chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT REC DTP/OPV ON 1-MAR-90 3 WKS LATER BECAME QUITE ILL W/ENCEPHALITIS & OPTIC NEURITIS REQUIRING HOSPITALIZATION.  BRAIN BIOPSY REVEALED PERIVASCULAR INFLAMMATION CONSISTENT W/POST VIRAL OR POST IMMUNIZATION COURSE, TAKING HIGHDOSE STERIOD
Patient was administered the AFLURIA vaccine on her left upper am. Her arm has been sore for at least a month at her site of injection and felt painful when lifting her arm. Her doctor advised her to take MOTRIN & warm compress. She only took one tablet only, but her pain continue.
Chills all night, sore arm, whole body is killing me, stomach cramps, headache.
dizziness & local rxn w/in 3hr of vax;noticed an eye floater;s/w opthalmologist who siad was harmless;
Moderna COVID-19 Vaccine EUA. Note: I was confirmed COVID positive 4/22/2020 with mild symptoms lasting approximately 4 days.  I received injection at 0600hrs (1/27/2021).  Noticed symptoms at approximately 1900hrs (1/27/2021).  Started with site soreness and mild swelling, fatigue, body & joint aches.  At about 0200hrs (1/28/2021) , I started a fever, body chills, and sweating.  At 0700hrs (1/28/2021), my fever spiked over 100 degrees. Temperature spiked at 101.1 degrees and continued to have chills, sweats, body aches and fatigue. This continued all of 1/28/2021.   By 1400hrs (1/29/2021) my temperature was normal. All other symptoms subsided. Very slight tenderness at injection site. Treatment was Motrin afternoon of 1/27/2021 & afternoon of 1/28/2021.
This spontaneous report as received from a consumer refers to herself, a 68 years old female psychologist. The patient was vaccinated with ZOSTAVAX (dose, route and Lot# not reported) on 08-OCT-2012. No other co-suspects were reported. Concomitant medications included LEVOXYL, estradiol and NASACORT. On 08-OCT-2012 the patient experienced itchiness at injection site, slight swelling at injection site, warmth at injection site and redness at injection site. No treatment information was reported. The outcome of itchiness at injection site, slight swelling at injection site, warmth at injection site and redness at injection site was reported as not recovered/not resolved. The relatedness for itchiness at injection site, slight swelling at injection site, warmth at injection site and redness at injection site was not reported for ZOSTAVAX. Additional information is not expected.
My two following menstrual cycles were abnormal both in terms of spotting and volume of blood/tissue passed. In August, I had unusual spotting and bleeding for 7 days in between my regular cycle. In September, my cycle lasted 7 days (4 days is typical) with 7 days of abnormal spotting  before my October cycle. The spotting in September was reduced compared to August but still completely abnormal for me (I have been tracking my cycle for years).
BLOOD CLOT IN CAROTID ARTERY; SUSPECTED CLINICAL VACCINATION FAILURE; SLEEPING ALL DAY; CHRONIC COUGH; SUSPECTED COVID-19 INFECTION; SMALL STROKE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: acid reflux, and allergic to some antibiotics. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included omeprazole for acid reflux. Patient received Janssen covid-19 vaccine around late May or early June (patient could not find vaccine card). On 18-OCT-2021, she was recently diagnosed with covid-19 (suspected covid-19 infection) and also experienced suspected clinical vaccination failure. On an unspecified date, she was feeling very sick, like 'the grip' from the 50s. she was throwing up, felt feverish at night time, very fatigued and was sleeping all day long. She currently was feeling better, but post nasal drip was causing a chronic cough. On JUL-2021, patient suffered a small stroke (at the end of July, approximately 2 months after getting the Janssen vaccine). Blood clot was discovered in her carotid artery. Surgery has been scheduled to repair some damage done while looking for the blood clot. Patient was put on blood thinners for 10 days post stroke but was not taking any at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small stroke, was recovering from suspected covid-19 infection, blood clot in carotid artery, and suspected clinical vaccination failure, had not recovered from chronic cough, and the outcome of sleeping all day was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0 20211103276- COVID-19 VACCINE AD26.COV2.S-Blood clot in carotid artery, small stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 20211103276- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
I experienced a breakthrough case of COVID-19 with sneezing, coughing and muscle aches.
83-year-old female with PMHx of HTN, HLD, dementia is being admitted for generalized weakness, episode of unresponsiveness at home   Patient unable to provide complete history due to her dementia. patient lives with her son and daughter who are at bedside   Family reports that the patient has been fatigued and sluggish for the past 2 days, she has had diarrhea and poor appetite during these past 2 days, this morning son went to  give her breakfast and found her unresponsive in bed, the patient had 1 episode of emesis as the son was trying to wake her up. he called EMS and patient was brought to the ER.  Since this morning patient has improved a fair amount however still feels very fatigued.  She complete denies any chest pain, shortness of breath, nausea, vomiting, recent fevers or chills, denies cough, congestion, headache, vision changes She has had some lower extremity edema, chronic She is not been out of the house much except to go to the doctor's appointment Family is not aware of any Covid exposure   Son states that the patient recently saw her family doctor and had a echocardiogram of her heart on 12/29 which was supposedly normal and patient is scheduled to see her PCP again on Tuesday to discuss further.  DISCHARGE DIAGNOSES: Covid Severe hypokalemia Hypomagnesemia CK elevation  Acute metabolic encephalopathy, resolved HOSPITAL COURSE: Patient is an 83-year-old female who presented with a chief complaint of fatigue, altered mental status and vomiting.  As a result of the vomiting her electrolytes were deranged severely with the admitting potassium of 2.4.  This was corrected as well as her magnesium.  She had AKI with a creatinine of 1.36 on admission and a baseline of 0.99 as well.  This was likely from dehydration.  The patient tested positive for COVID-19.  She had had her vaccine with her second dose of Moderna being on 6/17/2021.  She did not have a booster.  She had no respiratory symptoms.  She did well and went home in less than 48 hours after her acute metabolic encephalopathy had resolved.  She lives with her children.  It is recommended that she have a booster when she is completely recovered from her symptoms as she is at high risk given her age.
A 15 year old patient was administered Flublok Quadrivalent, No AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 years old patient (gender unspecified) who was administered a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number.
cold without fever; Ache all over the body; headache; chills; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold without fever), MYALGIA (Ache all over the body), HEADACHE (headache), CHILLS (chills) and FATIGUE (felt tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 071F21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement and Artificial cardiac pacemaker user. Concurrent medical conditions included Heart disease, unspecified (she had a mitral valve replacement and a pacemaker) since 2008. Concomitant products included APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, the patient experienced NASOPHARYNGITIS (cold without fever), MYALGIA (Ache all over the body), HEADACHE (headache), CHILLS (chills) and FATIGUE (felt tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold without fever), MYALGIA (Ache all over the body), HEADACHE (headache), CHILLS (chills) and FATIGUE (felt tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient had no Allergies to medications, food and other products Patient stated that no Other vaccines given within 1 month prior to Moderna COVID-19 vaccine Patient didn't seek medical care & was very sensitive to vaccines in general & patient always have adverse reactions, but not as longer as this time Patient had no change in status such as improvement or worsening   This case was linked to MOD-2022-563515 (Patient Link).
Woke up feeling a bit nauseous/ Experiencing nausea "on and off"; This is a spontaneous report received from a contactable consumer. A 14-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 01Jun2021 15:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient woke up feeling a bit nauseous. experiencing nausea "on and off" throughout the morning on 02Jun2021. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
HAIR FALLING OUT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hair falling out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair falling out was not reported. This report was non-serious.
Child received PENTACEL, HEP B, PREVNAR, ROTAVIRUS & flu vaccines, instead of PEDIARIX, HIB, PREVNAR, ROTAVIRUS & flu vaccines.  No adverse reaction or treatment necessary.
Cold; Arm swells up after injection; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma chronic, Diabetes, Blood pressure abnormal and Lipids abnormal. Concomitant products included METFORMIN and LISINOPRIL for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Arm swells up after injection) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) had not resolved and PERIPHERAL SWELLING (Arm swells up after injection) outcome was unknown.            She was seen by her primary care physician who prescribed her antibiotics, name unknown.  Based on the current available information and the temporal association of the product and start date of the events a causal relationship cannot be excluded.; Sender's Comments: based on the current available information and the temporal association of the product and start date of the events a causal relationship cannot be excluded.
BODY ACHE; CHILLS; SORE ARM; HEADACHE; TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, chills, sore arm, headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, chills, headache, sore arm and tired was not reported. This report was non-serious.
Pt had 3rd dose of Prevnar-1/11/02. Had had no previous reaction. Wake with hives on arms, legs and torso on 1/13/02. (Twin sister had been treated in ER day before). Benadryl was given. Hives resolved in 4 days.
This 86   year old   white  male received the Covid shot on 03/06/21  and died on   04/26/21 .  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Shoulder pain immediately as shot was injected too high in shoulder. Burning pain at the time. Currently 5 weeks later and I experience pain and aches all day and night. Lifting arm above head is most difficult. Removing clothing overhead and brushing and washing hair hurts. I plan on making doctor appointment to evaluate. No history of shoulder pain or injury. I am an athletic female in healthy condition. I currently do shoulder therapy and pain medication to control the pain.
hives head to waist; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of generalized urticaria in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On 08-SEP-2023, the patient received RSV vaccine and FLU VACCINE (NAME UNKNOWN). On 10-SEP-2023, 2 days after receiving RSV vaccine and FLU VACCINE (NAME UNKNOWN), the patient experienced generalized urticaria (Verbatim: hives head to waist).  The outcome of the generalized urticaria was not reported.   It was unknown if the reporter considered the generalized urticaria to be related to RSV vaccine.     It was unknown if the company considered the generalized urticaria to be related to RSV vaccine.   Additional Information: GSK receipt date: 10-SEP-2023 This case was reported the patient via interactive digital media. The patient got the RSV and flu vaccine on Friday.  The patient had all of the side effects.  Today (on the day of reporting) the patient woke up with hives head to waist.  The patient still beat the hospital though. It was unknown if the reporter considered the generalized urticaria to be related to Flu vaccine. Follow-up not possible as no contact details provided.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications are provided by the reporter. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Fever of 102.0 ax, rash on face & chest; treated by MD w/APAP;
Pt initially presented with a round swollen, itchy area on her right deltoid at the site of injection. She came back 2/1/2013 complaining of area still itching & swollen & bleeding.
Pain in left arm from shoulder down to elbow for about 24hrs.  Symptoms went away.  Diagnosed with Influenza A 14 days after receiving the vaccine, arm pain began again at this time and has been off and on occasionally since.  Until 11/24/09, severe arm pain from shoulder down to elbow causing limited range of motion with severe pain.  11/30/09 Vaccination records received for H1N1 administered on 10/16/09   12/01/09 OB Visit notes for DOS 11/24/09: DX: Pain in left arm from shoulder down to elbow.  Pt developed pain in left arm from shoulder down to elbow within 24hrs of receiving the H1N1 vaccine. Symptoms went away. On 11/24/09, Pt complained of arm pain again which got worse after Pt was diagnosed with influenza A causing limited range of motion.
pt recv vax 13MAR97 & 25MAR97 pt devel approx 10 chickenpox on back;chickenpox began to dry up on 26MAR97;pt recovered from sx;
The patient appeared to "faint" and then began to convulse upon completion of the injection. She was non-responsive for 1-2 minutes after which she began to communicate. She wished to vomit but did not. She moved to the floor and laid down complaining of being "hot". Gave BENADRYL 25mg PO then paramedics arrived and took over care. W/self transport to Urgent condition did not improve.
Splenic infarct 2 weeks after 2nd Moderna vaccination. Thrombophilia evaluation negative to date. No clear precipitating risk factor.
had 2nd dose of  Pfizer on 2/4/2021, at age 77 y.o. On 10/20/21, date of 3rd dose, patient developed fever and diarrhea.
Information has been received from a physician via another physician concerning a patient (age and gender not reported) with pertinent medical history and drug reaction/allergies not reported who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Concomitant medications were not reported. Subsequently on an unspecified date, the patient experienced Henoch-Schonlein purpura. No other details about this patient or the event were available. No product quality complaint was involved. Upon internal review, Henoch-Schonlein purpura was considered to be an other important medical event. No further information is available.
felling sick; fever; malaise; extreme nausea; throbbing of her arms and legs; dizziness; she started hemorrhaging female wise; she started hemorrhaging female wise; This is a spontaneous report from a contactable consumer, the patient, and other contactable consumers. A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8735), via an unspecified route of administration in the left arm on 27Apr2021 at 12:45 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in Dec2020 and was sick for 4 months, neutropenia, allergy to latex; until the virus in Dec2020, the patient would hemorrhage no less than 3 weeks and spotted always for 4 months since COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL 12 HOUR) and ethinylestradiol/levonorgestrel (PORTIA 21). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8732) on 31Mar2021 at 10:00 (at the age of 48-years-old) in the left arm for COVID-19 immunization and felt a little yucky. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took ciprofloxacin (CIPRO) and venlafaxine hydrochloride (EFFEXOR) and experienced allergies. On 29Apr2021 at 10:00 (also reported as 48 hours after the 2nd vaccination), the patient started gushing hemorrhaging female-wise. She described this as bleeding through her pads. Within a week in May2021, (also reported as a few days later), the patient experienced malaise, extreme nausea, throbbing of her arms and legs, and dizziness laying down. She said she felt really bad. She said she was rushed to the emergency room on 03May2021, and then again on 06May2021. The patient also reported feeling sick with fevers as of 04May2021 (also reported that she doesn't know when it started or ended) after the hospital, she was not able to make sense now. The patient was hospitalized for 3 days as of 06May2021 and was considering going back as she was feeling worse. At the hospital, the patient received fluids and antibiotics. The patient was treated with a supplement to slow the blood flow. She did not know if it was improving, persistent or worsening. For 3 days she could not take the supplement but started to bleed more yesterday (probably because she didn't take the supplement). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "she started hemorrhaging female wise", malaise, extreme nausea, throbbing of her arms and legs, dizziness, feeling sick and fever was not resolved.