neuropathy checked and I also had developed a sinus infection. It is 4/11/2011 and I still am experiencing the neuropathy in the vaccine arm and fatigue. The doctor further stated that I still have a hematoma at the vaccine site and it is thought that I experienced a rare chemical reaction as a result from the vaccine.
1/11 Woke up itch and a small puffy area that was warm to the touch at the injection site. Put ice and took Tylenol to help with swelling and pain. 1/12 Woke up with worsening situation. Put some hydrocortisone and ice to help. Called Dr. office and was advised to continue treatment and if it gets any worse, schedule an appt. 1/13 This time it looked mean and was six inches wide and four inches across. And at that time called doctor and tried to get a doctor to looked at it. Went to pharmacy where I got the shot and was advised the same. Wrapped in bandage to prevent scratching it and it helped. 1/14 Telehealth with doctor and she prescribed some antibiotics and steroid cream. Will see doctor again on the 1/20 for follow-up and check-up.
This spontaneous report was received from a physician referring to a 67 years old male patient with non-Hodgkin's lymphoma. The patient's medical history included stem cell transplant 2 years ago and he had no allergy history. It was reported that the patient was not exposed to chickenpox or shingles. On 16-AUG-2016, the patient was vaccinated with ZOSTAVAX injection, M-M-R II injection and PNEUMOVAX 23 injection, recommended by his physician (strength, lot number, expiration dates, and route of administration were not provided for all the vaccines). Concomitant therapies included atenolol, lorazepam, omeprazole (manufacturer unknown), tamsulosin hydrochloride, temazepam, pantoprazole and LEXAPRO, and intravenous acyclovir. The physician reported that on 23-AUG-2016, the patient was admitted to a medical center due to nausea and abdominal pain which began on an unspecified date in August 2016. The physician stated that it was determined in an unspecified way that the patient had transaminitis and high lipase levels on unspecified date. On 24-AUG-2016, the patient experienced fatigue, rash papulovesicular, herpes zoster disseminated. It was reported that the maximum temperature was 102 (units unspecified). The reporter also stated that the number of lesions of the rash papulovesicular were "too innumerable to count" and were located on the patient's torso and limbs. On 26-AUG-2016, the physician stated that the patient was transferred to another medical center for an unspecified reason. On 29-AUG-2016, A sample was obtained from the patient's skin where the lesion was located. The outcome of the abdominal pain, nausea, transaminitis, high lipase was unknown. The outcome of the rash papulovesicular, fatigue, abdominal pain and herpes zoster disseminated was not resolved. The relationship between the events and the suspect drugs was unknown. Additional information has been requested.
Asymptomatic Breakthrough COVID-19 case. Hospitalized 8/22/2021 for unknown duration
I had both the pneumonia 23 and Shingrix for shingles. The shyngrix burned bad as administered. A couple of hours later and the site swelled in a red circle. Very warm and hurt like a mule kicked it. Toward evening, I flt dizzy, and very tired. I felt flu like as the upper body ached and my throat became scratchy. My chest feels a little heavy. Today, I still feel tired and have a scratchy throat. I still have a ball at the site, but not nearly as painful. and not hot.I feel still a bit miserable.
Small red mildly raised rash on the upper part of my right arm near where I received the vaccine. Soreness more than first 5 days. Treatment benadryl cream and 1 Benadryl pill
When went from sitting to standing position noticed pain/numbness  on bottom of left foot.  When went to walk, pain shot up through foot with each step, making it difficult to walk.  This lasted for approximately 35 feet before resolving.
SEVERE TINNITUS 24 to 36 hours after the injection I suffered tinnitus in both ears, the same sound both times.  The reaction lasted for 2-3 days after the first injection.   After the second shot the tinnitus started about the same time after the shot but was louder, pulsating, and has not let up at all.  I am still suffering from this now.  The current outcome is that I will be seaking additional medical care if this does not improve.
Information has been received from a consumer concerning her daughter who has no known drug reactions/allergies and a history of high mercury levels who was vaccinated IM with a dose of MMR. It was reported that the patient had a similar vaccination schedule (exact vaccinations not provided) as her brother which included HIB conjugate vaccine, diphtheria toxoid (+) pertussis acellular 4-component vaccine (+) tetanus toxoid, HIB conjugate vaccine, poliovirus vaccine live oral, diphtheria toxoid (+) HIB conjugate vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid, varicella virus vaccine live and hepatitis B vaccine. It was reported that the vaccines were thimerosal free. Subsequently, the patient developed autism with motor and behavioral problems and was hospitalized. Lab diagnostic studies included: baby teeth analyzed for mercury content the result of which was 240 ppb, and chelating therapy to measure urine levels of mercury, results not reported. It was reported that the patient's mother's family has a genetic abnormality that prevents them from removing mercury from the body. At the time of the report the patient had not yet recovered. There was no product quality complaint involved. The patient's autism was considered to be disabling. The patient's brother (WAES0503USA01200) had a similar experience after vaccination with MMR. Additional information is not expected.
4.5" of erythema to (L) deltoid extending to elbow, increased heat & edema. Symptom began on day after injection. Mother began warm compress & Ibuprofen with no relief. Brought to office on day 2 of symptoms. DECADRON 1.5cc given to (R) thigh IM. ZITHROMAX 100mg/5ml 1 tsp. q day & Childrens ZYRTEC 1mg/ml 1/2 tsp q day prescribed.
Tenderness and redness followed up by a significant lump covering the majority of my left upper arm.
I had congestion, general body aches, sore throat; I used a home COVID-19 test, that did come back positive. I called my doctor's office, I had a telehealth visit with my doctor, discussed my symptoms, he called in a prescription of PAXLOVID that I was able to start April 4, 2023. I started feeling better within three days, with a little congestion. I tested negative on April 11, 2023, and was able to return to work.
I'm having a gout attack 2 days after Shingrix vaccination; This case was reported by a consumer via call center representative and described the occurrence of gout acute in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced gout acute. On an unknown date, the outcome of the gout acute was unknown.   It was unknown if the reporter considered the gout acute to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experience acute gout attack 2 days after receiving shingrix vaccine. The patient reported that he or she did not have a gout attack in 20 years and it happened 2 days after Shingrix vaccination. The patient wanted to know whether gout attack was the side effect of shingrix vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015 at 07:27, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 11.2 (5hours and 7mins) and 1.6 (2hours 37mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Chest pain 3 days after 2nd Pfizer Covid vaccination.  Worse lying down, improved sitting up High Sensitivity Troponin 2340 ng/l
Case number PHEH2015US018589, is an initial spontaneous report from a nurse received on 18 Sep 2015. This report refers to a 44 years old male patient. Concurrent condition included diabetes mellitus. Concomitant medications were not reported. Preivous vaccinations were well tolerated. The patient was vaccinated with FLUCELVAX, (batch number 173839) at a dose of 0.5 ml intramuscularly into right deltoid on 09 Sep 2015. On 10 Sep 2015 the patient experienced malaise, fever and headache. The events recovered on 15 Sep 2015. Seriousness and causality of the events was not reported.
Client approached staff stating she was not feeling well and was tearful.  Client was escorted to chair and within a few seconds had loss of consciousness lasting 15-20 seconds.  Client was slow to recover and remained pale, diaphoretic, and hypotensive several minutes following event.  30 minutes after LOC client continued to complain of light headedness and developed abdominal pain and nausea.  Pt maintained a pulse between 70-80bpm and a normal SPO2 at or above 98% on room air during the entire event.  Do to slow recovery and return to baseline and noted emesis the decision to was made to transport client to the local emergency department via mobile medical response.
Pt. c/o sore throat cough, starting day after flu shot given. Pt was checked out 9/21 & 9/23, dx with URI, advised supportive tx & to seek further care with any increased problem.
The pt experienced neurological symptoms which included numbness and tingling in legs and hands. The pt was diagnosed with Type I multiple sclerosis on 4/30/00. Was in remission at the time of vaccination.
p/vax pt devel a rash near inj site it was most intensely red, but also broke out on both upper & lower extremities including hands & tops of feet;tx cortaid 1% & claritin;described as eczematous dermatitis by dermatologist;
Had reaction to his right thigh within 24 hours. Red swollen, hot to the touch and it continues to grow.
Within 15 minutes of reaction symptoms appeared. Patient was transferred to local ER per ambulance. Follow up call to patient he states received IV steroids reaction improved and he left the ER about an hour after arriving.
This spontaneous report was received from a certified medical assistance referring to multiple unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M041513 with expiration date 11-OCT-2018 (dosage and route of administration were not reported) for prophylaxis which was reconsituyed with properly stored diluent. The vaccines which were exposed to temperature excursion from -14°C to -10°C for an unknown time frame because of data logger. The previous temperature excursion was -14°C to -10°C for 21 hours and 15 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA005396:
Fever, close-mouthed high-pitched scream, seemed unable to open her mouth, crying, fitful, rigid body, inconsolable, wouldn't sleep.
Arm initially sore and was told it should go away in a few days. However on day number 3 the pain  began to increased instead of decrease. The pain began to spread down my arm and up to my neck. I called the doctor who said give it a few more days for the pain to go away. By December the 7th the pain was more intense and I could no longer move my left arm or neck. The pain began to move into my chest. I went to the emergency room where test showed that I have continuous muscle spams throughout  my chest arm and upper back. I lost all movement in my left arm.
Patient developed increased pain, swelling and redness at site of MMR injection one week post vaccine administration, evaluated, diagnosed with cellulitis.
Chills; migraine; dizziness; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: El9267), intramuscularly, administered in right arm on 19Feb2021 at 15:30 (age at vaccination was 45-year-old) as dose number unknown, single for COVID-19 immunization. The patient's medical history included ulcerative colitis. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as workplace clinic. On 20Feb2021, the patient experienced chills, migraine, dizziness, and body aches. No therapeutic measures were taken as a result of the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Feel weak; Can't walk; Feel like I have the flu; Headache; Chills; Feel dizzy; Really sick for 3 days; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feel dizzy), MALAISE (Really sick for 3 days), ASTHENIA (Feel weak), GAIT DISTURBANCE (Can't walk) and INFLUENZA LIKE ILLNESS (Feel like I have the flu) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Feel dizzy), MALAISE (Really sick for 3 days) and NAUSEA (Nauseated). On 09-Jan-2021, the patient experienced ASTHENIA (Feel weak), GAIT DISTURBANCE (Can't walk), INFLUENZA LIKE ILLNESS (Feel like I have the flu), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, DIZZINESS (Feel dizzy), MALAISE (Really sick for 3 days), ASTHENIA (Feel weak), GAIT DISTURBANCE (Can't walk), INFLUENZA LIKE ILLNESS (Feel like I have the flu), HEADACHE (Headache), NAUSEA (Nauseated) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was 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.
Pt experienced facial flushing 10 minutes after TWINRIX given on 5-17-2010.  Prior to this immunization pt had taken 25 mg BENADRYL because of reaction of hives 12 hrs after MENACTRA vaccine - requiring BENADRYL and steroid.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74 years old male patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. In 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced Herpes Zoster. On an unspecified date, the patient was treated by a healthcare provider for Herpes Zoster. The outcome of Herpes Zoster was unknown. The reporter considered Herpes Zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.