chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin cancer; Psoriasis flare-up; Erythematous nodule; Post procedural complication; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (Skin cancer) in a 72-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In December 2021, the patient experienced SKIN MASS (Erythematous nodule) and POST PROCEDURAL COMPLICATION (Post procedural complication). On an unknown date, the patient experienced SKIN CANCER (Skin cancer) (seriousness criterion medically significant) and PSORIASIS (Psoriasis flare-up). At the time of the report, SKIN CANCER (Skin cancer) had not resolved, SKIN MASS (Erythematous nodule) and POST PROCEDURAL COMPLICATION (Post procedural complication) outcome was unknown and PSORIASIS (Psoriasis flare-up) was resolving.    mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications was reported.  In Aug-2021, the cancer was removed and as of Dec-2021 noticed it was still red spot and a lump on her nose, she thought there was cancer on the nose. She had a Plaque Psoriasis breakout due to coverage gap. No treatment medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 72-year-old female with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Skin cancer, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old female with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Skin cancer, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "extreme fatigue". Additional information: the patient experienced extreme fatigue 2 days after receiving the 2nd dose of the COVID-19 vaccine and it lasted less than 12 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
103 fever, lasted 30 hours. Controlled with Tylenol / ibuprofen. Shaking, felt awful, run down, exhausted.
No adverse event; a 2 month old child was vaccinated with Proquad; Information has been received from a medical assistant concerning a 2-month-old patient (gender not provided). The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided.  On 25-OCT-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA), lot # S005879, expiration date on 25-AUG-2010 (dosage, route and anatomical location were not provided) for prophylaxis (inappropriate age at vaccine administration).  No adverse event was reported.
PATIENT DESCRIBE REACTION AS PAINFUL. ASKED PATIENT IF THEY HAD ANY REDNESS OR WARMTH AT SITE OF INJECTION AND STATED NO, JUST PAIN.
Headache, Myalgia, Arthralgia, Fatigue, body aches, joint pain, chills and headache Narrative:
Began to run temp 3/12 in the afternoon with highest 104.2; mild dizziness, chills, headache, achiness after onset of temp. Soreness at injection site not severe, no other signs/symptoms.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 66 years old male patient was vaccinated with a dose (less than 0.5 ml) of FLUZONE HIGH DOSE (lot: UJ023A; expiry date: 25-Apr-2019) in the left deltoid on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case actual medication error due to vaccine under dose. It was also a case of syringe issue as there was leakage from the needle hub. It was not reported whether the patient experienced any adverse events after vaccination. 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 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. Documents held by sender: none.
pain all over her body; Her arm is sore; She hasn't been able to sleep; She was shaking last night; This is a spontaneous report from a contactable consumer (patient's child). A female patient of unspecified age received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 06Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got the vaccine (COVID 19 Vaccine by Pfizer) on 06Feb2021. And she had pain all over her body, her arm is sore, she hasn't been able to sleep, she was shaking at the night of 06Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Rheumatoid arthritis flare up; Fatigue; Fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jun2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till Dec2021 at (citrate free) (1 in 1 once) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Route of administration: intramuscular), administration date: May2021, for COVID-19 immunisation. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Feb2022, outcome "recovering", described as "Rheumatoid arthritis flare up"; FATIGUE (non-serious) with onset Jun2021, outcome "recovered" (2021), described as "Fatigue"; PYREXIA (non-serious) with onset Jun2021, outcome "recovered" (2021), described as "Fever". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of fatigue, rheumatoid arthritis flare up and fever with Humira (Adalimumab) was no reasonable possibility.  Causality for Pfizer BioNTech Covid-19 Vaccine: The reporter's causality for the event fatigue and fever was probable and for rheumatoid arthritis flare up was not reported.  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 information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Rheumatoid arthritis flare up, Fatigue and Pyrexia. 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
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The reporter stated that since 28-JUL-2014 an unspecified number of patients have been administered ROTATEQ dose, units, frequency, lot number were not reported that was improperly stored. This excursion was supported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient has come in with a red, inflamed knot on her right arm. She stated that it is hot to the touch and sensitive.
Around 2 pm I started feeling kind of loopy and had a hard time gathering my thoughts. Dream like. Then around 4 pm I started getting hot and felt like I was coming down with a cold. That continued on and off until I went to bed on the 04/22/21. I did take alka seltzer cold plus which helped a lot. Also my arm was VERY sore.
Cries a lot due to pain; This case was reported by a nurse via sales rep and described the occurrence of pain in a infant patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 3Y9KM, expiry date unknown) for prophylaxis.   Previously administered products included Fluzone (received on an unknown date ).   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, immediately after receiving FluLaval Tetra 2019-2020 season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that they have noticed that when an infant receives the Flulaval PFS vaccine the infant cries a lot due to pain. The healthcare professional office has received two lots of the Flulaval PFS vaccine for 2019 and 2020, lot 3Y9km and lot 24PP4. The reporter stated that if an infant is asleep and given the Fluzone vaccine manufactured by Sanofi, the infant would continue to sleep, but if an infant was asleep and was given the Flulaval PFS vaccine (GSK), the infant would wake up and cry and scream when the vaccine was being administered due to pain.  The patients demographics were not provided. The reporter consented to follow up.
The same day I got arm tenderness.  The 3rd day, I started having waves of nausea after the 3rd day and feel generally Ill. Feel sick off an on and some days are bad enough that they wake me up during the night.
Arm is killing him today like with the other 3 injections; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections) in an 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections). At the time of the report, VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-532671, MOD-2022-532678, MOD-2022-532374 (Patient Link).
4 year old recieved an expired Ipol expired by 9 days was given , no AE; Initial information received on 12-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4 years old female patient who was vaccinated with an expired 0.5 ml third dose of suspect IPV (VERO) lot number not reported via subcutaneous route in the right arm on 11-May-2020 as prophylactic vaccination during an injury visit and reported that ipol was expired by 9 days.  Medical history included- Injury, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) all for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  There were no side effects  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 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.  There will be no information on the batch number for this case.
Baby had been having apnea and has been in the NICU at our institution since birth. The baby had other reasons for apnea and had frequent episodes. These seemed to worsen around the time of the 60 day vaccines. We do not feel that these are necessarily correlated with the vaccine but wanted to report in case there are trends reported to add to the data. The covering physician saw the baby on 12/24 at 12pm and noted: "Resp: Currently in 250mL/min with no change in the frequent central apnea; Pulmonology consulted 12.20.21 for evaluation of central apnea;  Recommendation to continue caffeine; Continue 1/4 L via NC until repeat sleep study at CGA 40 weeks. Not recommending Phox2B testing at this time. Medications: caffeine 10 mg/kg/day; ABDs: Continues with multiple events daily. Now morning 12/24 with significant increase in apneic events, given 10/kg Caffeine bolus, increased to 1/2 L via NC and CBC and Blood culture to rule out infectious process. Will monitor closely, may need transfer to ICU for more aggressive respiratory management. Received d60 immunizations last night. PE unremarkable. Other VS stable. VBG 12/23 7.42/33 "
itchy rash at vaccination spot for 2 weeks sporadic muscle pain for 3 weeks at vaccination spot
18APR98 started swelling very hard w/heat in inj area-centered w/redness spreading in inside of arm;today site is hard & swollen w/redness radiating to inner part of arm, if worsens or inc to see MD;
12/26/22 I started sneezing, had a runny nose, itchy and runny eyes, and a cough. At first I thought it was allergies, but this seemed different from allergies. The next day, I had the same symptoms, the runny nose was worse. I went to a COVID testing site to take a COVID test.   Both the rapid and PCR tests were negative.  I figured it was a viral infection. My symptoms did not worsen, and I felt better within a few days. I figured it was just some type of virus.
Severe muscle pain and stiffness in the neck, upper back, shoulders, arms, and legs.  THIS HAS NOT ABATED AFTER TWO MONTHS.   It is significantly affecting daily activities:  walking is slow, painful, and unstable (leading to several near falls) ; painful head-turning prevents driving,  and normal activities are restricted.  Symptoms are worse in the morning but persist at some level all day.   Patient has had fibromyalgia for many years and knows that pain well; this is distinctly different and more sustained.
3 days p/vax devel fever of 103; would not sleep; would not eat; no vomiting; however pt had been camping & other kids also camping sick w/fever & vomiting; 7SEP95 few spots;
Extremely fatigued, headache, red patch over injection, chills, no appetite, vomited once. The chills started later that evening, approximately 12 hours after the shot, the remainder of the symptoms arrived the next morning and lasted approximately 24 hours.
Continuous itching; I have a rash to my neck and chest and both Arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Continuous itching) and RASH (I have a rash to my neck and chest and both Arms) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Continuous itching) and RASH (I have a rash to my neck and chest and both Arms). At the time of the report, PRURITUS (Continuous itching) and RASH (I have a rash to my neck and chest and both Arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
administration of FLUBLOK to a pediatric patient with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old female patient and there was administration of flublok (INFLUENZA QUADRIVALENT RECOMBINANT VACCINE) to a pediatric patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2022, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength: unknown) lot UJ909AA, expiration date: 30-Jun-2023 via intramuscular route in the left deltoid as Immunization.  On 22-OCT-2022 there was an administration of flublok to a pediatric patient with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (administration of FLUBLOK to a pediatric patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event     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.
blood pressure issues - had never had high blood pressure before; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure issues - had never had high blood pressure before) 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 HYPERTENSION (blood pressure issues - had never had high blood pressure before). At the time of the report, HYPERTENSION (blood pressure issues - had never had high blood pressure before) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Three hours after the injection of the 2nd dose, the right leg became swollen at a noticeable difference compared to the left leg.  Extreme swelling around the ankle and the knee.  Blood pressure at 136/83 and rate at 82 at 2pm.  Doctor called and advised to go to the ER.  Arrived at the ER and they reviewed vitals and discharged as they found a round red 1mm dot on the ankle and believed that a bug  bit me  shortly after the  injection was given.  It was possible a small gnat (no-see-ums) may have bit me as I did look down to scratch when I saw the swollen leg.
On 5/17/21 the Patient received the Moderna Covid Vaccine. She presented with a known allergy to PCN and Augmentin. This was not a reason for the patient not to get her vaccine today so Pharmacist proceeded to give her the shot. We asked for the patient to sit down and since she had some allergies we asked for her to wait for 30 min. Roughly ten minutes into her wait the patient started to complain of numbness of the face, so we went ahead and gave her a cold bottle of water. About two minutes later the patient began to complain of numbness in the arm along with hives on both arms and neck. At this point the patient looked very flush, disorientated, and acted as if she was going to pass out. I went and sat down with her and I could tell she was uncomfortable for which I got her some ice packs and started asking more questions about her reaction. I could tell the patient was very disorientated and she began to complain of swelling and tightness of the throat.  Once the patient began to complain of throat swelling/tightness. I had call code white and 911 due to the concern of anaphylaxis and pharmacy protocol.
Patient complained of dizziness, lightheadedness, substernal chest pain that was transient in nature.
Shoulder soreness. Left supraclavicular lymphadenopathy.  One swollen node was noted about one week after the first dose. The node was mobile and nontender. One day after the second dose was administered on 2/5/21, a second non-tender mobile node was found lateral to the first node in the left supraclavicular region. Supraclavicular nodes on the right were found to be palpable but not nearly as large.
Severe rash on chest, itching. Treated on 10/24/2011 with antibiotics and topical cream and antihistamines for itching.
Pt hx of DM Type I, HTN, reported pruritic uritcarial rash 5AM 12/21/2020 inner wrists, anterior distal LE bil. Resolved aprox 30 mins later. Urticaria recurred mid day 12/21/2020, pt treated with Benadryl 25mg PO, resolved. Urticaria returned evening of 12/21/2020 wrists, axilla, nape of neck. Pt treated with Benadryl 25mg PO, resolved. Urticaria returned 5AM AM 12/22/2020 similar distribution as evening of 12/21/2020. No air way or facial involvement. Pt treated with Benadryl 25mg PO, urticaria resolved. Sought medical eval 12/22/2020 around 10AM: no sx nor urticaria present. 1:30PM 12/22/2020 after eating lunch pt called to report recurrence of urticaria now involving face, lips tingling, itchy back. Administered 50mg Benadrly IM, observed, urticaria/pruritis resolved x 45 mins. Urticarial sx and lip tingling returned in 2 hours, pt transferred to ED for treatment with epinephrine, steriods, observation.