chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT REPORTS SEVERE PAIN AND SEVERELY LIMITED ROM IN LEFT ARM WITHIN 24 HOURS OF RECEIVING VACCINE.  AT 50 HOURS OUT, ONLY ABLE TO MOVE ARM APPROXIMATELY 30 DEGREES WHILE KEEPING ELBOW AT 90 DEGREE ANGLE.  PATIENT STATES HE BELIEVES THE VACCINE ADMINISTRATOR WAS DISTRACTED AND INJECTED THE VACCINE TOO HIGH.
Patient reports developing a rash 1 week after receiving Johnson & Johnson vaccine. Patient describes rash as bright red spots on bilateral legs from knees to ankles. Majority of spots are around the ankles on the inner aspect of leg. Spots are the size of a pinky finger tip and are not bothersome in the way of itching or hurting. Patient reports contacting PCP who instructed patient to contact the local health department. Patient spoke with a pharmacist who recommended she use a cream that she was unable to remember the name of when speaking with the reporter.
Patient received Moderna 6M-5Y for their first dose, was suppose to get Moderna 6M-5Y for their second dose. Pfizer 6M-4Y was given instead. Talked to dad today, no issues. Pt needs to get 3rd dose of Pfizer or Moderna to complete 3-dose primary series.
Itching; Within 30 mins, I got hives; Face was flushed; Redness on my cheeks/ red; Sore; Rash on the chest; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), URTICARIA (Within 30 mins, I got hives), RASH (Rash on the chest), FLUSHING (Face was flushed) and ERYTHEMA (Redness on my cheeks/ red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SALBUTAMOL (ALBUTEROL HFA), ALENDRONATE SODIUM (ALENDRONATE), ALPRAZOLAM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AZELASTINE, BUPROPION, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CITALOPRAM, IRON, HYDRALAZINE, IRBESARTAN and METHIMAZOLE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itching), URTICARIA (Within 30 mins, I got hives), RASH (Rash on the chest), FLUSHING (Face was flushed), ERYTHEMA (Redness on my cheeks/ red) and PAIN (Sore). At the time of the report, PRURITUS (Itching), URTICARIA (Within 30 mins, I got hives), RASH (Rash on the chest), FLUSHING (Face was flushed), ERYTHEMA (Redness on my cheeks/ red) and PAIN (Sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR
lips burning; tongue burning; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (lips burning) and TONGUE DISCOMFORT (tongue burning) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Flu: Flu vaccine (Last year). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulfa allergy), Allergy to nuts (hazel nuts) and Blood pressure high (diagnosed prior to getting the vaccine). Concomitant products included LABETALOL for Blood pressure high.    On 03-Oct-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. On 03-Oct-2022, the patient experienced ORAL DISCOMFORT (lips burning) and TONGUE DISCOMFORT (tongue burning). At the time of the report, ORAL DISCOMFORT (lips burning) and TONGUE DISCOMFORT (tongue burning) had not resolved.            On 30-Jan-2021 patient received the first dose of vaccine lot number 012M20A. On 27-Feb-2021 patient received the second dose of vaccine lot number 014M20A. On 01-Nov-2021 patient received the first booster dose of vaccine. On 13-Apr-2022 patient received the second booster dose of vaccine lot number 046L21A. It was reported that patient did not experienced similar event in the past. No death was not occurred and autopsy was not done. No treatment information was provided.
Metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. An unspecified age male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE) via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously took the first dose of BNT162B2 via an unspecified route of administration on 23Feb2021 as single dose for COVID-19 immunization and no reaction on previous exposure to drug. On an unspecified date, the patient had a metallic taste in mouth. And he had this effect ever since he received his shots and until the currently day. The patient wondered whether had a remedy for this effect. The patient had already spoken to his primary care doctor, about his concern. The outcome of event was unknown.  Information on the lot/batch number has been requested.
CHIEF COMPLAINT/REASON FOR VISIT Chest Pain (started several days ago, pt states his doctor called him and told him to come in)     HISTORY OF PRESENT ILLNESS     an 86-year-old gentleman who is brought in by EMS from home.  He states 1 week ago he developed this productive cough.  He also noted right-sided chest pain that radiates into the right lower abdomen.  He had had chills.  He states he just was not feeling well.  Yesterday he went in for COVID testing and it came back positive.  Today the outpatient COVID team had contacted the patient about ongoing care.  At that time patient had reported that he was feeling worse.  He continued to have the right-sided chest pain that radiated into the abdomen and at times felt short of breath.  Based on the symptoms he was directed to come into the emergency department.  Patient states that he did not want to come in but because the provider recommended and he came in for evaluation.  On arrival he denies any shortness of breath currently.  He states that the shortness of breath comes and goes.  The right-sided chest pain that radiates into the abdomen is always there and minimally.  Denies any exacerbating or relieving factors.  He denies ever having this type of pain in the past.  He continues to have a productive cough.  Denies any new back pain.  No fevers.  Has noted the sore throat occasionally.    Patient has chronic heart failure.  He states that he is actually down 2 lb.  Has not noticed any unusual swelling.
I had symptoms that started tendinitis in finger and the it moved to her ankle. Tendinitis persisted for about a week or two weeks. I was prescribed medication by the doctor but decided not to take it and the issue self resolved between 1 to 2 weeks.
I noted a 10 mm supraclavicular firm, mobile, nontender lymph node on left about 10 days after vaccine was given in the left arm. If has since reduced to about 7 mm in size.
Nonspecific erythematous rash right post auricular area that patient relates temporally to injection.
Pt returned to office 2 days following vaccination. Reported feeling pain & swelling at site of PNEUMOVAX injection. At office visit physician noted (R) deltoid swollen & warm. No redness, no papules. Enlarged (R) cervical chain. Temp 100.7. Tx BENADRYL, Ibuprofen, ice.
PATIENT PRESENTED TO CLINIC FOR VACCINES ON 11/22/2022. . PATIENT GAVE VERBAL HISTORY OF LMP 10/15/2022 & DENIED POSSIBILITY OF PREGNANCY AT THAT TIME. PATIENT WAS GIVEN THE ABOVE VACCINES. PER PATIENT VERBAL HISTORY AT VISIT TODAY, PATIENT ACKNOWLEDGED DOING A PREGNANCY TEST THE WEEK OF 11/24/2022 & IT WAS POSITIVE. HCG PREGNANCY TEST DONE TODAY WAS POSITIVE WITH QUANT. PENDING.
Vaccine was stored in refrigerator post expiry; Administered vaccine to patient post expiry; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator post expiry) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine to patient post expiry) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     Patient was not diagnosed or tested positive for COVID-19. Diagnosis for acute illness at the time of vaccination and up to one month before was unknown. Chronic or long standing conditions was unknown. Patient had no known drug allergies.     On 30-Mar-2022 at 10:45 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 10:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine to patient post expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator post expiry). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator post expiry) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine to patient post expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported. Date the vials was initial stored in refrigerator was 01 Mar 2022. Vial had not undergone any temperature excursions.  At the time of report none of the patient had reported adverse reaction. Treatment information was not provided.
patient presented to clinic today with two day history of pain, swelling, redness and warmth at injection site.  no fever chills, malaise or other new symptoms.  area of erythema covered entire deltoid area lateral humerus approx 10 cm dia .  swollen entire arm. tender. warm.
Patient received Moderna Covid-19 vaccine on 01/14/21. Patient revealed symptoms of red, warm, firm nodule left deltoid on 01/21/21. Patient also complained of itching at injection site. Referred to PCP for treatment.
Syncope w/ poss seizures down for 2 min. Shallow reps placed on NRB 21. BP 167/110. Hr112. RR 15.oxygen sat 100%. BGL 339mg/dl. 911 and transferred to ER.
Started out with what I thought were flu like symtoms - chills, then I was warm- extremly tired Then my chest started hurting- I thought this was the vaccine working- then I started getting short of breath- still thinking this is the vaccine working- then my chest started hurting extremely bad- and my abiity to breath  became worse- finaly I contacted my doctor-because I thought maybe I had gotten bronchitis- so she prescribed an inhaler in the mean time - I ordered a oygen meter- and my oxygen was registering in the 80s-  then my chest was getting more and more painful.  And then a few days later, my oxygen started dropping down to the 70s and my body temp dropped to 95.1- I was passing out at home, although I didnt realize that is what was happening, I would just wake up and an hour would have passed and I didnt even realized I was out, and this kept happening especially during the time that my temperature kept dropping below 95. I rushed to the emergancy room which after I had been there a long time- they found that I had a  *************** *********BLOOD CLOT- MASSIVE********************** A SADDLE BLOOD CLOT ************** IN  LUNGS They immediately admitted me, and immediately started me on Lovonox and Coumidin I am currently on oygen and I will have to take Coumidin for the rest of my life. Due to the size of the clot (5-6 inches) they were concerned about my heart, the clot caused a strained on the right side of my heart, so they put my on a different beta blocker Coreg to slow my heart rate down, I will also have to take this medication for the rest of my life
Approximately 1633 after varicella given at 1630 red area over lateral R thigh with 3cm welt in middle developed. Treated ice. Pt very fussy. 1655 alert crying off and on. Decreased redness and decreased welt. Pt dc'd home in good condition. Dr spoke with pt's mom in evening and no sign of red area or welt.
Itchy rashy hives all over. Swollen itch burning eyes. Throat inner ears tingly itchy
Severe headache, could not lift head from pillow. Nausea. Involuntary trembling, shaking and shivering. Missed work the day after vaccine. These symptoms lasted six hours. I am a very strong person who tolerates illness/injury well. This reaction was above and beyond anything I've ever felt. I am reporting this at this time because I just realized that this incident can be reported.  I do not want the booster. I refuse it.
marked local rxn lt deltoid;T100 A lasted 4-5 days 10x8cm swelling, erythema, warmth;tx motrin, cool compresses;
pressure on right side of jaw; tingling sensation on neck and throat; swelling of the throat; Vaccination site reaction; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (pressure on right side of jaw), PARAESTHESIA (tingling sensation on neck and throat), PHARYNGEAL SWELLING (swelling of the throat) and VACCINATION SITE REACTION (Vaccination site reaction) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN JAW (pressure on right side of jaw), PARAESTHESIA (tingling sensation on neck and throat), PHARYNGEAL SWELLING (swelling of the throat) and VACCINATION SITE REACTION (Vaccination site reaction). At the time of the report, PAIN IN JAW (pressure on right side of jaw), PARAESTHESIA (tingling sensation on neck and throat), PHARYNGEAL SWELLING (swelling of the throat) and VACCINATION SITE REACTION (Vaccination site reaction) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up information received on 20-APR-2021. Updated Events, durations, event outcome,and Event listedness
My doctor asked me if I would like a flu shot for my son and I said yes. The doctor was aware of my sons slight cold symptoms and still offered the shot. The nurse who gave my son the shot also noticed my son had a slight cough and she still proceeded with the vaccination.
Inappropriate age at vaccine administration; throwing up; Headache; Stomach pain; feels like no energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 24Nov2021 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 24Nov2021, outcome "unknown", described as "Inappropriate age at vaccine administration"; VOMITING (non-serious) with onset 24Nov2021, outcome "not recovered", described as "throwing up"; HEADACHE (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Stomach pain"; ASTHENIA (non-serious) with onset 24Nov2021, outcome "not recovered", described as "feels like no energy".  Additional information: The caller (mother) was calling about the pediatric Pfizer covid-19 vaccine on behalf of her son. The patient was having a reaction- he was throwing up, has headaches, stomach pain, and feels like no energy. The patient's symptoms started 1.5 hours ago.   No follow-up attempts are possible. No further information is expected.
Hypertensive urgency - BP 194/120, noon on 3/26/21, still high at 3:00 pm in doctor's office, sent to emergency room. BP as high as 220/203. By 11:00 pm on 3/26/21 was lowering, would jump back up. Discharged with BP 150's/100 on 3/27/21.  New BP medication prescribed  Stayed one night in hospital.
Intense eye swelling; Cheeks tingling; Cheek swollen; Cheeks numb; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Intense eye swelling), PARAESTHESIA (Cheeks tingling), SWELLING (Cheek swollen) and HYPOAESTHESIA (Cheeks numb) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Intense eye swelling), PARAESTHESIA (Cheeks tingling), SWELLING (Cheek swollen) and HYPOAESTHESIA (Cheeks numb). At the time of the report, EYE SWELLING (Intense eye swelling), PARAESTHESIA (Cheeks tingling), SWELLING (Cheek swollen) and HYPOAESTHESIA (Cheeks numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information was received on 21-May-2021 contains information regarding reporter mail address.
EMS brought pt to ED; O2 sats on room air are 50%; placed on CPAP; pt unresponsive; tested positive for COVID; intubated; went into cardiac arrest x 10 mins and a second time for 7 mins; family states they do not want CPR or medication to be used on patient; pt's condition worsened and he expired in the ED
After oral Rotavirus - given at 4 month check up developed Acute Gastroentitis.  Hospitalized IV hydration (1-22-07 to 1-23-07).   2/8/08 Received vax record & database updated w/additional vax.  Pt in usual state of health on day of vax.  2/8/08 Received hospital d/c summary which reveals patient experienced vomiting, reduced oral intake & urine output x 1 day.  Admitted 11/22-11/23/2007.  Vomiting resolved & feeding returned to normal but on day of d/c developed foul smelling diarrhea FINAL DX: dehydration; gastroenteritis; vomiting; incidental finding of left kidney pelviectasis.
02:00 am - 12 hours later, I had hot flashes followed by cold flashes. 08:00 am - nausea - that lasted until about 02:00 pm. I felt a little achy but not really muscle aches.  I took Motrin at 08:00 am and that helped. I took a nap and the morning after work. I was fine after that. Have had morning sickness from pregnancy - that probably started June 14th - lots of nausea and I'm on some anti-nausea medication   - 1/2 of Unisom tablet along with Vitamin B6 ( medication it may be helping somewhat but not taking it away completely) and  I also have some fatigue. (Anti nausea medicine is a sleeping pill so I also get extra fatigue from taking that.)  I experienced the same nausea with first pregnancy and had to do the same thing with anti-nausea medication. Positive pregnancy result: May 31, 2021 Pregnancy history - 2nd pregnancy - successful first pregnancy with birth of son; Estimated date of delivery for this pregnancy -  2/6/2022
Information has been received from a pharmacist via Pfizer (other company #: 2017241216) referring to a male patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot #, strength, dose and route unknown) for prophylaxis. On an unknown date, the patient experienced extreme limitation of arm movement and pain in vaccinated arm that lasted 2-3 days, then it resolved itself and was put out of commission for 2-3 days. The outcome of extreme limitation of arm movement was not reported. Action taken with the vaccine was not applicable. The causality assessment was not reported.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in 2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M044718, expiration date 07-MAY-2018 (dose and route of administration were not reported) which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). On an unknown date in approximately 2017, the patient's injection site was very red, swollen and warm to touch. The outcome of the events and the relatedness between the events and PROQUAD were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000669: US-009507513-1706USA004880: US-009507513-1707USA000668:
Runny nose. Bad cough. Headache. Tired. For 2-3 days.
Patient may have been given 0.2ml instead of 0.3ml of Pfizer COVID19 vaccine based on an error that the technician made when drawing the vaccine up into the syringe.  The patient was contacted and made aware. Based on the CDC and clinical guidelines, re-administration is not recommended since they received > 50% of the dose.
7.5cm x 8.0cm area of induration and erythema with mild tenderness and itching. Developed this after administration on right thigh area.
Top of feet were itching Sunday, August 15.  Thursday, August 19- rash on trunk, arms, back and legs. Benadryl is helping.  Rash comes back after Benadryl wears off
5 1/2 cm area of redness to (Lt) upper arm; 2nd raised, slightly red area, 2 cm x 3 1/2 cm to immediate (Rt) of above injection site; afebrile; s/s began 3/28/13 AM and increased during day.
Employee states she had L arm injection site pain same day of receiving flu vaccine. The next day she had L shoulder stiffness and pain which has still not resolved. Pain rates 3-7 on pain scale-worse with movement. She reports L shoulder to elbow "heaviness" and left arm weakness and decreased range of motion in L shoulder/arm..
received QUADRACEL vaccine instead of DAPTACEL vaccine/No AE; 18 month old patient received a dose of Quadracel/No AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2020SA026250. [same reporter]  This case involves an 18-month-old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered  and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  On 08-Jan-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA, expiry date: 13-Aug-2021] via an intramuscular route at the outer thigh for prophylactic vaccination.  It was a case of actual medication error due to Wrong product administered and Inappropriate age at vaccine administration.  At the time of report, 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 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.