chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mother called and states that Patient had a rash on his body from head to toe.  they were red raised bumps that blanched when touched.  mother states they appeared to be hives.  patient is complaining of being very itchy, but no signs of shortness of breath or difficulty breathing.  mother does not recall patient coming in contact or ingesting anything new other than patient having received the vaccination.  she was instructed to give Benadryl to assist with a possible allergic reaction and provider was notified.
Was my third dose of the Pfizer covid vaccine. Had the vaccine on Wednesday and by Friday morning I has a rash in and around my belly button as well as under my chest area. This also happened with the second does I had on 3/26/21 EP7534. I didn't realize it was because of the vaccine until it happened the next time and realized that it was an affect from the pfizer vaccine.   I received  does 1 EN6206 and 2 EP7534
Patient's caregiver presented a photo of what appeared to be an ulcer on the patient's upper arm . It was bandaged but the caregiver said it was at the injection site and was actively bleeding. Informed caregiver that I was not aware of this vaccine causing that reaction and referred her to her PCP or urgent care for treatment, whichever was quicker. Caregiver stated home health would be coming in the morning. Explained the risk and signs of infection; instructed caregiver to keep wound clean/covered and to seek medical attention if pain/redness/swelling occurred or worsened or if bleeding increased.
local rxn swelling, warm to touch, sore @ inject site x 6 days; severe asthma attack according to mom, prior to waking in AM 26MAY92;
Headache, Myalgia & Fever Narrative: Missed one day of work following 2nd dose due to flu like symptoms
Feeling unwell; Feels like tremors inside, like shaking; if she moves around too much she feels it more; When she moves around she feels more like chills and tremors kind of like anxiety; When she moves around she feels more like chills and tremors kind of like anxiety; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a female patient (wife). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 23Jul2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient felt like tremors inside, like shaking; if she moves around too much, she feels it more. When she moves around, she feels more like chills and tremors kind of like anxiety. Reporter stated that She did the 2nd dose of Pfizer vaccine (Unspecified Vaccine) on Friday and within a last couple of days, she's feeling unwell more than the first couple of days in particularly (incomplete sentence). I will explain it exactly, she felt like tremors inside, like shaking, if she moves around too much, she feels it more, if she rest, she feels better and then if again when she moves around she feels more like chills and tremors kind of like anxiety, so we wanted to make sure that it's not one of the serious side effects that we need to pursue somebody. I did have a way to check her vitals here, I had the thermometer, I had an oximeter and I have a blood pressure gauge so I can do that right now and let you know how it reads. Reporter also stated that this stuff was not going to help right now, I need to know if I need to take my wife to the emergency room or not and asked was there something you can help him. Outcome of the events was unknown.   Information about Lot/Batch number is requested.
Extreme changes in menstrual cycle. Prior to getting vaccinated, I experienced a regular cycle with light flow (no cramps) that lasted exactly 4 days (consistently, for the past 16 years). Since being vaccinated, I?ve experienced two abnormal cycles. The first cycle involved extreme pain and cramps, incredibly heavy flow that lasted for 6 days with spotting for 4 days afterward. The second, and more recent cycle was light and less painful, but I?ve been spotting for 7 days now. Every time I think it?s stopped, it starts back up.
This is a continuation from Dose 1 and 2  worsening symptoms pain in PIP,both elbows.I have more pain late at night causing me to not be able to sleep. Im exp stiffness and in the last month both hands little numb.The past week exp neck/back pain. I have had bloodwork which is has been normal. Before the vaccine I haven't had any of the symptoms.
This is a spontaneous report received from a non-contactable reporter (Consumer). A female patient of an unspecified age received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "suffered a severe case of pericarditis". 3 days after the second dose, the reporter's wife suffered a severe case of pericarditis and Pfizer did not provide any information regarding this concerning the booster, so basically the reporter's question is, does Pfizer advice people who already suffered from pericarditis as a side effects from m-RNA vaccine, does Pfizer advice to those people to get the booster right now? No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Contracted Covid. Had a congestion and a wheezy cough which caused me to take a home covid test and had a positive result. Doctor prescribed Paxlovid. Took it and by the time I took 2 full days of dosage, the symptoms were gone. Tiredness lasted a few weeks but now gone and never returned. I tested again 2 weeks later and still showed positive. I called the hospital and they told me I could test positive up to 90 days after.
Sore arm for two days.  Very painful joints for 3 days, especially hip joints, stiff neck
This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date the patient were vaccinated with improperly stored ROTATEQ lot # L023866 expiration date 24-MAR-2017. No adverse event was reported. It was exposed to temperature of -2 C(degree Celsius) for 410 hours. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had pinpoint rash to hands and feet swelling to hands and peeling of skin treated with couple rounds of steroids
After receiving a Tdap injection, I experienced extreme fatigue and soreness at the injection site.  Fatigue lasted for 4 days requiring me to sleep through out the day for 4 days.
Patient arrived to vaccinating nurse and was SOB, nurse asked caregiver why she was SOB, Caregiver stated this is normal for patient as she has a history of anxiety and SOB. Nurse vaccinated patient. Patient used her walker and sat down in the lobby next to her caregiver then a few minutes later stopped breathing. 911 was called, she had a DNR, there was no swelling of her face or lips.
transverse myelitis causing left leg loss of sensation and weakness. LP negative. Could not do brain or spine MRI scans d/t presense of retinal clip in eye. 3 days of IV solumedrol given. Some improvement, but not back to baseline as on 8/1/2022
Pain to right ear (stated); Right ear inner red and stated she had pain to her lymph nodes and that they were swollen. Also complained today 2/20/15 that lymph node under arm pit (Lt) is bigger.
ringing in my right ear; experienced numbness in his right ear.; complete deafness in my right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in my right ear), HYPOAESTHESIA (experienced numbness in his right ear.) and DEAFNESS UNILATERAL (complete deafness in my right ear) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced TINNITUS (ringing in my right ear) (seriousness criterion hospitalization), HYPOAESTHESIA (experienced numbness in his right ear.) (seriousness criterion hospitalization) and DEAFNESS UNILATERAL (complete deafness in my right ear) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 14-Mar-2021 to 15-Mar-2021 due to DEAFNESS UNILATERAL, HYPOAESTHESIA and TINNITUS. At the time of the report, TINNITUS (ringing in my right ear), HYPOAESTHESIA (experienced numbness in his right ear.) and DEAFNESS UNILATERAL (complete deafness in my right ear) outcome was unknown.            Patient mentioned Within 45 min after the injection, there was ringing in his right ear. 2 hrs after injection, he experienced numbness in his right ear. 3 hrs after injection, he experienced complete deafness in his right ear. 13Mar2021: He went to Urgent Care. 14Mar2011: He went to the Emergency Room. He stayed there under observation from 14Mar2021-15Mar2021. He saw neurologists, Internal medicine doctors, & a bunch of other doctors. No one could diagnose the problem.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Redness, swelling, and hot to the touch surrounding the injection site. Presented 24 hours after vaccination administered.
This spontaneous report as receive from a medical assistant refers to a 1 year old female patient. On 04-NOV-2014 the patient was vaccinated with an expired dose of M-M-R II 0.5 ml, subcutaneously in the right arm (lot # H018948, expiration date: 18-OCT-2014). No adverse effects noted. This is one of several reports from the same source. Additional information has been requested.
passed out 3 times; 3 seizures; Initial information received on 09-Mar-2023 regarding an unsolicited valid serious case received from a Non-Healthcare Professional.  This case involves a 16-year-old and unknown gender patient who passed out 3 times and had 3 seizures after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, expiry date, lot number: not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed serious events of passed out 3 times (loss of consciousness) and 3 seizures (seizure) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. These events were assessed as medically significant.  It was reported, the pediatrician shrugged it off. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the events (passed out 3 times, 3 seizures).  At time of reporting, the outcome was Unknown for the event passed out 3 times and was Unknown for the event 3 seizures.; Sender's Comments: Sanofi company comment dated 14-Mar-2023: This case involves a 16-year-old and unknown gender patient who passed out 3 times and had 3 seizures after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. Based upon the reported information, the role of vaccine cannot be assessed. Additional information regarding additional risk factor, medical treatment, family history, concomitant medications, medical history excluding other predisposing etiologies would be needed for complete assessment of the case.
Woke the next morning with a high pitch steady ringing in both ears. Has not subsided as of today
Swelling of hands and one foot (toes), with discomfort. Was taking acetaminophen, but switched to NAPROSYN.
metallic taste; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (metallic taste), PYREXIA (fever) and CHILLS (chills). At the time of the report, DYSGEUSIA (metallic taste), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No Concomitant medication provided.  No treatment drugs were provided.
Tuesday (day of vaccine) restless night of sleep Wednesday- chills, fatigue, restless sleep Thursday - passed out in school, fatigue, chills, nausea, restless sleep, dizzy/lightheaded, unbalanced, loss of appetite Friday - extreme fatigue, nausea, chills, dizzy/lightheaded, unbalanced, loss of appetite, restless sleep, felt like eyes were bouncing Saturday - fatigue, lightheaded/dizzy, restless sleep Sunday - fatigue, lightheaded/dizzy, diarrhea, rash on upper chest and upper back Monday - lightheaded/dizzy, diarrhea, rash on entire torso, vestibular deficits: Rhomberg EC = severe sway, headache at night Tuesday - + R hypofunction of vestibular system, dizzy/lightheaded, foggy, Diarrhea, headache in the morning, difficulty focusing to read school work Wednesday - fatigue when reading, continued balance deficits Thursday - able to return to school in person; dizzy/lightheaded, mild fatigue, continued balance/vestibular deficits Friday - feels 90% better but still unable to perform higher level athletic activities without dizziness. has to perform at slower pace.
I had a very mild soreness in my arm after receiving the Moderna vaccine for Dose 6. I was exposed to COVID-19 while on vacation. I tested positive for COVID-19 on 05/25/2023. I had a terrible cough and a runny nose. I went to an urgent care center and got a prescription for molnupiravir. The medication worked immediately.  I did have diarrhea on day three of taking the medication. As of today, I still feel fatigue and a runny nose.
Information has been received from a nurse concerning a female patient who in 1985 was vaccinated with MMR II. It was reported that the patient was vaccinated while pregnant and that she later miscarried. The nurse reported that the patient was seen in the office (date unspecified). The outcome was reported as recovered. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
This case was reported by a nurse and by a vaccines responsible physician and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PROQUAD (Merck; unknown route and injection site) given on 28 March 2014. On 28 March 2014, the subject received unspecified dose of KINRIX (.5 ml, left thigh instead of upper arm, unknown route). On 31 March 2014, 3 days after vaccination with KINRIX, the subject experienced injection site redness which led to a maladministration. Several doses of the caps of the vaccine were loose in the box; the doses of KINRIX with the loose tops were discarded but the remaining doses in the box were used for this subject. The reporter was unsure if the other doses used were safe to have used. The subject came and was seen by the doctor but no additional interventions or meds were ordered for him. At the time of reporting, the outcome of the event was unspecified. This case is one of the two cases reported by the same reporter linked to A1067553A. This case was associated to a product complaint. Conclusion regarding the complaint, received on 17 April 2014: According to the thorough investigation performed at the different production steps, and the observation of the returned samples, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Follow-up information received on 29 April 2014: At the time of reporting, the outcome of the event was improved.
Janssen covid 19 Vaccine EUA Symptoms experienced:  chills, low grade fever, body aches, headache, and heart racing.
Heart palpitations, tightening in chest, stuffed up nose, throat tight, dizziness. Called my physician and they said I was having a panic attack.  I have other mental issues but I know this wasn't a panic attack.  Never had a reaction from a flu shot; getting them over 20 years now.
This spontaneous report was received from a company representative via physician refers to a 19 month old patient (gender unspecified). On 03-Dec-2012, the patient was vaccinated with VARIVAX, Lot number was reported as 11011416, expiration date and route not reported). No concomitant medications were reported. On 03-DEC-2012, the patient developed 2 to 3 vesicles on the thigh a few hours later after the administration of VARIVAX. It was unspecified if laboratory studies were performed. Treatment rendered for the event was TYLENOL. The outcome of the event was unknown. The patient sought medical attention (went to the hospital). Additional information has been requested.
1/21 developed Right eye irritation and mydriasis. Next day developed ataxia and gait instability. Concern for optic neuritis. Initial MRI B was unrevealing Repeat MRI B 1/23 revealed multifocal punctate embolic infarcts. She continues with vision changes. On 3/1/2021 MRI orbits/brain reveal new areas of demyelination with one area enhancing, suggestive of demyelination disease. Treat with high dose IV solumedrol x 3Days. Continue physical therapy and reapeat MRI Brain in 3 months.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 01-NOV-2012 at 12:30, the patient was vaccinated with RECOMVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
arm is starting to swal, Swell; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is starting to swal, Swell) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is starting to swal, Swell). At the time of the report, PERIPHERAL SWELLING (arm is starting to swal, Swell) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
patient had dry mouth and throat tightness, headache and feeling warm immediately following vaccine. Benadryl given, patient observed and symptoms resolved within 30 minutes.
arm hurts, first time hurts more; felt poor, not good; weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts, first time hurts more), FEELING ABNORMAL (felt poor, not good) and ASTHENIA (weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts, first time hurts more), FEELING ABNORMAL (felt poor, not good) and ASTHENIA (weak). At the time of the report, PAIN IN EXTREMITY (arm hurts, first time hurts more), FEELING ABNORMAL (felt poor, not good) and ASTHENIA (weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-314593 (Patient Link).
Cutaneous red rash ("Covid arm")  on left arm at injection site;  developed on 8th day after injection; slight itch, slightly swollen, slightly sore, felt hot. Applied cold compresses and hydrocortisone cream that day, symptoms greatly improved by that evening. Only a slight red ring in effected area on arm the next day, all symptoms gone by 3rd day.
Patient received dose# 2 of Pfizer COVID-19 vaccine on 8/15/22 - developed itching ~ 1 hour after vaccine administration, that same day she also went to a water park and was playing in the water, mother says the water smelled funny.She had a fever that night and spots developed all over legs and arms the next day, still very itchy. No other concerns. Patient had an appointment with a provider on 8/19/2022 for this concern. Examination showed that pt had a rash of small hives all over legs and arms, not on face or back. Patient 's parent was advised to use OTC Benadryl every 6 hours as needed for itching; increase fluids; may apply calamine lotion or hydrocortisone cream to rash twice a day. Patient to return to clinic as needed if no improvement or for further concerns. As of the time of this this report, we've not had any further contact from patient's parent.