chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 01-Jul-2021  No treatment medications details were reported.  NDC number was reported as 80777-273-10.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Occurred 2  after shot heavy lung congestion heavy coughing heavy flem production/explusion
At 2nd dose Moderna appointment, patient reported a local reaction on her arm near injection site of 1st dose. Appeared on day 8 after immunization, with rash/hives, swollen, warm, hard, itchy. Lasted 48-72 hours and resolved without further intervention. Patient took claritin for the itching, and stayed for 30 min post-vax observation for 2nd dose
Patient developed arm pain starting from her shoulder and shooting down her arm shortly after receiving her vaccine. She described it as a nerve pain and is still experiencing symptoms today.
This spontaneous report as received from a Nurse refers to a patient of unknown age and gender. On 06-JAN-2015 the patient was vaccinated with second dose of an expired RECOMBIVAX HB injection 10 Y (lot # J014312, expiry date 07-SEP-2014). No concomitant medications were reported. It was also reported that the RECOMBIVAX HB did not have any temperature excursions. No adverse symptoms were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. Additional information has been requested.
Fever. Chills. Nausea. Body aches. Head ache.  Tylenol.  48 hours.
pt recvd vax & devel flu-like sx which persisted for 1 wk; 2 wks following vax devel malaise, diarrhea, weight loss, nausea, abdo pain; seen by MD; lab eval revealed AST 43, pos stool sample;
Arm soreness; HR raised a bit (from 54 to 70); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and HEART RATE INCREASED (HR raised a bit (from 54 to 70)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Shellfish allergy, Allergy (A lot of things), MS and Cholesterol blood excessive. Concomitant products included ATORVASTATIN for Cholesterol, GLATIRAMER ACETATE (GLATOPA) for MS, VANEX for Sleep disorder, DULOXETINE HYDROCHLORIDE (CYMBALTA), ACETYLSALICYLIC ACID (BABY ASPIRIN), BACLOFEN, VITAMIN D3 and FISH OIL (OMEGA 3 FISH OILS) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and HEART RATE INCREASED (HR raised a bit (from 54 to 70)). On 04-Mar-2021, HEART RATE INCREASED (HR raised a bit (from 54 to 70)) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 54 (Inconclusive) 54 beats per minute at rest and 70 (Inconclusive) 70 after the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Information was not provided.   This case was linked to MOD-2021-066704 (Patient Link).
Following the 2nd dose of the Pfizer vaccine the patient has experienced fatigue, generalized arthralgias, and axillary lymph node enlargement.
I had lay down for 10 min and everything in the room started to spin, I started screaming and called my daughter immediately, my daughter called 911 and I was so nervous. The paramedics came and I couldn't get up to open the door so it took them about 15 minutes until they really to me. I was taken to the hospital, they gave me an IV and I don't remember nothing at all. I woke up on the 4th day and I was released on that day. Some days I feel really dizzy and some days I'm okay. I got all of my vaccines and I was okay but the dizziness is still there since after the 2nd dose. This week has been really bad for me with this dizziness. I was referred to a specialist to see if they would help for the dizziness nut he was no good help. I was prescribed rosuvastatin 10MG for the dizziness.
Approximately 5 minutes after patient vaccinated she started feeling light headed and had bilateral tingling in her extremities.  Patient's mother indicated she had severe pre-eclampsia prior to her delivery 3 months ago.  History of hypertension, takes Labetalol 300mg  TID.  EMS transferred patient to emergency room due to hypertension (patient hasn't taken a second dose of 3 today).
L arm red, swollen, approx 3" diameter, painful - both injections given in same site - advised to apply cool compresses and may take Tylenol q 4 hr for comfort.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 07-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
injection site is hard; Arm redness; arm started swelling; arm started itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm redness), PERIPHERAL SWELLING (arm started swelling), PRURITUS (arm started itching) and VACCINATION SITE INDURATION (injection site is hard) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (Arm redness), PERIPHERAL SWELLING (arm started swelling) and PRURITUS (arm started itching). On an unknown date, the patient experienced VACCINATION SITE INDURATION (injection site is hard). At the time of the report, ERYTHEMA (Arm redness), PERIPHERAL SWELLING (arm started swelling), PRURITUS (arm started itching) and VACCINATION SITE INDURATION (injection site is hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment medication reported. Patient received the second vaccination in her left arm shoulder deltoid muscle.
Next morning she woke up with a bad headache. She took some advil then she vomited. Everything she drunk and ate that day she threw up. She went to the ER. Dr couldn't figure out what was going on.
Shortly after receiving the vaccine, client fell weak, dizzy.  Client reported that she had not taken her BP meds yet today.  BP was 170/100.  Encouraged to drink some water and eat snack.  Once home to take BP med and rest.  Left clinic after 30 minutes and dizziness had resolved.  BP still elevated 164/98 before she left the clinic.
The day after the vaccination I started to feel pain in the armpit area. When I touched the area, I felt a lump about the size of a quarter. The pain nor the size has diminished to this day.
Developed rash/redness at injection site. Went to Urgent Care, was given BENADRYL 25MG and released. We are unable to obtain further information from her.
This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ROTATEQ lot # L022446/expiration date- 14-FEB-2017, lot # L026740/expiration date- 20-APR-2017, lot # L026741/expiration date- 18-MAY-2017, lot # L027719/expiration date- 28-APR-2017, lot # L039638/expiration date- 23-AUG-2017, lot # L035636/expiration date- 21-MAY-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion and time frame was 49F for 143 hours and 34F for 24 hours. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Arm bad pain; Couldn't Eat; Arm burning; Couldn't get out of bed; Fever 101.4; Headache; Body Locking; Arm a little hot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Body Locking), FEELING HOT (Arm a little hot), PAIN IN EXTREMITY (Arm bad pain), DECREASED APPETITE (Couldn't Eat) and BURNING SENSATION (Arm burning) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Body Locking), PAIN IN EXTREMITY (Arm bad pain), DECREASED APPETITE (Couldn't Eat), BURNING SENSATION (Arm burning), DYSSTASIA (Couldn't get out of bed), PYREXIA (Fever 101.4) and HEADACHE (Headache). On an unknown date, the patient experienced FEELING HOT (Arm a little hot). At the time of the report, MUSCULOSKELETAL STIFFNESS (Body Locking), FEELING HOT (Arm a little hot), PAIN IN EXTREMITY (Arm bad pain), DECREASED APPETITE (Couldn't Eat), BURNING SENSATION (Arm burning) and DYSSTASIA (Couldn't get out of bed) had resolved and PYREXIA (Fever 101.4) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101.4 (High) Patient had 101.4 temperature.         Concomitant product use was not provided by the reporter. No treatment information was provided.
Injection site was immediately red. She had a full body rash within an hour that lasted about 4 hours. The injection site still has a red one inch ring around it after 4 days and a hard lump/knot. Last night around 100 hours after the vaccination the redness began fading and by 109 hours it has finally left. The swelling is about half the size currently.
Patient presented w/ RT arm weakness and trouble speaking on 10/26/2022 to ED and then was admitted to ICU.  LT MCA Occlusion was found on CTA and MRI
Urticarial rash to left shoulder, wrist, hand, and bilateral thighs with associated elevated heart rate.  No angioedema or other signs of anaphylaxis.  Symptoms improved with antihistamines. Reported to urgent care the following day and was treated with dose of Decadron and diphenhydramine.
Covid test result=Positive; Covid test result=Positive; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) first dose on 18Dec2020 04:45 PM (Lot number: EK5730) and second dose on 08Jan2021 (Lot number: EL3246) both via unknown route of administration at single dose in right arm for COVID-19 immunisation at Hospital. Medical history was not reported. No covid prior vaccination. Concomitant medication included sertraline. The patient previously took bactrim and had allergies. It was reported as Covid test result was Positive on 31Jan2021 and also reported as not sure if this was considered an adverse event but I did end up getting sick with COVID-19 about a month after my second vaccine after my child was exposed. I did have symptoms from the virus. I really did not have any symptoms after each vaccine. No treatment received for adverse events. No other vaccine in four weeks. Covid was tested post vaccination. The patient underwent labs and procedures included PCR Covid 19: negative on 26Jan2021 and PCR Covid 19: positive on 31Jan2021. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "COVID test result=Positive".
Patient did not have an adverse reaction. He was scheduled to receive the DTAP/HIB/Polio combo and it was given without the DTAP/Polio. The vaccine was administered again 4 weeks later. He did not have any adverse reaction from the 2nd dose of DTAP/HIB/Polio combination.
No adverse event experienced. Contacted by Immunization system because on 09/03/2022 the Covid-19 booster recommendations were changed so that the Pfizer (monovalent) should not be used for boosters and instead all boosters should be the new bivalent formulations. Patient was given the monovalent Pfizer instead of the bivalent Pfizer for his 2nd booster.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil.  The physician reported that the patient got the injection and fainted.  The patient recovered "same day".  Additional information has been requested.
per patient mother on 9/16/2022 interview mom reports pt "passed out" ~ 1 min but no er visits but rather ems was called and mom declined transport to er as her vitals were normal upon awakening.
Woke up with fatigue, fever and cough.  Obtained Paxlovid that evening. Symptoms resolved within 5 days.  The event is unlikely to be related to the vaccination.
Narrative: Headache, Myalgia, Arthralgia & CoughWheeze
Patient states that about 1.5 to 2 weeks after receiving the vaccine she broke out in itchy hives over body.  Most severe upper thighs and back,
Service member received smallpox and anthrax # 1 on 19 Jul 06 without any apparent difficulties. On 30 Jul 06 @ 2 AM he began having constant, non-radiating chest pains described as both dull and sharp at various intervals. The pains ranged in severity from 4-5/10 to 8-9/10 VAS, were worse when lying down, with increased physical activity and with rapid or deep respirations. Additionally he describes episodes of SOB with exertion, an awareness of rapid heart beat sensation within his chest and a cough productive for small amounts of clear mucus. While running during a physical training exercise he collapsed with a witness episode of loss of consciousness (only for a few seconds).There was no bowel or bladder control or any seizure activity. He took no medication for pain relief. He was admitted to  Medical Center where he had an abnormal EKG sinus rhythm with diffuse ST elevation with upright T-waves and P-R segment depression in multiple leads consistent with acute pericarditis. Labs-elevated cardiac enzymes  troponin I 7.42, CPK 532,  CPK-MB 22.2, CKP-MB percentage 4.1%; D. dimmer slightly elevated 572; slightly elevated AST & total protein 8.4 ; CBC- low MCV 76.8, low MCH; BMP  Normal.  He was placed on telemetry with serial cardiac enzymes and EKGs. An echo was performed and he was medicated with Prednisone, Ibuprofen and Protonix. Smoker
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
MOTHER CALLED REPORTED REDNESS, SWELLING, HARD, HOT TO THE TOUCH. CLIENT WAS TAKEN TO PCP RECOMMENDED TYLENOL, BENADRYL.
Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently on an unknown date the patient experienced syncope.  The outcome was not reported.  This is one of several reports from the same source.  Additional information is not expected.
PATIENT DESCRIBED LEFT SIDE OF FACE FEELING FUZZY. WITH SMILE DROPPING ON THAT SIDE. PATIENT  WAS ADVISED TO BE EVALUATED BY ED
Allergic reaction; Swollen arm; Really red; Itchy/ itching a lot; Inflamed; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Really red), PRURITUS (Itchy/ itching a lot), INFLAMMATION (Inflamed) and HYPERSENSITIVITY (Allergic reaction) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included Hospitalization (This  2nd dose was delayed because she was in the hospital.). Concomitant products included ROSUVASTATIN for Cholesterol, METFORMIN for Diabetes, HYDROCHLOROTHIAZIDE for Diuretic therapy, THIAMAZOLE (METHIMAZOLE) for Thyroid therapy, PROPRANOLOL, ALPRAZOLAM, TEMAZEPAM and DOXAZOSIN for an unknown indication.    On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Really red), PRURITUS (Itchy/ itching a lot) and INFLAMMATION (Inflamed). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Really red), PRURITUS (Itchy/ itching a lot), INFLAMMATION (Inflamed) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment provided was Benadryl.   Production indication of medications Propranolol is beta blocker, alprazolam is benzodiazepine , temazepam is benzodiazepine and doxazosin is alpha blocker.  Patient mentioned that the vaccination provider placed a round, Band-Aid like thing on arm before giving the injection that they did not do for the first injection.patient  described it as a white circle with a thin material. The first dose was also given in the left arm on 08Apr2021 and the lot number is 037A21B   This case was linked to MOD-2021-072929 (Patient Link).
Loose bowels, cramping (Thursday); Diarrhea, cramping, vomiting (Friday); cramping (milder) and loose bowels (Saturday/today). Talked with nurse at doctors office, they pointed me to the COVID hotline.
From the moment I got my booster shot, I experienced soreness in my arm (and could not use my left arm for anything because of the pain). The next day I had a severe headache which lasted the whole day and sore muscles everywhere and had a fever of 101.8. and it lasted until 12/25/21 in the morning (between 7-7:30 AM) I tried to call the nurse from my health insurance card to connect me to a health professional, but I was told that the wait was for 5 hours - I did not proceed with that instead I took some Tylenol and bedrest and about 1 AM in the morning my fever got back up again to 101 or 102. and I took some Ibuprofen. Overall, my side effects lasted from December 23-25.
recieved covid vaccine and was in observation tent. pt was on phone with her family when she felt a flushin sensation. pt was found on floor not remebering event. pt had dirt and abrsions to face forehead and bridge of nose. pt was placed in c collar and ice pack applied. bgl was taken @1351 107 hr 103 bp 122/75 o2 sat 97.   repeated at 1354 hr 79  02 99% bp 119/73. pt alert and orientated x 3.  seen by pnsite md and refered to er in care
six days after the 1st dose of vaccine administration pt developed a left arm pain, radiating to the arm pit and left breast, the injection site with big red hives.
pt recvd vax & devel severe aches, stomach cramps, testicular pain, diarrhea & vomiting; pt also exp shivering & a headache; tx w/ advil & fluids; pt devel epidymal orchitis; pt dx w/ toxic viral syndrome & epididymitis;
Patient reported that a few hours after the injection that he had a significant amount of swelling and pain in the upper left arm in the area surrounding the injection site. This had improved by the afternoon following, but the patient still complained of pain in the left elbow area.