chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received an expired vaccine as a 1st dose,dose administered after manufacture date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received an expired vaccine as a 1st dose,dose administered after manufacture date of expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received an expired vaccine as a 1st dose,dose administered after manufacture date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received an expired vaccine as a 1st dose,dose administered after manufacture date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug information does not provided. Treatment information does not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: The follow up received on 06-OCT-2021 includes no new information.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 69-year-old patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6200), at the age of 69, on Feb 14, 2021, single dose, and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6206), on Mar 10, 2021; both single dose, for COVID-19 immunisation. Medical history included type 2 diabetes (unspecified if ongoing); and cancer (unspecified if ongoing). The patient's concomitant medications not reported. The patient had pain in extremity (sore arm), fatigue/tiredness, onset 2021, with outcome of unknown; and skin graft (patient had a skin graft), onset Sep 19, 2021, with outcome of unknown. Skin graft evaluated at a physician office visit. Therapeutic measures were taken as a result of skin graft. Additional information: Therapeutic measures taken as a result of skin graft: antibiotic. No follow-up attempts possible. No further information expected.
It would be a GRADE 3 - Redness and swelling near the injection site. Is taking Tylenol and Motrin and using an ice pack on the swollen area.
This spontaneous report was received from a physician via a company representative and refers to her patient's father, a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, 21 days after receiving ZOSTAVAX, the patient developed shingles (herpes zoster). The outcome of herpes zoster was unknown. It was unknown if the patient sought medical attention, laboratory diagnostic studies were performed or if received any treatment. The causality between herpes zoster and ZOSTAVAX was not reported. Additional information has been requested.
my name is (privacy). I am an emergency room BSN RN who has not had a normal period since receiving my first two vaccinations. i have not ovulated since and have not bled which is abnormal for me since I had a completely normal period. being 24, my PMD doesn't want me to receive a booster at this time but my workplace agency will no allow my MD to make that decision since the CDC doesn't recognize this as an acceptable contraindication. I reside in (privacy) where the booster is mandatory. It started the month I got my vaccination
OVERWHELMING METAL TASTE IN MOUTH; This spontaneous report received from a patient concerned a 40 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207AZ1A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced overwhelming metal taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from overwhelming metal taste in mouth. This report was non-serious.
4 hours after shot flu like symptoms, eyes feels lethargic, dull pain and weakness in eyes. Flu like symptoms resolved after 36 hours after taking TYLENOL three times daily. Eyes still weak after 6 days. Patient will follow up with dr tomorrow.
Rash/hives on  front of neck and front of left shoulder.    Size on neck is approximately 2? L x 1? W.  Size on shoulder is approximately 1? L x 1? W.  Rash/hives ongoing and using Benadryl to calm the itching.
Initial report received from a health care professional on 07 June 2012. Several patients (number not specified), whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD vaccine (batch number UH452AC, site and route of administration-not reported) on unspecified dates. It was reported that on unspecified dates last year, several patients had reactions (NOS) to the dose of FLUZONE HD vaccine. Corrective treatment and laboratory investigations were not reported. As of 07 June 2012, the outcome was not reported. Documents held by sender: none.
Golf ball size knot appeared at injection site 45 minutes after receiving flu shot.  Cold compress applied to site.
Mother states 24 hrs after vaccine right arm swelled up. Redness noted. Warm to touch.
Staff pulled 2 vaccines from the frig and asked me to give them. I checked the date of 1 part of the Hib vaccine (the diluent) and it was not expired. I didn't know that the other part could have a different exp. date.
INJECTED 0206 PM ANXIETY ATTACK (WARM, SWEATING, LIGHTHEADED, DIZZY + NUMBNESS IN LEGS + ARMS) 4 TO 5 MIN AFTER VACCINATION. Pt GIVEN COLD PACKS + VITALS TAKEN. Pt OBSERVED FOR APPROX. 45 MINUTES ALL SYMPTOMS HAD SUBSIDED Pt STATE SHE WAS FINE. Pt RELEASED.
I had omnicron; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (I had omnicron) 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 COVID-19 (I had omnicron). At the time of the report, COVID-19 (I had omnicron) 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 product use was not provided by the reporter.    No treatment information provided.  Company comment:  This case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the dose of the mRNA-1273 . The exact dose number and time to onset were not provided. The rechallenge was not applicable due to unspecified dose number. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the dose of the mRNA-1273 . The exact dose number and time to onset were not provided. The rechallenge was not applicable due to unspecified dose number. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received on 15-DEC-2017 regarding a case in litigation from a lawyer concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 28-SEP-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration are unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 22-JAN-2013, the patient was treated at a physician's office for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 9 month old patient of unknown gender. On 06-JAN-2015 the patient was vaccinated with a dose of ROTATEQ (oral, dose, lot number and expiration date were not reported). This was the only dose of ROTATEQ that the patient had ever received. No known adverse effects. No PQC (product quality complaint) was involved. Additional information has been requested.
left arm was sore about 2.5 hours the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 09:30 (Lot number: 9581) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Feb2021 09:45, outcome "recovered", described as "left arm was sore about 2.5 hours the shot". According to the patient "it had felt like a had a Techna shot. The soreness went away 5-6 hours after the shot". Therapeutic measures were not taken as a result of pain in extremity. The patient has no COVID-19 prior vaccination and has not been tested for it post vaccination.   No follow-up attempts are possible. No further information is expected.
Itching all over body and red splotches on chest. This began about 30 minutes after the shot. The red splotches are gone after an hour and the itching is still  occurring but minor now.
Patient is a 78-year-old male with history of COPD, paroxysmal atrial fibrillation, ischemic cardiomyopathy, type 2 diabetes mellitus, status post mitral valve replacement with metallic valve on Coumadin, stage II: CAD status post LAR.  Presented to Hospital campus on account of severe shortness of breath in a patient with significant weakness.  Patient has had significant shortness of breath progressively worsening.  Patient was just discharged from this facility on 03/17/2021.  The patient was admitted on 03/05/201 on account of shortness of breath.  During the admission, patient had a multiloculated right-sided pleural effusion requiring video-assisted thoracoscopy and evacuation of hemothorax.  Associated with chest wall mass.  Subsequent biopsy revealed evidence of small cell carcinoma.  The patient was seen by oncology during that admission with a Mediport put in place.  With plans to follow-up with oncology outpatient for continued management and to hopefully initiate chemotherapy.  There was also concern for acute congestive heart failure and required diuresis.  Echocardiogram was showing EF of 40% at the time.  Now, patient is presented to the emergency room on account of significant weakness in the patient well developed worsening shortness of breath over the last couple of days.  Patient was still short of breath and weak he could not even get up the toilet seat.  When EMS saw the patient he was satting 80% on room air and required  6 L via nasal cannula.  Did not complain of any chest pain or cough with this finding.  Neither did he complain of any fever.  In the emergency room, patient was tachypneic and slightly tachycardic.  Lab work shows lactic acid of 2.3 glucose of 302 and creatinine of 1.90.  The patient's BNP was 1170 with GFR of 34.  Patient INR was 4.5.  Chest x-ray shows  Trace right pleural effusion. No pneumothorax.  With concern for pneumonia patient was given azithromycin and Unasyn.  Also with concern for possible CHF patient was given Bumex.
High fever (101), joint ache, chills, rash at site, tender site, swelled site.
So when I got the vaccine I had a sore arm and chills. The following Saturday I had a  terrible pain on my right side of my jaw. I took some meds. The next morning I took some Aleve and it helped the pain. I went to bed the net night and I got up my right leg was in pain. An then when I woke up on Monday morning it was the right leg that was in some terrible pain. An then I was able to get a doctor appt and my doctor didn't know why I was having that pain in both of my legs, because I am a healthy person. So she took my blood pressure  and it was high. She asked if I wanted a steroids shot and I said no.  I wanted to see if it would just go away. She said that she don't like taking shots or medicine if she don't have to. The pain just went away the second week of May 2022. I still can't chew on that side of my jaw.  Then my hand started aching and when I wake up in the morning my right leg is still aching. I am still having bad headaches as well. So I went to the doctor on yesterday and I had a mark on my right leg and my doctor did and ultra sound and found my lump nodes to be swollen and my ankles are swollen. She said that I have the symptoms of COVID but I didn't have COVID and my doctor said that I may have theses symptoms for at least another 3 months. Test was ran. My tests haven't come back as of yet.
Patient devloped myopericarditis confirmed by MRI 2 days following 2nd dose of vaccination, COVID negative, Respiratory panel negative
On 9-10-2010 I went to pharmacy (location above) & got Influenza vaccine & TDAP vaccine. This was on Fri. I was feeling ill all weekend, fever, body aches left arm pain at injection site. I improved by Monday & went to work. However, by Wed. 9-14-10 eve my arm was red at injection site and warm to the touch, it was very painful and I was again running a fever. On 9-15-2010 I went to medical center and was treated for infection/reaction & received script for SEPTRA & told to come back on Sat. 9-18-10. (See attached). Which I did. I missed work 2 days. My total out of pocket cost for this injection was $198.76. I would like to add that on 9-15-10 before going to medical center. I called pharmacy 800 # they told me I should probably go to my regular Dr. My Dr. ofc said they couldn't see me until evening & I shouldn't wait that long to be seen - so I went to an Urgent Care type facility. As a consumer, I want to know if pharmacy or anyone else, health insurance company, manufacturer should bare any financial responsibility in this. I await your reply.
Sensitivity to eating eggs that are less than hard boiled.  Never had an issue with this until patient started to receive vaccine in 2012. Now when patient eats eggs, patient gets diarrhea within a short time of eating them.  Did not make a connection to flu vaccine until this year.
itching; redness reemerged; pain at injection site; warm to touch; A spontaneous report (United States) was received from a consumer concerning a 74-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced Redness re-emerged/ vaccination site erythema, warm/ vaccination site warmth, pain/ vaccination site pain and itching/ vaccination site pruritus at injection site.  The patient's medical history was not provided. No Relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 30 Jan 2021, the patient developed Redness re-emerged, warm and pain at injection site.  On 6 Feb 2021, the patient experienced itching at the injection site.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On an unknown date, the outcome of the event redness re-emerged, warm, pain and itching at injection site were unknown.
Date of administration of vaccine was on 27Jul2022, The expiration date original stated 31Dec2069/ They never put it in the refrigerator; Administering to two patients a vaccine after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administering to two patients a vaccine after expiration date) and PRODUCT STORAGE ERROR (Date of administration of vaccine was on 27Jul2022, The expiration date original stated 31Dec2069/ They never put it in the refrigerator) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 062E21A, 011M20A and 013L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administering to two patients a vaccine after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of administration of vaccine was on 27Jul2022, The expiration date original stated 31Dec2069/ They never put it in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administering to two patients a vaccine after expiration date) and PRODUCT STORAGE ERROR (Date of administration of vaccine was on 27Jul2022, The expiration date original stated 31Dec2069/ They never put it in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies. The patient has not experienced any similar event in the past. Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were provided. Date the vial was initially stored in the refrigerator was that they never put it in the refrigerator.  The vial did not undergone any temperature excursions. Adverse event outcome was reported as recovered. Adverse event did not caused patient to seek medical care. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-615655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615655:Same Reporter (Patient
vesicular outbreak, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about 29-MAR-2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a pharmacy.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2010, the patient was treated by a physician, for vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Fever (elevated temperature) of 100.1. Generalized aches.  Self medicated with 600 mg ibuprofen.
Light headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Light headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Light headache). At the time of the report, HEADACHE (Light headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information not provided.
Rash at vaccine site for 3 weeks. Bruising below site for 1 month -still continuing
The Moderna vaccine vial was withdrawn more than 20 times. Patient was contacted, patient had experienced arm sore for one day.
I am also a previous Covid 19 survivor of the long hauler category.  Shortly after getting the Moderna vaccine i had to go to the ER because I was in so much pain. Susequent findings were an enlarged Ovary, the size of a grapefruit. The ovary was full of clots and required surgical removal.  Not known if it is associated with the vaccines or just a coincidence of timing. However it was not something that was a previous issue.
The morning after the second dose, I woke up with 104 F temperature, chills, massive headache and pain at the injection site.  Took Tylenol every 4 hours all day long - fever, chills and headache did not stop.  Had to spend all day in bed, could not eat, had to get someone to take care of my children - literally could not stay awake or function.  Next day I woke up feverish and with a mild headache, Tylenol worked and I was able to function although I did not feel completely well.  At night the fever came back and also pain in the back of the neck.  Fever was not as bad as the day before.  Today, Woke up with headache, tylenol worked and I am functional.  No fever.    The pain at site injection is reseeding; it was sore and lymph nodes of arm pit are still swollen but it does not bother me.  The other symptoms were scary.
12 days p/vax pt devel an inject site spot & 1 spot on abd, looked like mosquito bites, described as red & itchy w/scabby-like, scabbing over
Systemic: Allergic: Difficulty Breathing-Medium, Additional Details: pt began coughing, difficulty breathing within 5 minutes of pfizer 3rd dose. pt used albuterol at least twice during the 15 mins after before paramedics took pt to hospital. pt reported having itchy throat along with difficulty breathing but no headache. no swelling or generalized itchiness per pt. Pt had similar experience the first 2 doses (difficulty breathing and HA immediately after the vaccine but was manageable by albuterol alone). pt's bp was 134/85 with 57 pulse. on metoprolol
Localized eruption of skin on vaccine sight. Pt c/o c/o rash after IZ  IZs at WCC on 9/12/23 - mcv4, hpv, tdap - all 3 in L arm  states yesterday felt headache and body aches today got home from school and had swelling on L arm with warmth,  no open sores, discharge new izs to here were hpv and mvc4