chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Nurse Practitioner via a company representative refers to a patient of unknown age and gender. On 07-AUG-2013, the patient was vaccinated with dose 1 of GARDASIL (lot#, expiry not reported). On 21-AUG-2013, the patient was vaccinated with dose 2 of GARDASIL (lot#, expiry not reported). The nurse reported that the patient received doses of GARDASIL too close together. No adverse effect reported. Additional information has been requested.
A 16 year-old male exposed to a rabid kitten developed hives while being treated with RabAvert. This individual developed hives on his abdomen and upper legs after receiving the 2nd dose of series. The evaluating physician discontinued the series. There was no known history of allergies.   The patient was treated with Prednisone 30 mg, two hours prior to vaccination and 12 hours after vaccination. The patient was also given Benadryl, dose unknown. The event resolved.   The physician assessed the event to be related to treatment drug.
He was hit hard & the last several days he has been flat on his back & can barely move; started feeling off/wasn't myself; had no appetite; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling off/wasn't myself), DECREASED APPETITE (had no appetite) and MOBILITY DECREASED (He was hit hard & the last several days he has been flat on his back & can barely move) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 037C21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Raynaud's disease and Lyme disease (Chronic). Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced FEELING ABNORMAL (started feeling off/wasn't myself) and DECREASED APPETITE (had no appetite). On 26-Dec-2021, the patient experienced MOBILITY DECREASED (He was hit hard & the last several days he has been flat on his back & can barely move). At the time of the report, FEELING ABNORMAL (started feeling off/wasn't myself), DECREASED APPETITE (had no appetite) and MOBILITY DECREASED (He was hit hard & the last several days he has been flat on his back & can barely move) had not resolved.            No Treatment information was provided.  On 26Dec2021 he was hit hard & the last several days he has been flat on his back & can barely move. He has periodic flare ups from the Chronic Lyme & Psoriatic Arthritis that usually last 48 to 72 hours, but this has been going on the last several days. He made an appointment with his doctor, then canceled it after reading online there is nothing that can be done for him. He also called a local ER that told him that he could come in but there is nothing that they could do for him. He feels it is just a waiting game now.
DIFFICULTY IN WALKING; INCREASING PAIN ON LEFT FOOT; This spontaneous report received from a parent concerned a 30 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced difficulty in walking. On 16-APR-2021, the subject experienced increasing pain on left foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increasing pain on left foot, and the outcome of difficulty in walking was not reported. This report was non-serious.
Sore, red, and swollen arm at vaccine site (Saturday night). Arm symptoms increased the following day (Sunday). Monday - red rash on face which went away on Wednesday after taking antihistamines for 3 days.
Information has been received concerning a female who post vaccination experienced a severe local reaction that started within 24 hours and lasted 3 days. The entire arm was very swollen, red, hot, tight and severely painful. It was reported that the pt's experience resolved on 11/27/00.
Patient states his left arm hurt for 3 months after receiving the first dose of Shingrix. Refused to receive second dose. He did not seek care during that timeframe and did not have pain when seen for routine appointment in September 2019.
Large lump, swelling, tenderness, and shooting nerve pain to the hand during some movement. Took Ibuprofen and monitor for worsening condition.
Fatigue, shivering, vomiting, soreness near injection site, all over body aches,  welt/lump apex 3? down and 2? to right of injection site, about the size of a large marble
I had a shot while in good health Wed afternoon at 4pm.  I had a sore arm that night.  I awakened to void at 6 am Thursday morning.--and felt perfectly normal in and out and in again,  of bed.   There was the sudden onset about 655 AM  (while still in bed) of rapidly progressive right leg numbness and weakness.  It started in upper buttock/thigh and quickly went all the way down to the toes within mere minutes.  There wasn't much for pain, just a leg that instantly stopped working. I tried to get out of bed, and fell,  later fainted in the kitchen.  I was transported to the ER, where stroke protocol ruled out stroke.  Guillen Barre was felt unlikely.   Labs, brain MR were fine.  After a back MRI, the ER doctor suggested a tiny S1 disc herniation contacting the left S1 nerve was the cause of this complete loss of leg function across the L4-S1 nerve roots.?.   While I can accept this is possible, pain really hasn't been an issue. I can put on my right sock, no problem which hasn't been the case with past sciatica spells   I just want to document this event as it seems so weird, and I am seeing a neurologist as the sciatica diagnosis seems "shaky."    I am a physician and fully accept this may not relate to the flu shot, but the timing and course is so bizarre. As of today(Friday), I am now using a cane to assist walking.
Extreme pain in right arm.  High inflammatory markers:  CRP value 149.3.  Altered mental state.
sick after receiving the second dose; fever; rashes on the back; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick after receiving the second dose), PYREXIA (fever), RASH (rashes on the back) and OROPHARYNGEAL PAIN (sore throat) in a male 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 ILLNESS (sick after receiving the second dose), PYREXIA (fever), RASH (rashes on the back) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, ILLNESS (sick after receiving the second dose), PYREXIA (fever), RASH (rashes on the back) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-060408 (E2B Linked Report). This case was linked to MOD-2021-060408 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060408:Dose 1
SWOLLEN, HARDENED, REDDENED. ITCHY.  ALL SYMPTOMS STARTED THE NEXT DAY.
feeling like I was 500 lbs; I felt like an impending sense of doom; swollen lymph nodes in my neck; stiff neck; severe shivering; I needed assistance to walk safely to avoid falling; Intense pain in my left arm; dryness in my throat/severely dry throat; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration in right arm on 23Dec2020 17:15 at single dose for COVID-19 immunization. Medical history included acid reflux from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first Pfizer vaccine on 23Dec2020 at approximately 5:15 PM. The patient felt fine until about 11 PM at night, the patient stated, "when I began experiencing intense pain in my left arm and dryness in my throat" on 23Dec2020. I took a Benadryl and went to bed. At approximately 1 AM (24Dec2020) I woke up feeling like I was 500 lbs (I am about 175 lbs). I also had swollen lymph nodes in my neck, a stiff neck, a severely dry throat, and severe shivering. I attempted to navigate to the bathroom and felt like I needed assistance to walk safely to avoid falling. I felt like an impending sense of doom, and called my mom who is a nurse. She told me to contact the Pfizer #, but nobody was answering the phone at that time. I then started looking up on the internet if anyone else had experience what I was feeling after the vaccine and if the feeling passed, as I was not sure if I should go to the ER. I ended up falling asleep." The outcome of the events was recovering. The patient took Benadryl for events "intense pain in my left arm and dryness in my throat" as treatment. No treatment was given to the patient from the remaining events.  Information on the lot/batch number has been requested.
Approximately 6 days after received first dose of Moderna vaccine woke in morning with itching, redness, swelling and soreness at injection site.
nurse inadvertantly gave an expired dose of Menactra; Initial information received on 23-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old male patient who inadvertently received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  On 23-Aug-2019, the patient received a single 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5841AA (expiry: 08-MAR-2019) via intramuscular route in the right deltoid.  It was a case of actual medication error case due to expired vaccine used.    It was unknown whether any adverse event was experienced by patient or not.  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.  List of documents held by sender: none.
Was was inadvertently given a dose of Shingrix during a presumed acute outbreak of Zoster lesions. Pt seems to have not been adversely affected.
This spontaneous case was reported by a nurse and describes the occurrence of INFLAMMATION (inflammation in her body) and COVID-19 (still got covid twice) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation in her body) and COVID-19 (still got covid twice). At the time of the report, INFLAMMATION (inflammation in her body) and COVID-19 (still got covid twice) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Company comment.  This spontaneous case concerns a patient, with no reported relevant medical history, who experienced the unexpected AESI event of COVID - 19. The date of onset of the event was not reported neither vaccination date. No information about vaccination schedule was provided. At the time of the report the outcome of the event was unknown. No medical assessment or treatment has been informed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient, with no reported relevant medical history, who experienced the unexpected AESI event of COVID - 19. The date of onset of the event was not reported neither vaccination date. No information about vaccination schedule was provided. At the time of the report the outcome of the event was unknown. No medical assessment or treatment has been informed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 01-JAN-2013 the patient was vaccinated with ZOSTAVAX, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her excruciating nerve pain and symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  Additional information has been requested.
cannot determine if he patient took the bivalent or monovalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (cannot determine if he patient took the bivalent or monovalent) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71448) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (cannot determine if he patient took the bivalent or monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (cannot determine if he patient took the bivalent or monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (cannot determine if he patient took the bivalent or monovalent).    No concomitant medications was reported.  Dosage text of suspect Spikevax Bivalent was reported as Initial Booster. Patient was trying to get booster but the HCP cannot determine if patient took the bivalent or monovalent at the time of the patients last vaccination. The HCP was not sure if the 'S is the letter 's' or the number 5. No symptoms or signs but notated AE for confusion of which vaccine the patient received.  No treatment medications was reported.   Reporter did not allow further contact
Began menstruation on September 7th (AM) after having already had a full menstrual period as expected that went from August 29th through September 3rd.  The first period from 8/29 - 9/3 was expected and typical.  There was no menstruation between 9/4 and 9/6.  The second period went from 9/7 through 9/13.
Chest pain.  The patient reports that he first developed Covid symptoms on October 1.  He tested positive on the third.  Was hospitalized here with Covid pneumonia as well as pneumococcal pneumonia.  Here for 5 days, and went home.  States since he got home, he has had worsening right-sided chest pain, and feels like his ribs are broken.  Cannot take a deep breath without sharp shooting pain.  Feels short of breath with exertion, may be a little worse than when he was here before.  Had a temp today 100.1.
Patient was diagnosed with covid after being fully vaccinated. Currently has symptoms of runny nose and loss of taste.FYI_ item number 22 should have been left blank.
tia in right eye, on Friday morning on 4/16/ 21, between the hours of 8 am and 9:30 am, I went from feeling fine and sleeping to waking up not being able to hear in both ears, not being able to see anything out of my right eye, my left arm was completely number all the way up to my shoulder and neck, the right side of my tongue was numb and my blood sugar was  over 611. Initially they thought it was just a reaction to my high sugar levels, since the mri's showed I did not have evidence of a stroke. It wasn't until I saw a retina specialist the following Tuesday that she confirmed that yes I did have a stroke in my eye. I have not recovered my vision fully in my eye or the sensation in my tongue. I didn't connect it to the vaccination until I spoke with a friend whose sister also got pfizer 5 days before me and suffered a stroke 3 days before me, and two days after we spoke they announced Johnson& Johnson pause due to clots in women. The retina specialist says we will have to wait and see if the damage heals on it's own in the meantime I need to see her on a monthly basis.
With certain movements like moving arm towards the back and to side, there's a burning sensation and pain on the left upper arm. This started 2 days ago from today (11/6/16).
Muscle spasms, fever 100.6/HA. Benadryl/50mg po q 5h; Valium 5mg 2 po bid since 06/22/02. Steroid inj by PCP on 06/24/02.
After  a few  days following the vaccination, the  left shoulder pain at the injection site subsided. However,  I have on going lower arm pain between my elbow and wrist  especially when I am engaging my left arm in some kind of activity.  For example: Picking up or carrying something of any kind of weight;  twisting or lifting my left arm.
Bilateral pulmonary embolism; DVT; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Bilateral pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (DVT) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) outcome was unknown.            The HCP got the vaccine several weeks after quarantine after that. After her second dose, she had a clotting issue which she had never had before. She experienced bilateral pulmonary embolism and DVT and was in the ICU twice.   Action taken with the mRNA 1273 in response to the events was not applicable as the patient completed both the doses.  Reporter did not provide the causality.  Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient states that she noticed on 5/19/23 that there was a quarter size ring around injection site of redness. She states the arm is swollen and has slight pain/sensitivity to touch. She states she did not notice this until this morning. I contacted her normal primary care physician and left a message with them as well as advising patient to contact them to see they wanted her to have a visit with them.
had the vaccination and still got the shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccination and still got the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient returned to dose number 2 of series 1 week earlier than 21st day. Patient received dose. No reaction noted.