chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they got a little ill for a couple of days; arm being sore; couldn't get out of bed; tired; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (they got a little ill for a couple of days), PAIN IN EXTREMITY (arm being sore), MOVEMENT DISORDER (couldn't get out of bed) and FATIGUE (tired) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049022A) for COVID-19 prophylaxis.     It was reported that patient had no known allergies.  The patient's past medical history included Spinal stenosis (spinal stenosis in the back, started off taking Lyrica and then they gave injections and it went away.). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (041L20A, dose 1) on 29-Jan-2021, Moderna COVID-19 vaccine (023M20A. dose 2) on 27-Feb-2021, Moderna COVID-19 vaccine (033F21A, dose 3) on 01-Nov-2021, Moderna COVID-19 vaccine (001M21A and dose 4) on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Concurrent medical conditions included Blood pressure (Callers takes a couple of medications. Something for her blood pressure). Concomitant products included PREGABALIN (LYRICA) for an unknown indication.    On 07-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ILLNESS (they got a little ill for a couple of days), PAIN IN EXTREMITY (arm being sore), MOVEMENT DISORDER (couldn't get out of bed) and FATIGUE (tired). In 2022, ILLNESS (they got a little ill for a couple of days) had resolved. At the time of the report, PAIN IN EXTREMITY (arm being sore), MOVEMENT DISORDER (couldn't get out of bed) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient was generally healthy and had some issues that come and go and haven't had any trouble with vaccinations before. It was reported that patient had flu vaccination on 13-Oct-2023. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745579 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745579:Wife case, Master case
MALAISE; MILD DEHYDRATION; CHEST PAIN; CHILLS; GENERALIZED WEAKNESS; HEADACHE; This spontaneous report received from a physician concerned a female of unspecified age. 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced chest pain. On 09-APR-2021, the patient experienced chills. On 09-APR-2021, the patient experienced generalized weakness. On 09-APR-2021, the patient experienced headache. On 19-APR-2021, the patient experienced mild dehydration. On 19-APR-2021, the patient experienced malaise. Laboratory data included: CT scan (NR: not provided) UNKNOWN, and EKG (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, generalized weakness, chills, chest pain, malaise and mild dehydration was not reported. This report was non-serious.
pt recvd vax 27OCT93 & c/o bursitis in the arm of inject; following treatment w/ a steroid inject sx abated;
No adverse event; 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) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medicine were reported. Age of the patient is 78 years 0 month.  No treatment medicine were reported.
Red, swollen, hot/warm to the touch at site where varicella was administered. Left / SC.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: 6M9810), in left arm, on 05Mar2021 as dose 2, single (Lot number: EN6502), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "stroke" (unspecified if ongoing); "pneumothorax" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative twice 48 hours apart; (unspecified date) Negative, notes: tested negative twice 48 hours apart; (Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Rebound of COVID-19 symptoms and testing positive again, after symptoms went away and tested negative twice, 48 hours apart. Known allergies was no.
Med Error.  Today we were administering the second dose of vaccine to our employees. I am the sole person responsible for setting up the dose. I diluted the vaccine with 0.8 of normal saline rather than the 1.8 cc.
Per pt, she had red, swollen, tender left arm from below injection site to just above elbow that lasted 4 days. She took Benadryl to relieve symptoms. Symptoms got better each day and resolved by day 4.
Initial report received from the Health authority (MHRA-ADR-20535038-001) on 09 Dec 2009: This patient with medical history of asthma was vaccinated by Influenza (H1N1 influenza virus vaccine) (batch E9698-2), split virion inactivated on 30 Oct 2009. The patient experienced swollen tongue, swollen glands, felt warm had an inability to swallow, sore throat and her hearing was affected on 31 Oct 2009. The patient was seen by the doctor and was prescribed 5 mg of an unspecified steroid daily for one week. The outcome was reported to be completely recovered. The reporter assessed the case as serious.
Pt called and said she had some tingling in her face. She said she had a doctor's appointment she came back with a new prescription for the treatment of Bell's Palsy
Fever, starting 4/17/21, 5:00 pm, 100.3, reaching a high of 102.9 on 4/18/21 at 6:30 pm, last recording of fever of 99.7  on 4/19/21 at 10:30 am.  Very bad headache starting 4/17/21 at 5:00 pm.  Very painful at injection site starting 4/17/21 at 2:30 pm.
Pt received the vaccine on 4/1/22. By the afternoon her arm was very sore, and the pain continued to get worse to the point where she could not lift her arm to dress, or brush her hair. Her arm, shoulder remained tender and week so she saw her MD on Wednesday 4/6, who concluded a large localized reaction was resolving. The patient continues to have tenderness in the deltoid, but has increased mobility.
all prior shots have been pzifer and the symptoms were the same and reports filed this time dr wanted me to try moderna to see if the reaction was the same it was but the severe reactions were delayed by about 24 hours   within hours of the moderna vaccine i started to feel out of sorts by 5pm that evening i was very whiny and sore all over, headache and warm no fever yet my skin was turning red and felt very itchy around the mid section  very restless night my legs felt like they were in constant motion while i was laying in bed very restless and no sleep cried most of the night by the next morning i could not move or walk with out help i ached so very bad could stand alone needed help to get up and walk  very cold and could not keep warm fever at this time was 101 took tylenol and rotated with advil  would sweat trough clothes but could not stay warm   slept a lot but very out of body sleep  ... by 9 pm the night after the shot my fever was 102.5 in awful pain all over body pain headache and the rash was bad bright red all over the body... i do have pictures  it took several hours but my temp started to go down but very slow and my family was very close to taking me to the er...day three the body pain started to go away the fever was going down headache still intense and rash was still bad.   this all took about 5 days to go away but the headahe still is in and out and the rash is gone but my skin is very dry and peeling and flaky    I am shocked that moderna did the same thing but somewhat delayed   what does it mean , am i allergic or is it just my immune system fighting it  do i get child dose next time   i have no clue
Patient administered with Flublok instead of the regular flu shot , no reported adverse event; Initial information received on 01-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professionals via Regulatory Authority (under reference number 00837217).  This case involves 6 child (unknown gender) patients who were administered with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of the regular INFLUENZA VACCINE (wrong product administered).   The medical history, past medical treatment(s), vaccination(s) ,concomitant medication(s) and family history were not provided.  On 01-Nov-2021, the patients received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number QFAAZ150 and expiry date 30-Jun-2022) instead of the regular INFLUENZA VACCINE via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered (same day latency).  It was reported "Practice Manager states when the pharmacy provider sent the Flu shot to them they didn't realize it was FLUBLOK instead of the regular flu for a pediatric office and they administered 6 children the dose. Caller would like to know what to do?"  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
I woke up with significant Vertigo on May 9. threw up, extremely dizzy upon waking in the morning.  I've been dizzy since. On scale of 1-10 (where 10 = throwing up & 0 == no symptoms)  It was level 7 for first three days, then dropped to 6, then 5 then 4 over next 10 days.  I started seeing therapist to do Vertigo head movements to try to get rid of it.  Not much change. Its back to level 6-7 in past 2 days on May 17 &18, likely because I've done extra PT homework hoping that forcing more dizzy will get me through it. Not good, Im dizzy all day now and have SIGNIFICANT spirals about 4-6 times/day where it feels like my eye balls are spinning up into my eye sockets with certain head positions.
About 24 hours after the administration of the vaccine, patient developed a rash that was warm to the touch on right deltoid, below the injection site. The rash spanned all the way down to just above the elbow. It did not span the circumference of the arm, it only appeared on the outside of the deltoid, below the injection site. The patient did not experience any hives or itching. As of Monday, 10/9/17, the rash was disappearing.
After vaccines was drowsy for 2 days. Then became irritable, would not nap, had high pitched cry, seemed in pain and arched back. Difficult to comfort, alteration in sleep, low level of consciousness, less eye contact, lethargic, no smiling, staring off in space, rash on abd and legs, reduced feeding. Severe diarrhea, decreased movement of arms and legs.
After receiving the Pfizer Vaccine, first dose on the 12/3/2022, Patient had an allergic reaction neck down. After 3 hours of the vaccine she  had a rash all over her body except her private parts or her face. I can compare it with goosebumps but 3x the size, round and very hard at touching.  Itchy on times. This rash lasted for around 8 days. I provided Zyrtec and Benadryl.
Shoulder hurts; pain in shoulder;this is not the first time I had trouble with the shoulder; Shoulder hurts; pain in shoulder; this is not the first time I had trouble with the shoulder; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) via an unspecified route of administration in right upper arm on 09Jan2021 at single dose for COVID-19 immunization. Medical history included rotator cuff surgery on her left shoulder about 15 years ago and it was perfect and it didn't bother her anymore, atrial fibrillation (A-Fib) and so taking blood thinners (unspecified medications) and had trouble with the shoulder. Concomitant medications included blood thinners (unspecified medications). The patient experienced her shoulder hurt after being vaccinated with COVID-19 Vaccine in Jan2021. The patient took two Tylenol Extra Strength and arthritis pill because yesterday on 17Jan2021, it just had flared up. And also, this was not the first time she had trouble with the shoulder. So, the patient was not sure, she have had problems with it before. The patient did not visited a Physician's Office or Emergency Room, she had a shot (Unspecified Medications) about 5 years ago when it was hurting her so bad and it hadn't bothered her much since but every now and then it flares up. So, it just may be a clear coincidence. The outcome of event was unknown.
DEVELOPED GENERAL ACHES AND PAINS SIMILIAR TO FLU LIKE SYMPTOM, 48 HOURS LATER DEVELOPED RASH, ON INTERIOR UPPER ARM, 3-4 INCHES AWAY FROM INJECTION SITE.
Huge bruise w/hematoma on upper left arm. 9 days later still black and blue and swollen. Never had reaction to flu shot in 25+ years I've been getting them.
couldn't swallow very well at all - had to bend down to be able to swallow; lymph nodes were swollen; rash; swelling of the arm; A spontaneous report was received from a healthcare professional concerning a 72-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dysphagia (couldn't swallow very well at all - had to bend down to be able to swallow), lymphadenopathy ( lymph nodes were swollen), rash and swelling (swelling of the arm)  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient stated experiencing swelling of the arm, rash, lymph nodes were swollen, she also stated that she couldn't swallow very well at all - had to bend down to be able to swallow.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the known safety profile of mRNA-1273.
Information has been received from a nurse referring to an 11 month old patient of unknown gender. On 01-APR-1999, the patient was vaccinated with the first dose of VARIVAX (Merck) injection, (strength, lot number, expiry date, dose and route were not reported), before 12 months of age. On 26-APR-1999, the patient received the second dose of VARIVAX (Merck) which was inappropriate schedule of VARIVAX (Merck) administered. No adverse events were reported. Additional information has been requested.
hot area around the injection site; angry" area around the injection site; some bruising at the injection site/ bruising became worse/ bruising starting to fade; red area around the injection site; swollen area around the injection site/ raised area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red area around the injection site), INJECTION SITE WARMTH (hot area around the injection site), INJECTION SITE SWELLING (swollen area around the injection site/ raised area around the injection site), INJECTION SITE DISCOMFORT (angry" area around the injection site) and INJECTION SITE BRUISING (some bruising at the injection site/ bruising became worse/ bruising starting to fade) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Handicap and Hydrocephalus. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM CONTROL) for Gastroesophageal reflux, LISINOPRIL for Hypertension, MULTI VITAMINS & MINERALS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (red area around the injection site), INJECTION SITE WARMTH (hot area around the injection site), INJECTION SITE SWELLING (swollen area around the injection site/ raised area around the injection site), INJECTION SITE DISCOMFORT (angry" area around the injection site) and INJECTION SITE BRUISING (some bruising at the injection site/ bruising became worse/ bruising starting to fade). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE ERYTHEMA (red area around the injection site), INJECTION SITE WARMTH (hot area around the injection site), INJECTION SITE SWELLING (swollen area around the injection site/ raised area around the injection site), INJECTION SITE DISCOMFORT (angry" area around the injection site) and INJECTION SITE BRUISING (some bruising at the injection site/ bruising became worse/ bruising starting to fade) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I felt fine after a day of normal vaccine symptoms. I was fine until August 2022. The middle of August is when I started having back/chest pain and difficulty breathing. I thought it was my asthma. Around 8/15/2022 I went to urgent care. They did an MRI with contrast to see if I had blood clots. I would walk about 50-100 feet and I was wheezing. They told me I had multiple moderately sized blood clots in both lungs. I was sent to the hospital and put in ICU. They checked my heart and started me on Heparin and my symptoms improved really fast. I never needed oxygen though. They set me up with a cardiology and hematology consult. The doctors think it was COVID-19 related. The cardiologist doesn't think the clots started because of my heart. I have been taking ELIQUIS and I like it.
Information has been received from a physician concerning an 18 month old pt who on 11Dec04 was vaccinated with a dose of varicella virus vaccine live. On 10Jun05 the pt experienced a case of breakthrough. It was reported that the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Child received DTaP in R thigh on 9/20/02. Called physician on call on 9/21/02 c/o "orange-size" know at injection site; warm to touch, painful. Seen in ER same morning. Diagnosed with a sterile abscess. Given dose of Ibuprofen. Given prescription of Cephalexin 250/5 T tsp TID to take only if fever > 100.4. Mom called office on 9/23/02 to report incident. Child has had no fever to this point.
Stroke; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 30Jun2021 (Lot number: EW0191) at the age of 41 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Immune deficiency" (unspecified if ongoing). The patient took concomitant medications includes: IMMUNOGLOBULIN G HUMAN. Vaccination history included: BNT162B2 (dose 1, lot number: EW0191), administration date: 09Jun2021, for COVID-19 immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "Stroke". The patient was hospitalized for cerebrovascular accident. The event "stroke" was evaluated at the physician office visit. Therapeutic measures were taken as a result of cerebrovascular accident. Additional information: The patient stated, "I'm the one who got the stroke; I got the stroke like literally a couple weeks after, so I never got a booster shot, I was told not to get one. I have had been in hospital, in ICU the for 3 days. Now I have to get all kind of therapies physical therapy, occupational therapy and speech therapy."  No follow-up attempts are possible. No further information is expected.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/12/2023 ABDOMINAL PAIN
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2014, the patient was vaccinated with the first dose, on 06-MAR-2017 with the second dose and on 04-APR-2017, the patient was inadvertently vaccinated with the third dose of VARIVAX (dose, frequency, lot # and expiration date were not reported). Additionally, a sterile diluent (manufacturer unknown) was used to reconstitute the vaccines (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Dark red area 6cm around injection site left deltoid, raised swelling, slightly raised area. Reaction noted 48 hrs following injection 72 hrs. following redness 11cm x 6cm.