chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local skin reaction still visible after 48 hours softball sized red spot, slightly inflamed and itchy no visible swelling, no arm pain per patient.
we gave Patient Moderna Covid-19 Vaccine EUA booster instead of half dose (0.25) we gave a full dose of (0.5 mL) .we called the Patient, Patient daughter says he feels fine.
No adverse affects; an expired dose of GARDASIL 9 was administered; This spontaneous report was received from a health care worker, referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.  On 08-AUG-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency and route of administration not reported) (lot #: M041990, expiration date: 28-JUN-2019) (expired product administered) for prophylaxis. No adverse effects were reported. No product quality issue was involved.
ADMINISTRATION OF JANSSEN COVID 19 VACCINE THAT WERE EXPIRED BY TWO DAYS; This spontaneous report received from a health care professional concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, administered on 16-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-DEC-2021, the patient experienced administration of janssen covid 19 vaccine that were expired by two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of janssen covid 19 vaccine that were expired by two days was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240943.
This spontaneous report was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 23-AUG-2013 was vaccinated with VARIVAX (Merck), (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875 (Same reporter link). Additional information has been requested.
Pain in the same arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the same arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the same arm of the injection). At the time of the report, VACCINATION SITE PAIN (Pain in the same arm of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The patient is a 75 y.o. female with a history of Chronic hypoxemic respiratory failure (3-4L), COPD, HTN, HFpEF, R eye blindness who presented to the hospital 1/3/2023 with recurrent falls at home and confusion. CT head negative. Found to be COVID 19 +. Hospitalization complicated by AE COPD with hypercapnic respiratory failure requiring bipap.    1. Acute on chronic hypoxemic and hypercapnic respiratory failure: Baseline 3-4L Suspect acute shunt related to viral pneumonia on chronic VQ mismatch from COPD.  Briefly on 4-5 liters and improved to baseline. 1/8/2022 Worsened mental status and CO2 > 100, transferred to intermediate and placed on continuous BiPAP. Weaned to LFNC with BIPAP prn.  2. Acute metabolic encephalopathy: Multifactorial likely secondary to hypercapnia, dehydration, and polypharmacy. CT head and MRI brain nonacute.  Sleep hygiene ordered.  Discussed delirium precautions. Worsened 1/8/2022 and since improved. Resolved. 3. Acute exacerbation of COPD: Initially had mild wheezing then developed a progressive cough and sputum volume. No PFT on file. Pulmonology following. S/p Azithro. Pulm following, IV solumedrol followed by PO prednisone with steroid taper, 40mg daily taper by 10q3 days.  4. COVID-19 infection: Positive contacts at home, tested positive on 1/3/23.  Continue steroids.  5. Recurrent falls: 2 falls on day of admission, likely secondary to orthostatic hypotension and altered mentation in the setting of viral illness.  PT/OT. 6. Anxiety: PRN Klonopin initially held for AMS. Resumed home dose once mental status improved. Klonopin available prn. 7. HFpEF: Remains clinically hypovolemic.  Held home Lasix. 8. R eye blindness: Per Hx
arm felt little bit achy; passed out; cold swats; felt the room was spinning; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), COLD SWEAT (cold swats) and DIZZINESS (felt the room was spinning). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm felt little bit achy). On 23-Mar-2021, LOSS OF CONSCIOUSNESS (passed out), COLD SWEAT (cold swats) and DIZZINESS (felt the room was spinning) had resolved. On 25-Mar-2021, PAIN IN EXTREMITY (arm felt little bit achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   There was no concomitant medications reported. Treatment included as Ibuprofen.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Majority of the vaccine came out of the connection; Did not get the full dose; A spontaneous report was received from a healthcare professional concerning a 77-year-old, male patient who received a first dose of Moderna's COVID-19 vaccine, and some of the syringes and needles did not connect correctly, patient might have not gotten the full dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) Intramuscularly for prophylaxis of COVID-19 infection.   On 22-Jan-2021, reporter HCP (RN) stated that equipment for vaccination came from the state, and some of the syringes and needles did not connect correctly and due to that during administration, in two different patients, the majority of the vaccine came out of the connection and not into the patient's muscle. Reporter was concerned about that two patients might not gotten the full dose, and should they continue schedule and consider the vaccine legitimate or should they restart the series after 28 days. No treatment information was provided.   Action taken with the mRNA-1273 in response to the event was not reported.   The events, some of the syringes and needles did not connect correctly, patient might have not gotten the full dose were considered recovered/resolved.; Reporter's Comments: This report refers to a case of device connection issue and underdose for mRNA-1273, lot # unknown, with no associated AEs; Sender's Comments:  MOD-2021-014288:same reporter, different patient
started to have chest pain around 2 days after 2nd dosage. Went to ER for work up-negative cardiac tests. Came to my office on 8/6/21-ECG shows some minor abnormalities. I gave patients Naproxen BID and referred to cardiology due to symptoms sounded like pericarditis. Saw Dr. diagnosed with pericarditis on 8/11/21. Started on Medrol dose pack. Went back to Dr. on 8/18 symptoms were not better so started on colchicine and prontonix. Patient an echo on 8/17/21 and report is normal.
I am sick; Feeling weak, tired and drowsy; I am having terrible headaches; Feeling weak, tired and drowsy; Feeling weak, tired and drowsy; dizzy; nervous; "has blood pressure" everyday; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH8030) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Verbatim: Osteoarthritis; "Spinal stenosis" (unspecified if ongoing), notes: Verbatim: Spinal stenosis; "Migraine headache" (unspecified if ongoing), notes: Verbatim: Migraine headache; "Hypersensitivity" (unspecified if ongoing), notes: Verbatim: Allergy. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am sick"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "not recovered" and all described as "Feeling weak, tired and drowsy"; HEADACHE (non-serious), outcome "unknown", described as "I am having terrible headaches"; SOMNOLENCE (non-serious), outcome "unknown", described as "Feeling weak, tired and drowsy"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as ""has blood pressure" everyday"; ARTHRALGIA (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "had shoulder, back, neck, and knee pain"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, arthralgia, back pain, neck pain, arthralgia, myalgia.  Additional Information: No prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Received flu shot on 9/18/2014, first reported red itchy eyes on 9/22/2014, pharmacist recommened cool compresses and Claritin. Saw eye doctor on 9/26/2014. Was seen in PCP office on 9/29/2014, when she reported hives on her forearms. Advised use of hydrocortisone cream and oral Benadryl for symptoms of itching. No additional treatment needed. 10/3/2014 offered Medrol dose pack for continued hives on the arms.
Patient reported to RN that she felt lightheadedness and flushed immediately after receiving the injection. Patient denied any wheezing or SOB. Administered BENADRYL 25mg (1 dose) prophylactically. Patient's symptoms were completely gone 30 min after injection.
On day 7 of my vaccination I felt itching on the site of injection..which I saw it got swollen without touching it..I thought it would go away..but it kept itching not annoying ....so at 4:00 pm since I was working I took a look at it and it was huge ..red ..and swollen so I as an pharmacist decide to take Zyrtec 10 mg and took cephalexin 500mg  to take care if it was cellulitis.....I called my Doctor and showed him my arm and said to keep on taking the medicines I took for 5 days...I got better soon ...the itching got away immediately...the redness took a few days...to go away..... having this reactions I didn?t feel nothing else otherwise only on the site of the injection. I would like to know if my second vaccine should I be prepared to take Zyrtec before or immediately after reading the second dose...I would like to recall the following....I?m allergic to Aspirin...I have antibodies IgG..before the vaccine.....probably I was exposed and my body created the antibodies...I?m a pharmacist and work at a community Pharmacy....I saying this if this can be part of what I had as adverse reaction on the site of injection ....please let me know.......thank you
10 minutes after injection patient was concerned she was having tightening in her throat. BP stable, lungs CTA. 50mg oral Benadryl administered and within 7 minutes patient reported feeling better.  Patient waited an additional 20 minutes and then left.
This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with VAQTA lot # M039202, lot# reported as N005796, lot# M012261 and M032492 for prophylaxis. The vaccines were improperly stored at 47 degrees Fahrenheit to 77F for 4 hours, with previous temperature excursions of between 47F and 77F for 5 hours and between 9 degrees Celsius (C) and 25C for 8 minutes. On unknown dates, the patients experienced no adverse event. The reporter considered incorrect product storage to be not related to VAQTA. Additional information has been requested.; Sender's Comments: US-009507513-1707USA011012: US-009507513-1707USA011013: US-009507513-1707USA011014: US-009507513-1707USA011015:
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.
My left injection site arm was sore to the touch.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My left injection site arm was sore to the touch.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE PAIN (My left injection site arm was sore to the touch.). At the time of the report, VACCINATION SITE PAIN (My left injection site arm was sore to the touch.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-336789 (Patient Link).
Received the second dose of moderna at 1:30 pm on 12/11 and at 12 AM on 12/12 I woke up from my body shaking vigorously with nausea and increased heart rate. Was unable to get up from bed to take my temperature, Heart rate or blood pressure.  Called the emergency department to find out if I should go there. Shivering continued  for about 1 hour after taking Tylenol 1300 mg and clonazepam 0.25 mg for panic symptoms. I then slept for the remainder of the night and woke up with nervous system ?shock like? feelings of shivers and shaking.
Injection site pain and itch that has been continuous since several hours after the injection. Pain and itching persist to this day.
Muscle ache; Slight fever; Felt a little sick; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; solution for injection), via an unspecified route of administration on 10Feb2021 (batch/lot number was not reported) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (batch/lot number was not reported), via an unspecified route of administration on 20Jan2021 as 1st dose, single dose for COVID-19 immunization. The patient reported that she had a "reaction to her second shot". On an unspecified date, the patient experienced a slight fever and felt a little sick for 1 day on an unspecified date following her second dose. The patient also experienced muscle ache on an unspecified date. The outcome of the events slight fever and feeling sick was recovered while the outcome of the event muscle ache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
An 84-year-old male with a history of GI hemorrhage associated with a duodenal ulcer, hypertension, malignant lymphoma ?, atrial fibrillation. Patient was doing well and went for a routine follow-up visit with his pulmonologist for history of COPD.  On physical exam his heart rate was found to be elevated in the 140s which prompted an EKG revealing A. fib with RVR, patient was recommended to present to the ED. Patient denies any new symptoms, admits to recent worsening of his chronic cough (productive of yellow sputum which seems stable), but denies any fever/chills, palpitations, difficulty breathing, chest pain.
Not a severe adverse event, but I developed a rash to my left arm one week after vaccine.  It is about 3 inches, raised red, itchy, and warm to touch.
SHAKING CHILLS, FEVER, MALAISE, SEVERE HEADACHE, NAUSEA, LOSS OF APPETITE, WEAKNESS, FATIGUE SYMPTOMS STARTED ABOUT 10 HOURS AFTER RECIEVING THE SHOT TREATED WITH TYLENOL AND COOL CLOTHES TO HEAD FLUIDS FEVER BROKE AT 10:30 PM ON 03/17/2021, APPROX 19 HOURS AFTER RECEIVING THE VACCINE. SYMPTOMS SLOWLY SUBSIDED. PERSISTENT MILD TO MOD HEADACHE LASTED FOR SEVERAL DAYS
Child developed irritability with difficulty consoling scream, yell, fuss and moan 1 1/2 days after vaccines. Had rhinorrhea and cough develop at same time. Quieted after 4 hours but restarted next am and lasted all day- seen at urg. care evaluated and told non focal exam. Irritable that night- seen by us next day.
Same 4 day overall bad feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Aug2021 (Lot number: FC 3183) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing), notes: "lupus" (unspecified if ongoing); "lyme disease" (unspecified if ongoing); "associated vector bacterial infections" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: One antibiotic once made me sick, amoxicillin possibly". Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0198, lot unknown=False, administration date=02Aug2021, administration time=12:00 PM, dose number=1, vaccine location=Right arm), administration date: 02Aug2021, when the patient was 64 years old, for COVID-19 immunization.The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Same 4 day overall bad feeling". Additional information: It was reported that, she mentioned this to pharmacist at appointment for second vaccine, on 22Aug2021, but proceeded with 2nd shot, anyway. Second shot lot #, same pharmacy. Same 4 day overall bad feeling. She waited a month to see if this symptom would go away, it has not. She had not yet seen her doctor, will be forwarding this message to him. No other vaccine in in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. known allergies: One antibiotic once made me sick, amoxicillin possibly. She might have rheumatoid arthritis, lupus, and or Lyme disease and associated vector bacterial infections. Otherwise, healthy. Follow-up attempts are completed. No further information is expected.
First dose leaked due to poor technique from a new HCP; syringe connection; This spontaneous case was reported by a consumer and describes the occurrence of DOSE CALCULATION ERROR (First dose leaked due to poor technique from a new HCP) and DEVICE CONNECTION ISSUE (syringe connection) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DOSE CALCULATION ERROR (First dose leaked due to poor technique from a new HCP) and DEVICE CONNECTION ISSUE (syringe connection). At the time of the report, DOSE CALCULATION ERROR (First dose leaked due to poor technique from a new HCP) and DEVICE CONNECTION ISSUE (syringe connection) outcome was unknown. Not Provided      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.    This case was linked to MOD-2021-061094 (Patient Link).