chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had sharp shooting pains intermittently in my joints; dose_number = 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 12:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ankle had been sprained" (unspecified if ongoing); "knee had had surgery" (unspecified if ongoing); "prior injuries/ One injury was recent" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: 19Mar2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: 09Apr2021, for Covid-19 Immunization, reaction(s): "With the booster shot generally my side effects were similar and slightly milder than the 2nd shot". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 12:30, outcome "unknown", described as "dose_number = 3"; ARTHRALGIA (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "I had sharp shooting pains intermittently in my joints". Therapeutic measures were not taken as a result of arthralgia.  Additional information: With the booster shot generally her side effects were similar and slightly milder than the 2nd shot. Except there was a new side effect. The patient had sharp shooting pains intermittently in her joints but only joints that had prior injuries (ankle had been sprained, knee had had surgery) but not the other joints. One injury was recent while the other was 7 years old. The patient had not received any vaccine within four weeks. The patient was not tested since vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a resident. Pharmacy went to their facility to do three off site COVID vaccine clinics that were spaced at least 21 days apart per our CDC contract. Patient received 3 doses total of Pfizer. They were vaccinated on 1/07/21, 1/28/21, and 2/22/21. The facility has been notified of this incident. At this time, no adverse affects have been reported.
SkinRash & Diarrhea Narrative:  Hives general systemic, head, palms,right eye lid, back, abdomen. Hives continued to pop up for the next four days.
Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA227374 (same reporter). This case involves a two months old female patient who received DTaP-IPV component, while he received a 0.25 mL dose of vaccine PENTACEL lot C5545AA in the left thigh on 15-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PREVNAR 13 for Immunisation. It was also a case of actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had 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 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. List of documents held by sender: none.
Pt. c/o swollen Lt arm, warm to touch and redness observed. Pt. noticed that her Lt arm was swollen last night. Pt. instructed to apply cool compress to Lt arm for 3 - 5 minutes.
I had my 2nd Pfizer vaccine , Lot:EL9264 at 10:30 on Feb. 13, 2021 at MC.  I was beginning to get slight pain in my back by late afternoon the same day.  By bedtime, it was much worse.  I woke up around 2:am to go to the bathroom.  I couldn't even stand up.  My husband was able to help me and get me back to bed.  I had excruciating pain with every step.  I couldn't bend, turn, etc.  I spend all of the next 2 days in bed.  Yesterday, on the 3rd day, I was able to sit in a chair for a short time.  Today I am better and can get along without assistance.
According to vaccinating nurse, a few minutes after vaccination patient experienced a short (less than one minute) generalized seizure.  She was able to lower him to the ground and patient did not hit his head or suffer fall.  Two EMTs were on site and attended to patient.  911 was called and patient evaluated by medics.  Blood sugar and vital signs within normal limits. Patient' s father also came to the scene.  Patient and father refused transport to the local hospital.  Father stated they will go directly to the local emergency room for evaluation.
Patient presented to the ED for dyspnea on exertion and COPD on 1/28/22. Patient presented to the ED and was subsequently hospitalized for chronic congestive heart failure. These visits are within 6 weeks of receiving covid vaccination.
pt recv vax 18MAY98 & 4-5hr later devel numbness on skin on back of rt hand below the wrist up to the knuckles;
Patient thought she was receiving the Bivalent booster but the non-bivalent Pfizer vaccine was selected by mistake.
No adverse events was noted. No treatment was provided. Client remained in the observation area for 15 minutes and left with parent. No signs of acute distress was observed or noted. The client left the observation area at 1257.
over 12 hrs later extreme chills tenderness in arm feel like someone socked pt in arm; c/o extreme h/a for 2 days not relieved by ASA or APAP;
Day 9  red itchy rash Day 10 and 11. Arm puffy from elbow to shoulder, terrible itch,   day 12. Queasy stomach Day 13 and 14.  Extreme fatigue  stayed in bed or couch.
Rash spots arms, legs, feet and itchy; Rash spots arms, legs, feet and itchy; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 21Mar2021 at 13:30 (at the age of 47-years old) as a single dose for COVID-19 immunisation. Medical history included lactose/ gluten intolerance and known allergy with penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. On 22Mar2021, the patient experienced rash spots on arms, legs, feet and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events rash spots on arms, legs, feet and itchy was not resolved at the time of this report.   No follow-up attempts are needed Information about lot number cannot be obtained.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving nasal FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on 12-JAN-2015. The patient administered with expired FLUMIST Quadrivalent administered. The outcome of the expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious by the reporter.
Patients leg swelled and became red, patient was inconsolable. We treated with Benadryl and dexamethasone. Watched pt until we were comfortable with him leaving which was about 1 hour.
This spontaneous report as received from nurse refers to a 23 year old patient of unknown gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK, lot # N020144, expiry date: 01-NOV-2019). On 17-JAN-2018 the patient was vaccinated with improperly stored VARIVAX (lot # N021719, expiry date: 10-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. The reporter stated that at the time of the temperature excursion, the power was off for two days and the school would have been closed from 22-DEC-2017 to 02-JAN-2018. The reporter shared that the school would have opened after the winter break on 04-JAN-2018. The reporter also stated that the vaccines at the time looked like ice had melted and then had refroze on top of the vaccines. The reporter stated 3 patients would have been vaccinated after that time. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA013481:
was originally given 10 weeks expiration  (10/14/22) as originally directed. after vaccination had been given we were given a new exp date of 9/30/22 and was recalled.
Headache started as intermittent sharp pain on left side and top of head. After 6 hours changes to intermittent vise like pain on both sides and top of head. On a scale of 1 - 10 the pain was 6 Currently taking Naproxen 500mg  twice a day and Butalbital-acetaminophen-caff 50-325-40 mg every 6 hours
Pt had been on an outing to the city with family, returned home, sat on couch, had a seizure, then respiratory arrest, pt turned blue, husband administered cpr, but she died.
Developed eye problem after receiving 2nd Shingles vaccine. Was treated by cornea specialist for several months with anti-viral, elevated eye pressure and anti steroid inflammation. Needed multiple eye appointments for weeks to treat symptoms.
Patient had itching horrible for three weeks; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient had itching horrible for three weeks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PRURITUS (Patient had itching horrible for three weeks). At the time of the report, PRURITUS (Patient had itching horrible for three weeks) had resolved. Not Provided      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 medications were reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: follow up received on 8-Nov-21 contain no additional information, outcome of event updated to recovered from previous version captured as unknown. narrative updated.
Narrative: Pt received the vaccine on 3-15-21 and states that on 3-20-21 woke up with a "jack hammer" headache that lasted for 3 days and then a mild headache for a couple of days after this. States that she had to lie down due to the h/a. Denied that she had visual changes, difficulty thinking or any other symptoms. Headache lasted for a week total and has since resolved and deines any other symptoms at this time. Nurse informed pt that she would relay report to Doctor and advised pt to seek ER treatment if h/a or any other symptoms returned. PT aware and voiced understanding.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL was given. Subsequently the patient did not have menstrual period 4 months after GARDASIL was given. The patient sought medical attention. Additional information has been requested. This is one of two reports received from the same source.
Severe abdominal cramps, HR down to 28, BP would not register for 3-5 minutes, then HR  increased to 40and BP  100/41, nausea and vomiting, temp of 102, extreme weakness for 2-3 days.  Cardiology f/u appt end of week was satisfactory.
Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose Number: 7, 5 ; Pfizer/BioNTech, Dose Number:6 ; Janssen, Dose Number: 4; A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 6 (booster), single (Lot number: GH9694) at the age of 65 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 12Jan2023 as dose 7 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 5 (booster), single (Lot number: 005M21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 15Dec2021 as dose 4 (booster), single (Lot number: 210021A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "one coronary artery partially blocked" (unspecified if ongoing), notes: other medical history old age. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "not recovered", described as "Moderna, Dose Number: 7, 5 ; Pfizer/BioNTech, Dose Number:6 ; Janssen, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Mar2023) Negative, notes: using both BinaxNOW and FlowFlex; (02Mar2023) Negative, notes: using both BinaxNOW and FlowFlex; (03Mar2023) Negative, notes: using both BinaxNOW and FlowFlex; (04Mar2023) Negative, notes: using both BinaxNOW and FlowFlex; (05Mar2023) both showed very weak positive, notes: using both BinaxNOW and FlowFlex; (06Mar2023) both showed stronger positive, notes: using both BinaxNOW and FlowFlex; (07Mar2023) both showed VERY positive (strongly colored bars), notes: using both BinaxNOW and FlowFlex. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 24Feb2023 to 28Feb2023.
approximately 20 hours after vaccine woke with generalized myalgia.  Throughout the day began to feel weaker and getting confused.  C/O legs weighing 500 pounds and leg weakness with difficulty walking.  Intermittent chills.
Site soreness for approximately 38 hours. Throbbing headache and fatigue for a 24 hour period.
Immediately after receiving the injection I had tingly pins and needle feeling running up my arm neck and face, leaving the under side of my eye numb, this continued off and on for a week.
Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of May received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Pt recvd 3 doses of Engerix-B -3rd dose AUG & SEP91; 1MAR92 was determined to be a non-responder;
p/vax pt devel a fever of 102 & maculopapular & erythematous rash all over from face to feet;
rash all over her body/ rash on face; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over her body/ rash on face) and VACCINATION SITE PAIN (soreness at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Antidepressant therapy, BUSPIRONE for Anxiety, BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced RASH (rash all over her body/ rash on face) and VACCINATION SITE PAIN (soreness at the injection site). The patient was treated with IBUPROFEN (oral) at an unspecified dose and frequency. At the time of the report, RASH (rash all over her body/ rash on face) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included Birth control implant was reported.
Work up with a headache and sore arm and fatigue. Took 2 Tyneol, which helped.  Later in  mid morning started getting the chills which lasted until 8:00 p.m. on the same day.  Am fine now.
Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022 at 2:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Feb-2022 at 2:55 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination  or at the time of the adverse event were reported as unknown.  Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown.  Vaccine went into 2-8 C thaw state on or about 24-Dec-2021. The patient took booster dose.  No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Flu-like symptoms -- chills, achy, tired, loss of appetite. Started 2nd day.  Back to 100% normal by start of 3rd day.
This spontaneous report as received from a healthcare worker refers to 6 unspecified patients of unknown demographics. On unknown dates, the patients were administered improperly stored doses of VARIVAX (Merck) (lot # L009203, expiry date: 17-MAR-2017). No adverse effects were reported. Outcome was unknown. This case is also related to 1509USA006820, 1509USA006365, 1509USA006822, 1509USA006823, 1509USA006824 and 1509USA006821 (same reporter link). Additional information has been requested.
spot over eye lid, above lip, looked like mosquito bite- 2 days post vax same spots but larger looking like welts very red all over body;pt felt bad evening post vax dx hives by MD, chest pain, fatigue, diff breathing;
I got my 1st Pfizer vaccine on 1/22/21 and my second on 2/12/21.  Beginning in April of 2021, I started experiencing recurring sinus infections one after another.  I was treated for the first one in May with antibiotics.  I got another one the beginning of June, and was treated with antibiotics, and since that time, I have not been off antibiotics for more than 2-3 weeks without a sinus infection returning and necessitating the use of antibiotics, and at times, prednisone.  I had also been taking Zyrtec and Flonase daily to try to combat any allergies that might be causing these repeat infections.  It wasn't enough.  I had allergy testing done, and I reacted to almost everything on the test, and now I am on allergy shots.  I took allergy shots from the age of 10 to the age of 18.  I am now 36, and up until 2 months after my COVID vaccines, I had not had any significant allergy or sinus problems since I was a teenager.  It seems to me that this could be some type of immune system response to the vaccine, and my allergist has said this is possible since I went so many years without having major allergy issues and now am having such problems.  I have spent a lot of money on all of the office visits for all of these sinus infections, the antibiotics, and now the allergy shots.
pt recv vax 11NOV97 & 12NOV97 pt devel an itchy, red, raised, gen rash;pt was seen in ER on 18NOV98 by MD on 19NOV98;
I have developed a very painful region in the left deltoid muscle and the right deltoid muscle is less severe.  It prevents me from lifting my arm(s) higher than the elbow, and significant weakness in the both arms, especially the left.  My kneecaps also have significant weakness and pains and makes standing difficult.  this developed the day after the shot.   I also have significant fatigue all the time since receiving the shots.  The second shot (Right arm) was given March 5th.
Delayed cutaneous hypersensitivity 8 days after receiving Moderna SARS-CoV-2 vaccine.  Lasted for 3 days with complete resolution.  Utilized ibuprofen and antihistamine.  See pictures below.
Numbness on her lips; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness on her lips) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History 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 HYPOAESTHESIA ORAL (Numbness on her lips) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA ORAL (Numbness on her lips) and HEADACHE (Headache) outcome was unknown.            Concomitant and treatment information were not provided.
Information has been received from a medical assistant referring to unknown number of patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. Since February 2016 the patients were administered improperly stored GARDASIL 9 (lot# L020015, expiration date 16-AUG-2017, dose and route not reported). Concomitant therapy was not reported. The vaccine was improperly stored in 27.1 degree Fahrenheit for 10 minutes. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.