chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer; No adverse event; Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after excursion/ Received vaccine from vaccine that underwent a temperature excursion in the Freezer).    No concomitant medications were reported.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable. No adverse reactions reported for the patient.  No treatment medications were reported.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised that vaccine maintained activity needed to protect against covid 19 on date vaccine was administered.  Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
dizziness after taking the 2nd dose a week ago/she was dizzy; Her head started spinning; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself) from a Pfizer Sponsored Program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported by the patient that after receiving the second dose of vaccine a week ago on 13Feb2021 she experienced dizziness, she was dizzy, and her head started spinning. She wanted to know if that is connected to the vaccine. If it is, how long is it expected to last. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    It was unknown if the patient was ever diagnosed with or tested positive for COVID-19.  Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
client history of syncopy. Post administration of second dose client complained of lightheadedness, blurred vision and felt hot . Client was transferred to observation area via wheelchair. NP and EMT on site. client placed supine on mat. Vital signs obtained at 1429 HR 76, O2Sat 96% BP 92/62, @1433 HR 92, O2Sat 95% BP 109/67, Last VS @1447 HR 79 O2Sat 99%.  Client feeling better able to sit up in chair.  Client was provided snacks and drinks monitored in observation for 1hr before leaving. Father at his side, left without incident.
Arthritis like pain and immobility in mostly all joint; ankles; knees; hips; shoulders; elbows and wrists to fingers.
-Dark coloring (purple&blue) around knees  -Severe migraine beginning at 12:30 AM Today  -Severe joint pain hands & body. Can barely walk. Cannot work.  -Mild shortness of breath  -Mild Chills  The last time I felt this type of pain I ended up in the hospital for 3-4 days with extremely high white cell blood counts.  While I realize the vaccine may have side-effects, I'm also aware I have a weak immune system. So I'm taking extra precautions in the case things get worse.  I'm sure I'll get better but I'd rather say something and be safe. When I get sick I tend to go down quick and I don't have any family closeby to rely on in case of an emergency.  I'm completely played out on the floor hoping it will pass.  Not an emergency now but it could turn the other way as it has before.  Sorry for any inconveniences.
VACCINE EXPOSURE DURING PREGNANCY; ARM SORENESS; LOW GRADE FEVER; FATIGUE; This spontaneous pregnancy report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pregnant at the time of vaccination. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during pregnancy, arm soreness, low grade fever, and fatigue. The date of the patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, fatigue, arm soreness and vaccine exposure during pregnancy was not reported. This report was non-serious.
After several hours a bright red rash developed covering the entire right upper arm. She then reports feeling short of breath and itching throat with nausea and vomiting. She was advised to see a doctor but took at home breathing treatments instead. All symptoms have resolved.
There was no adverse event, however, the patient received a second dose of the Bivalent vaccine that she was not eligible for.  She had already received her primary series and all 3 booster shots she was eligible for. Patient states she has no side effects or problems related to this inappropriate dose.
both arms developed extensive erythema, warmth, discomfort.  both areas of erythema roughly 8x20cm.
high blood pressure and am on medication for it.; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 21Oct2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable other hcp (patient). A 55-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in right arm on 01May2021 12:00 (Lot Number: EW0172) as dose 2, single at the age of 55 years old for COVID-19 immunization. Medical history included diverticulitis. There were concomitant medications within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. Historic vaccine was bnt162b2 administered in left arm received on 10Apr2021 16:15 (Lot No: EP7533) as dose 1, single at the age of 55 years old for Covid-19 immunization. On 06Sep2021 14:00, the patient had high blood pressure and was on medication for it. The seriousness of event was hospitalization/prolongation of hospitalization. Event resulted in emergency room/department. Treatment received which included losartan presenbed, testing then admitted. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Node results: negative on 23Nov2020. Repeating node results negative on 30Nov2020. Nasal swab: negative on 30Mar2021. Nasal swab: negative on 06Sep2021. The outcome of high blood pressure was recovered/resolved with sequel in 2021.  No follow-up attempts are needed. No further information is expected.
Itchy, red, inflamed, hot rash just below injection site...expanded from dime-sized on first day it appeared (1/15/21) to approximately 4 inches in diameter within 48 hours...disappeared within 5 days.
unable to get 2nd shot at schedule time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unable to get 2nd shot at schedule time) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unable to get 2nd shot at schedule time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unable to get 2nd shot at schedule time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The second dose was scheduled for 31March202, but they were unable to get the shot at that time.
A non-serious spontaneous report of administration of expired product was received from a registered nurse/health professional concerning a 33-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 30-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Pt developed blisters/rash, hives, spread thru entire body, pt up day and night itching, raw skin. No clear diagnosis. No improvement any meds or creams. New blisters/swelling appears still at 2 weeks. 6-1-16 - responded to acyclovir topically.
9/7/21 pt admitted to the Hospital for hospice care; pt had a positive COVID test on both 8/25/21 and 9/3/21; pt passed away in the hospital; limited medical records received; death certificate and medical records sent to info@vaers.org per VAERS request
Headache, hight fever, chills, joint and body aches. Swollen gland and lymph node on side of injection site.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 22-MAR-2013 at 10:40 am, the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified). The physician reported that VAQTA was exposed to multiple low temperature excursions. Excursion time at -1: 1556.50 hours (also reported 17 hours, 442 hours, 2 -5/4 hours, 59 hours, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
A few hours after receiving the vaccine, I went to the hospital because I was having pressure in my chest. When I went to the ER they took my vitals and ran some test. I had elevated heart enzymes. They put me in an observation unit and kept me overnight. The next day, I had a echocardiogram which showed abnormalities in my left ventricle. They scheduled me for a heart catherization. They said I had a heart attack. On May 16, 2022, they gave me the heart catherization which ruled out a heart attack but shown that I had broken heart syndrome. I was prescribed baby Aspirin, Lipitor, Lisinopril, and Metoprolol Succinate. The doctors said it should resolve in about 1 or 2 months. I was released on May 17th. I would still get another vaccine if recommended.
Patient inadvertently recieved 2nd dose of Moderna series one week before schedule allows (21 days after 1st dose).  No adverse event other than error in dosing schedule
pt recv vax & 3 wk later devel mumps; MD reported 2 tsp;
22AUG95 c/o earache lt ear; noted swelling in front of ear; 23AUG95 swelling inc, spread into neck; saw MD denies fever, rash, achiness; swelling cont to inc, earache unresolved; referred to pvt MD;
Patient had syncopal episode after receiving MENACTRA & Tdap (BOOSTRIX) vaccines.
Right arm became sore almost immediately, now is swollen and red. Denies fever. Has been applying ice and was advised to switch to heat and continue Tylenol for pain.
Arm affected (left) was lightly swollen and reddened. She stated that she had a headache off and on since approx. 2 hours after shot.
The flu; Sore throat; Sputum; Cough; Headache; Fever; Chills; The hots; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (The hots), INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum) and COUGH (Cough) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING HOT (The hots) and CHILLS (Chills). On 15-Apr-2021, the patient experienced PYREXIA (Fever). On 16-Apr-2021, the patient experienced INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum), COUGH (Cough) and HEADACHE (Headache). At the time of the report, FEELING HOT (The hots), INFLUENZA (The flu), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Sputum), COUGH (Cough), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. Not Provided          Concomitant medication list was not provided. No treatment was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-219010 (Patient Link).
The patient is a 70-year-old male who presents to the emergency department with complaints of onset of right facial droop and numbness which began approximately 1 hour prior to arrival.  No prior similar episodes.  Patient does have a prior history of CVA.  Denies any focal weakness to his extremities.  Denies headache.  Denies visual changes.  Wife states he might have slight slurring of speech.  Patient does have a history of atrial fibrillation and is on Eliquis.  Took his Eliquis this morning.  Denies nausea or vomiting.  Denies chest pain or shortness of breath.
Nausea and headache still exist Day 6; Nausea and headache still exist Day 6; This is a spontaneous report from a non-contactable other healthcare professional. An adult female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) intramuscular (arm left) on 30Dec2020 at 11:00, at a single dose, for COVID-19 immunization. Relevant medical history included unspecified allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient showed a negative result on 17Dec2020. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered at patient's workplace (clinic). On 30Dec2020, at 15:00, the patient experienced nausea and headache which still exist until day 6. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has been tested post vaccination; however the results were unspecified.  No follow-up attempts are possible. No further information is expected.
Day after immunizations, rash on feet and arms with some swelling.  Seen in ER that day. Resolved in 1-2 days with PO Benadryl
He noticed in the area of the injcetion a big redness; Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (He noticed in the area of the injcetion a big redness) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high and Osteoporosis.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (He noticed in the area of the injcetion a big redness) and VACCINATION SITE WARMTH (Vaccination site warmth). At the time of the report, VACCINATION SITE ERYTHEMA (He noticed in the area of the injcetion a big redness) and VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes for elevated cholesterol and for osteoporosis. Treatment information was not provided.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Hives, face and arms. 2Tsp Benadryl given parent informed.
BURNING SENSATION IN BREAST; NOT FEELING WELL/DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 12-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2021, the patient experienced burning sensation in breast, and not feeling well/did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well/did not feel good and burning sensation in breast was not reported. This report was non-serious.
Fever 99.7 degrees, minor body aches, lasted about 6 hours, treated with Tylenol
Patient received her Moderna booster on 12/05/2021 at the Pharmacy. Patient states she have fever of 104F, severe weakness, fatigue, skin rash, diarrhea, vomiting, lost of appetite after the vaccine. She couldn't get a hold of her doctor for a week. She was just taking tylenol and drinking fluid and rest. She came to us (Clinic) 9 days later. Patient is feeling better overall, still have slight fatigue and rash in the chest.
Approximately 8 hours after receiving the dose, I began feeling tired, achy, feverish, and have the chills.  These symptoms have continued into the next day and I am still currently experiencing these symptoms.
Joint pain, extreme fatigue, chills, fever, nausea, and headache  Injection site: Swollen, hot to touch, red rash, firm
Pt complained of headache and fever on day following immunizations. Visit to the clinic 12/12/01 indicated probable vaccine reaction. Advil prescribed. Symptoms resolved by following day, (12/13/01). Temp at visit 103.3F
Information has been received from a consumer and a physician concerning a pt with no allergies and no past medical hx who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed a local rxn and was swollen from the elbow to the shoulder. Unspecified medical attention was sought and prescription drug treatment was required. It was noted that therapy with pneumococcal 23v polysaccharide vaccine was discontinued. A product quality complaint was not involved. The reporters also mentioned two other patients who experienced local reactions following vaccination with dose of pneumococcal 23v polysaccharide vaccine. The physician reported this was the first dose of pneumococcal 23v polysaccharide vaccine  for two of the pts and the third pt's vaccination hx was uncertain. Additional info has been requested.