chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shaking; couldn't walk properly, couldn't walk straight; totally fatigued; unbelievable headache; muscle pain; joint pain; fever of a 100° F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), GAIT DISTURBANCE (couldn't walk properly, couldn't walk straight), FATIGUE (totally fatigued), HEADACHE (unbelievable headache) and MYALGIA (muscle pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 048A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced GAIT DISTURBANCE (couldn't walk properly, couldn't walk straight), FATIGUE (totally fatigued), HEADACHE (unbelievable headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever of a 100° F). On 04-Nov-2021 at 1:00 AM, the patient experienced TREMOR (shaking). At the time of the report, TREMOR (shaking), GAIT DISTURBANCE (couldn't walk properly, couldn't walk straight), FATIGUE (totally fatigued), HEADACHE (unbelievable headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever of a 100° F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: 100 (High) 100 degree Farenheit.         No concomitant medication reported.  No treatment information was provided.  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.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 28-JUL-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route, and lot # not provided). Shortly after receiving ZOSTAVAX (exact onset date not further specified), the patient suffered from cranial nerve palsies in the sixth and seventh cranial nerves and lateral rectus palsy in the left eye and was diagnosed with binocular diplopia. In addition, the patient suffered from facial paralysis and was diagnosed with Bell's palsy. As a direct and proximate result of ZOSTAVAX, the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not recovered/not resolved. Causality assessment was related. Upon internal review, Bell's palsy/cranial nerve palsy in the seventh cranial nerve and cranial nerve palsy in the sixth cranial nerve/lateral rectus palsy in the left eye were considered to be medically significant events. Bell's palsy/cranial nerve palsy in the seventh cranial nerve, cranial nerve palsy in the sixth cranial nerve/lateral rectus palsy in the left eye, and binocular palsy were considered to be disabling.
Started noticing vision disturbances a couple of weeks after taking the 1st shot and was diagnosed with papilledema.
THERE WAS A TEMPERATUE EXCURSION 2 WEEKS PRIOR TO GIVING THE VACCINE
I started getting hives all over.   I went to an urgent care thinking it was an allergic reaction to something, even though I hadn't no food allergies.   I recieved a prednisone taper, which worked.   However, the hives reappeared a day after finishing the steroid taper.  I went to an allergist, and they took blood labs, and concluded I have chronic autoimmune urticaria.   I tried taking 4 zyrtec a day, but it did nothing.  The allergist tried me on a low dose prednisone each day, and it worked as long as I stayed on schedule.   We also didn't want this to be a long term thing.   He prescribed famotidine and told me to try Allegra.   Still no relief unless I also took prednisone.   Finally I was approved to start xolair injections each month.   After 4 months of being on xolair, I still get hives every day,  multiple times day.   However, I also take Allegra 4x/ day,  and the hives subside with that.
sz? 515PM-no preventitive APAP given, limpness, eyes rolled back, (no jerking) staring noted, collapse x 5 times; t100.3 last noc, irritability; mom stated seen by MD;
VAXELIS was administered to an 11-year-old; This non-serious spontaneous safety report with Agency Case ID # 02123715 was received by a partner on 07-MAR-2022 and forwarded to Agency on 09-MAR-2022 from a health care professional.   This case was considered off label use due to product use in unapproved population (VAXELIS was administered to an 11-year-old).  Due to the nature of the event, the causality between Vaxelis and the reported event of "VAXELIS was administered to an 11-year-old" is not applicable.  Further information is expected.
This case was reported by a pharmacist and described the occurrence of hives in a 54-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were unknown. It was unknown if the reporter considered the hives and rash to be related to Seasonal Influenza vaccine. Additional details were received as follows: This case has been linked with case US2015GSK180049, reported for the same patient for the events experienced after ENGERIX B adult and BOOSTRIX.
light headed tingling/numb hands, fingers, arms, legs, feet, chest and lips  Health department gave me a dose of Benadryl.
I had my second shot in my thigh February 11. I had a mild inflammation for 2 days and then nothing. But my right arm continues to throb.; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer reported started to receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on 11Jan2021, as single dose for covid-19 immunisation. Concomitant medication included Losartan 50mg. The patient had first dose on 20 Jan 2021.the patient is allergic to sulfar. The patient experienced mild inflammation for 2 days and then nothing after second dose. But her right arm continues to throb.  The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
mom called MD on call complained of fussy, irritable, moaning, crying, poor sleep. Fever 102 - 103. Slight redness at  vaccine site. called 08/12/2005 update no site redness, am fever 102.8, afeb over day, less irritability + appetite, poor sleep over day. Decrease activity.
Within 24 hours post vax pt developed respiratory congestion. Pt has a history of numerous allergies, specifically food coloring and corn syrup.
bone started aching badly; coughing; head started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone started aching badly), COUGH (coughing) and HEADACHE (head started to hurt) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BONE PAIN (bone started aching badly), COUGH (coughing) and HEADACHE (head started to hurt). At the time of the report, BONE PAIN (bone started aching badly), COUGH (coughing) and HEADACHE (head started to hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 02Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; budesonide, formoterol fumarate (SYMBICORT), (Batch/Lot number: unknown). The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Heart" (unspecified if ongoing); "Irregular Heartbeat" (unspecified if ongoing); "known allergies: Iodine in CT scan dye" (unspecified if ongoing), notes: known allergies: Iodine in CT scan dye. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ASPIRINE 325 MG; GABAPENTIN; LOSARTAN; METOPROLOL TARTRATE; NORTRIPTYLINE. Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin", notes: known allergies: Levaquin; Doxycycline, reaction(s): "known allergies: Doxycycline", notes: known allergies: Doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovered" (05Sep2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Aug2022 to 05Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Aches joints and muscles, fever, headache continuous, cough, vomiting, pain stomach, pain chest, pain knees and hips, pain elbow and shoulder, pain bone and joint, pain in feet like electrical shocks, skin rashes, extremely painful, sinus nasal continuous,
ACUTE DVT OF RIGHT POPLITEAL VEIN 3/23/2023 RIGHT FEMORAL NECK UNSPECIFIED TYPE FX, INIT ACUTE DVT OF RIGHT POPLITEAL VEIN 3/23/2023 RIGHT FEMUR COMMINUTED SHAFT FX, DISPL INIT
This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown demographics. On 27-SEP-2016, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # M009378 and expiration date: 23-APR-2018, (strength, dosage and route unspecified). The vaccine was exposed to temperature of 34.6F for the timeframe of 7 hours. The call was because of a data logger. No previous temperature excursion involved. No adverse effect reported. No product quality complaint involved. No further details provided. This is one of several reports received from the same reporter. Additional information has been requested.
Tingling down arm. Wait longer.No worse.Stretch arm.  Prn PCP or ER
Patient received a flu vaccine on 10/08/05. he then developed a cough, malaise and angioedema. He was admitted on 11/07/05 with nephritis. Biopsy on 11/30/05 showed necrotizing glomerulonephritis. Additional terms added from Dischare Summary rec'd 12/28/2005: Headacne, tachy. CHF, kidney failure, dec. urine output,  inc. creatinine/sr Discharge summary states drug reaction. msv Per 60 day folow up report-Patient died of end stage renal disease with multi-organ failure.
Feels uncomfortable like something's there; Really hard and really sore; Itching; Burning/ really sore; Red around incision area; Swollen arm; She also received second dose 23 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also received second dose 23 days after first dose), DISCOMFORT (Feels uncomfortable like something's there), VACCINATION SITE INDURATION (Really hard and really sore), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE PAIN (Burning/ really sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also received second dose 23 days after first dose). On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DISCOMFORT (Feels uncomfortable like something's there), VACCINATION SITE INDURATION (Really hard and really sore), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Burning/ really sore), VACCINATION SITE ERYTHEMA (Red around incision area) and VACCINATION SITE SWELLING (Swollen arm). On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also received second dose 23 days after first dose) had resolved. At the time of the report, DISCOMFORT (Feels uncomfortable like something's there), VACCINATION SITE INDURATION (Really hard and really sore), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Burning/ really sore), VACCINATION SITE ERYTHEMA (Red around incision area) and VACCINATION SITE SWELLING (Swollen arm) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant medications were not reported.  No treatment information was specified.
Post 4th vax, this pt experienced bacteremia. This was reported as "vaccine failure." Blood specimen was positive for Haemophilus influenzae type B. Outcome of pt was reported as "yes."  Follow up information received on 11/13/2000: "Information has been received concerning a 56 month old male who on 04/28/1992, 09/30/1992, 03/05/1993 and 06/07/1993 was vaccinated with the first, second, third and fourth doses of haemophilus b conjugate vaccine (manufacturer unknown).  Subsequently the patient experienced bacteremia.  This was reported as "vaccine failure".  This was considered a significant medical event.  A blood specimen was positive for Haemophilus influenzae type b.  The outcome status was reported as "yes".  Sixteen other patients were reported with adverse events following vaccination with haemophilus b conjugate vaccine: WAES: 00072311, 00072312, 00072313, 00072314, 00072315, 00072316, 00072317, 00072318, 00072319, 00072320, 00072321, 00072322, 00072323, 00072325, 00072326, and 00072327.  Additional information has been received from a published abstract titled "Haemophilus influenzae invasive disease among children aged <5 years--epidemiology in the United States.  1994-1999" From the 34th National Immunization Conference on Vaccine Preventable Diseases (WAES # 00102472); abstract is attached.
Within a few hours - experienced fatigue. By 8/23 I had chest pain slightly to the left, rapid breathing and palpitations.  My 8/24 my left lymph node under my armpit was also very tender, this lasted for 5 days. The chest pain lasted 7 days then started dissipating, took 10-11 days before pain was completely gone from chest. I consulted a doctor and was told to monitor symptoms for an additional 5 days. Left arm also had giant red blotch on the 8th day after injection with heat sensation that lasted almost 2 weeks.  Currently still feeling stiffness in left arm at injection site and some tingling in left palm.
Information has been received from a female patient with a history of low white blood cell count, who on 04-JUL-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 as part of what one of her nurses told her was standard procedure. Concomitant medication included mood stabilizers (name and manufacturer unspecified). She stated that she was in the hospital to monitor a low white blood cell count. Within 3 hours after the vaccination, the patient developed a blood blister on her nose and experienced minor joint pain. The next day on 05-JUL-2009 every joint in her body hurt and she could barely move. The patient went to the emergency room and within 20 minutes was completely paralyzed and was admitted to the hospital (name, address and length of stay unspecified). The patient was diagnosed with "vascecularitis." Her arms and legs had raw patches on them that were peeling. She had also developed a chronic cough. Labs and diagnostic tests included skin biopsy, result not reported. At the time of the report, the patient was recovering. Upon internal review, paralysis was considered to be an other important medical event. Additional information has been requested.
Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 01-Feb-2021, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. Not Provided          No medical history, concomitant medication or treatment information was reported.
On 24FEB91 pt c/o lt arm since receiving immun- burning @ inject site @ time of inject followed by continuing site pain & muscle pain esp w/movement of lt arm; dec ROM in lt shoulder, muscle weakness; Pain not relieved w/Ibuprofen;
21 y.o. c/o rash on arms torso chest for 4 days after getting VARICELLA #2 vaccine given 4 days prior to rash.
High fever (102 degrees), sore arms (can't raise arms). Diarrhea.
blotchy rash from shoulder to elbow; swelling of  lips; nausea; nausea; Diarrhea; red raised skin at injection site; injection site was itchy; Injection site warm to touch; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), INJECTION SITE ERYTHEMA (red raised skin at injection site), INJECTION SITE PRURITUS (injection site was itchy), INJECTION SITE WARMTH (Injection site warm to touch) and the first episode of NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), FAMOTIDINE and LEVONORGESTREL (MIRENA) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm soreness). On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red raised skin at injection site), INJECTION SITE PRURITUS (injection site was itchy) and INJECTION SITE WARMTH (Injection site warm to touch). On 27-Jan-2021, the patient experienced the first episode of NAUSEA (nausea) and DIARRHOEA (Diarrhea). On 01-Feb-2021, the patient experienced RASH (blotchy rash from shoulder to elbow), LIP SWELLING (swelling of  lips) and the second episode of NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 21-Jan-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 28-Jan-2021, INJECTION SITE ERYTHEMA (red raised skin at injection site), INJECTION SITE PRURITUS (injection site was itchy), INJECTION SITE WARMTH (Injection site warm to touch) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, RASH (blotchy rash from shoulder to elbow), LIP SWELLING (swelling of  lips) and the last episode of NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes: Cold Compress
This spontaneous report received from a consumer concerned a patient of an unspecified age, sex, race and ethnic origin. 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) with frequency 1 total administered, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  According to the hearsay on an unspecified date, one patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210829146-Covid-19 vaccine ad26.cov2.s-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Redness, swelling, heat, soreness 2 days after administered. RXN 1 inch below injection site.
Bell's Palsy right side and numbness of 1-2 toes on right foot
Moderna COVID-19 Vaccine EUA: 2nd dose  Please see continuation page ...  Inside arm and armpit itching after 5 minutes Diarrhea after 3 hrs which stopped in an hr Transient Shortness of breath after 15 hrs ( last about half an hr): oxygen level 95-100 Chills starting after 15 hr Slight fever ~99f Hearth beat: 95 (normal rate ~60) Extreme Nausea w/o vomiting for 3 to 4 hrs Extremely sensitive to smells (pleasant or unpleasant) triggering nausea Stomach and esophagus intense cramps for 4 hrs so intense that I had to call 911 (they didn't prescribe anything other than Tylenol or NyQuil which I couldn't take due to nausea) Passed out multiple times Hallucinations and talking gibberish Lack of concentration