chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate cellulitis; right axillary lymphadenopathy; COVID booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 16:30 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (COVID 19 Pfizer , 31Mar2021 Given by pharmacy clinic, administration time=12:00 PM, dose number=2, vaccine location=Right arm.), administration date: 31Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (COVID 19, Pfizer, 08Mar2021 Given by CVS, administration time=12:00 PM, dose number=1, vaccine location=Right arm.), administration date: 08Mar2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: CELLULITIS (medically significant) with onset 17Dec2021 08:00, outcome "not recovered", described as "Moderate cellulitis"; IMMUNISATION (non-serious) with onset 15Dec2021 16:30, outcome "unknown", described as "COVID booster"; LYMPHADENOPATHY (non-serious) with onset 17Dec2021 08:00, outcome "not recovered", described as "right axillary lymphadenopathy". The events "moderate cellulitis" and "right axillary lymphadenopathy" were evaluated at the physician office visit. Therapeutic measures were taken as a result of cellulitis, lymphadenopathy.  Other vaccine in four-weeks was No. Adverse event: Moderate cellulitis and right axillary lymphadenopathy on same side as COVID booster given. Covid prior vaccination was No. Covid tested post vaccination was No. No Known allergies. No other medical history. The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events immunization and cellulitis and BNT162B2.  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.
Patient stood up quickly and slowly slumped down wall -- passed out for a brief period (seconds) and came to.  Very pale and pupils dilated -- mom reported patient hadn't had breakfast.  Patient was given an orange juice and stayed in seated position.  Pupils returned to normal in seconds, color returned to normal in about 10 minutes. Patient reported feeling fine when family departed 30 minutes later.
I felt pain going down my arm and into my neck. The joints in my left arm got really tight. I woke up in the middle of the night and my left arm was numb. In about 2 weeks I started to get numb in both arms. After a few more weeks I woke up with numbness in my legs. I felt drained and I decided to go see my doctor, as I was driving to the doctor my feet went numb. After test were ran everything came back normal. My psorasis started to get worse.
Immediate break out in wheals, large throughout body, hives, severe pruritus (observed) emesis x 1. Ambulance called child taken to ER.
Rash and pain. Not horribly significant, but I figured this information might be helpful to someone tracking the affects of the vaccine. I feel fine otherwise, and don't feel it is a problem at this time.
I got on my right upper hand it was very painful; I got on my right upper hand, I got swelling and on the wrist; I got on my right upper hand, I got swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 88 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 88 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "I got on my right upper hand it was very painful"; JOINT SWELLING (non-serious), outcome "unknown", described as "I got on my right upper hand, I got swelling and on the wrist"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "I got on my right upper hand, I got swelling".  Additional information: "Consumer stated that 2 days later, she got on her right upper hand, she got swelling and on the wrist and it was very painful and she was calling to find out what can be done if anything (incomplete sentence)." When paraphrased the above concern, consumer stated that on the right palm of her right hand. Consumer stated that because, when she used the right hand, it was painful. Consumer stated that she wanted to talk to report this because it was still painful. Definitely because it was painful and she was probably going to the emergency room because it was not where the site, where the injection site was. It was not the area where she got the injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10AM here for Flu and last HPV - symptoms 2-6 hours later nauseated - vomited x 2; hot all day; no chills stomach ache; headache - shortly after injections; overall feeling of itchiness no hives no BENADRYL; MOTRIN and rest. 24 hours later feeling better. 10-19-12 48 hours resolved except redness/slight edema at flu vaccine site Rt. arm.
I have been experiencing ongoing side effects since I got the 2nd dose of the vaccine. I am having fever-like symptoms including fatigue, dizziness, a lot of tension/pressure in my head, difficulty breathing and abnormal heart rate, etc, every single day since I got the vaccine. These symptoms have persisted for nearly TWO months now, and are not going away. These side effects have a big impact on my daily life, make it difficult for me to perform daily activities.
This spontaneous report was received from a nurse refers to a 13 year old female patient (daughter of the reporter). The patient's pertinent medical history included overweight, the nurse stated that her daughter has always been overweight so the patient did not develop it after M-M-R II. There was no drug reaction or allergies reported. On an unknown date approximately in 1994 (also reported as, when the patient was 13 years old), the patient was vaccinated with M-M-R II (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant therapy was reported. On an unknown date approximately in 1994 the patient developed seizures (medically significant). On an unknown the patient underwent an Electroencephalogram (EEG) and unspecified lab test the results of which was unknown. It was reported that the patient sought medical attention. The patient was seen by an unspecified physician and she was placed on therapy with DEPAKOTE due to her seizures. The nurse stated that the DEPAKOTE controlled seizures until the patient went away to college and then the seizures went out of control. The nurse reported that the patient discontinued use of the DEPAKOTE and on an unknown date, she was placed on unspecified seizure medications but it did not help. On an unknown date in 2007, the patient was seen by an unspecified physician and was placed on therapy with DEPAKOTE and LAMICTAL. The nurse reported that the patient has not had any seizures since 2007. The action taken with the therapy with M-M-R II was unknown. The outcome of the event was reported as recovered. The relatedness of the event to the therapy with M-M-R II was unknown. There was no product quality issue reported. Upon internal review the event seizures was considered as medically significant. This is one of the several reports received from the same reporter. Additional information has been requested.
This is a spontaneous case initially received from other health professional (nurse) on 30-Oct-2018, concerning a 49-year-old, adult, female patient. The patient's concomitant medications were unknown. On 10-Oct-2018, the patient (who was under age of 65 years) was administered FLUAD (TIV) [dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250788, expiry date: not reported]. On the same day, after vaccination, the patient experienced headache at the night and felt pain and stiffness in her hand on the same arm. The patient also felt that, her heart was racing. The patient's treatment measures included ice pack on her arm. At the time of this report, the patient had notrecovered from the events pain in arm and heart racing and the outcome of the events headache and stiffness is not reported. The reporter assessed this case as non-serious.
Immunodeficiency; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunodeficiency) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunodeficiency) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Immunodeficiency) outcome was unknown.            No concomitant medication information was reported. The patient was concerned about Humira lowered immunity. No treatment information was reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EW6205), in right arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in right arm, on 23Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 22Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "low thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; DULOXETINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". Clinical course: anti viral details; product: COVID 19 Treatment, brand: Paxlovid; treatment start date: 16Jul2022, treatment stop date: 21Jul2022, indication: Treatment of COVID-19. Adverse event: After 5days on Paxlovid, I tested negative and felt better. 5 days later, I had symptoms again, retested and was positive. After 5 more days of isolation I still have symptoms. patient known allergies was No. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (21Jul2022) Negative, notes: After 5 days on Paxlovid, she tested negative; (26Jul2022) Positive, notes: 5 days later, she had symptoms again, retested and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Patient tested positive for Covid; Patient tested positive for Covid; The patient died; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on Feb2021 (Batch/Lot Number: En6303) as single dose, and dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: Ep7534) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient tested positive for COVID on 08Apr2021 which resulted in Emergency room/department or urgent care, and hospitalization for 3 days. Treatment included high flow oxygen, doxycycline, inhalers, and Rocephin. The patient underwent lab tests and procedures which included Nasal Swab: positive on 08Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: The patient died
4 days after vaccine, noticed swelling to lymph node on right clavicle. It is painful to touch.; 4 days after vaccine, noticed swelling to lymph node on right clavicle. It is painful to touch.; Pain radiates up the right side of neck towards the back of right ear; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 16Apr2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was 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 20Apr2021 at 16:00, 4 days after vaccine, the patient experienced swelling to lymph node on right clavicle, it was painful to touch and pain radiated up the right side of neck towards the back of right ear. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 swelling to lymph node on right clavicle, it was painful to touch and pain radiated up the right side of neck towards the back of right ear was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Upon receipt of vaccine at/around 1740 arm began to feel warm/tingly. After a few minutes I began to get dizzy, arm pain worsened and entire arm and face began to feel numb and tingle. The arm pain and soreness has decreased since the event. The dizziness is sporadic since the event. The left side of my face has continued to worsen since the injection, and is numb, loss of taste, feel, sensation, and dexterity.
Patient came for booster shot. Pfizer administered but noted on documentation of prior vaccine that a Pfizer vaccine was documented but with a Moderna lot number. Patient after vaccination obtained card that noted Moderna had been given for first vaccine.
Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 15-Mar-2022; Patient was administered Moderna COVID-19 dose after the 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 dose after the 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 15-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 dose after the 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 15-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 dose after the 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 15-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that, the vial was initially stored in the refrigerator on 08-Feb-2022 and vial did not undergo any temperature excursions.  No treatment information was provided.
Leg, ankle and feet cramps; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 26Feb2021 (Lot number: EN6200) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Time: 05:15 PM, Lot number: EL3246, Anatomical Location: Arm Right), administration date: 05Feb2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 26Feb2021 18:45, outcome "recovering", described as "Leg, ankle and feet cramps". Therapeutic measures were not taken as a result of muscle spasms.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
HEADACHE; FEVER; NAUSEA; TONGUE TINGLING; SKIN SENSITIVITY; BODY ACHES; This spontaneous report received from a consumer concerned a 26 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced tongue tingling. On MAR-2021, the subject experienced skin sensitivity. On MAR-2021, the subject experienced body aches. Laboratory data included: Body temperature (NR: not provided) 99.6. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, nausea, tongue tingling, skin sensitivity and body aches was not reported. This report was non-serious.
10/23/07 - Swelling to (L) arm with patchy rash-like symptoms from upper arm (deltoid) to forearm. Redness noted. Onset - redness and swelling with pain at site (deltoid) of injection. Tx: warm compresses to area q 2 hours.
No adverse event.  CDC advised to give everyone Moderna Bivalent vaccine and didn't release guidance regarding vial or dose to give, until after the vaccine was given.
administered an expired dose of fluzone quadrivalent single dose vials with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered an expired dose of Influenza Quadrival A-B Vaccine [FLUZONE QIV].and experienced no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2022, the patient received a dose of 0.5 mL once of suspect influenza quadrival A-B vaccine with (lot 33D9L, expiry date: 30 Jun 2022) (strength and formulation: unknown) via intramuscular route in unknown administration site for prophylaxis.  On 04-Oct-2022, (latency: same day) the patient was administered an expired dose of influenza quadrival A-B vaccine single dose vials with no reported adverse event (expired product administered).   No lab data was reported.  Action taken : Not Applicable.  Outcome : Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received flu shot 10/28/03 left arm. 11/17/03 noticed soreness of arm muscle and redness with pea-size sore at injection site. No drainage at site. Tx: apply polysporin to site, cover with bandaid and keep clean. Use current Rx of Vioxx for muscle soreness.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and a healthcare worker concerning an approximately 65 year old female patient with asthma, hypertensive cardiac disease, coronary artery disease, diabetes, Penicillin allergy, Sulfa allergy and ZESTRIL allergy. On 18-DEC-2012, the patient first received JANUVIA. On an unknown date in January 2013, the patient started therapy with JANUVIA, 100 milligrams (1 tablet, orally, once daily). Other suspect therapy included 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified) administered subcutaneously on 29-MAY-2013. Concomitant therapies included COREG, naproxen (reported as NAPROXYN), aspirin, clonidine, famotidine, amlodipine besylate, EXFORGE, BYSTOLIC, NOVOLOG, LIPITOR and nasal aerosol (unspecified). On 12-JUL-2013, the patient was discovered to be deceased. The cause of death was determined to be sudden death related to diabetes, coronary artery disease, and hypertensive cardiovascular disease. It was unknown if autopsy was performed. The patient was hospitalized on 04-JUL-2013 due to symptoms of her heart disease. Her discharge date from the hospital was unable to be determined. The relatedness for the event was unknown for JANUVIA and ZOSTAVAX. Additional information has been requested.