chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experiencing some rapid heartbeat; tightness in the muscle in upper right chest/discomfort in the chest on the right side; headache; tiredness; slight fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (experiencing some rapid heartbeat), CHEST DISCOMFORT (tightness in the muscle in upper right chest/discomfort in the chest on the right side), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (slight fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (experiencing some rapid heartbeat), CHEST DISCOMFORT (tightness in the muscle in upper right chest/discomfort in the chest on the right side), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (slight fever). At the time of the report, HEART RATE INCREASED (experiencing some rapid heartbeat), CHEST DISCOMFORT (tightness in the muscle in upper right chest/discomfort in the chest on the right side), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (slight fever) outcome was unknown.            Patient treatment information was not provided. Concomitant medication information was not provided.
Body soreness, general malaise for 3 days - like I dad the flu. No treatment but resolved itself after the third day.
PT GOT VACCINATION AT AROUND 3:00 ON 9-25-21  AND REPORTED TO RPH ON 9-27-21.  SHE DEVELOPED SYMPTOMS OVER THAT EVENING AND NEXT DAY OF REDNESS AND SWELLING AROUND INJECTION SIGHT AND IN SPOTS 2 TO 3 INCHES BELOW INJECTION SITE. SHE ALSO HAD FACIAL FLUSHING AND PRESSURE IN HER HEAD.  PT STATES THIMERISOL ALLERGY, MFR PKGE  STATES PRESERVATIVE FREE. SHE SAYS SHE WILL CONTINUE TO MONITOR HERSELF (PT IS A DR)
Magnesium low; Potassium low; Bowel resection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4417628-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159928) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTESTINAL RESECTION (medically significant) with onset 22Jan2022, outcome "unknown", described as "Bowel resection"; BLOOD MAGNESIUM DECREASED (medically significant), outcome "unknown", described as "Magnesium low"; BLOOD POTASSIUM DECREASED (medically significant), outcome "unknown", described as "Potassium low". The patient underwent the following laboratory tests and procedures: Blood magnesium: (07May2022) Low; Blood potassium: (07May2022) Low; Weight: (unspecified date) Losing. The action taken for adalimumab was unknown.  Clinical course: On unknown dates, the patient experienced weight loss/losing weight, low on magnesium, body was not absorbing nutrients and low on potassium. on 22Jan2022, the patient experienced bowel resection surgery. On 07May2022 the patient ended up in the emergency room, she was low on potassium and magnesium.  Causality For Humira (Adalimumab): The reporter's causality for the event(s) of bowel resection surgery, was no reasonable possibility. The reporter's causality for the event(s) of low on magnesium and low on potassium was not provided Agency opinion is that the events of bowel resection surgery, low on magnesium and low on potassium are not assessable.  The reporter's assessment of the causal relationship of "bowel resection", "magnesium low" and "potassium low" with the suspect product(s) BNT162b2 was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event bowel resection, magnesium low, potassium low and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Both Polio (IPV) vaccine and Pediarix (which also contains Polio) was given.  Mom was called to notify of the mistake. The child is fine. Had a sore arm, but had the Dtap in the Pediarix, which is common to have a sore arm..
The area is very red and swollen. It is also under the area. Two areas are affected. This happend the last time he got shots. It is also painful. It felt like it was very hot on the areas. NO tests were done. I do not want my child to go through this again. I want a waver so that he no longer has to go through this.
This patient received her first dose of Covid 19 vaccine by Moderna on January 12 at the pharmacy.  She tolerated it well.  She had a sore right arm at the site of injection for about 2 days.  Soon thereafter she developed some right lateral neck pain for several days that required Advil.  It was hard to turn her head.  That got better.  On January 20 in the evening, she noted pain and achiness in the right deltoid at the site of her shot.  It was pink allover and slightly swollen and mildly warm.  Today, the swelling was slightly more and the redness slightly more.  She asked to see me, her PCP, although I did not give the vaccine.  She denies any fever, chills, sweats.  She has no systemic achiness. She has pain  at the site, even if not touched.  It is slightly warm to touch.  Today the erythema has slightly progressed since yesterday when she marked it with a pen.  She has not taken any antipyretics for several days.  She has no rash elsewhere on the body. The erythema is 5 x 8 cm and oval in shape.  She also has some small right axillary lymphadenopathy.  There are no other lesions on the right upper extremity.
Complete numbness in hands and associated weakness; Complete numbness in hands and associated weakness; Administration date: 11Nov2022, dose number: 5; other vaccine same date product: Flu vaccine/other vaccine same date vaccine date: 11Nov2022; Administration date: 11Nov2022, dose number: 5; other vaccine same date product: Flu vaccine/other vaccine same date vaccine date: 11Nov2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 11Nov2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Post partum twins" (unspecified if ongoing), notes: Post partum twins. The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies. Vaccination history included: Covid-19 vaccine (Dose 4; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Nov2022, outcome "unknown" and all described as "Administration date: 11Nov2022, dose number: 5; other vaccine same date product: Flu vaccine/other vaccine same date vaccine date: 11Nov2022"; MUSCULAR WEAKNESS (non-serious), HYPOAESTHESIA (non-serious) all with onset 12Nov2022, outcome "recovering" and all described as "Complete numbness in hands and associated weakness". Therapeutic measures were not taken as a result of muscular weakness, hypoaesthesia. Additional information: Other vaccine in four weeks: Unknown. COVID prior vaccination: Unknown. COVID tested post vaccination: No.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Covid Pfizer 5-11yr vaccine given instead of  the Pfizer 12yr + vaccine.
Within a hour of receiving the vaccine, I felt left shoulder and posterior neck discomfort. A few hours after, I felt flushed and slightly feverish with generalized body aches. 6-7 hours after the vaccine, I experienced extreme fatigue, extremely high fever that registered as "err" consecutively on the thermometer numerous times (min of 5 times checked), severe headache, worsening body aches, left flank pain, GI upset with nausea, congestion, dizziness and many heart palpitations. The high fever broke around 11pm and my temp was 102 when checked then and I was drenched in sweat. The fever continued to decrease throughout the next 12 hours. The extreme fatigue, severe headache, dizziness , GI upset and nausea continued throughout the day Saturday and most of Sunday.  I also experienced burning in my chest that radiated into both shoulders, anterior/posterior neck and between both shoulder blades in my back all day Saturday. The burning has decreased over this past week, but I am still experiencing it with some exertion, but not consistently.  Fatigue continues some and SOB at random times.
pt recvd vax;cried all noc & had lt leg slightly swollen; to er; advised to put cold compress then warm;to cont apap & to call PED;
Day one post vaccination had soreness in left arm. On day four post vaccination developed redness, extreme soreness and fever at injection site down to just above left elbow. Saw MD 7/25/17, CBC was normal, put on KEFLEX for possible cellulitis. On 7/28/17, symptoms improved.
Client only administered liquid component of the MENVEO. Powder was not mixed in. LPN called Novartis to see if client needs to be reimmunized. They stated if she would be traveling outside the country or around a foreigner, to reimmunize. Called client's guardian and have left several messages. Will continue to try to contact client's guardian.
Patient entered monitoring area at 2:43 p.m to be observed for 30 mins due to concerns dealing with health condition. At approx. 20 min  the writer asked patient how she was feeling and patient stated that her chest felt tight, patient also stated that the tightness was not hindering her ability to breathe however it was not normal for her to feel that tightness. The writer asked her if the tightness was due to nerves or did she think it was for the vaccination. Patient stated she was not sure. Patient was offered some water and the ability to step outside to be able to remove her mask and get some fresh air. I accompanied patient outside for approx. 10 mins. Patient stated she felt a little better but still felt the tightness. The writer offered Benedryl as an option to help releave the sympotoms. V/S were taken B/p: 127/79; P67; O2 99; R 19. Benedryl 25 mg was administered Po at 3:20 pm. After approx. 20 mins of conversation with the patient she stated she felt much better and that she was well enough to go home. Patient left monitoring area at 3:45 pm.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left 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: "RA" (unspecified if ongoing); "myositis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Nucleic acid test: Positive; SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Information has been received from a physician concerning a 19 year old female patient with no pertinent medical history and no known drug allergy who in August 2008 was vaccinated with the first dose of GARDASIL. In January or February 2009 the patient was vaccinated with the second dose of GARDASIL. Concomitant therapy included birth control pills (unspecified) for years. In May 2009, the patient developed a blood clot in the leg that resulted in a pulmonary embolism. She was hospitalized for several days. She was currently considered to be recovered but still taking COUMADIN. Her initial and second dose of GARDASIL were given at another office so no administration information available. The physician could not give any other details and said he was not consulted on this case. He learned of the incident through the patient's mother. He did not have the name of the physician who administered the GARDASIL, and did not know the name of the hematologist who followed the patient. The physician did not offer to contact the patient's mother to gain this information. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination/therapy, lot numbers, healthcare provider name and contact information. Additional information has been requested.  9/18/09 Hospital records received DOS 5/27/09 to 6/4/09. Assessment: Right lower lobe pulmonary embolism acute. Left leg DVT. Iron deficiency anemia. Pleural effusion.  Viral syndrome 3 weeks prior followed by difficulty breathing. Patient now c/o increasing chest pain and shortness of breath last 7 days. Could not breath. Respiratory distress. Nonproductive cough. Decreased breath sounds right side. Anxiety. Tachycardia. Increased respiratory rate. Thoracocentesis. Acute mild renal failure. Right lower lobe pneumonia.  ICD-9 Codes: 415.19 Oth Pulm embolism/Infrac, 486 Pneumonia Organism NOS, 453.41 DVT Proximal Leg, 511.9 Pleural Effusion NOS, E932.2 ADV EFF Ovarian Hormones, 280.9 Iron Defic Anemia NOS, 564.00 Constipation NOS, 477.9 Allergic Rhinitis NOS
Patient complaint of pain to left arm and can not rise up to a certain height. No redness, swelling or warmness to touch noted on 5/21/18,5/25/18 or 5/29/2018.
HPV vaccine was incorrectly given to patient by RN instead of flu vaccine (fluzone) that was ordered by physician. Parents were informed. No side effects have been noted at time of reporting.
Cellulitis of right arm where vaccine was given. Antibiotics and antihistamines given.
1/21 vaccination By that evening, I started having chills by 5pm. Began to have body aches; 7pm. Low Grade fever increased to 102 overnight. I didn't sleep at all to no avail with Tylenol and Motrin. Nauseous.  1/22 pregnancy test; positive  By Friday evening, symptoms started to dissipate.  1/26 Miscarried; 4 weeks 3 days pregnant 1st pregnancy
30 DAYS AFTER I RECEIVED, FLU, TETANUS,PNEUMONIA,(DEC 2, 2003) I BEGAN TO BE IN GREAT PAIN ALL OVER MY ENTIRE BODY WHICH IS STILL CONTINUING AS NOW.  I AM  GOING INTO THE SEVENTH MONTH OF PAIN& SUFFERING  T THE TREAMENT WAS GIVEN: WAS A SERIES OF MEDICATIONS: IBUPROFEN 800MG, 600MG & 400MG, NABUMETONE TAB 500MG, HYDROCHLOROTHIAZIDE TAB 25MG PENICILLIN V POTASSIUM TAB 500 MG,  THE PAIN WAS ALL JOINTS, MY ARMS SEEM TO BE DISCONNECTING WITH  GREAT PAIN. COUPLE OF MY FINGERS ARE SWOLLEN AND BENT. THE DOCTORS SAID: IT WAS RHEUMTOID ARTHRITIS BUT THE TEST SHOWS, NEGATIVE
Left arm had intense pain at the time of injection, that affected my entire arm.  But the next day I also had a low grade fever so concentrated on treating it The pain  went away in a couple of days but returned in a few weeks confined in the upper arm. I controlled the pain then with ice, rest, and NSAIDS. Then last week pain returned in my entire arm at the most intense level ever, even more than at the time of the original injection. The pain also went into my shoulder and neck while producing a tight feeling in my back. I was prescribed a muscle relaxant, and told to use Lidocaine patches.  It still hurts at times but not nearly as intense as that episode.
Patient passed out about 15-30 seconds after receiving the vaccination and regained consciousness between 45 seconds to 1 minute. Patient was alert and oriented after regaining consciousness.
28th feb felt mild fatigue.  1 March had tightness in chest and trouble breathing, waitied and didnt get better.  Saw physician then admitted to emergency room.
1 of 2 pts who was vaxed w/Tetramune/MMR on 19OCT93 3PM exp 4 hrs of persistent crying (from 4AM to 8AM) on 20OCT93; pt had low grade fever; No other sx; not seen by MD; pt recovered;
pt recv vax 8APR96 & 30JUN97 pt devel 50-100 maculopapular lesions all over body & a temp of 101.3;
body aches; major headache all night long, all over her head. It was a pressure headache; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E49899), via an unspecified route of administration in the right deltoid on 18Dec2020 10:30 at a single dose for COVID-19 immunization. The patient's medical history included wolff-parkinson-white syndrome (WPW syndrome) from 2000, heart surgery from 2000, and allergic to sulfa with hives. Mother is diabetic and sister is prediabetic. There were no concomitant medications. On an unspecified date, she experienced body aches. She took paracetamol (TYLENOL). She also had major headache all night long, all over her head. It was a pressure headache. Someone gave her ibuprofen (MOTRIN) and within 3 hours she was totally fine. Outcome of the body aches was unknown and of the headache was recovered on an unspecified date.
Patient developed minor paralysis on (L) side of face. Left eye did not close completely resulting in dryness of eye. Some dropping of mouth week of 5/1/12.
This is a 77y.o. female with hx of +COVID-19, DM2, CKD stage 3, and respiratory failure with hypoxia who presents to by way of EMS, with a chief complaint of SOB. Per EMS, upon their arrival, pt's pulse ox was low 80s and she was placed on a nonrebreather. Currently pt is on 5L O2 saturating at 98%. She is AOx1, oriented to her name and presence in a hospital, unable to specify hospital name or reason for being here. Pt admits SOB, denies chest pain, abd pain, or HA.    Pt's daughter sitting at bedside notes taking the pt to 10 days ago for cough and fatigue. At that time she was dx'd with covid and sent home to quarantine. Over the next week her cough and fatigue worsened. Her daughter states the pt was found sitting in her own urine for 2 days and not coherent so she decided to call EMS. Per daughter, pt does not drink alcohol, smoke or use tobacco products or recreational drugs, and is not on O2 at home. Baseline is AOx3. Pt is full code.   Upon arrival to the ED:  o Vitals: T 97.3°F, BP 112/56, HR92, RR 18, SpO2 98% on RA.  o EKG demonstrates NSR with increased T wave amplitude in the anterolateral leads o Lab work obtained and remarkable for:  ? CBC: thrombocytosis (552) ? BMP: elevated BUN (79), Crt (1.93), decreased GFR (28) ? Trops: 0.04 and 0.03 o Imaging demonstrates:             CXR: multifocal pneumonia in the mid-lower portions of both lungs concerning for covid-PNA             Head CT: no acute intracranial process o Patient given decadron, azithromycin, rocephin o ID has been consulted
This spontaneous report was received from a physician (who had read an article in "JAMA (unspecified abbreviation)" network for dermatology) via pharmacy technician refers to a female patient in her 60's. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date since March of 2016 (reported as "6 weeks apart"), the patient was vaccinated with two doses of GARDASIL 9, intramuscularly for multiple squamous cell tumors (off label use). Then 3 weeks after, 2nd Intramuscular dose, patient took the 3 largest tumors and injected GARDASIL 9 directly into tumors 4 times over the next 9 months (inappropriate schedule of vaccine administered). The doses were given from March of 2016 through February of 2017. By time of the article in May of 2018, the patient was tumor free. No product quality complaint (PQC) was involved.
Abrupt onset of febrile seizures; 911 called and pt transported to ER.
SHE STATES SHE WOKE UP ON 11/16 AM WITH LEFT ARM REDNESS, PAIN, SWELLING, AND HEAT. THIS PHARMACIST RECOMMENDED VISIT TO URGENT CARE ASAP. SHE WENT TO URGENT CARE ON 11/17 AND RECEIVED ANTIBIOTICS FOR POSSIBLE INFECTION. ALL SYMPTOMS HAD RESOLVED BY 11/19 AM.
Patient received a slightly higher concentration of the covid vaccine as only 0.8ml of dilution was added instead of 1.8ml. Patient has not had any adverse reactions up until this point.
after the first shot i was lethargic , tired and bloated . after another week i had pinched nerve in my back with excruciating pain going down my leg and lost  muscle strenght with numbness  .  after 2nd shot > hit me like a large truck  .... 4 hours later developed chills , nausea and vomiting , dark urine , no appetite and taste is off , joint and muscle pain  .
Extreme Skin sensitivity - burning sensation at injection site at time of injection.   Extreme skin sensitivity - light tactile, heavy tactile touch painful Extreme temperature sensitivity - feeling very cold, freezing, uncontrollable shaking.
woke up sweating, clothes wet; did not feel sick; changed clothes and went back to bed
Patient administered DTaP/HepB/IPV and DTap/HIB/IPV at visit on 2/8/17.
Fussy, doesn't sleep more than 3 hours and arm and legs move (Jerky) lasts for 1-2 second-no tonic movements No eyeballs moving upward. Per parents childs legs were moving like "twitch".