chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
Neck hurt when turning; Feels like it's burning inside her body, like it is on fire; More stabbing in her body from time to time; the bones on top of feet hurt when moving; Moving arms back hurts; Not moving around like she did before the vaccine, moves like an old woman; Lots of muscle ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck hurt when turning), BURNING SENSATION (Feels like it's burning inside her body, like it is on fire), PAIN (More stabbing in her body from time to time), BONE PAIN (the bones on top of feet hurt when moving) and PAIN IN EXTREMITY (Moving arms back hurts) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck hurt when turning), BURNING SENSATION (Feels like it's burning inside her body, like it is on fire), PAIN (More stabbing in her body from time to time), BONE PAIN (the bones on top of feet hurt when moving), PAIN IN EXTREMITY (Moving arms back hurts), MOVEMENT DISORDER (Not moving around like she did before the vaccine, moves like an old woman), MYALGIA (Lots of muscle ache) and FATIGUE (Fatigue). At the time of the report, NECK PAIN (Neck hurt when turning), BURNING SENSATION (Feels like it's burning inside her body, like it is on fire), PAIN (More stabbing in her body from time to time), BONE PAIN (the bones on top of feet hurt when moving), PAIN IN EXTREMITY (Moving arms back hurts), MOVEMENT DISORDER (Not moving around like she did before the vaccine, moves like an old woman), MYALGIA (Lots of muscle ache) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Pt relative called <<on 10/15/10 Pt requested FLUVIRIN in both arms>> on 11/4/10 told member of management that pt had adverse reaction to 2 vaccination; on 11/5/10 he called back told another member of management same.
Tested positive for COVID-19 after receiving first dose of Moderna Vaccine; 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 COVID-19 (Tested positive for COVID-19 after receiving first dose of Moderna Vaccine) 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 COVID-19 (Tested positive for COVID-19 after receiving first dose of Moderna Vaccine). At the time of the report, COVID-19 (Tested positive for COVID-19 after receiving first dose of Moderna Vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) Negative.     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 was reported. Treatment medications was not provided.
1020 pt vomited in observation area BP 132/86 O2 Sat 97% HR 87
One week post vaccination, pt developed shortness of breath and a cough.  Pt was hospitalized with pneumonia.  Pt was in ICU for 1 week and tx with antibiotics. Pt was discharged on steroids and subsequently recovered. Patient in her late 60's who on 25-OCT-1999 was vaccinated with one dose of PNEUMOVAX. Concomitant therapy included one dose of FLUSHIELD administered IM. She was intubated for one week.
pt recv vax & devel spots resembling chickenpox;4/3/98 chickenpox confirmed by father;
Information has been received from a nurse concerning an approximately 17 year old female with asthma and a history of migraines and "bad headaches" who on 26-MAR-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot # 655205/1426F). Concomitant therapy included loratadine (unspecified), FLOVENT and albuterol (unspecified). On 26-MAR-2007 the patient went to the mall after receiving her first vaccination. She came home and felt very tired and went to bed that evening. When she woke up on 27-MAR-2007, she told her mother that she couldn't remember anything that happened yesterday after the mall. The patient's mother called the office to report that the patient's friends reported that the patient was "not acting right" for approximately one week after the vaccination with Gardasil. The patient sought unspecified medical attention by calling the office. On 27-MAR-2007, the patient recovered from the tiredness and lack of memory. On approximately 02-APR-2007, the patient recovered from "not acting right". Additional information has been requested.
RSV/pneumonia 5 months later  Sore arm for 1-2 days initially
Myalgia, Arthralgia, Fever, SORENESS AT INJECTION SITE Narrative:
Information has been received from a staff member of a physician's office, via a company representative, concerning a 15 year old female patient, who on 26-APR-2008 was vaccinated IM, with the second dose, 0.5 ml, of GARDASIL (lot # 659182/1757U). On 28-APR-2008 the patient developed an itchy rash on her arms and legs. The patient called the physician on the phone, but an office visit was not reported (treatment not specified). Additional information has been requested. 02/18/2010 Follow-up information was received from the physician's office. The patient had no illness or time of vaccination. On 30-APR-2008 the patient developed scattered erythema papules from mid-thigh to the ankle on both legs. The greater amount was on the left ankle. At the time of reporting the patient recovered from the scattered erythema papules. Additional information is not expected.
Pt had pneumonia (subq) & flu shot (IM) administered on right hand. 2-3 day experiencing pain radiating from top to elbow of arm. Area became red especially at site of adm (5 cent coin size) pt used TYLENOL for pain relief & pt had chills all through. Pt has had both shots previously with no ADR.
Tenderness at the SQ appearing anterior to the injections site; localized erythema near the vaccination site; This spontaneous case was reported by a physician and describes the occurrence of TENDERNESS (Tenderness at the SQ appearing anterior to the injections site) and ERYTHEMA (localized erythema near the vaccination site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness at the SQ appearing anterior to the injections site) and ERYTHEMA (localized erythema near the vaccination site). At the time of the report, TENDERNESS (Tenderness at the SQ appearing anterior to the injections site) and ERYTHEMA (localized erythema near the vaccination site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Patient noticed a localized erythema at the subcutaneous layer near the vaccination site (not exactly over it). It seems like the vaccine went there since the one who administered it pinched to arm.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow up received on 22 Nov 2021 contains significant information .Event added: Tiredness.
Patient came to the pharmacy requesting her Pfizer covid vaccine booster. Patient was given Pfizer covid vaccine first booster. Post imz monitoring, patient complained of tingling and weakness in the left arm/hand only where imz was given. She described it as her arm going to sleep. Patient was monitored an additional 20 minutes, patient stated that she is feeling better, but still has some weakness in her left arm. Patient was advised to take some Advil and monitor symptoms at home. She was informed if symptoms did not improve to contact provider, or if they worsened to go to the ER.
Patient had flu shot at 11:38. After receiving shot, she and her boyfriend got up to stand in line for receipt and gift card. She had an episode of syncope and passed out at 11:40 while her boyfriend caught her. She was out for a very brief moment (few seconds, then came back to). Laid patient down to increase bloodflow and her blood pressure was 102/72 with pulse of 92 at 11:41; Patient remained stable so sat her up at 11:47 and her blood pressure dropped to 58/38 with a pulse of 83; had patient lie back down and blood pressure returned to normal at 111/62 with pulse of 60 at 11:49. Continued to monitor patient until EMS arrived at 12:14. Patient was stable with normal values of blood pressure and pulse. She declined to go to hospital.
pt recvd vax & exp bulging eyes, swollen head, elevated liver function tests;
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Feb2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Feb2022; 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 27Feb2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Feb2022) in a 74-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 27-Feb-2022 at 10:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Feb-2022 at 10:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Feb2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Feb2022). 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 27Feb2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Feb2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that vaccines went into 2-8 degree Celsius on or about 20-Dec-2021.  It was reported that the Expiry date of vaccine was 04-April-2022. No treatment information provided.   This case was linked to MOD-2022-542869 (Patient Link).
PATIENT RECEIVED BOOSTER DOSE EARLIER THAN THE 6 MONTH RECOMMENDATION FROM DOSE #2; PATIENT IS AWARE AND STATES THAT HER LOCAL PHARMACIST (AT A PHARMACY) TOLD HER IT WAS OK TO GET THE BOOSTER DOSE SOONER. AT PUBLIC CLINIC THE CLOSE SPACING WAS MISSED DURING SCREENING.
Pt had seizure (febrile) on 11/20/00. Photograph also shows red, macular rash over face and body.
12 days after receiving Moderna booster I have had daily itchy skin, hives, and red lines all over my body. Were told the red lines are called dermatographia. Despite being on several different medications (prednisone, Pepcid, and daily high dose 4x a day prescription Allegra, and seeing several allergists and dermatologists) I still have the hives and dermatographia daily.
Child with generalized morbiliform rash now over entire body with mild itching.  Started on arms and trunk and spread to entire body.  No fever.
My right arm at the injection started aching during the first night.  The next day my underarm and shoulder started hurting and feeling stiff. Hurts to raise my arm.
nurse gave a 40 year old pregnant patient an injection of FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; nurse gave a 40 year old pregnant patient an injection of FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 40 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in context of nurse gave a 40 year old pregnant patient an injection of fluzone high dose quadrivalent with no reported adverse event .Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was 31 weeks pregnant.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 27-Jan-2022, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, injection ( strength: unknown) lot UJ768AC via intramuscular route in unknown administration site as Immunisation.  On 27-JAN-2022 the patient developed a non-serious event "nurse gave a 40 year old pregnant patient an injection of fluzone high dose quadrivalent with no reported adverse event" (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 27-JAN-2022 the patient developed a non-serious event "nurse gave a 40 year old pregnant patient an injection of fluzone high dose quadrivalent with no reported adverse event" (exposure during pregnancy) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (nurse gave a 40 year old pregnant patient an injection of FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event)  At time of reporting, the outcome was Unknown for the event nurse gave a 40 year old pregnant patient an injection of fluzone high dose quadrivalent with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Soreness at injection site for 24 hours.  Headache for 48 hours.
Patient recommended to get second dose after taking cetirizine 10mg 1 hour prior. After receiving dose, patient felt swelling in upper lip similar to previous reaction. Given diphenhydramine  25mg  PO and monitored. No worsening of symptoms or trouble breathing/throat closing. Patient sent home and will go to emergency if any worsening of symptoms.
patient stated having a strong phobia to needles. Immediately after the shot he became unresponsive; seemed to pass out. Then came around, said he was fine, and passed out again. came around, bit into snickers bar, then passed out a third time. EMT was enroute since the first episode and arrived in 5 minutes. RPH on duty turned over care to EMT. EMT evaluated patient for 15 minutes, and he signed out against them taking him to the hospital. patient sat for 25 minutes then appeared ok and left.
Right/ hand &fingers itching, swelling, knuckles and finger tips look bruised. Currently, fingers still slightly swollen, middle knuckles still look bruised, swelling goes up and down during day, swelling at night while sleeping.  Went to Dr. on 1/27; perscripted 800mg ibupthen 3X's day for 5 days, video conference 2/3 then 3 more days ,then as needed.  Took benedryl for itching and soaked hand in epsom salt.  Swelling went down some 1/28 about as of today 90% better but still having swelling and middle knuckles look bruised, no pain f I can get second vaccine event just swelling and itching.  Would like to know if sympthoms are vaccine related and if I can receive 2nd does?  Is there an alternative if I can't get second does?  Really would like to be vaccinated
Multiple blood clots, bleeding,  hematoma, bleeding events after heparin, swelling in lower body, gangrene in both feet, double below knee amputation, situation ongoing, still in hospital.
On the morning of April 28, 2021 between 5:00 a.m. and 6:00 a.m. I began feeling very nauseated. The nausea was followed by vomiting, profuse sweating and then chills. By 10:00 a.m., the  vomiting had subsided, but nausea remained until around noon. I later developed a "dull" headache.
Presented w/ SOB. Tx for COPD exacerbation d/t covid+ pneumonia w/ Dexamethasone and Remdesivir, Zinc and O2.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 26th January 2018, the patient received the 1st dose of SHINGRIX. On 26th January 2018, 8 hrs 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 pharmacist was the patient for this adverse event. The patient received SHINGRIX in left deltoid.
Around the injection site there is a raised red, painful, warm and itchy spot.  It started on 01/07/21  last night it was a 2 " x 2"  area. This morning it is 3" x   4".
Patient received vaccine and after 20 seconds stated he did not feel well and had a vasovagal response
coughs once in a while, may be a nervous cough every 40 min; voice hoarse; tested positive for Covid-19; tested positive for Covid-19; didn't feel well at all; bad headache; dry cough; This is a spontaneous report from a contactable consumer who reported for himself, a 70-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Wednesday, 06Jan2021, and on that day he had no problem. On Thursday, 07Jan2021, he started experiencing dry cough. On Friday, 08Jan2021, he didn't feel well at all and had a bad headache. On Saturday, 09Jan2021, he felt better but he tested positive for Covid-19. Today, 11Jan2021, he stated he feels good, he coughs once in a while, may be a nervous cough every 40 min. He had not experienced fever or chills, he breathes well, he can hold his breath for 5-10 seconds, no chest pain or congestion, but his voice was hoarse. Patient wanted to know if this has been reported before, and wanted to know how long should he test himself again for Covid-19. The events were reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number is requested.
Patient called the pharmacy on 2/5/18 to state that she had a reaction to her ZOSTAVAX injection which was administered on 2/2/18. She developed a hot, red, raised, itchy area surrounding the injection site. The size is approximately 10cm by 8 cm. Patient will contact her physician 2/6/18.