chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment drug were reported. This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392126 (Patient Link).; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Information was received from a pharmacist referring to a 25 year old female patient. The patient's concurrent condition, pertinent medical history and drug reactions were not reported. On an unknown date, the patient received an expired dose of GARDASIL 9 (intramuscular, lot # M017983 with expiration date 30-MAY-2018) for prophylaxis. This dose was the second dose of a three dose series. No adverse effects reported. No product quality complaint was involved.
A couple of hours after the vaccine I developed a fever, nausea, flu like symptoms, I had swelling, redness and soreness in my arm. I took some Tylenol for my symptoms that lasted for three days.
This medical assistant reports that a currently 4 year old female patient was vaccinated with MMR II, 0.5 mL unknown frequency on an unknown date for an unknown indication and VARIVAX (Merck), 0.5 mL unknown frequency on an unknown date for an unknown indication, and FLUMIST of an unknown dose, frequency and indication. She has no relevant medical history or concomitant medications (concomitant medication also reported as DTP). Her relevant past drug history was unknown. On 21-DEC-2012, she received FLUMIST. On 26-DEC-2012, the patient was given booster shots of MMR II and VARIVAX (Merck) within the same one month interval that she received her last dose of FLUMIST. As of 26-DEC-2012, she was not experiencing any adverse reaction. She had no relevant laboratory data. As of 26-DEC-2012, it was unknown if the patient will continue receiving MMR II, VARIVAX (Merck) or FLUMIST together within one month interval and the outcome of the event was unknown. Additional information has been requested.
Patient received a Pfizer for 1st dose in July 2021....patient was administered a 2nd dose of Moderna vaccine
Patient is a 67 y.o. female patient with history of paroxysmal A. fib, hypothyroidism, hyperlipidemia, GERD presented to  Hospital with myalgias and found to have COVID-19 infection. Pt initially needed 2L O2 via nasal cannula and she was treated with steroids. Symptoms improved. Further labs showed new diagnosis of type 2 diabetes. Pt stable for discharge with meds and recommendations as noted below. Pt agreeable with plan.    Acute respiratory failure with hypoxia Covid-19 Virus Infection Myalgias Sepsis on admission Patient was tachycardic and tachypneic.  Afebrile and now with leukocytosis.  Lactic acid WNL Date of onset of symptoms: 10/23 Symptoms present on admission: " Feeling like bronchitis" Date of covid positive test: 10/25 Vaccination status: vaccinated Imaging: CXR and CTPA. CTPA showed lungs show hyperaeration with chronic changes and atelectasis. Oxygen requirements on admission: 2L Current oxygen requirements: RA Medical therapy: steroids  Consultants following: None Anticipated special isolation end date: 11/3    Continue steroids and PRN tylenol on discharge   Newly diagnosed Type 2 Diabetes  Presented with hyperglycemia. A1c obtained and was 6.8 Metformin started. F/u with PCP for adjustment Prescribed glucose monitor and supplies   Poor p.o. intake Hypokalemia Hyponatremia Hypomagnesemia Recent poor appetite in setting of COVID infection. Initial labs: K of 2.8, sodium 132, magnesium 1.2 Replenish electrolytes and monitor IVF Encourage PO intake Paroxysmal A. Fib HTN CHA2DS2-VASC score = 3 Normal sinus rhythm on EKG this admission Normal left heart cath in 4/2022 Continue Eliquis, Cardizem, and propafenone   Microcytic anemia Patient has been anemic for over a year B12/folate WNL Iron studies and reticulocyte labs indicative of IDA Start PO iron   HLD Continue statin   Hypothyroidism Continue Synthroid   OSA She was diagnosed with OSA in 2009 but was unable to tolerate her CPAP.
Client given Menveo vaccine in left deltoid on yesterday.  Today has Approx. 4inchX5inch Swollen, Red, Warm to touch, with discomfort 6 on scale 1-10. Left hand tingling.
Information has been received from a registered nurse concerning an 11-year-old female who on 12-MAR-1996 was vaccinated with a dose of Varivax (Oka/Merck). On an unspecified date, the patient developed a generalized rash with 50 to 200 lesions. It was unknown if medical attention was sought. Additional information has been received from the registered nurse which indicated that she had no further information.
Red bloodshot eyes. Diagnosis of ophthalmologist was peripheral subepith opacities. Treatment: Tobramycin Oph. Sol./Prednisolone Acetate Oph. Sol.
Fever to 105 this morning, decreased to 100.4 after several hours, no treatment  given. Also listless.
pt recvd vax & 4 nocs p/inject passed out @ a bar (had 3 beers); exp itching the next day & had fatigue for next 3 days; treated w/DPH;
Initial report received on 06/Jun/2006. A male patient (no age or date of birth reported) received a dose of Je-Vax, lot number unknown, on an unspecified date. The route and site of administration were not reported. An unspecified amount of time post vaccination, the patient developed an injection site reaction consisting of redness, induration and tenderness. The patient's recovery status was reported as unknown. Follow up report received on 13/Jul/2006. Six days later, the patient developed an upset stomach without nausea or vomiting and was tired. The injection site reaction consisted of a 1.5 inch circumference area of redness, slight induration and mild warmth. The patient did not have any tenderness at the injection site (previously reported as injection site tenderness). The patient recovered from the events. Further information is not expected.
Fever, chills, myalgias, and sensitivity to touch of skin, beginning th evening of immunization.
Pt given Pediarix and Hep B injections both and no HIB vaccine. No reaction from patient noted.
About 3 or 4 daysafter the vaccine, I was coughing, nasal congestion. I could not stop until I went to urgent care, and they gave me 2 medications. I don't remember the name of the medications. I took one and completed it and threw it away. The other one gave me diarrhea.
A 28 year old male patient, with no medical history, received on 23 September 2008 a 0.5 ml right deltoid injection of IPOL (lot number "A0273"), a 0.5 ml left deltoid injection of ADACEL (lot number C2927AA), and a 0.1 ml left arm injection of TUBERSOL (lot number not reported). On the day of vaccination, the patient developed redness, swelling, firmness and itchiness at the right deltoid injection site. Corrective treatment was not reported. The patient had no illness at time of vaccination. Concomitant medication was a daily multivitamin and the patient received no other vaccines within the previous four weeks. At the time of the report, 26 September 2008, the patient had not recovered.
Patient lost consciousness a couple of minutes after receiving the vaccine, when he regained consciousness he was very sweaty, twitching, and mumbling incoherently. He said he does drink but he felt "wasted." EMS was called and checked him out on scene and stated that it was most likely anxiety related.
Woke up a few days later with terrible lower back pain.  I do not recall injuring my back the days prior.  I have had back pain before over the years from my job.  However, this pain was the worst its been and lasted more than 2 weeks.  I saw a chiropractor to help with the symptoms.  They have gotten much better, but are still there.   I also noticed that my right and left index finger were swollen and stiff in the knuckle closet to my hand.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age. The reporter stated that the office had stored ROTATEQ for one year below 35F with a lowest temperature of 29F. The temperature excursion could not be supported. He had no patient information available. Additional information has been requested.
Felt weak for 1 and half days after the following day of vaccination. Arm was sore and red swelling for a week and gone now but this area still itches even after a week, I don't know when this will go away.
Information has been received from a physician concerning male "in his 20's" with no pertinent medical history and no drug reactions/allergies who on 30-JUN-2005 was vaccinated with a dose of Varivax. There was no concomitant medication. On 02-JUL-2006, two days later, the patient developed chickenpox. He had lesions from head to toe. The physician had not yet seen the patient at the time of the report. The patient's chickenpox persisted. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There were no other details to report. There was no product quality complaint. Additional information has been requested.
Intense pain on the first three days, nothing provided relief. It still hurts a lot and can't raise it.
No adverse event; patient was administer half the dosage of the bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (patient was administer half the dosage of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for an unknown indication.     The patient's past medical history included Dental cavity. Previously administered products included for Product used for unknown indication: Flu shot in December 2020. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy, Heart disease, unspecified, Atrial fibrillation, Type 2 diabetes mellitus, High cholesterol and Blood pressure high. Concomitant products included WARFARIN SODIUM (COUMADIN), METFORMIN HYDROCHLORIDE (METFORMIN HCL), METOPROLOL and GABAPENTIN for an unknown indication.    On 12-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient was administer half the dosage of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient was administer half the dosage of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient was administer half the dosage of the bivalent vaccine).    Patient only received half the dose 0.25ml and patient wanted to know when the patient should receive the other 0.25 ml shot to complete the shot. Patient was taking other medication.  On 05Feb2021, patient received first dose of Moderna vaccine 0.5 milliliters, batch lot no 015N20A on Left Deltoid. On 05Mar2021, patient received second dose of Moderna vaccine 0.5 milliliters, batch lot no 032M20A on Left Deltoid. On 23Aug2021, patient received first booster dose of Moderna vaccine batch lot no 091D on Left Deltoid. Treatment medications were not reported.
Tinnitis left ear; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old female patient received BNT162B2 (Lot Number: EN6200), dose 2 via unknown route in right arm on 25Feb2021 at 10:00 AM (at the age of 75 years old) at single dose for covid-19 immunization. The patient medical history included breast cancer, atrial fibrillation and had known allergies: penicillin, sulfa, intravenous (IV) contrast. Patient was not pregnant. Concomitant medications included apixaban (ELIQUIS), diltiazem, propafenone, letrozole. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot Number: EN5318) via unknown route in left arm on 03Feb2021 at 03:45 PM at single dose for covid-19 immunization. The patient experienced Tinnitis left ear on 26Feb2021 at 05:00 AM. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No Covid prior vaccination and no Covid tested post vaccination. No treatment for the AE Tinnitis left ear. The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a other health professional refers to a 11 year old patient.    On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On 26-JUL-2017 the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9.
Fever of 101 degress,  took tylenol,  3 times throughout the day.  Fever broke  during the night Fatigue - lasted from early morning throughout the day  through the evening.  Did not continue the next day Chills- Intense chills appreared around 11:00 a.m. and continued until about 1:00 p.m.  After that the chills were moderate and stopped                 around 4:00 p.m. Headache - tylenol take for fever and headache.  Headache lasted through the evening and early night.  Was gone by morning. Muscle ache - extreme, sharp muscle pain in both thighs.  Appeared intermittently thoughout the day.  Subsided by evening, but      returned briefly the next morning.
Pt recvd measles vax 12APR91 & 10 days p/vax devel fever of 103; no further details were provided;
10/31  - weakness, loss of appetite,  11/6/21 - fall and visit to hospital ER - Asymptomatic COVID+ in ED. was on antibiotics for a UTI at time of ER visit.
Urticaria within 10 minutes after Hep A, IPV, & VARIVAX. Given 25 mg BENADRYL, easily swallowed. VSS. Monitored 20 min., hives improved.
Extreme fatigue, vomiting without nausea, headache, and fever chills. Fatigue, fever/chills, and headache lasted between 48-60 hours after vaccination given.
9:45 am: Patient presents with nausea and warmth in the face area. Vital signs: BP 174/73, HR 63, O2sat 98% 10:00 am: Vital signs: BP 151/98, HR 58, O2sat 97% 10:15 am: Vital signs: BP 140/59, HR 59, O2sat 97%
The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine.  It is still there but not as bad as it was initially.  I googled skin conditions and it looks like Livedo reticularis.  I went to my Cardiologist on 2/5/21 and he took bloodword CBC, Prothrombin Time and bloodwork was normal.  Cardiologist told me to go to a dermatologist.  My arm was sore also where the injection was and it was hard to lift my arm.  That lasted one day.  I also had aches and pains and was fatigued on 2/3/21 for 24 hours.
Pt received pneumovax 10/10/03, the following day she experienced facial paresthesia which did resolve.
Patient felt fine entering the office. 15 minutes after receiving her vaccine she started to feel fatigue, nauseas and a warm sensation in her arm. She spoke with provider and discussed with him that she did feel okay thinks it may have been her anxiety and was informed to go to the ER if any of her symptoms worsened
10/24/2019 - Patient experienced  decrease in ability to taste food/drink  10/27/2019 Patient notified her mother that she was unable to blink with left eye  10/27/19 Patient mother takes her to local Emergency Department, patient was briefly evaluated and told to return if symptoms worsened  10/28/19 Patient was scheduled with provider in this clinic for facial weakness. When patient was in triage with nurse, the patient has difficulty blinking, uneven blinking, smiling and frowning. Patient denied pain or numbness  Patient evaluated by Dr. Patient was diagnosed with Bells Palsy and referral to Neurologist is being scheduled.
Increased urination, slight fever, night sweats and body aches lasted about 24 hrs.
This spontaneous report as received from a licensed practical nurse via a company representative refers to an infant patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with one dose of ROTATEQ (lot # and expiry date unknown), 2 ml, oral for prevention of rotavirus. Immediately after the vaccine was administered, the "baby threw up" (described as the baby's "belly was very full") (infantile spitting up, abdominal distension). Subsequently, another dose of ROTATEQ (lot # and expiry date unknown), 2 ml, was administered (extra dose administered). The "baby threw up again". Treatment was provided for the event. No product quality complaint (PQC) was involved. The outcome of abdominal distension was unknown. Causality assessment was not provided by the reporter.
Extreme swelling around eyes. Three days before returning to normal. I have eaten eggs on numerous occasions since with no adverse effects.
12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tightness(headache), rigors, hot flashes.28th feeling off and fatigued, continued to feel better as the days went on and on the 31st  had diarrhea, rigors, temp of 99.3F, hot flashes, muscle aches now.
Pain to legs, high shrill cry for 3 hours, 101.2 temp. Discharge Summary received on 2/16/2005 states fever.
TIA (transient ischemic attack) [G45.9] left side weakness receive vaccine at pharmacy on 04/25/2021 and 05/25/2021 Admitted to hospital on 8/12/2021
Swelling and pain at left tricep/deltoid region. Pt complained of debilitating pain and discomfort. Has seen PCP twice and Rx'd with muscle relaxer and anti-inflammatory medication with little or no relief. Has appt with physician next week.
Mild L arm edema; L axillary tenderness; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (Mild L arm edema) and AXILLARY PAIN (L axillary tenderness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OEDEMA PERIPHERAL (Mild L arm edema) and AXILLARY PAIN (L axillary tenderness). At the time of the report, OEDEMA PERIPHERAL (Mild L arm edema) and AXILLARY PAIN (L axillary tenderness) had resolved. Not Provided          No Concomitant medication details were provided. No Treatment medication details were provided.
p/vax pt devel a papular, vesicular rash over rt cheek & in the preauricular area around the jaw;pt seen by MD dx w/herpes zoster;reporting MD did not think child devel the rash p/vax given;
Around 7pm I started with chills, body aches, diarrhea, nauseas, I was throwing up & headaches. I took extra strength Tylenol & the symptoms lasted for a little under 24 hrs.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported.
1st dose was administered on 25-Jan-2021, and 2nd dose was administered on 01-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 25-Jan-2021, and 2nd dose was administered on 01-Mar-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient had a reaction to lipitor). Concomitant products included ETANERCEPT (ENBREL), ATENOLOL and TAMSULOSIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 25-Jan-2021, and 2nd dose was administered on 01-Mar-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 25-Jan-2021, and 2nd dose was administered on 01-Mar-2021) outcome was unknown.            The patient had not tested COVID positive test or diagnosis ever. Patient had also mentioned that they took concomitant medications but does not specified the same for what. No treatment information was reported.   This case was linked to MOD-2022-558782, MOD-2022-558245 (Patient Link).
Vaccinee rec'd a series of 3 Engerix-B injects (deltoid) according to 0, 1, 6 mo schedule; About 1 mo following the 3rd dose, results of testing for Hepatitis B surface Antibody indicated had a low titer;