chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator/ Administered to the patient past expiration date 22-Jan-2022; 2  doses administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2  doses administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator/ Administered to the patient past expiration date 22-Jan-2022) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2  doses administered past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator/ Administered to the patient past expiration date 22-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2  doses administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator/ Administered to the patient past expiration date 22-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  The vaccines were stored in the refrigerator. Temperature ranges were between 2-5 Celsius. Start BUD was  reported as 27-AUG-2022.  Treatment information was not provided.
Pt recvd DTP/HIB on 12SEP approx 10AM; @ 11AM temp 100.7 @ 12 t102; 2300 temp 102.7 @ MN t102.1 APAP mo called ER more APAP ordered; Also non-high pitched cry, refusing to walk x 1 day;
fever (103.5 degrees), body aches, chills, nausea, fatigue, headache; beginning about 6 hours after vaccination, at its worst about 10 hours after vaccination and beginning to subside about 24 hours after vaccination; now, about 36 hours after vaccination, just fatigued
a patient received Fluzone Quadrivalent instead of Fluzone High Dose/ NO AE; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 78-years-old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: UJ428AA, expiry date: 30-Jun-2021 via an unknown route in left deltoid) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered) on 26-Aug-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approximately 12 days after receiving vaccine I experienced a rash at the injection site that was red, itchy, warm and painful. Then 1 week ago I noticed an indentation in that arm and continued soreness. I have lipoatrophy.
Pt received the above vaccines on 050108.  Child has cried and not eaten solids x4 days.  No vomiting, no diarrhea, no rashes.
ARM IS SWOLLEN AND IN PAIN, RADIATING PAIN DOWN ARM TO WRIST, UNDER ARM LYMPH NODES SWOLLEN, BREAST TENDER AND SWOLLEN, FEVER (103, 101, 100.8), MIGRAINE, NAUSEA, CHILLS, LIGHT HEADED, BODY ACHES, DIZZY, FATIGUE, RASH ON SIDES OF FACE, INJECTION SITE ITCHY, CONGESTION, SEE'S SPOTS
I STARTED FEELING LIKE A BAD COLD WAS COMING ON, I HAD LEFT ARM PAIN AND THEN IT WENT NUMB. I WAS HAVING HEART PALPATATIONS, I FELT WEAK & SO I WENT TO ER.
headache; increase INR of 6.6 recorded; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INTERNATIONAL NORMALISED RATIO INCREASED (increase INR of 6.6 recorded) and HEADACHE (headache) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included DILTIAZEM, HYDROCHLOROTHIAZIDE, AMLODIPINE, FERROUS SULFATE, K CL, ATORVASTATIN, LEVOTHYROXINE and Calcium Carbonate with Vit D for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced INTERNATIONAL NORMALISED RATIO INCREASED (increase INR of 6.6 recorded). On 02-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, INTERNATIONAL NORMALISED RATIO INCREASED (increase INR of 6.6 recorded) and HEADACHE (headache) outcome was unknown. Not Provided      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.
17JUL95 grandma called clinic spoke w/RN stated her daughter called & said both twins screaming;asked nurse what to do;RN urged pt to check on twins & to call PMD-having non characteristics screaming;
Pt recvd vax & exp recurrence of flu sx; sx included fever, cough, h/a, earache & sneezing; It was felt that the pt exp a serum sickness or systemic react;
Patient given 5-11 year old formulation and dose (orange cap) instead of 12+ formulation/dose (grey cap) resulting in a 20 mcg dose instead of a 30 mcg dose. CDC's "COVID-19 Vaccine Administration Errors" handout referenced, no repeat dose needed. Left message for patients father, awaiting return call.
Itchiness at injection site; Fever; Headache/strange headache; Painful arm / sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm / sore arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE PRURITUS (Itchiness at injection site), PYREXIA (Fever) and HEADACHE (Headache/strange headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful arm / sore arm) and PERIPHERAL SWELLING (Swollen arm). On 14-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache/strange headache). On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Pruritus, at an unspecified dose and frequency. On 14-Feb-2021, PAIN IN EXTREMITY (Painful arm / sore arm) and PERIPHERAL SWELLING (Swollen arm) had resolved. On 15-Feb-2021, PYREXIA (Fever) and HEADACHE (Headache/strange headache) had resolved. On 22-Feb-2021, VACCINATION SITE PRURITUS (Itchiness at injection site) had resolved.            No concomitant medications were reported.  Patient reported delayed injection site itchiness started 9 days post first vaccine dose. Patient administered one application of topical Benadryl gel and itchiness resolved immediately.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-063941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporters email address and  patients age was added.
I was given the 2nd injection, waited the 20 minutes, with no reaction. At that time, I was going to physical therapy because I slipped in mud and hurt my sciatica. When they had me doing stretching, I told the therapist I couldn't stretch out with my left arm and he said that it's because of the injection. 2 weeks passed and it was still hurting to the point it was uncomfortable, and my range of motion was horrible. I had to go back to the doctor for my 6-week check up for my leg, which was okay, but my arm I couldn't move. I went to ortho and they did x-rays and a CT scan or ultrasound and I was diagnosed with deltoid myositis. There was nothing they could do and he told me I could put lidocaine and numb it. I've been doing exercise with it and it feels like there's a lump near injection site between shoulder and elbow. He told me if he gave me steroid shot it would only make it worse. I've also noticed shortness of breath and leg cramps and I've never had that before. Shortness of breath started after the first shot but it went away, and it happened again last night with the leg cramps and feels like a stabbing pain in my leg and lasts for a few seconds and then goes away. I feel like my heart is fluttering a little, but it may be COVID related. It's alleviated, and the only thing that has helped is hemp cream. March 2021 I also seen internist and he told me to get a massage gun and try to use that to see if it breaks it up. Possibly had COVID late 2019.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 30-NOV-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Cortisone - nausea, diarrhea, facial flushing, bruising, fatigue
Shot was given on the left arm, up near the shoulder. Muscle soreness and aches in the shoulder started about 8 hours after and lasted three days.
Case number PHEH2013US016192, is an initial spontaneous report received from the medical assistant on 29 Jul 2013. This report refers to a 4 year old female child. It was reported that someone mistook MENVEO (batch number: M12013) intramuscularly for a MMR (batch number: unknown) and inadvertently administered to the patient on 23 Jul 2013. No adverse reaction was reported.
Hormonal changes after second vaccine. It felt like a second ovulation, sore breasts, skin breaking out. My period was then six days late. It is never, ever late. Not pregnant. Period continues to be less predictable than before vaccination. It used to be almost down to the day, a 31 day cycle. Now it varies, longer or shorter.
Muscle soreness below injection site. Continues to inability to move arm without pain. Continues to inability to lift arm without pain. Pain on touch. Pain while trying to sleep. Still ongoing.
On 05 Oct 2012 recd Flu vaccine in (L) deltoid (IM injection). Experienced pain during shot that increased in severity over the following week. On 12 Oct went for routine previously scheduled med. exam with primary care physician who became concerned with symptoms (pain, muscle weakness (L) side; face numb (L) side. Hospitalized 12-13 Oct 2012. Symptoms resolved in approximately 2 weeks. Can never take Flu shot again.
This spontaneous report as received from a pharmacist refers to a 24 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified date in July 2015 (reported a four months ago), the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Facial rash, fine erythematous was experienced  about 6 days post administration.  Thought it was viral exanthem. Submitted photos to Dr. who referred me to online. I am now being treated for this condition with medication.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # L034335, expire date 18-MAY-2017; dose and route unknown). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 72 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 96 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the third time was 24 hours with the lowest recorded temperature of 30 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The patient was feeling more Myalgia.; Fatigue; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of myalgia in an unspecified number of male patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced myalgia (Verbatim: The patient was feeling more Myalgia.) and fatigue (Verbatim: Fatigue). The outcome of the myalgia and fatigue were unknown.   It was unknown if the reporter considered the myalgia and fatigue to be related to Arexvy.     It was unknown if the company considered the myalgia and fatigue to be related to Arexvy.   Additional Information: GSK receipt date-25-OCT-2023 The Health Field Representative on a GSK vaccine project reported that a pharmacist stated in the pharmacy today (on the day of reporting) that a few patients, all over 60 years of age, reported feeling more fatigue and myalgia than normal after receiving the Arexvy Vaccine. The Health Field Representative did not had any further information about these events, nor any information about lot and expiry, route of administration, date of administration, or any distinguishing factors for the patients. The reporter consent to follow up with the pharmacy vaccination facility was obtained. The case is linked with US2023147947, by same reporter.; Sender's Comments:  US-GSK-US2023147947:2 of 2 report
Nausea, fatigue, headache, and body aches Treated with rest and Ibuprofen taken ever 4-6 hours Symptoms subsided within 24 hours of the start date
Subsequent to vax, this pt developed a fever of 104-105 F, chills, body aches, cough, and nasal drainage. A dx of influenza was made, however type was not specified. This pt's children and spouse all developed influenza post receipt of 1999-2000 formula.
1APR98 exam in clinic by MD dx w/varicella-multiple lesions head, trunk, extremities, cough, coryza, conjunctivitis;
extreme irritability x 2-2 1/2 days p/vax; almost hysterical initially;
The patient is a resident at a skilled nursing facility.  The facility filled out the paper work with consent from the patient & family that makes medical decisions.  We were under the impression this would be the first shot the patient would receive, but upon entering it into system, found out it is the third shot.  The patient got two doses prior; on 2/2/21 & 2/24/21.  The patient has had no adverse effects from this third dose.
12MAR93 was given polio the next morning lt jaw & cheek was swollen; to date it is still like this; has no fever or pain;
Case number PHEH2013US021979 is an initial spontaneous report from nurse received on 21 Oct 2013. This case refers to a patient of an unknown age. The patient received MENVEO (batch number: A12099) 0.4 ml intramuscularly on 16 Oct 2013. The nurse only drew up 0.4 ml and administered the patient. No adverse event was reported due to this medication error.
From initial information received on 12Oct04 from a health care professional regarding an adverse event occurring, it was reported that a 36 year old male pt received a dose of Menomune A/C/Y/W-135, lot number UE301AA, site of administration not reported, as well as a dose of TD ADS adult, lot number U1283AA, administered in the left deltoid, on 08Oct04. Routes of administration were not reported. The following day, the pt developed patchy red areas measuring approx five millimeters in size on one side of his buttocks bilaterally extending up his torso with approximately 30 in number on his torso. The red areas were also noted on his left arm and right elbow. Some of the sites were blistered and opened. No drainage was noted. The pt denied pruritus. Reportedly Benadryl was ordered. Per a physician, the symptoms persist. The pt also previously received Twinrix, on 08Sep04 with no reaction reported. He also received IPOL, Typhoid vaccine, manufacturer unk , Yellow fever vaccine, manufacturer unk and Measles Mumps and Rubella vaccine, on an unspecified date in August with no reactions reported. Lot numbers as well as routes and sites of admin for these vaccines were not reported. Reportedly, the pt did not recover from these events.
Employee reported lightheadedness; vitals obtained - employee tachycardic; hypertensive
pt recvd 2nd dose of MMR on 9APR92 following a local hospital measles epidemic; 16APR92 pt devel sore throat; next day devel maculopapular eruption; also devel cough, conjunctivitis, t39.5, koplik's spots, SOB, rash, vomiting, diff swallow
Within 1 second of injection completion - hot pain seared down from injection site to wrist.  30-60 seconds later while seated,  roof of mouth and face began to tingle, throat felt extremely dry and itchy and intense thirst, a very strong surge of nausea,  dizziness/vertigo, weakness of limbs- especially the hands.   60-120 seconds later body shaking, teeth chattering (but not from cold). 30-60 minutes later  Mild headache.  Allergic reaction symptoms came in waves of intensity for approximately 8-10 hours.
kidney infection; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Other medical history and concomitant medications were not reported. The patient received her second dose of the vaccine yesterday. After the vaccination she was diagnosed with a kidney infection (in Jan2021) and was prescribed nitrofurantoin. The event was reported as non-serious. The patient asked if she may take nitrofurantoin a day after receiving the Pfizer-BioNTech COVID-19 vaccine, asks if the antibiotic may impact the effectiveness of her vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested.
arm was going to fall off, terrible pain; Initial information received on 19-Nov-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp via Flu Social Media page.  This case involves a patient unspecified demographics who experienced arm was going to fall off, terrible pain while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation strength, dose, lot number, route in unknown administration site) for influenza vaccination.  On an unknown date, the patient developed a non-serious arm was going to fall off, terrible pain (pain in extremity) at unknown latency following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event arm was going to fall off, terrible pain.
The next day on 12/19  I was super sore. On 12/20  really bad joint pain and  I had rash located on my face and chest. I went to PCP on 12/21 seen PCP given EpiPen.
severe urticarial response over entire body, scalp, palms/soles, trunk, legs, arms, face  about 11 days after booster of Moderna
I experienced extreme fatigue, total body aches, stomach cramps, and fever for three days- three days after my injection.
Patient experienced Gout in his left foot  2 days after takin the vaccine. Patient has never had gout before. The gout was so painful that the patient had to crawl around the house. Patient has seen a DR. Patient says that he now has to watch what he eats. Patient said that foot swells at least once a month.
vertigo, lethargy, tinnitus, malaise, mild diaphoresis, confusion, nausea & vomiting
I had persistent chest tightness and cough; and difficulty breathing. Starting on the 1st and was seen on the 3rd at Urgent Care. Wheezing, they noticed that I was doing that when they checked me. They prescribed me with prednisone and Albuterol inhaling to open me up. They also provided an antibiotic in case it was bacterial. They have helped with my symptoms. I'm on the tail end of it, but I do feel better than last week. Note: I had the flu vaccine on the same day, don't know for sure what brand it was.
Information has been received from a physician via a company representative concerning a 16 year old female who on 27-MAR-2007 was vaccinated with a first dose of Gardasil (lot # not reported) IM from a single dose vial. On 27-MAR-2007, the patient experienced an injection site reaction almost immediately where the injection site swelled up bright red, like a balloon. Medical attention was sought. The physician reported that they rubbed it and put ice on the area in an attempt to control the swelling. The reporter stated that the physician may have given the patient Benadryl to treat the experience, but was not 100% certain. At the time of reporting, the patient improved and "is fine". Additional information has been requested.