chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-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 medications was provided. No treatment was provided.   This case was linked to MOD-2021-333886 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant follow-up the time of vial administered is changed from initial document.
Throwing up at the doctors office, complaining about headache, feeling dizzy and being tired afterwards. Had two seizures with throwing up in the car about 20 minutes afterwards.
Fainted after shot. Blood pressure 78/50. Had water and candy. Felt better after. Stayed with me for ~15 min.  Then left when he felt better
Patient administered vaccines Dtap and Hep B.  Patient is up to date on vaccines. Vaccines administered not needed.
2 days after getting shots child had soreness and swelling to arm. Motrin q 4-6 hours
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant product reported by reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 190 patient received a vaccine past the beyond use date from 9 different lot number vials. No treatment medication was reported. This case pertains to the 160th patient of the total 190 patients.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335:
Patient was given flu shot by PCP on 1/28/2020, presented to the Emergency Department for pain, swelling, and redness around the injection site
Nausea, nasal picking, inflamed,headache, tingling, metallic taste, heart burn, itching all over, migraine, dizziness.
After 35 min post vaccination patient was anxious and reported that she has "little tingling" on her upper lip. Throat feels like "pins and needles" inside. Mild headache. Given Benadryl 25 mg PO x1. Patient stable, released from vaccination site.
Moderna booster administered less than 6 months after primary Covid 19 vaccination series. No immediate reactions after administration.
diagnosed with Covid-19 and is currently in the hospital after getting a Comirnaty booster dose; diagnosed with Covid-19; diagnosed with Covid-19 and is currently in the hospital after getting a Comirnaty booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for covid 19 immunization; Bnt162b2 (Dose 2, MANUFACTURER UNKNOWN), for covid 19 immunization. The following information was reported: IMMUNISATION (medically significant), VACCINATION FAILURE (hospitalization, medically significant), outcome "unknown" and all described as "diagnosed with Covid-19 and is currently in the hospital after getting a Comirnaty booster dose"; COVID-19 (hospitalization, medically significant), outcome "unknown", described as "diagnosed with Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical Course: Caller got diagnosed with Covid-19 and is currently in the hospital after getting a Comirnaty booster dose. Caller wanted to know why this has happened. Caller added his doctors don't know why this occurred.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient was given a 3rd dose of Moderna Monovalent when they were due for their 1st Moderna Bivalent Booster. No harm to the patient. Patient was advised to return in 60 days from date of 3rd Moderna Monovalent vaccination to receive their 1st Bivalent Booster dose.
Vaccination of PNEUMOVAX 23 which caused swelling at the right cervical and right axillary lymph node causing enlargement/pain - adjacent to site of injections: right deltoid.
Paresthesias in sides of arms , thighs, finger tips and toes.  Partial  Right Facial droop with drooling.
2 swollen lymph nodes above collar bone on side of vaccination (right side of 2nd dose).  loose movable nodule about the size of pistachio nut in its shell.
death was from natural causes; collapsed; This is a spontaneous report from a contactable consumer.  A 73-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 at 73-years-old at a single dose for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing (on oxygen as needed, but not every day), oxygen therapy from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates (Gets flu shot every year around October). On 06Feb2021, the patient collapsed (medically significant) and experienced death was from natural causes (death, medically significant).  The clinical course was reported as follows: The reporter stated that his grandmother received the first dose of the Pfizer COVID-19 vaccine on 05Feb2021 and passed away on the morning of 06Feb2021.  The patient went to bed and woke up in the middle of the night around 03:00 to use the bathroom and collapsed and died within 10-15 minutes of collapsing. The patient was pronounced dead at the scene. The reporter asked: "What do you know about the news in the media about reports of death in nursing home elderly patients?"  The reporter wanted to know the ingredients of the Pfizer COVID-19 vaccine. The reporter wanted to know about the use of the Pfizer COVID-19 vaccine in patients with underlying conditions. The patient had COPD and was on oxygen as needed, but not every day. The Medical examiner said the death was from natural causes and the family was not doing an autopsy.  The patient had been tested for COVID and was negative. The patient underwent lab tests and procedures which COVID test: negative on an unspecified date. The clinical outcome of the event, death was from natural causes, was fatal. The clinical outcome of the event, collapsed, was unknown. The patient died on 06Feb2021 due to death was from natural causes.  An autopsy was not performed.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Reported Cause(s) of Death: death was from natural causes
Right arm from shoulder to hand stiff, numb, can't hold on to things without pain/can't sleep on right side arm get stiff and hurts.
Swelling of left side from clavicle extending up to jawline with lump that was movable. Redness and warmth at the site of swelling. Extreme fatigue and sweating spells.  Redness and warmth have resolved but small lump and faint swelling remains.
SWELLING OF LYMPH NODE; CYST NEAR INJECTION SITE; SORE JOINTS; CHILLS; SORE MUSCLES; INJECTION SITE SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced swelling of lymph node. On MAR-2021, the subject experienced cyst near injection site. On MAR-2021, the subject experienced sore joints. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced sore muscles. On MAR-2021, the subject experienced injection site sore. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from injection site sore, and the outcome of swelling of lymph node, cyst near injection site, chills, sore joints and sore muscles was not reported. This report was non-serious.
12FEB98 pt had rash on arms, legs, & chest that was scratching;noted rash in AM but it got worse in PM;pt felt warm but temp was snot taken;pt whined a lot & wanted to be held;did not eat well @ noon on12FEB98;
Fould smelling loose stools, associated with nasal congestion. No fever or vomiting noted.
tested positive for shingles; This spontaneous report was received from a physician via company representative and refers to a 6-year-old patient of unspecified gender. There was no information regarding the patient's medical history, concurrent condition or concomitant therapies details reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient developed shingles after being fully vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). No further information was provided. No additional adverse event or product quality complaint was reported. The outcome of the event was not reported.   The causality between the event and suspected vaccine was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  2304USA008287:Original Case : 2304USA008287 2304USA008293:Original Case : 2304USA008287 2304USA008294:Original Case : 2304USA008287
Mild pain in upper arm and shoulder when arm at rest, extreme pain in upper arm and shoulder when raising arm to do normal activities such as getting dressed, driving, washing hair, reaching for items on shelves.    Self care has consisted of ibuprofen, rest, "Ben Gay" cream. After waiting  approximately 6 weeks for  condition to improve with self care ( it has not ), doctor has recommended physical therapy, which I have not yet begun.
Patient was to get 0.3ml of the COVID 19 Bivalent vaccine but received 0.5ml instead.  Patient was in office for 30 minutes  with mother and sister after the vaccine was given with no reports of any signs or symptoms of any adverse reactions.
Post vax, pt fainted. Pt was breathing and moving extremities. Afterwards, used Ammonia inhalant and started to respond.
Approx 10 min after tetanus toxoid injection was given donor c/o lightheadedness/dizziness and nausea which lasted approx 20 min. Donor sat in plasma center until sx subsided and then left.
Break through case admission after two vaccine 3/1/21 Pfizer Lot# EN6202 3/22/21 Pfizer Lot# ER8727
Menstrual cycle changes; Period came 7 days early; This is a spontaneous report from a contactable nurse (patient herself). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the left arm on 05Feb2021 18:00 (at the age of 30-years-old), as first dose, single for COVID-19 immunisation. Medical history included hypothyroidism, autoimmune thyroiditis (Hashimoto), and anxiety. Concomitant medications included levothyroxine sodium (SYNTHROID); and escitalopram oxalate (LEXAPRO) both taken for an unspecified indication and both start and stop dates were not reported. Patient has no known allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient also reported that she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced menstrual cycle changes and her period came 7 days early on 12Feb2021. Patient did not received any treatment for the events reported. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
Significant sore throat pain, moderate cough, low fever, fatigue. That's all I experienced as part of the acute disease. No significant treatment, just ADVIL and TYLENOL. I tested positive for COVID-19 with an at home test on 02/04/2023. I began to have heart issues subsequent to that. It seems to be caused by the COVID-19 infection. These symptoms have not gone away. It raised my heart rate and caused heart palpitations. It also increased my blood pressure. Six weeks later and I'm still experiencing these symptoms. I did talk to my PCP and we are in the process of seeing a cardiologist.
A patient was administered an expired dose of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) 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 EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
High fever followed by mild rash after taking the Chickenpox vaccination. Doctor said he has symptoms of rubella virus.
Approx. 6 hours after receiving a nasal spray H1N1 child became flushed & had temp of 101.9. Did have runny nose before getting H1N1. Mom called 911 thought it was an allergy reac. 911 did not come to the home. Child did not need emergency care.
I formed bl9od clots in rt. leg. Discovered when foot swelled. Went to PCP and later was sent to er for ultrasound on leg. On 6/09/2021.
Severe chapped and cracked lips, particularly around the outline of the lips. Some puffiness of lips (especially the outline of lips).
High blood pressure after receiving the vaccine; Vertigo 16 days after receiving the vaccine; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high blood pressure after receiving the vaccine/hypertension, vertigo 16 days after receiving the vaccine/vertigo.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) for prophylaxis of COVID-19 infection.  On 25 Feb 2021, sixteen days after receiving vaccine the patient experienced the events high blood pressure and vertigo. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events high blood pressure and vertigo was unknown.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients were vaccinated with a dose of VAQTA (lot number, expiration date, dose, route were not reported) that underwent post supported temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
7/11/23  PATIENT SAID AFTER THE SHOT WHEN SHE GOT HOME HAD A HEADACHE, SHE TOOK HER BLOOD PRESURE AND HEART RATE.  BP AND HR (95) BOTH ELEVATED, ARM STARTED TO BECOME RED MAYBE 2X2 INCH AREA AND SORE .  TOOK BP AND HR LATER IN DAY HR REPORTED TO BE 93 BP ELEVEATED BUT NO NUMBERS AGAIN.  BY BEDTIME BP AND HR HAD RETURNED TO NORMAL.  DIDN'T BELIEVE SHE HAD A FEVER DURING THIS TIME.  NEXT DAY 7/12/23 WHEN SHE WOKE UP THE REDNESS ON ARM INCREASED TO AN AREA OF 6X2 INCHES AND WAS WARM, MAYBE SOME SWELLING AND SORE.  HR AND BP NORMAL. TODAY 7/13/23 WHEN CALLED AREA OF REDNESS A BIT SMALLER, NOT AS WARM BP AND HR NORMAL.  RECOMMENDED PAIN MED, COLD PACK TO ARM, CONTINUE TO MONITOR AREA THAT IS RED AND BP AND HR.  ALSO RECOMMENDED TO REACH OUT TO HER PCP
Body Aches; Little chills; Swollen Injection Site; Teeth were Chattering, she had Chills, and Uncontrollable Shivering; Sore Left Arm; Could not Lift her Left Arm beyond shoulder level; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm), LIMB DISCOMFORT (Could not Lift her Left Arm beyond shoulder level), MYALGIA (Body Aches), CHILLS (Teeth were Chattering, she had Chills, and Uncontrollable Shivering) and CHILLS (Little chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had only minimal symptoms (Only Fatigue).) on 01-Jan-2021.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm), LIMB DISCOMFORT (Could not Lift her Left Arm beyond shoulder level), CHILLS (Teeth were Chattering, she had Chills, and Uncontrollable Shivering) and VACCINATION SITE SWELLING (Swollen Injection Site). On 18-Mar-2021, the patient experienced MYALGIA (Body Aches) and CHILLS (Little chills). On 17-Mar-2021, CHILLS (Teeth were Chattering, she had Chills, and Uncontrollable Shivering) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Left Arm), LIMB DISCOMFORT (Could not Lift her Left Arm beyond shoulder level) and VACCINATION SITE SWELLING (Swollen Injection Site) outcome was unknown and MYALGIA (Body Aches) and CHILLS (Little chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
After an hour & a half I started feeling very short of breath. When I took a deep breath I got a pain in my chest. This continued for 2 hours. I called my doctor & she suggested if it got worse to go to the ER. I got better without going to the ER within 2 hours.
On Sunday, 4/11  my eyelids were tingling, it then went to my forehead, entire face and both of my arms. My muscles stiffened and my hands/thumbs were cramping inward. My hands were also red and blotchy during this time. My face was tight and hard to move or talk. This entire incident lasted in total around 20 minutes or so. I seem to be okay since that incident, I have had a headache off and on. Not sure if it?s related to the vaccine but I haven?t experienced anything like this before.
Patient was already vaccinated for Influenza on 9/26/18, second one was given in error. Patient had no adverse reaction to first or second vaccine.
Received Pfizer vaccine on 2/2/2021, noticed that left hand was achy and swollen on 2/3/2021 and on 2/4/2021, she noticed that her right hand was swollen.
expired dose of PROQUAD that was inadvertently administered to a patient; This spontaneous report as received from a nurse regarding a 6 years old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not provided.  On 10-AUG-2020, an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) (lot S003862 and expiration date: 08-AUG-2020; strength, dose, frequency, route, anatomical location were not reported) for prophylaxis was inadvertently administered to the patient (expired product administered). It was unable to determine if vaccine had a previous temperature excursion or not. The outcome of the event was not provided.
The first day, I had chills and then on the 2nd day, I started getting body aches. Then that went away in about a day or two. Then a few days later, I thought I had a fever or something like that, I just felt warm. I didn't measure temperature or anything. All I know is that I remember feeling odd. Towards the end of November, I started coughing. I started coughing continuously every day more so. The last 4 days, maybe because of the cold, the area around my rib cage is sore. I started using albuterol because of the asthma starting yesterday because I was experiencing shortness of breath when I am coughing. The coughing has almost subsided, but the pain is  all around still there. Denied assistant in person at the doctor because they required a COVID test before coming because of the cough.
Around 2pm (27 hours after vaccine) fever jumped to 103.6.  This lasted for three hours.  Every bone ached.  Eyeballs ached.  Couldn't lift my head.  SO sleepy.  It was awful.  Then it was over.  I still was uncomfortable for the next 48 hours but not like it was.  Temperature was back to normal.  But overall felt badly.
Wrong diluent was used to reconstitute HIB vaccine-Instead of diluent provided with vaccine sterile water was used No adverse effects from this event
This is not a confirmed adverse effect but a potential relationship.  About 2 weeks after my second dose I was having major pain and tingling in my left leg.  Shortly after I got rash and very painful blisters on my left buttock, crack, and anus.  Went to urgent care and was diagnosed with Shingles.  I am On a two week cycle of Humira. My last dose was on April 29.