chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as receivd from a registered nurse refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were inadvertently administered with unknown number of doses of improperly stored VARIVAX (Merck) (dose strength, route unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
developed chest pressure, taken to ED via ambulance.  D-dimer and tropinin elevated.  CT PE Angio = 5.0 x 3.4 cm soft tissue lesion in the anterior mediastinum which could represent residual thymic tissue although size and convex margins appear greater than expected for age.  ECHO = There is mild left ventricular systolic dysfunction. There is mild global hypokinesis. The visually  estimated LVEF is 46-51%. The quantitative LVEF based on modified Simpson's method is 51%. CT consulted, sent for bx of mass, on repeat imaging with MRI had decreased in size so bx canceled.  Bx of L axillary node = benign.
Information has been received from a health professional concerning an adult female who on 25Oct05 was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). On 24Oct05 the pt experienced a fever, swelling and arm pain at the injection site. She was seen by the physician and was ordered acetaminophen (Tylenol). At the time of this report, the pt was recovering from swelling and arm pain at the injection site but her fever persisted. Additional information has been requested.
too painful; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician states a patient received the first dose of Shingrix in the deltoid, but it was too painful, so he was asking if the second dose could be given in his thigh. The physician declined to provide additional details on the call, stating she did not have the patient's permission to do so.  She consented to follow up from safety. The reporter consented to follow up.
First dose 20-Mar-2021/Second dose 11-Oct-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 20-Mar-2021/Second dose 11-Oct-2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2022, 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) (Solution for injection in pre-filled pen). On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 20-Mar-2021/Second dose 11-Oct-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 20-Mar-2021/Second dose 11-Oct-2021) outcome was unknown.    No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded. No treatment medications were reported.   This case was linked to MOD-2022-589696 (Patient Link).
Twitching in arches of feet that progressed throughout my  entire body and face. I also had an internal  tremor all over my body that made my voice shaken and teeth chatter.
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program. A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 26Mar2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced positive COVID-19 test with symptoms on 04Apr2021. The clinical course was reported as follows: The patient had her first vaccination 26Mar2021 and tested positive for COVID-19 on 04Apr2021, reported as 9 days after vaccination. It was reported that she was exposed to COVID-19 one to two days before vaccination. She had a low-grade fever of 99 Fahrenheit in Apr2021 for 1 day, along with feeling tired, and brain fog.  On 12Apr2021, she tested negative for COVID-19. The pharmacist was questioning if she can safely receive her second dose as scheduled or she should wait an additional week. The clinical outcome of positive COVID-19 test with symptoms was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Since the event Covid-19 occurred 9 days after the administration of first dose of vaccine BNT16B2, a temporal relation between the onset of event and administration of vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt recvd 2nd dose of vax 14AUG92 & w/in 20 minutes pt exp hives localized upper arm upper quad & hard raised nodules under skin or wrists @ pulse site;
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient has a large knot that developed and has swollen and is red/warm to the touch. Concerned because she is 48 hours post shot and still having symptoms.
A few hours after my second dose on 1/08/2021, I had some adverse reactions that worried me, including arm numbness, tingling around my mouth and cheeks, a splitting headache/blurry vision, joint and muscle pain and dizziness. I called e-medicine and had a video call with a E-Medicine provider who told me to keep monitoring my symtoms and go to the ER if they got worse (fortunately they didn't); however there are some lingering effects. Currently I still am experiencing headaches (around my ears and temple area) with joint pain/body aches and occasional tingling/burning sensations in my fingers and feet.
makes her arm feel like she has tendonitis; red lump was swollen; red lump that was lower than the injection site; red lump was itchy at times; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (makes her arm feel like she has tendonitis), SWELLING (red lump was swollen), VACCINATION SITE MASS (red lump that was lower than the injection site), PRURITUS (red lump was itchy at times) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced TENDONITIS (makes her arm feel like she has tendonitis), SWELLING (red lump was swollen), VACCINATION SITE MASS (red lump that was lower than the injection site), PRURITUS (red lump was itchy at times), PYREXIA (fever) and HEADACHE (headache). At the time of the report, TENDONITIS (makes her arm feel like she has tendonitis), SWELLING (red lump was swollen), VACCINATION SITE MASS (red lump that was lower than the injection site), PRURITUS (red lump was itchy at times), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-103322 (Patient Link).
Chest pain starting 11 days after 2nd dose. Chest pain still occurring and worsening.  Hurts to take deep breaths. Made worse by laying on my back. Shortness of breath
On 6-30-11, c/o left arm hurting. Mother reports upper left arm is "hard to the touch." No fever. No redness or swelling noted. Plans to give anti-inflammatory med today. Encouraged movement of arm, cool pack to area. If condition worsens, recommend to contact PMD.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284754, 2018SA284750 (same reporter). This case involves a three years old patient who received vaccine FLUZONE QUADRIVALENT lot U1997AA via intramuscular route in the left vastus lateralis on 03-Oct-2018 (expiry date 30-Jun-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Incorrect product storage. It was reported that patients were given vaccines that were outside of the recommended temp range (below 32F). It was unknown if patient experienced any adverse 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 Directive and Module VI of the 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.
Intense itching and hives all over both arms, both legs, and chest. This also happened with 2014's vaccine but at the time I atributed it to intense stress and possibly a detergent reaction. It took 8 months, numerous visits to the dermatologist and countless medications and creams to finally clear up.
I tested positive for COVID on 5/24/2022   with minor symptoms. My Doctor prescribed a round of Prolovid and symtpons went away.  Started testing negative after 5 days.
Head to toe rash all over body, baseball sized red and swollen at injection site, migraines and blurry vision, trouble sleeping
2.3 days after immunizations very fussy, inconsolable, decreased appetite. UOP good, BM good, no red streaks to legs and not hot to the touch. No rashes.
brain fog; shocking; i have terrible fatigue; shaking some; The initial case was missing the following minimum criteria: unspecified drug. Upon receipt of follow-up information on 02Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EJ1686 and expiration date was not reported),via an unspecified route of administration on 26Feb2021 (at the age of 58-years-old) at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EJ1686 and expiration date was not reported),via an unspecified route of administration on 05Feb2021 (at the age of 58-years-old) at dose 1, single for covid-19 immunization and had no reaction on exposure to vaccine. The patient experienced brain fog, shocking, had terrible fatigue and had some shaking on 28Feb2021. Further stated that side effects were horrible and missing work at times. The events resulted in emergency room visit. Patient was not hospitalized due to the events. No treatment was given for events. The outcome of the events was not recovered.
Extreme soreness in upper arm. By 9/28/16 could not lift arm. Loss of muscle control-strength. Pain and no use of arm too 10/6/16. Still sore, hard to raise arm and hurts.
Swollen lymph nodes in armpit under am that vaccine was taken in. soreness in arm and feeling ill for the next few days
mild arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix (the exact date of vaccine was unknown) and experienced mild arm soreness. It was unclear how soon after the vaccine the arm soreness began or when it dissipated. The reporter consented to follow- up. For tolerance of 2nd dose, refer case US2021AMR132546.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR132546:Same reporter
I feel dizzy and woozy, almost like I'm drunk.   S/S started 20 minutes after injection.  Also nausea w/o emesis, fatigue
Itching noticeably started on Mar 3. It was a very intense itch for about 4 to 5 days. Itch intensity was around the injection site  where a noticeable  red ring about the size of my fist surrounded the injection site. I also had an intense itch around my groin area.
expired dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided by reporter.  No treatment medication was provided by reporter.
Started in the morning with chills, body ache, fever.  By 2:00pm or so I became unable to communicate, and per my wife, appeared to be hallucinating.  Could not stand up.  Once helped to my feet, could not walk unassisted.  A friend came by to see how I was  and I have zero recollection of him being here.  My wife got me into bed, and a few hours later I "came back to consciousness" with a massive headache.  The following morning was "back to earth" so to speak, but for two more days felt achy, tired, lethargic.
Information has been received from a physician concerning a 3 year old patient who on 8/3/00 was vaccinated with a dose of varicella virus vaccine. On 1/7/02, the patient experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no treatment and no hospitalization. The patient recovered. No product quality complaint was involved. This is one patient out of 40 reported. Thirty nine other cases (WAES0409USA01861, 0409USA01863, through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Influenza injection administered at 09:20 on 10/01/2004 immediate reaction arm devloped redness at site and bump or knot developed measuring about 2.5cm.
gained weight; swollen feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (gained weight) and PERIPHERAL SWELLING (swollen feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not asked) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced WEIGHT INCREASED (gained weight) and PERIPHERAL SWELLING (swollen feet). At the time of the report, WEIGHT INCREASED (gained weight) and PERIPHERAL SWELLING (swollen feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Initial information was received from a physician and follow up from a licensed practical nurse concerning a 20 year old female who was vaccinated with the first (lot # 657621/0387U), the second (lot # 657736/0389U) and the third (lot # 658563/1063U, 0.5ml) dose of GARDASIL on 21-MAY-2007, 20-JUL-2007 and 23-NOV-2007 respectively. No other vaccinations were given at the time of the GARDASIL doses. Concomitant therapy included ORTHO TRI-CYCLEN for birth control and GEL DIFFERIN and minocycline for acne. When the patient came into the office on 22-APR-2009 for a "wellness exam", she told the physician that in November 2008 she saw the dermatologist for warts on her face. According to the patient, the dermatologist said the warts were caused by the GARDASIL and prescribed ALDARA. At the 22-APR-2009 visit, the physician saw no sign of facial warts, so told the patient to discontinue the ALDARA and follow-up with the dermatologist. Additional information has been requested.
Diffuse joint pain and swelling involving the knees, ankles and toes of both legs/feet that started two days following the vaccinations. Symptoms resolved slowly over a period of two weeks.
Severe Lupus flareup - flu-like symptoms including fever and body aches, open mouth ulcers in roof of mouth, severe joint and muscle pain especially in feet and hands, and fatigue.
Extreme fatigue hours after the vaccine. The next day the same with some vomiting and flu like symptoms
Severe nerve reaction cause all back muscles to spasm causing massive pain. I was in the ER 3 different times to deal with the amount of pain caused. This was the newest Covid booster shot I just received.
Itching started 1 week post first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching started 1 week post first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching started 1 week post first shot). At the time of the report, PRURITUS (Itching started 1 week post first shot) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
This is a spontaneous report from a contactable nurse. A 21-month-old female patient received PREVNAR 13 (Lot# R49358, Exp date Apr2018, NDC# 0005197102), via an unspecified route of administration, on 12Apr2017, at 0.5 ml single, for immunisation. The patient's medical history was not reported. Concomitant medications included PENTACEL and hepatitis b vaccine (unspecified trade name) both for immunisation. The patient experienced grabbing her foot or her hand and stopping what she was doing and screaming out loud on 13Apr2017 with outcome of not recovered, possible joint pain on an unspecified date with outcome of unknown.
Left side of upper lip swelled, noticed at 10pm. Still swollen next morning - did not take anything until 9 AM 10/8/13 took 4mg chlorpheniramine.
Adverse: tingling in upper left jaw. Severe pain in upper arm muscles. As day progressed-pain in left side  neck. which progressed next day to both sides. Extreme lower back pain which hindered getting up. Next day pain experienced all over back, arms, shoulder. Stomach ached with burning sensation.  Unable to eat solids. Called stomach doctor & made an appointment for 2-14-23.  Skin of entire body sensitive to touch. Electrical like pain radiated from area touched.  Headaches & pounding in head. Slept most of vaccination day and following day - moved slowly.  Symptoms continued but lessened after 7 days.  First time with this brand. All others were Pfiser. Last booster 2-2021  Not sure if booster related or caused  but ended up in emergency hospital 10 days later . Not entirely sure the cause (gastritis or gall bladder) but was treated for sepsis.  No more COVID shots.  My opinion no one should experience this kind of  side effects.   Do no more harm
she still feels sick until now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) 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: MALAISE (non-serious) with onset 2021, outcome "not recovered", described as "she still feels sick until now". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.