chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She continues with those palpitations; She feels like she has tachycardia; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (She continues with those palpitations), TACHYCARDIA (She feels like she has tachycardia), CHILLS (Chills) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076c21a and 053E21A) for COVID-19 vaccination.     No medical history were provided by the reporter.  Concomitant products included MECLIZINE [MECLOZINE] for Dizziness.   On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced TACHYCARDIA (She feels like she has tachycardia), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced PALPITATIONS (She continues with those palpitations). At the time of the report, PALPITATIONS (She continues with those palpitations), TACHYCARDIA (She feels like she has tachycardia), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            This is a spontaneous case concerning a 65-year-old female patient with no relevant medical history reported, who experienced non-serious unexpected events of Palpitations, Tachycardia, Chills and Pyrexia. The events occurred on an unknown date after the second dose of mRNA-1273. The rechallenge for event Palpitations was not applicable as the outcome after dose 1 is unknown. The rechallenge for event Tachycardia and Chills was not applicable as these events occurred only after second dose and no additional dosing is expected. The rechallenge for event Pyrexia was positive as the adverse event resolved prior to second dose and reoccur. The benefit-risk relationship of mRNA-1273 is not affected by this report. No treatment medications provided. She felt like she had tachycardia.   This case was linked to MOD-2021-355796 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 65-year-old female patient with no relevant medical history reported, who experienced non-serious unexpected events of Palpitations, Tachycardia, Chills and Pyrexia. The events occurred on an unknown date after the second dose of mRNA-1273. The rechallenge for event Palpitations was not applicable as the outcome after dose 1 is unknown. The rechallenge for event Tachycardia and Chills was not applicable as these events occurred only after second dose and no additional dosing is expected. The rechallenge for event Pyrexia was positive as the adverse event resolved prior to second dose and reoccur. The benefit-risk relationship of mRNA-1273 is not affected by this report.
autoimmune flare up including swollen, chapped, cracked lips; raw throat; sores in mouth; eczema on eyelids starting one week after vaccine and continuing to today; treatment with antihistamines (Zyrtec, Zantac, Benadryl)
Pt admitted to ED for SOB, choking sensation hours post Moderna COVID-19 vaccine, dose #2. Concerned for possible anaphylaxis/allergic reaction.  Pt was diagnosis of  acute on chronic hypoxemic respiratory failure.  Questionable vaccine related reaction.
Patient reported that she has had hypersalivation since receiving the vaccine.  She said it started almost instantly after she left the pharmacy.  She says it is still happening the day after receiving her vaccine.
Lost all sense of taste, I can't taste anything; This is a spontaneous report from a contactable consumer (Patient).  A 63-year-old patient of unknown gender received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0171 and expiry date: Not reported), via an unspecified route of administration into the left arm on 13May2021 at 08: 00 as dose 2, single (Age at vaccination: 62-year-old) for COVID-19 immunization. Medical history included: Diabetes mellitus (ongoing). Concomitant medications included: Dulaglutide (TRULICITY) one shot once week and Metformin for Diabetes mellitus. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EW0171 and expiry date: Not reported), via an unspecified route of administration into the left arm on 22Apr2021 as dose 1, single (Age at vaccination: 62-year-old) for COVID-19 immunization. On 13May2021, the patient had shot at 08: 00 O'clock and started noticing symptoms 4 hours after getting the shot. The patient was having a strange reaction. The patient had lost all sense of taste everything. Tried 'soda', every kind and variety 'of soda', they were all taste like salsa. The patient could not taste anything. The patient had lab work done about 2 weeks ago between the 2 shots. The patient had a doctor visit last week. Laboratory date included: Hemoglobin A1C, CBC (complete Blood Count), Urinalysis and diabetic test. The results were not reported. The patient did not receive any treatment for adverse events. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Concomitant products included FLOMAX and gabapentin. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain and chills. On an unknown date, the outcome of the fever, pain and chills were recovered/resolved. The reporter considered the fever, pain and chills to be related to SHINGRIX. Additional details were provided as follows: The case was reported for reporter's husband. The patient reported that she and her husband had the SHINGRIX. The patient had chills, fever, and achiness and lasted about 5 days. This was 1of 2 cases, reported by the same reporter.
it was hard for her to turn head "it must having affected the little joints in my head/neck ( ~ 10 days); after the first 2 doses she was really achy; after the first 2 doses she was really achy and tired; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (it was hard for her to turn head "it must having affected the little joints in my head/neck ( ~ 10 days)), MYALGIA (after the first 2 doses she was really achy), FATIGUE (after the first 2 doses she was really achy and tired) and ARTHRALGIA (joint aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHROPATHY (it was hard for her to turn head "it must having affected the little joints in my head/neck ( ~ 10 days)), MYALGIA (after the first 2 doses she was really achy), FATIGUE (after the first 2 doses she was really achy and tired) and ARTHRALGIA (joint aches). At the time of the report, ARTHROPATHY (it was hard for her to turn head "it must having affected the little joints in my head/neck ( ~ 10 days)), MYALGIA (after the first 2 doses she was really achy), FATIGUE (after the first 2 doses she was really achy and tired) and ARTHRALGIA (joint aches) outcome was unknown.            Concomitant mediations were not reported.  Patient stated after the first 2 doses she was really achy and tired and it was hard for her to turn head it must having affected the little joints in my head/neck (10 days). She also mentioned joint aches.  Treatment information was not reported.   This case was linked to MOD-2022-533476, MOD-2022-533335 (Patient Link).
real rapid heartrate with a duration of 4 hours; a lot of shaking with a duration of 4 hours; a lot of nausea with a duration of 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (real rapid heartrate with a duration of 4 hours), TREMOR (a lot of shaking with a duration of 4 hours) and NAUSEA (a lot of nausea with a duration of 4 hours) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced TACHYCARDIA (real rapid heartrate with a duration of 4 hours), TREMOR (a lot of shaking with a duration of 4 hours) and NAUSEA (a lot of nausea with a duration of 4 hours). On 23-Feb-2021, TACHYCARDIA (real rapid heartrate with a duration of 4 hours), TREMOR (a lot of shaking with a duration of 4 hours) and NAUSEA (a lot of nausea with a duration of 4 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 11-MAR-2017, the patient was vaccinated with M-M-R II (dose, strength, frequency, anatomical location, lot number and expiration date were not reported), intramuscularly, for prophylaxis. No adverse effects were reported. Additional information has been requested.
pt recv vax 21OCT95 & devel tingling in legs 2NOV95, hosp 7NOV;recovered w/residual damage, unable to work;dx GBS;
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 18-APR-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reports as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Awoke on Day 2 post injection with extremely stiff neck on side vaccine was received. Neck stiffness and pain with lateral movement slowly subsided over 3 -4days. No  known sequelae.
Coughing; Body aches; Fever of 101; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) received from an unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 21:00, the patient experienced body aches, fever of 101, headache, fatigue and coughing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches, fever of 101, headache, fatigue and coughing was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
ADMINISTRATION ERROR. Patient was under age for the Moderna BOOSTER vaccine. No adverse reaction.
This all began on 04/16/2022. I am not sure if it is related but the doctor thought it may have started to wake up something. I went in my hot tub and then took a shower and the rash bright red it looked like a line from my ear to my neck that was in a V shape. it went a little under both breasts and a little under my arm pit. It was itchy, hot and painful. My head was itchy also, so I was using Sarna lotion liberally all over. By Sunday or Monday I was using hydrocortisone cream on my neck because that was the worst. After that the symptoms slowly diminished so each day was a little better. I kept my EpiPen with me, I though I may needed to go to a quick care place, but decided to wait. I got in to see my doctor 04/20/2022. She looked at the rash, however it was much better and I was told stop the hydrocortisone cream and stay out of the hot tub. I have just been taking luke warm showers. Every so often I get a light itchy feeling and I just rub it lightly. It is mostly gone now.
Outbreak of shingles on the face and head. Received medicine (which didn't help) and symptoms subsided after about a month.
the second dose gave me covid arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I normally have migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for Covid-19 immunization, reaction(s): "The first dose had side effects". The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "the second dose gave me covid arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt developed scattered dime size and smaller rash, day after shots given, over face, arms, and torso. Ran low grade fever, laid around and wouldn't eat. Rash did not itch. Gave BENADRYL p.o.
1st shot...none 2nd shot:  1st night-fever, headache, chills major all over stiffness                          2nd night- fever over 100 degrees, major chills and shivering, joint stiffness, no headache                          3rd night-  no fever but MAJOR sweating, sweating, sweating.  No headache, stiffness much improved.                           4th day - all symptoms almost gone, no headache, stiffness improved.  Arm still sore
This is a spontaneous report from contactable Pediatrician. A 2-year-old male patient received the fourth dose of PREVNAR on the 10Sep2007. Past vaccines included the first dose of PREVNAR on the 30Oct2006, the second dose on 09Jan2007 and the third dose on 13Mar2007. There were no relevant medical history and concomitant medications. The patient experienced wheezing since an unknown date in 2009. The patient also experienced recurrent ear infections (date unknown). Therapeutic measures taken an a result of the events includes two surgeries for the recurrent ear infections and unspecified bronchodilators for the wheezing. At the time of report, the clinical outcome of the reported events was unknown. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR.
A pharmacy employee reported that the patient developed swelling at the Acel-Imune injection site. He recovered. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Acel-Imune lot 469-396.
BOOSTER DOSE ADMINISTERED PRIOR TO THE RECOMMENDED INTERVAL;   2ND DOSE WAS ADMNISTERED ON 9/9/2021
CLIENT ARRIVED IN HEALTH UNIT FOR DEPO PROVERA AND GARDASIL INJECTIONS,  AFTER BOTH INJECTIONS CLIENT SAID "SHE FELT LIKE SHE WAS GOING TO PASS OUT." CLIENT WAS EASED TO FLOOR AFTER PASSING OUT CLIENT THEN HAD A CONVULSIVE SEIZURE FOR APPROXIMATELY 2 MINUTES WITH BLADDER INCONTINENCE. B/P AT TIME WAS 129/68 FOLLOWING SEIZURE B/P WAS 128/35. MANUAL B/P WAS 132/78. CLIENT A/O X 3 WHEN LHU WITH MOTHER. ADVISED TO REPORT TO EMERGENCY DEPARTMENT ASAP FOR FURTHER EVALUATION. NO HISTORY OF SEIZURES REPORTED. CLIENT AND MOTHER VERBALIZED UNDERSTANDING OF NEED FOR FURTHER EVALUATION AT EMERGENCY DEPARTMENT. CLIENT STABLE WHEN LEFT LHU 10/14/2011 1:30 PM attemptedt to call client for follow up information on condition and MD evaluation.  Both numbers listed for client stated out of service with no option to leave voicemail message.
Client developed soreness in the arm the day after receiving vaccine. It seemed to improve, but now almost 4 weeks later continues with a lump & pain at injection site. Encouraged client to take Tylenol or Ibuprofen as per norm meds taken, measure lump & redness & Benadryl prn with precautions for increased drowsiness.
PT SPOUSE REPORTS OUTBREAK OF SHINGLES OCCURRED APPROX 10 DAYS AFTER RECEIVING FLUARIX
Shortly after my second dose I developed an extreme metallic taste in my mouth. Within days it consumed the limited sense of smell I had post-Covid (early January positive test). I have been looking into metallic taste, and at this point, I'm concerned because instead of improving, it is more pronounced.  Additionally, my 18 year old son who had his first dose of Moderna on 4/4/21 started complaining of a metallic taste the next day and has also seen the taste/smell get worse. He is referring to any gas he expels as "chemical farts" because it does have an extreme  chemical smell.
(Small Pericardial effusion). Acute pain in the chest, esophagus and throat, pain when breathing, fever, severe headache, diarrhea, fatigue. 12 hrs admitted and 3 days later admitted to hospital. Where a pericardiocentesis was performed.
Sore injection site. Injection was given via tuberculin syringe and did not penetrate the muscle, it was subcutaneous. My dose was a waste and I may not have immunity due to operator error.
Pediatric patients (6 & 7 years old) received the First Pediatric dose of Moderna COVID-19 Vaccine from a vial that was meant to be used for 6 Months to 5-years-old.; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Pediatric patients (6 & 7 years old) received the First Pediatric dose of Moderna COVID-19 Vaccine from a vial that was meant to be used for 6 Months to 5-years-old.) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Pediatric patients (6 & 7 years old) received the First Pediatric dose of Moderna COVID-19 Vaccine from a vial that was meant to be used for 6 Months to 5-years-old.). At the time of the report, INCORRECT DOSE ADMINISTERED (Pediatric patients (6 & 7 years old) received the First Pediatric dose of Moderna COVID-19 Vaccine from a vial that was meant to be used for 6 Months to 5-years-old.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.
Syncopal episode with seizure-like activity of the extremities for 3-5 seconds.
Patient was diagnosed with Acute Myocarditis with no previous history of any heart issues.    From Patient Medical file:  The patient was given 650 mg of Tylenol orally as he presented on 12/24/21 with a fever of 102.  Initial EKG and chest x-ray performed.  The EKG was suspicious for pericarditis according to Dr.  Chest x-ray was clear.  Dr. suggested running a troponin level.  This was surprisingly elevated over 22.  Case was discussed with cardiology who recommended an echocardiogram and admission to the hospital for further observation and management.  Screening blood work was ordered.  The patient was comfortable with admission.  Case was discussed with the hospitalist.  At this point, symptoms seem to be suspicious of myocarditis.  It is entirely possible that this is a by product of his recent COVID-19 vaccination.
headache, diarrhea, nasal congestion, sinus congestion, post nasal drainage, sneezing. starting 12/5/21
VASOVAGAL SYNCOPE- PATIENT PASSED OUT.  PATIENT CAME TO MOMENTS LATER.
81 year old male presented to Emergency Department on 10/16/22 with a chief complaint of significant shortness of breath. Oxygen saturation was 87% on room air, patient required 10 L of oxygen, oxygen saturation improved to 97%. Admitted for acute hypoxic respiratory failure. Extensive work up done, all negative including pneumonia, PE, CHF exacerbation. Hospitalization thought to be due to inflammatory reaction to the flu and/or covid vaccinations that he received on 10/14/22. Patient was eventually weaned off of oxygen and hemodynamically/clinically stable upon discharge on 10/18/22.  Of note, patient does have a history of receiving both the flu vaccine and the covid vaccine - does not appear that this type of reaction has happened before after receiving these vaccines. However, upon review of vaccine records, it appears that patient received the bivalent covid vaccine. Recent vaccine history is as follows: -10/14/22: Moderna COVID-19 Bivalent vaccine -10/14/22: Fluad Quadrivalent vaccine -03/31/21: Moderna COVID-19 vaccine -03/03/21: Moderna COVID-19 vaccine -10/01/20: Flu Trivalent PF vaccine
had first dose of Ipol on 15OCT2021 and second on 09AUG2022 with no reported adverse event; Initial information received on 11-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had first dose of IPV (VERO) [IPOL] on 15oct2021 and second on 09aug2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination; HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 15-Oct-2021 Patient had received a 0.5ml (dose 1) 1X (once) first dose of IPV (VERO) vaccine (strength, formulation was unknown, lot T1E871M and expiry date: 10-Oct-2022) via intramuscular route in the left deltoid for Immunization and on 09-Aug-2022, the patient received a second dose of 0.5ml 1X(once) dose of same vaccine (strength, formulation, lot number and expiry date was unknown) via intramuscular route in the left deltoid for Immunization (inappropriate schedule of product administration, Latency: 9 months 25 days).  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.