chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, itchy rashes; Red, itchy rashes; This is a spontaneous report from a non-contactable consumer (patient herself). A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 03Mar2021 (at the age of 43-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included Crohn's disease, COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took humira and purinethol and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced red, itchy rashes (rash pruritic and rash erythematous) on 04Mar2021. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of both the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Myalgia   Pt woke up this morning with swollen face with redness, pounding headache and neck pain. Pt is now at PCP office. Narrative:
Patient received 1st dose of Moderna COVID-19 vaccine 02/09/2021. Patient tested positive for COVID-19 03/17/2021. Patient subsequently admitted to the hospital for COVID-19 infection.
@1710 Patient verbalized he was feeling dizzy. Patient appeared dazed and became nonverbal. Emergency Response team was notified. Patient was noted as diaphoretic and clammy. @1712 Bp 53/38, HR43. Epi 0.3mg IM was administered to patient left thigh. Patient was placed on oxygen via NonBreather mask and feet were elevated. @1716 patient became alert and responsive. patient verbalized he doesn't remember anything.  EMS arrived on scene @ 1720. Patient verbalized to EMS he felt better. Patent was able to stand and walk on his own and denied any dizziness. EKG was performed by EMS and showed normal sinus rhythm. Phone consult was conducted between the patient and MD attached to the fire department via telephone. Patient verbalized to the MD he felt better and he declined to be taken to the hospital. Patient was able to exit the vaccination tent on his own and called a uber home.
Hypoxia on 3/12/21 in afternoon around 3pm. New Right lower lobe Infiltrate on Chest Xray 3/12/21. Cough 3/13/21. Worsening generalized weakness 3/12/21 7am, Nausea 3/12/21 7am, No appetite 3/12/21 7am. Malaise 3/12/21 7am. Encouraged fluids. Placed on oxygen via nasal canula. Started Levaquin antibiotic. Started on Guaifenisin cough syrup. Patient is still on Oxygen and antibiotic as of this report.  Incentive spirometer ordered 3/15/21
p/vax pt devel swelling, redness & itchy & feverish rt arm;
The day after the vaccine and currently I keep getting sharp pains in the center of my chest just behind the sternum.; It has interfered with my everyday activities as well as my sleep; It has interfered with my everyday activities as well as my sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 11:00 (Lot number: FC3180) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 21Aug2021 08:00, outcome "not recovered", described as "The day after the vaccine and currently I keep getting sharp pains in the center of my chest just behind the sternum."; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), SLEEP DISORDER (non-serious) all with onset 21Aug2021 08:00, outcome "not recovered" and all described as "It has interfered with my everyday activities as well as my sleep". The events "the day after the vaccine and currently i keep getting sharp pains in the center of my chest just behind the sternum.", "it has interfered with my everyday activities as well as my sleep" and "it has interfered with my everyday activities as well as my sleep" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of chest pain, loss of personal independence in daily activities, sleep disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient known allergies was not reported.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 19 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 06-MAY-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
This spontaneous report as received from a Licensed Practical Nurse refers to a 62 years old female patient. Patient received a dose of PNEUMOVAX23 (0.5 mL, subcutaneous in her left arm, Lot# reported as H018441, exp 28-FEB-2014) on 13-DEC-2012, and she called the practice the next day, 14-DEC-2012, reporting that she was experiencing left arm swelling, fever, and sweats. She had received a dose of PNEUMOVAX23 (Lot#, dose, route unspecified). in "November 2011." She was diagnosed as having cellulitis in her left arm and prescribed KEFLEX by the physician on-call over the weekend and she had now recovering from the events. The reporting nurse would like to request a lot check for this lot of PNEUMOVAX23, lot # H018441, exp 28-FEB-2014. This was one of several reports that received from the same source. Additional information has been requested.
PATIENT REPORTS PAIN IN ARM STARTING 4 TO 5 DAYS AFTER SHOT ADMINISTERED. PAIN HAS PERSISTED, SOMEWHAT MITIGATED BY ACETAMINOPHEN OR IBUPROFEN. MOVEMENT MAKES THE PAIN WORST.
Mom states clinic said pt was not giving adequate fever med p/elevated temp of 105 following immun;
Dizziness; Tingling sense like needles in hands and feet; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 (Lot number: EN6205) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling sense like needles in hands and feet". Therapeutic measures were taken as a result of dizziness, paraesthesia.  Additional information: Treatment: Benadryl.  No follow-up attempts are possible. No further information is expected.
This spontaneous prospective pregnancy report as received from a nurse refers to a 17 year old female patient with no pertinent medical history and no drug reactions and allergies. On 31-JUL-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (dose and route not reported) lot # K002912, expiry date 26-FEB-2016 for routine administration. Concomitant therapies included prenatal vitamins. The patient did not know that she was pregnant and she received (Merck) VARIVAX. Nurse reported that the patient was 10 weeks and 6 days pregnant (Merck) VARIVAX was in the first trimester. The patient became pregnant with Last Menstrual Period date (LMP) of approximately 16-MAY-2014 (calculated by subtracting 10 weeks and 6 days from 31-JUL-2014) and Estimated Delivery Date (EDD) of approximately 20-FEB-2015 (calculated by adding 40 weeks to 16-MAY-2014). There was no treatment given for the event. The pregnancy outcome was outcome pending. The fetus outcome was unknown. It was also reported that at the time of the report, the patient was 21 weeks and 2 days pregnant (LMP also estimated 17-MAY-2014, EDD estimated to 21-FEB-2105). Diagnostic studies included ultrasound scan for pregnancy and routine prenatal tests (dates and results not specified). Additional information has been requested.
but person can get pretty damn sick after getting one, take it from patient.; Initial information received on 08-Dec-2020 regarding an unsolicited non-valid (unevaluable event) non-serious case received from a consumer.  This case involves a patient who reported that person can get pretty sick after getting one, take it from him/her (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient reported that person can get pretty sick after getting one, take it from him/her (illness), (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Fever of 103.5, headache, vomiting, difficulty breathing, pale, weak, dizzy overall soreness  11/30/09 DS for DOS 11/21/09 - 11/23/09: Final DX: Fever, leukocytosis, likely secondary to viral infection, HX of rheumoatoid arthritis, HX of migraine headache, acute on chronic.    Pt presented to the hospital with c/o myalgias, fever and headaches and mild cold. Pt had nausea, vomiting, fever of 103 degrees F, SOB, abdominal pain, diarrhea and worsening of her upper back pain. Pt with leukocytosis. Pt was  imuncompromised due to use of steroids and methotrexate. Viral etiology was considered and treatment was started with Tamiflu. Pt discharged home in stable condition.
91yrs old male was admitted to the hospital for dyspnea and lower extremity edema. Patient was found to have acute on chronic systolic heart failure. Patient was treated with intravenous diuresis. Patient tested positive for Covid-19 pneumonia and was placed on isolation. He was transfer to rehabilitation center for rehab.
late for second dose; believes injection was administered too high on arm; severe pain in waist; svere pain in left shoulder; Severe Pain in left arms/arm pain for 5 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe Pain in left arms/arm pain for 5 weeks), PRODUCT DOSE OMISSION ISSUE (late for second dose), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (believes injection was administered too high on arm), PAIN (severe pain in waist) and ARTHRALGIA (svere pain in left shoulder) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Cholesterol.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Severe Pain in left arms/arm pain for 5 weeks), PAIN (severe pain in waist) and ARTHRALGIA (svere pain in left shoulder). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (late for second dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (believes injection was administered too high on arm). At the time of the report, PAIN IN EXTREMITY (Severe Pain in left arms/arm pain for 5 weeks), PRODUCT DOSE OMISSION ISSUE (late for second dose), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (believes injection was administered too high on arm), PAIN (severe pain in waist) and ARTHRALGIA (svere pain in left shoulder) outcome was unknown.            Concomitant product Unspecific thyroid medication and Unspecific cholesterol medication.  Treatment was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received; AE information was updated.
weird feeling; felt high not thinking clearly; swollen lymph nodes; fatigued; achy arm/She woke up at 3AM feeling very achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (weird feeling), EUPHORIC MOOD (felt high not thinking clearly), LYMPHADENOPATHY (swollen lymph nodes), FATIGUE (fatigued) and MYALGIA (achy arm/She woke up at 3AM feeling very achy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced FEELING ABNORMAL (weird feeling), EUPHORIC MOOD (felt high not thinking clearly), LYMPHADENOPATHY (swollen lymph nodes), FATIGUE (fatigued) and MYALGIA (achy arm/She woke up at 3AM feeling very achy). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 05-May-2021, FEELING ABNORMAL (weird feeling), EUPHORIC MOOD (felt high not thinking clearly), FATIGUE (fatigued) and MYALGIA (achy arm/She woke up at 3AM feeling very achy) had resolved. On 05-Jun-2021, LYMPHADENOPATHY (swollen lymph nodes) had resolved.            No concomitant medication was reported.
Next day: fever 100.2 Muscle aches, joint pain, nausea, fatigues, head ache all day thru early evening Day 2: no fever, joint pain, muscle aches, head ache and nausea all less then day before
6 weeks out woke up with nose bleed x3 days. Went to ER ran test platlet count was at 2,000.sent to be admitted at hospital started steroids, fusion treatments. Was in hospital 16 days platlet count would not stay steady and was very low had bone marrow Which came back fine. Had spleen removed that was eating up all platelets. Had to have blood and was diagnosed with ITP which I never had before.  Was perfectly healthy up to this time
Temp 101; loss of taste; severe muscle pain; severe headache; throat closing; heart arrhythmias; severe congestion; injection site pain; burning in hands and feet. Saw general practitioner the following week.
History of CMT (Charcot-Marie-Tooth disease).  Neurology visit on 12/07/2021. Last visit was in 12/11/2018. Weakness & numbness of her hands and feet have gotten worse especially after the COVID Pfizer vaccine first dose (Nov 17/2021). Since then, she started to have burning sensation on both upper (circumfrential) and lowr extremities (posterior side) which lasted a couple of days. She also felt pins and needles in hands and hamstrings muscles. She reports increased weakness (she used to do wt lifting easily of a 25 bounds that she is not able to do anymore). She also been tripping over feet. She noticed worsening of her balance while walking. Cramps are mostly on arms, hamstring and middle back.
Strange taste in mouth immediately, pain in injection arm, stinging pain in lower part of injection arm and in calf muscle, dizziness, tinnitus, abdominal pain, constipation, brain fog, memory loss, chest pain, forgetfulness, headache, earache in both inside and outside of both ears, ribs hurt, dryness in mouth, sore throat, nightmares, trouble sleeping, joint pain, muscle pain, fatigue
Fever, chills, sore muscles, severe stomach pains treated with antibiotics specifically designed for gall bladder.
This case was reported by a lawyer and described the occurrence of joint pain in a 28 year old female pt who received lyme disease vaccine recombinant (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received Lymerix. At an unk time after receiving Lymerix, the pt experienced joint pain, tingling, fatigue, headaches, and multiple neurologic complaints.  Time to onset, treatment, and outcome were not reported.
Pt recv vax on 2/17/99; on 2/18/99 pt exp pink splotches & raised area on right thigh vax site; tx=warm compresses
Systemic: Chills-Severe, Systemic: Fainting-Severe, Systemic: Other- High heart rate, 121 BPM, high anxiety, body shaking chills, passed out for about 30 seconds, was able to speak and breath normally
w/in 30mins of vax pt began high pitched screaming & unconsolable crying, then vomited a total of 3x 1hr p/inj turned pale w/blue lips & was extremely diff to arouse;if stimulated to aroused state began screaming & crying;unresponsive;t100
Patient  Per Patient Email:  "I see on the paperwork that we should contact you with any reactions   I did have some minor allergic reactions: ? My tongue swelled up ? My throat swelled up ? My throat felt / still feels sore ? The site of the injection is sore and swollen   After my 30 minute wait in the vaccination center, I sat with my husband outside by the ER, just to be on the safe side.  I have had severe anaphylaxis several times in my life, so I could recognize what was happening. Sometimes it starts with the tongue and throat swelling and gets worse / life-threatening later, other times it dissipates.    Today it gradually dissipated (the tongue and throat swelling), and now is almost back to the usual state. My throat and arm are both still sore, but the allergic reaction has calmed down.    I do have an epi-pen and I do have Benadryl (pill form). I plan to take the Benadryl soon, but thought I should perhaps email prior (it will likely put me to sleep)."
Temperature between 99.5 to 101, fever, chills, sweats, general malaise, tired for approximately 2 and half days
After 6 month vaccination - had seizure within 24 hours (afebrile). No other seizures since occurred.
Sick; COVID; COVID; Kidney number was high; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4252170-00.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 07Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1158135) at 40 mg (40 mg (citrate free)), subcutaneous for psoriatic arthropathy. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARBIDOPA + LEVODOPA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID"; RENAL FUNCTION TEST ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "Kidney number was high"; ILLNESS (non-serious), outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: Renal function test: (2022) High, notes: Kidney numbers [Renal function test], 2022, High; (unspecified date) Abnormal. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Events of Sick, and non-serious leakage when administers Humira shot, COVID, and Kidney number was high with Single Dose Pen, Adalimumab Solution for Injection. In Dec 2021, the patient had hip replacement. He got the COVID booster and got COVID after getting booster. Alternative Etiology for COVID with Adalimumab Solution for Injection: Event more likely related to SARS CoV-2 pandemic outbreak for tis elderly patient with psoriatic arthritis. Event more likely related to SARS CoV-2 pandemic outbreak for tis elderly patient with psoriatic arthritis. Change History: On 10 Oct 2022, Received updates for events. Pfizer COVID-19 vaccine was updated as suspect. Assessment results of event Hip replacement was updated as No reasonable possibility. Lab test was updated.  The reporter considered "covid" related to BNT162b2. The reporter's assessment of the causal relationship of "sick" and "kidney number was high" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the limited available data events drug ineffective and suspected covid-19 are possibly related to the suspect BNT162B2 and other events illness and renal function test abnormal are not related to suspect.
My left arm was and is still swollen and tender to touch. My left shoulder is also tender to touch. The area of my arm that was the most swollen was very warm. Today, it is not warm. I also became very tired and slept 10 hours. Today I am congested and shouldn?t be considering I am following my usual medication routine for my daily allergies.
HAD ALLERGIC TYPE REACTION TO VACCINE.  HAS ITCHING AND HIVES.
Information has been received from a physician, via a company representative, concerning a 16 year old female patient, who was vaccinated (date not specified) with the first dose of Gardasil, and following vaccination (time duration not specified), she fainted. The physician confirmed that the patient recovered within a period of 10 minutes. The physician reported that the patient later received both the second and third doses of Gardasil, and was fine after each dose. Additional information has been requested.
The patient was revaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) vaccine less than 5 years between doses; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1902USA008705), concerning to a 67-year-old female patient.  On 01-JAN-2015 and 16-SEP-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis respectively (Inappropriate schedule of vaccine administered).  This is one of two reports from the same patient.; Sender's Comments:  US-009507513-1902USA008705:
11/30/21 presents to ED for " fatigue and nausea". PMHx of "HTN, CKD, DVT"
Six minutes after receiving COVID 19 Vaccine patient reported to the vaccine administration area and reported dizziness and chest pain that was localized in the center of her chest described as a pinching sensation with inhaling and exhaling. Member reported to the vaccine administration area and stated that immediately after receiving her vaccines she began to feel slightly dizziness but approximately 6 minutes after her vaccine she began to have a localized chest discomfort located in the center of her chest described as a pinching sensation with inhaling and exhaling. At members arrival to the vaccine administration area she was instructed to lay down and an in initial set of vitals were obtained. As member continued to lay down. After 5 minutes vitals were reassessed, member then stated that she chest pain subsided and was non reproducible. Doctor of the dental clinic spoke with the patient cleared her to leave at 0950. Member was instructed that if this pain returns or she develops any additional side effects to report to the nearest ER