chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intermittent bradycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRADYCARDIA (medically significant), outcome "unknown", described as "intermittent bradycardia". Addition information: Customer Verbatim: Is it possible to receive a medical exemption from Pfizer if I am experiencing intermittent bradycardia since receiving both covid vaccinations last year. I understandably do not want to take the booster shot but am mandated to do so as. (Place withheld) healthcare professional.  The lot number for bnt162b2 was not provided and will be requested during follow up.
One Week of URI symptoms presented to hospital 10/20 S/P fall and difficulty walking. He had respiratory failure and required intubation 10/21, Plasma pheresis and IVIG.  12/29/06 Received medical records from hospital which reveal patient admitted 10/30/06-11/6/06 for severe weakness & respiratory distress.  Patient had been transferred from outlying hospital where he presented on 10/20 s/p fall & difficulty walking one day prior.  Had symptoms of URI for approx 1 week prior & was being treated w/oral antibiotics.  Diagnosis was initially made at outlying hospital & patient received plasmapheresis x 5 cycles, last on 10/26, & was placed on ventilator.  LP done at outlying hospital.  Neuro, cardio & critical care consults done at second hospital.  Patient received IVIG  Received trach & PEG feeding tube.  Transferred to skilled nursing facility still on vent & antibiotics. FINAL DX: Guillain Barre Syndrome; respiratory failure; & pneumonia.
Gave Novartis H1N1 vaccine (4yrs and older) 0.5ml IM. Should have given Sanofi Pasteur H1N1 vaccine (6 months and older) 0.5ml IM. No signs or symptoms of distress noted.
I went into Atrial Fibrillation on 06/19/2020 , the day after the injection. I became unconscious while exercising and was transported by medic unit to Hospital. I received a cardioversion on 06/22/2020 and was prescribed Flecainide and Xarelto and went home. These  efforts and drugs did not work. I remained in A -Fib 60% of the time until I was given a cardiac ablation on 10/08 2020. There were times I thought I might die!
Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of breath, myalgias, cough, headache, and chest pain. Hospitalized with acute hypoxemic respiratory failure secondary to COVID-19 infection: administered steroids, antivirals, and anticoagulation. Patient currently hospitalized.
Received YF (yellow fever) vaccine and approx 50 min later returned to office C/O rash, lip swelling, facial swelling C/W anaphylaxis epinephrine 0.3 mg IM; BENADRUL 50mg IM stat.
A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 42-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment are not applicable, and the event is considered resolved.
8/13/08 Mother called health dept-concerned with increased temp with excessive pain in arm.  RN questioned mother clarified T 102.  Td arm sore; no localized reaction.  8/14/08 - Pt okay upon rising - no fever - min. soreness at site.
This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CC1BZIA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Ovarian cancer ((20 years ago)), Glaucoma and Deep vein thrombosis leg. Concomitant products included METFORMIN, PRASUGREL HYDROCHLORIDE (EFFIENT), GLIPIZIDE, FENOFIBRATE, LOSARTAN, TRAZODONE, ATORVASTATIN, LINAGLIPTIN (TRADJENTA), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), MECLIZINE HCL, ACETYLSALICYLIC ACID (BABY ASPIRIN), FERROUS SULFATE (SULFATE DE FERROUS), VITAMIN C [ASCORBIC ACID], FOLIC ACID, ZINC, CALCIUM and MAGNESIUM for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced LETHARGY (lethargy), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at a dose of UNK dosage form. On 13-Mar-2021, LETHARGY (lethargy), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache) had resolved.            Concomitant Medications also include i.e., eyedrops for glaucoma   This case was linked to MOD21-167887 (E2B Linked Report). This case was linked to MOD-2021-400304, MOD-2021-400464 (Patient Link).; Sender's Comments:  MOD21-167887:
No adverse event; 2 patients were vaccinated with vaccines after manufacturing expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients were vaccinated with vaccines after manufacturing expiry date) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients were vaccinated with vaccines after manufacturing expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients were vaccinated with vaccines after manufacturing expiry date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 patients were vaccinated with vaccines after manufacturing expiry date).    No concomitant medications were reported.   HCP stated patient was  vaccinated with vaccines after manufacturing expiry date. Patient number 2 received the vaccine on 19-Dec-2022. No AEs were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.   This case was linked to MODERNATX, INC.-MOD-2023-708312 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-708312:same reporter
Patient received his Shingrix shot on 3/21/2021 and started doxycycline 100 mg on 3/22/2021. On 3/23/2021, he broke out in welts and rashes all over his body; he reportedly took Benadryl which reduced the welts, but the rashes remained. Patient stated the rashes are not itchy, but they are very red. The patient called into the pharmacy on 3/26/2021 to report the incident. I explained to the patient it is difficult to say for certain whether it was the antibiotic or the vaccine that caused his reaction and I therefore would not feel comfortable giving him the second dose of the Shingrix vaccine. The patient understood and said he would discuss the situation with his primary care provider upon his appointment on 4/12/2021.
How long can the reaction last; This case was reported by a other health professional via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter asked how long can the reaction last after vaccination.
Full body paresthesia began on 4/16/21 with tingling and pins & needles. Worsened over the course of a month to additional stinging, burning sensations from head to toe. After that first month, sensations starting waning very slowly, with occasional flare-ups. Still experiencing this after 7 months. Have taken  AdvilPM every night for 5 months, to allay the worsening feeling at night and allow sleep.
This spontaneous report as received from a nurse (L.V.N.) refers to a 12 years old female patient with asthma. The patient had drug allergies to loracarbef. The patient was vaccinated with a dose of GARDASIL (lot # reported as H010123, expiration date 16-JAN-2012) intramuscularly in the right arm on 14-AUG-2012. Concomitant medications included PROAIR, VERAMYST and ADVAIR. It was reported that the patient developed symptoms tingling and numbness on the palm of her right hand after receiving GARDASIL. The symptoms then progressed to the rest of the right arm and left arm. The patient sought for medical attention by going to an emergency room and released. No treatment was given. Lab diagnostics studies performed were reported as none At the time of the report, the patient was recovering. Additional information has been requested.
It was reported in a published article, that a female patient, with no reported history of symptoms of acute rubella infection, including rash, fever, lymphadenopathy, or arthralgia, who in Oct 2003 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)(manufacturer unknown). On Feb 16 2004 the patient came into contact with people affected with a rubella outbreak, as it was reported that in utero infection of the fetus likely occurred 5-7days after exposure. On Mar 26 2004 the patient reported to an emergency department and was determined by a urine test to be pregnant, with confirmation by a blood test. Her last menstrual period and conception were projected to have occurred on Feb 8 2004 and Feb 22 2004, respectively. During a routine prenatal visit, one month later, the patient was determined to be immune to rubella on the basis of presence of rubella specific IgG antibodies. On Nov 4 2004 she gave birth to a female infant weighing 5lbs, 10oz. The estimated gestational age was approximately 38 weeks on the basis of a prenatal ultrasound performed during the first trimester of pregnancy. At birth the infant was noted to have a left eye cataract, which prompted referral to an ophthalmologist, who repaired the cataract five weeks later. A newborn hearing screen was conducted and the infants right ear passed the screening test but the left ear required further evaluation by an audiologist. No other physical abnormalities were noted. During two subsequent well baby visits, a head circumference of less than the fifth percentile was noted, with no other abnormalities. At an age of 10 weeks, the infant was taken to an emergency department with fever, vomiting, irritability, and poor feeding and was hospitalized. During the hospital course the infant received diagnoses of microcephaly, patient ductus arteriosus, bilateral hearing impairment, hepatosplenomegaly, and failure to thrive. It was reported that on the basis of these clinical findings congential rubella syndrome was suspected. The diagnosis was confirmed by positive rubella IgM and positive viral cultures from urine and nasopharyngeal specimens. The genetic sequence was determined to be that of the wild type rubella virus. Information received on Nov 29 2005 contained the following adverse experienced nausea Mar 26 2004 and vomiting Mar 26 2004. Additional information is not expected. A copy of the published article is attached as further documentation of the patients experience.
Erythematous edematous (L) upper arm, bronchospasms. Rocephin, Prelone syrup, CXR. F/U in 1 day.
Fever of 102°, body aches, nausea, skin hurt, wrists and ankles hurt, headache
pt recvd vax & Lt Arm began swelling; got red, hard; felt like she was going to pass out; BP inc 160/80; flushed diaphoretic; tx w/ DPH & Zantac;
Patient got a rash at injection site on 6/9/17 in the afternoon and then on 6/11/17 she noticed an itchy rash on her back at which point she went to urgent care and her provider diagnosed the rash as zoster icd-10 B02.9.
Developed itchy red rash/hives on both fore arms(slowly fading out), headache(about 2 hours after shot for 20-30 minutes) and nausea(within 10 minutes of receiving shot and lasting about 15 minutes).
Given Dtap and Rotateq on 7/15/21 at around 12 noon.  Pt did well until 3:30 pm on 7/17/21 when began unconsolable crying x 30-45 min and had limb shaking and "clicking" mouth sounds.  No fever.  At 45 min, all symptoms subsided and pt has gotten back to baseline
Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of the group along with Moderna. Treatment details was not reported by the reporter. This case contains information about 12th patient out of 25 patients. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
shanking chills (fever taken = 101.9), body aches, fatigue, nausea & vomiting
whole body intense itching without provocation, worst on feet, hands, trunk. scratching produces red wheals. no response to moisturizer. occurs multiple times daily. Use of daily cetirizine reduces symptom frequency and intensity and distribution: feet and abdomen and upper back remain most likely to start itching without provocation.  Patient does not have history of seasonal or food allergies.
Sore arm; Chills; Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Sore arm), CHILLS (Chills), EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: High dose flu (Manufacturer- Sanofi Pasteur Lot number- UJ731AB Route- Intramuscular Body site- Left arm) on 30-Sep-2021. Past adverse reactions to the above products included No adverse event with High dose flu. Concurrent medical conditions included Hypercholesteraemia and Erectile dysfunction. Concomitant products included TADALAFIL (CIALIS) for Erectile dysfunction, SIMVASTATIN for Hyperlipidemia.    On 29-Oct-2021 at 1:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On an unknown date, the patient experienced MYALGIA (Sore arm) and CHILLS (Chills). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved. At the time of the report, MYALGIA (Sore arm) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It is reported that patient had no allergies and no history of COVID-19.  The patient experienced sore arm and chills. The symptoms went away within 24 hours.
The morning after the shot, my daughter had a 2-hour long bought of vomiting. She was incredibly fatigued and feverish as well. She previously had no reaction to the Pfizer series.
Information has been received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients received doses of improperly stored VAQTA (lot #, dose and route not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Physical reaction; Neurological symptom; This spontaneous case was reported by a health care professional and describes the occurrence of NEUROLOGICAL SYMPTOM (Neurological symptom) and MALAISE (Physical reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (Neurological symptom) and MALAISE (Physical reaction). At the time of the report, NEUROLOGICAL SYMPTOM (Neurological symptom) and MALAISE (Physical reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to the events was not provided.   Reporter did not allow further contact
I got mild and moderate in pain in my chest. I never had it at night, but I had it during the day. It happened at the end of April until the end of June. I also had shortness of breath. I feel like I can't do my full inhale of air. I had pain when I did inhale. I had an appointment with my PCP, but I did not have an appointment with my PCP three weeks. I told myself that if it got worse, I would go to urgent care.
tested positive for Covid; tested positive for Covid; loss of strength/ lack of stability/ weakness/he is still very weak; aches; drowsiness; loosing weight; lower leg edema; lethargic; still dizzy; triggered his immune system and his immune system is now one heck of a fight; swelling; loss of appetite; shortness of breath where he cannot walk; unable to walk; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 81, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Oct2020 to an unknown date and was hospitalized for almost a week; chronic lymphocytic leukaemia (CLL) from an unknown date and unknown if ongoing, open heart surgery from an unknown date and unknown if ongoing and 'severe spines' from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 02Feb2021 for COVID-19 immunization and experienced light headiness, chills, dizziness, fever, tired, loss of appetite and very weak. The patient experienced lack of stability/loss of strength, aches, pains, difficulty breathing within 24 hours of the second dose in Feb2021 and was hospitalized. While in the hospital for two days, the patient underwent lab tests which included Sars-Cov-2 test after the second dose which came back positive. The patient had symptoms which included nauseous, very exhausted, shortness of breath and lethargic the evening of the second shot and ended up being transported by ambulance to the hospital. The patient experienced continued weakness, shortness of breath, drowsiness, lost weight, lower leg edema, shortness of breath where he cannot walk, swelling, still is dizzy, lack of appetite after discharge and "have triggered his immune system; his immune system is now in one heck of a fight" on an unknown date, Feb2021. The patient underwent lab tests and procedures which included D-Dimer test (fibrin degradation products): elevated on an unknown date from previous diagnosis of Covid back in Oct2020, was hospitalized for about a week and upon discharge he continued to feel fatigue with elevated D-dimer; fibrin degradation products: unknown results on 17Mar2021, investigation tests after hospitalization on an unknown date and all of his test results were normal. The clinical outcome of the events COVID-19, asthenia, somnolence, weight decreased, lower leg edema, lethargy, and immune system disorder was unknown; for pain, dizziness, swelling, decreased appetite, dyspnea and gait inability was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Woke up early Sunday very hot to touch, not feeling good, complaining of muscle aches, tired and ears painful. Gave Tylenol on 7/16, FNP. No ear infection found and instructed to continue Tylenol or Advil. On 7/18, mom states child is acting fine.
Pt says injection site hurts and right arm difficult in raising arm. Pt did go to ER.
Information has been received from a physician concerning a 17 year old female who on 24-MAR-2008 was vaccinated with her first dose of GARDASIL (lot number 658556/1060U).  Concomitant therapy included HAVRIX.  The patient was fine in the office then went immediately to dance practice.  During dance practice, she noticed the arm she received the GARDASIL and one side of her body turned red (unspecified which arm and which side).  This red color lasted 30 minutes then she completely recovered.  No further information available.  The patient sought unspecified medical treatment with a call to the office.  Additional information has been requested.