chrisvoncsefalvay/vaers-outcomes huggingface dataset:
erythematous area approx 4" diameter @ inj site;pt advised to use warm compresses & APAP for discomfort;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23  0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice.  The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 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.
I tested positive for COVID-19 on September 22, 2022.  My symptoms began September 19, 2022, with a scratchy throat.  I noticed on the 20th that I was also starting to feel fatigued and have a little dizziness.  I didn?t sleep very well that night.  I would get up to urinate and get a drink of water during the night.  I was experiencing confusion on the nights.  I began coughing up phlegm.  I was severely fatigued during the day and slept most of each day.  I began to have chills on the 21st.  My symptoms began to let up a little bit the 23rd ? the 26th.  I tested positive again on September 30th.  I was feeling better on October 3rd.  I took another test on October 15th I was still positive using a home antigen test.  As of today, my symptoms include dizziness, swollen sinuses, forgetfulness and blood from sinuses when I blow my nose.
Injection in the shoulder, too far up on the arm and along the needle; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Injection in the shoulder, too far up on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 09-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Injection in the shoulder, too far up on the arm). On 09-Mar-2021, PRODUCT ADMINISTRATION ERROR (Injection in the shoulder, too far up on the arm) had resolved. Not applicable          Reporter did not allow further contact
Beginning Friday 4/19/19 sore, arm flu like symptoms, blood pressure elevated to 178mmhg (systolic) 84mmhg (diastolic), heart rate was 96, patient felt like there was three dropped heart beats for every 5 normal heart beats, varying for 3 dropped heart beats for every 10 normal heart beats. This continued in an irregular fashion for all of 4/20. Then on 4/21 30 normal heart beats followed by a few dropped.  Blood pressure was 150 (systolic ) and heart rate was in the high 80s on sunday 4/21/19.  Patient felt all better by monday 4/22 and blood pressure had returned to baseline blood pressure (140/68) heart rate was in the low 70s upon rising prior to meds which is normal for patient.  Patient is a nurse and self monitored blood pressure and heart rate with devices at home.  She did take an extra lisinopril and asprin on saturday 4/20/19.
Developed a fever, 48 hours, post vax. Fever waxed and waned X 5 days. Developed maculopapular rash over trunk and neck on the 4th day, post vax. His underlying Type 1 DM has been difficult to control with blood sugars over 200. Follow-up information as of 11/3/00, pt is doing well and rash is abating.
Patient to receive first dose of 0.5ml, pharmacist administered 0.25 ml booster dose
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Since 01-JAN-2015, improperly stored VARIVAX (Merck) (lot#, expiration date, dose, frequency and route were unknown) were administered to multiple unspecified patients. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
rash on my arm 10 days now almost down to my elbow; itches a tiny bit; rash very aggravated by warmth; sleeping more often; temp slightly raised to 98F; went away overt the weekend and came back in full force yesterday; This spontaneous case was reported by a consumer and describes the occurrence of RASH, PRURITUS, FEELING HOT, SOMNOLENCE, and PYREXIA in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN B 1-6-12 for an unknown indication.    On 26-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 RASH, PRURITUS, FEELING HOT, SOMNOLENCE, PYREXIA, and SYMPTOM RECURRENCE. At the time of the report, RASH, PRURITUS, FEELING HOT, SOMNOLENCE, PYREXIA, and SYMPTOM RECURRENCE outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used cold wash cloths as treatment.   This case was linked to MOD-2021-101140 (Patient Link).
1025 per our policy after a 20 minute wait, injection sites x4 on child were checked. Fine rash noted at DTap, IPV, and MMR injection sites.  Rash was very red and extended over a large area on arms bilt. 1027 Benadryl PO given. Child's skin color pale. 1030 rash climbing up neck on to chin and moving across back and chest.  Epinephrine sq administered per protocol for generalized anaphylaxis reaction. No respiratory distress noted. No coughing. No SOB. Breath sounds clear upon auscultation. P.84 R.36. Health Officer called.  MD covering for health officer called. 1039 Rash decreasing.  Color improved. Child talking without difficulty.1103 Rashes almost completely gone. Skin W/D/P. Breath sounds remain clear. 1110 Child to MD who was covering for health officer.
This spontaneous report as received from a nurse refers to two patients of unknown age. Two patients were vaccinated with the first two doses of RECOMBIVAX HB (dose and lot # were unknown) intramuscularly on 05-APR-2012 and 12-JUL-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if two patients sought medical attention. Additional information has been requested.
dose administered around 16 hours passed puncture time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered around 16 hours passed puncture time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered around 16 hours passed puncture time). On 20-Apr-2021, EXPIRED PRODUCT ADMINISTERED (dose administered around 16 hours passed puncture time) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant details were provided No treatment details were provided
Seizure - lasted about 15 minutes - CEMS and Emergency report states Multiple seizures.Final Diagnosis from emergency was Febrile Seizure- Complex.
Swelling, redness of arm, mostly resolved but have mild continued pain and itching as of 11/21/2021.
5/13/14 father in to clinic stating his son had "shots yesterday". Father stated his son felt fine yesterday and upon arising the next day his son ate a bowl of tomato soup at around 640am.  He stated his son c/o not feeling well.  But wanted to go to school. Father stated he was called from the school around 750am.  That his son had projectile vomiting. After he got home father stated his son had "loose stools with abdominal cramping.  Stated he "looked funny". He noticed a rash to his face, neck, and back, as well as both arms on inside.  He stated it went away quickly and he did c/o itching the the right arm.  The father stated he checked the date on the can of soup and it had expired on June 2012.  The father stated his son is home resting and after a nap stated felt better.  Father requested info if this could be related to vaccines the child received or from the 2 year old expired soup the child consumed. Frequent adverse reactions were discussed with the father and informed the father to follow up with child's PCP if vomiting persists or for further evaluation. Father verbalized understanding.
Patient discharged after (2) inpatient admission. Patient is a 42-year-old female with past medical history of obesity and alcohol abuse and dependence who presented to the hospital with acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Patient was admitted to the hospital on high-flow nasal cannula.  Patient was able to be weaned to room air fairly quickly.  Patient was treated with IV steroids.  CT angiogram of the chest did not reveal any pulmonary embolism or significant respiratory disease.  I believe the patient had a large component of anxiety, as well as alcohol withdrawal.  Patient stated she drinks between 7-824 oz cans of beer every day and had stopped drinking the evening prior to admission.  Patient was treated with Librium to avoid alcohol withdrawal which she responded to well.  Patient was weaned to room air, she was not having any clinical signs of withdrawal. She was then considered stable for discharge home.  Patient will finish 10 day course of Decadron for her COVID pneumonia.  Patient will also be sent home on a Librium taper for a few days.  Patient was in agreement this plan.  Patient was counseled on cessation of alcohol use.  Patient will follow-up with PCP.  Patient discharged home in stable condition.
9 month old patient received a dose of FLUBLOK instead of Fluzone Quadrivalent/ no AE.; 9 month old patient received a dose of FLUBLOK instead of Fluzone Quadrivalent/ no AE.; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a nine-months-old male patient who was administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ518AA, expiry date- 30-Jun-2021) instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] via intramuscular route in the left thigh for prophylactic vaccination on 23-Oct-2020 (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications none.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency on the same day).  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 holders 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.
Received HIB & PCV 7 in left thigh on 07/14/2003.  Woke up this AM left thigh 2 1/4 x 1/5 erythema, hard, hot to touch.
pt recvd vax & 1 1/2-3 days later pt exp nausea, diarrhea, fever, & vomiting; pt had upper & lower GI's which were non-diagnostic;
Mrs requested a walk-in Pfizer-Biontech COVID-19 booster dose on 10/06/2021. She filled out the COVID-19 Immunization consent form and after the administering Pharmacist (myself) reviewed her paperwork, Mrs. was called back into the immunization room. Mrs. and I discussed her career as a nurse and I understood she was aware of side effects for the booster Pfizer Biontech COVID-19 immunization. I asked which arm she preferred the vaccine to be administered in, and she stated she preferred her right arm in case her arm is sore afterward. She mentioned she previously received two injections in her right arm (June 2021: Pneumovax and Shingrix at the same time) and she experienced heaviness/pain/inability to lift her arm, and in case she has pain/soreness again she wanted it in the right arm. I confirmed she was here to receive the Pfizer Biontech COVID immunization, swabbed her arm with alcohol, and administered the vaccine into the right deltoid using the triangle technique. Immediately, the patient yelped and expressed the vaccination was painful. No bleeding occurred at the injection site. She shook/moved her arm around as I was discarding the needle in the sharps container. I massaged the area with a cotton swab and placed a bandage. I asked if she was okay and she mentioned she had nerve pain like this before due to a car accident which resulted in nerve pain in her neck. She denied wanting to wait in the immunization monitoring area, reminded me she was a nurse, and stated she would be in the near area if anything were to happen. She mentioned again she felt pain in her arm, so before she left the immunization room, I raised her sleeve and examined the vaccination site. I confirmed I administered the vaccine in the appropriate area on her deltoid, and she agreed, and again mentioned has a history of nerve issues/nerves being in the wrong area, and she was okay, and she left the pharmacy to shop.  On 10/07/2021 I received a phone call from Mrs. regarding pain in her arm. She stated she could not sleep the night prior and is unable to lift her arm. She feels like the injection hit a nerve and she has "frozen shoulder", but "doesn't believe the needle went into the bursa". She wants to see her PCP regarding her arm and wanted to know if she would be reimbursed. She again stated she has prior neck/nerve issues due to a car accident and previous vaccines administered. She stated she took Naproxen and it did not provide any relief. When asked if she tried applied hot/cold compress she stated she was currently in a hot tub. She stated she was going to try to take a muscle relaxer that she had gotten from an ER doctor after her car accident. After reviewing my employer's policy/procedures with management, I followed up with the patient and recommended she follows up with her PCP, as it is outside my scope of practice to diagnose and she has tried to alleviate the pain with my suggestions without success. She agreed and understood and is following up with her PCP. I expressed my apologies, and wished her well-being.
SHORTNESS OF BREATH, CHEST PAIN, RAPID HEART BEAT. 12/15/08 MR received for DOS 11/13-14/2008 with DX:  Chest pain. Pt presented with several week hx of dizziness and h/a, now with substernal chest pain which radiates into the neck, associated with palpitations, SOB and nausea.  VS, EKG, O2 sats, and cardiac enzymes all WNL. Sx improved with nitro. Admitted for further w/u which was (-). 1/28/2010 Intermitten episodes of rapid heart beat.
Headache and fever/sweating that lasted from 10:00 PM on April 1st to 10:00 AM on April 2nd.
After the 2nd dose vaccine,  I am pregnant and go every week for check up since I am high risk.  On 4/7/2021, protein was found in my urine which is a indicator for preeclampsia /high blood pressure. I would go in for doctor's visit weekly to check my bp reading.   My bp readings were 150/90 range and I had to be induced at 37 weeks.  The baby is healthy but had a little jaundice at birth. I was put on bp medication labetatol for 3 weeks.   After the deliver, I had 4 episodes of bleeding and hemorrhage.  I was found to have retained placenta and had surgery on 5/2021 for that and was hospitalized for 3 days (Hospital).
Chills and flu like symptoms started at 6pm, tachycardia lasting approximately 2 hours started at 1am, followed by severe nausea and fever that lasted until medicated in ER.  Flu like symptoms - malaise, headache, weakness -  persisted through12/12/2021.  2cm red rash at injection site painful to touch persists currently.
Parotid  Gland/Lymph Node Swelling. Significant swelling on left side. Unable to eat due to swelling for two days.
Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic sx
Patient's spouse called. He states that the patient has redness going down her arm. It is the first time she has received the high dose (even though she is 70). I recommened benadryl and tylenol/ibuprofen.
FIRST VACCINE 1/25/21, HERE FOR SECOND VACCINE/ PT AWARE OUT OF RECOMMENDED TIMEFRAME FOR VACCINATION. VACCINE ADMINISTERED.
Initial signs of severe shaking which developed into a under the skin rash covering both legs from groin to feet & also on one hand. No itching was experienced with this rash. Pt states that as of 9-12-11 it is completely gone.
localized redness, hot & inflammed site of infect (rt arm); no fever; itching & burning;
Fever, chills, headache, body ache, lack of apetite, impaired sense of smell and taste, extremely sore arm, significant fatigue.  It's been more than one week, arm is still sore and still suffer from significant fatigue and overall lower feeling of wellbeing.  Also sense of taste and smell still impaired.
Red area below injection site. Large in diameter and round. Hot to touch.  Hard to touch. non painful. itchy. lasted 2 weeks
Received influenza and Hep A vaccine 9/12/2012. Client was fine that day. 9/14/2012 900 pm complained of back pain severe - took TYLENOL - better L - eased up - still hurt Sat morning 9/15/2012 - complained of backache upper (L) quadrant started feeling dizzy 100 pm vomited 9/17 and 9/18 headache nausea and dizziness comes and goes.
DVT to lower extremity diagnosed 7/15/2021.  Also, fractured femur to same side 6/13/2021.
This serious spontaneous case, initially received on 20-Jun-2018, reported by other health professional and concerns an elderly male patient. The patient's historical condition included sickness (gets sick the same time every year, as reported). On an unspecified date in 2016, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture: not reported). On an unspecified date, after the administration of vaccine, the patient experienced serious flu. At the time of this report, the outcome of the event was not reported.
Approximately one week after receiving the vaccine my upper arm started to itch quite a bit. Now, although it doesn't itch too much, the upper arm is covered in what appears to be a red rash.
Left arm red; lemon size. Few other areas. Slight warmth to touch. Patient booked with doctor.
child recv vax & mom devel a mild rash & devel varicella pneumonia, hosp & became hypoxic;pt was d/c p/approx 1wk was hosp & doing well;
TIRED, FATIGUED SLIGHT SORE ARM AT INJECTION SITE RESOLVED 1/31/2021.  Narrative:
10 days after vaccine (sunday 1/24/2021), woke up with some small red bumps on joints of fingers, palm, and back of right hand, progressed more throughout day. on monday morning 1/25/2021, woke up to left hand having small bumps in those locations and right hand's bumps progressed to be bigger. there was also some small bumps on one toe of right foot. next day, they became bigger and blister-like appearance. some blisters that were close together merged. noticed one on left elbow and three on right elbow. it's still been progessing to be bigger and more painful.
11:10 - *Safety Officer called by vaccinator lead to incident with vaccinator. *Client was here for Moderna 2nd dose, was accidentally given Pfizer by vaccinator. *Client was given appropriate identification slips (Moderna, 2nd dose) but assigned to Pfizer table by line flow. *Vaccinator did not verbally confirm vaccine type with client prior to vaccinating. *Vaccinator failed to check prior vaccine logged into system.
Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There was no temperature data for that storage unit.  Treatment information was not reported.