chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Side effects due to the Moderna injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects due to the Moderna injection) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects due to the Moderna injection). At the time of the report, VACCINATION COMPLICATION (Side effects due to the Moderna injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information about concomitant medication provided.  No treatment information provided.
Information has been receive from a medical assistant referring to a 6 months old female patient. No relevant medical history or concurrent conditions were reported. On 04-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash appearing on trunk,arms,legs,intermittant throughout the day; Redness itiching with hives on her neck trunk; Redness itiching with hives on her neck trunk; Redness itiching with hives on her neck trunk; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness itiching with hives on her neck trunk), PRURITUS (Redness itiching with hives on her neck trunk), URTICARIA (Redness itiching with hives on her neck trunk) and RASH (Rash appearing on trunk,arms,legs,intermittant throughout the day) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced ERYTHEMA (Redness itiching with hives on her neck trunk), PRURITUS (Redness itiching with hives on her neck trunk) and URTICARIA (Redness itiching with hives on her neck trunk). On 13-Dec-2021, the patient experienced RASH (Rash appearing on trunk,arms,legs,intermittant throughout the day). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness itiching with hives on her neck trunk), PRURITUS (Redness itiching with hives on her neck trunk), URTICARIA (Redness itiching with hives on her neck trunk) and RASH (Rash appearing on trunk,arms,legs,intermittant throughout the day) had not resolved.            No relevant concomitant medications were provided. No treatment information was provided. Patient continued to experience symptoms and had no resolution at the time of reporting.   This case was linked to MOD-2021-406383, MOD-2021-410574 (Patient Link).
Heart palpation; back and shoulder pain; back and shoulder pain; High blood pressure; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 13:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to sofa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient had experienced heart palpitation, shoulder and back pain and high blood pressure. Adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events heart palpitation, high blood pressure, back and shoulder pain was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Pt received inj. on 5/23/08. Broke out in rash on 6/6/08. Saw MD on 6/16/08 and confirmed shingle breakout.
Feeling unwell/ NOT FEELING WELL; 1st dose COVID-19 Vaccine 20-DEC-2020, 2nd dose COVID-19 Vaccine 1-Feb-2021; Illness; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), MALAISE (Feeling unwell/ NOT FEELING WELL), ILLNESS (Illness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose COVID-19 Vaccine 20-DEC-2020, 2nd dose COVID-19 Vaccine 1-Feb-2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 01-Jul-2021, the patient experienced COVID-19 (COVID-19). On 29-Dec-2021, the patient experienced ILLNESS (Illness). On an unknown date, the patient experienced MALAISE (Feeling unwell/ NOT FEELING WELL) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose COVID-19 Vaccine 20-DEC-2020, 2nd dose COVID-19 Vaccine 1-Feb-2021). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, MALAISE (Feeling unwell/ NOT FEELING WELL) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose COVID-19 Vaccine 20-DEC-2020, 2nd dose COVID-19 Vaccine 1-Feb-2021) outcome was unknown and ILLNESS (Illness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, SARS-CoV-2 test: (Positive) Positive.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
Swelling of lower legs and hand (right side). No swelling of face.  Told patient to call Docotor and goto ER.
low heart rate after vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101117509 (Pfizer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthamtic" (unspecified if ongoing), notes: she is on a blood thinner, asthamtic, and has pacemaker; "pacemaker" (unspecified if ongoing), notes: she is on a blood thinner, asthamtic, and has pacemaker. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunisation. The following information was reported: HEART RATE DECREASED (non-serious), outcome "unknown", described as "low heart rate after vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: caller mentioned she experienced a low heart rate after receiving the 2nd dose. (Name withheld) also mentioned before having the 1st dose of Pfizer vaccine she is on a blood thinner, asthamtic, and has pacemaker.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIZZINESS (Light headed). At the time of the report, DIZZINESS (Light headed) outcome was unknown.            No concomitant medications provided. No treatment information provided.   Reporter did not allow further contact
Fever, rash headache, itching, pain in the arm, redness on the site of the vaccine administration (right arm) and redness in the left arm.
GERD; Dizziness soon; Armpit glands swollen; Shortness of breath; Severe chest pain; Severe headache; Nauseous; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DIZZINESS (Dizziness soon), AXILLARY PAIN (Armpit glands swollen), DYSPNOEA (Shortness of breath) and CHEST PAIN (Severe chest pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included RISPERIDONE (RISPERDAL), SIMVASTATIN, TAMSULOSIN, FINASTERIDE and PANTOPRAZOLE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD), DIZZINESS (Dizziness soon), AXILLARY PAIN (Armpit glands swollen), DYSPNOEA (Shortness of breath), CHEST PAIN (Severe chest pain), HEADACHE (Severe headache), NAUSEA (Nauseous) and VOMITING (Throwing up). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Mar-2021, GASTROOESOPHAGEAL REFLUX DISEASE (GERD) outcome was unknown and DIZZINESS (Dizziness soon), AXILLARY PAIN (Armpit glands swollen), DYSPNOEA (Shortness of breath), CHEST PAIN (Severe chest pain), HEADACHE (Severe headache), NAUSEA (Nauseous) and VOMITING (Throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient described severe throat soreness.  Experienced trouble swallowing, could not eat for the remainder of day.
covid arm; warm to the touch; red marking on arm/ redness; Pain in the arm/ hurts/ hurts to touch the red part; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE ERYTHEMA (red marking on arm/ redness) and VACCINATION SITE PAIN (Pain in the arm/ hurts/ hurts to touch the red part) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included DICLOFENAC, FUROSEMIDE, FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), MONTELUKAST, OMEPRAZOLE, AMLODIPINE, GUAIFENESIN (MUCINEX), TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL (VENTOLIN [SALBUTAMOL]), VITAMIN C [ASCORBIC ACID], VITAMIN E NOS and IRON for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE ERYTHEMA (red marking on arm/ redness) and VACCINATION SITE PAIN (Pain in the arm/ hurts/ hurts to touch the red part). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE ERYTHEMA (red marking on arm/ redness) and VACCINATION SITE PAIN (Pain in the arm/ hurts/ hurts to touch the red part) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Headache, Myalgia, NauseaVomiting, Numbness in bottom lip Narrative:
Narrative: Covid positive Following Completion of Covid vaccine series 03/23 Covid vaccine dose #1 04/20 Covid Vaccine dose #2 05/21 Covid positive, tested as part of pre-procedure testing, no symptoms reported.
Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021.  After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat.  Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm
had mild fever of 100.9 on 17MAY95 then it went higher & devel convuls lasting a few mins;
Initially, patient had swollen left cheek swelling that seemed improved by next day. Then developed significant right cheek swelling with violacious skin, nontender. On oral exam, both parotid glands had significant erythema and edema around the duct. Patient remained relatively asymptomatic.
On both lower extremities only, scattered erythematous, 3 mm-10mm macules with central clearing. lesions arose within fifteen minutes of vaccinations (pt was asleep within 5 minutes of administration and experienced. No labored breathing, cyanosis, or swelling of mucous membrane.
Same day of shot experienced sore arm and shoulder pain. To date dull numbness and decreased range of motion to left upper arm. Have been working on range of motion  exercises, but progress is slow..never had  ARM PROBLEMS BEFORE SHOT.
Was given DTaP #5 in left upper arm on 8/6/03. Today developed redness around injection site at least 4 x 4cm. No fever, no N/VID, no difficulty swallowing, talking, breathing. No voice changes. Arm swollen and child states his arm itches.
Next day while at park with children I started feeling chest pain. It was similar to really bad heart burn. The pain was gradually getting worse and worse. At one point I got light headed and felt like I was going to pass out. I told my wife I had to get somewhere warm because I was freezing. We went to the car and turned on the heater. After approximately 10-15 minutes the chest pain went away. I still had chills and fever for the rest of the day.   I was told this was an side effect of the vaccine. More recently while discussing with my medical provider, I had myocarditis. I also was advised to submit this report.
Pfizer BioNTech COVID-19 Vaccine EUA   Symptoms started the following morning after getting second COVID-19 vaccine. Symptoms were fever, nausea, chills, headache, myalgia, and fatigue. All symptoms resolved by the evening on 1/25/2021 except fatigue. Fatigue still present on 1/26/2021.
Patient fainted in waiting room was diaphoretic and pale. No injury occurred. Vitals at time of incident (10:35) are as follows blood sugar 75 Pulse 51 respirations 14 pulse ox 97% Blood pressure 102/80. Patient was given juice, color returned to her lips/face. Patient was monitored for 10 minutes by nurse and provider.
administered the FLUZONE HIGH-DOSE QIV to 9 employees that are under the age of 65 with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER) and 2022SA448075(CLUSTER).  This case involves Adult and unknown gender patient who was administered the fluzone high-dose qiv who was under the age of 65 with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength and dose not reported; lot UT7729CA) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the the fluzone high-dose qiv was administered to 9 employees that are under the age of 65 with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.; Sender's Comments:  related FLUZONE HD QIV CASE 01340119: related FLUZONE HD QIV CASE 01340226: related FLUZONE HD QIV CASE 01340229: related FLUZONE HD QIV CASE 01340234: related FLUZONE HD QIV CASE 01340240: related FLUZONE HD QIV CASE 01340243: related FLUZONE HD QIV CASE 01340302: related FLUZONE HD QIV CASE 01340314:
Infant had a sudden event with cyanosis, pallor, bradycardia and shallow breathing. This lasted approximately 20 minutes. Occurred about 5 minutes after immunizations. Discharge record for the overnight hospitalizations gives a diagnosis of immunization reaction.
On Wednesday, November 23rd, 2022, our family was exposed to COVID-19. I started having symptoms on Saturday, November 26, 2022. I had a stuffy nose, post nasal drip, sore throat, stomachache, heartburn, diarrhea, and body aches. I also had a headache with a migraine aura, and my lymph nodes were swollen. I had brain fog as well. By November 29, 2022, I went to check the mail around the corner and experienced shortness of breath and fatigue. My partner and roommate were both positive for COVID-19, but I tested negative for COVID-19 multiple times. I had a telehealth appointment. The doctor said I probably had COVID-19. She prescribed PAXLOVID but I didn't take it since the window for that was closing by the time I picked up the medicine. I took extra vitamin D3 and extra JUICE PLUS. I used a NETI POT for nasal irrigation.
body ache; fever; chills; sharp headache / dull headache; pain at injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), INJECTION SITE PAIN (pain at injection site left arm), PYREXIA (fever), CHILLS (chills) and HEADACHE (sharp headache / dull headache) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site left arm). On an unknown date, the patient experienced PAIN (body ache), PYREXIA (fever), CHILLS (chills) and HEADACHE (sharp headache / dull headache). On 15-Feb-2021, INJECTION SITE PAIN (pain at injection site left arm) had resolved. At the time of the report, PAIN (body ache), PYREXIA (fever), CHILLS (chills) and HEADACHE (sharp headache / dull headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided as, Tylenol 4-6 times daily, then changed to Advil 17-MARCH-2021 one dose 4-6 times daily. On 18-March-2021 Advil increased to 3 doses, every 4-6 hours daily IV fentanyl, gabapentin, naproxen, tramadol, Fioricet. On 23-MARCH-2021 caller consulted ER and treatment included CT scan, lab, IV fentanyl with a pain score 6 out of 10. A Zoom follow up appointment has taken place on 29-MARCH-2021 and medications were changed to Rx naproxen, fioricet,no tramadol and tapering off gabapentin.
I had a rash on my arm and chest a couple of hours after the vaccination. They told me if the rash didn't go away after a couple of days, I would need an antibiotic to treat the rash and cellulitis that developed under the injection site. I had heart palpitations 02/28/2021 and went to the emergency room; they ran EKGs and blood work tests to see what was wrong with the heart. They diagnosed me with supraventricular tachycardia (STV) and I had a follow-up with a cardiologist two days later. I again had a heart palpitation episode on 10/15/2021 where my heart rate was 225+bpm for a couple of hours and another STV episode on 12/26/2021 where my heart rate was 220+ bpm for a couple of hours. I still haven't recovered since then; I have an echocardiogram appointment upcoming on 02/11/2022 to prepare for surgery. I will meet with an electro cardiologist on 02/21/2022 who will be performing my cardio ablation to treat my STV on 03/10/2022.
Extreme tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 01Jun2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jun2021, the patient experienced extreme tiredness. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme tiredness was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post vax, the pt developed fevers, chills, generalized malaise, myalgias, arthralgias, and extreme fatigue. Left arm was extremely inflamed, swollen, and tender. She also experienced intense headaches.
Soreness at injection site moderate. Low grade fever (99.5) starting around 9pm on the evening of vaccination. Chills. Fever resolved during the night. Also received a seasonal flu shot at the same time in the opposite arm. Not sure of the exact vaccine which is why I did not select one for your drop down menu.