chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigue; full body aches; chills; high fever; joint pain; extreme nausea; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Feb2022 10:15 (Lot number: FJ1614) at the age of 21 years as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TDAP, administration date 18Jan2022; NEXPLANON. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0158, Location of injection: Arm Right), administration date: 15Apr2021, when the patient was 20 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Right), administration date: 25Mar2021, when the patient was 20 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "Extreme fatigue"; PAIN (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "full body aches"; CHILLS (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "high fever"; ARTHRALGIA (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "joint pain"; NAUSEA (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "extreme nausea"; DIZZINESS (non-serious) with onset 04Feb2022 17:00, outcome "recovering", described as "dizziness".  Additional information: Day of shot: Extreme fatigue leading to full body aches and chills, high fever, joint pain, extreme nausea and dizziness. Day after: full body aches and pain, joint pain, fatigue, dizziness. Patient had no known allergies. Patient had no COVID prior vaccination and was not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient received Pneumovax in left arm on 10/8/07. Started 10/9, left arm felt stiff. Then, the left arm became very hard, stiff, red, and warm. Patient had temperature up to 102. Was diagnosed with cellulitis and admitted to a hospital.  11/30/07 Reviewed hosptial medical records which reveal patient experienced fever, chills, dry cough, malaise & redness at site of pneumo injection.  Had been seen at urgent care facility & referred to ER for elevated WBC.  Admitted 10/11-10/12/2007.  Temp on admit was 102.3.  Tx/w IV antibiotics & antihistamine FINAL DX: no d/c summary available, admit & d/c dates obtained verbally.  Left arm cellulitis.
Pt reports feeling dizziness, difficulty breathing and chest tightness about 40 mins post injection.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine (lot#, route and site of administration not reported). Subsequently, the patient has a syncopal episode. At the time of this report, the patient's outcome was unknown. Follow up information has been received from a physician concerning a 16 year old female patient with no other relevant medical histories who on 09-DEC-2009, at 11:30, was vaccinated with the second dose of GARDASIL vaccine (lot#665547/1318Y) into the left arm, a second dose of VARIVAX vaccine (Oka/Merck) (lot# 665040/1086Y) into the right arm and a second dose of ADACEL (lot# UF460CA) into the right arm. On 09-DEC-2009 the patient developed syncope and a brief tonic clonic seizure that lasted 5-10 seconds. The patient was having her annual physical examination at time of vaccination. No medical attention was sought. There were no laboratory diagnostics studies performed. On 09-DEC-2009 the patient recovered. Upon internal review, tonic clonic seizure was considered to be an other important medical event. This is one of several reports from the same source. Additional information is not expected.
Pt screaming uncontrollably ran temp 102 p/shot, Mom stated that child screamed off & on since getting the shot 22APR; referred to MD who advised APAP & warning not to take pertussis again & to monitor childs condition;
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2022 at 12:33 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Feb-2022 at 12:33 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022). 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 19 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient received booster dose vaccination time was given on 19 Feb 2022 at 12:33:17. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. We no longer possess this lot number. Treatment medications were not reported.
18JUL95 330PM c/o soreness in lt arm @ inj site; 19JUL95 230PM c/o severe arm soreness inj site, h/a, dizziness, lt hip pain/side of leg; T101.3 orally, lt arm inj site hot to touch & hard on palpation; tx ice pack to arm, rest, inc fluids
ErythemaMultiform, UrticariaPruritus, none Narrative:  given benadryl in the clinic
On January 27th noticed itching, erythema, warm to touch at site of injection. Applied topical anti-itch cream and took BENADRYL. States condition gets worse over time.
08/23/2002 5x4 cm (widest length & width); plus redness; plus warmth; plus pain to touch.
The day of his DTaP vaccination, April 11, 2003, patient was playing outside with a large, glider airplane made out of lightweight foam.  It circled in the air and hit him on the thigh apparently very near the location of his vaccination.  He exclaimed that it hurt and then he took about ten steps in a semi-circle whereupon he fell to the ground.  His father asked him if he was OK, but he did not respond.  His father then noticed what appeared to be slight, jerking motions similar to that of a seizure.  His father called his name again without a response, so he picked him up.  He then began to cry softly and complain that his head and leg hurt.  From the time of the hit to being picked up lasted perhaps 1-2 minutes.  The "seizure-like" movements lasted only 5-10 seconds.  His father took him inside where he complained of being very weak.  He appeared very pale, disoriented, and somewhat clammy.  After about 10 minutes, he slowly started to respond to questions, but he was not eager to play or walk on his own.  We took him to the ER where they performed an EKG that proved negative.  The ER physician and his pediatrician felt perhaps it was a "vagel" response.  In November 2003, approximately 5 days after getting a flu shot, he had what appeared to be another seizure.  After watching other kids getting flu shots at church, he expressed concern about getting another shot and he complained that his flu shot hurt.  Approximately, 10 minutes later, he fell to the ground.  Thinking he was playing, his father called his name three times.  His father then thought he noticed a slight "seizure-like" movement.  He also noticed that he had a blank stare. His father immediately picked him up and noted that he was limp.  A few seconds later, pt. began crying and complaining about a headache.  He continued to cry and complain about what he described as a bad headache for 15-20 minutes.  His parents took him to the ER.  While waiting to be seen, he soon began to feel totally well without any complaints.  Later that evening, after occasionally complaining about headaches, he began to say he saw "sparkles" and that the "house was moving."  We took him back to the ER and they performed another EKG that proved negative. For a few days, he complained about being dizzy. On the third day, while riding in the van, he started complaining about being dizzy and started to act sleepy.  His complaints increased and he began to become less responsive, so his father took him to the ER where a catscan was taken that was negative.  A few days later, he was seen by a neurologist who determined that pt. had had seizures on both occasions.  He is not on any seizure medication.
This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  2/27/21: Pt received 1st Moderna vaccine 2/4/2021. She states that her symptoms 1st started out as a slight postnasal drip, which turned into a hoarse voice with a cough, which turned into a head cold, which has turned in due shortness of breath, diarrhea, and cough with associated chills. After 17 days of cold-like symptoms, pt was tested on 2/26 for COVID and tested positive. 2/27, pt worsened and presented to ED. Upon arrival to the emergency department, the patient's temperature is 100.2° F, heart rate 96, respiratory rate 24, saturating 84% on room air with blood pressure 164/84.  The patient's laboratory studies were significant for BUN 17, CR 1.47, lactate 2.2, D-dimer 6.79, and phosphorus 2.2.  The patient's chest x-ray showed no acute findings.  CT chest showed extensive acute bilateral pulmonary emboli involving most of the lobar and segmental branches, right greater than left with no saddle embolus.  Findings borderline for right heart strain, correlate with echocardiogram.  Peripheral ground-glass airspace opacities consistent with atypical/viral pneumonitis.  Reactive mediastinal and hilar lymphadenopathy.  EKG showed normal sinus rhythm, heart rate 93 with inferior infarct-age undetermined.  The patient was administered 1 L IV NS, ceftriaxone 1 g IV, azithromycin 500 mg IV, and heparin IV bolus and drip for PE indication. Remdesivir started.  2/28/21: Pt on 3 L oxygen. Azithromycin, ceftriaxone, remdesivir continued. Vancomycin started.  3/1/21: 1 L oxygen via nasal cannula. Small, nonproductive cough. Pt complains of SOB.  3/2/21: 1/2 blood cultures from 2/27 positive for CoNS. Vancomycin discontinued. Pt feeling much better. Still on 1 L oxygen via nasal cannula. More alert.  3/3: 5 day remdesivir course and azithromycin, ceftriaxone course completed. Patient weaned off oxygen. Pt discharged home with oxygen as a precaution. Pt also enrolled in COVID Safe At Home telehealth program.
After the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD-2021-413535, MOD-2021-413554 (Patient Link).
(R) deltoid PNEUMOVAX 0.5 mL IM @ 12:00 5/1/10 (0.5 ml) administered.  AM 5/2/10 (R) upper extremity red, warm to touch, tender when touched. MD aware. At 1430 5/2 area sl. less reddened however not returned to pre-vaccination state of health.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. No information about the patient's pertinent medical histories, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX injection, lot # M040137 with expiration date on 28-SEP-2018, lot # M042858 with expiration date on 21-OCT-2018, lot # M042496 with expiration date on 19-OCT-2018, lot # M044347 with expiration date on 04-NOV-2018 and lot # M044349 with expiration date on 04-NOV-2018 (dose and route of administrations were not reported). All of the VARIVAX vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) injection, lot # M046372 with expiration date on 08-JUL-2019. Administered doses of vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 20 minutes. Digital data logger was involved in recording the temperature excursion. The vaccine underwent a previous temperature excursion of 32 to 35 degrees Fahrenheit for 40 minutes. No adverse effects were reported. Additional information has been requested.
Unknown time of onset, this is when patient sought treatment in Immediate Care setting; clinician notes from that encounter: "Mom says pt had flu shot 2 days ago, then that night mom noticed his right deltoid was a bit red and a bit swelling. Swelling and redness increased since yesterday. Mom gave him Benadryl last night and maybe this am (she was not sure loratadine or Benadryl this am). His arm is a bit tender but not much pain. He still played soccer. He is still active as usual. He appeared well at home to mom besides the right arm problem. He has not had fever, swelling throat, lips, tongue, face or anywhere else besides the right upper arm. No rashes in body, abd pain, diarrhea, chest pain, SOB. He used to have mild allergies with egg and peanut at age 1 after the allergy tests. He had flu shot every year the last several years without reactions. He has been eating eggs and peanuts without reactions the last several years. Mom noted he grew out of his allergies.  He is not taking any regular medication besides vitamin. He is a healthy kid in general." Pt prescribed OTC analgesics and antibiotic in case infection present.
Information has been received from a physician concerning a 21 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL.  On 06-MAY-2008 the patient was vaccinated IM into the deltoid with a second 0.5ml dose of GARDASIL.  The patient developed unspecified arm pain at an unspecified time after the injection and inability to raise the arm above the shoulder level which caused her disability from her work.  The patient sought treatment with a chiropractor.  At the time of the report the patient was not recovered.  The physician considered the unspecified arm pain and inability to raise the arm above the shoulder level to be disabling.  Additional information has been requested.
died twice and was brought back; had huge blisters all over me; have numerous scars.; This case was reported by a consumer via media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included allergy.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening), blister and scar. On an unknown date, the outcome of the near death experience and blister were unknown and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the near death experience, blister and scar to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not  reported. The patient got the Shingles vaccine, took a reaction, died twice and was brought back, and had huge blisters all over and still had numerous scars. After receiving Tuberculosis (TB) vaccine, arm swelled up 3 times bigger and got blood poisoning. Twice after that when tested for employment at a hospital, the patient had the same reaction.  Booster vaccine (unknown name vaccine) had to have it 3 times, scabbed up and arm became infected all 3 times. The patient have horrible allergies. The patient said not a fan of vaccines. No contact details were reported.
4/22 pneumovax given. 4/24 pain redness, swelling below area of inj L mid arm. Tx'd Keflex, warm compresses 4/26 LUE swelling axilla to wrist medially, 4 cm oval swellng medial to antecubital area, tender
Pt received covid vaccine at 11:05, began having tickling throat and lips.  Received 10mg Zyrtec.  Began having chest tightness, received 0.3mg epinephrine IM.  EKG done, showed normal sinus.  Benadryl 50mg IM given.  EMS called and transferred to ER
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 02/17/22 at 3:30pm. Patient has not reported to Medical Clinic with symptoms at this time.
Pt reports Vaccination on Friday,  Fatigue on Saturday,  Rash starting on full body rash starting on Sunday that presented as dry flaky red lesion to his entire body and has continued to progress slowly with no oral involvement
Lymph node swelling in left underarm started the following day and continued to increase for about 24 hours to the size of a baseball.  Swelling has stabilized.  Waiting for swelling to decrease.  Will seek medical attention next week if swelling does not decline.
1 1/2" x 3" reddened site, warm & inflamed;bruised @ site 1/2" x 1/2" induration 1 1/2" x 3";fatigued x 2 days;inflammation x 3 days;
fever; shivering; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received second dose of bnt162b2 (IZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Feb2021 at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 for covid-19 immunisation. On an unspecified date in 2021 The patient experienced fever, shivering. Reporter had a fever, and he is shivering after the 2nd dose. Reporter is asking if he can take Tylenol after the 2nd dose. Reporter also asked if it will lessen the effectiveness of the vaccine. Reporter had the 2nd dose today 24Feb2021. Outcome of the events was unknown.  No follow up attempts are possible. Information on lot number/batch number cannot be requested. No further information is expected.
Approximately 5 minutes after vaccinations, patient began coughing and gagging and complaints of pain in feet. Looked pale. 5 minutes later, developed erythroderma and was scratching his ears and crying. Given Benadryl 25mg. Observed for 40 minutes. Pruritus and paleness resolved.
Vaccines given 6/11/03. On 6/13, child acted like he couldn't walk, irritable; temp got up to 102 degrees. Called satellite office. Used Ibuprofen and Tylenol to help with the fever. 6/23/03: Child is "acting normal" and did not require hospitalization or physician care.
The patient described feeling hot all over, hard to catch her breath, felt like a panic attack, blood pressure slightly elevated lasted 30 minutes.  Patient describes nausea and vomiting for 3 hours last night 8pm -11pm last night.  Patient describes cold / sweats and shivering
my legs getting very tired and weak,my legs started to bother me,legs were so heavy, especially in the upper leg; arm pain where the shot was at,my left arm has started bothering me, it is really sore; trouble sleeping at night; My ankles started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (my legs getting very tired and weak,my legs started to bother me,legs were so heavy, especially in the upper leg), PAIN IN EXTREMITY (arm pain where the shot was at,my left arm has started bothering me, it is really sore), SLEEP DISORDER (trouble sleeping at night) and ARTHRALGIA (My ankles started to hurt) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), CLOPIDOGREL BISULFATE (PLAVIX), Isosorbide mononitrate tabs, Carvedilol tabs and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 02-Feb-2021, 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 experienced LIMB DISCOMFORT (my legs getting very tired and weak,my legs started to bother me,legs were so heavy, especially in the upper leg), PAIN IN EXTREMITY (arm pain where the shot was at,my left arm has started bothering me, it is really sore), SLEEP DISORDER (trouble sleeping at night) and ARTHRALGIA (My ankles started to hurt). At the time of the report, LIMB DISCOMFORT (my legs getting very tired and weak,my legs started to bother me,legs were so heavy, especially in the upper leg), PAIN IN EXTREMITY (arm pain where the shot was at,my left arm has started bothering me, it is really sore), SLEEP DISORDER (trouble sleeping at night) and ARTHRALGIA (My ankles started to hurt) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment details included Stopped taking regularly Crestor 40 mg when the leg problem started.